CellCept 1 g/5 ml powder for oral suspension

Immunosuppressants.

CellCept 1 g/5 ml powder for oral suspension is used to prevent your body rejecting a transplanted kidney, heart or liver. CellCept 1 g/5 ml powder for oral suspension is used together with other medicines known as ciclosporin and corticosteroids.

Do not take CellCept:

• If you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid or any of the other ingredients of CellCept.
• If you are breastfeeding.

Take special care with CellCept:

You should inform your doctor immediately:

• In case of 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 suffer from phenylketonuria (a rare, hereditary disorder of the metabolism).
• If you are planning to become pregnant, or if you fall pregnant while taking CellCept.

CellCept 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.

Taking other medicines:

Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, even those not prescribed.

If you answer yes to any of the following questions talk to your doctor before you start to take CellCept:

• 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, phosphate binders (used in patients with chronic renal failure to reduce the absorption of phosphate) or any other medicines (including those you can buy without a prescription) that your doctor does not know about?
• Do you need to receive vaccines (live vaccines)? Your doctor will have to advise you what is indicated for you.

Taking CellCept with food and drink:

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

Pregnancy and breast feeding:

Use of CellCept 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 CellCept for your health are more important than the possible risks to your unborn baby.

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

Do not take CellCept 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 CellCept
• During your entire treatment with CellCept
• For 6 weeks after you stop taking CellCept

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 CellCept.

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

Important information about some of the ingredients of CellCept 1 g/5 ml powder for oral suspension:

CellCept 1 g/5 ml powder for oral suspension contains aspartame. If you suffer from phenylketonuria (a rare, hereditary disorder of the metabolism), talk to your doctor before you start to take this medicine.

This medicine also contains sorbitol which is a sugar. If you have been told by your doctor that you have an intolerance to some sugars, such as sorbitol, contact your doctor before taking this medicinal product.

Always take CellCept 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 CellCept oral suspension is as follows:

Kidney Transplant

Adults:
The first dose will be given within 72 hours after the transplant operation. The recommended daily dose is 10 ml suspension (2 g of the active ingredient) taken as 2 separate doses. This means taking 5 ml suspension in the morning and then 5 ml suspension 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 body surface area (height and weight). The recommended dose is 600 mg/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 15 ml suspension (3 g of the active ingredient) taken as 2 separate doses. This means taking 7.5 ml suspension in the morning then 7.5 ml suspension in the evening.

Children:
No data are available to recommend the use of CellCept in children who have received 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 medications. The recommended daily dose is 15 ml suspension (3 g of the active ingredient) taken as 2 separate doses. This means taking 7.5 ml suspension in the morning then 7.5 ml suspension in the evening.

Children:
No data are available to recommend the use of CellCept in children who have received a liver transplant.

Method and route of administration

It is recommended that the pharmacist reconstitutes CellCept oral suspension for you prior to dispensing.

To reconstitute the suspension the pharmacist will proceed as follows:

Preparation of suspension

1. Tap the closed bottle several times to loosen the powder.

2. Measure 94 ml of purified water in a graduated cylinder.

3. Add approximately half of the total amount of purified water to the bottle and shake the closed bottle well for about 1 minute.

4. Add the remainder of water and shake the closed bottle well for about 1 minute.

5. Remove child-resistant cap and push bottle adapter into neck of bottle.

6. Close bottle with child-resistant cap tightly. This will assure the proper seating of the bottle adapter in the bottle and child-resistant status of the cap.

7. Write the date of expiration of the reconstituted suspension on the bottle label. (The shelf-life of the reconstituted suspension is 2 months.)

Avoid inhalation or direct contact with skin or mucous membranes of the dry powder as well as direct contact of the reconstituted suspension with the skin. If such contact occurs, wash thoroughly with soap and water; rinse eyes with plain water.

To withdraw the suspension with the oral dispenser proceed as follows:

1. Shake closed bottle well for about 5 seconds before each use.

2. Remove child-resistant cap.

3. Before inserting the tip of the dispenser into bottle adapter, push the plunger completely down toward the tip of the dispenser. Insert tip firmly into opening of the bottle adapter.

4. Turn the entire unit (bottle and dispenser) upside down.

5. Pull the plunger out slowly until the desired amount of medication is withdrawn into the dispenser (see figure).

6. Turn the entire unit right side up and remove the dispenser slowly from the bottle.

7. Dispense directly into mouth and swallow. Do not mix with any liquid prior to dispensing.

8. Close bottle with child-resistant cap after each use.

9. Immediately after administration: Disassemble dispenser, rinse under running tap water and air dry prior to next use.

Care should be taken to avoid contact of the skin with the suspension. If such contact occurs, wash thoroughly with soap and water.

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

If you take more CellCept than you should:

If you take more suspension 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 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.

If you stop taking CellCept:

Stopping your treatment with CellCept 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 product, ask your doctor.

Like all medicines, CellCept 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.

CellCept 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 CellCept 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 CellCept 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.

Other unwanted effects may include:

Disorders of the skin such as acne, cold sores, shingles, skin growth, hair loss, rash,itching.

Urinary disorders such as kidney problems or the urgent need to pass urine.

Disorders of the digestive system and mouth such asconstipation, nausea, indigestion, pancreas inflammation, intestinal disorders including bleeding, inflammation of the stomach, liver problems, inflammation of the colon, loss of appetite, flatulence, swelling of the gums and mouth ulcers.

Disorders of the nerves and senses such as convulsions, tremor, dizziness, depression, drowsiness, numbness, muscle spasms, anxiety, changes in thinking or mood.

Metabolic, blood and vascular disorders such as weight loss, gout, high blood sugar, bleeding, bruises, change in blood pressure, abnormal heart beat and dilation of blood vessels may be seen.

Disorders of the lungs such aspneumonia, bronchitis, shortness of breath, cough, fluid on the lungs/chest cavity, sinus problems.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet whilst you are taking CellCept, please tell your doctor or pharmacist. However, do not stop taking your medicine unless you have discussed this with your doctor first.

Keep out of the reach and sight of children.

Do not use after the expiry date stated on the carton and bottle label (EXP).

The shelf-life of the reconstituted suspension is two months. The pharmacist will write the date of expiration on the bottle label in the black box next to "Use before". Do not use the suspension past this expiry date.

Powder for oral suspension: do not store above 30°C.

Reconstituted suspension: do not store above 30°C.

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 CellCept contains

• The active substance is mycophenolate mofetil
• The other ingredients are:

CellCept 1 g/5 ml powder for oral suspension:
sorbitol
silica, colloidal anhydrous
sodium citrate
soybean lecithin
mixed fruit flavour
xanthan gum
aspartame* (E951)
methyl parahydroxybenzoate (E218)
citric acid anhydrous

* contains phenylalanine equivalent to 2.78 mg/5 ml of suspension.

What CellCept looks like and contents of the pack

CellCept 1 g/5 ml powder for oral suspension:
Each bottle contains 110 g of powder for oral suspension. When reconstituted, the volume of the suspension is 175 ml, providing a usable volume of 160 ? 165 ml.
A bottle adapter and 2 oral dispensers are also provided.

Marketing Authorisation Holder

Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom

Manufacturing Authorisation holder responsible for batch release
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:

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