MYSILDECARD 20 mg FILM-COATED TABLETS

Introduction

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, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Mysildecard and what is it used for
2. What you need to know before you take Mysildecard
3. How to take Mysildecard
4. Possible side effects
5. Storing Mysildecard
6. Contents of the pack and other information

1. What is Mysildecard and what is it used for

Mysildecard contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.

Mysildecard reduces blood pressure in the lungs by widening the blood vessels in the lungs.

Mysildecard is used to treat high blood pressure in the blood vessels of the lungs (pulmonary arterial hypertension) in adults and children and adolescents from 1 to 17 years.

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 that contain nitrates or nitric oxide donors such as amyl nitrite (“poppers”). These medicines are often given to relieve chest pain (or angina). Mysildecard can increase the effects of these medicines. You should tell your doctor if you are taking any of these medicines. If you are not sure, consult your doctor or pharmacist.
• if you are taking riociguat. This medicine 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 caused by blood clots). PDE5 inhibitors, such as sildenafil, have shown that they increase the hypotensive effect of this medicine. If you are taking riociguat or are not sure, consult 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 for fungal infections such as ketoconazole or itraconazole or medicines that contain ritonavir (for HIV).
• if you have previously experienced a loss of vision due to a problem with blood flow to the nerve of the eye called non-arteritic anterior ischemic optic neuropathy (NAION)

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting treatment with Mysildecard if

• you have a disease due to a blockage or narrowing of a vein in the lungs rather than a blockage or narrowing of an artery.
• you have a serious heart problem.
• you have a problem with the heart's pumping chambers.
• you have high blood pressure in the blood vessels of the lungs.
• you have low blood pressure at rest.
• you lose a large amount of body fluids (dehydration) which can occur when you sweat a lot or do not drink enough fluids. This can happen if you are ill with fever, vomiting, or diarrhea.
• you suffer from a rare inherited eye disease (retinitis pigmentosa).
• you suffer from an abnormality of the red blood cells (sickle cell anemia), blood cell cancer (leukemia), bone marrow cancer (multiple myeloma), or any disease or deformity of the penis.
• you currently have stomach ulcers or bleeding disorders (such as hemophilia) or nosebleeds.
• you use medicines for erectile dysfunction.

When PDE5 inhibitors, including sildenafil, are used to treat erectile dysfunction (ED), the following visual adverse effects have been reported with an unknown frequency: decreased or sudden, temporary, or permanent loss of vision in one or both eyes. If you experience a reduction or loss of vision, stop taking Mysildecard and inform your doctor immediately(see also section 4).

Prolonged, sometimes painful, erections have been observed in men after taking sildenafil. If you have an erection that lasts for more than 4 hours, stop taking Mysildecard and consult your doctor immediately(see also section 4).

Special precautions in patients with kidney or liver problems

You should inform your doctor if you have kidney or liver problems, as a dose adjustment may be necessary.

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 using, have recently used, or might use any other medicines.

• Medicines that contain nitrates or nitric oxide donors such as amyl nitrite (“poppers”). These medicines are often given to relieve chest pain or angina (see section 2. What you need to know before you take Mysildecard).

Tell your doctor or pharmacist if you are taking riociguat (see section 2).

• Treatments for pulmonary hypertension (e.g., bosentan, iloprost).

• Medicines that contain St. John's Wort (herbal medicine), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among others, to treat epilepsy).

• Medicines that inhibit blood clotting (e.g., warfarin), although they have not caused any adverse effects.

• Medicines that contain erythromycin, clarithromycin, telithromycin (antibiotics used to treat certain bacterial infections), saquinavir (for HIV), or nefazodone (for depression), as a dose adjustment may be necessary.
• Alpha-blocker therapy (e.g., doxazosin) for the treatment of hypertension or prostate problems, as the combination of the two medicines can cause symptoms of reduced blood pressure (e.g., dizziness, fainting).

Taking Mysildecard with food and drink

Do not take grapefruit juice when 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 not be used during pregnancy unless absolutely necessary. Mysildecard should not be given to women of childbearing age unless adequate contraceptive methods are used.

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

Driving and using machines

Mysildecard may cause dizziness and affect vision. You should know how you react to this medicine before driving vehicles or using machines.

Mysildecard contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet, i.e., it is essentially “sodium-free”

3. How to take Mysildecard

Take this medicine exactly as your doctor has told you.

