МИКОФЕНОЛАТО 250 МГ Капсулы

Содержание инструкции

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

Micofenolato Mofetile Tillomed Italia 250 mg capsule

Micofenolato mofetile

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 or pharmacist.
• 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 or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Micofenolato Mofetile Tillomed Italia and what it is used for

Micofenolato Mofetile Tillomed Italia 250 mg capsules contain micofenolate mofetil.
This medicine belongs to a group of medicines called “immunosuppressants”.
Micofenolato Mofetile Tillomed Italia is used to prevent your body from rejecting a
kidney, heart or liver transplant.
Micofenolato Mofetile Tillomed Italia must be used in association with other
medicines such as cyclosporine and corticosteroids.

2. What you need to know before taking Micofenolate Mofetil Tillomed Italia

WARNING
Micofenolate causes congenital defects and spontaneous abortion. If you are a woman who is able to
become pregnant, you must have a negative pregnancy test result before starting the
treatment and follow your doctor's advice regarding contraception.
Your doctor will talk to you and give you written information, particularly about the effects of
micofenolate on the unborn child. 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. Also read the information within this paragraph under the
headings “Warnings and precautions” and “Pregnancy and breastfeeding”.

Do not take Micofenolate Mofetil Tillomed Italia:

• if you are allergic (hypersensitive) to micofenolate mofetil, mycophenolic acid or any of the other ingredients of this medicine (listed in section 6),
• if you are a woman who is able to become pregnant and have not had a negative pregnancy test before your first prescription, as micofenolate causes congenital defects and spontaneous abortion,
• if you are currently pregnant, if you suspect you are pregnant or are planning to become pregnant,
• if you are not using any effective contraceptive method (see Pregnancy, contraception and breastfeeding),
• if you are breastfeeding with breast milk. Do not take this medicine if any of the above conditions apply to you. If you have any doubts, talk to your doctor or pharmacist before using Micofenolate Mofetil Tillomed Italia.

Warnings and precautions
Contact your doctor immediately before taking Micofenolate Mofetil Tillomed
Italia:

• if you experience signs of infection such as fever or sore throat,
• if you experience unexpected bruising or bleeding (haemorrhage),
• if you have ever had digestive problems, such as a stomach ulcer,
• if you are planning a pregnancy or if you become pregnant during treatment with Micofenolate Mofetil Tillomed Italia. If any of the above conditions apply to you (or if you have any doubts), contact your doctor immediately before taking Micofenolate Mofetil Tillomed Italia.

Effect of sunlight
Micofenolate Mofetil Tillomed Italia lowers the body's defenses, leading to an
increased risk of skin cancer. Limit exposure to the sun and UV rays by:

• wearing protective clothing that covers your head, neck, arms and legs,
• using high-protection factor sun creams.

Other medicines and Micofenolate Mofetil Tillomed Italia
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those obtained without a prescription and herbal medicines.
This is because Micofenolate Mofetil Tillomed Italia can alter the activity of other medicines.
Other medicines can also alter the activity of Micofenolate Mofetil Tillomed Italia.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines
before taking Micofenolate Mofetil Tillomed Italia:

• azathioprine or other medicines that suppress the immune system, prescribed after an organ transplant,
• cholestyramine - used to treat high cholesterol,
• rifampicin - an antibiotic used to prevent and treat infections such as tuberculosis (TB),
• antacids or proton pump inhibitors - used for problems with acidity in the stomach such as indigestion,
• phosphate binders - used in patients with chronic renal failure to reduce phosphate absorbed from 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 have a vaccination (live vaccine) during treatment with Micofenolate
Mofetil Tillomed Italia, tell your doctor or pharmacist first. The doctor will inform you which
vaccine is suitable for you.
You must not donate blood during treatment with Micofenolate Mofetil Tillomed
Italia and for at least six weeks after stopping treatment. Men must not
donate sperm during treatment with Micofenolate Mofetil Tillomed Italia and for
at least 90 days after stopping treatment.

Micofenolate Mofetil Tillomed Italia with food and drink
The consumption of food and drinks has no effect on treatment with Micofenolate Mofetil
Tillomed Italia.

