Prospect: information for the user
Myfortic 360 mggastro-resistant tablets
micophenolic acid (as sodium micophenolate)
Read this prospect carefully before starting to take this medicine, as it contains important information for you.
1.What Myfortic is and for what it is used
2.What you need to know before starting to take Myfortic
3.How to take Myfortic
4.Possible adverse effects
5.Storage of Myfortic
6.Contents of the package and additional information
Myfortic contains a substance called mycophenolic acid. It belongs to a class of medications known as immunosuppressants.
Myfortic is used to prevent your body's immune system from rejecting the transplanted kidney. It is used in combination with other medications that contain cyclosporine and corticosteroids.
Mycophenolate causes congenital malformations and spontaneous abortions. If you are a woman who can become pregnant, you must have a negative pregnancy test result before starting treatment and follow the contraceptive advice provided by your doctor.
Your doctor will explain and provide written information, particularly about the effects of mycophenolate on unborn babies. Read the information carefully and follow the instructions.
If any of the above cases apply to you, inform your doctor without taking Myfortic.
Consult your doctor or pharmacist before taking Myfortic:
You should also be aware that:
Children and Adolescents
Due to the lack of data, it is not recommended to use Myfortic in children and adolescents.
Older Adults
Older adults (65 years of age or older) may take Myfortic without the need to adjust the recommended normal dose.
Other Medications and Myfortic
Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.
Particularly, you should inform your doctor if you are taking any of the following medications:
You should also inform your doctor if you plan to receive anyvaccines.
You should not donate blood during treatment with Myfortic and at least 6 weeks after completing treatment. Men should not donate semen during treatment with Myfortic and at least 90 days after completing treatment.
Taking Myfortic with Food and Drinks
Myfortic can be taken with or without food. You should choose whether to take your tablets with or without food and take them in the same way every day. This is to ensure that the same amount of medication is absorbed by your body every day.
Pregnancy and Breastfeeding
If you are pregnant or breastfeeding, or believe you may be pregnant, consult your doctor or pharmacist before taking this medication. Your doctor will discuss the risks and alternative treatment options with you that may prevent organ transplant rejection if:
If you become pregnant during treatment with mycophenolate, inform your doctor immediately. However, continue taking mycophenolate until you see your doctor.
Pregnancy
Mycophenolate causes a very high frequency of spontaneous abortions (50%) and severe damage to the unborn baby (23-27%). Among the malformations reported are ear, eye, facial (cleft lip and palate), finger development, heart, esophagus (tube connecting the throat to the stomach), kidney, and nervous system (such as spina bifida) abnormalities. Your baby may be affected by one or more of these.
If you are a woman who can become pregnant, you must have a negative pregnancy test result before starting treatment and follow the contraceptive advice provided by your doctor. Your doctor may request multiple pregnancy tests to ensure you are not pregnant before starting treatment.
Breastfeeding
Do not take Myfortic if you are breastfeeding. This is because small amounts of the medication may pass into breast milk.
Contraception in Women Taking Myfortic
If you are a woman who can become pregnant, you must use an effective contraceptive method with Myfortic. This includes:
Consult your doctor to see which contraceptive method is most suitable for you. This will depend on your individual situation. It is recommended to use two contraceptive methods as this will reduce the risk of unintended pregnancy.Consult your doctor as soon as possible if you believe your contraceptive method may not have been effective or if you have forgotten to take the contraceptive pill.
You are considered not susceptible to becoming pregnant if your case is one of the following:
Contraception in Men Taking Myfortic
The available evidence does not indicate a higher risk of malformations or spontaneous abortion if the father takes mycophenolate. However, the risk cannot be completely ruled out. As a precaution, it is recommended that you or your female partner use a reliable contraceptive method during treatment and for 90 days after stopping Myfortic.
If you are planning to have a child, consult your doctor about the possible risks.
The influence of Myfortic on the ability to drive and operate machines is small.
Myfortic contains sodium
This medication contains 26 mg of sodium (main component of table salt/for cooking) in each Myfortic 360 mg tablet. This is equivalent to 1.3% of the maximum daily sodium intake recommended for an adult.
Myfortic contains lactose
If your doctor has told you that you have an intolerance to certain sugars (including lactose, galactose, or glucose), consult them before taking Myfortic.
Follow exactly the administration instructions for Myfortic as indicated by your doctor. Myfortic can only be prescribed by a doctor with experience in treating transplant patients. If you have any doubts, consult your doctor or pharmacist before using this medication.
How much to take
The recommended daily dose of Myfortic is 1,440 mg (4 Myfortic 360 mg tablets). They should be taken in 2 separate doses of 720 mg each (2 Myfortic 360 mg tablets).
