MOFETIL MYCOPHENOLATE KERN PHARMA 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Mycophenolate Mofetil 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. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

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

1. What Mycophenolate Mofetil Kern Pharma is and what it is used for

Mycophenolate Mofetil Kern Pharma belongs to a group of medicines called immunosuppressants. These medicines are used to prevent your body from rejecting a transplanted kidney, heart, or liver. Mycophenolate Mofetil is used together with other medicines such as cyclosporins and corticosteroids.

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

WARNING

Mycophenolate causes birth defects and miscarriages. If you are a woman who can become pregnant, you must have a negative pregnancy test before starting treatment and must follow the contraceptive advice given by your doctor.

Your doctor will explain and give you written information, particularly about the effects of mycophenolate on unborn babies. Read the information carefully and follow the instructions.

If you do not understand these instructions completely, please consult your doctor again so that they can explain them to you again before you take mycophenolate. See more information below in this section, under the headings “Warnings and precautions” and “Pregnancy and breastfeeding”.

Do not take Mycophenolate Mofetil Kern Pharma

• 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 can become pregnant and have not had a negative pregnancy test before the first prescription, as mycophenolate can cause birth defects and miscarriages.
• If you are pregnant or plan to become pregnant or think you may be pregnant.
• If you are not using effective contraception (see Pregnancy, fertility, and breastfeeding).
• 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 problems with your digestive system, such as stomach ulcers.
• If you plan to become pregnant or have become pregnant during treatment with this medicine.

Sunlight effects

Mycophenolate Mofetil reduces your body's defense mechanism. For this reason, there is a higher risk of skin cancer. Limit the amount of sunlight and UV light you absorb by:

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

Taking Mycophenolate Mofetil Kern Pharma with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription, including herbal medicines. This is because mycophenolate mofetil can affect how other medicines work. Other medicines can also affect how mycophenolate mofetil works.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines before starting mycophenolate mofetil:

• Immunosuppressant medicines (such as azathioprine, cyclosporin A, or tacrolimus) - which were given to you after your transplant operation.
• 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 acid problems such as indigestion.
• Phosphate binders - used in patients with chronic kidney failure to reduce phosphate absorption into the blood, such as sevelamer.
• Uricosuric agents used to increase the excretion of uric acid in the urine, such as probenecid.
• Angiotensin II receptor antagonists used to treat high blood pressure (such as telmisartan).
• Antivirals used to treat certain viral infections (such as acyclovir or ganciclovir).

Vaccines

If you need to have 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 can have.

Do not donate blood during treatment with mycophenolate mofetil and for at least 6 weeks after stopping treatment. Men should 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

Food and drink intake does not affect your treatment with mycophenolate mofetil.

Pregnancy, fertility, and breastfeeding

Contraception in women taking Mycophenolate Mofetil Kern Pharma

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

• Before starting to take mycophenolate mofetil.
• During all treatment with mycophenolate mofetil.
• Until 6 weeks after stopping mycophenolate mofetil.

Consult your doctor to see which contraceptive method is most suitable for you. This will depend on your personal situation. It is recommended to use two contraceptive methods as this will reduce 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 forgotten to take your contraceptive pill.

You are considered not to be at risk of becoming pregnant if your situation is one of the following:

• You are post-menopausal, i.e., you are at least 50 years old and your last period was more than a year ago (if your periods have stopped due to cancer treatment, you may still be able to become pregnant).
• You have had your fallopian tubes and both ovaries removed by surgery (bilateral salpingo-oophorectomy).
• You have had your uterus removed by surgery (hysterectomy).
• Your ovaries do not work (premature ovarian failure that has been 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 started having periods.

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 precaution, it is recommended that you or your female partner use a reliable contraceptive method during treatment and until 90 days after stopping mycophenolate mofetil.

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

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 you can take to prevent organ transplant rejection if:

• You plan to become pregnant.
• You have missed a period or have unusual menstrual bleeding or suspect you may be pregnant.
• You have had unprotected sex.

