500 mg film-coated tablets
mycophenolate mofetil
What Myfenax is and what it is used for
Myfenax belongs to a group of medicines called immunosuppressants.
The active substance in this medicine is called mycophenolate mofetil.
Myfenax tablets are used to prevent the body from rejecting a transplanted kidney, heart, or liver. Myfenax is used with other medicines with similar functions (eg cyclosporine and steroids ).
What you need to know before taking Myfenax
WARNING
Myfenax causes birth defects and miscarriages. If you are a woman and could become pregnant, you must show a negative pregnancy test before starting treatment and you must follow your doctor’s instructions on contraception.
Your doctor will talk to you and give you written information, especially about the effects mycophenolate has on the fetus. Read the information carefully and follow the instructions. If you do not fully understand these instructions, ask your doctor to explain them again before taking mycophenolate. See also further information in this section under “Warnings and precautions” and “Pregnancy, contraception and breast-feeding”.
Do not take Myfenax
- if you are allergic to mycophenolate mofetil, mycophenolate acid or any of the other ingredients of this medicine (listed in section 6).
- if you are a woman and may become pregnant and have not had a negative pregnancy test before receiving your first prescription, as mycophenolate causes birth defects and miscarriages.
- if you are pregnant, planning to become pregnant or think you may be pregnant.
- if you are not using effective contraception (see Pregnancy, contraception and breastfeeding).
- if you are breast-feeding.
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Myfenax.
Warnings and cautions
Tell your doctor immediately before starting treatment with Myfenax:
- if you experience signs of infection (eg fever, sore throat), unexpected bruising and / or bleeding.
- if you have or have had any digestive problems, e.g. stomach ulcer .
- if you are planning to become pregnant or become pregnant while you or your partner are using Myfenax.
Myfenax reduces the body’s defense mechanisms, therefore there is an increased risk of skin cancer. For this reason, you should avoid sun 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 should not donate semen during treatment with Myfenax and for at least 90 days after stopping treatment.
Children and young people
Myfenax is used in children and adolescents (ages 2 to 18 years) to prevent the rejection of a transplanted kidney.
Myfenax should not be used in children and adolescents (age 2 to 18 years) for heart or liver transplantation.
Myfenax should not be used at all by children under 2 years of age.
Other medicines and Myfenax
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you answer yes to any of the following questions, please consult your doctor before starting treatment with Myfenax tablets:
- Are you taking any medicine that contains:
- azathioprine or any other medicine that weakens your immune system (these can sometimes be given after a transplant)
- cholestyramine (used to treat high cholesterol )
- rifampicin ( antibiotic )
- acid-binding agents or proton pump inhibitors (used for stomach acid problems such as digestive problems)
- phosphate-binding drug (used by patients with chronic renal failure to reduce phosphate uptake )
- antibiotics (used to treat bacterial infections)
- isavuconazole (used to treat fungal infections)
- telmisartan (used to treat high blood pressure )
- or any other medicine (including medicines you can buy without a prescription) that your doctor does not know about?
- Do you need to be vaccinated (live vaccine)? Your doctor must advise you on what applies to you.
Pregnancy, contraception and breastfeeding
Use of contraceptives in women taking Myfenax
If you are a woman and could become pregnant, you must always use two effective methods of contraception with Myfenax. It includes:
- before starting treatment with Myfenax
- during the entire treatment period with Myfenax
- for 6 weeks after stopping treatment with Myfenax
Talk to your doctor about which contraceptive method is best for you. It depends on your situation. Two forms of contraception are preferred as it reduces the risk of accidental pregnancy. Contact your doctor immediately if you think your contraceptive has not worked or if you have forgotten to take your pills.
Women who meet any of the following criteria cannot become pregnant:
- You have passed menopause , ie turned at least 50 years old and your last menstrual period was more than a year ago (if your menstrual period has stopped due to treatment for cancer, there is a chance that you may become pregnant)
- Your fallopian tubes and both ovaries have been surgically removed (bilateral salpingo -oophorectomy )
- Your uterus has had surgery ( hysterectomy )
- Your ovaries have stopped working (premature menopause determined by a gynecologist)
- You have been born with any of the following conditions that are rare and lead to the inability to conceive: XY genotype, Turner syndrome or congenital absence of uterus
- You are a child or teenager who has not yet had your period.
Use of contraceptives in men taking Myfenax
Available data do not indicate an increased risk of birth defects or miscarriage if the father takes mycophenolate. However, the risk can not be completely ruled out. As a precautionary measure, it is recommended that you or your female partner use reliable contraception during treatment and for a further 90 days after stopping Myfenax.
