20 mg film-coated tablets
sildenafil
What Mysildecard is and what it is used for
Mysildecard contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Mysildecard lowers blood pressure in the lungs by dilating the blood vessels in the lungs.
Mysildecard is used to treat adults and children and adolescents from 1 to 17 years of age with high blood pressure in the blood vessels of the lungs ( pulmonary arterial hypertension ).
What you need to know before taking Mysildecard
Do not take Mysildecard:
- if you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
- if you are taking medicines that contain nitrates or nitric oxide donors such as amyl nitrite (“poppers”). These medications are often given to relieve angina (or angina pectoris ). Mysildecard can cause a severe increase in the effect of these medicines. Tell your doctor if you are taking any of these medicines. If you are not sure, ask your doctor or pharmacist.
- if you take riociguat. This medicine is used to treat pulmonary arterial hypertension (ie high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (ie high blood pressure in the lungs due to blood clots). PDE5 inhibitors, such as Mysildecard, have been shown to increase the antihypertensive effect of this medicine. If you are taking riociguat or if you are not sure, talk to your doctor.
- if you have recently had a stroke , heart attack, severe liver disease or very low blood pressure (<90/50 mmHg).
- if you are taking medicines containing ketoconazole or itraconazole to treat fungal infections or medicines containing ritonavir (for HIV ).
- if you have ever before lost your sight due to a problem with the blood flow to the nerve in the eye called non-arteritic anterior ischemic optic infarction / neuropathy (NAION).
Warnings and cautions
Talk to your doctor before taking Mysildecard if you:
- have a disease that is due to a blocked or narrowed vein in the lung, rather than a blocked or narrowed artery .
- have severe heart problems
- have problems with the chambers of the heart.
- have high blood pressure in the blood vessels of the lungs.
- have low blood pressure at rest.
- loses a large amount of body fluids ( dehydration ) which can occur if you sweat a lot or do not drink enough fluid. This can happen if you are sick with fever, vomiting or diarrhea.
- have a rare inherited eye disease ( retinitis pigmentosa ).
- have abnormal red blood cells (sickle cell anemia), blood cell cancer ( leukemia ), bone marrow cancer (multiple myeloma ), any disease of the penis or deformed penis.
- right now have stomach ulcers or a bleeding disorder (such as hemophilia ) or problems with nosebleeds.
- uses drugs for erectile dysfunction .
When used to treat male erectile dysfunction (ED), the following side effects on vision have been reported with PDE5 inhibitors, including sildenafil, at an unknown frequency: partial, sudden, temporary, or permanent visual impairment or loss of vision in one or both eyes.
If you experience sudden visual impairment or loss of vision, stop taking Mysildecard and contact your doctor immediately (see also section 4).
Prolonged and sometimes painful erections have been reported in men after using sildenafil. If you get an erection that lasts longer than 4 hours, stop taking Mysildecard and contact your doctor immediately (see also section 4).
Especially to take into account for patients with kidney or liver problems:
You should tell your doctor if you have kidney or liver problems, as your dose may need to be adjusted.
Children
Mysildecard should not be given to children under 1 year of age.
Other medicines and Mysildecard
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines:
- Drugs containing nitrates, or nitric oxide donors such as amyl nitrite (“poppers”).
- These medicines are often given to relieve angina pectoris or angina (see section 2. What you need to know before you take Mysildecard).
- Tell your doctor or pharmacist if you are already taking riociguat (see section 2).
- Treatment for pulmonary hypertension (eg bosentan , iloprost). Medicines containing St. John ‘s wort (herbal medicine), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin and phenobarbital (used, among others, to treat epilepsy ).
- Blood-thinning drugs (eg warfarin ) even if they do not show any side effects.
- Medicines containing erythromycin, clarithromycin, telithromycin ( antibiotics for the treatment of specific bacterial infections ), saquinavir (for the treatment of HIV ) or nefazodone (for depression), as your dose may need to be adjusted.
- Alpha-receptor blockers (eg doxazosin ) for the treatment of high blood pressure or prostate problems, as the combination of the two drugs can cause symptoms that lead to a decrease in your blood pressure (eg dizziness and dizziness).
Mysildecard with food and drink
You should not drink grapefruit juice while you are being treated with Mysildecard.
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. Mysildecard should be used during pregnancy only when needed.
Mysildecard should not be given to women of childbearing potential unless appropriate contraception is used.
Mysildecard passes into breast milk in very small amounts and is not expected to harm the baby.
Driving and using machines
Mysildecard may cause dizziness and affect vision. You should be aware of how you react to the medicine before driving or using machines.
Mysildecard contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, ie essentially ‘sodium-free’.
