Myfenax 250 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Myfenax 250 mg hard capsules EFG mycophenolate mofetil

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 or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Myfenax is and what it is used for

Myfenax is a medicine used to suppress immune system activity.

The active substance in this medicine is mycophenolate mofetil.

Myfenax is used to prevent the body from rejecting a transplanted kidney, heart, or liver. It is used in combination with other medicines that have a similar function (i.e. cyclosporine and corticosteroids).

2. What you need to know before starting to take Myfenax

WARNING

Mycophenolate causes birth defects 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 on 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 more information in this section under the headings “Warnings and precautions” and “Pregnancy, contraception and breastfeeding”.

Do not take Myfenax,

• 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 who could 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 planning to become pregnant, or think you might be pregnant.
• if you are not using effective contraception (see Pregnancy, contraception 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 Myfenax.

Warnings and precautions

Talk to your doctor before starting treatment with Myfenax:

• if you are over 65 years old, as you may have a higher risk of developing adverse reactions such as certain viral infections, gastrointestinal bleeding, and pulmonary edema compared to younger patients.
• if you experience any signs of infection (e.g. fever, sore throat), unexpected bruising and/or bleeding.
• if you have or have had any gastrointestinal problems, e.g. stomach ulcers.
• if you plan to become pregnant, or if you become pregnant while you or your partner are taking Myfenax.
• if you have a hereditary enzyme deficiency such as Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome.

Myfenax reduces your body's defense mechanisms. For this reason, there is an increased risk of developing skin cancer. Therefore, you should limit exposure to sunlight and ultraviolet (UV) light by wearing protective clothing and using sunscreen with a high protection factor.

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

Children and adolescents

Myfenax is used in children and adolescents (between 2 and 18 years of age) to prevent rejection of a kidney transplant.

Myfenax must not be used in children and adolescents (between 2 and 18 years of age) for heart or liver transplant.

Myfenax must never be used in children under 2 years of age, as safety and efficacy data in this age group are limited and dosage recommendations cannot be made.

Other medicines and Myfenax

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

If you answer "yes" to any of the following questions, consult your doctor before starting to take Myfenax:

• Are you taking any medicine containing:

• azathioprine or another immunosuppressant (sometimes given after transplant surgery),

• colestyramine (used to treat patients with high blood cholesterol levels), rifampicin (antibiotic),

• 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 absorption),

• antibiotics (used to treat bacterial infections),

• isavuconazole (used to treat fungal infections),

• telmisartan (used to treat high blood pressure),

• or any other medicine (including those available without a prescription) that your doctor does not know about?

• Do you need to receive a vaccine (live organism vaccine)? Your doctor will advise you on the most appropriate one for you.

Pregnancy, contraception and breastfeeding

Contraception in women taking Myfenax

If you are a woman who could become pregnant, you must use an effective method of contraception. This includes:

• Before starting to take Myfenax
• During treatment with Myfenax
• For up to 6 weeks after stopping Myfenax

Talk to your doctor to determine which method of contraception is most suitable for you. This will depend on your personal situation. The use of two methods of contraception 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 cannot 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 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 child or adolescent who has not yet started menstruating.

Contraception in men taking Myfenax

Available evidence does not indicate an increased risk of birth defects or miscarriage if the father takes mycophenolate. However, the risk cannot be completely ruled out. As a precaution, you or your female partner are advised to use a reliable method of contraception during treatment and for 90 days after stopping Myfenax.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will discuss with you 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 effective contraception.

If you become pregnant while taking mycophenolate, inform your doctor immediately. However, continue taking Myfenax until you see your doctor.

Pregnancy

Mycophenolate causes a very high rate of spontaneous abortions (50%) and serious harm to the unborn baby (23–27%). Reported birth defects include abnormalities of the ears, eyes, face (cleft lip and palate), finger development, 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 advice on contraception. Your doctor may require more than one pregnancy test to confirm you are not pregnant before starting treatment.

