МИКОФЕНОЛАТО 500 мг Фильм-coated таблетки

Содержание инструкции

1. Micofenolato Mofetile AHCL 500 mg film-coated tablets
   1. What is Micofenolate Mofetil AHCL and what is it used for
   2. What you need to know before you take Micofenolate Mofetil AHCL
   3. How to take Micofenolato Mofetile AHCL
   4. Possible side effects
   5. How to store Micofenolato Mofetile AHCL
   6. Package contents and other information

Micofenolato Mofetile AHCL 500 mg film-coated tablets

Generic medicine

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Micofenolato Mofetile AHCL is and what it is used for
• 2. What you need to know before you take Micofenolato Mofetile AHCL
• 3. How to take Micofenolato Mofetile AHCL
• 4. Possible side effects
• 5. How to store Micofenolato Mofetile AHCL
• 6. Contents of the pack and other information

1. What is Micofenolate Mofetil AHCL and what is it used for

Micofenolate Mofetil AHCL 500 mg film-coated tablets belong to a group of medicines
called “immunosuppressants”.
Micofenolate Mofetil AHCL is used to prevent the body from rejecting a transplanted kidney, heart or liver.
Micofenolate Mofetil AHCL must be administered together with other medicines, such as
cyclosporine and corticosteroids.

2. What you need to know before you take Micofenolate Mofetil AHCL

WARNING
Micofenolate causes birth defects and miscarriage. If you are a woman who could become pregnant, it is
necessary to provide a negative pregnancy test before starting treatment and you must follow the contraceptive
method recommended by your doctor.
Your doctor will explain and give you written information, particularly regarding the effects of micofenolate on
unborn children. Read the information carefully and follow the instructions.
If you do not fully understand these instructions, ask your doctor to explain them again before taking the
micofenolate. See also further information in this paragraph in "Warnings and precautions" and
"Pregnancy and breastfeeding".

Do not take Micofenolate Mofetil AHCL

• If you are allergic to micofenolate mofetil, mycophenolic acid or any of the other ingredients of this medicine (listed in section 6).
• If you are a woman who could become pregnant and have not provided a negative pregnancy test before the first prescription, because micofenolate causes birth defects and miscarriage.
• If you are pregnant, if you are planning to become pregnant or think you might be pregnant.
• If you are not using effective contraception (see Pregnancy, contraception and breastfeeding).
• If you are breastfeeding. Do not take this medicine if any of these conditions apply to you. If you are not sure, ask your doctor or pharmacist before taking Micofenolate Mofetil AHCL.

Warnings and precautions
Talk to your doctor, pharmacist or nurse immediately before starting treatment with
Micofenolate Mofetil AHCL.

• If you are over 65 years old, you may have a higher risk of developing adverse events such as some viral infections, gastrointestinal bleeding and pulmonary edema compared to younger patients
• If you have a sign of infection such as fever or sore throat
• If you have any unexplained bruising or bleeding
• If you have ever had a problem with the digestive system, such as a stomach ulcer
• If you are planning a pregnancy or have become pregnant while you or your partner are being treated with micofenolate mofetil tablets
• If you have a hereditary enzyme deficiency, such as Lesch-Nyhan syndrome and Kelley-Seegmiller syndrome.

If any of the above applies to you (or if you are unsure), talk to your doctor immediately
before starting treatment with micofenolate mofetil.

Effect of sunlight
Micofenolate mofetil reduces the body's defenses. Consequently, there is an increased risk of skin cancer.
Limit the amount of sunlight and ultraviolet rays you take. Do this:

• by wearing protective clothing that also covers the head, neck, arms and legs
• by using sunscreens with a high protection factor.

Children and adolescents
Paediatric population aged 2 to 18 years:
Micofenolate Mofetil AHCL is used in children and adolescents (aged 2 to 18 years) to prevent rejection of
a transplanted kidney.
Micofenolate Mofetil AHCL should not be used in children and adolescents (aged 2 to 18 years) who have
undergone heart or liver transplantation.
Micofenolate Mofetil AHCL should not be used in children under 2 years of age because, based on
limited safety and efficacy data for this age group, dosage recommendations cannot be formulated.