If you are not sure, consult your doctor or pharmacist again.

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

Use in children and adolescents

For children and adolescents from 1 to 17 years, the recommended dose is 10 mg three times a day for children and adolescents ≤ 20 kg or 20 mg three times a day in children and adolescents > 20 kg, administered with or without food. In children, doses higher than those recommended should not be used. This medicine should only be used for cases where 20 mg three times a day is to be administered. For administration in patients ≤ 20 kg and in other younger patients who cannot swallow tablets, other pharmaceutical forms more suitable for their needs can be used.

If you take more Mysildecard than you should

Do not take more medicine than your doctor has told you.

If you have taken more medicine than you were told, consult your doctor immediately.

Taking more Mysildecard than you should can increase the risk of known side effects.

If you forget to take Mysildecard

If you forget to take Mysildecard, take the dose as soon as you remember and then continue taking your medicine at the usual times. Do not take a double dose to make up for forgotten doses.

If you stop taking Mysildecard

Sudden stopping of treatment with Mysildecard may lead to worsening of your symptoms. Do not stop taking Mysildecard unless your doctor tells you to. Your doctor will tell you how to reduce the dose over a few days before stopping it 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, stop taking Mysildecard and inform your doctor immediately (see also section 2):

• if you experience a sudden loss of vision (frequency not known).
• if you have an erection that lasts for more than 4 hours. Prolonged, sometimes painful, erections have been reported in men after taking sildenafil (frequency not known).

Adults

The following side effects have been reported very frequently (may affect more than 1 in 10 patients): headache or facial flushing, indigestion, diarrhea, and pain in arms and legs.

The following side effects have been reported frequently (may affect up to 1 in 10 patients): infection under the skin, flu-like symptoms, inflammation of the nasal passages, reduction in the number of red blood cells (anemia), fluid retention, difficulty sleeping, anxiety, migraine, tremor, tingling sensation, burning sensation, reduced sense of touch, bleeding from the back of the eye, vision changes, blurred vision, and sensitivity to light, effects on color perception, eye irritation, red eyes, dizziness, bronchitis, nosebleeds, runny nose, cough, stuffy nose, stomach inflammation, gastroenteritis, heartburn, hemorrhoids, abdominal distension, dry mouth, hair loss, skin flushing, night sweats, muscle pain, back pain, and increased body temperature.

The following side effects have been reported infrequently (may affect up to 1 in 100 patients): reduced visual acuity, double vision, abnormal sensation in the eye, penile bleeding, presence of blood in the semen and/or urine, and gynecomastia in men.

The following have also been reported with an unknown frequency (frequency cannot be estimated from the available data): skin rash, sudden loss of hearing, and reduced blood pressure.

Children and adolescents

The following serious side effects have been reported frequently (may affect up to 1 in 10 patients): pneumonia, right heart failure, cardiac arrest, high blood pressure in the lungs, chest pain, dizziness, respiratory infections, bronchitis, viral gastroenteritis, urinary tract infections, and tooth perforation.

The following serious side effects were considered related to treatment and have been reported infrequently (may affect up to 1 in 100 patients): allergic reaction (such as skin rash, facial swelling, lip and tongue swelling, sneezing, difficulty breathing or swallowing), seizures, irregular heartbeat, hearing changes, shortness of breath, inflammation of the digestive tract, and sneezing due to changes in air flow.

The following side effects have been reported very frequently (may affect more than 1 in 10 patients): headache, vomiting, throat infection, fever, diarrhea, flu, and nosebleeds.

The following side effects have been reported frequently (may affect up to 1 in 10 patients): nausea, increased erections, pneumonia, and runny nose.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. 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. Storing 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 the month.

This medicine does not require any special storage conditions.

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 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 citrate).
• The other ingredients are:

Core of the tablet: microcrystalline cellulose (PH 102), anhydrous calcium hydrogen phosphate, sodium croscarmellose, and magnesium stearate.

Coating: hypromellose (6 mPas), titanium dioxide (E 171), and triacetin.

Appearance of Mysildecard and contents of the pack

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

Marketing authorization holder and manufacturer

Marketing authorization holder:

Mylan S.A.S

117 Allée des Parcs

69800 Saint Priest

France

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

You can ask for more information about this medicine from the local representative of the marketing authorization holder:

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/. There are also links to other web sites about rare diseases and orphan medicines.