Sildenafil aurovitas

Package leaflet: Information for the user

Sildenafil Aurovitas, 20 mg, film-coated tablets
Sildenafilum
Read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

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

When not to use Sildenafil Aurovitas:

• If the patient has a known allergy to sildenafil or any of the other ingredients of this medicine (listed in section 6).
• If the patient is taking nitrates or nitric oxide-releasing drugs, such as amyl nitrite. These medicines are used to treat chest pain (angina). Sildenafil Aurovitas may enhance the effects of these drugs; therefore, 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 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 Aurovitas have been shown to enhance the blood pressure-lowering effect of riociguat. 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 the treatment of HIV).
• 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 Aurovitas, discuss this with your doctor.
Inform your doctor about:

• A condition more likely related to blockage or narrowing of a vein in the lungs rather than a blockage or narrowing of an artery.
• Severe heart disease.
• Disorders affecting blood flow through the heart chambers.
• Increased blood pressure in the blood vessels of the lungs.
• 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 – retinitis pigmentosa.
• A red blood cell disorder (sickle cell anemia), a blood cancer (leukemia), a 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 medications for erectile dysfunction.

During treatment with phosphodiesterase type 5 inhibitors, including sildenafil, for erectile dysfunction, the following adverse effects related to vision 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 blurred vision occurs, stop taking Sildenafil Aurovitas immediately and consult a doctor without delay (see also section 4).
In men taking sildenafil, prolonged and sometimes painful erections have been observed. If an erection lasts longer than 4 hours, stop taking Sildenafil Aurovitas immediately and consult a doctor without delay (see also section 4).

Use of Sildenafil Aurovitas 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 Aurovitas must not be used in children under 1 year of age.

Sildenafil Aurovitas 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 nitric oxide-releasing drugs, such as amyl nitrite ("poppers"). These medicines are used to treat angina or chest pain (see section 2 "Important information before using Sildenafil Aurovitas").
• 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).
• Anticoagulant medicines (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 to treat depression), as dose adjustment may be necessary.
• Alpha-blockers (e.g. doxazosin), used to treat high blood pressure or benign prostatic hyperplasia, because concomitant use may cause symptoms of low blood pressure (e.g. dizziness, feeling of emptiness in the head).
• Medicines containing sacubitril/valsartan, used in the treatment of heart failure.

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

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Sildenafil Aurovitas may be used during pregnancy only if absolutely necessary.
Use of Sildenafil Aurovitas is not recommended in women of childbearing potential unless they are using effective contraception methods.
Sildenafil Aurovitas passes into human milk in very small amounts, and a negative effect on breastfed infants is not expected.

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

Sildenafil Aurovitas contains lactose
Sildenafil Aurovitas contains monohydrate lactose. Patients previously diagnosed with intolerance to certain sugars should consult their doctor before using Sildenafil Aurovitas.

Sildenafil Aurovitas contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Sildenafil Aurovitas

This medicine should always be used exactly as directed by your doctor. 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 those weighing ≤ 20 kg, or 20 mg three times daily 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
the dose of 20 mg three times daily is required. For patients weighing ≤ 20 kg and other younger
patients who cannot swallow tablets, other suitable pharmaceutical forms of the medicine are
available.
Taking more Sildenafil Aurovitas than recommended
Do not take more than the recommended amount of this medicine.
If you take more than the recommended dose, contact your doctor immediately. Taking more than
the recommended dose of Sildenafil Aurovitas may increase the risk of experiencing the adverse
reactions described.
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 according to the prescribed schedule. Do not take a double dose to make up for the missed
dose.
Stopping Sildenafil Aurovitas
Stopping Sildenafil Aurovitas suddenly may lead to worsening of the clinical condition. Do not stop
taking this medicine without your doctor's advice. Your doctor may decide to reduce the dose over
several days before stopping treatment.
If you have any further questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the following adverse effects occur, stop taking Sildenafil Aurovitas and contact a doctor immediately (see also section 2):

• in case of sudden vision loss or vision impairment (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 (affecting more than 1 in 10 patients): headache, sudden facial flushing, indigestion, diarrhoea, and pain in arms or legs.
Common adverse effects (reported in 1 in 10 patients) include: subcutaneous infections, flu-like symptoms, sinusitis, reduced number of red blood cells (anaemia), fluid retention, difficulty falling asleep, 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, bronchitis, nosebleeds, nasal discharge, cough, nasal congestion, gastric mucosal inflammation, gastritis and enteritis, heartburn, haemorrhoids, bloating, dry mouth, hair loss, skin redness, night sweats, muscle pain, back pain, and increased body temperature.
Adverse effects reported less commonly (observed in 1 in 100 patients): 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 low blood pressure have also been reported, with frequency unknown (frequency cannot be estimated from available data).

Children and adolescents
The following serious adverse effects were reported commonly (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 dental caries.
Serious adverse effects considered related to treatment and reported less commonly (observed in 1 in 100 patients) include: allergic reactions (such as skin rash, facial swelling, swelling of lips and tongue, shortness of breath, difficulty breathing or swallowing), seizures, irregular heartbeat, hearing disturbances, shortness of breath, gastrointestinal inflammation, and wheezing due to obstructed airflow.
Very common adverse effects (occurring in more than 1 in 10 patients) include: headache, vomiting, throat infections, fever, diarrhoea, influenza, and nosebleeds.
Common adverse effects (observed in 1 in 10 patients) include: nausea, increased frequency of erections, pneumonia, and nasal discharge.

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

5. How to store Sildenafil Aurovitas

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the cardboard
package after: expiry (EXP). The expiry date refers to the last day of the stated month.
There are no special storage requirements for this medicinal product.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. Doing so helps protect
the environment.

6. Contents of the pack and other information

What Sildenafil Aurovitas contains

• The active substance is sildenafil. Each coated tablet contains 20 mg of sildenafil (as sildenafil citrate).
• The other ingredients are:
  Tablet core: calcium hydrogen phosphate, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.
  Tablet coating: lactose monohydrate, hypromellose 15 cP, titanium dioxide (E171), triacetin.

What Sildenafil Aurovitas looks like and contents of the pack
White, round, biconvex, film-coated tablets with a diameter of 6.6 mm, embossed with the number "20" on one side and smooth on the other.
Sildenafil Aurovitas film-coated tablets are available in blister packs of 28, 30, 90 and 300 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, lokal 27
01-909 Warsaw
Poland

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 medicinal product is authorised in the European Economic Area under the following names:
Belgium: Sildenafil AB 20 mg filmomhulde tabletten
Czech Republic: Sildenafil Aurovitas
France: SILDENAFIL QUIVER 20 mg, comprimé pelliculé
Germany: Sildenafil PUREN PAH 20 mg Filmtabletten
Italy: Sildenafil Aurobindo Italia
Netherlands: Sildenafil Aurobindo 20 mg, filmomhulde tabletten
Poland: Sildenafil Aurovitas
Portugal: Sildenafil Aurovitas
Spain: Sildenafilo Aurovit 20 mg comprimidos recubiertos con película EFG