Minitran 5, Minitran 10, Minitran 15

Minitran

Glyceril trinitrate

What You Need To Know About Minitran Patches

Please read this carefully before you start to use your medication. This leaflet only provides a summary of the information available

on your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

Your medication is called a Minitran patch

It consists of a clear patch containing glyceryl trinitrate which is applied to the skin. The clear film consists of low density

polyethylene and silicone-coated polyester. The patch also contains the following ingredients: isooctyl acrylate/acrylamide copolymer,

ethyl oleate, glyceryl monolaurate. There are three strengths available ; your doctor will have chosen the strength which best suits your

condition.

A Minitran 5 patch contains 18mg of glyceryl trinitrate. The average amount delivered in 24 hours is 5mg.

A Minitran 10 patch contains 36mg of glyceryl trinitrate. The average amount delivered in 24 hours is 10mg.

A Minitran 15 patch contains 54mg of glyceryl trinitrate. The average amount delivered in 24 hours is 15mg.

Each pack (all strengths) contains 30 patches.

Who produces your medication

Name and address of manufacturer:

3M Santé

Zone industrielle

Avenue du 11 Novembre

F-45312 Pithiviers Cedex

France

3M Health Care,

Derby Road Loughborough

Leicestershire

LE11 5SF

United Kingdom

Batch numbers Fxxxxxx are batch released at 3M Santé, Batch numbers Uxxxxxx are batch released at 3M Health Care.

Name and address of product licence holder:

Meda Pharmaceuticals Ltd.

Skyway House

Parsonage Road

Takeley

Bishop's Stortford

CM22 6PU

UK

What your medication is prescribed for

Glyceryl trinitrate is one of a group of medicines called vasodilators which widen blood vessels and improve blood flow to the tissues

and muscle (including heart muscle). When you apply a patch to your skin the glyceryl trinitrate passes slowly through your skin and into

your blood stream.

Minitran patches may be used to help prevent attacks of angina (chest pain). They reduce the need for under-the-tongue glyceryl

trinitrate tablets or spray.

Minitran 5 patches may also be used to improve blood flow to the site of an intravenous cannula. In patients receiving injections or

infusions via their arm or leg veins, they help to keep the veins open.

Important points to note before using Minitran patches

If medication for erectile dysfunction, such as sildenafil (Viagra), tadalafil (Cialis) or vardenafil (Levitra), is being used by

patients taking nitrate preparations such as Minitran a severe and possibly dangerous fall in blood pressure may occur. This would result

in collapse, unconsciousness, and could be fatal. You should not take Viagra, Cialis or Levitra whilst using Minitran.

If you are pregnant, think you might be pregnant or are trying to become pregnant, or are taking other medications, please tell your

doctor before using Minitran patch.

You should not use these patches if you are known to be allergic to glyceryl trinitrate, or other medicines containing nitrates.

These patches should not be used by patients with glaucoma, low blood pressure, severe anaemia, aortic or mitral stenosis (heart valve

disease), pericarditis (inflammation of the lining of the heart) or raised intracranial pressure (high pressure within the skull).

Please tell your doctor if you suffer from any heart or lung conditions.

Minitran patches may be used to help prevent angina attacks. If you do have an attack of chest pain you should use under-the-tongue

glyceryl trinitrate tablets or a similar medication as instructed by your doctor.

Glyceryl trinitrate may lower your blood pressure and make you feel dizzy or light-headed, particularly when changing position

suddenly. You should be especially careful if you are driving, operating machinery or drinking alcohol.

Minitran patches are not recommended for use in children.

If you see any other doctor or dentist, please tell them that you are using Minitran patch.

What to do if you are taking other medicines

Please tell your doctor if you are receiving any of the following medicines:

• vasodilators (medicines used, for example, for angina (e.g. nitrates) or to reduce blood pressure (e.g. hydralazine,
  
  minoxidil).


• calcium antagonists or beta-blockers (medicines used, for example, for angina, heart arrhythmia's (irregular heart beat) or to
  
  reduce blood pressure).


• ACE inhibitors (medicines used, for example, for heart failure or to reduce blood pressure).


• neuroleptics (medicines for psychiatric illness).


• diuretics (water tablets).


• anti-hypertensives (medicines for reducing blood pressure).


• tricyclic anti-depressants.


• dihydroergotamine.


• aspirin or other non-steroidal anti-inflammatory drugs.

Your doctor or pharmacist will advise you about these medicines.

Use of Minitran patches during pregnancy and breast feeding

Glyceryl trinitrate should not normally be used if you are pregnant or if you are breast feeding, unless your doctor tells you to.

When to apply Minitran patches

For angina patients.

The usual starting dose is one Minitran 5 patch each day. Your doctor will have chosen the strength which best suits your condition and

will advise you on how long to wear the patch each day. Your patch may be worn for either 24 hours or for only part of each day. A new

patch must be applied at approximately the same time each day. Please follow your doctor's instructions.

If you forget to use a new patch, apply it as soon as you remember.

If you are not sure when to use your patch please ask your doctor or pharmacist.

For patients with an intravenous cannula.

Usually your doctor or nurse will apply one Minitran 5 patch next to your intravenous cannula. The patch will be left on for 24 hours

and then changed. It will be removed once your intravenous treatment is stopped.

Minitran patches should not be used by children.

Where to apply Minitran patches

For angina patients.

You can apply the patch to the chest, shoulders or upper arm. You should apply the patch to a hairless area of the skin to ensure that

good contact is made.

Do not apply the patch to broken skin such as cuts or grazes.

Use a different area of skin every time you apply a patch. It is best to let a few days pass before putting another patch on the same

area of skin.

The skin should be clean and dry before applying a patch. This is to make sure that the patch sticks properly.

Do not use dusting powder or any greasy substance e.g. ointments or creams on the skin before applying a patch.

A Minitran patch sticks well to the skin during showering, bathing and swimming.

For patients with an intravenous cannula.

Your doctor or nurse will apply the patch next to your intravenous cannula.

How to apply a Minitran patch

• 
  1. Start at notched corner. Tear pouch along dotted line. Remove patch from pouch.

• 
  2. Bend patch so that the oval patterned liner notch pops up ; remove tab and discard liner.

• 
  3. Apply sticky side of patch to upper arm or chest. Remove and discard oval patterned liner.