Take your tablets in the morning and at night.
The first dose of 720 mg will be administered within 72 hours after the transplant.
If you have severe kidney problems
Your daily dose should not exceed 1,440 mg (4 Myfortic 360 mg tablets).
Myfortic intake
Swallow the tablets whole with a glass of water.
Do not break, crush, or divide the tablets.
Do not take any broken or divided tablets.
Treatment should be continued as long as immunosuppression is needed to prevent your body from rejecting your transplanted organ.
If you take more Myfortic than you should
In case of overdose or accidental ingestion, consult a doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. Bring the tablets with you and if you have finished them, bring the empty packaging.
If you forget to take Myfortic
If you forget to take a dose of Myfortic, take it as soon as you remember, unless it is almost time for your next dose. In this case, take the next dose at your regular time. Ask your doctor for advice. Do not take a double dose to make up for the missed doses.
If you interrupt treatment with Myfortic
Do not interrupt treatment with Myfortic unless your doctor tells you to. Stopping treatment with Myfortic may increase the risk of your body rejecting your transplanted kidney.
If you have any other questions about the use of this medication, ask your doctor or pharmacist.
Older patients may experience more side effects because they have a reduced immune defense.
Immunosuppressants, including Myfortic, reduce the body's defense mechanisms, preventing the rejection of the transplanted organ. Consequently, the body will not be in normal conditions to fight infections. Therefore, if you are taking Myfortic, you may contract more infections than normal, such as brain, skin, mouth, stomach, and intestinal infections, lung, and urinary tract infections.
Your doctor will perform regular blood tests to monitor any changes in the number of your blood cells or levels of substances carried in your blood, such as sugar, fat, and cholesterol.
Some side effects can be severe:
If you experience any of the mentioned side effects after taking Myfortic, inform your doctor immediately.
Other side effects may include:
Very common(can affect more than1 in 10 patients)
Common(can affect up to1 in 10 patients)
Rare(can affect up to1 in 100 patients)
Unknown frequency(cannot be estimated from available data)
Other side effects reported with similar medicines to Myfortic
Additional side effects have been reported with the group of medicines to which Myfortic belongs: colon inflammation (large intestine), stomach wall inflammation caused by cytomegalovirus, development of a cavity in the intestinal wall, resulting in severe abdominal pain with possible bleeding, gastric or duodenal ulcers, reduced white blood cell count, specifically or of all blood cells, severe infections, such as heart and valve inflammation and meningeal inflammation, shortness of breath, cough, which may be due to bronchiectasis (a condition in which the respiratory tract is abnormally dilated) and other less common bacterial infections that normally result in severe pulmonary alteration (tuberculosis and atypical mycobacterial infection). Consult your doctor if you develop persistent cough or shortness of breath.
Reporting of side effects
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus.You can also report them directlythrough theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano (www.notificaRAM.es).By reporting side effects, you can contribute to providing more information on the safety of this medicine.
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.
This medication does not require any special storage temperature. Store Myfortic in the original packaging to protect it from moisture.
Do not use this medication if you observe that the packaging is damaged or shows signs of having been manipulated.
Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications that you no longer need at the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.
-The active ingredient is mycophenolic acid (as sodium mycophenolate). Each Myfortic tablet contains 360 mg of mycophenolic acid.
-The other components are:
-Tablet core: cornstarch, povidone, crospovidone, lactose, anhydrous colloidal silica, magnesium stearate.
-Tablet coating: hypromellose phthalate, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).
Appearance of the product and contents of the package
Myfortic 360 mg gastro-resistant tablets are oval-shaped, pale orange-red tablets, coated with a film, with the inscription “CT” on one face.
Myfortic 360 mg gastro-resistant tablets are presented in blister packs containing 50, 100, 120 or 250 tablets.
Only some package sizes may be marketed
Marketing Authorization Holder
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona, Spain
Novartis Pharma GmbH
Roonstrasse 25
D-90429 Nürnberg
Germany
Novartis Poland Sp. z o.o.
ul. Marynarska 15, 02-674 Warszawa
Poland
Novartis Pharma GmbH
Jakov-Lind-Straße 5, Top 3.05
1020 Wien
Austria
Lek d.d., PE PROIZVODNJA LENDAVA
Trimlini 2D, Lendava, 9220
Slovenia
Novartis Pharmaceutical Manufacturing LLC
Verovskova Ulica 57
Ljubljana, 1000
Slovenia
Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nürnberg
Germany
This medicinal product is authorized in the member states of the European Economic Area with the following name:
Myfortic:Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden.
Last review date of this leaflet:10/2024
Other sources of information
Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es./
Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care.