Mysildecard - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Mysildecard 20 mg film-coated tablets sildenafil

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Mysildecard is and what it is used for

• 2. What you need to know before you take Mysildecard

• 3. How to take Mysildecard

• 4. Possible side effects

• 5. How to store Mysildecard

• 6. Contents of the pack and other information

1. 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 brings down blood pressure in the lungs by widening the blood vessels in the lungs. Mysildecard is used to treat adults and children and adolescents from 1 to 17 years old with high blood pressure in the blood vessels in the lungs (pulmonary arterial hypertension).

2. What you need to know before you take 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 containing nitrates, or nitric oxide donors such as amyl nitrate (“poppers”). These medicines are often given for relief of chest pain (or “angina pectoris”). Mysildecard can cause a serious increase in the effects of these medicines. Tell your doctor if you are taking any of these medicines. If you are not certain, ask your doctor or pharmacist.
• if you are taking riociguat. This drug is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs secondary to blood clots).PDE5 inhibitors, such as sildenafil have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.
• if you have recently had a stroke, a heart attack or if you have severe liver disease or very low blood pressure (<90/50 mmHg).
• if you are taking a medicine to treat fungal infections such as ketoconazole or itraconazole or medicines containing ritonavir (for HIV).
• if you have ever had loss of vision because of a problem with blood flow to the nerve in the eye called non-arteritic anterior ischaemic optic neuropathy (NAION).

Warnings and precautions

Talk to your doctor before taking Mysildecard if you:

• have a disease due to a blocked or narrow vein in the lungs rather than a blocked or narrow artery.
• have a severe heart problem.
• have a problem with the pumping chambers of your heart.
• have high blood pressure in the blood vessels in the lungs.
• have low blood pressure at rest.
• lose a large amount of body fluids (dehydration) which can occur when you sweat a lot or do not drink enough liquids. This can happen if you are sick with a fever, vomiting, or diarrhoea.
• have a rare inherited eye disease (retinitis pigmentosa).
• have an abnormality of red blood cells (sickle cell anaemia), cancer of blood cells (leukaemia), cancer of bone marrow (multiple myeloma), or any disease or deformity of the penis.
• currently have a stomach ulcer, a bleeding disorder (such as haemophilia) or problems with nose bleeds.
• take medicines for erectile dysfunction.

When used to treat male erectile dysfunction (ED), the following visual side effects have been reported with PDE5 inhibitors, including sildenafil at an unknown frequency; partial, sudden, temporary, or permanent decrease or loss of vision in one or both eyes.

If you experience sudden decrease 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 taking sildenafil. If you have an erection, which lasts continuously for more than 4 hours, stop taking Mysildecard and contact your doctor immediately (see also section 4).

Special considerations 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 below 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.

• Medicines containing nitrates, or nitric oxide donors such as amyl nitrate (“poppers”). These medicines are often given for relief of angina pectoris or “chest pain” (see section 2. Before you take Mysildecard)
• Tell your doctor or pharmacist if you are already taking riociguat (see section 2).
• Therapies for pulmonary hypertension (e.g. bosentan, iloprost)
• Medicines containing St. John’s Wort (herbal medicinal product), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin and phenobarbital (used, among others, to treat epilepsy)
• Blood thinning medicines (for example warfarin) although these did not result in any side effect.
• Medicines containing erythromycin, clarithromycin, telithromycin (these are antibiotics used to treat certain bacterial infections), saquinavir (for HIV) or nefazodone (for mental depression), as your dose may need to be adjusted.
• Alpha-blocker therapy (e.g. doxazosin) for the treatment of high blood pressure or prostate problems, as the combination of the two medicines may cause symptoms resulting in the lowering of your blood pressure (e.g. dizziness, light headedness).

Mysildecard with food and drink

You should not drink grapefruit juice while you are being treated with Mysildecard.

Pregnancy and breast-feeding

If you are pregnant, or breast-feeding, 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 not be used during pregnancy unless strictly necessary.

Mysildecard should not be given to women of child bearing potential unless using appropriate contraceptive methods.

Mysildecard passes into your breast milk at very low levels and would not be expected to harm your baby.

Driving and using machines

Mysildecard can cause dizziness and can affect vision. You should be aware of how you react to the medicine before you drive or use machines.

Mysildecard contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. How to take Mysildecard

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

For adults, the recommended dose is 20 mg three times a day (taken 6 to 8 hours apart) taken with or without food.

Use in children and adolescents

For children and adolescents aged 1 year to 17 years old, the recommended dose is either 10 mg three times a day for children and adolescents ^ 20 kg or 20 mg three times a day for children and adolescents > 20 kg, taken with or without food. Higher doses should not be used in children. This medicine should be used only in case of administration of 20 mg three times a day. Other pharmaceutical forms may be more appropriate for administration to patients ^ 20 kg and other younger patients who are not able to swallow tablets.

If you take more Mysildecard than you should

You should not take more medicine than your doctor tells you to.

