Mycophenolate mofetil Teva
mycophenolate mofetil
mycophenolate mofetil
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What Mycophenolate mofetil Teva is and what it is used for
What you need to know before you take Mycophenolate mofetil Teva
How to take Mycophenolate mofetil Teva
Possible side effects
How to store Mycophenolate mofetil Teva
Contents of the pack and other information
Mycophenolate mofetil Teva is used to prevent your body rejecting a transplanted kidney, heart or liver. It is used in combination with other medicines with a similar function (i.e. 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, contraception and breast-feeding”.
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 Mycophenolate mofetil Teva.
Talk to your doctor straight away before starting treatment with Mycophenolate mofetil Teva:
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 experience any evidence of infection (e.g. fever, sore throat), unexpected bruising and/or bleeding.
if you have or ever have had any problems with your digestive system, e.g. stomach ulcers.
if you are planning to become pregnant, or if you get pregnant while you or your partner are taking Mycophenolate mofetil Teva.
if you have a hereditary enzyme deficiency such as Lesch-Nyhan and Kelley-Seegmiller syndrome.
Mycophenolate mofetil Teva reduces your body’s defence mechanism. Because of this, there is an increased risk of skin cancer. Therefore you should limit your exposure to sunlight and ultraviolet (UV) light by wearing appropriate protective clothing and using a sunscreen with a high protection factor.
You must not donate blood during treatment with Mycophenolate mofetil Teva and for at least
6 weeks after stopping treatment. Men must not donate semen during treatment with Mycophenolate mofetil Teva and for at least 90 days after stopping treatment.
Mycophenolate mofetil Teva is used in children and adolescents (aged 2 to 18) to prevent a body rejecting a transplanted kidney.
Mycophenolate mofetil Teva should not be used in children and adolescents (aged 2 to 18) for heart or liver transplantation.
Mycophenolate mofetil Teva should not be used at all in children under 2 years because based on the limited safety and efficacy data for this age group no dose recommendations can be made.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you answer yes to any of the following questions talk to your doctor before you start to take Mycophenolate mofetil Teva:
Are you taking any medicines containing:
azathioprine or other immunosuppressive agents (which are sometimes given to patients after a transplant operation),
cholestyramine (used to treat patients with high blood cholesterol),
rifampicin (antibiotic),
antacids or proton pump inhibitors (used for acid problem in your stomach such as indigestion),
phosphate binders (used in patients with chronic kidney failure to reduce the absorption of
phosphate),
antibiotics (used to treat bacterial infections), o isavuconazole (used to treat fungal infections), o telmisartan (used to treat high blood pressure)
or any other medicines (including those you can buy without a prescription) that your doctor does not know about?
Do you need to have a vaccination (live vaccines)? Your doctor will have to advise you what is indicated for you.
If you are a woman who could become pregnant you must use an effective method of contraception with Mycophenolate mofetil Teva. This includes:
Before you start taking Mycophenolate mofetil Teva
During your entire treatment with Mycophenolate mofetil Teva
For 6 weeks after you stop taking Mycophenolate mofetil Teva.
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 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.
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 Mycophenolate mofetil Teva.
If you are planning to have a child, talk to your doctor about the potential risks and alternative therapies.
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 Mycophenolate mofetil Teva 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 which 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 Mycophenolate mofetil Teva if you are breast-feeding. This is because small amounts of the medicine can pass into the mother’s milk.
Mycophenolate mofetil Teva 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.
This medicine contains less than 1 mmol sodium (23 mg) per hard 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.
Your treatment is started and monitored by a doctor who is specialised in transplants. The usual way to take Mycophenolate mofetil Teva is as follows:
Adults
The first dose will be given within 72 hours after the transplant operation. The recommended daily dose is 8 capsules (2 g of the active ingredient) taken as 2 separate doses. This means taking 4 capsules in the morning then 4 capsules in the evening.
Children and adolescents (aged 2 to 18)
The dose given will vary depending on the size of the child. Your doctor will decide the most appropriate dose based on body surface area (height and weight). The recommended dose is 600 mg/m2 taken twice a day.
