Mycophenolate Mofetil Sandoz 500 mg film-coated tablets – patient leaflet, side effects, dosage

1. What Mycophenolate Capsules are and what they are used for

Mycophenolate mofetil contains mycophenolate mofetil.

• This belongs to a group of medicines called “immunosuppressants”.

Mycophenolate Capsules is used to prevent your body rejecting a transplanted organ in adults and children.

• A kidney, heart or liver.

Mycophenolate Capsules should be used together with other medicines:

• Ciclosporin and corticosteroids.

2. What you need to know before you take Mycophenolate Capsules

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 Mycophenolate Capsules if:

• If you are allergic (hypersensitive) 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 Capsules.

Warnings and precautions

Talk to your doctor straight away before taking Mycophenolate Capsules:

• 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 Mycophenolate Capsules.
• 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 taking Mycophenolate Capsules.

The effect of sunlight

Mycophenolate Capsules 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

Children, especially those under 6 years old, may be more likely than adults to have some side effects, including diarrhoea, vomiting, infections, fewer red cells and fewer white cells in the blood, and possibly lymph or skin cancer.

Capsules are only appropriate for children who are capable of swallowing solid medication without the risk of choking. The medicine should therefore only be given in line with the doctor’s prescription.

If you are not sure about anything for your child’s treatment, talk to your doctor or pharmacist before use.

Other medicines and Mycophenolate Capsules

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes, medicines obtained without a prescription, including herbal medicines. This is because Mycophenolate Capsules can affect the way some other medicines work. Also other medicines can affect the way Mycophenolate Capsules works.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines before you start Mycophenolate Capsules:

• azathioprine or other medicines which 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 vaccine (a live vaccine) while taking Mycophenolate Capsules, 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 Mycophenolate Capsules and for at least 6 weeks after stopping treatment. Men must not donate semen during treatment with Mycophenolate Capsules and for at least 3 months after stopping treatment.

Mycophenolate Capsules with food and drink

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

Pregnancy, contraception and breast-feeding

Contraception in women taking Mycophenolate Capsules

If you are a woman who could become pregnant, you must use an effective method of contraception with Mycophenolate Capsules. This includes:

• Before you start taking Mycophenolate Capsules
• During your entire treatment with Mycophenolate Capsules
• For 6 months following completion of Mycophenolate Capsules.

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 Mycophenolate Capsules

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 effective contraceptive measures during treatment and for 3 months following completion of Mycophenolate Capsules treatment.

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 an effective method of contraception.

If you do become pregnant during the treatment with mycophenolate, you must inform your doctor immediately. However, keep taking Mycophenolate Capsules 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 Mycophenolate Capsules if you are breast-feeding. This is because small amounts of the medicine can pass into the mother’s milk.

Driving and using machines

Mycophenolate mofetil 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.

Mycophenolate mofetil contains sodium

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

3. How to take Mycophenolate Capsules

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 you from rejecting 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

• Capsules are only appropriate for children who are capable of swallowing solid medication without the risk of choking. The medicine should therefore only be given in line with the doctor’s prescription. If you are not sure, talk to your doctor or pharmacist before use.
• The dose given will vary depending on the size of the child.
• Your child’s 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 initial dose is 600 mg/m² taken twice a day. The recommended maintenance dose remains at 600 mg/m² twice a day (maximum total daily dose of 2 g). The dose should be individualised based on the doctor’s clinical assessment.

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

• Capsules are only appropriate for children who are capable of swallowing solid medication without the risk of choking. The medicine should therefore only be given in line with the doctor’s prescription. If you are not sure, talk to your doctor or pharmacist before use.
• The dose given will vary depending on the size of the child.
• Your child’s 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 initial dose is 600 mg/m² taken twice a day. The dose should be individualised based on the doctor’s clinical assessment. If well tolerated, the dose can be increased to 900 mg/m² twice daily if required (maximum total daily dose of 3 g).

Liver transplant

Adults

• The first dose of oral mycophenolate mofetil 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

• Capsules are only appropriate for children who are capable of swallowing solid medication without the risk of choking. The medicine should therefore only be given in line with the doctor’s prescription. If you are not sure, talk to your doctor or pharmacist before use.
• The dose given will vary depending on the size of the child. • Your child’s 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 initial dose is 600 mg/m² taken twice a day. The dose should be individualised based on the doctor’s clinical assessment. If well tolerated, the dose can be increased to 900 mg/m² twice daily if required (maximum total daily dose of 3 g).

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 Mycophenolate Capsules than you should

If you take more of this medicine 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 Mycophenolate Capsules

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.

If you stop taking Mycophenolate Capsules

Do not stop taking this medicine 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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

Fighting infections

Mycophenolate mofetil 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 mycophenolate mofetil patients 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 disorders,
• 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.

Additional side effects in children and adolescents

Children, especially those under 6 years old, may be more likely than adults to have some side effects, including diarrhoea, vomiting, infections, fewer red cells and fewer white cells in the blood, and possibly lymph or skin cancer.

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 Yellow Card Scheme: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in Google play or Apple App store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Mycophenolate Capsules

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.

Do not store above 30°C

HDPE container after first opening: use within 2 months

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.

6. Contents of the pack and other information

What Mycophenolate Capsules contains

• The active substance is mycophenolate mofetil. Each capsule contains 250 mg of mycophenolate mofetil.
• The other ingredients in the capsule content are pregelatinised maize starch, croscarmellose sodium, povidone (K90F) magnesium stearate. The capsule shell consists of gelatin, red iron oxide (E 172), yellow iron oxide(E 172), titanium dioxide (E 171), FD&C Blue #2 indigo carmine aluminium lake (E 132)

What Mycophenolate Capsules look like and contents of the pack

Hard gelatin capsules (size 1) with blue opaque cap and orange opaque body

PVC/PE/PVDC/Aluminium blister: 30, 50, 100, 150, 200,300, 360 and 600 capsules.

HDPE container: 250 capsules

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Sandoz Limited

Park View, Riverside Way

Watchmoor Park

Camberley, Surrey

GU15 3YL

United Kingdom

Manufacturers

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany or

LEK S.A., ul. Domaniewska 50 C, 02-672 Warszawa, Poland

Lek Pharmaceuticals d.d., Verovśkova 57, 1526 Ljubljana, Slovenia

Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austria

Lek Pharmaceuticals d.d., Trimlini 2D, 9220 Lendava, Slovenia

This leaflet is last revised in 12/2024.