• 
  4. Press patch firmly in place.

In the unlikely event of a patch not sticking or falling off, simply apply a new patch on a different area of the skin.

Do not re-apply a patch once it has been removed from the skin.

What to do in case of accidental swallowing or application of too many patches

Please contact your nearest hospital casualty department, or tell your doctor, immediately.

What might happen when you are using Minitran patches

Like most medicines, glyceryl trinitrate may cause some side-effects.

When you first use Minitran patches you may notice some side-effects. These include headache, hypotension (low blood pressure),

tachycardia (fast heart rate), fainting, palpitations (fast heart beat), hot flushes and dizziness.

Sometimes your skin may become red and/or itchy where you have used the patch. This will usually disappear after you have removed the

patch. Please make sure that you use a different area of skin every time you apply a patch.

Other side-effects which may occur include feeling or being sick.

As with other skin preparations, use of Minitran patches over a long period of time may result in your skin becoming sensitive to this

product. If this happens to you, please consult your doctor.

If you notice any other side-effects, please tell your doctor or pharmacist.

If any side-effects continue for more than a few days, please tell your doctor.

Storing your medication

Keep Minitran patches in a safe place where children cannot reach them.

Store the patches below 25ºC in a dry place and out of direct sunlight.

Do not use this product after the expiry date printed on the original container.

If your doctor decides to stop treatment, return any unused patches to your pharmacist.

Date of update of leaflet : December 2009

REMEMBER: This medication is only for YOU. Never give it to others. It may harm them even if their symptoms seem to be

the same as yours.

The information provides a summary of the information available on Minitran patches.

Further information is available from your doctor or pharmacist.

Minitran is a trademark of MEDA AB.

The Triangle Logo on the packaging is a trademark of 3M and is used under license.

562l97M2110UK00

Zortress

Generic Name: everolimus (Oral route)

e-ver-OH-li-mus

Oral route(Tablet)

Zortress(R): Increased susceptibility to infection and the possible development of lymphoma and other malignancies may result from immunosuppression. Only physicians experienced in immunosuppressive therapy and management of transplant patients should prescribe everolimus. Reduced doses of cyclosporine should be used in combination with everolimus in order to reduce renal dysfunction and monitoring of cyclosporine and everolimus whole blood trough concentrations is recommended. The use of everolimus has resulted an increase risk of graft loss within the first 30 days post-transplantation .

Commonly used brand name(s)

In the U.S.

• Afinitor


• Zortress

Available Dosage Forms:

• Tablet

Therapeutic Class: Immune Suppressant

Uses For Zortress

Everolimus is used to treat advanced (late-stage) kidney cancer in patients who have already been treated with other medicines (e.g., sorafenib, sunitinib) that did not work well.

Everolimus belongs to the group of medicines known as antineoplastics or cancer medicines. It works by interfering with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected, other unwanted effects will also occur. Some of these may be serious and must be reported to your doctor, while others may cause concern but may not be serious.

Everolimus is also used together with other medicines to lower the body's natural immunity in patients who receive kidney transplants. When a patient receives an organ transplant, the body's white blood cells will try to get rid of (reject) the transplanted organ. Everolimus works to suppress the immune system and prevents the white blood cells from getting rid of the transplanted organ.

This medicine is also used to treat subependymal giant cell astrocytoma (SEGA), a brain tumor seen in patients with an inherited condition called tuberous sclerosis (TS).

Everolimus is also used to treat a type of pancreatic cancer called pancreatic neuroendocrine tumor (PNET), that has advanced, metastatic (cancer that has spread), or cannot be treated with surgery.

Before you begin treatment with everolimus, you and your doctor should talk about the benefits this medicine will do as well as the risks of using it.

This medicine is available only with your doctor's prescription.

Before Using Zortress

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of everolimus in the pediatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of everolimus to treat SEGA in children. However, safety and efficacy have not been established in children younger than 3 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of everolimus in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine Type 4, Live


• Adenovirus Vaccine Type 7, Live


• Amprenavir


• Aprepitant


• Atazanavir


• Bacillus of Calmette and Guerin Vaccine, Live


• Carbamazepine


• Clarithromycin


• Cyclosporine


• Diltiazem


• Efavirenz


• Erythromycin


• Fluconazole


• Fosamprenavir


• Indinavir


• Influenza Virus Vaccine, Live


• Itraconazole


• Ketoconazole


• Lovastatin


• Measles Virus Vaccine, Live


• Mumps Virus Vaccine, Live


• Nefazodone


• Nelfinavir


• Nicardipine


• Phenobarbital


• Phenytoin


• Poliovirus Vaccine, Live


• Posaconazole


• Rifabutin


• Rifampin


• Rifapentine


• Ritonavir


• Rotavirus Vaccine, Live


• Rubella Virus Vaccine, Live


• Saquinavir


• Simvastatin


• Smallpox Vaccine


• St John's Wort


• Telithromycin


• Typhoid Vaccine


• Varicella Virus Vaccine


• Verapamil


• Voriconazole


• Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood clotting problems or


• Diabetes or


• Hepatitis B infection, history of or


• Hyperglycemia (high sugar in the blood) or


• Hyperlipidemia (high cholesterol in the blood) or


• Hypertriglyceridemia (high fat in the blood) or


• Hypoxia (low oxygen in the blood) or


• Lung or breathing problems or


• Lymphoma (cancer of the lymph glands) or


• Proteinuria (protein in the urine) or


• Skin cancer—Use with caution. May make these conditions worse.

• Galactose intolerance or


• Glucose-galactose malabsorption (a rare genetic disorder) or


• Lactose intolerance or


• Lapp lactase deficiency (a rare genetic disorder) or


• Liver disease, severe—Should not be used in patients with these conditions.

• Infection (e.g., bacteria, fungus, virus, or protozoa)—May decrease your body's ability to fight infection.

• Liver disease, mild to moderate—Use with caution. You may require a smaller dose. Talk with you doctor if you have concerns about this.

Proper Use of everolimus

This section provides information on the proper use of a number of products that contain everolimus. It may not be specific to Zortress. Please read with care.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

If you have a kidney transplant, you might have to take this medicine for the rest of your life to prevent rejection of the kidney. Do not change your dose or stop taking this medicine without first checking with your doctor.

