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MYCOT 500 MG FILM-COATED TABLETS

Active substance(s): MYCOPHENOLATE MOFETIL

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Rowex Limited
Mycot 500 mg Film-coated Tablets
1.3.1.3 Package Leaflet

Confidential

Page 1
17/10/2013

Package leaflet: Information for the patient
Mycot 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 Mycot is and what it is used for
2. What you need to know before you take Mycot
3. How to take Mycot
4. Possible side effects
5. How to store Mycot
6. Contents of the pack and other information
1.

What Mycot is and what it is used for

Mycot belong to the class of drugs known as immunosuppressants.
Mycophenolate tablets are used to prevent your body rejecting a transplanted kidney, heart or
liver.
Mycot is used together with other medicines known as ciclosporin and corticosteroids.
2.

What you need to know before you take Mycot

Do not take Mycot 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.

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Rowex Limited
Mycot 500 mg Film-coated Tablets
1.3.1.3 Package Leaflet

Confidential

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17/10/2013

Warnings and precautions
Talk to your doctor or pharmacist before taking Mycot 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 Mycot.
 you suffer from an enzyme defect called ‘Lesch-Nyhan syndrome’ or ‘Kelley Seegmiller
syndrome’.
 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 body’s defence mechanism.
Other medicines and Mycot
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 ‘proton pump inhibitors’ 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 Mycot during pregnancy may cause miscarriage or damage to your unborn baby
(abnormal development of ears for example).
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 Mycot for your health are more important than the possible risks to your
unborn baby.

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JMV

Rowex Limited
Mycot 500 mg Film-coated Tablets
1.3.1.3 Package Leaflet

Confidential

Page 3
17/10/2013

If you become pregnant while taking Mycot, do not stop taking it, but tell your doctor about
your pregnancy as soon as possible.
Do not take Mycot 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 Mycot
 During your entire treatment with Mycot
 For 6 weeks after you stop taking Mycot
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 Mycot.
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.
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 Mycot. In addition, your female partners are

PIL.30047/0002.005d

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V015: PRAC recommendation

JMV

Rowex Limited
Mycot 500 mg Film-coated Tablets
1.3.1.3 Package Leaflet

Confidential

Page 4
17/10/2013

recommended to use highly effective contraception during your treatment and for a total of 13
weeks after the last dose of Mycot.
Driving and using machines
Mycophenolate mofetil has not been shown to impair your ability to drive or operate
machinery.
3. How to take Mycot
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 then 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 then 3 tablets in the evening.
Children:
No data are available to recommend the use of mycophenolate mofetil in children who have
received a heart transplant.
Liver Transplant
Adults:

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JMV

Rowex Limited
Mycot 500 mg Film-coated Tablets
1.3.1.3 Package Leaflet

Confidential

Page 5
17/10/2013

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 then 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 Mycot 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 Mycot
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 Mycot
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:
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Rowex Limited
Mycot 500 mg Film-coated Tablets
1.3.1.3 Package Leaflet







Confidential

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17/10/2013

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 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 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

PIL.30047/0002.005d

28/08/2014

V015: PRAC recommendation

JMV

Rowex Limited
Mycot 500 mg Film-coated Tablets
1.3.1.3 Package Leaflet










Confidential

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17/10/2013

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, 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/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 Mycot

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 to protect the
environment.
6.

Contents of the pack and other information

PIL.30047/0002.005d

28/08/2014

V015: PRAC recommendation

JMV

Rowex Limited
Mycot 500 mg Film-coated Tablets
1.3.1.3 Package Leaflet

Confidential

Page 8
17/10/2013

What Mycot 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 Mycot looks like and contents of the pack
PVC/PE/PVdC/Al blister
Pack sizes: 50, 150, 250 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Rowex Ltd
Bantry
Co Cork
Ireland
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
This leaflet was last revised in 02/2016.

PIL.30047/0002.005d

28/08/2014

V015: PRAC recommendation

JMV

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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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