Other medicines and Micofenolate Mofetil AHCL
Tell your doctor or pharmacist if you are taking, have recently taken or are planning to take any other medicines,
including over-the-counter medicines, herbal remedies, because micofenolate mofetil can
affect how other medicines work and other medicines can affect how micofenolate mofetil works.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines before
starting to take micofenolate mofetil:

• azathioprine or other medicines that suppress the immune system - given after a transplant
• cholestyramine - used to treat high cholesterol levels
• rifampicin - an antibiotic used for the prevention and treatment of infections, such as tuberculosis (TB)
• antacids, or proton pump inhibitors - used for stomach acid problems, such as indigestion
• phosphate binders - used by people with chronic kidney failure to reduce the amount of phosphate absorbed into the blood.
• antibiotics - used to treat bacterial infections
• isavuconazole - used to treat fungal infections
• telmisartan - used to treat high blood pressure
• aciclovir, valaciclovir or ganciclovir

Vaccines
If you need to be vaccinated (a live vaccine) during treatment with Micofenolate Mofetil AHCL,
consult your doctor or pharmacist first. The doctor will advise you on which vaccines you can receive.
You should not donate blood during treatment with Micofenolate Mofetil and for at least 6 weeks after
stopping treatment. Men should not donate sperm during treatment with Micofenolate
Mofetil AHCL and for at least 90 days after stopping treatment.

Micofenolate Mofetil AHCL with food and drink
Taking food and drink has no effect on treatment with Micofenolate Mofetil AHCL.

Pregnancy, contraception and breastfeeding
Contraception in women taking Micofenolate Mofetil AHCL
If you are a woman who could become pregnant, you must use effective contraception while taking Micofenolate
Mofetil AHCL. This includes:

• Before starting to take Micofenolate Mofetil AHCL
• During the entire treatment with Micofenolate Mofetil AHCL
• For 6 weeks after stopping taking Micofenolate Mofetil AHCL Talk to your doctor about the most suitable contraception for you. This will depend on your individual situation. Two contraceptive methods are preferable that will reduce the risk of unwanted pregnancies. Contact yourdoctor as soon as possible if you think your contraception may not have been effective or if you haveforgotten to take your contraceptive pill.

If you cannot become pregnant, any of the following conditions apply to you:

• You are post-menopausal, i.e. you are at least 50 years old and your last menstrual period was more than a year ago (if your periods have stopped because you have had cancer therapy, then there is still a possibility that you may become pregnant)
• Your fallopian tubes and both ovaries have been surgically removed (bilateral salpingo-oophorectomy)
• Your uterus has been surgically removed (hysterectomy)
• Your ovaries no longer function (premature ovarian failure, which has been confirmed by a specialist gynaecologist)
• You were born with one of the rare conditions that make pregnancy impossible: XY genotype, Turner syndrome or uterine agenesis
• You are a child or adolescent who has not yet started having menstrual periods.

Contraception in men treated with Micofenolate Mofetil AHCL
Available evidence does not indicate an increased risk of birth defects or miscarriage if the father
takes micofenolate. However, a risk cannot be completely excluded. As a precaution, it is
recommended that you or your female partner use reliable contraceptive methods during treatment
and for 90 days after stopping Micofenolate Mofetil AHCL.
If you are planning to have a child, talk to your doctor about the potential risks and alternative therapies.

Pregnancy and breastfeeding:
If you are pregnant or breastfeeding, if you think you may be pregnant or are planning a
pregnancy, talk to your doctor or pharmacist before taking this medicine. Your doctor will explain the
risks in case of pregnancy and the alternatives that can be adopted to prevent organ rejection if:

• You are planning a pregnancy.
• You miss or think you have missed a menstrual period, or have unusual vaginal bleeding, or suspect you are pregnant.
• You have unprotected sexual intercourse without using effective contraception. If you become pregnant during treatment with micofenolate, you should inform your doctor immediately. However, continue to take Micofenolate Mofetil AHCL until your doctor reviews you.

Pregnancy
Micofenolate causes a very high rate of miscarriages (50%) and serious birth defects (23-27%)
in the unborn child. The birth defects that have been reported include abnormalities of the
ears, eyes, face (cleft lip/palate), development of the fingers, heart, esophagus (tube
connecting the throat to the stomach), kidneys and nervous system (e.g. spina bifida (where the bones of the
spine are not properly developed)). Your baby may be affected by one or more of
these.
If you are a woman who can become pregnant, you must provide a negative pregnancy test before
starting treatment and must follow the contraceptive advice given by your doctor. The doctor may
require more than one test to make sure you are not pregnant before starting treatment.

Breastfeeding
Do not take Micofenolate Mofetil AHCL if you are breastfeeding. This is because small amounts of the medicine
can pass into breast milk.