Adults
The first dose will be given within 5 days following the transplant operation. The recommended daily dose is 12 capsules (3 g of the active ingredient) taken as 2 separate doses. This means taking 6 capsules in the morning then 6 capsules in the evening.
Children
There is no information for the use of Mycophenolate mofetil Teva in children with a heart transplant.
Adults
The first dose of oral Mycophenolate mofetil Teva will be given to you at least 4 days after the transplant operation and when you are able to swallow oral medicines. The recommended daily dose is 12 capsules (3 g of the active ingredient) taken as 2 separate doses. This means taking 6 capsules in the morning then 6 capsules in the evening.
Children
There is no information for the use of Mycophenolate mofetil Teva in children with a liver transplant.
Swallow your capsules whole with a glass of water. You can take them with or without food. Do not break or crush them and do not take any capsules that have broken open or split. Avoid contact with any powder that spills out from damaged capsules. If a capsule breaks open accidentally, wash any
powder from your skin with soap and water. If any powder gets into your eyes or mouth, rinse thoroughly with plenty of plain, fresh water.
Treatment will continue for you as long as you need immunosuppression to prevent rejection of your transplanted organ.
It is important not to take too many capsules. Contact your nearest hospital Accident and Emergency department or a doctor for advice if you have swallowed more capsules than you have been told to take or if you think a child has swallowed any.
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 forgotten dose.
Do not stop taking Mycophenolate mofetil Teva because you feel better. It is important to take the medicine for as long as the doctor has told you to. Stopping your treatment with Mycophenolate mofetil Teva may increase the chance of rejection of your transplanted organ. Do not stop taking your medicine unless your doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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).
you have black or bloody stool or if you vomit blood or dark particles that look like coffee grounds. These may be signs of bleeding in the stomach or intestines.
The frequency of certain side effects is dependent on the transplanted organ, i.e. some side effects can occur more or less often depending on whether this medicinal product is being taken to prevent your body from rejecting a transplanted heart or a transplanted kidney. For the sake of clarity each side effect is always listed under its highest frequency.
Very common (may affect more than 1 in 10 people)
bacterial, viral and/or fungal infections
serious infection which may affect the whole body
decrease in the number of white blood cells, platelets or red blood cells, which can result in increased risk of infections, bruising, bleeding, breathlessness and weakness
bleeding underneath the skin
increase in the number of white blood cells
too much acid in the body
high level of cholesterol and/or lipids in the blood
high level of sugar in the blood
high level of potassium in the blood, low level of potassium, magnesium, calcium and/or phosphate in the blood
high level of uric acid in the blood, gout
feeling restless, abnormalities of thought, perception and levels of awareness, depression, feeling anxious, difficulty in sleeping
increased tension of the muscles, shaking, sleepiness, feeling dizzy, headache, tingling, pricking or numbness
faster heart beat
low/high blood pressure, widening of blood vessels
accumulation of fluid in the lung, shortness of breath, cough
bloated belly
vomiting, stomach pain, diarrhoea, feeling sick
constipation, indigestion, wind (flatulence)
decreased appetite
changes in different laboratory parameters
inflammation of the liver, yellowing of the skin and whites of the eyes
growth of the skin, rash, acne
muscle weakness
joint pain
kidney problems
blood in the urine
fever, feeling of coldness, pain, feeling weak and feeble
fluid retention in the body
part of an internal organ or tissue bulging through a weak spot in the abdominal muscles
muscle pain, neck and back pain
Common (may affect up to 1 in 10 people)
skin cancer, non-cancerous growth of the skin
abnormal and excessive growth of tissue
decrease in the number of all blood cells
benign enlargement of the lymph nodes, inflammatory changes of the skin (pseudolymphoma)
decreased weight
abnormal thinking
fit
distortion of the sense of taste
blood clot that forms within a vein
inflammation of the tissue that lines the inner wall of the abdomen and covers most of the abdominal organs
bowel blockage
inflammation of the colon which causes abdominal pain or diarrhoea (sometimes caused by cytomegalovirus), ulcer of the mouth and/or stomach and/or duodenum, inflammation of the stomach, oesophagus and/or mouth and lips
belching
hair loss
feeling unwell
overgrowth of the gum tissue
inflammation of the pancreas, which causes severe pain in the abdomen and back
Uncommon (may affect up to 1 in 100 people)
protozoal infections
proliferation of the lymphatic tissue, including malignant tumours
insufficient production of red blood cells
serious diseases of the bone marrow
accumulation of lymphatic fluid within the body
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.
