180 mg entero-tablet is
mycophenolic acid
What Mycophenolic Acid Accord is and what it is used for
Mycophenolic Acid Accord contains a substance called mycophenolic acid. This belongs to a group of medicines called Immunosuppressive medicines.
Mycophenolic Acid Accord is used to prevent the body’s immune system from rejecting a transplanted kidney. It is used together with other medicines that contain ciclosporin and corticosteroids.
Mycophenolic acid contained in Mycophenolic Acid Accord 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.
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”.
What you need to know before using Mycophenolic Acid Accord
Do not use Mycophenolic Acid Accord
- if you are allergic 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 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 Using contraceptives in women and men).
- if you are breast-feeding (see also “Pregnancy and breast-feeding”).
Tell your doctor without taking Mycophenolic Acid Accord if any of the above apply to you.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Mycophenolic Acid Accord:
- if you have or have had severe digestive problems, such as stomach ulcers .
- if you have a rare hereditary deficiency of the enzyme hypoxanthine -guanine phosphoribosyltransferase (HGPRT) such as Lesch-Nyhan’s or Kelley-Seegmiller’s syndrome.
You should also be aware that
- Mycophenolic acid Accord reduces the skin’s protection from the sun. This increases the risk of skin cancer. You should limit your exposure to sunlight and ultraviolet (UV) light by covering exposed areas as much as possible and regularly using sunscreen with a high protection factor. Consult a doctor about how to protect yourself from the sun.
- If you already have hepatitis B or C, Mycophenolic Acid Accord may increase the risk of recurrence. The doctor can analyze the blood and check if there are symptoms of these diseases. If you experience symptoms (yellowing of the skin and eyes, nausea, loss of appetite, dark urine), consult 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 want to check the level of antibodies in your blood during treatment with Mycophenolic Acid Accord, especially if the infections recur and you are also taking other immunosuppressive medicines, and will tell you if you can continue to take Mycophenolic Acid Accord.
- If you get any signs of infection (such as fever or sore throat) or unexpected bruising or bleeding, tell your doctor immediately.
- Your doctor may want to check your white blood cell count during treatment with Mycophenolic Acid Accord, and will tell you if you can continue to take Mycophenolic Acid Accord.
- The active substance, mycophenolic acid, is not the same as other related medicines such as mycophenolate mofetil. You should not switch between medications unless your doctor tells you to.
- Use of Mycophenolic Acid Accord during pregnancy may harm the fetus (see also “Pregnancy and breast-feeding”) and increase the risk of miscarriage (miscarriage).
Other drugs and Mycophenolic Acid Accord
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, talk to a doctor if you are taking any of the following:
- Other immunosuppressive drugs, such as azathioprine or tacrolimus.
- Drugs used to treat high cholesterol levels such as cholestyramine.
- Activated carbon used to treat digestive problems such as diarrhea, upset stomach, and gas.
- Antacids (for heartburn and acid reflux) containing magnesium and aluminum.
- Medicines used to treat viral infections such as aciclovir or ganciclovir.
Also, tell your doctor if you are planning to get vaccinated.
You must not leave blood during treatment with mycophenolic acid and for at least 6 weeks after stopping treatment. Men should not donate semen during treatment with mycophenolic acid and for at least 90 days after stopping treatment.
Mycophenolic Acid Accord with food, drink and alcohol
Mycophenolic Acid accords can be taken with or without food. You must choose whether you take your tablets with or without food and then take them, in the same way, every day. This is done to ensure that the same amount of medication is absorbed into your body every day.
Elderly patients
Elderly people (65 years and older) can take Mycophenolic Acid Accord without having to adjust dose one.
Children and young people
The use of Mycophenolic Acid Accord in children and adolescents is not recommended due to a lack of data.
Use of Contraceptives in Women Taking Mycophenolic Acid Accord
If you are a woman and could become pregnant, you must always use an effective method of contraception with Mycophenolic Acid Accord. It includes:
- Before you start taking Mycophenolic Acid Accord
- Throughout treatment with Mycophenolic Acid Accord
- For 6 weeks after stopping treatment with Mycophenolic Acid Accord.
Talk to your doctor about the most suitable contraceptives for you. 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 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 Mycophenolic Acid 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 an additional 90 days after stopping Mycophenolic Acid Accord.