Driving and using machines
Micofenolate Mofetil AHCL moderately impairs the ability to drive and operate tools or
machinery.
If you feel sleepy, dizzy or confused, talk to your doctor or nurse and do not drive or operate
tools or machinery until you feel better.

Micofenolate Mofetil AHCL contains Sodium:This medicine contains less than 1 mmol (23 mg) of sodium
per dose, i.e. essentially ‘sodium-free’.

3. How to take Micofenolato Mofetile AHCL

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your doctor
or pharmacist.

How much to take
The amount you take depends on the type of transplant you have undergone. Usual doses are illustrated
below. Treatment will continue as long as necessary to prevent organ rejection.

Kidney transplant
Adults

• The first dose is administered within 3 days of the transplant surgery.
• The daily dose is 4 tablets (2 g of the medicine) taken in 2 separate doses.
• Take 2 tablets in the morning and then 2 tablets in the evening.

Children (aged between 2 and 18 years)

• The administered dose varies depending on the size of the child.
• The doctor will decide the most appropriate dose based on the child's height and weight (body surface area - measured in square meters or “m”). The recommended dose is 600 mg/m taken twice a day.

Heart transplant
Adults

• The first dose is administered within 5 days of the transplant surgery.
• The daily dose is 6 tablets (3 g of the medicine) taken in 2 separate doses.
• Take 3 tablets in the morning and then 3 tablets in the evening. Children
• No data are available regarding the use of micofenolato mofetile in children undergoing heart transplantation.

Liver transplant
Adults

• The first dose of oral micofenolato mofetile will be administered at least 4 days after the transplant surgery and when you are able to ingest oral medicines.
• The total daily dose is 6 tablets (3 g of the medicine) taken in 2 separate doses.
• Take 3 tablets in the morning and then 3 tablets in the evening. Children
• No data are available regarding the use of micofenolato mofetile in children undergoing liver transplantation.

Method and route of administration:
Swallow the tablets with a glass of water. Do not break or crush them.

If you take more Micofenolato Mofetile AHCL than you should
If you take more Micofenolato Mofetile AHCL than you have been told to take or if someone else accidentally ingests
the tablets, seek immediate medical attention or go directly to hospital. Bring
with you the packaging of the medicine.

If you forget to take Micofenolato Mofetile AHCL
If you forget to take the medicine at any time, take it as soon as you remember, then
continue therapy at the usual time. Do not take a double dose to make up for a missed dose.

If you stop taking Micofenolato Mofetile AHCL
Do not stop treatment with Micofenolato Mofetile AHCL unless your doctor tells you to.
Stopping treatment may increase the risk of organ rejection.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

See your doctor immediately if you notice any of the following serious side effects – you may
need urgent medical attention:
you have signs of infection, such as fever or sore throat

• you have any unexplained bruising or bleeding
• you have a skin rash, swelling of the face, lips, tongue or throat, with difficulty breathing
• you may be having a severe allergic reaction to the medicine (such as anaphylaxis, angioedema).

Common problems
Some of the most common disorders are diarrhea, decreased white blood cells or red blood cells in the
blood, infections and vomiting. Your doctor will perform regular blood tests to check for any
changes:

• in the number of blood cells or signs of infection.

Children may be more likely than adults to experience some side effects. These include
diarrhea, infections, fewer white blood cells and fewer red blood cells in the blood.

Fighting infections
Mycophenolate mofetil lowers the body's defenses to prevent it from rejecting the transplant. As a
result, the body will not be able to fight infections effectively as it would in
normal conditions. This means you may get infections more frequently, for
example of the brain, skin, mouth, stomach and intestines, lungs and urinary tract.

Tumors of the lymphatic system and skin
As can happen with other substances of this type (immunosuppressants), a very small number of
patients treated with mycophenolate mofetil have developed tumors of the lymphatic system and skin.

Side effects of a general nature
You may experience side effects affecting the whole body. These include severe
allergic reactions (such as anaphylaxis, angioedema), fever, feeling tired, sleep disorders,
pains (in the stomach, chest, muscles or joints), headache, flu-like symptoms and swelling.
Other side effects may include:

Skin disorderssuch as:

• acne, cold sores, skin hypertrophy, shingles, hair loss, skin rashes and itching.

Urinary tract disorderssuch as:

• blood in the urine.

