Silungo

Package Leaflet: Information for the Patient

Silungo, 20 mg, Film-Coated Tablets

Sildenafil

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep the package leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Silungo and what is it used for
• 2. Important information before taking Silungo
• 3. How to take Silungo
• 4. Possible side effects
• 5. How to store Silungo
• 6. Contents of the pack and other information

1. What is Silungo and what is it used for

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

2. Important information before taking Silungo

When not to take Silungo:

• If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
• If you are 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 pectoris"). Silungo may significantly enhance the effects of these medicines, and therefore, you should inform your doctor about taking them. In case of doubt, consult your doctor or pharmacist.
• If you are taking riociguat. This is a medicine 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). It has been shown that PDE5 inhibitors, such as sildenafil, enhance the blood pressure-lowering effect of this medicine. If you are taking riociguat or are unsure, inform your doctor.
• If you have recently had a stroke, heart attack, or have severe liver disease or very low blood pressure (<90>
• If you are taking medicines used to treat fungal infections, such as ketoconazole,

itraconazole or ritonavir (used to treat HIV).

• If you have ever had a loss of vision due to a disturbance in blood flow to the optic nerve, called non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Before taking Silungo, discuss it with your doctor. Inform them about:

• Disease related to blockage or narrowing of a vein in the lungs, rather than blockage or narrowing of an artery.
• Severe heart disease.
• Disturbances in blood flow through the heart chambers.
• Increased blood pressure in the pulmonary blood vessels.
• Decreased blood pressure at rest.
• Loss of a large amount of fluid (dehydration), which may occur due to excessive sweating or insufficient fluid intake. This may also occur in case of fever, vomiting, or diarrhea.
• A rare, inherited eye disease (retinitis pigmentosa) .
• Abnormalities related to red blood cells (sickle cell anemia), blood cancer (leukemia), bone marrow cancer (multiple myeloma), or any disease of the penis or its anatomical deformity.
• Peptic ulcer disease, bleeding disorders (such as hemophilia), or frequent nosebleeds.
• Taking medicines used to treat erectile dysfunction.

During treatment with phosphodiesterase type 5 inhibitors, including sildenafil, the following side effects have been reported, with an unknown frequency, related to vision disorders:
partial, unexpected, transient, or permanent decrease or loss of vision in one or both eyes.
In case of unexpected decrease or loss of vision, stop taking Silungo and seek medical attention immediately(see also section 4).
In men taking sildenafil, prolonged, and sometimes painful erections have been observed. In case of an erection lasting longer than 4 hours, stop taking Silungo and seek medical attention immediately(see also section 4).
Taking the medicine in patients with kidney or liver disease
Inform your doctor about kidney or liver disease, as it may be necessary to adjust the dose of the medicine.

Children

Silungo should not be taken by children under 1 year of age.

Silungo and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan 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 pectoris or "chest pain" (see section 2 "When not to take Silungo").
• Inform your doctor or pharmacist if you are taking riociguat.
• Other treatments for pulmonary hypertension (e.g., bosentan, iloprost) taken at the same time.
• Medicines containing St. John's Wort (a herbal medicine), rifampicin (an antibiotic), carbamazepine, phenytoin, or phenobarbital (used to treat epilepsy).
• Medicines that inhibit blood clotting (e.g., warfarin), although they did not cause side effects.
• Medicines containing erythromycin, clarithromycin, telithromycin (antibiotics), saquinavir (used to treat HIV), or nefazodone (used to treat depression), as it may be necessary to adjust the dose.
• Alpha-adrenergic blockers (e.g., doxazosin), used to treat high blood pressure or prostate enlargement, as taking these medicines together may cause symptoms that lead to decreased blood pressure (e.g., dizziness, feeling of emptiness in the head).
• Medicines containing sacubitril with valsartan, used to treat heart failure.

Taking Silungo with food and drink

While taking Silungo, do not drink grapefruit juice.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine. Silungo may only be taken during pregnancy if it is absolutely necessary. It is not recommended to take Silungo in women of childbearing age unless they use appropriate contraceptive methods.
Silungo passes into breast milk in very small amounts, and it is not expected to negatively affect the breastfed child.

Driving and using machines

Silungo may cause dizziness and vision disturbances. Check your reaction to the medicine before driving or operating machinery.

Silungo contains lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Silungo contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially "sodium-free".

