Mycophenolate mofetil Kern Pharma 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Micofenolato de mofetilo Kern Pharma 500 mg film-coated tablets EFG

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 further questions, ask your doctor or pharmacist.
• 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 side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

What is in this leaflet:

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

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

Micofenolato de mofetilo Kern Pharma belongs to a group of medicines called immunosuppressants. These medicines are used to prevent the body from rejecting a transplanted kidney, heart, or liver. Micofenolato de mofetilo is used in combination with other medicines known as cyclosporines and corticosteroids.

2. What you need to know before starting to take Mycophenolate Mofetil Kern Pharma

WARNING

Mycophenolate causes birth defects and spontaneous abortions. If you are a woman who can 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 mycophenolate on unborn babies. 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 mycophenolate. See further information below in this section under the headings “Warnings and precautions” and “Pregnancy and lactation”.

Do not take Mycophenolate Mofetil Kern Pharma

• If you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid, or to any of the other ingredients of this medicine (listed in section 6).
• If you are a woman who can become pregnant and have not obtained a negative result on a pregnancy test before the first prescription, as mycophenolate may cause birth defects and spontaneous abortions.
• If you are pregnant or intend to become pregnant, or think you might be pregnant.
• If you are not using effective contraception (see Pregnancy, fertility and lactation).
• If you are breastfeeding.

Warnings and precautions

Tell your doctor immediately before taking this medicine:

• If you experience any signs of infection (e.g. fever, sore throat), unexpected bruising and/or bleeding.
• If you have or have had gastrointestinal problems, for example, stomach ulcers.
• If you plan to become pregnant or become pregnant during treatment with this medicine.

Effects of sunlight

Mycophenolate mofetil reduces your body's defence mechanisms. 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 high-protection-factor sunscreen cream.

Taking Mycophenolate Mofetil Kern Pharma with other medicines

Inform 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 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:

• Immunosuppressants (such as azathioprine, cyclosporine A or tacrolimus) – administered after transplant surgery.
• Cholestyramine – a medicine used to treat high cholesterol levels.
• Antibiotics used to prevent and treat infections (such as rifampicin, to treat tuberculosis (TB), or ciprofloxacin and amoxicillin plus clavulanic acid, or norfloxacin and metronidazole).
• 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, such as sevelamer.
• Uricosuric agents used to increase urinary excretion of uric acid, such as probenecid.
• Angiotensin II receptor antagonists used to treat hypertension (such as telmisartan).
• Antivirals used to treat certain viral infections (such as aciclovir or ganciclovir).

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 Mycophenolate Mofetil Kern Pharma with food and drinks

The intake of food and drinks does not affect your treatment with mycophenolate mofetil.

Pregnancy, fertility and lactation

Contraception in women taking Mycophenolate Mofetil Kern Pharma

If you are a woman who can become pregnant, you must always use two effective contraceptive methods. This includes:

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

Consult your doctor to determine which contraceptive method is most suitable for you. This will depend on your personal circumstances. The use of two contraceptive methods is recommended, as this reduces the risk of unintended pregnancy. Consult 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 at risk of becoming 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 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 girl or adolescent who has not yet started menstruation.

Contraception in men taking Mycophenolate Mofetil Kern Pharma

Available evidence does not indicate an increased risk of birth defects or miscarriage if the father takes mycophenolate. However, the risk cannot be completely excluded. As a precautionary measure, you or your female partner are advised to 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.

Pregnancy and lactation

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

• You intend to become pregnant.
• You have missed a period or think you may have missed a menstrual 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 mofetil, inform your doctor immediately. However, continue taking mycophenolate mofetil until you see your doctor.

Pregnancy

Mycophenolate mofetil causes a very high frequency of spontaneous abortions (50%) and serious harm to the unborn baby (23–27%). Reported malformations include abnormalities of the ears, eyes, face (cleft lip and palate), finger development, heart, oesophagus (the tube connecting the throat to the stomach), kidneys, and nervous system (e.g., spina bifida (where the spinal bones do not develop properly)). Your baby may be affected by one or more of these.

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

Lactation

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

Driving and use of machines

Mycophenolate mofetil tablets have not been shown to affect your ability to drive or operate machinery.

3. How to take Mycophenolate Mofetil Kern Pharma

Follow exactly the administration instructions given by your doctor for this medicine. Consult your doctor or pharmacist if you have any doubts. The usual way to take mycophenolate mofetil is as follows:

Kidney transplant

Adults: The first dose should be administered within 72 hours after the transplant surgery. The recommended daily dose is 4 tablets (2 g of active substance), 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 administered will vary depending on the child's size. Your doctor will decide the most appropriate dose based on body surface area (weight and height). 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 recommended daily dose is 6 tablets (3 g of active substance), given in two divided doses. This means taking 3 tablets in the morning and 3 tablets in the evening.

Children and adolescents: There are no data available to recommend the use of mycophenolate mofetil in children and adolescents who have received a heart transplant.

Liver transplant

Adults:

The first oral dose of mycophenolate mofetil should be given at least 4 days after the transplant surgery and once the patient is able to swallow oral medication. The recommended daily dose is 6 tablets (3 g of active substance), given in two divided doses. This means taking 3 tablets in the morning and 3 tablets in the evening.

Children and adolescents:

There are no data available to recommend the use of mycophenolate mofetil in children and adolescents who have received a liver transplant.