This medicine comes with a Medication Guide and a patient information leaflet. Read the information carefully and make sure you understand it before taking this medicine. If you have any questions, talk to your doctor.

Everolimus works best when there is a constant amount in the blood. You can keep the amount constant by taking the dose at the same time each day.

You may take this medicine with or without food. However, you should take it the same way (with or without food) each time.

Swallow the tablet whole with a glass of water. Do not break, crush, or chew it. If you accidentally break or crush the tablet, wash your hands with water right away.

If you cannot swallow the tablets, you may dissolve the tablets in a glass (30 mL) of water. Gently stir it before drinking the medicine. Rinse the glass with the same amount of water and swallow it immediately.

Grapefruits and grapefruit juice may increase the effects of everolimus by increasing the amount in the body. You should not eat grapefruit or drink grapefruit juice while you are taking this medicine.

If you have a kidney transplant, everolimus will be given together with another medicine that suppresses the immune system called cyclosporine. It should be taken at the same time with the cyclosporine capsules.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  
  • For advanced kidney cancer:
    
    • Adults—10 milligrams (mg) once a day. Your doctor may adjust your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For brain tumor or subependymal giant cell astrocytoma (SEGA):
    
    • Adults and children 3 years of age and older—Dose is based on body size and must be determined by your doctor. The starting dose is 2.5 to 7.5 milligrams (mg) once a day. Your doctor may adjust your dose if needed.
    
    
    • Children younger than 3 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  • To prevent kidney transplant rejection:
    
    • Adults—At first, 0.75 milligram (mg) two times per day, spaced 12 hours apart. Your doctor may adjust your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For advanced pancreatic cancer or pancreatic neuroendocrine tumor (PNET):
    
    • Adults—10 milligrams (mg) once a day. Your doctor may adjust your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of this medicine, you may still take it up to 6 hours after the time you normally take it. However, if it is more than 6 hours, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Protect the medicine from direct light. Keep your medicine in the original package until you are ready to use it.

Precautions While Using Zortress

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control while you are using this medicine and for at least 8 weeks after stopping treatment. If you think you have become pregnant while using the medicine, tell your doctor right away.

If you are male and plan to have children, talk with your doctor before using this medicine. This medicine may decrease fertility in men.

This medicine may cause a serious lung problem called noninfectious pneumonitis. Stop using this medicine and check with your doctor right away if you have chest pain, chills, a cough, fever, shortness of breath, or troubled breathing.

Check with your doctor right away if you develop the following symptoms while using this medicine: agitation; coma; confusion; decreased urine output; depression; dizziness; headache; hostility; irritability; lethargy; muscle twitching; nausea; rapid weight gain; seizures; stupor; swelling of the face, ankles, or hands; or unusual tiredness or weakness. These may be symptoms of a serious kidney problem.

While you are being treated with everolimus, and after you stop taking it, it is important to talk to your doctor about the immunizations (vaccines) you should receive. Do not get any vaccine without your doctor's approval. Everolimus may lower your body's resistance and there is a chance you might get the infection the vaccine is meant to prevent. In addition, other persons living in your household should not receive certain vaccines since there is a chance they could pass the infection on to you. Talk to your doctor if you have questions about this.

Everolimus can temporarily lower the number of white blood cells in your blood, which increases the chance of getting an infection and prevents you from healing correctly after an injury. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.


• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.


• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.


• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.


• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.


• Avoid contact sports or other situations where bruising or injury could occur.

This medicine may increase your risk for getting skin cancer. When you begin taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.


• Wear protective clothing, including a hat, and sunglasses.


• Apply a sunblock product that has a skin protection factor (SPF) of at least 15, or higher if you have a fair complexion.


• Apply a sunblock lipstick that has an SPF of at least 15 to protect your lips.


• Do not use sunlamps, tanning beds, or tanning booths.


• If you have any questions about this, check with your doctor.

Everolimus may cause a serious type of allergic reaction called angioedema. This may occur more often when it is used with certain heart and blood pressure medicines called ACE inhibitors (e.g., captopril [Capoten®], enalapril [Vasotec®], fosinopril [Monopril®], quinapril [Accupril®], or ramipril [Altace®]). Stop taking this medicine and tell your doctor right away if you have a rash; itching; a large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs; trouble with breathing; or chest tightness while you are using this medicine.

If you have a kidney transplant, this medicine may increase your risk for having a blood clot in the new kidney. This usually occurs within the first 30 days after the kidney transplant. Check with your doctor right away if you are making less urine, or if you have pain in your groin, lower back, side, or stomach; dark-colored urine; a fever; or nausea or vomiting.

If you are taking this medicine after a kidney transplant, it may increase your risk for developing a rare and serious virus infection called BK virus-associated nephropathy (BKVAN). The BK virus may affect how your kidneys work and cause a transplanted kidney to fail. Check with your doctor right away if you are having more than one of these symptoms: bloody urine; a decreased frequency or amount of urine; increased thirst; loss of appetite; lower back or side pain; nausea; swelling of the face, fingers, or lower legs; trouble with breathing; unusual tiredness or weakness; vomiting; or weight gain.

Everolimus may cause mouth ulcers and sores in some patients. Tell your doctor right away if you have pain, discomfort, or open sores in your mouth while you are using this medicine. You may use a special mouthwash or mouth gel to treat these ulcers. Ask your doctor what type of products to use.

This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.

