Myclausen 500 mg film-coated tablets

Myclausen is a medicine used to suppress immune activity. The active substance of Myclausen is mycophenolate mofetil.
Myclausen is used to prevent your body from rejecting a transplanted kidney, heart or liver. It is used together with other medicines with a similar function (i.e. ciclosporin and corticosteroids).

Do not take Myclausen

- if you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid or any of the other ingredients of Myclausen.

- if you are breast-feeding.

Take special care with Myclausen

Patients taking Myclausen should be monitored carefully.

You should inform your doctor immediately:

- 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 fall pregnant while taking Myclausen.

Myclausen 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 UV light by wearing appropriate protective clothing and using a sunscreen with a high protection factor.

Myclausen should be avoided in patients with rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) (an enzyme which acts against conditions such as gout).

Use in children

Children (under 2 years of age)
Myclausen is not recommended for use in children under 2 years of age.

Children and adolescents (aged 2 to 18 years)
No data are available to recommend the use of Myclausen in children and adolescents who have received a heart transplant or a liver transplant.

Taking other medicines

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

Speak with your doctor if you are taking any of the following:

medicines containing:
- azathioprine or other immunosuppressive agents (which are sometimes given to patients after a transplant operation)
- cholestyramine (used to treat patients with high cholesterol)
- rifampicin (antibiotic)
- antacids
- phosphate binders (used in patients with chronic renal failure to reduce the absorption of phosphate)
- vaccines (live vaccines).

Taking Myclausen with food and drink

Taking food and drink has no influence on your treatment with Myclausen.

Pregnancy and breast-feeding

Use of Myclausen during pregnancy may cause miscarriage or damage to your unborn baby (abnormal development of ears for example).

If you plan to become pregnant, discuss with your doctor alternative medicines to best prevent rejection of your transplanted organ. In certain situations, you and your doctor may decide that the benefits of taking Myclausen for your health are more important than the possible risks to your unborn baby.

If you become pregnant while taking Myclausen, do not stop taking it, but tell your doctor about your pregnancy as soon as possible.

Do not take Myclausen if you are:

• Breast-feeding
• Pregnant (unless your doctor clearly tells you)

Tell your doctor straight away if:

• You think you may be pregnant
• You are breast-feeding
• You plan to start a family in the near future

You must always use an effective method of birth control:

• Before you start taking Myclausen
• During your entire treatment with Myclausen
• For 6 weeks after you stop taking Myclausen

You should talk to your doctor about the most suitable methods for birth control for you based on your individual situation.

Women who are capable of becoming pregnant must have a negative pregnancy test BEFORE starting treatment with Myclausen.

You are a woman who is not capable of becoming pregnant if any of the following 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 (bilateral salpingo-oophorectomy).
• Your uterus has been surgically removed (hysterectomy).
• You have premature failure of the ovaries, confirmed by a specialist gynaecologist.
• You have been diagnosed with one of the following rare conditions that some patients are born with that make pregnancy impossible: the XY genotype, Turner?s syndrome or uterine agenesis.
• You are a child/teenager who has not started having periods, and cannot become pregnant.

Driving and using machines

Myclausen has not been shown to impair your ability to drive or operate machinery.

Treatment with Myclausen should be initiated and maintained by appropriately qualified transplant specialists.

Always take Myclausen exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual way to take Myclausen is as follows:

Kidney Transplant

Adults
The first dose will be given within 72 hours after the transplant operation. The recommended daily dose is 4 tablets (2 g of the active ingredient) taken as 2 separate doses. This means taking 2 tablets in the morning then 2 tablets in the evening.
In renal transplant patients with severe chronic renal impairment, outside the immediate post-transplant period, the recommended daily dose should not be greater than 1 g administered twice a day.

Children and adolescents (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 body surface area (height and weight). The recommended dose is 600 mg per m 2 taken twice a day.

Heart Transplant

Adults
The first dose will be given within 5 days following the transplant operation. The recommended daily dose is 6 tablets (3 g of the active ingredient) taken as 2 separate doses. This means taking 3 tablets in the morning then 3 tablets in the evening.

Liver Transplant

Adults
The first dose of oral Myclausen will be given to you at least 4 days after the transplant operation and when you are able to swallow oral medications. The recommended daily dose is 6 tablets (3 g of the active ingredient) taken as 2 separate doses. This means taking 3 tablets in the morning and then 3 tablets in the evening.

Method and route of administration

Swallow your tablets whole with a glass of water. Do not break or crush them.

Treatment will continue for as long as you need immunosuppression to prevent you from rejecting your transplanted organ.