Pregnancy, contraception and breastfeeding
Contraception in women taking Micofenolate Mofetil Tillomed Italia
If you are a woman who is able to become pregnant, you must use an effective
contraceptive method with Micofenolate Mofetil Tillomed Italia. This means:

• before starting to take Micofenolate Mofetil Tillomed Italia,
• during the entire treatment with Micofenolate Mofetil Tillomed Italia,
• for 6 weeks after stopping treatment with Micofenolate Mofetil Tillomed Italia. Talk to your doctor about the most suitable contraceptive method for you. This will depend on your individual situation. The use of two contraceptive methods is preferable to reduce the risk of unwanted pregnancy. Contact your doctor as soon as possible if you think that thecontraceptive used may not have been effective or if you have forgotten to take thecontraceptive pill.You are a woman who is unable to become pregnant if any of the following conditions apply to you:
• 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 cycle has stopped because you have undergone cancer treatment, 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 insufficiency, which has been confirmed by a gynaecologist),
• you were born with one of the following rare conditions that make pregnancy impossible: XY genotype, Turner syndrome or uterine agenesis,
• you are a child or adolescent who has not yet had her first menstrual period.

Contraception in men taking Micofenolate Mofetil Tillomed Italia
Although available clinical data do not indicate an increased risk of malformations or
miscarriages when the father is taking micofenolate, this risk cannot be
completely excluded. As a precaution, therefore, you and your partner are advised to
use a reliable contraceptive method during treatment and for 90 days after
stopping therapy with Micofenolate Mofetil Tillomed Italia.
If you are planning a pregnancy, talk to your doctor about the potential risks.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are
breastfeeding, ask your doctor or pharmacist for advice before taking this
medicine. The doctor will discuss with you the risks in case of pregnancy and alternative
treatments you can undergo to prevent rejection of the transplanted organ if:

• you are planning a pregnancy,
• you miss or think you have missed a menstrual period, if you have unusual vaginal bleeding or if you suspect you are pregnant,
• you have had unprotected sex. If you become pregnant during treatment with micofenolate, you should inform your doctor immediately. In any case, continue to take Micofenolate Mofetil Tillomed Italia until you see your doctor.

Pregnancy
Micofenolate very frequently causes abortion (50%) and serious congenital defects (23-27%)
in the unborn child. Reported congenital defects include abnormalities of the ears, eyes,
face (cleft lip/palate), finger development, heart, esophagus (tubular organ
connecting the throat and stomach), kidneys and nervous system (e.g. spina
bifida [where the bones of the spine are not fully developed]). The baby may
have one or more of these defects.
If you are a woman who is able to become pregnant, you must have a negative pregnancy test
before starting treatment and follow your doctor's advice regarding
contraception. The doctor may require more than one test to make sure you are not
pregnant before starting treatment.

Breastfeeding
Do not take Micofenolate Mofetil Tillomed Italia if you are breastfeeding with breast milk. Small
amounts of the medicine may pass into breast milk.

Driving and using machines
Micofenolate Mofetil Tillomed Italia should not affect your ability to drive vehicles or
use tools or machines.

3. How to take Micofenolato Mofetile Tillomed Italia

Take this medicine following the doctor's instructions exactly. If you have doubts
consult your doctor or pharmacist.

How much to take
The amount you need to use depends on the type of transplant you have received. Usual doses are
indicated 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 of the transplant surgery.
• The daily dose is 8 capsules (2 g of medicine), divided into two 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 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 administered twice a day.

Heart transplant
Adults

• The first dose is administered within 5 days of the transplant surgery.
• The daily dose is 12 capsules (3 g of medicine), divided into two separate administrations.
• Take 6 capsules in the morning and 6 capsules in the evening. Children
• There is no information regarding the use of Micofenolato Mofetile Tillomed Italia in children with heart transplant.

Liver transplant
Adults

• The first dose of oral Micofenolato Mofetile Tillomed Italia will be administered at least 4 days after the transplant and when you are able to ingest medicines orally.
• The daily dose is 12 capsules (3 g of medicine), divided into two separate administrations.
• Take 6 capsules in the morning and 6 capsules in the evening.

Children

• There is no information regarding the use of Micofenolato Mofetile Tillomed Italia in children with a liver transplant.

Taking the medicine
Swallow the capsules whole with a glass of water

• Do not break or crush the capsules. Do not take any broken or opened capsules.

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 the skin.
• If this happens, wash the affected area thoroughly with water and soap.

If you take more Micofenolato Mofetile Tillomed Italia than you should
If you take more Micofenolato Mofetile Tillomed Italia than you should, contact a doctor or
go to the hospital immediately. Do the same if someone else accidentally
takes the medicine. Bring the medicine packaging with you.