Zortress Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Bloating or swelling of the face, arms, hands, lower legs, or feet


• bloody nose


• chest pain


• cough or hoarseness


• cracked lips


• decreased weight


• diarrhea


• difficult or labored breathing


• difficulty with swallowing


• fever or chills


• general feeling of discomfort or illness


• lower back or side pain


• painful or difficult urination


• rapid weight gain


• shortness of breath


• sores, ulcers, or white spots on the lips, tongue, or inside the mouth


• swelling or inflammation of the mouth


• thickening of bronchial secretions


• tightness in the chest


• tingling of the hands or feet


• troubled with breathing


• unusual weight gain or loss


• wheezing

Less common

• Bleeding after defecation


• bleeding gums


• bloody urine


• blurred vision


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• coughing up blood


• decreased frequency or amount of urine


• decreased urine output


• dilated neck veins


• dry mouth


• extreme fatigue


• fast, pounding, or irregular heartbeat or pulse


• flushed, dry skin


• fruit-like breath odor


• headache


• increased blood pressure


• increased hunger


• increased menstrual flow or vaginal bleeding


• increased thirst


• increased urination


• irregular breathing


• loss of appetite


• loss of consciousness


• nausea


• nervousness


• nosebleeds


• paralysis


• pounding in the ears


• prolonged bleeding from cuts


• red or black, tarry stools


• red or dark brown urine


• runny nose


• slow heartbeat


• sore throat


• stomachache


• sweating


• uncomfortable swelling around the anus


• unexplained weight loss


• unusual tiredness or weakness


• vomiting


• weight gain

Incidence not known

• Agitation


• coma


• confusion


• depression


• dizziness


• hostility


• irritability


• lethargy


• muscle twitching


• rapid weight gain


• seizures


• stupor


• swelling of the face, ankles, or hands

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abdominal or stomach pain


• change in taste


• dry skin


• itching skin


• lack or loss of strength


• loss of taste


• pain in the arms or legs


• rash


• sleeplessness


• trouble with sleeping


• unable to sleep

Less common

• Back pain


• blistering, peeling, redness, or swelling of the palms, hands, or bottoms of the feet


• bumps on the skin


• burning, dry, or itching eyes


• discharge or excessive tearing


• discoloration of the fingernails or toenails


• excess air or gas in the stomach or intestines


• flushing or redness of the skin


• full feeling


• jaw pain


• numbness, pain, tingling, or unusual sensations in the palms of the hands or bottoms of the feet


• passing gas


• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid


• sleepiness or unusual drowsiness


• unusually warm skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Zortress side effects (in more detail)

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More Zortress resources

• Zortress Side Effects (in more detail)
• Zortress Dosage
• Zortress Use in Pregnancy & Breastfeeding
• Zortress Drug Interactions
• Zortress Support Group
• 0 Reviews for Zortress - Add your own review/rating

• Zortress Prescribing Information (FDA)


• Zortress MedFacts Consumer Leaflet (Wolters Kluwer)


• Zortress Consumer Overview


• Everolimus Professional Patient Advice (Wolters Kluwer)


• Afinitor Prescribing Information (FDA)


• Afinitor Monograph (AHFS DI)


• Afinitor Consumer Overview


• Afinitor MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Zortress with other medications

• Brain Tumor
• Organ Transplant, Rejection Prophylaxis

Norimin Tablets

Norimin

Please read this leaflet carefully before you start to take Norimin.

This leaflet gives you some information about how to take your pills. The leaflet can’t tell you everything about Norimin. So if you have any questions or are not sure about anything, ask your doctor, clinic or pharmacist.

Some information about Norimin

Norimin contains two hormones - a progestogen hormone called norethisterone and an oestrogen hormone called ethinylestradiol. These two hormones act together to prevent pregnancy.

What is in Norimin?

Each Norimin pill contains:

• 1 milligram of norethisterone and 35 micrograms of ethinylestradiol (the ‘active’ ingredients); and


• maize starch, polyvidone, magnesium stearate and lactose (the ‘inactive’ ingredients).

Norimin tablets are white and have the word ‘SEARLE’ on one side and ‘BX’ on the other side. They are packed in blister strips and come in packs of 63 pills.

One of the active ingredients in this medicine is ethinylestradiol. This is the new name for ethinyloestradiol. The ingredient itself has not changed.

Who supplies Norimin?

Norimin is supplied by:

PHARMACIA

Pharmacia Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

UK

Who makes Norimin?

Norimin is made by:

Searle Division of Monsanto plc

Morpeth

Northumberland

NE61 3YA

United Kingdom

What is Norimin for?

Norimin is a combined oral contraceptive pill you take to prevent you becoming pregnant.

Before you take Norimin

Norimin may not be suitable for all women. Before you take Norimin, make sure your doctor knows if you have ever had any of the following conditions.

• Blood clots in the legs, blood clots in varicose veins, the lungs, the brain or elsewhere (coronary and cerebral thrombotic disorders).


• A heart attack, angina or a stroke.


• High levels of fats in your blood (hyperlipidaemia or other disorders of body fats).


• Cancer of the breast, cervix, vagina or womb (mammary or endometrial cancer).


• If during pregnancy you had:
  
  
  • pruritus (itching of the whole body);
  • jaundice, for which your doctor could not find the cause; or
  • pemphigoid gestationis (a rash previously known as herpes gestationis).


• Certain types of jaundice (Dubin-Johnson or Rotor syndrome).


• Bad migraines.


• Vaginal bleeding, for which your doctor could not find the cause.


• Liver tumours.


• Liver disease.

If you are pregnant or are trying to get pregnant, you should not take the pill.

What I should know before taking Norimin

If you had irregular periods or no periods in the past, you may stop ovulating (releasing eggs from your ovaries). You may also stop having normal periods after you have stopped using the combined pill. If you have any of these conditions you may find it better to use a different contraceptive method. You should ask your doctor or clinic for advice.

It is possible that sometimes certain long-term diseases may get worse while you are taking the pill. See the section, ‘Reasons for careful medical checks’.

The pill and thrombosis

Some evidence suggests that women who take the pill are more likely to develop various blood circulation disorders than women who don’t take the pill.

A thrombosis is a blood clot. A thrombosis can develop in veins or in arteries and can cause a blockage. The chance of a thrombosis forming in women taking the pill and women not taking the pill is rare. When blood clots form in arteries they can cause chest pain (angina), strokes (blood clots in or bleeding from the blood vessels in the brain) and heart attacks.

If blood clots form in veins, they can often be treated with no long term danger. On rare occasions a piece of thrombosis may break off. It can travel to the lungs to cause a condition called pulmonary embolism. Therefore in rare cases a thrombosis can cause serious permanent disability and could even be fatal.

It is important to note that a thrombosis can form in people who are not taking the pill as well as those who are taking it. The risk is higher in women who take the pill than in women who don’t take the pill, but is not as high as the risk during pregnancy. The excess risk of thrombosis is highest during the first year a woman ever uses a combined oral contraceptive pill.

For healthy non-pregnant women:

the chance of having a blood clot is about 5 in 100,000 each year.

