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Arzip 250mg Capsules

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

ARZIP 250 MG CAPSULES

Mycophenolate mofetil

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 or pharmacist.

•    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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Arzip is and what it is used for

2.    What you need to know before you take Arzip

3.    How to take Arzip

4.    Possible side effects.

5.    How to store Arzip

6.    Contents of the pack and other information.

1. WHAT ARZIP IS AND WHAT IT IS USED FOR

The name of this medicine is Arzip 250mg Capsules (called Arzip throughout this leaflet).

Arzip 250mg Capsules contain mycophenolate mofetil. This belongs to a group of medicines called “immunosuppressants”.

Arzip capsules are used to prevent your body rejecting a transplanted kidney, heart or liver. Arzip should be used together with other medicines known as ciclosporin and corticosteroids.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ARZIP

Do not take Arzip

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

•    If you are pregnant or breast feeding.

Warnings and precautions

Talk to your doctor before taking Arzip::

•    If you have a sign of infection (e.g. fever, sore throat),

•    If you have 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 get pregnant while taking Arzip

•    If any of the above apply to you (or you are not sure), talk to your doctor straight away before taking Arzip.

The effect of sunlight

Arzip reduces your body’s defence mechanism. Because of this, there is an increased risk of skin cancer. Limit the amount of sunlight and UV light you get. Do this by:

•    wearing protective clothing which also covers your head, neck, arms and legs

•    using a sunscreen with a high protection factor.

Other medicines and Arzip

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Arzip can affect the way some other medicines work. Also other medicines can affect the way Arzip works.

In particular, tell your doctor or pharmacist if you are taking any of the following

medicines before you start Arzip:

•    azathioprine or other medicines which suppress your immune system (given after a transplant operation),

•    cholestyramine (used to treat patients with high cholesterol),

•    rifampicin (an antibiotic used to prevent and treat infections such as tuberculosis),

•    antacids or proton pump inhibitors (used for acid problems in your stomach such as indigestion),

•    phosphate binders (used in patients with chronic kidney 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.

Vaccines

If you need to have a vaccine (a live vaccine) while taking Arzip, talk to your doctor or

pharmacist first. Your doctor will have to advise you what vaccines you can have.

Arzip with food and drink

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

Pregnancy, breast-feeding and fertility

   If you are pregnant, do not take Arzip. Use of Arzip during pregnancy may cause miscarriage or damage to your unborn baby (affecting development of ears for example). In certain situations, you and your doctor may decide that the benefits of taking Arzip for your health are more important than the possible risks to your unborn baby.

   If you plan to become pregnant, talk to your doctor first. Your doctor will talk to you about other medicines you can take to prevent rejection of your transplanted organ.

   If you become pregnant while taking Arzip, do not stop taking it, but tell your doctor about your pregnancy straight away.

If you are able to become pregnant, you must have a pregnancy test before you start Arzip. You can only start Arzip if the test is negative.

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 by surgery (bilateral salpingo-oophorectomy).

•    Your womb (uterus) has been surgically removed (hysterectomy).

•    Your ovaries no longer work (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,

Contraception

You must always use an effective method of birth control:

•    Before you start taking Arzip

•    During your entire treatment with Arzip

•    For 6 weeks after you stop taking Arzip.

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

Breast-feeding

Do not take Arzip if you are breast-feeding. This is because small amounts of the medicine can pass into the mother’s milk.

Driving and using machines:

Arzip is not likely to affect your ability to drive oruse any tools or machines.

3 HOW TO TAKE ARZIP

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 after the transplant operation.

•    The daily dose is 8 capsules (2 g of the active ingredient), taken as 2 separate doses.

•    Take 4 capsules in the morning and then 4 capsules 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 your child’s height and weight (body surface area - measured as square metres or “m2”).

The recommended dose is 600 mg/m2 taken twice a day.

Heart transplant

Adults

•    The first dose is given within 5 days following the transplant operation.

•    The daily dose is 12 capsules (3 g of the active ingredient), taken as 2 separate doses.

•    Take 6 capsules in the morning and then 6 capsules in the evening.

Children

There is no information for the use of Arzip in children with a heart transplant.

Liver transplant

Adults

•    The first dose of oral Arzip 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 active ingredient), taken as 2 separate doses.

•    Take 6 capsules in the morning and then 6 capsules in the evening.

Children

There is no information for the use of Arzip in children with a liver transplant.

Taking the medicine

•    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 plenty of plain, fresh water.

• .

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

If you take more Arzip than you should

If you take more capsules than you shouldor if someone else accidentally takes your medicine, immediately see a doctor or go to a hospital straight away. Take the medicine pack with you.

If you forget to take Arzip

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 Arzip

Do not stop taking your medicine unless your doctor tells you to. Stopping your treatment with Arzip may increase the chance of rejection of your transplanted organ.

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

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 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

•    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 some side effects such as diarrhoea, infections, fewer white cells and fewer red cells in the blood.

Fighting infections

Arzip reduces your body’s own defence mechanisms to stop you rejecting your transplanted kidney, heart or liver. 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 Arzip 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 in sleeping, pains (such as stomach, chest, joint/muscle, pain on passing urine), 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:

•    kidney problems or the urgent need to pass urine.

Digestive system and mouth problems such as:

•    swelling of the gums and mouth ulcers,

•    inflammation of the pancreas, colon or stomach,

•    gut problems including bleeding, liver problems,

•    constipation, feeling sick (nausea), indigestion, loss of appetite, wind.

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, unusual 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.

Reporting of side effects

If you get any side effects, talk to your doctor 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 ARZIP

Keep this medicine out of the sight and reach of children.

Do not store above 30 °C. Store in the original package in order to protect from moisture.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.

Do not throw away any medicines via waste water 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 Arzip 250mg Capsules contain:

The active substance is mycophenolate mofetil.

The other ingredients are:

Content of the capsules: cellulose microcrystalline, hydroxy propyl cellulose, povidone K 90, croscarmellose sodium, talc,

magnesium stearate.

Capsule shells: gelatin,

sodium lauryl sulphate, potassium hydroxide, shellac,

propylene glycol,

indigo carmine (E132), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), black iron oxide (E 172),

What Arzip 250mg Capsules look like and contents of the pack

Arzip 250mg Capsules are light blue/peach, size ‘ 1 ’ hard gelatin capsules imprinted with ‘MMF’ on cap and ‘250’ on body.

Arzip 250mg Capsules are obtainable in blister packs of 20, 100 and 300 capsules. Not all pack sizes may be marketed.

Marketing authorisation holder: Winthrop Pharmaceuticals, PO Box 611, Guildford, Surrey, GU1 4YS, UK.

Or

Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Manufacturers:

SOFARIMEX Industria Quimica e Farmaceutica Lda, Avda das Industrias - Alto deColaride,Agualva, 2735-213 Cacem- Portugal or

ACCORD HEALTHCARE LIMITED, Sage House 319, Pinner Road, North Harrow, Middlesex HA1 4HF- United Kingdom Or

S. C. Zentiva S. A, 50 Theodor Pallady Blvd., District 3, 032266 Bucharest, Romania

This medicinal product is authorised in the Member States of the EEA under the following names:

United Kingdom Arzip 250 mg Capsules

Spain    Micofenolato de mofetilo Zentiva 250 mg capsulas EFG

France    Mycophenolate Mofetil Zentiva 250 mg gelules

This leaflet was last revised in January 2015 © 2015 Zentiva