If you are planning to have a baby, talk to your doctor about the potential risks and alternative treatments.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will talk to you about the risks of pregnancy and what options you can take to prevent your transplanted organ from being rejected if:
- You are planning to get pregnant.
- You have skipped or think you have skipped a period, if you have unusual menstrual bleeding or if you think you are pregnant.
- You have sex without using a safe method of contraception.
If you become pregnant during treatment with mycophenolate, you must inform your doctor immediately. However, continue to take Myfenax until you meet him or her.
Pregnancy
Mycophenolate causes a very high frequency of miscarriages (50%) and severe birth defects (23‑27%) in the unborn baby. Fetal injuries that have been reported include malformations of the ears, eyes, face (cleft lip/palate), malformations in the development of the fingers, heart, esophagus (the tube that connects the pharynx to the stomach), kidneys, and nervous system (such as spinal hernias). are properly developed)). Your child may have one or more of these birth defects.
If you are a woman and could become pregnant, you must show a negative pregnancy test before starting treatment and you must follow your doctor’s instructions on contraception. Your doctor may require more than one test to make sure you are not pregnant before starting treatment.
Breast-feeding
Do not take Myfenax if you are breastfeeding. This is because small amounts of the drug can pass into breast milk.
Driving and using machines
Myfenax has a moderate effect on your ability to drive motor vehicles and use tools or machines. If you feel drowsy, numb, or confused, talk to your doctor or nurse and do not drive or use any tools or machines until you feel better.
Myfenax contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per film-coated tablet, ie essentially ‘ sodium-free. is next to “sodium-free”.
How to take Myfenax
Always take Myfenax exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Your treatment is started and supervised by a doctor who specializes in transplants.
The most common way to take Myfenax is as follows:
In kidney transplantation
Adults
The first dose is given within 72 hours after transplantation. The recommended daily dose is 4 tablets (2 g of the active substance), which are divided into 2 doses per day. This means that you should take 2 tablets in the morning and 2 tablets in the evening.
Children and adolescents (age 2 to 18 years)
The dose one is given may vary depending on the size of the child. Your doctor will determine the most appropriate dose based on your body surface area (height and weight). The recommended dose is 600 mg / m 2 twice daily.
In heart transplantation
Adults
The first dose is given within 5 days after transplantation. The recommended dose is 6 tablets (3 g of the active substance), which are divided into 2 doses per day. This means that you take 3 tablets in the morning and 3 tablets in the evening.
Children
There is no information on the use of Myfenax in children with a heart transplant.
In liver transplantation
Adults
You will receive the first dose of oral Myfenax no earlier than 4 days after the transplant and when you can swallow the medicine. The recommended daily dose is 6 tablets (3 g of the active substance), which are divided into 2 doses per day. This means that you take 3 tablets in the morning and 3 tablets in the evening.
Children
There is no information on the use of Myfenax in children with a liver transplant.
Method of administration
Swallow your tablets whole along with a glass of water. You can take them with or without food. You should not break or crush them.
The treatment continues as long as you need immunosuppression to prevent the body from rejecting the transplanted organ.
If you take more Myfenax than you should
It is important not to take too many tablets. If you have taken more tablets than you were prescribed or if someone else accidentally took your medicine, consult a doctor or hospital immediately.
If you forget to take Myfenax
If you ever forget to take the medicine, take your dose as soon as you remember. Then continue to take your dose at the usual times.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Myfenax
Do not stop taking Myfenax even if you feel better. You must continue your medication for as long as your doctor prescribes it. The risk of rejection of the transplanted organ may increase if your treatment with Myfenax is stopped. Do not stop taking your medicine unless your doctor tells you to.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Talk to a doctor immediately if you notice any of the following serious side effects – you may need urgent medical attention:
- you get signs of infection such as fever or sore throat
- you get unexpected bruising or bleeding
- you get a rash, swelling of the face, lips, tongue or throat, with difficulty breathing – you may have had a severe allergic reaction to the medicine (such as anaphylaxis , angioedema )
- you get black or bloody stools or if you cough up blood or dark particles that look like coffee grounds. This may be a sign of bleeding in the stomach or intestines.
The frequency of certain side effects depends on the transplanted organ, ie. Some side effects can occur more or less often depending on whether this drug is taken to prevent the body from being struck by a transplanted heart or a transplanted kidney. For the sake of clarity, each side effect is always listed below its highest frequency.
