Patient Information Leaflet

Silungo, 20 mg, film-coated tablets
sildenafil
Please read the following information carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

What Silungo is and what it is used for
Important information before taking Silungo
How to take Silungo
Possible side effects
How to store Silungo
Contents of the pack and other information

1. What Silungo is and what it is used for

Silungo contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Silungo lowers blood pressure in the lungs by relaxing the pulmonary blood vessels.
Silungo is used to treat high blood pressure in the pulmonary arteries (pulmonary arterial hypertension) in adults, children and adolescents aged 1 year to 17 years.

2. Important information before using Silungo

When not to use Silungo:

If the patient is allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
If the patient is taking nitrates or medicines that release nitric oxide, such as amyl nitrite (so-called poppers). These medicines are often used to treat chest pain (or "angina"). Silungo may greatly enhance the effects of these medicines, so the patient should inform the doctor about their use. If in doubt, consult a doctor or pharmacist.
If the patient is 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 been shown to enhance the blood pressure-lowering effect of this medicine. If the patient is taking riociguat or is unsure, they should inform their doctor.
If the patient has recently had a stroke, heart attack, or has severe liver disease or very low blood pressure (< 90/50 mmHg).
If the patient is taking medicines used to treat fungal infections, such as ketoconazole,

itraconazole or ritonavir (used in HIV treatment).

If the patient has ever experienced vision loss due to impaired blood flow to the optic nerve, known as non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Before starting Silungo, discuss this with your doctor. Inform your doctor about:

A condition more related to blockage or narrowing of a vein in the lungs rather than an artery.
Severe heart disease.
Disorders affecting blood flow through the heart chambers.
Increased pressure in the blood vessels of the lungs.
Low blood pressure at rest.
Significant fluid loss (dehydration), which may occur with excessive sweating or insufficient fluid intake. This may also occur with fever, vomiting, or diarrhea.
A rare inherited eye disease (retinitis pigmentosa).
A disorder of red blood cells (sickle cell anemia), a blood cancer (leukemia), a bone marrow cancer (multiple myeloma), or any penile disease or anatomical deformity of the penis.
Peptic ulcer disease, bleeding disorders (such as hemophilia), or frequent nosebleeds.
Taking medicines used for erectile dysfunction.

During the use of phosphodiesterase type 5 inhibitors, including sildenafil, for the treatment of erectile dysfunction,
the following adverse effects have been reported with unknown frequency related to visual disturbances:
partial, sudden, transient or permanent weakening or loss of vision in one or both eyes.
If sudden vision loss or weakening occurs, treatment with Silungo must be discontinued immediately and
the patient should seek medical advice without delay (see also section 4).
In men using sildenafil, prolonged and sometimes painful erections have been observed. If an erection lasts
longer than 4 hours, treatment with Silungo must be discontinued immediately and the patient should seek
medical advice without delay (see also section 4).
Treatment with Silungo in patients with kidney or liver disease
Inform your doctor if you have kidney or liver disease, as dose adjustment may be necessary.
Children
Silungo must not be used in children under 1 year of age.
Silungo and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.

Medicines containing nitrates or medicines that release nitric oxide, such as amyl nitrite (so-called poppers). These medicines are used to treat angina or "chest pain" (see section 2 "When not to use Silungo").
Inform your doctor or pharmacist if the patient is taking riociguat.
Concurrent use of other treatments for pulmonary hypertension (e.g. bosentan, iloprost).
Medicines containing St. John's wort (herbal remedy), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, or phenobarbital (used among others in epilepsy treatment).
Medicines that inhibit blood clotting (e.g. warfarin), even though they have not caused adverse effects.
Medicines containing erythromycin, clarithromycin, telithromycin (antibiotics used to treat bacterial infections), saquinavir (used in HIV treatment), or nefazodone (used to treat depression), as dose adjustment may be necessary.
α-adrenergic blocking medicines (e.g. doxazosin), used to treat high blood pressure or benign prostatic hyperplasia, as concomitant use may cause symptoms of low blood pressure (e.g. dizziness, feeling of emptiness in the head).
Medicines containing sacubitril with valsartan, used in the treatment of heart failure.

