Mysildecard

Package leaflet: Information for the patient

Mysildecard 20 mg film-coated tablets

sildenafil
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Mysildecard is and what it is used for
2. What you need to know before taking 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 class of medicines known as
phosphodiesterase type 5 (PDE5) inhibitors. Mysildecard reduces blood pressure in the blood vessels of the
lungs by dilating the pulmonary blood vessels.
Mysildecard is used to treat adults, children, and adolescents from 1 to 17 years of age with high blood
pressure in the blood vessels of the lungs (pulmonary arterial hypertension).

2. What you need to know before taking Mysildecard

Do not take Mysildecard
if you are allergic to sildenafil or to any of the other ingredients of this medicine
(listed in section 6).
if you are taking medicines containing nitrates or if you are using substances that release
nitric oxide, such as amyl nitrate ("poppers"). These medicines are often
used to relieve episodes of chest pain (or "angina pectoris"). Mysildecard may
cause a significant increase in the effects of these medicines. Inform your doctor if you are
taking any of these medicines. If you have any doubts, 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 due to blood clots). PDE5 inhibitors, such as sildenafil, have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, inform 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 previously experienced vision loss caused by a problem with blood flow to the optic nerve called non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Talk to your doctor before taking Mysildecard if:
the condition is due to obstruction or narrowing of a pulmonary vein rather than an artery.
you have a serious heart condition.
you have problems with the heart ventricles.
you have high blood pressure in the blood vessels of the lungs.
you have low blood pressure while at rest.
you are losing large amounts of body fluids (dehydration), which may occur when sweating excessively or not drinking enough fluids. This may happen if you are ill with fever, vomiting, or diarrhea.
you have a rare inherited eye disease (retinitis pigmentosa).
you have an abnormality of red blood cells (sickle cell anemia), a blood cell tumor (leukemia), a bone marrow tumor (multiple myeloma), or any disease or deformity of the penis.
you currently have a stomach ulcer, a bleeding disorder (such as hemophilia), or nosebleeds.
you are taking medicines for erectile dysfunction.

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

After taking sildenafil, prolonged and sometimes painful erections have been reported in men. If you have an erection that persists continuously for more than 4 hours, stop
taking Mysildecard and contact your doctor immediately (see also section 4).

Special precautions for patients with kidney or liver problems
If you have kidney or liver problems, you must inform your doctor, as a dose adjustment may be necessary.

Children
Mysildecard must not be administered to children under 1 year of age.

Other medicines and Mysildecard
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Medicines containing nitrates or substances that release nitric oxide, such as amyl nitrate ("poppers"). These medicines are often used to relieve episodes of angina pectoris or "chest pain" (see section 2. What you need to know before taking Mysildecard).
Inform your doctor or pharmacist if you are already taking riociguat (see section 2).
Therapies for pulmonary arterial hypertension (e.g. bosentan, iloprost).
Medicines containing St. John’s wort (herbal remedy), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (also used for epilepsy).
Medicines that inhibit blood coagulation (e.g. warfarin), although no adverse effect has been observed.
Medicines containing 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 high blood pressure or prostate problems, as the combination of these two medicines may cause symptoms leading to low blood pressure (e.g. dizziness, lightheadedness).
Medicines containing sacubitril/valsartan, used for the treatment of heart failure.

Mysildecard with food and drinks
You should not drink grapefruit juice while being treated with Mysildecard.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. Mysildecard should not be taken during pregnancy unless absolutely necessary.
Mysildecard must not be administered to women of childbearing potential unless they are using adequate contraceptive methods.
Mysildecard passes into breast milk in small amounts and is not considered harmful to the infant.

Driving and using machines
Mysildecard may cause dizziness and may affect vision. Before driving or operating machinery, you should be aware of how you react to this medicine.

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

3. How to take Mysildecard

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
For adults, the recommended dose is 20 mg three times daily (taken 6–8 hours apart), with or without food.

Use in children and adolescents
For children and adolescents aged 1 to 17 years, the recommended dose is 10 mg three times daily for those weighing ≤ 20 kg, or 20 mg three times daily for those weighing > 20 kg, taken with or without food. Higher doses should not be used in children. This medicine should only be used when a dosage of 20 mg three times daily is required. Other pharmaceutical forms may be more suitable for administration to patients weighing ≤ 20 kg and to younger patients who are unable to swallow tablets.

If you take more Mysildecard than you should
Do not take more medicine than prescribed by your doctor.
If you take more than the prescribed amount, contact your doctor immediately. Taking more Mysildecard than recommended may increase the risk of known adverse effects.

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

If you stop taking Mysildecard
Stopping treatment with Mysildecard suddenly may cause symptoms to worsen. Do not stop treatment with Mysildecard unless instructed by your doctor. Your doctor may advise you to gradually reduce the dose over several days before stopping treatment completely.

If you have any doubts about how to use this medicine, consult 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 must stop taking Mysildecard and contact your doctor immediately (see also section 2):

• sudden decrease or loss of vision (frequency not known)
• an erection that lasts continuously for more than 4 hours. After taking sildenafil, prolonged and sometimes painful erections have been reported, with frequency not known.

Adults
Very common side effects (may affect more than 1 in 10 people) are:
headache, facial flushing, indigestion, diarrhoea, and pain in arms or legs.