Other side effects ar
Very common (may affect more than 1 user in 10)
- bacterial , viral and / or fungal infections
- severe infection that can affect the whole body
- reduction in the number of white blood cells , platelets or red blood cells , which may increase the risk of infection , bruising, bleeding, shortness of breath and weakness
- bleeding under the skin
- increase in the number of white blood cells
- too much acid in the body
- high levels of cholesterol and / or fats in the blood
- high level of sugar in the blood
- high level of potassium in the blood, low level of potassium , magnesium , calcium and / or phosphate in the blood
- high level of uric acid in the blood, gout
- restlessness, deviations in thoughts, perceptions (perception) and level of consciousness, depression, anxiety, difficulty sleeping
- increased muscle tension, tremor, drowsiness, dizziness, headache, tingling, tingling or numbness
- faster heartbeat
- low / high blood pressure , dilation of blood vessels
- fluid retention in the lungs, shortness of breath, cough
- bloated stomach
- vomiting, abdominal pain, diarrhea, nausea.
- constipation, indigestion, gas in the stomach
- reduced appetite
- changes in different laboratory values
- inflammation of the liver, yellowing of the skin and whites of the eyes
- growth on the skin, rash, acne
- muscle weakness
- joint pain
- kidney problems
- blood in the urine
- fever, cold, pain, malaise, weakness and lethargy
- fluid accumulation in the body
- part of an internal organ or tissue that bulges out through a weak point in the abdominal muscles
- muscle aches, neck and back pain.
Common (may affect up to 1 in 10 people)
- skin cancer, non-cancerous growth on the skin
- abnormal and vigorous tissue growth
- reduction of all types of blood cells
- benign ( benign ) enlargement of lymph nodes , inflammatory changes on the skin (pseudolymphoma)
- weight loss
- abnormal thinking
- seizures
- altered sense of taste
- blood clot that forms in a vein
- inflammation of the membrane that covers the inside of the abdominal wall and most organs in the abdomen
- intestinal blockage
- inflammation of the colon, causing stomach pain or diarrhea (sometimes caused by cytomegalovirus ), ulcers in the mouth and / or stomach and / or duodenum , inflammation of the stomach, esophagus and / or mouth and lips
- belching
- hair loss
- feeling sick
- enlargement of the gums
- inflammation of the pancreas, which causes severe pain in the abdomen and back.
Uncommon side effects (may affect up to 1 in 100 people)
- protozoal infections
- growth of lymphatic tissue , including malignant tumors .
- insufficient production of red blood cells
- severe diseases of the bone marrow a
- accumulation of lymph fluid in the body
- shortness of breath, cough which may be due to bronchiectasis (a condition in which the airways are abnormally dilated) or pulmonary fibrosis (scarring of the lungs). Tell your doctor if you develop persistent cough or shortness of breath
- reduction in the number of antibodies in the blood
- severe decrease in certain types of white blood cells (possible symptoms are fever, sore throat, frequent infections ) ( agranulocytosis ).
Has been reported (occurs in an unknown number of users)
- changes on the inside of the small intestine (villi intestinal atrophy )
- severe inflammation of the membrane covering the brain and spinal cord
- severe inflammation of the heart and heart valves
- bacterial infections, which usually lead to serious lung disease ( tuberculosis , atypical mycobacterial infection)
- severe kidney disease (BK virus associated nephropathy )
- severe central nervous system disease (JC virus associated progressive multifocal leukoencephalopathy)
- reduction of certain types of white blood cells ( neutropenia )
- change in the shape of certain white blood cells .
Do not stop taking your medicine without first discussing it with your doctor.
How to store Myfenax
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is mycophenolate mofetil.Each tablet contains 500 mg of mycophenolate mofetil.
- The other ingredients are:
Film-coated tablets
Microcrystalline cellulose
Povidone K-30
Croscarmellose sodium
Magnesium stearateTablet cover
Hypromellose (HPMC 2910)
Titanium dioxide (E171)
Macrogol (PEG 400)
Talc
Indigo carmine aluminum pigment (E132)
Iron oxide black (E172)
Iron oxide red (E172)
What the medicine looks like and contents of the pack
Film-coated tablets:
Slightly purple, oval, film-coated tablets, debossed with ‘M500’ on one side and the other side blank.
Myfenax 500 mg film-coated tablets are available in PVC / PVdC aluminum blisters in pack sizes of 50, 100, 150, 50 x 1 or 100 x 1 tablets and in multipacks containing 150 (3 packs of 50) tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Teva BV
Swensen 5
2031GA Haarlem
Netherlands
Manufacturer
Teva Pharmaceutical Works Private Limited Company
Pallagi út 13.
Debrecen H-4042
Hungary
Teva Operations Poland Sp. Zoo
Mogilska 80 Str.
31-546 Krakow
Poland
Pharmachemie BV
Swensen 5
2031 GA Haarlem
The Netherlands
For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:
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