Breastfeeding

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

Driving and using machines

The effect of Myfenax on the ability to drive and use machines is moderate. If you feel drowsy, dazed, or confused, talk to your doctor or nurse and do not drive or operate tools or machinery until you feel better.

Myfenax contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per hard capsule; hence, it is essentially “sodium-free”.

3. How to take Myfenax

Follow exactly the instructions for using this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Your treatment will be initiated and monitored by a transplant specialist physician.

The usual way to take Myfenax is as follows:

Kidney transplant

Adults

The first dose should be administered within 72 hours after transplant surgery. The recommended daily dose is 8 capsules (2 g of active substance), taken in two divided doses. This means taking 4 capsules in the morning and 4 capsules in the evening.

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

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

Heart transplant

Adults

The first dose should be administered within 5 days after transplant surgery. The recommended daily dose is 12 capsules (3 g of active substance), taken in two divided doses. This means taking 6 capsules in the morning and 6 capsules in the evening.

Children

There is no information available on the use of Myfenax in children undergoing heart transplantation.

Liver transplant

Adults

The first dose of oral Myfenax should be given at least 4 days after transplant surgery and once you are able to swallow oral medication. The recommended daily dose is 12 capsules (3 g of active substance), taken in two divided doses. This means taking 6 capsules in the morning and 6 capsules in the evening.

Children

There is no information available on the use of Myfenax in children undergoing liver transplantation.

Method of administration and route

Swallow the capsules whole with a glass of water. You may take it with or without food. Do not break or crush the capsules, and do not take any capsule that is broken or opened. Avoid contact with powder spilled from damaged capsules. If a capsule is accidentally broken or opened, wash the skin thoroughly with soap and water. If powder gets into the eyes or mouth, rinse thoroughly with plenty of running water.

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

If you take more Myfenax than you should

It is important not to take too many capsules. If you take more capsules than prescribed, or if you think a child has taken any, contact your doctor or the nearest hospital emergency department immediately.

If you forget to take Myfenax

If you forget to take a dose, take it as soon as you remember, and then continue with your regular dosing schedule.

Do not take a double dose to make up for a missed dose.

If you stop taking Myfenax

Do not stop taking Myfenax even if you feel better. It is important to continue taking the medicine for as long as your doctor has instructed. Stopping treatment with Myfenax may increase the risk of rejection of the transplanted organ. Do not discontinue unless instructed by your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Contact a doctor immediately if you notice any of the following serious adverse effects; you may require urgent medical treatment:

• signs of infection such as fever or sore throat.
• unexpected bruising or bleeding.
• skin 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).
• black or bloody stools, or vomiting blood or dark particles resembling ground coffee. These may be signs of bleeding in the stomach or intestines.

The frequency of certain adverse effects depends on the transplanted organ; that is, some adverse effects may occur more or less frequently depending on whether this medicine is being taken to prevent rejection of a transplanted heart or a transplanted kidney. For clarity, each adverse effect is always listed according to its highest frequency.

Other adverse effects

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

• bacterial, viral and/or fungal infections

• severe infection that may affect the entire body

• decreased number of white blood cells, platelets or red blood cells, which may result in increased risk of infections, bruising, bleeding, difficulty breathing, and weakness

• bleeding under the skin

• increased number of white blood cells

• excess acid in the body

• high levels of cholesterol and/or lipids in the blood

• high blood sugar levels

• high potassium levels in the blood, low levels of potassium, magnesium, calcium and/or phosphate in the blood

• high levels of uric acid in the blood, gout

• restlessness, disturbances in thought, perception and levels of consciousness, depression, anxiety, difficulty sleeping

• increased muscle tension, spasms, drowsiness, dizziness, headache, tingling, prickling or numbness

• faster heartbeat

• low/high blood pressure, dilation of blood vessels

• fluid accumulation in the lungs, difficulty breathing, cough

• bloated abdomen

• vomiting, stomach pain, diarrhea, nausea

• constipation, indigestion, gas (flatulence)