Taking Silungo with food and drink
Do not consume grapefruit juice while taking Silungo.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine. Silungo may be used during pregnancy only when absolutely necessary. Use of Silungo in women of childbearing potential is not recommended unless they use appropriate contraceptive methods.
Silungo passes into human milk in very small amounts and is not expected to have a negative effect on breastfed infants.
Driving and operating machinery
Silungo may cause dizziness and visual disturbances. The patient should assess their reaction to the medicine before driving or operating machinery.
Silungo contains lactose
Patients previously diagnosed with intolerance to certain sugars should consult their doctor before using this medicine.
Silungo contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to take Silungo

This medicine should always be taken according to the doctor's instructions. If in doubt, consult
your doctor or pharmacist.
The recommended dose for adults is 20 mg three times daily (taken every 6-8 hours),
with or without food.
Use in children and adolescents
For children and adolescents aged 1 year to 17 years, the recommended dose is 10 mg three times daily
for children and adolescents with body weight ≤ 20 kg, or 20 mg three times daily for children and
adolescents with body weight > 20 kg, taken with or without food. Higher doses should not be used in children. This medicine should only be used when the dose of 20 mg three times daily is required. For patients with body weight ≤ 20 kg and other younger patients who cannot swallow tablets, other available pharmaceutical forms of the medicine may be appropriate.
Taking more Silungo than recommended
Do not take more medicine than prescribed by your doctor.
If you take more medicine than recommended, contact your doctor immediately. Taking more Silungo than recommended may increase the risk of experiencing the described adverse effects.
Missing a dose of Silungo
If you miss a dose of Silungo, take it as soon as possible and continue taking the medicine at your usual time. Do not take a double dose to make up for a missed dose.
Stopping Silungo
Stopping Silungo abruptly may lead to worsening of symptoms. Do not discontinue treatment without your doctor's advice. Your doctor may decide to reduce the dose gradually over several days before stopping treatment.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, treatment with Silungo should be discontinued immediately and medical advice should be sought without delay (see also section 2):

in case of unexpected weakness or loss of vision (frequency unknown),
in case of an erection lasting continuously for more than 4 hours. In men treated with sildenafil, prolonged and sometimes painful erections have been observed (frequency unknown).

Adults
Very common (reported in more than 1 in 10 patients): headache, sudden facial flushing, dyspepsia, diarrhoea, and pain in arms or legs.
Common adverse reactions (reported in 1 in 10 patients) include: subcutaneous infections, influenza-like symptoms, sinusitis, reduced number of red blood cells (anaemia), fluid retention, difficulty sleeping, anxiety, migraine, tremor, tingling sensation, feeling of warmth, reduced skin sensitivity, bleeding in the back of the eye, visual disturbances, blurred vision, photophobia, colour vision disturbances, eye irritation, eye hyperaemia (red eyes), dizziness, bronchitis, nosebleeds, nasal congestion, cough, nasal discharge, gastric mucosal inflammation, gastritis and enteritis, heartburn, haemorrhoids, flatulence, dry mouth, hair loss, skin redness, night sweats, muscle pain, back pain, and increased body temperature.
Adverse reactions reported less commonly (observed in 1 in 100 patients) include: reduced visual acuity, double vision, abnormal eye sensations, penile bleeding, blood in semen and/or urine, and gynaecomastia (breast enlargement in men).
Skin rash, sudden worsening or loss of hearing, and decreased blood pressure have also been reported, with unknown frequency (frequency cannot be estimated from available data).

Children and adolescents
The following serious adverse reactions have been frequently reported (observed in 1 in 10 patients): pneumonia, heart failure, right ventricular failure, cardiogenic shock, increased pulmonary arterial pressure, chest pain, fainting, respiratory tract infection, bronchitis, viral gastroenteritis, urinary tract infection, and dental caries.
Serious adverse reactions considered related to treatment and reported less commonly (observed in 1 in 100 patients) include: allergic reactions (such as skin rash, facial swelling, lip and tongue swelling, wheezing, difficulty breathing or swallowing), seizures, irregular heartbeat, hearing disturbances, shortness of breath, gastrointestinal tract inflammation, and wheezing due to obstructed airflow.
Very common adverse reactions (observed in more than 1 in 10 patients) include: headache, vomiting, throat infections, fever, diarrhoea, influenza, and nosebleeds.
Common adverse reactions (observed in 1 in 10 patients) include: nausea, increased frequency of erections, pneumonia, and nasal congestion.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181 C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Silungo

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the specified month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Silungo contains

The active substance is sildenafil. Each tablet contains 20 mg of sildenafil (as citrate).
The other ingredients are:
Tablet core: microcrystalline cellulose (PH 101), calcium hydrogen phosphate, sodium croscarmellose, hypromellose (5 cp), microcrystalline cellulose (PH 102), magnesium stearate.
Coating: hypromellose (5 cp), titanium dioxide (E 171), lactose monohydrate, triacetin.

What Silungo looks like and contents of the pack
White or almost white, round, biconvex coated tablets, embossed with the mark "20" on one side and smooth on the other.
Coated tablets are available in blisters containing 90 tablets or in blisters containing 50 tablets or in a package containing 6 cardboard boxes with 50 tablets each (300 tablets).
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Importer
Marketing Authorisation Holder:
UAB Norameda
Meistrų G. 8A
02189 Vilnius
Lithuania
Importer:
UAB Norameda
Meistrų G. 8A
02189 Vilnius
Lithuania