Skip to Content

UK Edition. Click here for US version.

ARZIP 500MG FILM-COATED TABLETS

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

PACKAGE LEAFLET: INFORMATION FOR THE USER
ARZIP 500 MG FILM-COATED TABLETS
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 500mg film-coated tablets (called Arzip throughout
this leaflet).
Arzip 500mg film-coated tablets contain mycophenolate mofetil. This belongs to a group
of medicines called “immunosuppressants”.
Arzip is 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 breast feeding.
Warnings and precautions
Talk to your doctor immediately

if you experience any evidence 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, such as
stomach ulcers.
if you are planning to become pregnant, or if you get pregnant while 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.
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 (for the treatment of 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, drink and alcohol
Taking food and drink has no influence 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 (abnormal 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, discuss with your doctor alternative medicines
to best 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.

Women who are capable of becoming pregnant must have a negative pregnancy test
BEFORE starting treatment with Arzip.
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 salpingooophorectomy).
 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.
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 or operate machinery.

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 4 tablets (2 g of the active ingredient), taken as 2 separate doses.
 Take 2 tablets in the morning and then 2 tablets 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 6 tablets (3 g of the active ingredient), taken as 2 separate doses.
 Take 3 tablets in the morning and then 3 tablets 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 6 tablets (3 g of the active ingredient), taken as 2 separate doses.
 Take 3 tablets in the morning and then 3 tablets in the evening.
Children
There is no information for the use of Arzip in children with a liver transplant.
Taking the medicine
 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
rejecting your transplanted organ.
If you take more Arzip than you should
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 straightaway.
If you forget to take Arzip

Do not take a double dose to make up for a forgotten dose.
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 Arzip
Stopping your treatment with Arzip 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.

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 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. Consequently your body will not be as good as normal
at fighting infections. So if you are taking Arzip you may therefore catch more infections
than usual, such as infections of the brain, skin, mouth, stomach and gut, lungs and
urinary tract.
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 25 °C.
Do not use the tablets after the expiry date (EXP) shown on the outer box.
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 Arzip 500mg film-coated tablets contain
The active substance is mycophenolate mofetil
The other ingredients of Arzip 500mg film-coated tablets are:
The tablet core:
microcrystalline cellulose
povidone K-90
hyprolose
croscarmellose sodium
talc
magnesium stearate
The film coating of the tablet:
hypromellose
titanium dioxide (E171)
polyethylene glycol 400
iron oxide – red (E 172)
indigo carmine aluminium varnish (E 132)
iron oxide – black (E172)
What Arzip 500mg film-coated tablets look like and contents of the pack
Arzip 500mg film-coated tablets are purple capsule-shaped biconvex (curved outwards
on both sides) tablets, with “AHI” stamped on one side and “500” on the other.
Arzip 500mg film-coated tablets are obtainable in blister packs of 50, 150 and 250
tablets. (The final printed version of the package leaflet should only show the pack sizes
available on the market).
Marketing authorisation holder: Winthrop Pharmaceuticals, PO Box 611, Guildford,
Surrey, GU1 4YS, UK
Or

Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Manufacturer:
Or
SOFARIMEX – Indústria Química e Farmacêutica, Lda, Av. Das Indústrias, Alto de
Colaride, Agualva, PT 2735 -213 Cacém, Portugal
Or
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Or
S. C. Zentiva S. A, 50 Theodor Pallady Blvd., District 3, 032266 Bucharest, Romania

(only the final printed leaflet to state the actual manufacturing site)
This medicinal product is authorised in the Member States of the EEA under
the following names:
United Kingdom
Arzip 500 mg film-coated tablets
Spain
Micofenolato de mofetilo Zentiva 500 mg comprimidos
recubiertos con película EFG

This leaflet was last revised in September 2014
© 2014 Zentiva.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide