Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - cellcept

Document Subject

Generated Narrative: MedicinalProductDefinition mp7864f63eceae865956b53410a93ee1e9

identifier: http://ema.europa.eu/identifier/EU/1/96/005/001 CellCept

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: CellCept 250 mg hard capsules

type: Full name

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part: nan

type: Invented name part

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part: nan

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Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-7864f63eceae865956b53410a93ee1e9

identifier: http://ema.europa.eu/identifier/EU/1/96/005/001 CellCept

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - cellcept

Attesters

What is in this leaflet

1. What CellCept is and what it is used for
2. What you need to know before you take CellCept
3. How to take CellCept
4. Possible side effects
5. How to store CellCept
6. Contents of the pack and other information

CellCept contains mycophenolate mofetil.

• This belongs to a group of medicines called immunosuppressants .
  CellCept is used to prevent your body rejecting a transplanted organ.
• A kidney, heart or liver.
  CellCept should be used together with other medicines:
• Ciclosporin and corticosteroids.

WARNING Mycophenolate causes birth defects and miscarriage. If you are a woman who could become pregnant, you must provide a negative pregnancy test before starting treatment and must follow the contraception advice given to you by your doctor.

Your doctor will speak to you and give you written information, particularly on the effects of mycophenolate on unborn babies. Read the information carefully and follow the instructions. If you do not fully understand these instructions, please ask your doctor to explain them again before you take mycophenolate. See also further information in this section under Warnings and precautions and Pregnancy and breast-feeding .

Do not take CellCept:

• If you are allergic to mycophenolate mofetil, mycophenolic acid or any of the other ingredients of this medicine (listed in section 6).
• If you are a woman who could be pregnant and you have not provided a negative pregnancy test before your first prescription, as mycophenolate causes birth defects and miscarriage.
• If you are pregnant or planning to become pregnant or think you may be pregnant
• If you are not using effective contraception (see Pregnancy, contraception and breast-feeding).
• If you are breast-feeding. Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking CellCept.

Warnings and precautions
Talk to your doctor straight away before starting treatment with CellCept:

• If you are older than 65 years as you may have an increased risk of developing adverse events such as certain viral infections, gastrointestinal bleeding and pulmonary oedema when compared to younger patients
• If you have a sign of infection such as a fever or sore throat
• If you have any unexpected bruising or bleeding
• If you have ever had a problem with your digestive system such as a stomach ulcer
• If you are planning to become pregnant or if you get pregnant while you or your partner are taking CellCept
• If you have a hereditary enzyme deficiency such as Lesch-Nyhan and Kelley-Seegmiller syndrome

If any of the above apply to you (or you are not sure), talk to your doctor straight away before starting treatment with CellCept.

The effect of sunlight CellCept reduces your body s defences. As a result, there is an increased risk of skin cancer. Limit the amount of sunlight and UV light you get. Do this by:

• wearing protective clothing that also covers your head, neck, arms and legs
• using a sunscreen with a high protection factor.

Children Do not give this medicine to children younger than 2 years because based on the limited safety and efficacy data for this age group no dose recommendations can be made.

Other medicines and CellCept Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, such as herbal medicines. This is because CellCept can affect the way some other medicines work. Also other medicines can affect the way CellCept works. In particular, tell your doctor or pharmacist if you are taking any of the following medicines before you start CellCept:

• azathioprine or other medicines that suppress your immune system given after a transplant operation
• cholestyramine used to treat high cholesterol
• rifampicin an antibiotic used to prevent and treat infections such as tuberculosis (TB)
• antacids or proton pump inhibitors used for acid problems in your stomach such as indigestion
• phosphate binders used by people with chronic kidney failure to reduce how much phosphate gets absorbed into their blood
• antibiotics used to treat bacterial infections
• isavuconazole used to treat fungal infections
• telmisartan used to treat high blood pressure

Vaccines If you need to have a vaccination (a live vaccine) while taking CellCept, talk to your doctor or pharmacist first. Your doctor will have to advise you on what vaccines you can have.

