Mycophenolate mofetil Aurobindo

Package leaflet: Information for the user

Mycophenolate mofetil Aurobindo 500 mg film-coated tablets

Equivalent medicine
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Micofenolato mofetile Aurobindo contains mycophenolate 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 Micofenolato mofetile Aurobindo

WARNING
Mycophenolate causes congenital malformations and spontaneous abortion. If you are a woman of childbearing potential, you must have a negative pregnancy test before starting treatment and follow your doctor’s advice regarding contraception.
Your doctor will discuss this with you and provide written information, particularly about the effects of mycophenolate on the unborn child. Read this information carefully and follow the instructions.
If you do not fully understand these instructions, ask your doctor to explain them again before taking mycophenolate. Also read the information provided in this section under "Warnings and precautions" and "Pregnancy and breastfeeding".
Do not take Micofenolato mofetile Aurobindo:

• if you are allergic to mycophenolate mofetil, mycophenolic acid, or any of the other ingredients of this medicine (listed in section 6);
• if you are a woman of childbearing potential and have not had a negative pregnancy test before the first prescription, as mycophenolate causes congenital malformations and spontaneous abortion;
• if you are pregnant, suspect you may be pregnant, or are planning a pregnancy;
• if you are not using any effective contraceptive method (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, speak with your doctor or pharmacist before taking Micofenolato mofetile Aurobindo.
Warnings and precautions
Inform your doctor immediately before starting treatment with Micofenolato mofetile Aurobindo:

• if you are over 65 years of age, as you may have an increased risk of adverse events such as certain 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 unexplained bruising or bleeding;
• if you have ever suffered from a digestive disorder, for example a gastric ulcer;
• if you are planning a pregnancy or become pregnant while you or your partner are being treated with Micofenolato mofetile Aurobindo;
• if you suffer from an inherited enzyme deficiency such as Lesch-Nyhan or Kelley-Seegmiller syndrome.

If any of the above conditions apply to you (or if you have any doubts), inform your doctor immediately before starting treatment with Micofenolato mofetile Aurobindo.
Effects of sunlight
Micofenolato mofetile Aurobindo lowers the body's defenses, increasing the risk of skin cancer. Limit exposure to sunlight and UV rays by:

• wearing protective clothing covering the head, neck, arms, and legs;
• using sunscreen products with high sun protection factor.

Children
Do not administer this medicine to children under 2 years of age, as based on limited safety and efficacy data in this age group, dosage recommendations cannot be established.
Other medicines and Micofenolato mofetile Aurobindo
Talk to your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription, such as herbal remedies. Micofenolato mofetile Aurobindo may alter the action of other medicines, and other medicines may interact with Micofenolato mofetile Aurobindo.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines before taking Micofenolato mofetile Aurobindo:

• azathioprine or other medicines that suppress the immune system, prescribed after organ transplantation;
• 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 kidney failure to reduce phosphate absorbed into the blood;
• antibiotics, used to treat bacterial infections;
• isavuconazole, used to treat fungal infections (mycoses);
• telmisartan, used to treat hypertension.

Vaccines
If you need to be vaccinated (live vaccine) during treatment with Micofenolato mofetile Aurobindo, inform your doctor or pharmacist first. Your doctor will advise you which vaccine is appropriate for you.
You must not donate blood during treatment with Micofenolato mofetile Aurobindo and for at least 6 weeks after stopping treatment. Men must not donate sperm during treatment with Micofenolato mofetile Aurobindo and for at least 90 days after stopping treatment.
Micofenolato mofetile Aurobindo with food and drink
Food and drink do not affect treatment with Micofenolato mofetile Aurobindo.
Contraception in women taking Micofenolato mofetile Aurobindo
If you are a woman of childbearing potential, you must use an effective contraceptive method while taking Micofenolato mofetile Aurobindo. This means:

• before starting Micofenolato mofetile Aurobindo;
• throughout the entire treatment with Micofenolato mofetile Aurobindo;
• for 6 weeks after stopping treatment with Micofenolato mofetile Aurobindo.

Talk to your doctor about the most suitable contraceptive method for you. This will depend on your individual situation. Using two contraceptive methods is preferable to reduce the risk of unintended pregnancy. Contact your doctor as soon as possible if you think your contraceptive method may not have been effective or if you missed taking your contraceptive pill.
You cannot 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 one year ago (if your menstrual cycle has stopped due to cancer treatment, you may still be able to become pregnant);
• both fallopian tubes and both ovaries have been surgically removed (bilateral salpingo-oophorectomy);
• the uterus has been surgically removed (hysterectomy);
• your ovaries no longer function (premature ovarian failure, confirmed by a gynecological specialist);
• 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 Micofenolato mofetile Aurobindo
Although available clinical data do not indicate an increased risk of malformations or spontaneous abortions when the father is taking mycophenolate, this risk cannot be completely ruled out. As a precaution, you and your partner are therefore advised to use a reliable contraceptive method during treatment and for 90 days after stopping therapy with Micofenolato mofetile Aurobindo.
If you are planning a pregnancy, talk to your doctor about potential risks and alternative treatments.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine. Your doctor will discuss with you the risks associated with pregnancy and alternative treatments you may receive to prevent organ transplant rejection if:

• you are planning a pregnancy;
• you miss or think you may have missed a menstrual period, have unusual menstrual bleeding, or suspect you are pregnant;
• you have had sexual intercourse without using effective contraceptive methods.