For women taking the pill containing either levongestrel or norethisterone (a second generation pill):

the chance of having a blood clot is about 15 in 100,000 each year.

For women taking the pill containing desogestrel or gestodene (a third generation pill):

the chance of having a blood clot is about 25 in 100,000 each year.

For women who are pregnant:

the chance of having a blood clot is about 60 in 100,000 pregnancies.

The risk of heart attacks and strokes for women who use the combined pill increases with age and smoking. Other conditions also increase the risk of blood clots in the arteries. These include being greatly overweight, having diseased arteries (atherosclerosis), high blood pressure during pregnancy (pre-eclamptic toxaemia), high blood levels of cholesterol, and diabetes. If you have any of these conditions, you should check with your doctor or clinic to see if the pill is suitable for you. Smokers over 35 are usually told to stop taking these pills.

Breast Cancer

Every woman is at risk of breast cancer whether or not she takes the pill. Breast cancer is rare under the age of 40 years, but the risk increases as a woman gets older.

Breast cancer has been found slightly more often in women who take the pill than in women of the same age who do not take the pill. If women stop taking the pill, this reduces the risk so that 10 years after stopping the pill, the risk of finding breast cancer is the same as for women who have never taken the pill. Breast cancer seems less likely to have spread when found in women who take the pill than in women who do not take the pill.

It is not certain whether the pill causes the increased risk of breast cancer. It may be that women taking the pill are examined more often, so that breast cancer is noticed earlier. The risk of finding breast cancer is not affected by how long a woman takes the pill but by the age at which she stops. This is because the risk of breast cancer strongly increases as a woman gets older.

The chart below shows the background chances of breast cancer at various ages for 10,000 women who have never taken the pill (black bars) and for 10,000 women whilst taking the pill and during the 10 years after stopping it (grey bars). The small extra risk of finding breast cancer can be seen for each age group. This small possible additional risk in women who take the pill has to be balanced against the fact that the pill is a very effective contraceptive and it helps prevent cancer of the womb or ovary.

Estimated number of breast cancers in 10,000 women who took the pill for 5 years then stopped, or who never took the pill

Taking any medicine carries some risk. You can use the information in this leaflet, and the advice your doctor or clinic has given you to weigh up the risks and benefits of taking the pill. Don’t be embarrassed, ask as many questions as you need to.

Reasons for careful medical checks

Your doctor or clinic will give you regular check-ups while you are taking Norimin. Your blood pressure will be checked before you start the pill and then at regular intervals whilst you are on the pill. If your blood pressure goes up, your doctor may tell you to stop taking Norimin. They may also check your breasts and reproductive organs, including taking a cervical smear at regular intervals, if this is considered necessary by the doctor.

Tell your doctor if you have any of the following conditions.

• Migraine, asthma, epilepsy, heart or kidney disease, high blood pressure (hypertension) or you have a previous history of these conditions. This is because the pill may cause fluid retention which can make these conditions worse.


• Diabetes.

If you have any of the following conditions and they appear to get worse or they appear for the first time, your doctor or clinic may tell you to stop taking the pill.

• High blood pressure.


• Diabetes.


• Multiple sclerosis


• Tetany (muscle twitches)


• Breast problems


• Varicose veins.


• Migraine.


• Epilepsy.


• Kidney disease.


• Severe depression.


• Fibroids in your uterus.


• Gallstones.


• Liver problems.


• Sickle-cell anaemia.


• Diseases of the heart and blood vessels (cardiovascular disease).


• Otosclerosis (an inherited form of deafness).


• Porphyria (a metabolic disease).


• Chloasma (brown patches on your skin which can happen during pregnancy but may not fade completely).


• Any disease that is likely to get worse during pregnancy.

If you use any combined pill you may retain fluid which can make it uncomfortable to wear contact lenses.

Other medicines and Norimin

Several medicines can interfere with the way the pill works. These include some drugs that treat epilepsy, arthritis, tuberculosis and some antibiotics or sedatives. Other less common medicines may also have this effect. You may have to use another contraceptive method, such as a condom, while you are taking these medicines and during the next seven days. In some situations, your doctor or clinic may tell you to use extra precautions for longer. If while using these extra precautions you run beyond the end of the blister strip, start the next blister strip without a break. Always mention you are on the pill if a doctor, dentist or hospital prescribes you any medicine.

The herbal remedy St John’s wort (Hypericum perforatum) should not be taken at the same time as this medicine. If you already take a St John’s wort preparation, stop taking the St John’s wort and mention it to your doctor.

Blood tests

The pill may affect the results of certain blood tests, so tell your doctor that you are on the pill if you need any blood tests.

How to take Norimin

Starting your first blister strip

• Take the first pill on your first day of bleeding. This is the day when your period starts. If you are not having periods, ask your doctor or clinic when you should start taking your pill.


• Take the pill marked with the correct day of the week.


• You will be protected at once as long as you take a pill every day.


• You can take the pill at a time that suits you, but you must take it at about the same time every day.


• Take a pill every day until you finish a blister strip.


• If you cannot start the pill on the first day of your period you may start to take it on any day up to the fifth day. However, if you do this, you may not be protected for the first seven days, so you should use another method of contraception such as a condom during those days.

Starting the next blister strip

• Once you have finished all 21 pills, stop for seven days. You will probably bleed during some or all of these seven days.


• Then, start the blister strip. Do this whether or not you are still bleeding. You will always start the blister strip on the same day of the week.


• You are protected during the seven day break, but only if you start the next blister strip on time. The first pill in your blister strip is the worst pill of all to miss or take late.

What do I do if I have a stomach upset or I am sick?

Norimin may not work if you are sick or have severe diarrhoea. You should carry on taking your pills as normal, but use a condom while you are ill and for the next seven days. If these seven days run beyond the end of the blister strip, start the next blister strip without a break.

What do I do if I miss a period?

If you have taken all your pills properly, it is very unlikely that you are pregnant. Take your next blister strip as normal. If you have not taken them correctly, see your doctor or clinic at once. You should do the same if you miss a second period. If you do get pregnant whilst you are taking this type of pill there may be a very small increased risk that your baby will have an abnormality. Ask your doctor to discuss this risk with you.

What do I do if my periods are different?

