Mycophenolate mofetil Tecnigen 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Mycofenolate mofetil TecniGen 500 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you:

• Keep this leaflet, as 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 and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Micofenolato de mofetilo TecniGen is and what it is used for

Micofenolato de mofetilo TecniGen contains mycophenolate mofetil. It belongs to a group of medicines called "immunosuppressants".

Mycophenolate mofetil is used to prevent the body from rejecting a transplanted organ.

• Kidney, heart, or liver.

Mycophenolate mofetil must be used in combination with other medicines:

• cyclosporine and corticosteroids.

2. What you need to know before starting to take Micofenolato de mofetilo TecniGen

WARNING

Micofenolato causes congenital malformations and spontaneous abortions. If you are a woman who could become pregnant, you must have a negative pregnancy test result before starting treatment and must follow your doctor's advice regarding contraception.

Your doctor will explain and provide you with written information, particularly about the effects of micofenolato on unborn babies. Please read this information carefully and follow the instructions.

If you do not fully understand these instructions, please consult your doctor again for further explanation before taking micofenolato. See more information below in this section under the headings “Warnings and precautions” and “Pregnancy and breastfeeding”.

Do not take Micofenolato de mofetilo TecniGen:

• If you are allergic (hypersensitive) to mycophenolate 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 obtained a negative result on a pregnancy test before the first prescription, as micofenolato may cause congenital malformations and spontaneous abortions.
  • If you are pregnant or planning to become pregnant, or think you might be pregnant
  • If you are not using effective contraception (see Pregnancy, fertility and breastfeeding)

If you are breastfeeding.

Do not take this medicine if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking mycophenolate mofetil.

Warnings and precautions:

Talk to your doctor or pharmacist before starting to take mycophenolate mofetil.

• If you have any signs of infection such as fever or sore throat,

  • If you develop unexpected bruising or bleeding.

• If you have ever had a gastrointestinal problem, such as a stomach ulcer.

• If you are planning to become pregnant or become pregnant during treatment with mycophenolate mofetil.

If any of the above apply to you (or if you are unsure), consult your doctor immediately before taking mycophenolate mofetil.

Effect of sunlight

Mycofenolate mofetil reduces your body's defenses. For this reason, there is an increased risk of developing skin cancer. Limit your exposure to sunlight and UV light by:

• Wearing appropriate protective clothing that also covers your head, neck, arms, and legs
• Using a sunscreen with high protection factor.

Taking Micofenolato de mofetilo TecniGen with other medicines

Inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines. This includes medicines obtained without a prescription, including herbal medicines.

This is because mycophenolate mofetil may affect how other medicines work. Also, other medicines may affect how mycophenolate mofetil works.

Specifically, inform your doctor or pharmacist if you are taking any of the following medicines before starting mycophenolate mofetil:

• Azathioprine or another medicine that suppresses the immune system – given after transplant surgery
• Cholestyramine – used to treat high cholesterol levels
• 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 absorption in 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 receive a vaccine (live organism vaccine) during treatment with mycophenolate mofetil, consult your doctor or pharmacist first. Your doctor will advise you on which vaccines you may receive.

You must not donate blood during treatment with mycophenolate mofetil and for at least 6 weeks after stopping treatment. Men must not donate semen during treatment with mycophenolate mofetil and for at least 90 days after stopping treatment.

Taking Micofenolato de Mofetilo TecniGen with food, drinks and alcohol

Taking food and drinks does not affect your treatment with mycophenolate mofetil.

Pregnancy, breastfeeding and fertility

Contraception in women taking mycophenolate mofetil

If you are a woman who could become pregnant, you must always use two effective methods of contraception. This includes:

• Before starting mycophenolate mofetil
• Throughout treatment with mycophenolate mofetil
• Up to 6 weeks after stopping mycophenolate mofetil.

Talk to your doctor to determine the most suitable contraceptive method for you, based on your personal circumstances. The use of two contraceptive methods is recommended 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 have missed taking your contraceptive pill.

