Mycophenolate Teva Film-Coated Tablets

MYCOPHENOLATE TEVA is used to prevent your body rejecting a transplanted kidney, heart or liver. It is used together with other medicines with a similar function such as ciclosporin and corticosteroids.

Follow your doctor’s instructions carefully. They may differ from the general instructions in this leaflet. MYCOPHENOLATE TEVA causes birth defects and miscarriage; therefore precautions must be taken to prevent pregnancy with MYCOPHENOLATE TEVA. If you are a woman who could become pregnant, you must have a negative pregnancy test before starting treatment with MYCOPHENOLATE TEVA. You should also use effective contraception as advised by your doctor. Male patients should use condoms and their female partners should use contraception as advised by your doctor. See Pregnancy and breastfeeding.

Do not take MYCOPHENOLATE TEVA:

• If you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid or any of the other ingredients of MYCOPHENOLATE TEVA.
• If you are pregnant or breastfeeding your baby, see Pregnancy and breastfeeding.

Warnings and precautions:

Take special care with MYCOPHENOLATE TEVA: When you are treated with MYCOPHENOLATE TEVA you have an increased risk of developing lymphomas and other malignancies (cancer), particularly of your skin. To minimise any risk of skin cancer you should limit exposure to sunlight and UV light by wearing protective clothing and using sunscreen with a high protection factor.

Inform your doctor before taking MYCOPHENOLATE TEVA if:

• you experience any evidence of infection (e.g. fever, sore throat), unexpected bruising and/or bleeding
• you ever have or have had any problems with your digestive system for example stomach ulcers
• you have a rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan and Kelley-Seegmillar syndrome (which causes kidney problems and gout characterised by painful swelling of the foot)
• you have severe kidney problems
• you are taking other medicines to suppress your immune system such as azathioprine (see Other medicines and MYCOPHENOLATE TEVA)
• you are over 65 years old.

Inform your doctor if you develop shortness of breath or a persistent cough while taking MYCOPHENOLATE TEVA, which can be due to bronchiectasis (a condition in which the lung airways are abnormally dilated) or pulmonary fibrosis (scarring of the lung). Inform your doctor if you experience fatigue, lethargy and/or abnormal paleness of the skin (pallor) while taking MYCOPHENOLATE TEVA. Inform your doctor if you get infected with Covid-19 while taking MYCOPHENOLATE TEVA. You must not donate blood during treatment with MYCOPHENOLATE TEVA and for at least 6 weeks after stopping treatment. Men must not donate semen during treatment with MYCOPHENOLATE TEVA and for at least 90 days after stopping treatment.

Do not share medicines prescribed for you with any other person. Always take MYCOPHENOLATE TEVA exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. If you have the impression that the effect of MYCOPHENOLATE TEVA is too strong or too weak, talk to your doctor or pharmacist. Your doctor will determine your dose according to your condition.

How to take MYCOPHENOLATE TEVA 500:

MYCOPHENOLATE TEVA 500 tablets should be taken on an empty stomach (i.e. 1 hour before or 3 hours after food). Swallow your tablets whole with a glass of water. Do not break or crush them.

How to take MYCOPHENOLATE TEVA 250:

MYCOPHENOLATE TEVA 250 capsules should be taken on an empty stomach (i.e. 1 hour before or 3 hours after food). Swallow your capsules whole with a glass of water. 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 water.

Your doctor will tell you exactly how long you will need to take MYCOPHENOLATE TEVA tablets or capsules. Treatment with MYCOPHENOLATE TEVA will continue for as long as your immune system needs to be suppressed to prevent your body from rejecting your transplanted organ.

If you take more MYCOPHENOLATE TEVA than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take MYCOPHENOLATE TEVA: If you forget to take a dose of MYCOPHENOLATE TEVA, take it as soon as you remember, then carry on with the next dose at the usual time. Do not take a double dose to make up for forgotten individual doses.

If you stop taking MYCOPHENOLATE TEVA: Do not stop taking MYCOPHENOLATE TEVA because you feel better. It is important to take MYCOPHENOLATE TEVA for as long as the doctor has told you to. Stopping your treatment with MYCOPHENOLATE TEVA may increase the chance of rejection of your transplanted organ. Do not stop taking MYCOPHENOLATE TEVA unless your doctor tells you to.

If you have any further questions on the use of MYCOPHENOLATE TEVA, ask your doctor or pharmacist.

MYCOPHENOLATE TEVA can have side effects. Not all side effects reported for MYCOPHENOLATE TEVA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking MYCOPHENOLATE TEVA, please consult your healthcare provider for advice.

If any of the following happens, stop taking MYCOPHENOLATE TEVA and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to MYCOPHENOLATE TEVA. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• signs of infection or flu-like symptoms such as a fever or sore throat, as well as infections of the chest, stomach, bladder, mouth, skin or vagina
• any unexpected bruising or bleeding, weakness, breathlessness
• blood in your stools or urine
• growths of the skin or changes in your skin
• convulsions, increased tension in the muscles, shaking and muscle weakness
• severe chest pain, irregular heartbeat
• yellowing of the skin and eyes
• difficulty passing urine, decreased or frequent urination
• swelling of your body.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following which may occur frequently:

• high blood sugar (causes thirst and frequent urination), gout (painful, swelling of the feet), dehydration
• agitation, confusion, depression, anxiety, abnormal thinking, difficulty sleeping, hallucinations, changes in your mood or thoughts
• drowsiness, dizziness, headache, pins and needles, taste disturbances
• blurred or abnormal vision, eye infection, burst vessel in the eye
• ear pain, loss of hearing, ringing in the ears
• high or low blood pressure (causes headaches or fainting), blood clots
• cough, asthma (tight chest), shortness of breath
• nausea (feeling sick), vomiting, stomach pain, diarrhoea (loose stools), constipation, indigestion, flatulence, swollen stomach, mouth sores, difficulty swallowing, decreased appetite
• rash, acne (pimples), hair loss, sweating, excessive hair growth, sores on the skin, swollen face
• joint pain, pelvic pain, neck pain, leg cramps, muscle pain, back pain, muscle weakness
• difficulty in maintaining an erection
• feeling ill, lack of energy, pale skin
• changes in your weight.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store at or below 25 °C. Keep in the original package and protect from light and moisture. STORE ALL MEDICINES OUT OF REACH OF CHILDREN. Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, MYCOPHENOLATE TEVA capsules should not be opened or crushed. Avoid inhalation, or direct contact with skin or mucous membranes, of the powder contained in MYCOPHENOLATE TEVA capsules. If such contact occurs, wash thoroughly with soap and water, rinse eyes with plain water.

Do not take MYCOPHENOLATE TEVA after the expiry date shown on the pack. Do not use any MYCOPHENOLATE TEVA from a pack that is damaged or shows signs of tampering. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).