This is normal when you start the pill. You will probably have less bleeding. You may also have a little bleeding while you are taking the pills (this is called ‘break-through bleeding’). If this happens, do not stop taking your pills. This should stop within two or three months. If the bleeding is heavy, do not stop taking the pill but talk to your doctor or clinic. If your periods seem different, do not stop taking the pills and just mention it to your doctor or clinic at your next visit.

What do I do if I am having an operation?

If you are planning to have an operation, which will mean lying in bed for more than a whole day, or any operation on your legs, it is best that you stop taking this type of pill at least four weeks before your operation. This does not apply to some minor operations. You can usually start to take the pill again two weeks after the operation. Talk to your doctor or clinic about another method of contraception you can use until the operation. For example, you may use a progestogen-only pill.

If you are having treatment for varicose veins, stop taking the combined pill four weeks before your treatment and stay off it until 3 months after your last treatment.

What do I do if I have an accident or I am ill?

If you have an accident or illness which means that you will have to stay in bed, it is best to stop taking the pill until you are active again.

Smoking

Smoking increases the risks to your health and some of the risks of taking the pill. It is always best to stop smoking. If you do smoke, your doctor or clinic may tell you to change your method of contraception when you are 35 or over.

What do I do if I want a baby?

If you want to have a baby it is best to wait until you have stopped taking the pill for three months or at least until your regular periods have returned. You can always use another contraceptive method such as a condom. Only rarely do regular periods take some time to return. Once you have had one period, it is easier to work out when your baby is due. However, if you do get pregnant as soon as you stop taking Norimin, this is not harmful.

What do I do if I am changing pill brands?

Take the first pill of your new blister strip on the day immediately after you have finished your old blister strip. Your period will usually be delayed until the new blister strip is finished, but you may have some break-through bleeding during the first few days of the new blister strip. This is quite normal and you will still be protected against pregnancy. If you do have a break, ask your doctor or clinic whether you need an extra contraceptive method such as a condom.

What do I do if I have just had a baby?

• If you are breast feeding, you should not take the combined pill. This is because the oestrogen in the pill may reduce the amount of milk you produce. You should be able to take the progestogen-only pill instead. Ask your doctor or clinic for advice.


• If you are not breast feeding, you may start taking the pill 21 days after your baby is born. This will protect you immediately. If you start later than this, you may not be protected until you have taken the pill for seven days.

What do I do if I have just had a miscarriage or abortion?

You may be able to start taking the pill immediately. If you can, you will be protected straight away. Ask your doctor or clinic if you should do so.

Overdose

If you take more than the recommended number of pills, or if you discover someone has taken a lot of pills, contact your doctor immediately.

What do I do if I forget to take a pill?

• If you forget to take a pill take it as soon as you remember and take the next one at your normal time. This may mean taking two pills on the same day.


• If you are 12 or more hours late in taking one or more pills, it may not work. As soon as you remember, take your last missed pill and carry on taking your pills normally. However, you may not be protected for the next seven days, so either avoid sexual intercourse or use an extra contraceptive method, such as a condom.

If you have fewer than seven pills in your blister strip after you have missed taking your pill, you should complete the blister strip and start the next blister strip without a break. This will give you protection from when you took the last missed pill. You may not have a period until the end of two blister strips, but this will not harm you. You may also have some bleeding on days when you take the pill.

Norimin Tablets Side Effects

All medicines can sometimes cause problems. If you are worried about side effects, talk to your doctor. These effects should become less of a problem as your body gets used to the pills.

You may notice a change in your sex drive, and have irregular vaginal bleeding or changes in your period.

Other side effects that you might have include nausea, stomach upsets, tender breasts, weight gain, changes in appetite, headaches, depression, high blood pressure, and changes in the way your body breaks down sugars, fats or vitamins. If you have fibroids in your uterus, these may also get worse.

Reasons to get medical help immediately

The cause of these symptoms may have nothing to do with the pill but you may need treatment. Stop taking your pills at once and tell your doctor if you have:

• migraines which get worse, especially if your sight is affected, you see flashing lights, your limbs feel weak, you lose the sensation or feel a different sensation in your limbs, or you have a fit;


• a sudden sharp or severe pain in the chest;


• suddenly become short of breath or breathing is painful;


• coughed up blood;


• painful or inflamed veins in your legs;


• a crushing type of chest pain or your chest feels heavy;


• a very first attack of migraine (a bad headache with sickness);


• sudden and unusual severe headaches;


• dizziness or you faint;


• a problem with your sight or speech;


• swollen arms or legs;


• jaundice (your skin or the whites of your eyes look yellow);


• a severe rash; or


• swelling or tenderness in your stomach.

How to store Norimin

Store your Norimin pills in a dry place, away from direct sunlight and below 25ºC. Make sure children cannot see or reach them.

Don’t take Norimin after the ‘expiry date’ shown on the box. If your pack is out of date, take it to your pharmacist who will get rid of the pills safely.

If you have any comments on the way this leaflet is written, please write to Medical Information at Searle, High Wycombe.

This leaflet was written in May 2007.

Norimin is a contraceptive. It will not protect you against sexually-transmitted diseases including AIDS. For safer sex, use a condom as well as your usual contraceptive.

Norimin and Pharmacia are registered trademarks.

Ref: NM 2_0

Procto-kit

Generic Name: hydrocortisone acetate

Dosage Form: cream
Procto-kit 1% (Proctosol-HC 2.5%) Procto-kit 2.5%

(Hydrocortisone Cream, USP)

FOR TOPICAL USE ONLY

Procto-kit Description

Hydrocortisone is a synthetic steroid used as anti-inflammatory and antipruritic agent. Its chemical name is Pregn-4-ene-3,20-dione, 11,17,21- trihydroxy-, (11 β)- With empirical formula as C21 H3005 and molecular weight 362.47. Its structural formula is:

Procto-kit™ 1 % (Hydrocortisone Cream USP, 1 %) (Each gram contains 10 mg of Hydrocortisone) Proctosol-HC® 2.5%, Procto-kit™ 2.5% (Hydrocortisone Cream USP, 2.5%) (Each gram contains 25 mg of Hydrocortisone) in a base containing Purified Water, Propylene Glycol, Propylene Glycol Monostearate, Mineral Oil and Lanolin Alcohol, Isopropyl Palmitate, Polysorbate 60, Cetyl Alcohol, Sorbitan Monostearate, Polyoxyl 40 Stearate, Sorbic Acid, Methylparaben and Propylparaben.

