MYCOPHENOLATE MOFETIL SANDOZ 500MG FILM-COATED TABLETS

Active substance: MYCOPHENOLATE MOFETIL

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Mycophenolate mofetil Sandoz 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 Mycophenolate is and what it is used for
2. What you need to know before you take
Mycophenolate
3. How to take Mycophenolate
4. Possible side effects
5. How to store Mycophenolate
6. Contents of the pack and other information

1

What Mycophenolate is and
what it is used for

Mycophenolate belongs to the class of drugs
known as immunosuppressants.
Mycophenolate tablets are used to prevent your
body rejecting a transplanted kidney, heart or liver.
Mycophenolate is used together with other
medicines known as ciclosporin and corticosteroids.

2

What you need to know before
you take Mycophenolate

Do not take Mycophenolate if:
• you are allergic (hypersensitive) to
mycophenolate mofetil, mycophenolic acid or
any of the other ingredients of this medicine
(listed in section 6).
• you are breast-feeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking
Mycophenolate if:
• you experience any evidence of infection (e.g.
fever, sore throat), unexpected bruising and/or
bleeding.
• you have, or ever have had any problems with
your digestive system, e.g. stomach ulcers.
• you are planning to become pregnant, or if
you fall pregnant while taking Mycophenolate.
• you suffer from an enzyme defect called
ʻLesch-Nyhan syndromeʼ or ʻKelley Seegmiller
syndromeʼ.
• Limit your exposure to sunlight and UV light by
wearing appropriate protective clothing and
using a sunscreen with a high protection
factor. There is an increased risk of skin
cancer because mycophenolate reduces your
bodyʼs defence mechanism.
Other medicines and Mycophenolate
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, including medicines obtained without
a prescription.

Take care with the following medicines:
• Azathioprine or tacrolimus or other
immunosuppressive agents (which are
sometimes given to patients after a transplant
operation)
• Colestyramine (used to treat patients with high
blood cholesterol)
• Rifampicin, ciprofloxacin or amoxicillin plus
clavulanic acid (antibiotics)
• Antacids or medicines called ʻproton pump
inhibitorsʼ like omeprazole or pantoprazole
(used treat diseases related to the acid in the
stomach)
• Phosphate binders (used in patients with
chronic renal failure to reduce the absorption
of phosphate)
• Aciclovir, ganciclovir (for viral infections)
• Live vaccines should be avoided. Your doctor
will have to advise you what is indicated for you.

Pregnancy and breast-feeding
Use of Mycophenolate during pregnancy may
cause miscarriage or damage to your unborn
baby (abnormal development of ears for example).

SZ00000LT000

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 Mycophenolate for your
health are more important than the possible risks
to your unborn baby.

If you become pregnant while taking
Mycophenolate, do not stop taking it, but tell your
doctor about your pregnancy as soon as possible.
Do not take Mycophenolate 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 Mycophenolate
• During your entire treatment with Mycophenolate
• For 6 weeks after you stop taking
Mycophenolate.
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 Mycophenolate.

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, Turnerʼs
syndrome or uterine agenesis.
• You are a child/teenager who has not started
having periods, and cannot become pregnant.
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 Mycophenolate.
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 Mycophenolate.
Driving and using machines
Mycophenolate mofetil has not been shown to
impair your ability to drive or operate machinery.

3

How to take Mycophenolate

Always take this medicine exactly as your doctor
or pharmacist has told you. 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 and 2 tablets in the evening.

Children and adolescents (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 and 3
tablets in the evening.

Please turn over

Children:
No data are available to recommend the use of
mycophenolate mofetil in children who have
received a heart transplant.

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

Method and route of administration
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 Mycophenolate 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 straight away.

If you forget to take Mycophenolate
Do not worry, take it as soon as you remember.
If it is almost time to take the next dose, wait until
then and continue with your usual schedule.
Do not double the dose to make up for the one
missed.

If you stop taking Mycophenolate
Stopping your treatment with mycophenolate
mofetil 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.