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 Mycophenolic Acid 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), 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 Mycophenolic Acid Accord if you are breastfeeding. This is because small amounts of the drug can pass into breast milk.
Driving and using machines
Mycophenolic Acid Accord has not been shown to affect your ability to drive or use machines. 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.
Mycophenolic acid Accord contains sodium
This medicine contains 0.61 mmol (13.9 mg) sodium per tablet. This should be considered by patients on a low-salt diet.
How to use Mycophenolic Acid Accord
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Mycophenolic Acid Accord will only be prescribed to you by a doctor who has experience in the treatment of transplant patients. If you are not sure, talk to your doctor, pharmacist, or nurse.
This is how much you should take
The recommended daily dose of Mycophenolic Acid 180 mg is 1440 mg (8 tablets of 180 mg). This is taken in 2 separate doses of 720 mg each (4 tablets of 180 mg). Take the tablets in the morning and the evening.
The first dose of 720 mg will be given within 72 hours after transplantation.
If you have severe kidney problems
Your daily dose should not exceed 1440 mg (8 tablets of 180 mg).
How to take Mycophenolic Acid Accord
Swallow the tablets whole with a glass of water.
Do not break or crush the tablets.
Do not take any tablet that is damaged or broken.
The treatment will last as long as you need immunosuppression to prevent your body from rejecting your transplant.
If you use more Mycophenolic Acid Accord than you should
If you have taken too much Mycophenolic Acid Accord, 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. Medical care may be necessary.
Take the tablets with you and show them to your doctor or hospital staff. Bring the empty package if you have no tablets left.
If you forget to use Mycophenolic Acid Accord
If you forget to take Mycophenolic Acid Accord, take it as soon as you remember unless it is time for your next dose soon. Then take the next dose at the usual time. Ask your doctor for advice. Do not take a double dose to make up for a forgotten dose.
If you stop using Mycophenolic Acid Accord
Do not stop taking Mycophenolic Acid Accord unless your doctor tells you to. If you stop taking Mycophenolic Acid Accord, this can lead to an increased risk of your body rejecting the transplanted kidney.
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. Elderly patients may experience more side effects due to reduced immune systems.
Immunosuppressive drugs, including Mycophenolic Acid Accord, weaken the body’s defense mechanism to prevent you from rejecting your transplanted organ. The consequence is that your body is not as good as usual at fighting infection. If you take Mycophenolic Acid Accord, you may therefore have more infections than usual, such as infections of the brain, skin, mouth, stomach, intestines, lungs, and urinary tract.
Your doctor will perform regular blood tests to monitor any changes in your blood cell counts or levels of substances in your blood, such as sugar, fat, and cholesterol.
Some effects can be serious:
- Signs of infection include fever, chills, sweating, fatigue, drowsiness, or lack of energy. If you take Mycophenolic Acid Accord, you are at greater risk than usual of contracting viral , bacterial and fungal infections. Such infections can affect several parts of your body, but the most affected parts are the kidneys, bladder , upper and lower respiratory tract.
- mixed vomiting, black or bloody stools, stomach or intestinal ulcers.
- swelling of glands , formation of a new skin or increase of an existing skin growth, or changes of an existing birthmark. A very small number of Mycophenolic Acid Accord patients have developed skin cancer or lymph node cancer, which may affect patients taking immunosuppressive drugs.
Talk to your doctor immediately if you experience any of the above after taking Mycophenolic Acid Accord.
Other side effects can be:
Very common ( may affect more than 1 in 10 people )
- diarrhea
- low level of white blood cells
- low level of calcium in the blood ( hypocalcaemia )
- low level of potassium in the blood ( hypokalaemia )
- high level of uric acid in the blood (hyperuricemia)
- high blood pressure ( hypertension )
- joint pain ( arthralgia )
- anxiety.
