500 mg film-coated tablets
mycophenolate mofetil
What Mycophenolate Mofetil Actavis is and what it is used for
Mycophenolate mofetil Actavis contains mycophenolate mofetil.
- It belongs to a group of medicines called “immunosuppressants”.
Mycophenolate mofetil Actavis is used to prevent the body from rejecting a transplanted organ.
- Kidney, heart or liver.
Mycophenolate mofetil Actavis should be used with other medicines:
- Ciclosporin and corticosteroids .
Mycophenolate mofetil contained in Mycophenolate mofetil Actavis may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Mycophenolate mofetil Actavis
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 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 and breast-feeding”.
Do not take Mycophenolate Mofetil Actavis:
- 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 and may become pregnant and have not taken 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 Mykofenolatmofetil Actavis.
Warnings and cautions
Tell your doctor before taking Mykofenolatmofetil Actavis:
- if you have signs of infection such as fever or sore throat
- if you have any unexpected bruising or bleeding.
- if you have or have had digestive problems such as a stomach ulcer .
- if you are planning to become pregnant or become pregnant while you or your partner are taking Mykofenolatmofetil Actavis.
- if you have a rare hereditary deficiency of the enzyme hypoxanthine – guanine -phosphoribosyl- transferase (HGPRT), such as Lesch-Nyhan and Kelley-Seegmiller syndrome, Mycophenolate mofetil Actavis should be avoided.
If any of the above apply to you (or you are not sure), talk to your doctor immediately before taking Mykofenolatmofetil Actavis.
Effect of sunlight
Mycophenolate mofetil Actavis reduces the body’s defenses. A consequence of this is an increased risk of skin cancer. Limit the amount of sun and UV light you are exposed to. Do this by:
- Wear protective clothing that also covers your head, neck, arms and legs
- use a sunscreen with a high protection factor.
Other medicines and Mycophenolate mofetil Actavis
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This is because mycophenolate mofetil Actavis may affect the way some other medicines work. Other medicines may also affect the way Mycophenolate mofetil Actavis works.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines before starting Mykofenolatmofetil Actavis:
- azathioprine or other medicines that weaken your immune system – given after a transplant operation
- aciclovir – used to treat and prevent (in people with compromised immune systems) viral infections, such as cold sores, genital herpes , shingles and chickenpox
- cholestyramine – used in the treatment of high cholesterol
- rifampicin – an antibiotic used to prevent and treat infections such as tuberculosis (TB)
- antacids or proton pump inhibitors – used for stomach acid problems such as digestive problems
- phosphate-binding drug – used by people with chronic kidney failure to reduce the amount of phosphate absorbed into the blood
- drugs that affect the liver cycle
- ganciclovir (used to treat and prevent CMV ( cytomegalovirus ) infection , especially if you also have kidney problems
- norfloxacin and metronidazole in combination.
- antibiotics – used to treat bacterial infections
- isavuconazole – used to treat fungal infections
- telmisartan – used to treat high blood pressure .
Vaccines
If you need to be vaccinated (with live vaccines) while taking Mykofenolatmofetil Actavis, talk to your doctor or pharmacist first. Your doctor must then advise you on which vaccines you can get.
You must not donate blood during treatment with Mycophenolate mofetil Actavis and for at least 6 weeks after stopping treatment. Men should not donate semen during treatment with Mycophenolate mofetil Actavis and for at least 90 days after stopping treatment.
Mycophenolate mofetil Actavis with food and drink
Consumption of food and drink does not affect treatment with Mycophenolate mofetil Actavis.
Pregnancy, contraception and breastfeeding
Use of contraceptives in women taking Mycophenolate mofetil Actavis
If you are a woman and could become pregnant, you must use an effective method of contraception with Mykofenolatmofetil Actavis. It includes:
- Before you start taking Mycophenolate mofetil Actavis
- Throughout treatment with Mycophenolate mofetil Actavis
- For 6 weeks after stopping treatment with Mycophenolate mofetil Actavis.
Talk to your doctor about the most suitable contraceptives 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 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, 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 inability to conceive: XY genotype, Turner syndrome or congenital uterine insufficiency
- You are a child or teenager who has not yet had your period.
Use of contraceptives in men taking Mycophenolate mofetil Actavis
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 Mycophenolate mofetil Actavis.
If you are planning to have a baby, talk to your doctor about the potential risks.
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 Mycophenolate mofetil Actavis until you see 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 perform 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 Mycophenolate mofetil Actavis if you are breastfeeding. This is because small amounts of the drug can pass into breast milk.
Driving and using machines
Mycophenolate mofetil Actavis has a moderate effect on your ability to drive or 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.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Mycophenolate mofetil Actavis contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
How to use Mycophenolate mofetil Actavis
Always take Mycophenolate mofetil Actavis exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
How much to take
The amount you should take depends on the type of transplant you have received. The recommended dose is shown below.
Treatment should continue for as long as you need to prevent rejection of the transplanted organ.
Kidney transplant
Adults
- The first dose is given within 3 days after transplantation.
- The daily dose is 4 tablets (2 g of the medicine), taken as 2 separate doses .
- Take 2 tablets in the morning and 2 tablets in the evening.
Children and adolescents (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 child’s height and weight (body area – measured as square meters or “m 2 “). The recommended dose is 600 mg / m 2 twice daily.