decrease in the amount of antibodies in the blood
severe reduction in the number of certain white blood cells (possible symptoms are fever, sore throat, frequent infections) (agranulocytosis)
Not known (frequency cannot be estimated from the available data)
alterations of the inner wall of the small intestine (intestinal villous atrophy)
serious inflammation of the membrane that covers the brain and spinal cord
serious inflammation of the heart and its valves
bacterial infections usually resulting in a serious lung disorder (tuberculosis, atypical mycobacterial infection)
serious disease of the kidney (BK virus associated nephropathy)
serious disease of the central nervous system (JC virus associated progressive multifocal leucoencephalopathy)
decrease in the number of certain white blood cells (neutropenia)
change of the shape of certain white blood cells
Do not stop taking your medicine unless you have discussed this with your doctor first.
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 blister and carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines no longer required. These measures will help to protect the environment.
The active substance is mycophenolate mofetil.
Each capsule contains 250 mg mycophenolate mofetil.
The other ingredients are: Capsule content Pregelatinised maize starch Povidone K-30 Croscarmellose sodium Magnesium stearate Capsule shells
Cap
Indigo carmine (E132)
Titanium dioxide (E171) Gelatin
Body
Red iron oxide (E172) Yellow iron oxide (E172) Titanium dioxide (E171) Gelatin
Black ink containing: shellac, black iron oxide (E172), propylene glycol and potassium hydroxide
Hard capsules
Body: caramel opaque, printed ‘250’ axially in black ink. Cap: light blue opaque printed ‘M’ axially in black ink.
Mycophenolate mofetil Teva 250 mg hard capsules are available in PVC/PVdC-aluminium blisters in pack sizes of 100 or 300 or 100 x 1 capsules per carton.
Not all pack sizes may be marketed.
Teva B.V. Swensweg 5 2031GA Haarlem Netherlands
Teva Pharmaceutical Works Private Limited Company Pallagi út 13.
Debrecen H-4042 Hungary
Pharmachemie B.V. Swensweg 5
2031 GA Haarlem The Netherlands
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373
UAB Teva Baltics Tel: +370 52660203
Тева Фарма ЕАД Тел: +359 24899585
Teva Pharma Belgium N.V./S.A./AG Belgique/Belgien
Tél/Tel: +32 38207373
Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111
Teva Gyógyszergyár Zrt. Tel: +36 12886400
Teva Denmark A/S Tlf: +45 44985511
Teva Pharmaceuticals Ireland L-Irlanda
Tel: +44 2075407117
TEVA GmbH
Tel: +49 73140208
Teva Nederland B.V. Tel: +31 8000228400
UAB Teva Baltics Eesti filiaal Tel: +372 6610801
Teva Norway AS Tlf: +47 66775590
Specifar Α.Β.Ε.Ε. Τηλ: +30 2118805000
ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070
Teva Pharma, S.L.U. Tel: +34 913873280
Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300
Teva Santé
Tél: +33 155917800
Teva Pharma - Produtos Farmacêuticos, Lda. Tel: +351 214767550
Pliva Hrvatska d.o.o. Tel: +385 13720000
Teva Pharmaceuticals S.R.L. Tel: +40 212306524
Teva Pharmaceuticals Ireland Tel: +44 2075407117
Pliva Ljubljana d.o.o. Tel: +386 15890390
Teva Pharma Iceland ehf. Sími: +354 5503300
TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267911
Teva Italia S.r.l. Tel: +39 028917981
Teva Finland Oy
Puh/Tel: +358 201805900
Specifar Α.Β.Ε.Ε. Ελλάδα
Τηλ: +30 2118805000
Teva Sweden AB Tel: +46 42121100
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666
Teva Pharmaceuticals Ireland Ireland
Tel: +44 2075407117