3. How to take Silungo

Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose for adults is 20 mg three times a day (taken every 6-8 hours), taken with or without food.

Taking Silungo in children and adolescents

For children and adolescents from 1 to 17 years old, the recommended dose is 10 mg three times a day for children and adolescents with a body weight of ≤ 20 kg or 20 mg three times a day for children and adolescents with a body weight of > 20 kg, taken with or without food. Do not take higher doses in children. This medicine should only be taken when given at a dose of 20 mg three times a day. For patients with a body weight of ≤ 20 kg and other younger patients who cannot swallow tablets, other pharmaceutical forms of the medicine may be suitable.

Taking more Silungo than prescribed

Do not take more Silungo than your doctor has prescribed.
If you have taken more Silungo than prescribed, contact your doctor immediately. Taking more Silungo than prescribed may increase the risk of side 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 the usual time. Do not take a double dose to make up for the missed dose.

Stopping Silungo

Suddenly stopping Silungo may worsen symptoms. Do not stop taking the medicine without consulting your doctor. Your doctor may decide to gradually reduce the dose of the medicine over a few days before stopping treatment.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Silungo can cause side effects, although not everybody gets them.
If you experience any of the following side effects, stop taking Silungo and seek medical attention immediately (see also section 2):

• sudden loss of vision (frequency unknown),
• erection lasting longer than 4 hours. In men taking sildenafil, prolonged and sometimes painful erections have been observed (frequency unknown).

Adults
Very common (more than 1 in 10) side effects include: headache, sudden reddening of the face, indigestion, diarrhea, and pain in the arms or legs.
Common (more than 1 in 100) side effects include: skin infections, flu-like symptoms, sinusitis, decreased red blood cell count (anemia), fluid retention, difficulty sleeping, anxiety, migraine, tremors, tingling, burning sensation, decreased skin sensitivity, bleeding in the back of the eye, vision disturbances, blurred vision, increased sensitivity to light, color vision disturbances, eye irritation, conjunctivitis (red eyes), dizziness, bronchitis, nosebleeds, runny nose, cough, inflammation of the stomach lining, stomach and intestinal inflammation, heartburn, hemorrhoids, bloating, dry mouth, hair loss, skin reddening, night sweats, muscle pain, back pain, and increased body temperature.
Uncommon (more than 1 in 1,000) side effects include: decreased visual acuity, double vision, abnormal eye sensations, penile bleeding, blood in semen and/or urine, and breast enlargement in men.
Also reported are skin rash and sudden hearing loss, as well as decreased blood pressure, with an unknown frequency (frequency cannot be estimated from the available data).
Children and adolescents
The following serious side effects have been reported commonly (more than 1 in 10): pneumonia, heart failure, right heart failure, cardiogenic shock, increased pulmonary arterial pressure, chest pain, fainting, respiratory tract infections, bronchitis, viral gastroenteritis, urinary tract infections, and tooth decay.
Serious side effects considered to be related to treatment and reported uncommonly (more than 1 in 100) include: allergic reactions (such as skin rash, face, lips, tongue, or throat swelling, wheezing, difficulty breathing or swallowing), seizures, irregular heartbeat, hearing disturbances, shortness of breath, gastrointestinal inflammation, wheezing due to disturbed airflow.
Very common (more than 1 in 10) side effects include: headache, vomiting, sore throat, fever, diarrhea, flu, and nosebleeds.
Common (more than 1 in 100) side effects include: nausea, increased frequency of erections, pneumonia, and runny nose.
Reporting side effects
If you experience any side effects, including those not listed in the package leaflet, tell your doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Silungo

Keep the medicine out of sight and reach of children.
Do not take the medicine after the expiry date stated on the carton after the expiry date (EXP). The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
Medicines should 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 pack 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, film-coated tablets, with "20" engraved on one side and smooth on the other.
Film-coated tablets are available in blisters containing 90 tablets or in blisters containing 50 tablets or in a pack containing 6 cardboard boxes of 50 tablets (300 tablets).
Not all pack sizes may be marketed.

Marketing authorization holder and importer

Marketing authorization holder:

UAB Norameda
Meistrų G. 8A
02189 Vilnius
Lithuania

Importer:

UAB Norameda
Meistrų G. 8A
02189 Vilnius
Lithuania
Date of last revision of the package leaflet:09/2023