250 mg mycophenolate mofetil capsules
What Mycophenolate Mofetil Accord is and what it is used for
The full name of your medicine is Mykofenolatmofetil Accord.
Mycophenolate mofetil Accord 250 mg capsules contain mycophenolate mofetil. It belongs to a group of medicines called “immunosuppressants”.
Mycophenolate mofetil Accord is used to prevent the body from rejecting a transplanted kidney, heart, or liver.
Mycophenolate mofetil Accord should be used with other medicines, such as cyclosporine and steroids.
The mycophenolate mofetil contained in the mycophenolate mofetil Accord may also be authorized for the treatment of other conditions not mentioned in this leaflet. 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 using Mykofenolatmofetil Accord
Do not use Mycophenolate Mofetil Accord
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 use Mycophenolate Mofetil Accord
- 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 could 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 an effective contraceptive (see Pregnancy, contraception and breast-feeding).
- 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 immediately before taking Mykofenolatmofetil Accord.
Warnings and cautions
Tell your doctor immediately before starting treatment with Mykofenolatmofetil Accord if:
- you have signs of infection such as fever or sore throat
- you have had an unexpected bruising or bleeding
- you have or have had digestive problems such as stomach ulcers
- you are planning to become pregnant or become pregnant while you or your partner are using Mykofenolatmofetil Accord
- if you have a rare hereditary deficiency of the enzyme hypoxanthine – guanine -phosphoribosyl- transferase (HGPRT), such as Lesch-Nyhan and Kelley-Seegmiller syndrome.
If any of the above applies to you (or you are not sure), talk to your doctor immediately before taking Mykofenolatmofetil Accord.
Effect of sunlight
Mycophenolate mofetil Accord 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 Accord
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
It includes over-the-counter medicines, such as herbal remedies. This is because mycophenolate mofetil Accord may affect the way some other medicines work. Other medicines may also affect the effect of Mycophenolate Mofetil Accord.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines before starting Mykofenolatmofetil Accord:
- azathioprine or other medicines that weaken your immune system – given after a transplant operation
- 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
- antibiotics – used to treat bacterial infections
- isavuconazole – used to treat fungal infections
- telmisartan – used to treat high blood pressure
- aciclovir, ganciclovir and valganciclovir – used to treat and prevent viral infections.
Vaccines
If you need to be vaccinated (with a live vaccine) while taking Mykofenolatmofetil Accord, 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 Mykofenolatmofetil Accord and for at least 6 weeks after stopping treatment. Men should not donate semen during treatment with Mycophenolate mofetil Accord and for at least 90 days after stopping treatment.
Mycophenolate mofetil Accord with food and drink
Intake of food and drink has no effect on treatment with mycophenolate mofetil.
Pregnancy, contraception and breastfeeding
Use of contraceptives in women taking Mykofenolatmofetil Accord
If you are a woman and could become pregnant, you must use an effective method of contraception with Mykofenolatmofetil Accord. It includes:
- Before you start taking Mykofenolatmofetil Accord
- Throughout treatment with Mycophenolate Mofetil Accord
- For 6 weeks after stopping treatment with Mycophenolate mofetil Accord.
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 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 period was more than a year ago (if your 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 removed (bilateral salpingo ‑ophorectomy )
- 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 that 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 Mykofenolatmofetil Accord
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 Mykofenolatmofetil Accord.
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 Mykofenolatmofetil Accord 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), development of the fingers, heart, esophagus (the tube that connects the pharynx to the stomach), kidneys, and nervous system (for example, spinal hernias [where the vertebrae in the spine are not 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 Mykofenolatmofetil Accord if you are breastfeeding. Small amounts of the drug may pass into breast milk.
Driving and using machines
Mycophenolate mofetil Accord 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 attention. 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.
How to use Mycophenolate mofetil Accord
Always take this medicine 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 usual dose is shown below. Treatment should continue for as long as you need to prevent rejection of the transplanted organ.
Kidney transplantation
Adults:
- The first dose is given within 3 days after transplantation.
- The daily dose is 8 capsules (2 g of the drug), taken as 2 separate doses .
- Take 4 capsules in the morning and 4 capsules in the evening.
Children (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 one 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.
Heart transplant
Adults:
- The first dose is given within 5 days after transplantation.
- The daily dose is 12 capsules (3 g of the drug), taken as 2 separate doses .
- Take 6 capsules in the morning and 6 capsules in the evening.
Children:
- There is no information on the use of mycophenolate mofetil in children who have received a heart transplant.
Liver transplantation
Adults:
- You will receive the first dose of oral Mycophenolate Mofetil Accord no earlier than 4 days after the transplant and when you are able to swallow the medicine.
- The daily dose is 12 capsules (3 g of the drug), taken as 2 separate doses .
- Take 6 capsules in the morning and 6 capsules in the evening.
Children:
- There is no information on the use of mycophenolate mofetil in children who have received a liver transplant.
Method of administration
- Swallow the capsules whole with a glass of water.
- Do not break or crush them
- Do not take capsules that are open or split.
- Be careful not to let any powder from a broken capsule get into your eyes or mouth.
- If this happens, rinse thoroughly with plain water.