If you take more Myclausen than you should

It is important not to take too many tablets.
If you take more tablets than you have been told to take, or if someone else accidentally takes your medicine, immediately see a doctor or go to a hospital straight away.

If you forget to take Myclausen

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 Myclausen

Do not stop taking Myclausen because you feel better.
Stopping your treatment with Myclausen 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, Myclausen can have side effects, although not everybody gets them. Some of the more usual problems are diarrhoea, fewer white cells and/or red cells in your blood, infection and vomiting. Your doctor will do regular blood tests to monitor any changes in the number of your blood cells or changes in the levels of any of the substances carried in your blood, e.g. sugar, fat, cholesterol. Children may be more likely than adults to have side effects such as diarrhoea, infections, fewer white cells and fewer red cells in the blood.

Myclausen reduces your body?s own defence mechanisms to stop you rejecting your transplanted kidney, heart or liver. Consequently your body will not be as good as normal at fighting infections. So if you are taking Myclausen you may therefore catch more infections than usual, such as infections of the brain, skin, mouth, stomach and intestines, lungs and urinary tract. As can happen in patients taking this type of medicine, a very small number of Myclausen patients have developed cancer of the lymphoid tissues and skin.

General unwanted effects affecting your body as a whole could include hypersensitivity (such as anaphylaxis, angioeodema), fever, lethargy, difficulty in sleeping, pains (such as abdominal, chest, joint/muscle, pain on passing urine), headache, flu symptoms and swelling.

Very common side effects likely to affect more than 1 user in 10- Diarrhoea, vomiting, feeling sick
- Decrease in normal amounts of different blood cells, which can result in increased risk of infections, bruising, bleeding, breathlessness and weakness
- Bacterial, fungal and viral infections of the digestive and urinary tract, cold sores and shingles.

Common side effects likely to affect 1 to 10 users in 100
- Changes in different laboratory parameters, including increase in liver enzymes, kidney function changes such as creatinine, potassium, blood sugar, blood lipids, cholesterol, phosphates, magnesium, calcium and uric acid
- Kidney problems with increased levels of urea
- Disorders of the digestive system such as constipation, indigestion, flatulence, belching, inflammation of the mouth, oesophagus, stomach, intestine, liver or pancreas and gastrointestinal bleeding
- Convulsions, increased tension in the muscles, shaking and muscle weakness, joint pain - Sleeplessness, dizziness and headache, tingling or numbness, change of the sence of taste, loss of appetite, weight loss
- Inflammation and infections of the respiratory and gastrointestinal tract, sore throat, inflammation of the sinuse, runny and itchy nose
- Skin cancer or non-cancerous growth of the skin and fungal infections of the skin and vagina - Changes in blood pressure, faster heart beat, dilation of blood vessels
- Fluid retention in the body, fever, discomfort, lethargy and weakness
- Inflammation of the liver (indicated by dark coloured urine), yellowing of the skin and whites of the eyes
- Unusual bruising or bleeding, including vomiting blood or passing blood in your stools

Uncommon side effects likely to affect 1 to 10 users in 1,000
- Proliferation of the lymphatic tissue, including malignant tumours
- Inflammation or infections of the heart and its valves and of the membrane that covers the brain and spinal cord.

Other side effects that have been reported where frequency has not been established - Hypersensitivity (allergic) reactions
- There have been isolated reports of interstitial lung disease and pulmonary fibrosis in patients treated with mycophenolate mofetil in combination with other immunosuppressive agents, some of which have been fatal.

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 pharmacist.

Keep out of the reach and sight of children.

Do not use the tablets after the expiry date 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.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Myclausen contains

The active substance is mycophenolate mofetil.
Each tablet contains 500 mg mycophenolate mofetil

The other ingredients are:

Tablet core:
Microcrystalline cellulose
Povidone (K-30)
Croscarmellose sodium
Magnesium stearate

Tablet coat:
Polyvinyl alcohol (partially hydrolysed)
Titanium dioxide (E171)
Macrogol 3000
Talc

What Myclausen looks like and contents of the pack

White round film-coated tablets.
Myclausen 500 mg film-coated tablets are available in PVC-aluminium blisters in
pack sizes of 50 or 150 per carton.

Marketing Authorisation Holder

Herbert J. Passauer GmbH & Co. KG
Stubenrauchstrasse 33
14167 Berlin
Germany

Manufacturer

Lindopharm GmbH
Neustrasse 82
40721 Hilden
Germany

This leaflet was last approved in {MM/YYYY}