You must not donate blood during treatment with CellCept and for at least 6 weeks after stopping treatment. Men must not donate semen during treatment with CellCept and for at least 90 days after stopping treatment.

CellCept with food and drink Taking food and drink has no effect on your treatment with CellCept.

Contraception in women taking CellCept If you are a woman who could become pregnant, you must use an effective method of contraception with CellCept. This includes:

• Before you start taking CellCept
• During your entire treatment with CellCept
• For 6 weeks after you stop taking CellCept. Talk to your doctor about the most suitable contraception for you. This will depend on your individual situation. Two forms of contraception are preferable as this will reduce the risk of unintended pregnancy. Contact your doctor as soon as possible, if you think your contraception may not have been effective or if you have forgotten to take your contraceptive pill.

You cannot become pregnant if any of the following conditions applies to you:

• You are post-menopausal, i.e. at least 50 years old and your last period was more than a year ago (if your periods have stopped because you have had treatment for cancer, then there is still a chance you could become pregnant)
• Your fallopian tubes and both ovaries have been removed by surgery (bilateral salpingo-oophorectomy)
• Your womb (uterus) has been removed by surgery (hysterectomy)
• Your ovaries no longer work (premature ovarian failure, which has been confirmed by a specialist gynaecologist)
• You were born with one of the following rare conditions that make pregnancy impossible: the XY genotype, Turner s syndrome or uterine agenesis
• You are a child or teenager who has not started having periods.

Contraception in men taking CellCept The available evidence does not indicate an increased risk of malformations or miscarriage if the father takes mycophenolate. However, a risk cannot be completely excluded. As a precaution you or your female partner are recommended to use reliable contraception during treatment and for 90 days after you stop taking CellCept.

If you are planning to have a child, talk to your doctor about the potential risks and alternative therapies.

Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will talk to you about the risks in case of pregnancy and the alternatives you can take to prevent rejection of your transplant organ if:

• You plan to become pregnant.
• You miss or think you have missed a period, or you have unusual menstrual bleeding, or suspect you are pregnant.
• You have sex without using effective methods of contraception. If you do become pregnant during the treatment with mycophenolate, you must inform your doctor immediately. However, keep taking CellCept until you see him or her.

Pregnancy Mycophenolate causes a very high frequency of miscarriage (50%) and of severe birth defects (23 - 27%) in the unborn baby. Birth defects that have been reported include anomalies of ears, of eyes, of face (cleft lip/palate), of development of fingers, of heart, oesophagus (tube that connects the throat with the stomach), kidneys and nervous system (for example spina bifida (where the bones of the spine are not properly developed). Your baby may be affected by one or more of these.

If you are a woman who could become pregnant, you must provide a negative pregnancy test before starting treatment and must follow the contraception advice given to you by your doctor. Your doctor may request more than one test to ensure you are not pregnant before starting treatment.

Breast-feeding Do not take CellCept if you are breast-feeding. This is because small amounts of the medicine can pass into the mother s milk.

Driving and using machines CellCept has a moderate influence on your ability to drive or use any tools or machines. If you feel drowsy, numb or confused, talk to your doctor or nurse and do not drive or use any tools or machines until you feel better.

CellCept contains sodium This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially sodium- free .

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

How much to take The amount you take depends on the type of transplant you have had. The usual doses are shown below. Treatment will continue for as long as you need to prevent rejection of your transplant organ.

Kidney transplant Adults

• The first dose is given within 3 days of the transplant operation.
• The daily dose is 8 capsules (2 g of the medicine) taken as 2 separate doses.
• Take 4 capsules in the morning and then 4 capsules in the evening. Children (aged 2 to 18 years)
• The dose given will vary depending on the size of the child.
• Your doctor will decide the most appropriate dose based on your child s height and weight (body surface area measured as square metres or m2 ). The recommended dose is 600 mg/m taken twice a day.