Method of use and route of administration

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

Treatment will continue as long as immunosuppression is needed to prevent rejection of the transplanted organ.

If you take more Mycophenolate Mofetil Kern Pharma than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, call the Toxicology Information Service at telephone number 91 562 04 20 (indicating the medicine and amount ingested), or go to the nearest hospital emergency department.

If you forget to take Mycophenolate Mofetil Kern Pharma

If you ever forget to take your medicine, take it as soon as you remember, and then continue at your usual times.

Do not take a double dose to make up for forgotten doses.

If you stop taking Mycophenolate Mofetil Kern Pharma

Stopping treatment with mycophenolate mofetil may increase the risk of rejection of the transplanted organ. Do not stop taking it unless your doctor tells you to.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Children are more likely than adults to experience side effects such as diarrhea, infections, and decreased numbers of white and/or red blood cells in the blood.

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

• If you have symptoms of infection such as fever or sore throat.
• If you develop bruising or unexpected 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).

Very common adverse effects (may affect more than 1 in 10 people):

• Sepsis, gastrointestinal candidiasis, urinary tract infections, herpes simplex, herpes zoster.
• Decreased numbers of white or red blood cells in the blood, such as leukopenia, thrombocytopenia, anemia.
• Vomiting, abdominal pain, diarrhea, nausea.

Common adverse effects (may affect up to 1 in 10 people):

• Pneumonia, flu-like syndrome, respiratory tract infection, respiratory moniliasis, gastrointestinal infection, candidiasis, gastroenteritis, infection, bronchitis, pharyngitis, sinusitis, fungal dermatitis, skin candidiasis, vaginal candidiasis, nasal discharge and itching.
• Skin cancer, or non-cancerous skin growths.
• Pancytopenia, leukocytosis.
• Acidosis, hyperkalemia, hypokalemia, hyperglycemia, hypomagnesemia, hypocalcemia, hypercholesterolemia, hyperlipidemia, hypophosphatemia, hyperuricemia, gout, loss of appetite.
• Agitation, confusion, depression, anxiety, altered thinking, insomnia.
• Seizure, increased muscle tension, tremor, somnolence, myasthenic syndrome, dizziness, headache, tingling or numbness sensation, taste disturbance.
• Increased heart rate.
• Hypotension, hypertension, vasodilation.
• Pleural effusion (fluid in the lung/thoracic cavity), difficulty breathing, cough.
• Gastrointestinal bleeding, peritonitis, ileus, colitis (including cytomegalovirus colitis), gastric ulcer, duodenal ulcer, gastritis, esophagitis, stomatitis, pancreatitis, constipation, dyspepsia, flatulence, belching, gingival enlargement.
• Hepatitis, jaundice, hyperbilirubinemia (liver inflammation, yellowing of the skin and whites of the eyes).
• Cutaneous hypertrophy, skin rash, acne, alopecia.
• Arthralgia (joint pain).
• Kidney problems.
• Edema (fluid retention in the body), fever, chills, pain, general malaise, asthenia.
• Increased enzyme levels, increased serum creatinine, increased serum lactate dehydrogenase, increased serum urea, increased serum alkaline phosphatase, weight loss.

Uncommon adverse effects (may affect up to 1 in 100 people):

• Proliferation of lymphoid tissue, including malignant tumors.
• Inflammation or infection of the heart and its valves, and of the membrane covering the brain and spinal cord.
• Severe decrease in white blood cell count, increasing the likelihood of infections (agranulocytosis).

Adverse effects with unknown frequency:

• Atrophy of intestinal villi.
• Severe infection of brain cells (Progressive Multifocal Leukoencephalopathy). Serious infections such as meningitis, infective endocarditis, tuberculosis, and atypical mycobacterial infection. BK virus-associated nephropathy. Aplastic anemia and bone marrow suppression.
• Hypersensitivity reactions, including angioneurotic edema and anaphylactic reaction.
• Interstitial lung disease and pulmonary fibrosis. Bronchiectasis.
• Hypogammaglobulinemia.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet while taking this medicine, inform your doctor or pharmacist. However, do not stop taking the medicine unless you have discussed it with your doctor first.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Mycophenolate Mofetil Kern Pharma

Keep out of sight and reach of children.

Do not use the tablets after the expiry date shown on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C. Keep in the outer packaging to protect from light.

Medicines should 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 are unsure, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Mycophenolate Mofetil Kern Pharma 500 mg tablets

• The active substance is mycophenolate mofetil. Each tablet contains 500 mg of mycophenolate mofetil.

• The other components (excipients) are:

Tablet core: microcrystalline cellulose (Avicel PH 101), povidone (K-90), hydroxypropyl cellulose, sodium croscarmellose, talc, and magnesium stearate.

Coating: hypromellose 6cps, titanium dioxide (E 171), Macrogol 400, iron oxide red (E 172), indigo carmine aluminum lake (E 132), iron oxide black (E 172), and talc.

Appearance of the product and contents of the pack

Mycophenolate Mofetil Kern Pharma 500 mg tablets are film-coated, biconvex, capsule-shaped, purple-colored tablets, engraved with "AHI" on one side and "500" on the other.

The tablets are available in boxes containing 50 tablets.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

This leaflet was approved in March 2018.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) www.aemps.gob.es