How to take Mysildecard
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
For adults, the recommended dose is one 20 mg three times daily (taken at 6 to 8-hour intervals) with or without food.
Use in children and adolescents
For children and adolescents between 1 year and 17 years of age, the recommended dose is either 10 mg three times daily for children and adolescents weighing 20 kg or less, or 20 mg three times daily for children and adolescents weighing more than 20 kg. Taken with or without food. Higher doses should not be used in children. This medicine should only be used when administering 20 mg 3 times daily. Other forms of medicine are more suitable for the treatment of patients weighing less than 20 kg, as well as for younger patients who can not swallow tablets.
If you take more Mysildecard than you should
Do not take more medicines than your doctor tells you to do. If you take more medicines than you have been told to take, contact your doctor immediately. Taking more Mysildecard than you should increase the risk of known side effects.
If you forget to take Mysildecard
If you forget to take Mysildecard, take a dose as soon as you remember. Then continue to take your medicine at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Mysildecard
Sudden discontinuation of Mysildecard treatment may make your symptoms worse. Do not stop taking Mysildecard unless your doctor tells you to. Your doctor may ask you to reduce your dose for a few days before stopping completely.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
If you experience any of the following side effects, stop taking Mysildecard and contact your doctor immediately (see also section 2):
- if you experience a sudden deterioration or loss of vision (no known frequency).
- if you have an erection that lasts longer than 4 hours. Prolonged and sometimes painful erections have been reported in men after taking sildenafil (no known frequency).
Adults
The side effects that were reported as very common (may affect more than 1 in 10 people) were: headache, flushing, digestive problems, diarrhea, and pain in the arms and legs.
Side effects reported as common (may affect up to 1 in 10 people) were: subcutaneous infection, flu-like symptoms, sinusitis, decreased red blood cell count ( anemia ), fluid retention, difficulty sleeping, anxiety, migraines, tremors, numbness and tingling, burning sensation, decreased sensitivity of the skin, bleeding in the back of the eye, effects on vision, blurred vision and light shading, effect on color vision, eye irritation, bloodshot eyes / red eyes, dizziness, tracheal cataracts, nosebleeds, runny nose, cough, nasal congestion, stomach intestinal inflammation, heartburn, hemorrhoids, distended abdomen, dry mouth, hair loss, redness of the skin, night sweats, muscle aches, back pain, and increased body temperature.
Side effects that were reported as uncommon (may affect 1 in 100 people) were: decreased visual acuity, double vision, abnormal sensation in the eyes, bleeding in the penis, the presence of blood in semen and/or urine, and breast enlargement in men.
Skin rash and sudden loss or loss of hearing and decreased blood pressure have also been reported with an unknown frequency (frequency can not be calculated from the available data).
Children and young people
The following serious side effects have been reported commonly (occurring in up to 1 user in 10): pneumonia, heart failure, right ventricular failure, heart-related shock, high blood pressure in the lungs, chest pain, fainting, respiratory tract infection, tracheal inflammation, viral and intestinal viral infection.
The following serious side effects were considered treatment-related and have been reported as uncommon (occurring in up to 1 user in 100): allergic reactions (such as rash, swelling of the face, lips, and tongue, wheezing, difficulty breathing and swallowing), convulsions, irregular heartbeat, hearing loss, shortness of breath, inflammation of the stomach and intestines, wheezing due to obstructed airflow.
Side effects reported as very common (affects more than 1 user in 10) were: headache, vomiting, throat infection, fever, diarrhea, flu, and nosebleeds.
Side effects reported as common (affects up to 1 user in 10) include nausea, increased erection, pneumonia, and runny nose.
How to store Mysildecard
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 after EXP. The expiration date is the last day of the specified month.
This medicinal product does not require any special storage instructions.
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 sildenafil. Each tablet contains 20 mg of sildenafil (in the form of citrate).
Other ingredients are:
- Tablet core: microcrystalline cellulose ( PH 102), calcium hydrogen phosphate, croscarmellose sodium (see section 2 ‘Mysildecard contains sodium’)and magnesium stearate.
- Film-coated: hypromellose (6 mPas), titanium dioxide (E171) and triacetin.
What the medicine looks like and contents of the pack
Mysildecard film-coated tablets are white and round. The tablets are marked with M on one side and SL over 20 on the other. The tablets are supplied in blisters in packs containing 90, 300, and (90 × 1) tablets. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Viatris Limited
Damastown Industrial Park,
Mulhuddart, Dublin 15,
DUBLIN
Ireland
Manufacturer:
Mylan Hungary
Mylan utca 1,
Komárom,
2900,
Hungary
Mylan Germany GmbH
Branch release Bad Homburg vd Hoehe, Benzstrasse 1
Bad Homburg vd Hoehe
Hessen, 61352,
Germany