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MOMETIL 500MG FILM-COATED TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Mometil 500mg film-coated tablets
Mycophenolate mofetil
Read all of this leaflet carefully before you start taking this medicine.
-

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. Do not pass it on to others. It may
harm them, even if their symptoms are the same as yours.
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.

In this leaflet:
1.
2.
3.
4.
5.
6.
1.

What Mometil is and what it is used for
Before you take Mometil
How to take Mometil
Possible side effects
How to store Mometil
Further information
WHAT MOMETIL IS AND WHAT IT IS USED FOR

Mometil contains the active ingredient mycophenolate mofetil which is one group of drugs
known as immunosuppressant agents. Immunosuppressants are used to prevent rejection of
transplanted organs like kidney, heart or liver and work by stopping your immune system
from reacting to the transplanted organ
Mometil may be used together with other medicines known as ciclosporin and corticosteroids
2.

BEFORE YOU TAKE MOMETIL

Do not take Mometil:
if you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid or any
of the other ingredients of Mometil (listed in ‘FURTHER INFORMATION’)
if you breast-feeding
Take special care with Mometil:
Tell your doctor if any of the following applies to you:
if you think you may have an infection (signs may include fever, chills, local
inflammation, sore throat or ulcers in the mouth, but there could be other symptoms),
any evidence of unexpected bruising or any unexpected bleeding.
if you are suffering or have suffered from problems with your digestive system (such as
ulcers or bleeding).
Mometil 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 tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.

Some medicines may interfere with Mometil.
If you are taking any of the medicines listed below talk to your doctor before you start taking
Mometil:








antacids - a class of medicines for indigestion or heartburn
azathioprine - is a drug used to suppress the body’s own defence system
cholestyramine (used to treat patients with high cholesterol)
other immunosuppressant
phosphate binders – used in patients with chronic renal failure to reduce the
absorption of phosphate
rifampicin – an antibiotic used treat infections
vaccinations - as they may not be as effective as normal. Vaccination with live
vaccines should be avoided.

Taking Mometil with food and drink
Taking food and drink has no influence on your treatment with Mometil
Pregnancy and breast-feeding
Do not take Mometil if you are breastfeeding.
You must not use mycophenolate during pregnancy unless clearly indicated by your doctor.
Your doctor should advise you about using contraception before taking Mometil, whilst
taking mycophenolate, and for six weeks after you have stopped taking Mometil. This is
because mycophenolate may cause damage, including problems with development of the ears,
to your unborn baby. Tell your doctor straight away if you are pregnant, breast-feeding,
become pregnant or plan to start a family in the near future.
Driving and using machines
Mometil has not been shown to impair your ability to drive or operate machinery

3.

HOW TO TAKE MOMETIL

Always take Mometil exactly as your doctor has told you. You should check with your doctor
or pharmacist if you are not sure. The usual dose 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.
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/m2 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.
Children:

No data are available to recommend the use of Mometil in children who have received a heart
transplant.
Liver Transplant
Adults:
The first dose of oral Mometil 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 then 3 tablets in the evening.
Children:
No data are available to recommend the use of Mometil in children who have received a liver
transplant.

Method and route of administration
The tablets should be swallowed 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 Mometil than you should
Never take more than the recommended dose each day. If you or someone else swallows
several of these tablets all together, contact your doctor, pharmacist or hospital emergency
department immediately. Always take any tablets left over with you and also the box, as this
will allow easier identification of the tablets.
If you forget to take Mometil
If you forget to take your medicine at any time, take it as soon as you remember unless it is
almost time for your next dose then go on as before. Do not take a double dose to make up for
a forgotten dose
If you stop taking Mometil
Always take Mometil exactly as your doctor has told you. Never stop taking your medicine or
change the dose yourself, however well you feel unless you have discussed this with your
doctor first. This is important to ensure your transplanted organ keeps working properly
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4.

POSSIBLE SIDE EFFECTS

Like all medicines, Mometil can cause 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
Mometil 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 Mometil 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
Mometil 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, angioedema), 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 as constipation, 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 as pneumonia, 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,
please tell your doctor or pharmacist
However, do not stop taking your medicine unless you have discussed this with your doctor
first.

5.

HOW TO STORE MOMETIL

Keep out of the reach and sight of children.
Do not use Mometil after the expiry date which is stated on the carton. The expiry date refers
to the last day of that month.
There are no special storage precautions for mycophenolate tablets.
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.

6.

FURTHER INFORMATION

What Mometil contains
The active substance is Mycophenolate mofetil

The other ingredients are:
Tablet core:
microcrystalline cellulose
povidone K-90
croscarmellose sodium
magnesium stearate
silica collodial anhydrous
Tablet coating:
hypromellose
hydroxypropyl cellulose
titanium dioxide (E171)
macrogol 400
iron oxide yellow (E172)
iron oxide red (E172)
indigo carmine aluminium lake (E132)
What Mometil looks like and contents of the pack
Mometil are supplied as violet coloured caplet shaped film-coated tablets in blisters
containing 50 or 150 tablets.
Not all pack sizes may be marketed
Marketing Authorisation Holder
Eurogenus Farmacêutica Sociedade Unipessoal Lda
Rua Alto do Montijo, 13 - 2º Dtº
2790-012 Portela Carnaxide
Portugal
Manufacturer
Sofarimex – Indústria Química e Farmacêutica, Lda
Av. Das Indústrias,
Alto de Colaride,
Agualva,
2735-213 Cacém
Portugal
and
Monteresearch
Via IV Novembre 94,
20021 Bollate (MI)
Italy
This medical product is authorised in the Member States of the EEA under the
following names:
UK: Mometil 500 mg Film-coated tablet

CZ: Mometil 500 mg
EE: Mometil
HU: Mometil 500 mg Filmtabletta
LT: Mometil 500mg Plèvele dengtos tabletès
LV: Mometil 500 mg apvalkotas tabletes
PL: Mometil
RO: Mometil 500 mg Comprimate filmate
This leaflet was last approved on 01/2010

+ 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.

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