Procto-kit - Clinical Pharmacology

Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions.

The mechanism of anti-inflammatory activity of topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses (See DOSAGE AND ADMINISTRATION).

Indications and Usage for Procto-kit

Topical corticosteroids are indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Contraindications

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Precautions

General

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.

Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.

Therefore, patients receiving a large dose of potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.

Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (See PRECAUTIONS - Pediatric Use).

If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.

In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

Information for the Patient

Patients using topical corticosteroids should receive the following information and instructions:

1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.


2. Patients should be advised not to use this medication for any disorder other than for which it was prescribed.


3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.


4. Patients should report any signs of local adverse reactions especially under occlusive dressings.


5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.

Laboratory Tests

The following tests may be helpful in evaluating the HPA axis suppression:

Urinary free cortisol test.

ACTH stimulation test.

Carcinogenesis and Mutagenesis and Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.

Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

Pregnancy category C

Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Nursing Mothers

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Pediatric Use

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome, than mature patients, because of a larger skin surface area to body weight ratio.

Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of pediatric patients.

Adverse Reactions

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence:

Burning Perioral dermatitis

Itching Allergic contact dermatitis

Irritation Maceration of the skin

Dryness Secondary infection

Folliculitis Skin Atrophy

Hypertrichosis Striae

Acneiform eruptions Miliaria

Hypopigmentation

Overdosage

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).

Procto-kit Dosage and Administration

Topical corticosteroids are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

How is Procto-kit Supplied

Procto-kitTM 2.5% (Hydrocortisone Cream USP, 2.5%) in 28.35 g (1 oz) tubes NDC 10631-406-01.

Manufactured for;

Ranbaxy Laboratories Inc.

Jacksonville, FL 32216 USA

Mfd By:

Taro Pharmaceuticals Inc

Brampton, Ontario, Canada L6T 1C1

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

Carton Label 28.35 grams

Procto-kit  hydrocortisone  cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 10631-405 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE ACETATE 10 mg  in 1 g

Inactive Ingredients Ingredient Name Strength WATER   PROPYLENE GLYCOL   PROPYLENE GLYCOL MONOSTEARATE   ISOPROPYL PALMITATE   POLYSORBATE 60   CETYL ALCOHOL   SORBITAN MONOSTEARATE   POLYOXYL 40 STEARATE   SORBIC ACID   METHYLPARABEN   PROPYLPARABEN

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 10631-405-01 28.35 g In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/01/1995

Procto-kit  hydrocortisone  cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 10631-406 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE ACETATE 25 mg  in 1 g

Inactive Ingredients Ingredient Name Strength WATER   PROPYLENE GLYCOL   PROPYLENE GLYCOL MONOSTEARATE   ISOPROPYL PALMITATE   POLYSORBATE 60   CETYL ALCOHOL   SORBITAN MONOSTEARATE   POLYOXYL 40 STEARATE   SORBIC ACID   METHYLPARABEN   PROPYLPARABEN

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 10631-406-01 28.35 g In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/01/1995

Procto-kit  hydrocortisone  cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 10631-407 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE ACETATE 25 mg  in 1 g

Inactive Ingredients Ingredient Name Strength WATER   PROPYLENE GLYCOL   PROPYLENE GLYCOL MONOSTEARATE   ISOPROPYL PALMITATE   POLYSORBATE 60   CETYL ALCOHOL   SORBITAN MONOSTEARATE   POLYOXYL 40 STEARATE   SORBIC ACID   METHYLPARABEN   PROPYLPARABEN

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 10631-407-01 28.35 g In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/01/1995

Labeler - Ranbaxy Laboratories Inc (169932519)

Registrant - Ranbaxy Pharmaceuticals Inc (937890044)

Establishment
Name	Address	ID/FEI	Operations
Taro Pharmaceuticals Inc		206263295	manufacture

Revised: 02/2010Ranbaxy Laboratories Inc

More Procto-kit resources

• Procto-kit Use in Pregnancy & Breastfeeding
• Procto-kit Drug Interactions
• Procto-kit Support Group
• 15 Reviews for Procto-kit - Add your own review/rating

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Prostin E2 Sterile Solution 10 mg / ml Intravenous

Prostin E2 Sterile Solution 10 mg/ml

Dinoprostone

Pharmacia Logo

Read all of this leaflet carefully before you are given this medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or nurse.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

In this leaflet:

• 1. What Prostin E2 Sterile Solution is and what it is used for


• 2. Before you are given Prostin E2 Sterile Solution


• 3. How Prostin E2 Sterile Solution is given to you


• 4. Possible side effects


• 5. How to store Prostin E2 Sterile Solution


• 6. Further information

What Prostin E2 Sterile Solution is and what it is used for

Prostin E2 Sterile Solution contains the prostaglandin dinoprostone and is used to “induce” labour. This means that the medicine will help your uterus (womb) to start contracting and you will go into labour. Dinoprostone is similar to the natural ‘E2’, type of prostaglandins which are made in your body when labour starts. It will only be given to you in a hospital or clinic.

You could need this treatment for different reasons:

• if your baby has died in your womb;


• if it is required to end your pregnancy for health reasons;


• if you have an abnormal growth of the placenta called a ‘hydatidiform mole’.

Before you are given Prostin E2 Sterile Solution

Most women can be treated with Prostin E2. Some women may need extra checks during treatment and for some women a different treatment may be better. Your doctor or nurse will ask you questions before giving you Prostin E2 to make sure it is safe for you. If you do not understand any of the questions, ask your doctor or nurse to explain.

If you are having a pregnancy termination (abortion), it is very important for it to be complete. This is because prostaglandins given at this stage in pregnancy may cause abnormalities in the foetus. If your doctor thinks that the abortion has not worked completely, you will need another treatment, probably an operation.

Do not use Prostin E2 Sterile Solution:

• If you have had an allergic reaction (e.g. wheezing, breathlessness, swelling of the hands, face, itchy rash or redness of the skin) to dinoprostone or any other prostaglandin or any of the other ingredients in the infusion, which are listed in Section 6 below.