If you become pregnant during treatment with mycophenolate, you must inform your doctor immediately. In any case, continue taking Micofenolato mofetile Aurobindo until you see your doctor.
Pregnancy
Mycophenolate very frequently causes miscarriage (50%) and serious congenital malformations (23–27%) in the unborn child. Reported congenital malformations include abnormalities of the ears, eyes, face (cleft lip/palate), finger development, heart, esophagus (the 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 of childbearing potential, you must have a negative pregnancy test before starting treatment and follow your doctor’s advice regarding contraception. Your doctor may require more than one test to ensure you are not pregnant before starting treatment.
Breastfeeding
Do not take Micofenolato mofetile Aurobindo if you are breastfeeding. Small amounts of the medicine may pass into breast milk.
Driving and using machines
Micofenolato mofetile Aurobindo has a moderate influence on the ability to drive vehicles or use tools or machines. If you feel drowsy, dizzy, or confused, consult your doctor or nurse and do not drive or operate tools or machinery until you feel better.
Micofenolato mofetile 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 Mycophenolate mofetil Aurobindo

Take this medicine exactly as your doctor or pharmacist has told you. If you have
any doubts, consult your doctor or pharmacist.
How much to take
The dose you should take depends on the type of transplant you have received. The usual doses are listed
below. Treatment will continue for as long as you need to prevent rejection of the transplanted organ.
Kidney transplant
Adults

• The first dose should be administered within 3 days after the transplant surgery.
• The daily dose is 4 tablets (2 g of medicine), divided into two separate doses.
• 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.
• Your doctor will determine the most appropriate dose based on the child's height and weight (body surface area measured in square meters or “m²”). The recommended dose is 600 mg/m² given twice daily.

Heart transplant
Adults

• The first dose should be administered within 5 days after the transplant surgery.
• The daily dose is 6 tablets (3 g of medicine), divided into two separate doses.
• Take 3 tablets in the morning and 3 tablets in the evening.

Children

• There is no information available on the use of Mycophenolate mofetil Aurobindo in children who have undergone heart transplantation.

Liver transplant
Adults

• The first dose of oral Mycophenolate mofetil Aurobindo will be administered at least 4 days after the transplant surgery and once you are able to swallow oral medication.
• The daily dose is 6 tablets (3 g of medicine), divided into two separate doses.
• Take 3 tablets in the morning and 3 tablets in the evening.

Children

• There is no information available on the use of Mycophenolate mofetil Aurobindo in children who have undergone liver transplantation.

How to take the medicine

• Swallow the tablets whole with a glass of water.
• Do not break or crush the tablets.

If you take more Mycophenolate mofetil Aurobindo than you should
If you take more Mycophenolate mofetil Aurobindo than you should, contact a doctor or go to hospital
immediately. Do the same if someone else accidentally takes the medicine. Take the
medicine pack with you.
If you forget to take Mycophenolate mofetil Aurobindo
If you forget to take your medicine, take it as soon as you remember, then continue taking it as usual.
Do not take a double dose to make up for the forgotten dose.
If you stop taking Mycophenolate mofetil Aurobindo
Do not stop taking Mycophenolate mofetil Aurobindo unless your doctor tells you to.
Stopping treatment may increase the risk of rejection of the transplanted organ.
If you have any questions about how to use 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.
Talk to a 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 develop unexpected bruising or bleeding;
• you develop a 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 more common problems are diarrhoea, decreased white or red blood cells in the blood, infections, and vomiting. Your doctor will carry out regular blood tests to check for any changes:

• in blood cell counts or signs of infection.

Children may be more likely than adults to develop certain side effects. These include diarrhoea, infections, and decreased white and red blood cells in the blood.
Fighting infections
Mycophenolate mofetil Aurobindo lowers the body’s defences to prevent rejection of the transplant. As a result, the body may not be able to fight infections effectively as it normally would. This means you may get infections more often, for example infections affecting the brain, skin, mouth, stomach and intestine, lungs, or urinary tract.
Lymphatic system and skin tumours
As with other medicines of this type (immunosuppressants), a very small number of patients taking Mycophenolate mofetil Aurobindo have developed tumours of the lymphatic system and skin.
General side effects
You may experience side effects affecting the body as a whole. These include severe allergic reactions (such as anaphylaxis, angioedema), fever, feeling tired, sleep disturbances, pain (in stomach, chest, muscles or joints), headache, flu-like symptoms, and swelling.
Other possible side effects may include:
Skin disorders such as:

• acne, cold sores, herpes zoster, skin thickening, hair loss, rash, and itching.

Urinary system disorders such as:

• blood in the urine.

Gastrointestinal and mouth disorders such as:

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

Nervous system disorders such as:

• dizziness, drowsiness, or paraesthesia (tingling or numbness)
• tremors, muscle spasms, seizures
• feeling anxious or depressed, changes in mood or thinking.

Heart and blood vessel disorders such as:

• changes in blood pressure, fast heartbeat, and dilation of blood vessels.

Lung disorders such as:

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

Other disorders such as:

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

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 Mycophenolate mofetil Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
Store below 30°C.
Do not dispose of medicines via 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 substance is mycophenolate mofetil. Each film-coated tablet contains 500 mg of mycophenolate mofetil.
• The other ingredients are: Tablet core: Microcrystalline cellulose (grades 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, iron oxide red, titanium dioxide, indigo carmine (FD & C Blue No. 2) aluminium lake.

Description of the appearance of Micofenolato mofetile Aurobindo and pack sizes
Film-coated tablet.
Purple, modified capsule-shaped film-coated tablets, approximately 17.8 x 8.9 mm,
with “M1” engraved on one side and smooth on the other.
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 European Economic Area Member States under the following names:
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