Package leaflet: Information for the user

ACCEMPA 180 mg AND 360 mg GASTRO-RESISTANT TABLETS

mycophenolic acid

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-    Keep this leaflet. You may need to read it again.

-    If you have any further    questions, ask your doctor, pharmacist or nurse.

-    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 is in this leaflet:

1.    What Accempa is and what it is used for

2.    What you need to know before you take Accempa

3.    How to take Accempa

4.    Possible side effects

5.    How to store Accempa

6.    Contents of the pack and other information

1. What Accempa is and what it is used for

Accempa contains a substance called mycophenolic acid. This belongs to a group of medicines called immunosuppressants.

Accempa is used to stop the body’s immune system from rejecting a kidney transplant. It is used together with other medicines containing ciclosporin and corticosteroids.

2. What you need to know before you take Accempa

Do not take Accempa

•    if you are allergic to mycophenolic acid, mycophenolate sodium, mycophenolate mofetil or any of the other ingredients of this medicine (listed in section 6)

•    if you are breast-feeding (see also “Pregnancy, breast-feeding and fertility”)

•    If you are a woman of child bearing potential and you are not using highly effective contraception methods.

If any of the above apply to you, tell your doctor without taking Accempa.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Accempa:

•    if you have or have ever had serious digestive problems, such as a stomach ulcer

•    if you have a rare hereditary enzyme deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan or Kelley-Seegmiller syndrome.

You should also be aware that

•    Accempa lowers the skin's level of protection from the sun. This increases the risk of skin cancer. You should limit your exposure to sunlight and ultraviolet (UV) light by covering

exposed skin areas as much as possible and regularly applying sunscreen with a high protective factor. Ask your doctor for advice on protection from the sun

•    if you get any signs of infection (such as fever or a sore throat) or unexpected bruising or bleeding you should tell your doctor straight away

•    your doctor may want to check your white blood cell count during treatment with Accempa, and will tell you whether you can continue taking Accempa

•    the active substance, mycophenolic acid, is not the same as other similar-sounding medicines such as mycophenolate mofetil. You should not switch between medicines unless your doctor tells you to

•    use of Accempa in pregnancy may harm the foetus (see also “Pregnancy and breast-feeding”) and increase the risk of pregnancy loss.

Children and adolescents

The use of Accempa in children and adolescents is not recommended due to lack of data.

Other medicines and Accempa

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, you should talk to your doctor if you are taking any of the following:

•    other immunosuppressant medicines such as azathioprine or tacrolimus

•    medicines used to treat high blood cholesterol levels such as cholestyramine

•    activated charcoal used to treat digestive problems such as diarrhoea, upset stomach, and gas

•    antacids that contain magnesium and aluminium

•    medicines used to treat viral infections such as aciclovir or ganciclovir.

You should also tell your doctor if you plan to have any vaccinations.

Accempa with food and drink and alcohol

Accempa can be taken with or without food. You need to choose whether to take your tablets with or without food and then take them in the same way each day. This is to make sure that the same amount of your medication is absorbed into your body each day.

Elderly patients

Elderly people (age 65 years or older) can take Accempa without any need to adjust the usual recommended dose.

Pregnancy, breast-feeding and fertility

If you are a woman you should make sure that you are not pregnant, by means of a negative pregnancy test, before you start taking Accempa. Because mycophenolic acid may harm the foetus and increase the risk of pregnancy loss, Accempa should not be used during pregnancy unless clearly necessary.

If you are a woman, your doctor should advise you about contraception before you start taking Accempa. You must use contraception before and while taking it and for 6 weeks after you have stopped taking it. Tell your doctor straight away if you become pregnant during treatment with Accempa.

It is not known whether Accempa passes into breast milk. Do not breast-feed during treatment with Accempa or for 6 weeks after you have stopped taking Accempa.

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

If you are a sexually active man it is recommended to use condoms during treatment, and for a total of 13 weeks after your last dose of Accempa. In addition, your female partners are recommended to use highly effective contraception during your treatment and for a total of 13 weeks after the last dose of Accempa.

Driving and using machines

Accempa has not been shown to affect your ability to drive or use machines.

Accempa contains sodium

Accempa 180 mg Gastro-resistant Tablets contains 0.61 mmol (13.9 mg) sodium per tablet. To be taken into consideration by patients on a controlled sodium diet.

