Micofenolato de mofetilo kern pharma 500 mg comprimidos recubiertos con pelicula efg

Product Information for the User

Micofenolate Mofetil Kern Pharma 500 mg Film-Coated Tablets

Read this entire product information carefully before starting to take this medicine, as it contains important information for you.

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed to you alone, and you should not give it to others even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

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

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

3. How to take Micofenolate Mofetil Kern Pharma

4. Possible adverse effects

5. Storage of Micofenolate Mofetil Kern Pharma

6. Contents of the pack and additional informationl

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

WARNING

Mycophenolate causes congenital malformations and spontaneous abortions. If you are a woman who can become pregnant, you must have a negative pregnancy test result before starting treatment and follow the contraceptive advice provided by your doctor.

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

If you do not fully understand these instructions, please consult your doctor again to have them explained to you before taking 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, to mycophenolic acid, or to any of the other components of this medication (including those listed in section 6).
• If you are a woman who can become pregnant and have not obtained a negative pregnancy test result before the first prescription, as mycophenolate may cause congenital malformations and spontaneous abortions.
• If you are pregnant or intend to become pregnant or believe you may be pregnant.
• If you are not using effective contraceptives (see Pregnancy, Fertility, and Breastfeeding).
• If you are breastfeeding.

Warnings and Precautions

Inform your doctor immediately before taking this medication:

• If you experience any signs of infection (e.g., fever, sore throat), unexpected bleeding, or bruising.
• If you have or have had gastrointestinal problems, such as stomach ulcers.
• If you are planning to become pregnant or have become pregnant during treatment with this medication.

Effects of Sunlight

Mycophenolate mofetil reduces your body's defense mechanism. As a result, there is a greater risk of developing 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-factor sunscreen cream.

Taking Mycophenolate Mofetil Kern Pharma with Other Medications

Inform your doctor or pharmacist if you are taking or have recently taken other medications, including those purchased without a prescription, including herbal medications. This is becausemycophenolate mofetilmay affect how other medications work. Other medications may also affect howmycophenolate mofetilworks.

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

• Immunosuppressive medications (such as azathioprine, cyclosporine A, or tacrolimus) – administered after transplant surgery.
• Colestiramine – medication 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 disease to reduce phosphate absorption in 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 hypertension (such as telmisartan).
• Antivirals used to treat certain viral infections (such as aciclovir or ganciclovir).

Vaccinations

If you need to receive a vaccine (live vaccine) during treatment with mycophenolate mofetil, consult your doctor or pharmacist first. Your doctor will advise on the vaccines that can be administered.

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

Taking Mycophenolate Mofetil Kern Pharma with Food and Beverages

The consumption of food and beverages 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 contraceptive methods. This includes:

• Before starting to take mycophenolate mofetil.
• During the entire treatment with mycophenolate mofetil.
• For at least 6 weeks after stopping mycophenolate mofetil.

Consult your doctor to see which contraceptive method is most suitable for you. This will depend on your individual 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 believe your contraceptive method may not have been effective or if you have forgotten to take the contraceptive pill.

You are considered not susceptible to becoming pregnant if your case is one of the following:

• You are postmenopausal, i.e., you are at least 50 years old and your last period occurred more than a year ago (if your periods have stopped due to cancer treatment, there is still a possibility that you may become pregnant).
• Your fallopian tubes and ovaries have been surgically removed (bilateral salpingo-oophorectomy).
• Your uterus has been 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 diseases 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 Kern Pharma

The available evidence does not indicate a higher risk of malformations or spontaneous abortion if the father takes mycophenolate. However, the risk cannot be completely ruled out. As a precaution, it is recommended that you or your female partner use a reliable contraceptive methodduring treatment and for at least 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, or believe you may be pregnant, consult your doctor or pharmacist before taking this medication. Your doctor will discuss the risks and alternative treatment options that you can take to prevent organ transplant rejection if:

• You intend to become pregnant.
• You have missed or suspect a menstrual period or have unusual menstrual bleeding.
• 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 spontaneous abortions (50%) and severe damage to the unborn baby (23-27%). Among the malformations reported are ear, eye, facial (cleft lip and palate), finger development, heart, esophagus (tube connecting the throat with the stomach), kidney, and nervous system (e.g., spina bifida) abnormalities. 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 follow the contraceptive advice provided by your doctor. Your doctor may request multiple pregnancy tests 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 medication may pass into breast milk.