Mycophenolate mofetil Actavis is not recommended for kidney transplant patients under 2 years of age.
Heart transplant
Adults
- The first dose is given within 5 days after transplantation.
- The daily dose is 6 tablets (3 g of the medicine), taken as 2 separate doses .
- Take 3 tablets in the morning and 3 tablets in the evening.
Children and young people
- There is no information on the use of Mycophenolate mofetil Actavis in children with a heart transplant.
Liver transplant
Adults
- You will receive the first dose of oral Mycophenolate mofetil Actavis no earlier than 4 days after the transplant and when you are able to swallow the medicine.
- The daily dose is 6 tablets (3 g of the medicine), taken as 2 separate doses .
- Take 3 tablets in the morning and 3 tablets in the evening.
Children and young people
- There is no information on the use of Mycophenolate Mofetil Actavis in children with a liver transplant.
Taking the medicine
- Swallow the tablets whole along with a glass of water.
- You should not split or crush them.
If you use more Mycophenolate mofetil Actavis than you should
If you take more Mycophenolate mofetil Actavis than you should, contact your doctor, hospital, or the Poison Information Center immediately for risk assessment and advice. Also, do it if someone else e.g. a child accidentally took your medicine. Bring the medicine pack.
If you forget to use Mycophenolate mofetil Actavis
If you ever forget to take this medicine, take it 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 using Mycophenolate mofetil Actavis
Do not stop taking Mykofenolatmofetil Actavis unless your doctor tells you to. If you stop treatment, the risk of the transplanted organ being rejected may 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.
Tell a doctor immediately if you notice any of the following serious side effects – you may need urgent medical attention:
- you have 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 ).
Common side effects are
Some of the most common side effects are diarrhea, fewer white or red blood cells, infection, and vomiting. Your doctor will regularly take blood samples to check for changes in:
- the number of blood cells or signs of infection .
Children and young people
Children may get some side effects more easily than adults. It includes diarrhea, infection, decrease in the number of white and red blood cells.
Older
Elderly patients (≥65 years) may generally be at greater risk of developing adverse reactions. Elderly patients taking Mycophenolate mofetil Actavis, in combination with other medicines that reduce the body’s defenses, may also be at greater risk for certain infections, such as bleeding in the stomach and fluid in the lungs, compared to younger patients.
Fight your infection
Mycophenolate mofetil Actavis reduces your body’s defenses. This prevents you from rejecting the graft. As a result, your body will not be as good at fighting infection as it used to be. This means that you can get more infections than normal. It includes infection in your brain, skin, mouth, stomach, intestines, lungs, and urinary tract.
Cancer of the lymph nodes and skin
As may occur in patients taking this type of medicine (immunosuppressive agents), a very small number of mycophenolate mofetil Actavis patients have developed cancer of the lymph tissue and skin.
General adverse effects
You can get general side effects that affect your entire body. It includes severe allergic reactions (such as anaphylaxis, angioedema ), fever, feeling very tired, sleep disturbances, pain (such as in the stomach, chest, joints, and muscles), headaches, flu symptoms, and swelling.
Other side effects may include:
Skin side effects such as:
- acne , cold sores, shingles , skin growth, hair loss, rash, itching .
Urinary tract side effects such as:
- blood in urine.
Side effects are in the gastrointestinal tract and mouth such as:
- swelling of the gums, altered taste sensation and cold sores
- inflammation of the esophagus, pancreas, colon or stomach
- intestinal diseases including bleeding, and stomach ulcers , liver problems
- diarrhea, constipation, nausea, indigestion, loss of appetite, gas tension and belching.
Side effects are in the central and peripheral nervous system such as:
- feeling of dizziness, drowsiness or numbness
- tremors, muscle twitching, seizures
- feeling anxious or depressed, changes in mood or thinking.
Side effects in the heart and blood vessels such as:
- altered blood pressure , increasing heart rate, dilation of blood vessels.
Lung side effects such as:
- pneumonia , tracheitis
- shortness of breath, cough, which may be due to bronchiectasis (a condition in which the airways in the lungs are abnormally dilated) or pulmonary fibrosis (scarring of the lung). Contact a doctor if you develop persistent cough or shortness of breath.
- fluid in lungs or chest cavity
- problems with the sinuses.
Other side effects are such as:
- weight loss, gout , high blood sugar, bleeding, bruising.
How to store Mycophenolate mofetil Actavis
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 and blister after EXP. The expiration date is the last day of the specified month.
Do not store above 25 ° C. Store in the outer carton. Sensitive to light.
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 film-coated tablet contains 500 mg of mycophenolate mofetil.
- Other ingredients are:Tablet core:, microcrystalline cellulose (E460), povidone, hydroxypropylcellulose, croscarmellose sodium, talc, magnesium stearate.Film coating: Hypromellose (E464), titanium dioxide (E171), macrogol, red iron oxide (E172), indigo carmine aluminum pigment (E132), black iron oxide (E172), talc.
What the medicine looks like and contents of the pack
Purple, capsule-shaped, biconvex film-coated tablet, engraved “AHI” on one side and “500” on the other, 18 mm long, 9 mm wide, and 7 mm thick.
White opaque PVC / PvdC aluminum blister packs.
Pack sizes: 50, 100, and 150 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Actavis Group PTC ehf.
Reykjavikurvegur 76-78
220 Hafnarfjörður
Iceland