- Be careful not to let powder from a broken capsule get on the skin. If this happens, wash the area thoroughly with soap and water
If you take more Mycophenolate mofetil Accord than you should
If you have ingested too much medicine or if e.g. a child inadvertently ingested the medicine immediately contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. Bring the medicine pack.
If you forget to take Mykofenolatmofetil Accord
If you forget to take this medicine at any time, 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 Mycophenolate Mofetil Accord
Do not stop taking Mykofenolatmofetil Accord unless your doctor tells you to. If you stop the 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, pharmacist, or nurse.
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
- 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 have had a severe allergic reaction to the medicine (such as anaphylaxis , angioedema ).
Other side effects may include :
Very common (may affect more than 1 user in 10)
- Sepsis (blood poisoning), fungal infection of the gastrointestinal tract, urinary tract infection, herpes simplex, herpes zoster
- Leukopenia (decreased white blood cell count ), thrombocytopenia (decreased platelet count ), anemia (anemia)
- Vomiting, abdominal pain, diarrhea, nausea
Common (may affect up to 1 in 10 people)
- Pneumonia , influenza , respiratory tract infection, fungal infection of the respiratory tract, infection of the gastrointestinal tract, fungal infections, inflammation of the stomach and intestines, infections , bronchitis , pharyngitis, sinusitis, fungal infection of the skin, fungus of the skin, fungus of the vagina , inflammation of the vagina
- Skin cancer, benign tumor of the skin
- Pancytopenia (lack of cells in the blood), leukocytosis (increased number of white blood cells )
- Acidosis (increased number of acids in the body), hyperkalaemia (high levels of potassium in the blood), hypokalaemia (low levels of potassium in the blood), hyperglucemia (high levels of glucose in the blood), hypomagnesemia (low levels of magnesium in the blood), hypocalcaemia (low levels of calcium in the blood), hypercholesterolemia (high levels of cholesterol in the blood), hyperlipidemia (increased levels of fat in the blood), hypophosphatemia (low levels of phosphate in the blood), hyperuricemia (elevated levels ofuric acid in the blood), gout , anorexia
- Agitation (feeling of anxiety), confusion, depression, anxiety, abnormal thoughts, insomnia
- Seizures, hypertension (high blood pressure ), tremor (tremors), somnolemns (numbness), muscle weakness, dizziness, headache, parastesis (ant crawls in the skin), taste disturbance
- Tachycardia (palpitations)
- Hypontension (low blood pressure ), hypertension (high blood pressure ), dilated blood vessels
- Fluid retention in the alveoli, dyspnoea (shortness of breath), cough
- Gastrointestinal bleeding, peritonitis, intestinal perforation, inflammation of the colon, gastric ulcer , duodenal ulcer , gastritis, inflammation of the esophagus , inflammation of the oral mucosa, constipation, acid regurgitation, flatulence, belching
- Hepatitis (inflammation of the liver), jaundice, increase in bilirubin in the blood
- Thickened skin, rash, acne , hair loss
- Arthralgia (joint pain)
- Impaired renal function
- Edema (fluid retention), fever, chills, pain, malaise, weakness
- Increase in liver enzymes, increase in blood creatinine, increase in blood lactate enzyme, increase in blood urea, increase in alkaline phosphate in the blood, weight loss
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 can more easily get some side effects than adults. It can be diarrhea, infection, a decrease in the number of white and red blood cells.
Fight your infection
Mycophenolate mofetil Accord reduces your body’s defenses. It prevents rejection of the graft. As a result, your body will not fight infection as well as before. 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
Patients taking this type of medicine (immunosuppressants) may experience very little mycophenolate mofetil Accord patients developing cancer of the lymph and skin.
General side effects ar
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 are
- weight loss, gout , high blood sugar, bleeding, bruising.
How to store Mycophenolate Mofetil Accord
- 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 label or carton after EXP. The expiration date is the last day of the specified month.
- Do not store above 30 ° C.
- Do not use this medicine if you notice any signs of deterioration of the capsule.
- 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 cap contains 250 mg of mycophenolate mofetil.
Other ingredients are:
Cellulose microcrystalline, hydroxypropyl cellulose, povidone K 90, croscarmellose sodium, talc, and magnesium stearate.
Capsule shell: Gelatin, sodium lauryl sulfate, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), indigo carmine (E 132).
Black label ink contains Shellac, black iron oxide.
What the medicine looks like and contents of the pack
Mycophenolate mofetil Accord is light blue/peach-colored, hard gelatin capsules of size “1”, marked with “MMF” on the upper part and 250 on the lower part. The capsules are filled with white to off-white powder.
Mycophenolate mofetil Accord is packaged in blister cards of 100 and 300 capsules respectively.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare BV
Winthontlaan 200
3526 kV Utrecht
Netherlands
Manufacturer
Accord Healthcare Limited
Sage House,
319, Pinner Road,
North Harrow,
Middlesex, HA1 4HF,
UK
Accord Healthcare BV,
Winthontlaan 200,
3526 kV Utrecht,
Netherlands
Accord Healthcare Polska Sp.z oo,
ul. Lutomierska 50,95-200 Pabianice, Poland