• loss of appetite

• changes in various laboratory parameters

• liver inflammation, yellowing of the skin and whites of the eyes

• skin growth, rash, acne

• muscle weakness

• joint pain

• kidney problems

• blood in the urine

• fever, chills, pain, feeling of tiredness and weakness

• fluid retention in the body

• protrusion of an internal organ or tissue through a weak spot in the abdominal muscles (hernia)

• muscle, neck and back pain

Common (may affect up to 1 in 10 people)

• skin cancer, non-cancerous skin growth
• abnormal and excessive tissue growth
• decreased number of all blood cells
• benign enlargement of lymph nodes, inflammatory skin changes (pseudolymphoma)
• weight loss
• abnormal thinking
• seizures
• altered sense of taste
• blood clot forming inside a vein (thrombosis)
• inflammation of the tissue lining the inner wall of the abdomen and covering most abdominal organs (peritonitis)
• intestinal obstruction
• inflammation of the colon causing abdominal pain or diarrhea (sometimes caused by cytomegalovirus), mouth and/or stomach and/or duodenal ulcers, inflammation of the stomach, esophagus and/or mouth and lips
• belching
• hair loss
• general malaise
• overgrowth of gum tissue
• pancreatitis, causing severe abdominal and back pain

Uncommon (may affect up to 1 in 100 people)

• protozoal infections

• growth of lymphatic tissue, including malignant tumors

• insufficient production of red blood cells

• serious bone marrow disorders, accumulation of lymphatic fluid in the body

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

• decreased levels of antibodies in the blood

• severe reduction in the number of certain white blood cells (possible symptoms include fever, sore throat, frequent infections) (agranulocytosis)

Frequency not known (cannot be estimated from available data)

• changes in the inner lining of the small intestine (intestinal villous atrophy)
• severe inflammation of the membrane covering the brain and spinal cord (meningitis, encephalitis)
• severe inflammation of the heart and its valves (endocarditis, myocarditis)
• bacterial infections usually causing serious lung disease (tuberculosis, atypical mycobacterial infection)
• serious kidney disease (BK virus-associated nephropathy)
• serious central nervous system disease (JC virus-associated progressive multifocal leukoencephalopathy)
• decreased number of certain white blood cells (neutropenia)
• changes in the shape of certain white blood cells

Do not stop taking this medicine unless you have discussed it first with your doctor.

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.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Myfenax

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Myfenax:

• The active substance is mycophenolate mofetil. Each capsule contains 250 mg of mycophenolate mofetil.
• The other components are:

Contents of the capsule

Pregelatinized maize starch

Povidone K-30

Sodium croscarmellose

Magnesium stearate

Capsule shell

Cap

Indigo carmine (E 132)

Titanium dioxide (E 171)

Gelatin

Body

Red iron oxide (E 172)

Yellow iron oxide (E 172)

Titanium dioxide (E 171)

Gelatin

Black printing ink containing: shellac, black iron oxide (E 172), propylene glycol and potassium hydroxide.

Appearance of the product and contents of the pack

Hard capsules

Body: opaque caramel-coloured, printed with “250” axially in black ink
Cap: opaque light blue, printed with “M” axially in black ink.

Myfenax 250 mg hard capsules are available in PVC/PVdC-aluminium blister packs in pack sizes of 100, 300 or 100 x 1 capsules, and in multiple packs containing 300 (3 packs of 100) capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva B.V.
Swensweg 5
2031GA Haarlem
The Netherlands

Manufacturers

Teva Pharmaceutical Works Private Limited Company
Pallagi út 13
Debrecen H-4042
Hungary

Teva Operations Poland Sp. Z.o.o.
Mogilska 80 Str.
31-546 Krakow
Poland

Pharmachemie B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:

Date of the latest review of this leaflet: {month/YYYY}

Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu