Sildenafil zentiva

Patient Information Leaflet

Sildenafil Zentiva 20 mg film-coated tablets
Sildenafilum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them 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.

Leaflet Contents

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

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

When not to use Sildenafil Zentiva:

• 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. These medicines are used to treat chest pain (angina). Sildenafil Zentiva may enhance the effects of these medicines, so the patient should inform their 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 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 Zentiva 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 or 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 Sildenafil Zentiva, 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 blood pressure in the pulmonary blood vessels.
• Low blood pressure at rest.
• Significant fluid loss (dehydration), which may occur due to excessive sweating or insufficient fluid intake. This may also occur during fever, vomiting, or diarrhea.
• A rare inherited eye disorder called retinitis pigmentosa.
• Any red blood cell disorder (sickle cell anemia), blood cancer (leukemia), bone marrow cancer (multiple myeloma), or any penile disorder or anatomical deformity of the penis.
• Peptic ulcer disease, bleeding disorders (such as hemophilia), or frequent nosebleeds.
• Use of medicines for erectile dysfunction.

During treatment with phosphodiesterase type 5 inhibitors, including sildenafil, for erectile dysfunction, the following adverse effects related to visual disturbances have been reported with unknown frequency: partial, sudden, transient or permanent weakening or loss of vision in one or both eyes.
If sudden vision loss or visual impairment occurs, discontinue use of Sildenafil Zentiva immediately and 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, stop taking Sildenafil Zentiva and seek immediate medical attention (see also section 4).

Use of Sildenafil Zentiva in patients with kidney or liver disease
Inform your doctor if you have kidney or liver disease, as dose adjustment may be necessary.

Children
Sildenafil Zentiva must not be used in children under 1 year of age.

Sildenafil Zentiva 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 those that release nitric oxide, such as amyl nitrite (so-called "poppers"). These are used in the treatment of angina—chest pain (see section 2 "Important information before using Sildenafil Zentiva").
• Riociguat.
• Other concurrent treatments for pulmonary hypertension (e.g. bosentan, iloprost).
• Medicines containing St. John's wort (Hypericum perforatum)—an 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 been associated with adverse effects.
• Medicines containing erythromycin, clarithromycin, telithromycin (antibiotics used to treat bacterial infections), saquinavir (used in HIV treatment), or nefazodone (used in depression treatment), as dose adjustment may be required.
• α-Adrenergic blockers (e.g. doxazosin), used to treat high blood pressure or benign prostatic hyperplasia (BPH), because concomitant use may cause symptoms of low blood pressure (e.g. dizziness, lightheadedness).
• Medicines containing sacubitril with valsartan, used in the treatment of heart failure.

Taking Sildenafil Zentiva with food and drink
Do not consume grapefruit juice during treatment with Sildenafil Zentiva.

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. Sildenafil Zentiva may be used during pregnancy only if absolutely necessary.
Use of Sildenafil Zentiva is not recommended in women of childbearing potential unless they are using appropriate contraceptive methods.
Sildenafil passes into human milk in very small amounts, and is not expected to have adverse effects on breastfed infants.

Sildenafil Zentiva contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning it is considered "sodium-free".

Driving and operating machinery
Sildenafil Zentiva may cause dizziness and visual disturbances. The patient should assess their individual response to the medicine before driving or operating machinery.

3. How to use Sildenafil Zentiva

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your 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 aged 1 to 17 years, the recommended dose is 10 mg three times a day for those weighing ≤ 20 kg, or 20 mg three times a day 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 dose of 20 mg three times a day is required. For patients weighing ≤ 20 kg and other younger patients who cannot swallow tablets, other suitable pharmaceutical forms of the medicine are available.

If you take more Sildenafil Zentiva than you should
Do not take more than the recommended amount.
If you take more medicine than recommended, contact your doctor immediately. Taking more Sildenafil Zentiva than recommended may increase the risk of experiencing the side effects described.

If you forget to take Sildenafil Zentiva
If you miss a dose of Sildenafil Zentiva, take it as soon as possible and then continue taking the medicine according to your prescribed schedule. Do not take a double dose to make up for a missed dose.

If you stop taking Sildenafil Zentiva
Stopping Sildenafil Zentiva suddenly may lead to worsening of your clinical condition. Do not stop taking this medicine without your doctor’s advice. Your doctor may decide to gradually reduce the dose over several days before stopping treatment completely.

If you have any further questions about the use of this medicine, ask 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, stop taking Sildenafil Zentiva and contact a doctor immediately (see also section 2):

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

Adults
Very common adverse reactions (occurring in more than 1 in 10 patients):

• headache,
• sudden flushing of the face,
• diarrhoea, indigestion,
• pain in hands or legs.

Common adverse reactions (occurring in 1 in 10 patients):

• skin infections, flu-like symptoms, bronchitis, sinusitis, cold, gastritis and enteritis,
• 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, light sensitivity, colour vision disturbances, eye irritation, eye congestion (red eyes),
• dizziness,
• nosebleeds, cough, nasal congestion,
• heartburn, haemorrhoids, bloating, dry mouth,
• hair loss, skin redness, night sweats,
• muscle pain, back pain,
• increased body temperature.

Uncommon adverse reactions (occurring in 1 in 100 patients):

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

Adverse reactions that occurred with unknown frequency (frequency cannot be estimated from the available data):

• sudden worsening or loss of hearing,
• low blood pressure,
• skin rash.

Children and adolescents
The following serious adverse reactions have been reported as common (occurring 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 as uncommon (occurring in 1 in 100 patients) include:
• allergic reactions (such as skin rash, facial swelling, swelling of lips and tongue, dyspnoea, difficulty breathing or swallowing), seizures, irregular heartbeat, hearing disturbances, shortness of breath, gastrointestinal inflammation, wheezing due to obstructed airflow.

Very common adverse reactions (occurring in more than 1 in 10 patients) include:

• headache, vomiting, sore throat, fever, diarrhoea, influenza, and nosebleeds.

Common adverse reactions (occurring in 1 in 10 patients) include:

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

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

5. How to store Sildenafil Zentiva

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. The batch number is indicated on the packaging following the abbreviation "Lot".
No special storage conditions are required. Store in the original packaging to protect from moisture and light.
Medicines must not be disposed of via the sewage system or in household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Sildenafil Zentiva contains

• The active substance is sildenafil. Each tablet contains 20 mg of sildenafil (as citrate).
• Other ingredients are: calcium hydrogen phosphate (anhydrous), microcrystalline cellulose (type 102), sodium croscarmellose, magnesium stearate, coating: hypromellose 2910, microcrystalline cellulose, polyglycolysed 40 stearate 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 packed in blisters of 90 film-coated tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 further information about this medicinal product and its names in the Member States of the
European Economic Area, please contact the representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00