Serious side effects
If you notice one of the following serious side
effects, talk to your doctor or go to a hospital
immediately:
• In case of any evidence of infection (e.g. fever,
sore throat)
• Unusual bruising or bleeding, includes
vomiting blood or passing blood in your stools
• Fits (convulsions)
• Yellowing of the skin and eyes, unusual
tiredness or fever, dark coloured urine (signs
of inflamed liver)
• Hypersensitivity reactions (anaphylaxis,
angioedema): If you develop a swelling of the
eyelids, face, lips, mouth or tongue, start to
itch or have difficulty in breathing or
swallowing, or extreme dizziness.
Other possible side effects
Elderly patients may generally be at increased
risk of side effects.
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.

Following side effects are very common (may
affect more than 1 in 10 people):
• Fewer white cells and/or red cells or platelets
in your blood. 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
• Diarrhoea, feeling or being sick, abdominal pain
• Cold sores, shingles
• Urinary tract infections, urgent need to pass
urine.
Following side effects are common (may
affect up to 1 in 10 people):
• Infections of the brain, skin, mouth,
stomach and intestines, and lungs:
Mycophenolate mofetil reduces your bodyʼs
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 mycophenolate mofetil you may
therefore catch more infections than usual
• As can happen in patients taking this type of
medicine, a very small number of
mycophenolate mofetil patients have developed
cancer of the lymphoid tissues and skin

• Infections, such as flu symptoms, vaginal thrush
• Metabolic and nutrition disorders, such as
weight loss, loss of appetite, gout, high blood
sugar, high blood fat and cholesterol
• Blood, cardiac and vascular disorders such
as bleeding, bruises, increased level of white
blood cells, change in blood pressure, abnormal
heart beat and dilation of blood vessels
• Nervous system and psychiatric disorders
such as convulsions, tremor, dizziness,
numbness, muscle spasms, headache, anxiety,
depression, confusion, agitation, drowsiness,
changes in thinking or mood, insomnia
• Respiratory and thoracic disorders such as
pneumonia, bronchitis, shortness of breath,
cough, fluid on the lungs/chest cavity, sinus
problems, runny or blocked nose (rhinitis),
pharyngitis
• Gastrointestinal disorders such as
constipation, indigestion, pancreas inflammation,
intestinal disorders including bleeding,
inflammation of the stomach or oesophagus,
gastric ulcer, duodenal ulcer, liver problems,
inflammation of the colon, inflammation of the
abdominal cavity, flatulence, swelling of the
gums, mouth ulcers and impaired taste
• Skin disorders such as acne, skin growth,
hair loss, rash, itching
• Renal and urinary disorders such as kidney
problems
• General disorders such as fever, chills,
malaise, weakness, pain (such as chest,
joint/muscle) and swelling.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme
(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 Mycophenolate

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, blister or the label
after EXP. The expiry date refers to the last day
of that month.
This medicinal product does not require any
special storage conditions.

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 Mycophenolate contains
• The active substance is mycophenolate
mofetil. Each film-coated tablet contains
500 mg of mycophenolate mofetil.
• The other ingredients are:
Core content:
Cellulose microcrystalline, povidone, talc,
magnesium stearate, croscarmellose sodium.
Coating content:
Hypromellose, hydroxypropylcellulose,
titanium dioxide (E171), macrogol (400), iron
oxide black (E172), iron oxide red (E172).

What Mycophenolate looks like and contents
of the pack
PVC/PE/PVdC/Al blister
Pack sizes: 50, 100, 120, 150, 180, 250
film-coated tablets.
HDPE bottle
Pack sizes: 50, 150 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz Ltd, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

Manufacturer
Lek Pharmaceuticals d.d., Verovśkova 57, 1526
Ljubljana, Slovenia or LEK S.A., ul. Podlipie 16,
95-010 Stryków, Poland or LEK S.A., ul.
Domaniewska 50 C, 02-672 Warsaw, Poland or
Salutas Pharma GmbH, Otto-von-Guericke-Allee
1, 39179 Barleben, Germany or Salutas Pharma
GmbH, Dieselstrasse 5, 70839 Gerlingen,
Germany or Lek Pharmaceuticals d.d, Trimlini
2D, 9220 Lendava, Slovenia.
This leaflet was last revised in 10/2013.

SZ00000LT000

Expand view ⇕

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
(web3)