Driving and Operating Machinery

No studies have shown that mycophenolate mofetil tablets affect your ability to drive or operate machinery.

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

Renal Transplant

Adults:The first dose should be administered within the 72-hour interval following the transplant surgery. The recommended daily dose is 4 tablets (2 g of active ingredient), administered in 2 separate doses. This means taking 2 tablets in the morning and another 2 tablets at night.

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

Heart Transplant

Adults:The first dose should be administered within the 5-day interval following the transplant surgery. The recommended daily dose is 6 tablets (3 g of active ingredient), administered in 2 separate doses. This means taking 3 tablets in the morning and another 3 tablets at night.

Children and adolescents:No data are 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 administered once at least 4 days have passed since the transplant surgery and when able to swallow oral medication. The recommended daily dose is 6 tablets (3 g of active ingredient), administered in 2 separate doses. This means taking 3 tablets in the morning and another 3 tablets at night.

Children and adolescents:

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

Form 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 Toxicological Information Service, phone 91 562 04 20 (indicating the medication and the amount ingested), or go to the nearest hospital emergency service.

If you forget to take Mycophenolate mofetil Kern Pharma

If you ever forget to take the medication, take it as soon as you remember and then continue with your usual schedule.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Mycophenolate mofetil Kern Pharma

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

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

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

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

• If you have an infection symptom such as fever or sore throat.
• If you develop petechiae or unexpected bleeding.
• If you have a rash, facial swelling, lip, tongue, or throat swelling with difficulty breathing. You may be having a severe allergic reaction to the medicine (such as anaphylaxis, angioedema).

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

• Sepsis, gastrointestinal candidiasis, urinary tract infections, herpes simplex, herpes zoster.
• Decrease in the number of white blood cells or red blood cells in the blood, such as Leucopenia, thrombocytopenia. Anemia.
• Vomiting, abdominal pain, diarrhea, nausea.

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

• Pneumonia, influenza-like illness, respiratory tract infection, moniliasis respiratory, gastrointestinal infection, candidiasis, gastroenteritis, infection, bronchitis, pharyngitis, sinusitis, dermatitis mycotic, skin candidiasis, vaginal candidiasis, nasal secretion and itching.
• Skin cancer, or non-cancerous skin growths.
• Pancitopenia, leucocytosis.
• Acidosis, hyperkalemia, hypokalemia, hyperglycemia, hypomagnesemia, hypocalcemia, hypercholesterolemia, hyperlipidemia, hypophosphatemia, hyperuricemia, gout, loss of appetite.
• Agitation, confusion, depression, anxiety, thought alteration, insomnia.
• Convulsion, increased muscle tension, tremor, somnolence, myasthenic syndrome, dizziness, headache, sensation of tingling or numbness, change in taste.
• High 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, gum enlargement.
• Hepatitis, jaundice, hyperbilirubinemia (inflammation of the liver, yellow discoloration of the skin and the white of the eyes).
• Cutaneous hypertrophy, skin rash, acne, alopecia.
• Arthralgia (joint pain).
• Renal 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 it more likely to have infections (agranulocytosis).

Side effects of unknown frequency:

• Intestinal villous atrophy.
• Severe brain cell infections (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 angioneuritic edema and anaphylactic reaction.
• Pulmonary interstitial disease and pulmonary fibrosis. Bronchiectasias.
• Hypogammaglobulinemia.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this prospectus, while taking this medicine, inform your doctor or pharmacist. However, do not stop taking the medicine unless you have consulted with your doctor first.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for human use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

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

Do not store at a temperature above25°C. Store in the outer packaging to protect it from light.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Micofenolato de mofetilo Kern Pharma 500 mg tablets

• The active ingredient is micofenolato de mofetilo. Each tablet contains 500 mg of micofenolato de mofetilo.

• 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 in aluminium lake (E 132), iron oxide black (E 172), and talc.

Appearance of the product and contents of the packaging

Micofenolato de mofetilo Kern Pharma 500 mg tablets are film-coated, biconvex, capsule-shaped tablets, purple in color, with the imprint “AHI” on one face and “500” on the other.

The tablets are available in packs of 50 tablets.

Holder of the marketing authorization and responsible 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 medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)www.aemps.gob.es