Gastrointestinal and oral disorderssuch as:

• gum swelling and mouth ulcers
• inflammation of the pancreas, colon or stomach
• gastrointestinal disorders including bleeding
• liver disorders
• diarrhea, constipation, discomfort (nausea), indigestion, loss of appetite and flatulence.

Nervous system disorderssuch as:

• feeling dizzy, drowsy or paresthesia
• tremors, muscle spasms, convulsions
• feeling anxious or depressed, changes in mood and thinking.

Heart and blood vessel disorderssuch as:

• changes in blood pressure, increased heart rate, swelling near blood vessels.

Lung disorderssuch as:

• pneumonia, bronchitis
• shortness of breath, cough, which may be caused by bronchiectasis (a condition in which the airways are abnormally dilated) or pulmonary fibrosis (scarring of lung tissue). See your doctor if you have a persistent cough or shortness of breath
• fluid accumulation in the lungs or chest
• sinusitis.

Other disorderssuch as:

• weight loss, gout, high blood sugar, bleeding, bruising.

Reporting side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist.
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information about the safety of this
medicine.

5. How to store Micofenolato Mofetile AHCL

• Do not store at a temperature above 25°C. Keep the blister in the outer packaging to protect the medicine from light.
• 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 after “Scad.”. The expiry date refers to the last day of that month.
• Always return any unused medicine to the pharmacist. Keep it only on the advice of your doctor.
• Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Micofenolato Mofetile AHCL contains
The active ingredient is 500 mg of mycophenolate mofetil
The other ingredients are:
Tablet core: microcrystalline cellulose, povidone, hydroxypropylcellulose, sodium croscarmellose,
talc, magnesium stearate.
Tablet coating: hypromellose 6 cps, titanium dioxide (E171), macrogol 400, red iron oxide
(E172), indigo carmine aluminum lake (E132), black iron oxide (E172), purified talc.

Description of the appearance of Micofenolato Mofetile AHCL and package contents:
Micofenolato Mofetile AHCL 500 mg tablets are film-coated tablets with a lavender color,
capsule-shaped, biconvex with “AHI” imprinted on one side and “500” on the other side.
Micofenolato Mofetile AHCL is available in blisters in packs of 50, 150 and 250 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
Netherlands

Manufacturers:
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
Netherlands
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50,95-200 Pabianice,
Poland
LABORATORI FUNDACIÓ DAU
C/ C, 12-14 Pol. Ind. Zona Franca,
Barcelona, 08040 Spain
Accord Healthcare single member S.A.
64th Km National Road Athens,
Lamia, Schimatari, 32009, Greece

This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:
Member
StateMedicinal product name
Austria Mycophenolate Mofetil Accord 500mg Filmtabletten
Belgium Mycophenolate Mofetil Accord Healthcare 500mg comprimés
pelliculés
Cyprus Mycophenolate Mofetil Accord 500 mg επικαλυμμένα με
λεπτό υμένιο δισκία
Denmark Mycophenolate Mofetil Accord 500 mg Filmovertrukne
tabletter
Estonia Mycophenolate Mofetil Accord 500mg õhukese
polümeerikattega tabletid
Finland Mycophenolate Mofetil Accord 500mg Tabletti,
kalvopäällysteinen / Filmdragerade tabletter
France Mycophenolate Mofetil Accord healthcare 500mg comprimé
pelliculé
Germany Mycophenolate Mofetil Accord 500mg Filmtabletten
Greece Myfetil 500 mg επικαλυμμένα με λεπτό υμένιο δισκία
Ireland Mycophenolate Mofetil 500mg film-coated Tablets
Italy Micofenolato Mofetile AHCL 500 mg film-coated tablets
Latvia Mycophenolate Mofetil Accord 500mg apvalkotās tabletes
Lithuania Mycophenolate Mofetil Accord 500 mg plėvele dengtos
tabletės
Malta Mycophenalate Mofetil 500mg
Norway Mycophenolate Mofetil Accord 500mg Tablett, filmdrasjert
Poland Mycofit, 500 mg, tabletki powlekane
Portugal Micofanolato de Mofetil Accord 500 mg comprimidos
revestidos por pelicula
Spain Micofenolato de mofetilo STADA 500 mg comprimidos
recubiertos con película EFG
Sweden Mycophenolate Accord 500 mg Filmdragerade tabletter
Netherlands Mycophenolaat Mofetil Accord 500mg Filmomhulde Tabletten
United Kingdom Mycophenolate Mofetil 500mg Film–coated Tablets