Sildenafil Zentiva

Leaflet attached to the packaging: patient information

Sildenafil Zentiva 20 mg film-coated tablets

Sildenafil

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

• Keep the leaflet, so you can read it again if you need to.
• If you have any doubts, consult a 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.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Sildenafil Zentiva and what is it used for

Sildenafil Zentiva contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE5).
Sildenafil Zentiva lowers blood pressure in the lungs by relaxing the blood vessels in the lungs.
Sildenafil Zentiva 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 Sildenafil Zentiva

When not to take Sildenafil Zentiva:

• If the patient has been diagnosed with an allergy 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. These medicines are used to treat chest pain (angina pectoris). Sildenafil Zentiva may enhance the effects of these medicines, and the patient should inform their doctor about taking them. In case of doubt, consult a doctor or pharmacist.
• If the patient is taking riociguat. This medicine is used to treat pulmonary 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 Zentiva, 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>
• If the patient is taking medicines used to treat fungal infections, such as ketoconazole, itraconazole, or ritonavir (used to treat HIV).
• If the patient has ever had a loss of vision due to a blood flow disorder in the eye called non-arteritic anterior ischemic optic neuropathy.

Warnings and precautions

Before starting Sildenafil Zentiva, the patient should discuss it with their doctor.
The patient should inform their doctor about:

• Diseases related to blockage or narrowing of a vein in the lungs, rather than blockage or narrowing of an artery.
• Severe heart disease.
• Disorders of blood flow through the heart chambers.
• Increased blood pressure in the pulmonary vessels.
• Decreased blood pressure at rest.
• Loss of large amounts 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 called 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 vision loss or decreased vision in one or both eyes.
In case of sudden vision loss or decreased vision, the patient should stop taking Sildenafil Zentiva and consult their doctor immediately (see also section 4).
In men taking sildenafil, prolonged and sometimes painful erections have been observed. If an erection lasts longer than 4 hours, the patient should stop taking Sildenafil Zentiva and consult their doctor immediately (see also section 4).
Taking the medicine in patients with kidney or liver disease
The patient should inform their doctor about kidney or liver disease, as it may be necessary to adjust the dose of the medicine.

Children

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

Sildenafil Zentiva and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.

• Medicines containing nitrates or nitric oxide-releasing medicines, such as amyl nitrite (so-called poppers). These medicines are used to treat angina pectoris - chest pain (see section 2 "Important information before taking Sildenafil Zentiva").
• Riociguat.
• Other treatments for pulmonary hypertension (e.g., bosentan, iloprost) taken at the same time.
• Medicines containing St. John's Wort (Hypericum perforatum) - 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 benign prostatic hyperplasia (BPH), as concurrent use of these medicines may cause symptoms of low blood pressure (e.g., dizziness, lightheadedness).
• Medicines containing sacubitril with valsartan, used to treat heart failure.

Taking Sildenafil Zentiva with food and drink

While taking Sildenafil Zentiva, the patient should not drink grapefruit juice.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. Sildenafil Zentiva may only be used during pregnancy if it is absolutely necessary.
Sildenafil Zentiva is not recommended for women of childbearing age unless they use appropriate contraceptive methods.
Sildenafil passes into breast milk in very small amounts, and it is not expected to negatively affect the breastfed child.

Sildenafil Zentiva contains sodium

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

Driving and using machines

Sildenafil Zentiva may cause dizziness and vision disturbances. The patient should check their reaction to the medicine before driving or operating machinery.

3. How to take Sildenafil Zentiva

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
The recommended dose for adults is 20 mg three times a day (taken every 6-8 hours), with or without food.

Use 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 weighing ≤ 20 kg or 20 mg three times a day for children and adolescents weighing > 20 kg, with or without food. Higher doses should not be taken in children. This medicine should only be used when administering a dose of 20 mg three times a day. For patients weighing ≤ 20 kg and other younger patients who cannot swallow tablets, other suitable pharmaceutical forms of the medicine are available.