Accempa 360 mg Gastro-resistant Tablets contains 1.21 mmol (27.9 mg) sodium per tablet. To be taken into consideration by patients on a controlled sodium diet.

3. How to take Accempa

Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Accempa will only be prescribed for you by a doctor with experience in treating transplant patients. Check with your doctor, pharmacist or nurse if you are not sure.

How much to take

The recommended daily dose of Accempa is 1440 mg (8 tablets of 180 mg or 4 tablets of 360 mg). This is taken as 2 separate doses of 720 mg each (4 tablets of 180 mg or 2 tablets of 360 mg).

Take your tablets in the morning and in the evening.

The first dose of 720 mg will be given within 72 hours after transplantation.

If you have severe kidney problems

Your daily dose should not be more than 1440 mg (8 tablets of 180 mg or 4 tablets of 360 mg). Taking Accempa

Swallow the tablets whole with a glass of water.

Do not break or crush the tablets.

Do not take any tablets that are broken or split.

Treatment will continue for as long as you need immunosuppression to stop your body rejecting your transplant.

If you take more Accempa than you should

If you take more Accempa than you should, or if someone else has taken your tablets, talk to a doctor or go to a hospital straight away. Medical attention may be necessary. Take the tablets with you and show them to your doctor or to the hospital staff. If you have run out of tablets, take the empty packaging with you.

If you forget to take Accempa

If you forget to take Accempa, take it as soon as you remember unless it is almost time for your next dose. Then take your next dose at the usual time. Ask your doctor for advice. Do not take a double dose to make up for a forgotten dose.

If you stop taking Accempa

Do not stop taking Accempa unless your doctor tells you to. Stopping Accempa may increase the chance of your body rejecting your kidney transplant.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Elderly patients may experience more side effects due to a reduced immune defence.

Immunosuppressants, including Accempa, reduces your body’s own defence mechanisms to stop you rejecting your transplanted organ. Consequently your body will not be as good as normal at fighting infections. So if you are taking Accempa, you may therefore catch more infections than usual such as infections of the brain, skin, mouth, stomach and intestines, lungs and urinary tract.

Your doctor will perform regular blood tests to monitor any changes in the number of your blood cells or in the levels of substances carried in your blood, such as sugar, fat and cholesterol.

Some effects could be serious:

•    signs of infection including fever, chills, sweating, feeling tired, drowsy, or lack of energy. If you are taking Accempa you may be more likely to get an infection than usual. Such infections could affect various parts of your body, but the parts most commonly affected are the kidneys, bladder, upper and/or lower airways

•    vomiting blood, black or bloody stools, stomach or intestinal ulcer

•    swelling of your glands, development of a new skin growth or enlargement of an existing skin growth, or changes in an existing mole. As can happen in patients taking immunosuppressants, a very small number of Accempa patients have developed cancer of the skin or lymph nodes.

If you experience any of the above after taking Accempa, talk to your doctor straight away.

Other side effects may include:

Very common (may affect more than 1 in 10 people)

•    diarrhoea

•    low level of white blood cells.

Common (may affect up to 1 in 10 people)

•    low level of red blood cells which can result in tiredness, breathlessness and looking pale (anaemia)

•    unexpected bleeding and bruising (possible signs of a low level of blood platelets)

•    headache

•    cough

•    abdominal or stomach pain, inflammation of the lining of the stomach, abdominal bloating, constipation, indigestion, wind (flatulence), loose stools, feeling sick (nausea), being sick (vomiting)

•    tiredness, fever

•    abnormal results of liver or kidney function tests

•    respiratory infections.

Uncommon (may affect up to 1 in 100 people)

•    fast or irregular heartbeat, fluid in the lungs

•    a growth that looks like a sac (cyst) containing fluid (lymph)

•    trembling, difficulty in sleeping

•    itching, redness and swelling of eyes, blurred vision

•    wheezing

•    belching, bad breath, bowel blockage, lip ulcers, heartburn, tongue discolouration, dry mouth, inflammation of the gums, inflammation of the pancreas leading to severe upper stomach pain, blockage of the salivary glands, inflammation of the inner lining of the abdomen

•    infection of the bones, blood and the skin

•    blood in urine, damage to the kidney, pain and difficulty passing urine

•    hair loss, skin bruising

•    inflammation of the joints, back pain, muscle cramps

•    loss of appetite, increased level of lipids, sugar, cholesterol, or decreased level of phosphate in the blood

•    signs of flu (such as tiredness, chills, sore throat, aching joints or muscles), swelling of ankles and feet, feeling thirsty or weak

•    strange dreams, believing things that aren't true (delusions)

•    inability to get or keep an erection.