Heart transplant Adults

• The first dose is given within 5 days of the transplant operation.
• The daily dose is 12 capsules (3 g of the medicine) taken as 2 separate doses.
• Take 6 capsules in the morning and then 6 capsules in the evening. Children
• There is no information for the use of CellCept in children with a heart transplant.

Liver transplant Adults

• The first dose of oral CellCept will be given to you at least 4 days after the transplant operation and when you are able to swallow oral medicines.
• The daily dose is 12 capsules (3 g of the medicine) taken as 2 separate doses.
• Take 6 capsules in the morning and then 6 capsules in the evening.
  Children
• There is no information for the use of CellCept in children with a liver transplant.

Taking the medicine Swallow your capsules whole with a glass of water

• Do not break or crush them
• Do not take any capsules that have broken open or split.

Take care not to let any powder from inside a broken capsule get into your eyes or mouth.

• If this happens, rinse with plenty of plain water.

Take care not to let any powder from inside a broken capsule get onto your skin.

• If this happens, wash the area thoroughly with soap and water.

If you take more CellCept than you should If you take more CellCept than you should, talk to a doctor or go to a hospital straight away. Also do this if someone else accidentally takes your medicine. Take the medicine pack with you.

If you forget to take CellCept If you forget to take your medicine at any time, take it as soon as you remember. Then continue to take it at the usual times. Do not take a double dose to make up for a missed dose.

If you stop taking CellCept Do not stop taking CellCept unless your doctor tells you to. If you stop your treatment you may increase the chance of rejection of your transplant organ.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, CellCept can cause side effects, although not everybody gets them.

Talk to a doctor straight away if you notice any of the following serious side effects you may need urgent medical treatment:

• you have a sign of infection such as a fever or sore throat
• you have any unexpected bruising or bleeding
• you have a rash, swelling of your face, lips, tongue or throat, with difficulty breathing - you may be having a serious allergic reaction to the medicine (such as anaphylaxis, angioeodema).

Usual problems Some of the more usual problems are diarrhoea, fewer white cells or red cells in your blood, infection and vomiting. Your doctor will do regular blood tests to check for any changes in:

• the number of your blood cells or signs of infections

Children may be more likely than adults to have some side effects. These include diarrhoea, infections, fewer white cells and fewer red cells in the blood.

Fighting infections CellCept reduces your body s defences. This is to stop you rejecting your transplant. As a result, your body will not be as good as normal at fighting infections. This means you may catch more infections than usual. This includes infections of the brain, skin, mouth, stomach and gut, lungs and urinary system.

Lymph and skin cancer As can happen in patients taking this type of medicine (immune-suppressants), a very small number of patients on CellCept have developed cancer of the lymphoid tissues and skin.

General unwanted effects You may get general side effects affecting your body as a whole. These include serious allergic reactions (such as anaphylaxis, angioeodema), fever, feeling very tired, difficulty sleeping, pains (such as stomach, chest, joint or muscle), headache, flu symptoms and swelling.

Other unwanted effects may include: Skin problems such as:

• acne, cold sores, shingles, skin growth, hair loss, rash, itching.

Urinary problems such as:

• blood in the urine.

Digestive system and mouth problems such as:

• swelling of the gums and mouth ulcers,
• inflammation of the pancreas, colon or stomach,
• gastrointestinal disorders including bleeding,
• liver disorder,
• diarrhoea, constipation, feeling sick (nausea), indigestion, loss of appetite, flatulence.

Nervous system problems such as:

• feeling dizzy, drowsy or numb,
• tremor, muscle spasms, convulsions,
• feeling anxious or depressed, changes in your mood or thoughts.

Heart and blood vessel problems such as:

• change in blood pressure, accelerated heartbeat widening of blood vessels.