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 miscarriages (50%) and severe damage to the unborn baby (23-27%). Among the birth defects reported are ear, eye, facial (cleft lip and palate), finger, heart, esophagus (tube connecting the throat to the stomach), kidney, and nervous system defects (such as 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 can become pregnant, you must have a negative pregnancy test before starting treatment and must follow the contraceptive advice given by your doctor. Your doctor may request 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

It has not been shown that mycophenolate mofetil tablets affect your ability to drive or use machines.

3. How to take Mycophenolate Mofetil Kern Pharma

Follow exactly the instructions for administration of this medicine given by your doctor. 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 given within 72 hours after the transplant operation. The recommended daily dose is 4 tablets (2 g of active ingredient), given in 2 divided doses. This means taking 2 tablets in the morning and 2 tablets in the evening.

Children and adolescents (between 2 and 18 years):The dose given will vary depending on the size of the child. Your doctor will decide which dose is most suitable, taking into account the body surface area (weight and height). The recommended dose is 600 mg/m², given twice a day.

Heart transplant

Adults:The first dose should be given within 5 days after the transplant operation. The recommended daily dose is 6 tablets (3 g of active ingredient), given in 2 divided doses. This means taking 3 tablets in the morning and 3 tablets in the evening.

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

Liver transplant

Adults:

The first dose of mycophenolate mofetil should be given orally once at least 4 days after the transplant operation and when you are able to swallow oral medication. The recommended daily dose is 6 tablets (3 g of active ingredient), given in 2 divided doses. This means taking 3 tablets in the morning and 3 tablets in the evening.

Children and adolescents:

There is no data 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 organ transplant rejection.

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, telephone 91 562 04 20 (indicating the medicine and the amount ingested), or go to the emergency department of the nearest hospital.

If you forget to take Mycophenolate Mofetil Kern Pharma

If you ever forget to take the medicine, take it as soon as you remember and then continue at the 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 chances of organ transplant rejection. Do not stop taking it unless your doctor tells you to.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Children are more likely than adults to have side effects such as diarrhea, infections, decreased white blood cell count and/or red blood cell count in the blood.

Tell your doctor immediately if you notice any of the following serious side effects, as you may need urgent medical treatment:

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

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

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

Common side 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, cutaneous 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 tone, tremor, somnolence, myasthenic syndrome, dizziness, headache, sensation of tingling or numbness, change in taste.
• Increased heart rate.
• Hypotension, hypertension, vasodilation.
• Pleural effusion (fluid in the lung cavity/thoracic cavity), difficulty breathing, cough.
• Gastrointestinal bleeding, peritonitis, ileus, colitis (including cytomegalovirus colitis), gastric ulcer, duodenal ulcer, gastritis, esophagitis, stomatitis, pancreatitis, constipation, dyspepsia, flatulence, eructation, gum hypertrophy.
• Hepatitis, jaundice, hyperbilirubinemia (inflammation of the liver, yellowing of the skin and whites of the eyes).
• Skin 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 side effects(may affect up to 1 in 100 people):

• Lymphatic tissue proliferation, including malignant tumors.
• Inflammation or infection of the heart and its valves and the membrane covering the brain and spinal cord.
• Severe decrease in the number of white blood cells, making infections more likely (agranulocytosis).

Side effects of unknown frequency:

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

If you think any of the side effects you are experiencing is serious or if you notice any side 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 consulted your doctor first.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for human use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Micofenolate Mofetil Kern Pharma

Keep out of sight and reach of children.

Do not take the tablets after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C. Store in the outer packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and unused medicines at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Micofenolate Mofetil Kern Pharma 500 mg Tablets

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

• The other components (excipients) are:

Core of the tablets: 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, red iron oxide (E 172), carmine indigo lake (E 132), black iron oxide (E 172), and talc.

Appearance of the Product and Package Contents

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

The tablets are available in packs of 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 inMarch 2018.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es