Sildenafil Aurovitas

Leaflet attached to the packaging: information for the user

Sildenafil Aurovitas, 20 mg, film-coated tablets

Sildenafil um

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

• Keep this leaflet, you may need to read it again.
• In case of 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 Aurovitas and what is it used for
• 2. Important information before taking Sildenafil Aurovitas
• 3. How to take Sildenafil Aurovitas
• 4. Possible side effects
• 5. How to store Sildenafil Aurovitas
• 6. Contents of the pack and other information

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

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

2. Important information before taking Sildenafil Aurovitas

When not to take Sildenafil Aurovitas:

• If the patient has been diagnosed with an allergy to sildenafil or any other component 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 Aurovitas may enhance the effects of these medicines, and therefore, the patient should inform their doctor about taking them. In case of doubts, 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 Aurovitas, 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 disturbed blood flow to the optic nerve, known as non-arteritic anterior ischemic optic neuropathy.

Warnings and precautions

Before starting to take Sildenafil Aurovitas, discuss it with your doctor.
Inform them 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 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 vision loss or decreased vision in one or both eyes.
In case of unexpected vision loss or decreased vision, stop taking Sildenafil Aurovitas 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 Sildenafil Aurovitas 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

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

Sildenafil Aurovitas 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 "Important information before taking Sildenafil Aurovitas").
• 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 (a medicine used to treat bacterial infections), 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 used to treat bacterial infections), 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/valsartan, used to treat heart failure.

Taking Sildenafil Aurovitas with food and drink

While taking Sildenafil Aurovitas, do not drink grapefruit juice.

Pregnancy, breastfeeding, and fertility

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.
Sildenafil Aurovitas may only be taken during pregnancy if it is absolutely necessary.
It is not recommended to take Sildenafil Aurovitas in women of childbearing age unless they use appropriate contraceptive methods.
Sildenafil Aurovitas passes into breast milk in very small amounts and is not expected to harm the baby.

Driving and using machines

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

Sildenafil Aurovitas contains lactose

Sildenafil Aurovitas contains lactose monohydrate. If you have been told that you have an intolerance to some sugars, contact your doctor before taking Sildenafil Aurovitas.

Sildenafil Aurovitas contains sodium

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

3. How to take Sildenafil Aurovitas

Always take this medicine exactly as your doctor has told you. If you are not sure, 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 Sildenafil Aurovitas in children and adolescents

For children and adolescents from 1 year to 17 years old, the recommended dose is 10 mg three times a day for children and adolescents with a body weight ≤ 20 kg or 20 mg three times a day for children and adolescents with a body weight > 20 kg, taken with or without food. Do not take higher doses in children. This medicine should only be taken when the dose is 20 mg three times a day. For patients with a body weight ≤ 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 Aurovitas than recommended

Do not take more than the recommended dose of the medicine.
If you have taken more than the recommended dose of the medicine, contact your doctor immediately. Taking a higher dose of Sildenafil Aurovitas than recommended may increase the risk of side effects.

Missing a dose of Sildenafil Aurovitas

If you miss a dose of Sildenafil Aurovitas, take it as soon as possible and continue taking the medicine as scheduled. Do not take a double dose to make up for the missed dose.

Stopping Sildenafil Aurovitas

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

4. Possible side effects

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

• unexpected vision loss or decreased vision (frequency not known),
• erection lasting longer than 4 hours. In men taking sildenafil, prolonged and sometimes painful erections have been observed (frequency not known).

Adults
Very common (more than 1 in 10 patients) side effects include: headache, sudden reddening of the face, nausea, diarrhea, and pain in the arms or legs.
Commonly reported (observed in 1 in 10 patients) side effects include:subcutaneous 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, conjunctival congestion (red eyes), dizziness, bronchitis, nosebleeds, runny nose, cough, stuffy nose, gastritis, gastrointestinal inflammation, heartburn, hemorrhoids, bloating, dry mouth, hair loss, skin reddening, night sweats, muscle pain, back pain, and increased body temperature.

Side effects reported not very often (observed in 1 in 100 patients) include:

decreased visual acuity, double vision, abnormal eye sensations, penile bleeding, blood in semen and/or urine, and breast enlargement in men.
Also reported were skin rash and sudden hearing loss, as well as decreased blood pressure, which occurred with an unknown frequency (frequency cannot be estimated from the available data).

Children and adolescents

The following serious side effects were reported very often (observed in 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 not very often (observed in 1 in 100 patients) included: allergic reactions (such as skin rash, face, lip, and tongue swelling, shortness of breath, difficulty breathing or swallowing), seizures, irregular heart rhythm, hearing disturbances, shortness of breath due to disturbed air flow.

Very common side effects (observed more than 1 in 10 patients) include:

headache, vomiting, throat infections, fever, diarrhea, flu, and nosebleeds.
Common side effects (observed in 1 in 10 patients) include:nausea, increased frequency of erections, pneumonia, and runny nose.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Sildenafil Aurovitas

Keep the medicine out of the sight and reach of children.
Do not take the medicine after the expiry date stated on the blister and carton after: expiry date (EXP). The expiry date refers to the last day of the month.
There are no special precautions for storage of the medicinal product.
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 Sildenafil Aurovitas contains

• The active substance is sildenafil. Each film-coated tablet contains 20 mg of sildenafil (as sildenafil citrate).
• The other ingredients are: Tablet core: calcium hydrogen phosphate, microcrystalline cellulose, sodium croscarmellose, silicon dioxide, and magnesium stearate.

Tablet coating: lactose monohydrate, hypromellose 15cP, titanium dioxide (E171), and triacetin.

What Sildenafil Aurovitas looks like and contents of the pack

White, round, biconvex, film-coated tablets with a diameter of 6.6 mm, engraved with "20" on one side and smooth on the other.
Sildenafil Aurovitas film-coated tablets are available in blisters in pack sizes containing 28, 30, 90, and 300 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw

Manufacturer:

APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
BBG 3000 Birzebbugia
Malta
Arrow Génériques,
26 avenue Tony Garnier
69007 Lyon
France

This medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium:
Sildenafil AB 20 mg film-coated tablets
Czech Republic:
Sildenafil Aurovitas
France:
SILDENAFIL QUIVER 20 mg, film-coated tablet
Germany:
Sildenafil PUREN PAH 20 mg film-coated tablets
Italy:
Sildenafil Aurobindo Italia
Netherlands:
Sildenafil Aurobindo 20 mg, film-coated tablets
Poland:
Sildenafil Aurovitas
Portugal:
Sildenafil Aurovitas
Spain:
Sildenafilo Aurovit 20 mg film-coated tablets

Date of last revision of the leaflet: 10/2022