If you take more medicine than you have been told to take contact your doctor immediately. Taking more Mysildecard than you should may 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 times. Do not take a double dose to make up for a forgotten dose.

If you stop taking Mysildecard

Suddenly stopping your treatment with Mysildecard may lead to your symptoms getting worse. Do not stop taking Mysildecard unless your doctor tells you to. Your doctor may tell you to reduce the dose over a few days before stopping completely.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following side effects you should stop taking Mysildecard and contact a doctor immediately (see also section 2):

if you experience sudden decrease or loss of vision (frequency not known)

if you have an erection, which lasts continuously for more than 4 hours. Prolonged and sometimes painful erections have been reported in men after taking sildenafil (frequency not known).

Adults

Side effects reported very commonly (may affect more than 1 in 10 people) were headache, facial flushing, indigestion, diarrhoea and pain in the arms or legs.

Side effects reported commonly (may affect up to 1 in 10 people) included: infection under the skin, flu-like symptoms, inflammation of the sinuses, reduced number of red blood cells (anaemia), fluid retention, difficulty sleeping, anxiety, migraine, shaking, “pins and needles”-like sensation, burning sensation, reduced sense of touch, bleeding at the back of the eye, effects on vision, blurred vision and light sensitivity, effects on colour vision, eye irritation, bloodshot eyes /red eyes, vertigo, bronchitis, nosebleed, runny nose, cough, stuffy nose, stomach inflammation, gastroenteritis, heartburn, piles, abdominal distension, dry mouth, hair loss, redness of the skin, night sweats, muscle aches, back pain and increased body temperature.

Side effects reported uncommonly (may affect 1 in 100 people) included: reduced sharpness of vision, double vision, abnormal sensation in the eye, penile bleeding, presence of blood in semen and/or urine, and breast enlargement in men.

Skin rash and sudden decrease or loss of hearing and decreased blood pressure have also been reported at an unknown frequency (frequency cannot be estimated from the available data).

Children and adolescents

The following serious adverse events have been reported commonly (may affect up to 1 in 10 people); pneumonia, heart failure, right heart failure, heart related shock, high blood pressure in the lungs, chest pain, fainting, respiratory infection, bronchitis, viral infection in the stomach and intestines, urinary tract infections and tooth cavities.

The following serious adverse events were considered to be treatment related and were reported uncommonly (may affect up to 1 in 100 people), allergic reaction (such as skin rash, swelling of the face, lips and tongue, wheezing, difficulty breathing or swallowing), convulsion, irregular heart-beat, hearing impairment, shortness of breath, inflammation of the digestive tract, wheezing due to disrupted airflow.

Side effects reported very commonly (may affect more than 1 in 10 people) were headache, vomiting, infection of the throat, fever, diarrhoea, flu and nosebleed.

Side effects reported commonly (may affect up to 1 in 10 people) were nausea, increased erections, pneumonia and runny nose.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. 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 expiry date refers to the last day of that month.

This medicinal product does not require any special storage condition.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Mysildecard contains

• – The active substance is sildenafil. Each tablet contains 20 mg of sildenafil (as the citrate).

• – The other ingredients are:

What Mysildecard looks like and contents of the pack

Mysildecard film-coated tablets are white and round in shape. The tablets are marked with M on one side and SL over 20 on the other. The tablets are provided in blisters in packs containing 90, 300 and (90 × 1) tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Viatris Limited

Damastown Industrial Park,

Mulhuddart, Dublin 15,

DUBLIN

Ireland

Manufacturer:

Mylan Hungary Kft.

Mylan utca 1,

Komárom,

2900,

Hungary

Mylan Germany GmbH

Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1

Bad Homburg v. d. Hoehe

Hessen, 61352,

Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Luxembourg/Lu­xemburg

Mylan bvba/sprl

Tel: + 32 02 658 61 00

(Belgique/Belgien)

Magyarország

Mylan EPD Kft

Tel: + 36 1 465 2100

Malta

V.J. Salomone Pharma Ltd

Tel: + 356 21 22 01 74

Nederland

Mylan BV

Tel: +31 (0)20 426 3300

Norge

Mylan Healthcare Norge AS

Tel: + 47 66 75 33 00

Österreich

Arcana Arzneimittel GmbH

Tel: +43 1 416 2418

Polska

Mylan Healthcare Sp. z.o.o.

Tel: + 48 22 546 64 00

Portugal

Mylan, Lda.

Tel: + 351 21 412 72 56

Romania

Aurobindo Pharma Romania SRL

Tel: 004021 361 1011

Slovenija

Mylan Healthcare d.o.o.

Tel: + 386 1 23 63 180

Slovenská republika

Mylan s.r.o.

Tel: +421 2 32 199 100

Suomi/Finland

Mylan Finland OY

Puh/Tel: +358 20 720 9555

Sverige

Mylan AB

Tel: + 46 855 522 750

United Kingdom (Northern Ireland)

Mylan IRE Healthcare Limited

Tel: +353 18711600

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:. There are also links to other websites about rare diseases and treatments.

36