Common side effects (may affect up to 1 in 10 people) include:
subcutaneous infections, flu-like symptoms, sinusitis, reduced number of red blood cells (anaemia), fluid retention, sleep disorders, anxiety, headache, tremor, prickling sensations, burning sensations, reduced sense of touch, bleeding in the back of the eye, visual disturbances, blurred vision, light sensitivity, effects on colour perception, eye irritation, eye inflammation/redness, dizziness, bronchitis, nosebleeds, increased nasal discharge, cough, nasal congestion, stomach inflammation, gastroenteritis, heartburn, haemorrhoids, abdominal bloating, dry mouth, hair loss, skin redness, night sweats, muscle pain, back pain, and increased body temperature.

Uncommon side effects (may affect up to 1 in 100 people) include:
reduced visual acuity, double vision, abnormal sensation in the eye, penile bleeding, blood in the semen and/or urine, and excessive development of breast tissue in males.

Additionally, skin rash, sudden decrease or loss of hearing, and decrease in blood pressure have been reported, with frequency not known (frequency cannot be estimated from the available data).

Children and adolescents
The following serious adverse events have been commonly reported (may affect up to 1 in 10 people): pneumonia, heart failure, right-sided heart failure, cardiac shock, high blood pressure in the lungs, chest pain, fainting, respiratory infection, bronchitis, viral stomach and intestinal infection, urinary tract infection, and dental caries.

The following serious adverse events considered related to treatment have been reported uncommonly (may affect up to 1 in 100 people): allergic reactions (such as skin rash, swelling of the face, lips and tongue, wheezing, difficulty breathing or swallowing), seizures, irregular heartbeat, hearing impairment, shortness of breath, inflammation of the digestive tract, and wheezing due to breathing problems.

Very common side effects (may affect more than 1 in 10 people) were:
headache, vomiting, throat infection, fever, diarrhoea, influenza, and nosebleeds.

Common side effects (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, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex 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 stated on the packaging, following "Exp." The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Mysildecard contains
The active substance is sildenafil. Each tablet contains 20 mg of sildenafil (as citrate).
The excipients are:
Tablet core: microcrystalline cellulose (PH 102), calcium hydrogen phosphate, sodium
croscarmellose (see section 2 “Mysildecard contains sodium**”) and magnesium stearate.
Film coating: hypromellose (6 mPa·s), titanium dioxide (E171) and triacetin.

Description of the appearance of Mysildecard and contents of the pack
Mysildecard tablets are white, film-coated and round in shape. The tablets are marked with "M" on one side and "SL" over "20" on the other side. The tablets are available in blisters containing 90, 300 and (90 x 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

Manufacturers:
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 further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien Lietuva
Mylan bvba/sprl UAB GL Pharma Vilnius
Tél/Tel: + 32 02 658 61 00 Tel.: +370 5 261 0705

България Luxembourg/Luxemburg
Майлан ЕООД Mylan bvba/sprl
Тел.: +359 2 44 55 400 Tél/Tel: + 32 02 658 61 00
(Belgique/Belgien)

Česká republika Magyarország
Viatris CZ s.r.o Mylan EPD Kft
Tel: + 420 222 004 400 Tel.: + 36 1 465 2100

Danmark Malta
Viatris ApS V.J. Salomone Pharma Ltd
Tlf: +45 28 11 69 32 Tel: + 356 21 22 01 74

Deutschland Nederland
Viatris Healthcare GmbH Mylan BV
Tel: +49 800 0700 800 Tel: +31 (0)20 426 3300

Eesti Norge
G.L. Pharma Eesti OÜ Viatris AS
Tel.: +372 50 87 043 Tlf: + 47 66 75 33 00

Ελλάδα Österreich
Generics Pharma Hellas ΕΠΕ Arcana Arzneimittel GmbH
Τηλ: +30 210 993 6410 Tel: +43 1 416 2418

España Polska
Viatris Pharmaceuticals, S.L.U. Mylan Healthcare Sp. z.o.o.
Tel: + 34 900 102 712 Tel.: + 48 22 546 64 00

France Portugal
Substipharm Mylan, Lda.
Tél: +33 1 43181300 Tel: + 351 21 412 72 56

Hrvatska România
Mylan Hrvatska d.o.o. Aurobindo Pharma Romania SRL
Tel: +385 1 23 50 599 Tel: 004021 361 1011

Ireland Slovenija
Mylan Ireland Limited Mylan Healthcare d.o.o.
Tel: +353 1 8711600 Tel: + 386 1 23 63 180

Ísland Slovenská republika
Icepharma hf Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: +421 2 32 199 100

Italia Suomi/Finland
Mylan Italia S.r.l Viatris Oy
Tel: + 39 02 612 46921 Puh/Tel: +358 20 720 9555

Κύπρος Sverige
Varnavas Hadjipanayis Ltd Viatris AB
Τηλ: +357 2220 7700 Tel: + 46(0)8 630 19 00

Latvija United Kingdom (Northern Ireland)
SIA G.L. Pharma Riga Mylan IRE Healthcare Limited
Tel: +371 67887140 Tel: +353 18711600

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/. In addition, links to other websites on rare diseases and their therapeutic treatments are provided.