MICOFENOLATO 250 mg Hard Capsule

Содержание инструкции

1. Micofenolato Mofetile Accord 250 mg hard capsules
   1. What is Micofenolato Mofetile Accord and what is it used for
   2. What you need to know before taking Micofenolate Mofetil Accord
   3. How to take Micofenolato Mofetile Accord
   4. Possible side effects
   5. How to store Micofenolato Mofetile Accord
   6. Package Contents and Other Information

Micofenolato Mofetile Accord 250 mg hard capsules

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 their symptoms are the same as yours, as it could 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 Accord is and what it is used for
• 2. What you need to know before you take Micofenolato Mofetile Accord
• 3. How to take Micofenolato Mofetile Accord
• 4. Possible side effects
• 5. How to store Micofenolato Mofetile Accord
• 6. Contents of the pack and other information

1. What is Micofenolato Mofetile Accord and what is it used for

The full name of the medicine is Micofenolato Mofetile Accord 250 mg hard capsules.
Micofenolato Mofetile Accord 250 mg hard capsules belongs to a group of medicines called
“immunosuppressants”.
Micofenolato Mofetile Accord is used to prevent your body from rejecting a transplanted kidney, heart
or liver. Micofenolato Mofetile Accord must be taken together with other medicines,
such as cyclosporine and corticosteroids.

2. What you need to know before taking Micofenolate Mofetil Accord

WARNING
Micofenolate causes birth defects and miscarriage. If you are a woman who could become pregnant, a
negative pregnancy test is necessary 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
micofenolate. See also further information in this paragraph in "Warnings and precautions" and
"Pregnancy and breastfeeding".

Do not take Micofenolate Mofetil Accord:

• 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, as 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.

Warnings and precautions
Contact your doctor immediately before starting treatment with Micofenolate Mofetil Accord 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
• you have a sign of infection, such as fever or sore throat
• you have any unexplained bruising or bleeding
• you have ever had a problem with the digestive system, such as a stomach ulcer
• you are planning a pregnancy or if you become pregnant while you or your partner are being treated with Micofenolate Mofetil Accord.
• 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), contact your doctor immediately before
taking Micofenolate Mofetil Accord.

Effect of sunlight
Micofenolate Mofetil Accord reduces the body's defenses. Consequently, there is an increased risk of
skin cancer. Limit the amount of sunlight and ultraviolet radiation you receive. Do this by:

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

Children
Do not give the medicine to children under 2 years of age because, based on limited safety and efficacy data for this age group, no dose recommendations can be made.

Other medicines and Micofenolate Mofetil Accord
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 medicines, because Micofenolate Mofetil
Accord can affect how other medicines work and other medicines can affect how Micofenolate Mofetil Accord works.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines before
starting to take Micofenolate Mofetil Accord:

• 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

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

Micofenolate Mofetil Accord with food and drink:
Taking food and drink has no effect on treatment with micofenolate mofetil.

Pregnancy, contraception and breastfeeding:
Contraception in women taking Micofenolate Mofetil
If you are a woman who could become pregnant, you must use an effective contraceptive method together with
Micofenolate Mofetil. This includes:

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

You cannot become pregnant if any of the following conditions apply:

• You are postmenopausal, i.e. you are at least 50 years old and your last menstrual period was more than a year ago (if your menstrual cycles have stopped because you have had cancer therapy, 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 gynecologist)
• 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 cycles.

Contraception in men treated with Micofenolate Mofetil
Although clinical data available do not indicate an increased risk of malformations or miscarriages if the
father is taking micofenolate. However, the risk cannot be completely excluded. As a precaution, it is
recommended that you or your partner use a reliable contraceptive method during treatment and for 90
days after stopping Micofenolate Mofetil.
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, ask 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 rejection of the organ transplant 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 sexual intercourse without using effective contraception. If you become pregnant while taking micofenolate, you must inform your doctor immediately. However, continue to take Micofenolate Mofetil 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), finger development, 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 could become pregnant, a negative pregnancy test is necessary before starting
treatment and you must follow the contraceptive advice given by your doctor. Your doctor may require more
than one test to ensure you are not pregnant before starting treatment.

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

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

Micofenolate mofetil capsules contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially "sodium-free".

3. How to take Micofenolato Mofetile Accord

Take this medicine exactly as your doctor has told you. 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 for as long as necessary to prevent rejection of the transplanted organ.

Kidney transplant
Adults:

• The first dose is administered within 3 days following the transplant surgery.
• The daily dose is 8 capsules (2 g of medicine), divided into 2 separate administrations.
• Take 4 capsules in the morning and 4 capsules in the evening.

Children (aged between 2 and 18 years):

• The dose to be administered will depend on the child's body surface area.
• The doctor will decide the most appropriate dosage based on your child's height and weight (body surface area) measured in square meters or “m ”. The recommended dose is 600 mg/m administered twice a day.

Heart transplant
Adults:

• The first dose is administered within the first 5 days following the transplant surgery.
• The daily dose is 12 capsules (3 g of medicine) taken in 2 separate doses.
• Take 6 capsules in the morning and 6 capsules in the evening.

