MICOFENOLATO 500 mg Film-Coated Tablets

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1. Micofenolato mofetile Aurobindo 500 mg film-coated tablets
   1. What is Micofenolato mofetile Aurobindo and what is it used for
   2. What you need to know before taking Micofenolate mofetil Aurobindo
   3. How to take Micofenolato mofetile Aurobindo
   4. Possible side effects
   5. How to store Micofenolato mofetile Aurobindo
   6. Package Contents and Other Information

Micofenolato mofetile Aurobindo 500 mg film-coated tablets

Generic medicine

Read this leaflet carefully before 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 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 or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Micofenolato mofetile Aurobindo and what is it used for

Micofenolato mofetile Aurobindo contains micofenolate mofetil.

• This belongs to a group of medicines called “immunosuppressants”.

Micofenolato mofetile Aurobindo is used to prevent the body from rejecting a transplanted organ.

• Kidney, heart or liver.

Micofenolato mofetile Aurobindo must be used in combination with other medicines:

• Cyclosporine and corticosteroids.

2. What you need to know before taking Micofenolate mofetil Aurobindo

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 treatment and follow your doctor's advice regarding contraception.
Your doctor will talk to you and give you written information, especially 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 Aurobindo:

• 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 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 pregnant, suspect you may be pregnant, or are planning to become pregnant;
• if you are not using any effective method of contraception (see Pregnancy, contraception and breastfeeding);
• if you are breastfeeding.

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 taking Micofenolate mofetil Aurobindo.

Warnings and precautions
Tell your doctor immediately before starting treatment with Micofenolate mofetil
Aurobindo:

• if you are over 65 years of age, as you may have an increased risk of developing adverse events such as some viral infections, gastrointestinal bleeding and pulmonary edema compared to younger patients;
• if you have signs of infection such as fever or sore throat;
• if you experience unexpected bruising or bleeding;
• if you have ever suffered from a digestive disorder, such as a stomach ulcer;
• if you are planning a pregnancy or if you become pregnant while you or your partner are being treated with Micofenolate mofetil Aurobindo;
• if you suffer from a hereditary enzyme deficiency such as Lesch-Nyhan syndrome and Kelley-Seegmiller syndrome.

If any of the above conditions apply to you (or you have any doubts), tell your doctor immediately before starting treatment with Micofenolate mofetil Aurobindo.

Effects of sunlight
Micofenolate mofetil Aurobindo lowers the body's defenses, leading to a higher risk of
skin cancer. Limit your exposure to the sun and UV rays by:

• wearing protective clothing that covers your head, neck, arms and legs;
• using products with a high sun protection factor.

Children
Do not give this medicine to children under 2 years of age because, based on limited safety and efficacy data for this age group, it is not possible to make recommendations
on the dose.

Other medicines and Micofenolate mofetil Aurobindo
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including those obtained without a prescription, such as herbal medicines. Micofenolate
mofetil Aurobindo can in fact alter the activity of other medicines. Other medicines can also
interact with Micofenolate mofetil Aurobindo.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines before
taking Micofenolate mofetil Aurobindo:

• 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 stomach acidity problems 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 (mycoses);
• telmisartan, used to treat high blood pressure.

Vaccines
If you are to be vaccinated (live vaccine) during treatment with Micofenolate mofetil
Aurobindo, tell your doctor or pharmacist first. Your doctor will advise you which vaccine is suitable
for you.
You must not donate blood during treatment with Micofenolate mofetil Aurobindo and for at least
6 weeks after stopping treatment. Men must not donate sperm during
treatment with Micofenolate mofetil Aurobindo and for at least 90 days after stopping
treatment.

Micofenolate mofetil Aurobindo with food and drink
The consumption of food and drinks has no effect on treatment with Micofenolate mofetil Aurobindo.

Contraception in women taking Micofenolate mofetil Aurobindo
If you are a woman who is able to become pregnant, you must use an effective method of contraception with
Micofenolate mofetil Aurobindo. This means:

• before starting to take Micofenolate mofetil Aurobindo;
• during the entire treatment with Micofenolate mofetil Aurobindo;
• for 6 weeks after stopping treatment with Micofenolate mofetil Aurobindo.

Talk to your doctor about the most suitable method of contraception for you. This will depend on your individual situation. The use of two methods of contraception is preferable to reduce the risk of unwanted pregnancy. Contact your doctor as soon as possible if you think that the contraceptive used may not have been effective or if you have forgotten to take your contraceptive pill.
You cannot become pregnant if any of the following conditions apply to you:

• you are menopausal, 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 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 had her first menstrual period.

Contraception in men taking Micofenolate mofetil Aurobindo
Although the available clinical data do not indicate an increased risk of malformations or spontaneous
abortions when the father takes mycophenolate, this risk cannot be completely ruled out.
As a precaution, therefore, you and your partner are recommended to use a reliable method of contraception during treatment and for 90 days after stopping therapy with Micofenolate
mofetil Aurobindo.
If you are planning a pregnancy, talk to your doctor about the potential risks and alternative therapies.

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

• you are planning a pregnancy;
• you miss or think you have missed a menstrual period, if you have unusual menstrual bleeding or if you suspect a pregnancy;
• you have had unprotected sex.