• If you have current heart, lung, kidney or liver disease

Your doctor or nurse will not use Prostin E2 to start or strengthen your labour in certain circumstances if:

• you have had a Caesarean section or any major surgery to your womb


• you had a difficult labour or traumatic delivery in a previous pregnancy


• you had any abnormal contractions of your womb that were too strong or went on for too long during a previous labour


• you have an infection of your womb, ovaries or tubes (pelvic inflammatory disease) unless you are receiving treatment for these, or if you have ever had such an infection in the past


• you have been told that you will have an obstructed labour

Take special care with Prostin E2 Sterile Solution:

Tell your doctor or nurse if you have or have had in the past any of the following conditions as they may want to monitor you more closely.

• heart, lung, kidney or liver disease


• glaucoma (raised pressure in the eye)


• epilepsy


• suffered from asthma


• hypertension (high blood pressure) at any time, including during this or any previous pregnancy


• been told you had abnormally strong contractions of your womb during a previous labour


• scarring of your womb from a previous operation

Your doctor or nurse will ask you questions before giving you Prostin E2 to make sure it is safe for you.

If you do not understand any of the questions, ask your doctor or nurse to explain.

Taking other medicines:

Prostin E2 Sterile Solution can make you more sensitive to another medicine called oxytocin which is used to strengthen contractions. Medical staff will normally try not to use this medicine at the same time as Prostin E2 Sterile Solution. If used with this medicine in sequence, your doctor or nurse will watch over the womb contractions very carefully.

Your doctor may give you antibiotics before you start this prostaglandin treatment.

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breastfeeding

Prostin E2 will only be given to you in the late stages of pregnancy to induce labour.

Although prostaglandins are present in breast milk, you are not expected to be breast-feeding as this medicine is used to terminate the pregnancy.

Driving and using machinery

No effect on your ability to drive or use machinery is expected after being given Prostin E2.

How Prostin E2 Sterile Solution is given to you

This product can only be used in hospitals and clinics with specialised units for pregnancy and childbirth (obstetric units). Medical staff will be available at all times.

Prostin E2 Sterile Solution is diluted before use with a salt (saline) or sugar (dextrose) solution and given by an intravenous drip.

Medical staff will adjust the dose to suit you. It depends on why you need the treatment and how you react to it. The mixture is made up to contain 5 micrograms /ml of Prostin E2 Sterile Solution and the drip is set to deliver 2.5 micrograms per minute. This is given for 30 minutes, after which the dose is either kept the same or increased to 5 micrograms per minute, depending on how you respond. It could then be increased again after a further four hours if necessary. The doctor or nurse will want to give you enough Prostin E2 to keep you in labour, but they will want to make sure that the contractions do not become too strong.

Medical staff will be keeping a very close eye on you during your treatment. They should be able to act quickly if you have side-effects or if your womb reacts too strongly to the dose you are given. You might just need a lower dose, or you might need a Caesarean section or some other obstetric procedure.

You should not normally be given Prostin E2 Sterile Solution for more than two days at a time.

Tell your doctor or nurse if you think you have been given too much Prostin E2 Sterile Solution. Symptoms of this would be excessive contractions of your womb (very strong, frequent and painful contractions) or severe side-effects, such as feeling and being sick. If you have such symptoms, the rate at which Prostin E2 Sterile Solution is being given should be reduced, or the treatment should be stopped. If you have a massive overdose, so that the muscles of your womb become very tense and over-active, you might need another obstetric procedure.

Your doctor or nurse will do internal checks to make sure that your cervix is opening enough. They will also check your contractions to make sure that they are not too strong.

Possible side effects

Like all medicines Prostin E2 Sterile Solution can cause side effects, although not everybody gets them.

If you have asthma, Prostin E2 Sterile Solution could cause you to have an asthmatic attack. You must tell your doctor or nurse if you suffer from asthma or if you start having difficulty in breathing.

Rare side effects

Rare but serious side effects which can sometimes happen include the following:

• tearing or bursting of the wall of your womb (uterine rupture)


• heart attack


• allergic reactions (symptoms may include wheezing, breathlessness, swelling of the hands, face, itchy rash or redness of the skin). If you get any of these symptoms please tell your doctor or midwife straight away.

Common side effects

• vomiting (being sick)


• nausea (feeling sick)


• diarrhoea

These have seldom been bad enough for the woman to stop the treatment.

Other side effects

As prostaglandins make the body go into labour in the same way as it would happen naturally, anything that can happen in a natural labour can also happen if you have been given Prostin E2. Talk to your nurse or doctor about this if you want to know more, as they will be able to give you the information that you need.

These include:

• sudden blockage of a blood vessel with amniotic fluid (the fluid which surrounds the baby) or by a blood clot in the lungs. This could cause chest pain and shortness of breath.


• abnormally strong, frequent or long contractions of the womb, slowing or quickening of the baby’s heart rate and distress in the baby


• abnormally strong, frequent or long contractions of the womb, slowing or quickening of the baby’s heart rate and distress in the baby


• high blood pressure in the mother


• very quick opening of the cervix


• running a high temperature


• backache


• rash


• heart attack

In some women the number of white blood cells rises during treatment. This will not cause you any symptoms, but your doctor or nurse may mention this if you have a blood sample taken.

You might have reddening and irritation in the area around the needle for two to five hours after the needle has been removed.

If you think you may be having any of the above side effects, or you are worried about anything unusual happening during your labour, please tell your doctor or nurse.

How to store Prostin E2 Sterile Solution

The medicine will be kept out of the reach and sight of children.

Prostin E2 will not be given to you after the expiry date which is stated on the packs. The expiry date refers to the last day of that month.

Your hospital pharmacist will store this medicine in a refrigerator at 4 °C before use.

Further information

What Prostin E2 Sterile Solution contain:

The active substance is called dinoprostone. It also contains ethanol (alcohol).

What Prostin E2 Sterile Solution looks like and contents of the pack

Prostin E2 Sterile Solution is available in a pack that contains a small, closed glass container (ampoule) containing 0.5 ml of Prostin E2 Sterile Solution.

Marketing Authorisation Holder:

Pharmacia Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

UK

Manufacturer:

Pfizer Manufacturing Belgium NV

Rijksweg 12

B-2870 Puurs

Belgium

For further information on this medicine, please contact Pfizer Medical Information on: 01304 616161.

This leaflet was last updated in July 2008.

Ref: PR 1_1