Children:

• No information is available regarding the use of micofenolato mofetile in children undergoing heart transplantation.

Liver transplant
Adults:

• The first oral dose of Micofenolato Mofetile Accord will be administered at least 4 days after the transplant and when you are able to take medicines orally.
• The daily dose is 12 capsules (3 g of medicine) taken in 2 separate doses.
• Take 6 capsules in the morning and 6 capsules in the evening.

Children:

• No information is available regarding the use of micofenolato mofetile in children with a liver transplant.

Dosage and method of administration

• Swallow the capsules with a glass of water.
• Do not break or crush the capsules and do not take capsules that are broken or opened.
• Be careful to avoid contact between the powder leaking from damaged capsules and your eyes or mouth.
• If this happens, rinse with plenty of running water.
• Be careful to avoid contact between the powder leaking from damaged capsules and your skin. If this happens, wash the area thoroughly with water and soap.

If you take more Micofenolato Mofetile Accord than you should
If you take more Micofenolato Mofetile Accord than you should, tell a doctor or go to hospital immediately. Do the same if someone else accidentally takes the medicine. Bring the package of the medicine with you.

If you forget to take Micofenolato Mofetile Accord
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 Accord
Do not stop taking Micofenolato Mofetile Accord unless your doctor tells you to. Stopping treatment may increase the risk of rejection of the transplanted organ.
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.

Consult your doctor immediately if you notice any of the following serious side effects – you may
need urgent medical treatment:

• 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 problems are diarrhea, a lower number of white blood cells or red blood cells in the
blood, infection and vomiting. Your doctor will perform regular blood tests to check for any
change:

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

The likelihood of some side effects is higher in children than in adults. These effects
include diarrhea, infections, a lower number of white blood cells and a lower number of red blood cells in the
blood.

Fighting infections
Micofenolato Mofetile Accord reduces the body's defenses. This happens to prevent rejection of the
transplant. As a result, your body will not be able to fight infections as well as it normally does.
This means that you may get more infections than usual. These include infections
affecting the brain, skin, mouth, stomach and intestines, lungs and urinary tract.

Tumors of lymphoid tissue and skin
As can happen in patients taking this type of medicine (immunosuppressants), a very small number of patients treated with Micofenolato Mofetile Accord have developed tumors of lymphoid tissue and
skin.

General side effects
You may experience general side effects that affect the whole body. These include
severe allergic reactions (such as anaphylaxis, angioedema), fever, feeling extremely tired, difficulty
sleeping, pains (such as stomach pain, chest pain, joint or muscle pain), headache, flu-like symptoms and swelling.
Other side effects may include:

Skin problemssuch as:

• acne, cold sores, shingles, skin growth, hair loss, rash, itching

Urinary problemssuch as:

• blood in the urine

Problems of the digestive system and mouthsuch as:

• swollen gums and mouth ulcers,
• inflammation of the pancreas, colon or stomach,
• gastrointestinal disorders, including bleeding,
• liver disorders,
• diarrhea, constipation, feeling unwell (nausea), indigestion, loss of appetite, flatulence

Nervous system problemssuch as:

• feeling dizzy, sleepy or numb,
• tremor, muscle spasms, convulsions,
• feeling anxious or depressed, changes in mood or thinking

Heart and blood vessel problems,such as:

• changes in blood pressure, increased heart rate, widening of blood vessels

Lung problemssuch as:

• pneumonia, bronchitis,
• shortness of breath, cough, which may be due to bronchiectasis (a condition in which the airways of the lungs are abnormally dilated) or pulmonary fibrosis (scarring of the lung). See a doctor if you experience persistent cough or shortness of breath.
• fluid in the lungs or inside the chest,
• problems with the sinuses.

Other problemssuch as:

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

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

5. How to store Micofenolato Mofetile Accord

• 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 label or the packaging box after “Exp.”. The expiry date refers to the last day of that month.
• Store at a temperature below 30°C.
• Do not use this medicine if you notice visible signs of deterioration.
• 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 Accord contains:
The active ingredient is micofenolate mofetil. Each capsule contains 250 mg of micofenolate mofetil.
The excipients are: microcrystalline cellulose, hydroxypropylcellulose, povidone K 90, sodium croscarmellose,
talc and magnesium stearate.
Capsule shell composition: gelatin, sodium lauryl sulfate, titanium dioxide (E171), iron oxide
red (E172), iron oxide yellow (E172), indigo blue (E132).
Black ink composition: Shellac, Black iron oxide.

Description of the appearance of Micofenolato Mofetile Accord and package contents:
Micofenolato Mofetile Accord 250 mg capsules are hard gelatin capsules of blue/peach color,
size ‘1’, with ‘MMF’ imprinted on the cap and ‘250’ on the body, containing powder from white to
whitish in color.
Micofenolato Mofetile Accord is available in blisters in packs of 100 and 300 capsules.
Not all pack sizes may be marketed.

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

Manufacturer:
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
Netherlands
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50,95-200 Pabianice,
Poland
Accord Healthcare single member S.A.
64th Km National Road Athens, Lamia,
Schimatari, 32009,
Greece