If you become pregnant during treatment with mycophenolate, you should tell your doctor immediately. In any case, continue to take Micofenolate mofetil Aurobindo until you see
your doctor.

Pregnancy
Micofenolate very frequently causes abortion (50%) and serious congenital defects (23-27%) in
the newborn. Reported congenital defects include abnormalities of the ears, eyes, face
(cleft lip/palate), finger development, heart, esophagus (the tubular organ that connects
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. Your doctor may
request more than one test to make sure you are not pregnant before starting
treatment.

Breastfeeding
Do not take Micofenolate mofetil Aurobindo if you are breastfeeding. Small amounts of
medicine may pass into breast milk.

Driving and using machines
Micofenolate mofetil Aurobindo moderately impairs the ability to drive vehicles or use tools or machinery. If you feel sleepy, dizzy or confused, see your doctor or nurse
and do not drive vehicles or use tools or machinery until you feel better.

Micofenolate mofetil Aurobindo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Micofenolato mofetile Aurobindo

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

How much to take
The amount you need to take depends on the type of transplant you have received. The usual doses are indicated
below. Treatment will continue as long as you need 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 4 tablets (2 g of medicine), divided into 2 separate administrations.
• Take 2 tablets in the morning and 2 tablets 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 following the transplant surgery.
• The daily dose is 6 tablets (3 g of medicine), divided into 2 separate administrations.
• Take 3 tablets in the morning and 3 tablets in the evening.

Children

• There is no information on the use of Micofenolato mofetile Aurobindo in children with a heart transplant.

Liver transplant
Adults

• The first dose of oral Micofenolato mofetile Aurobindo will be administered at least 4 days after the transplant surgery and when you are able to swallow medicines orally.
• The daily dose is 6 tablets (3 g of medicine), divided into 2 separate administrations.
• Take 3 tablets in the morning and 3 tablets in the evening.

Children

• There is no information on the use of Micofenolato mofetile Aurobindo in children with a liver transplant.

Taking the medicine

• Swallow the tablets whole with a glass of water.
• The tablets must not be broken or crushed.

If you take more Micofenolato mofetile Aurobindo than you should
If you take more Micofenolato mofetile Aurobindo than you should, inform a doctor or go to 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 Aurobindo
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 Aurobindo
Do not stop taking Micofenolato mofetile Aurobindo 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 or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

• develops signs of infection such as fever or sore throat;
• develops unexpected bruising or bleeding;
• develops a skin rash, swelling of the face, lips, tongue or throat, with difficulty breathing; you may have 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 blood cells or signs of infection.

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 Aurobindo 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 experience infections more frequently
for example infections affecting the brain, skin, mouth, stomach and intestines, the
lungs and the urinary tract.

Lymphatic system and skin tumors
As can happen with other substances of this type (immunosuppressants), a very small number of
patients treated with Micofenolato mofetile Aurobindo 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 tired, sleep disturbances,
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, shingles, skin hypertrophy, hair loss, rash 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 or thinking.

Heart and blood vessel disorderssuch as:

• changes in blood pressure, increased heart rate and 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 are abnormally dilated) or pulmonary fibrosis (scarring of lung tissue). See your doctor if you have a persistent cough or shortness of breath, fluid buildup in the lungs or chest
• sinusitis.

Other disorderssuch as:

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

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 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 Aurobindo

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 and on the blister after
EXP. The expiry date refers to the last day of that month.
Store at a temperature below 30°C.
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 Aurobindo contains

• The active ingredient is mycophenolate mofetil. Each film-coated tablet contains 500 mg of mycophenolate mofetil.
• The other ingredients are: Tablet core: Microcrystalline cellulose (grade 101 & 102), sodium croscarmellose, povidone (K-90), anhydrous colloidal silica, magnesium stearate.
• Tablet coating: Hypromellose 2910 (3 mPas & 50 mPas), hydroxypropyl cellulose, macrogol 400, talc, red iron oxide, titanium dioxide, indigo carmine (FD & C Blue No. 2) aluminum lake.

Description of the appearance of Micofenolato mofetile Aurobindo and package contents
Film-coated tablet.
Film-coated tablets of violet color, capsule-shaped, approximately 17.8 x 8.9 mm, with
“M1” imprinted on one side and smooth on the other side.
Micofenolato mofetile Aurobindo 500 mg film-coated tablets are available in
blister packs.

Pack sizes:

Blister packs: 50, 100, 150 and 300 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
via San Giuseppe, 102

• 21047 - Saronno (VA) Italy

Manufacturer
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000
Malta
Generis Farmacêutica S.A.
Rua João de Deus, 19, Venda Nova,

• 2700- 487 Amadora Portugal

Arrow Generiques
26 avenue Tony Garnier
69007 Lyon
France

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Belgium: Mycophenolate Mofetil AB 500 mg filmomhulde tabletten/comprimés
pelliculés/Filmtabletten
France: Mycophenolate Mofetil Arrow 500 mg, comprimé pelliculé
Italy: Micofenolato mofetile Aurobindo
Netherlands: Mycofenolaatmofetil Auro 500 mg, filmomhulde tabletten
Portugal: Micofenolato de mofetil Generis Phar
Spain: Micofenolato de mofetilo Aurovitas 500 mg comprimidos recubiertos con película EFG