If you forget to take Micofenolato Mofetile Tillomed Italia
If you forget to take the medicine, take it as soon as you remember, then continue to
take it as usual. Do not take a double dose to make up for a missed dose.

If you stop taking Micofenolato Mofetile Tillomed Italia
Do not stop treatment with Micofenolato Mofetile Tillomed Italia unless your
doctor has told you to. If you stop treatment, it may increase the risk of rejection of your
transplanted organ.
If you have any questions about 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.

Seek immediate medical attention if you notice any of the following serious side effects; urgent medical treatment may be necessary:

• presents signs of infection such as fever or sore throat,
• presents unexpected bruising or bleeding,
• presents skin rash, swelling of the face, lips, tongue or throat, with difficulty breathing; this may be 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. The doctor will perform regular blood tests to
check for any changes:

• in the number of cells in the blood,
• in the blood level of certain substances such as sugars, fats or cholesterol. Children may be more likely than adults to develop some side effects. These include diarrhea, infections and decreased white blood cells and red blood cells in the blood.

Fighting infections
Micofenolato Mofetile Tillomed Italia lowers the body's defenses to prevent
rejection of the transplant. Consequently, the body will not be able to fight infections effectively
as it would under normal conditions. This means that you may be more likely to experience
infections. These infections include infections affecting
the brain, skin, mouth, stomach and intestines, lungs and
the 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 have developed tumors of the lymphatic system and
skin.

Side effects of a general nature
You may experience side effects concerning the body in general. These
include severe allergic reactions (such as anaphylaxis, angioedema), fever, feeling of
fatigue, sleep disturbances, pain (in the stomach, chest, muscles or joints
when urinating), headache, flu-like symptoms and swelling.

Other side effects may include:
Skin disorderssuch as:

• acne, herpes labialis, herpes zoster, skin hypertrophy, hair loss, rash and itching

Urinary tract disorderssuch as:

• kidney problems or urgent need to urinate

Gastrointestinal and oral disorderssuch as:

• gum swelling and mouth ulcers,
• inflammation of the pancreas, colon or stomach,
• intestinal disorders including bleeding, liver problems,
• constipation, discomfort (nausea), indigestion, loss of appetite, flatulence. Nervous system disorderssuch as:
• feeling of dizziness, drowsiness or paresthesia,
• tremors, muscle spasms, convulsions,
• feeling of anxiety or depression, altered mood and thinking.

Heart and blood vessel disorderssuch as:

• changes in blood pressure, abnormal heartbeat, dilation of blood vessels.

Lung disorderssuch as:

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

Other problemssuch as:

• weight loss, gout, high blood sugar levels, bruises and bleeding.

Reporting side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects you can help provide more information on
the safety of this medicine.

5. How to store Micofenolato Mofetile Tillomed Italia

• 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 package (EXP.) and on the blister. The expiry date refers to the last day of that month.
• Do not store at a temperature above 30 °C.
• Store in the original package to protect the medicine from moisture.
• 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 Tillomed Italia Contains
The active ingredient is mycophenolate mofetil. Each capsule contains 250 mg of mycophenolate
mofetil.
The other ingredients are:
Capsule content
Pregelatinized starch
Sodium croscarmellose
Povidone ( K 90 )
Magnesium stearate
Capsule shell
Gelatin
Indigo carmine (E132)
Titanium dioxide (E171)
Red iron oxide (E172)
Yellow iron oxide (E172)
Ink
Shellac
Black iron oxide (E172)
Potassium hydroxide

Description of the Appearance of Micofenolato Mofetile Tillomed Italia and Package Contents
The capsules of Micofenolato Mofetile Tillomed Italia are hard gelatin capsules of
size “1”, with an opaque blue cap and an opaque brown body, imprinted in
black “EM” on the capsule cap and “250” on the body, filled with granular powder from
white to off-white.
Micofenolato Mofetile Tillomed Italia 250 mg capsules are distributed in divisible blister packs for
unit dose in opaque white/aluminum PVC from 100 x 1 or 300 x 1
capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Tillomed Italia S.r.l.
viale Richard 1, Torre A
20143, Milan
Italy

Manufacturer
Emcure Pharma UK Limited
Basepoint Business Centre
110 Butterfield, Great Marlings
Luton, LU2 8DL
United Kingdom

Tillomed Laboratories Limited
220 Butterfield, Great Marlings
Luton, LU2 8DL
United Kingdom

Tillomed Pharma GmbH
Manhagener Allee 36
22926 Ahrensburg
Germany

This leaflet was last updated in MM/YYYY