Taking a higher dose of Sildenafil Zentiva than recommended

The patient should not take more than the recommended dose of the medicine.
If the patient has taken more than the recommended dose of the medicine, they should contact their doctor immediately. Taking a higher dose of Sildenafil Zentiva than recommended may increase the risk of side effects.

Missing a dose of Sildenafil Zentiva

If the patient misses a dose of Sildenafil Zentiva, they should take it as soon as possible and continue taking the medicine as directed. The patient should not take a double dose to make up for the missed dose.

Stopping Sildenafil Zentiva

Suddenly stopping Sildenafil Zentiva may worsen the patient's condition. The patient should not stop taking the medicine without consulting their doctor. The doctor may decide to reduce the dose of the medicine for a few days before stopping treatment.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Sildenafil Zentiva can cause side effects, although not everybody gets them.
If the patient experiences any of the following side effects, they should stop taking Sildenafil Zentiva and consult their doctor immediately (see also section 2):

• sudden unexpected 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 side effects (more than 1 in 10 patients)

• headache,
• sudden flushing of the face,
• diarrhea, nausea,
• pain in the arms or legs.

Common side effects (more than 1 in 100 patients)

• infections of the skin and subcutaneous tissue, flu-like symptoms, bronchitis, sinusitis, cold, gastroenteritis
• reduced red blood cell count (anemia),
• fluid retention,
• difficulty sleeping, anxiety,
• migraine, tremors, tingling, feeling of warmth, decreased skin sensitivity,
• bleeding in the back of the eye, vision disturbances, blurred vision, increased sensitivity to light, color vision disturbances, eye irritation, conjunctival hyperemia (red eyes),
• dizziness,
• nosebleeds, cough, stuffy nose,
• heartburn, hemorrhoids, bloating, dry mouth,
• hair loss, skin flushing, night sweats,
• muscle pain, back pain,
• fever.

Uncommon side effects (more than 1 in 1,000 patients) include:

• reduced visual acuity, double vision, abnormal eye sensations,
• penile bleeding, blood in semen and/or urine, and breast enlargement in men.

Side effects with unknown frequency (frequency cannot be estimated from the available data).

• sudden severe hearing loss,
• low blood pressure,
• skin rash

Children and adolescents

The following serious side effects have been reported frequently (more than 1 in 10 patients):

• pneumonia, heart failure, right ventricular 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 patients) include:
• allergic reactions (such as skin rash, facial swelling, mouth and tongue swelling, wheezing, difficulty breathing or swallowing), seizures, irregular heartbeat, hearing disturbances, shortness of breath, gastrointestinal inflammation, wheezing due to airway obstruction.

The following very common side effects (more than 1 in 10 patients) include:

• headache, vomiting, throat infections, fever, diarrhea, flu, and nosebleeds.

The following common side effects (more than 1 in 100 patients) include:

• nausea, increased frequency of erections, pneumonia, and cold.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. 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:
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Sildenafil Zentiva

The medicine should be stored out of sight and reach of children.
Do not use this 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 stated.
The batch number is stated on the packaging after the abbreviation "Lot".
No special storage conditions.
Store in the original packaging to protect from moisture and light.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Sildenafil Zentiva contains

• The active substance of the medicine is sildenafil. Each tablet contains 20 mg of sildenafil (as citrate).
• The other ingredients are: calcium hydrogen phosphate (anhydrous), microcrystalline cellulose (type 102), croscarmellose sodium, magnesium stearate, coating: hypromellose 2910, microcrystalline cellulose, macrogol stearate 40 type I, titanium dioxide (E 171).

What Sildenafil Zentiva looks like and contents of the pack

Sildenafil Zentiva is a white, round, biconvex, film-coated tablet.
The tablets are packaged in blisters of 90 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Zentiva k.s., U kabelovny 130, Dolni Mĕcholupy, 102 37 Prague 10, Czech Republic.

Manufacturer:

S.C. Zentiva S.A., 50 Theodor Pallady Blvd., district 3, 032266 Bucharest, Romania

For more information about the medicine and its names in the Member States of the European Economic Area, the patient should contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o.o.
Bonifraterska 17 Street
00-203 Warsaw
tel.: +48 22 375 92 00
Date of last revision of the leaflet:February 2024