You are considered not able to become pregnant if you meet any of the following criteria:

• You are post-menopausal, i.e., you are at least 50 years old and your last menstrual period occurred more than one year ago (if your periods have stopped due to cancer treatment, you may still be able to become pregnant)
• You have had both fallopian tubes and both ovaries surgically removed (bilateral salpingo-oophorectomy)
• You have had your uterus surgically removed (hysterectomy)
• Your ovaries do not function (premature ovarian failure confirmed by a specialist gynecologist)
• You were born with one of the following rare conditions that make pregnancy impossible: XY genotype, Turner syndrome, or uterine agenesis
• You are a girl or adolescent who has not yet started menstruating.

Contraception in men taking mycophenolate mofetil

Available evidence does not indicate an increased risk of congenital malformations or miscarriage if the father is taking mycophenolate. However, the risk cannot be completely ruled out. As a precautionary measure, you or your female partner should use a reliable contraceptive method during treatment and for up to 90 days after stopping mycophenolate mofetil.

If you are planning to have a child, consult your doctor about possible risks and alternative treatments.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine. Your doctor will discuss the risks and alternative treatments available to prevent rejection of the transplanted organ if:

• You plan to become pregnant.
• You miss a period or think you may have missed a period, have unusual menstrual bleeding, or suspect you may be pregnant.
• You have had sexual intercourse without using an effective contraceptive method.

If you become pregnant during treatment with mycophenolate, inform your doctor immediately. However, continue taking mycophenolate mofetil until you see your doctor.

Pregnancy

Micofenolato causes a very high frequency of spontaneous abortions (50%) and serious harm to the unborn baby (23–27%). Malformations that have been reported include abnormalities of the ears, eyes, face (cleft lip and palate), fingers, heart, esophagus (the tube connecting the throat to the stomach), kidneys, and nervous system (e.g., spina bifida (where the bones of the spine do not develop properly)). Your baby may be affected by one or more of these.

If you are a woman who could become pregnant, you must have a negative pregnancy test result before starting treatment and must follow your doctor's contraceptive advice. Your doctor may require more than one pregnancy test to ensure you are not pregnant before starting treatment.

Breastfeeding

Do not take mycophenolate mofetil if you are breastfeeding. This is because small amounts of the medicine may pass into breast milk.

Driving and using machines:

The influence of mycophenolate mofetil on the ability to drive and use machines is moderate. If you feel drowsy, dazed, or confused, speak with your doctor or nurse and do not drive or operate tools or machinery until you feel better.

Micofenolato de mofetilo TecniGen contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per film-coated tablet; therefore, it is essentially “sodium-free”.

3. How to take Mycophenolate Mofetil TecniGen

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

Dose to be taken

The dose you should take depends on the type of transplant you have received. The usual doses are shown below. Treatment will continue for as long as necessary to prevent rejection of the transplanted organ.

Kidney Transplant

Adults:

• The first dose should be administered within 3 days after the transplant surgery.
• The recommended daily dose is 4 tablets (2 g of the medicine), given in two divided doses.
• This means taking 2 tablets in the morning and 2 tablets in the evening.

Children and adolescents (between 2 and 18 years of age):

• The dose varies depending on the child's size.
• Your doctor will determine the most appropriate dose based on the child's height and weight (body surface area measured in square meters “m²”). The recommended dose is 600 mg/m², administered twice daily.

Heart Transplant

Adults:

• The first dose should be administered within 5 days after the transplant surgery.
• The recommended daily dose is 6 tablets (3 g of the medicine), given in two divided 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 in children who have received a heart transplant.

Liver Transplant

Adults:

• The first dose should be administered at least 4 days after the transplant surgery and once the patient is able to swallow oral medication.
• The daily dose is 6 tablets (3 g of the medicine), given in two divided 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 in children who have received a liver transplant.

How to take this medicine

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

If you take more Mycophenolate Mofetil TecniGen than you should

If you take more tablets than prescribed, or if someone accidentally takes your medicine, you must immediately contact your doctor or go to a hospital, or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Mycophenolate Mofetil TecniGen

If you forget to take a dose, take it as soon as you remember. Then continue taking the medicine at your usual times. Do not take a double dose to make up for a missed dose.

If you stop taking Mycophenolate Mofetil TecniGen

Do not stop taking mycophenolate mofetil unless your doctor tells you to.