Not known (frequency cannot be estimated from the available data)

•    rash

•    lung problems such as:

- shortness of breath, cough, which can be due to bronchiectasis (a condition in which the lung airways are abnormally dilated), and other less common bacterial infections usually resulting in a serious lung disorder (tuberculosis and atypical mycobacterial infection). Talk to your doctor if you develop a persistent cough or breathlessness.

Other side effects reported with medicines similar to Accempa

Additional side effects have been reported with the group of medicines that Accempa belongs to: inflammation of the colon (large intestine), inflammation of the stomach lining caused by cytomegalovirus, development of a hole in the intestinal wall, resulting in severe abdominal pain with possible bleeding, stomach or duodenal ulcers, a low level of specific white blood cells or of all blood cells, serious infections such as inflammation of the heart and its valves and of the membrane that covers the brain and spinal cord, and other less common bacterial infections usually resulting in a serious lung disorder (tuberculosis and atypical mycobacterial infection).

Reporting of side effects

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Accempa

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 carton. The expiry date refers to the last day of that month.

This medicinal product does not require any special temperature storage conditions.

Store in the original package in order to protect from light.

Do not use this medicine if you notice visible signs of deterioration.

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 Accempa contains

The active substance is mycophenolic acid (as mycophenolate sodium).

Each tablet contains 180 mg of mycophenolic acid.

Each tablet contains 360 mg of mycophenolic acid.

The other ingredients are:

Tablet core:

Cellulose Microcrystalline (E460), Croscarmellose sodium (E468), Povidone K30 (E1201), Talc (E553b), Silica, colloidal anhydrous (E551), Magnesium stearate (E470b).

Accempa 180 mg Gastro-resistant Tablets Tablet Coating:

Methacrylic acid - ethyl acrylate copolymer (1:1), talc (E553b, titanium dioxide (E171), triethyl citrate (E1505), silica, colloidal anhydrous (E551), sodium hydrogen carbonate (E500), iron oxide yellow (E172), indigo carmine aluminium lake (E132), sodium laurilsulfate (E487).

Accempa 360 mg Gastro-resistant Tablets Tablet Coating:

Methacrylic acid - ethyl acrylate copolymer (1:1), talc (E553b), titanium dioxide (E171), triethyl citrate (E1505), silica, colloidal anhydrous (E551), sodium hydrogen carbonate (E500), iron oxide yellow (E172), iron oxide red (E172), sodium laurilsulfate (E487).

Tablet Imprinting:

Shellac glaze, partially esterified (E904), iron oxide black (E172), propylene glycol (E1520).

What Accempa looks like and contents of the pack

Accempa 180 mg Gastro-resistant Tablets are lime green coloured, round shaped, biconvex bevelled edged enteric-coated tablets imprinted with M1 on one side with black ink and plain on the other side

Accempa 360 mg Gastro-resistant Tablets are peach coloured, oblong shaped, biconvex, enteric-coated tablets imprinted with M2 on one side with black ink and plain on the other side.

Accempa 180 mg and 360 mg Gastro-resistant Tablets are available in blister packs containing 50, 100, 120 and 250 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder TEVA UK Limited, Eastbourne, BN22 9AG, UK

Manufacturer

Teva Pharma B.V., Swensweg 5, Haarlem, 2031 GA, The Netherlands *OR

Merckle GmbH, Ludwig-Merckle-StraBe 3, Blaubeuren, 89143, Germany *OR

PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.), Prilaz baruna Filipovica 25, Zagreb, 10000, Croatia *OR

Pharmadox healthcare Ltd., KW20A Kordin Industrial Park, Paola PLA 3000, Malta

This leaflet was last revised in 01/2015.

PL 00289/1895 PL 00289/1896

* Only the actual site of batch release will appear on the printed version of the leaflet