Common ( may affect 1 in 10 people )
- low level of red blood cells which can lead to fatigue, shortness of breath and paleness ( anemia )
- low levels of platelets which can lead to unexpected bleeding and bruising ( thrombocytopenia )
- headache
- cough
- abdominal or abdominal pain, inflammation of the stomach lining , bloating, constipation, indigestion, flatulence , loose stools, nausea, vomiting
- fatigue, fever
- abnormal test results for liver and kidney function
- respiratory tract infections
- high level of potassium in the blood ( hyperkalaemia )
- low level of magnesium in the blood ( hypomagnesaemia )
- dizziness
- low blood pressure ( hypotension )
- shortness of breath ( dyspnoea )
- acne
- weakness ( asthenia )
- muscle pain ( myalgia )
- swollen hands, ankles or feet (peripheral edema )
- itching
Uncommon (may affect 1 in 100 people )
- rapid heartbeat ( tachycardia ) or irregular heartbeat (ventricular extrasystole), fluid in the lungs ( pulmonary edema )
- an outgrowth that looks like a bladder ( cyst ) that contains fluid ( lymph ) (lymphocele)
- tremors, difficulty sleeping
- redness and swollen eyes ( conjunctivitis ), blurred vision
- hissing breathing
- belching, bad breath, blockage in the colon ( ileus ), sores on the lips, heartburn, discoloration of the tongue, dry mouth , gingivitis, inflammation of the pancreas leading to severe pain in the upper abdomen ( pancreatitis ), blocked salivary gland (blockage of the salivary gland) , inflammation of the inner peritoneum ( peritonitis )
- infection of bones, blood and skin
- blood in the urine, damage to the kidney, pain and difficulty urinating
- hair loss, bruising
- inflammation of joints ( arthritis ), back pain, cramps
- loss of appetite, high blood fats ( hyperlipidemia ), high blood sugar ( diabetes ), high cholesterol ( hypercholesterolemia ) or decreased levels of phosphate in the blood ( hypophosphatemia )
- signs of flu (such as fatigue, chills, sore throat, aching joints and muscles), swollen ankles and feet, pain, stiffness, feeling of thirst or weakness
- strange dreams, misconceptions (delusions)
- inability to get or maintain an erection
- cough, difficulty breathing, painful breathing (possible symptoms of interstitial lung disease)
No known frequency (frequency can not be calculated from available data)
- rash
- fever, sore throat, frequent infection (possible symptoms of white blood cell deficiency ) ( agranulocytosis )
Other side effects have been reported with drugs similar to Mycophenolic Acid Accord
Additional side effects have been reported for the group of medicines to which Mycophenolic Acid belongs: inflammation of the colon, inflammation of the peritoneum caused by cytomegalovirus, the formation of a hole in the intestinal wall, resulting in severe abdominal pain with possible bleeding, gastrointestinal ulcers, low level of special white blood cells or all types of blood cells, serious infections such as inflammation of the heart and its valves and membrane covering the brain and spinal cord, shortness of breath, cough, which may be due to bronchiectasis (a condition in which the airways in the lungs are abnormally dilated). Other less common bacterial infections usually result in serious lung disease ( tuberculosis and atypical mycobacterial infection ). Talk to your doctor if you experience a persistent cough or shortness of breath.
How to store Mycophenolic Acid 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 carton.
The expiration date is the last day of the specified month.
No special temperature instructions.
Store in the original package. Sensitive to light
Do not use this medicine if you notice visible deterioration.
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 of mycophenolic acid.
Other ingredients are:
Tablet core: Microcrystalline cellulose (E460), croscarmellose sodium (E468), povidone K30 (E1201), talc (E553b), colloidal anhydrous silica (E551), magnesium stearate (E470b).
Tablet coating:
Methacrylic acid-ethyl acrylate copolymer (1: 1), talc (E553b), titanium dioxide (E171), triethyl citrate (E1505), colloidal anhydrous silica (E551), sodium bicarbonate (E500), yellow iron oxide (E172), indigo carmine aluminum lacquer (E132) E487).
Embossing of the tablet:
Shellack glaze, partially esterified (E904), black iron oxide (E172), propylene glycol (E1520), ammonium hydroxide (E527).
What the medicine looks like and contents of the pack
Mycophenolic acid Accord has lime green color, round shape, biconvex beveled edges enteric-coated tablets embossed with M1 in black on one side and without pressure on the other side
Mycophenolic Acid Accord is available in blister packs containing 20, 50, 100, 120, and 250 tablets.
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
Paradox Healthcare Limited
KW20A Kordin Industrial Park,
Paola PLA 3000, Malta
Accord Healthcare Polska Sp.z oo,
ul. Lutomierska 50,95-200 Pabianice, Poland
Accord Healthcare BV,
Winthontlaan 200,
3526 kV Utrecht,
Netherlands