Lung problems such as:

• pneumonia, bronchitis,
• shortness of breath, cough, which can be due to bronchiectasis (a condition in which the lung airways are abnormally dilated) or pulmonary fibrosis (scarring of the lung). Talk to your doctor if you develop a persistent cough or breathlessness.
• fluid on the lungs or inside the chest,
• sinus problems.

Other problems such as:

• weight loss, gout, high blood sugar, bleeding, bruising.

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton after EXP.
• Do not store above 25 C.
• Store in the original package in order to protect from moisture.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What CellCept contains

• The active substance is mycophenolate mofetil. Each capsule contains 250 mg mycophenolate mofetil.
• The other ingredients are:

• CellCept capsules: pregelatinised maize starch, croscarmellose sodium, polyvidone (K-90), magnesium stearate
• Capsule shell: gelatin, indigo carmine (E132), yellow iron oxide (E172), red iron oxide (E172), titanium dioxide (E171), black iron oxide (E172), potassium hydroxide, shellac.

What CellCept looks like and contents of the pack

• CellCept capsules are oblong-shaped with one end blue and the other end brown. They have CellCept 250 printed in black on the capsule cap and Roche printed in black on the capsule body.
• They are available as a carton of 100 or 300 capsules (both in blister packs of 10) or as a multipack containing 300 (3 packs of 100) capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder Roche Registration GmbH
Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany

Manufacturer Roche Pharma AG, Emil-Barell-Str. 1, 79639 Grenzach Wyhlen, Germany.

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien N.V. Roche S.A. T l/Tel: +32 (0) 2 525 82 Lietuva UAB Roche Lietuva
Tel: +370 5 2546

: +359 2 818 44 Luxembourg/Luxemburg (Voir/siehe Belgique/Belgien)

esk republika Roche s. r. o. Tel: +420 - 2 20382Magyarorsz g Roche (Magyarorsz g) Kft. Tel: +36 - 1 279 4Danmark Roche Pharmaceuticals A/S Tlf: +45 - 36 39 99 Malta (See Ireland)

Deutschland Roche Pharma AG Tel: +49 (0) 7624 Nederland Roche Nederland B.V. Tel: +31 (0) 348 438Eesti Roche Eesti O
Tel: + 372 - 6 177 Norge Roche Norge AS Tlf: +47 - 22 78 90
Roche (Hellas) A.E.
: +30 210 61 66 sterreich Roche Austria GmbH Tel: +43 (0) 1 27Espa a Roche Farma S.A. Tel: +34 - 91 324 81 Polska Roche Polska Sp.z o.o. Tel: +48 - 22 345 18 France Roche T l: +33 (0)1 47 61 40 Portugal Roche Farmac utica Qu mica, Lda Tel: +351 - 21 425 70 Hrvatska Roche d.o.o. Tel: + 385 1 47 22 Rom nia Roche Rom nia S.R.L. Tel: +40 21 206 47 Ireland Roche Products (Ireland) Ltd. Tel: +353 (0) 1 469 0Slovenija Roche farmacevtska dru ba d.o.o. Tel: +386 - 1 360 26 sland
Roche Pharmaceuticals A/S c/o Icepharma hf S mi: +354 540 8Slovensk republika
Roche Slovensko, s.r.o. Tel: +421 - 2 52638Italia Roche S.p.A. Tel: +39 - 039 2Suomi/Finland Roche Oy
Puh/Tel: +358 (0) 10 554 K
. . & . : +357 - 22 76 62 Sverige Roche AB Tel: +46 (0) 8 726 1Latvija Roche Latvija SIA Tel: +371 - 6 7039United Kingdom (Northern Ireland) Roche Products (Ireland) Ltd. Tel: +44 (0) 1707 366This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website:
http://www.ema.europa.eu

Package leaflet: Information for the user

CellCept 500 mg powder for concentrate for solution for infusion mycophenolate mofetil

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet: