| Myfortic 180 mg enteric-tablet is |
| Myfortic 360 mg enteric-tablet is |
| mycophenolic acid (as sodium mycophenolate) |
What Myfortic is and what it is used for
Myfortic contains a substance called mycophenolic acid and belongs to a group of medicines called immunosuppressants.
Myfortic is used to prevent the body’s immune system from rejecting a transplanted kidney. Myfortic is used with other medicines that contain ciclosporin and corticosteroids.
What you need to know before taking Myfortic
WARNING
Mycophenolate 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 the doctor’s instructions on contraception.
Your doctor will give you both oral and written information, in particular about the effects of mycophenolate on the fetus. Read the information carefully and follow the instructions. If you do not understand the instructions, ask your doctor to explain again before taking mycophenolate. See also further information in this section under “Warnings and precautions” and “Pregnancy and breast-feeding”.
Do not take Myfortic:
- if you are allergic (hypersensitive) to mycophenolic acid, sodium mycophenolate, mycophenolate mofetil 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 taken a pregnancy test with negative results 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 Use of contraception in women and men)
- if you are breast-feeding (see also “Pregnancy and breast-feeding”).
If any of the above apply to you, talk to your doctor before taking Myfortic.
Warnings and cautions
Talk to your doctor or pharmacist before taking Myfortic:
- if you have or have had severe digestive problems, such as stomach ulcers .
- if you have a rare hereditary deficiency of hypoxanthine – guanine -phosphoribosyl- transferase (HGPRT) such as Lesch-Nyhans and Kelley-Seegmiller syndrome.
You should also be aware that:
- Myfortic reduces the skin’s ability to protect against the sun. This increases the risk of skin cancer. You should therefore avoid sunlight and UV light by wearing protective clothing and often lubricate yourself with sunscreen with a high protection factor. Ask your doctor for advice on how to protect yourself from sunlight.
- If you have had hepatitis B or C, Myfortic may increase the risk of these diseases recurring. Your doctor may do a blood test and look for symptoms of these diseases. If you experience any symptoms (yellow skin and yellow eyes, nausea, loss of appetite, dark urine) you should contact a doctor immediately.
- If you experience persistent cough or shortness of breath, especially when taking other immunosuppressive drugs, contact your doctor immediately.
- Your doctor may check your antibody levels during treatment with Myfortic and tell you if you can continue to take Myfortic. This is followed especially closely in case of recurrent infections and if you are also taking other immunosuppressive drugs.
- If you get signs of infection (eg fever, sore throat), unexpected bruising or bleeding, you should contact a doctor immediately.
- Your doctor may check your white blood cell levels during treatment with Myfortic and will tell you if you can continue to take Myfortic.
- The active substance mycophenolic acid is not the same medicine as other medicines with similar names, eg mycophenolate mofetil. Do not switch between different medications unless your doctor tells you to.
- Use of Myfortic during pregnancy may harm the fetus (see also “Pregnancy and breast-feeding”) and increase the risk of miscarriage.
Other medicines and Myfortic
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
In particular, you should tell your doctor if you are taking any of the following:
- other immunosuppressive drugs containing azathioprine or tacrolimus.
- drugs used to treat high cholesterol levels, such as cholestyramine.
- activated carbon used to treat digestive problems, such as diarrhea, stomach upset and flatulence.
- antacids (so-called antacids) containing magnesium and aluminum.
- drugs used to treat viral infections, such as aciclovir or ganciclovir.
Also, tell your doctor if you are planning to get vaccinated.
You must not donate blood during treatment with Myfortic and for at least 6 weeks after stopping treatment. Men should not donate semen during treatment with Myfortic and for at least 90 days after stopping treatment.
Myfortic with food and drink
Myfortic can be taken with or without food. However, you must choose to either take a dose at a meal or between meals and then continue with the chosen option, so that the same dose of medicine is absorbed into the body every day.
Older
Dose adjustment is not necessary for elderly patients (65 years and older).
Children and young people
Myfortic is not recommended for use in children and adolescents as safety and efficacy have not been established in this age group.
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 steps 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 different 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 mycophenolate until you have talked to your doctor.
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 (eg spinal hernias, where the vertebrae in the spine do not are properly developed). The child may have one or more of these deformities.
If you are a woman and could become pregnant, you must perform a pregnancy test with negative results before starting treatment and you must follow the 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 Myfortic if you are breastfeeding. This is because small amounts of the drug can pass into breast milk.
Contraceptives for women taking Myfortic
If you are a woman and could become pregnant, you must always use an effective contraceptive with Myfortic, which includes:
- before you start taking Myfortic
- throughout treatment with Myfortic
- for 6 weeks after stopping treatment with Myfortic.
Talk to your doctor about which contraceptives are 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 forgot to take your birth control 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, however, it is possible that you may become pregnant)
- fallopian tubes and both ovaries have been removed (bilateral salpingo -oophorectomy )
- the uterus has been operated on ( hysterectomy )
- the ovaries have stopped working (premature menopause determined by a gynecologist)
- you have been born with any of the following conditions which are rare and lead to inability to conceive: XY genotype, Turner syndrome or congenital absence of uterus
- you are a child or teenager who has not yet menstruated.
Contraceptives for men taking Myfortic
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 at least another 90 days after stopping Myfortic.
If you are planning to have a baby, talk to your doctor about the potential risks.
Driving and using machines
Myfortic has not been shown to affect your ability to drive or use machines.
Myfortic contains sodium and lactose
Myfortic contains sodium
Myfortic 180 mg: this medicine contains 13 mg of sodium (the main ingredient in table salt/table salt) per tablet. This corresponds to 0.65% of the maximum recommended daily sodium intake for adults.
Myfortic 360 mg: this medicine contains 26 mg sodium (the main ingredient in table salt/table salt) per tablet. This corresponds to 1.3% of the highest recommended daily intake of sodium for adults.
Myfortic contains lactose
If you have been told by your doctor that you have an intolerance to some sugars (including lactose, galactose, or glucose ), contact your doctor before taking Myfortic.
How to take Myfortic
Always take Myfortic exactly as your doctor has told you. Myfortic is only prescribed by doctors who have experience in treating transplant patients. Ask your doctor or pharmacist if you are unsure.
How much to take
The recommended daily dose of Myfortic is 1440 mg (equivalent to 8 tablets of 180 mg or 4 tablets of 360 mg). Myfortic should be taken as 2 separate doses of 720 mg in each dose (equivalent to 4 tablets of 180 mg or 2 tablets of 360 mg).
The tablets should be taken morning and evening.
You will receive the first 720 mg dose within 72 hours of transplantation.
If you have severe kidney problems
The daily dose should not exceed 1440 mg (equivalent to 8 tablets of 180 mg or 4 tablets of 360 mg).
How to take Myfortic
The tablets should be swallowed whole with a glass of water.
Do not split or crush the tablets.
Do not take any tablets that are broken.
Treatment will continue as long as you need immunosuppression to prevent rejection of the transplanted kidney.
If you take more Myfortic than you should
If you have taken too many Myfortic tablets, or if, for example, a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. Treatment measures may be necessary. Take the tablets with you and show them to your doctor or healthcare professional. If the tablets run out, take the empty pack with you.
If you forget to take Myfortic
If you forget to take Myfortic, take the tablets as soon as you remember unless it is almost time for your next dose. Then you only take the next dose at the usual time. Ask your doctor for advice if you are unsure. Do not take a double dose to make up for a forgotten dose.
If you stop taking Myfortic
Never stop taking Myfortic yourself, unless your doctor has told you to stop. If you stop taking Myfortic, the risk of the body rejecting the transplanted kidney will increase.
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.
Elderly patients may experience more side effects due to a weakened immune system.
Immunosuppressive drugs, including Myfortic, reduce the body’s defense mechanisms. In this way, the rejection of the transplanted organ can be avoided. At the same time, the body’s resilience is reduced. Therefore, a patient is at greater risk of getting an infection during treatment with Myfortic as the body is not able to fight infection as well as before. Infections in the brain, skin, mouth, gastrointestinal tract, lungs, and urinary tract are examples of such infections.
Your doctor will take regular blood tests to check if there are any changes in the number of blood cells or the content of other substances in the blood, such as sugar, fat, and cholesterol.
Some side effects can be serious:
- Signs of infection , ie fever, chills, sweating, feeling tired, drowsy or lack of energy. When you take Myfortic you can get more viral , bacterial and fungal infections than normal. The infections are most common in the urinary tract, upper and / or lower respiratory tract.
- Bloody vomiting, black stools or blood in stools, stomach or intestinal ulcers.
- Swollen lymph nodes , appearance of growth on the skin or enlargement of pre-existing growth, or change in birthmark. A few patients who have taken Myfortic have developed skin cancer or cancer of the lymph nodes, which may occur in patients taking immunosuppressive drugs.
Contact your doctor as soon as possible if you experience any of the above side effects after taking Myfortic.
Other side effects:
Very common ( may affect more than 1 in 10 people)
- low levels of white blood cells
- low levels of calcium in the blood ( hypocalcaemia )
- low levels of potassium in the blood ( hypokalaemia )
- high levels of uric acid in the blood (hyperuricemia)
- high blood pressure ( hypertension )
- anxiety
- diarrhea
- joint pain ( arthralgia ).
Common ( may affect up to 1 in 10 people )
- anemia , which can cause fatigue, shortness of breath and pallor ( anemia )
- low levels of platelets which can lead to unexpected bleeding and bruising ( thrombocytopenia )
- high levels of potassium in the blood ( hyperkalaemia )
- low levels of magnesium in the blood ( hypomagnesaemia )
- dizziness
- headache
- cough
- low blood pressure ( hypotension )
- shortness of breath ( dyspnoea )
- abdominal pain, inflammation of the lining of the stomach , tense abdomen, constipation, indigestion, flatulence , loose stools, feeling of nausea (nausea), nausea (vomiting)
- fatigue, fever
- abnormal liver or kidney function values
- respiratory tract infections
- acne
- weakness ( asthenia )
- muscle pain ( myalgia )
- swollen hands, ankles or feet (peripheral edema )
- itching .
Uncommon (may affect up to 1 in 100 people )
- rapid heartbeat ( tachycardia ) or extra heartbeat (ventricular extrasystole), fluid accumulation in the lungs ( pulmonary edema )
- bulge on the skin ( cyst ) that contains fluid ( lymph ) (lymphocele)
- tremors, insomnia
- red and swollen eyes ( conjunctivitis ), blurred vision
- hissing breathing
- belching, bad breath, irritable bowel syndrome ( ileus ), cold sores, heartburn, discoloration of the tongue, dry mouth , growth of gums, inflammation of the pancreas leading to severe upper abdominal pain ( pancreatitis ), blockage of the salivary glands, peritonitis ( peritonitis )
- inflammation of bone tissue, infection of blood and skin
- blood in the urine, kidney damage, burning sensation when urinating or difficulty urinating
- hair loss, bruising
- joint inflammation ( arthritis ), back pain, muscle cramps
- loss of appetite, elevated blood fats (hyperlipidemia), elevated blood sugar ( diabetes ), elevated cholesterol ( hypercholesterolemia ) or decreased phosphate levels in the blood ( hypophosphatemia )
- flu-like symptoms (eg fatigue, chills, sore throat, joint or muscle pain), swollen ankles and feet, pain, stiffness, thirst, weakness
- abnormal dreams, delusions
- impotence
- cough, difficulty breathing, painful breathing (possible symptoms of interstitial lung disease).
No known frequency (occurs in an unknown number of users )
- rash
- fever, sore throat, frequent infection (possible symptoms of white blood cell deficiency ) ( agranulocytosis ).
Other side effects have been reported with similar drugs
Other side effects reported with the drug group to which Myfortic belongs:
inflammation of the colon, inflammation of the lining of the stomach caused by cytomegalovirus, development of ulcers across the intestinal wall leading to severe stomach pain possibly with bleeding, gastric ulcer or duodenal ulcers, lack of certain types of white blood cells or all blood cells, serious infections such as inflammation of the heart and heart valves, meningitis, shortness of breath, cough, which may be due to bronchiectasis (a condition in which the airways in the lungs are abnormally dilated) and other less common bacterial infections that usually lead to severe lung disease ( tuberculosis and atypical mycobacterial infection ). Talk to your doctor if you develop a persistent cough or shortness of breath.
How to store Myfortic
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 carton. The expiration date is the last day of the specified month.
No special temperature instructions.
Store in the original package. Moisture sensitive.
Do not use this medicine if the package is damaged or shows signs of opening.
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 mycophenolic acid (as sodium mycophenolate).
Each tablet contains 180 mg and 360 mg of mycophenolic acid, respectively.
- Other ingredients are:
- Tablet core 180 mg and 360 mg: maize starch, povidone, crospovidone, lactose , colloidal anhydrous silica, magnesium stearate.
- Tablet cover 180 mg: hypromellose phthalate, titanium dioxide (E 171), yellow iron oxide (E 172), indigo carmine (E 132).
- Tablet cover 360 mg: hypromellose phthalate, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).
What the medicine looks like and contents of the pack
Myfortic 180 mg enteric tablets are light green, film-coated round tablets imprinted with “C” on one side and are supplied in blister packs containing 20, 50, 100, 120, or 250 tablets.
Myfortic 360 mg enteric tablets are light orange-red, film-coated oval tablets imprinted with “CT” on one side and are supplied in pressure packs containing 50, 100, 120, or 250 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Novartis Sverige AB
Box 1218
164 28 Kista
Tel: 08-732 32 0