Stopping treatment may increase the risk of rejection of the transplanted organ.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, mycophenolate mofetil can cause adverse effects in some patients, although not everyone experiences them.

Contact your doctor immediately if you notice any of the following serious adverse effects, as you may require urgent medical treatment:

• if you have signs of infection such as fever or sore throat
• if you develop unexplained bruising or bleeding
• if you develop a rash, swelling of the face, lips, tongue, or throat, with difficulty breathing.

You may be experiencing a severe allergic reaction to the medicine (such as anaphylaxis, angioedema).

Frequent problems

Some of the more common problems include diarrhea, decreased number of white and/or red blood cells in the blood, infection, and vomiting. Your doctor will carry out regular blood tests to monitor for any changes in:

• blood cell counts or signs of infection

Adverse effects are more likely to occur in children than in adults. These include diarrhea, infections, and reduced levels of white and red blood cells in the blood.

Fighting infections

Treatment with mycophenolate mofetil reduces the body's natural defenses. This is intended to prevent transplant rejection. For this reason, the body is also less able to fight infections as effectively as under normal conditions. This means you may be more prone to infections than usual. These may include infections affecting the brain, skin, mouth, stomach and intestines, lungs, and urinary system.

Skin and lymphatic cancer

As with other patients taking this type of medicine (immunosuppressants), a very small number of patients treated with mycophenolate mofetil have developed cancers of lymphoid tissues and skin.

General unwanted effects

General adverse effects affecting the whole body may occur. These include severe allergic reactions (such as anaphylaxis, angioedema), fever, extreme tiredness, difficulty sleeping, pain (such as stomach pain, chest pain, joint pain, muscle pain, pain during urination), headache, flu-like symptoms, and swelling.

Other adverse effects may include:

Skin problems such as:

• acne, cold sores, shingles, skin growths, hair loss, rash, itching.

Urinary problems such as:

• blood in the urine.

Digestive and mouth problems such 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 problems such as:

• dizziness, drowsiness, or numbness
• seizures, tremor, muscle spasms
• feelings of anxiety or depression, changes in mood or thinking.

Heart and blood vessel problems such as:

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

Lung problems such as:

• pneumonia, bronchitis

• difficulty breathing, cough, which may be due to bronchiectasis (a condition in which the lung airways are abnormally widened) or pulmonary fibrosis (scarring of the lung). Consult your doctor if you develop a persistent cough or shortness of breath.

• fluid in the lungs or inside the chest cavity

• problems with the sinuses.

Other problems such as:

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaran.es.

5. Storage of Mycophenolate mofetil TecniGen

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after (EXP.). The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice any visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Mycophenolate Mofetil TecniGen

• The active substance is mycophenolate mofetil. Each tablet contains 500 mg of mycophenolate mofetil.
• The other components are:

Core:

Microcrystalline cellulose (Avicel PH101),
Sodium croscarmellose (Ac-di-sol),
Povidone (Kollidon K90),
Magnesium stearate.

Coating:

Hypromellose 3cP,
Hydroxypropyl cellulose,
Titanium dioxide (E171),
Macrogol 400,
Hypromellose 50cP,
Indigo carmine lake (E132),
Iron oxide red (E172).

Appearance of the product and contents of the pack

Mycophenolate Mofetil TecniGen 500 mg film-coated tablets are presented as oblong, violet-colored, film-coated tablets. They are packed in PVC+PCTFE+PE/Aluminum blisters containing 50 tablets.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Tecnimede España Industria Farmacéutica, S.A.
Avda. de Bruselas, 13, 3º D.Edificio América. Polígono Arroyo de la Vega,
28108 Alcobendas (Madrid), Spain

Manufacturer:

Tecnimede - Sociedade Técnico–Medicinal, S.A.
Quinta da Cerca, Caixaria
2565-187 Dois Portos
Portugal

This medicinal product is authorized in the following EU Member States under the following names:

Spain: Mycophenolate Mofetil TecniGen 500 mg film-coated tablets EFG
Portugal: Mycophenolate Mofetil TecniGen

Date of the most recent review of this leaflet: October 2021.

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/