Patient Information Leaflet: Read this leaflet carefully before using the medicine, as it contains important information for you.

Sildenafil Aurovitas, 50 mg, film-coated tablets
Sildenafil Aurovitas, 100 mg, film-coated tablets
Sildenafilum
Read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet so that you can read it again if needed.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents:

What Sildenafil Aurovitas is and what it is used for
What you need to know before taking Sildenafil Aurovitas
How to take Sildenafil Aurovitas
Possible side effects
How to store Sildenafil Aurovitas
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. The medicine works by helping to relax blood vessels in the penis, increasing blood flow to the penis during sexual stimulation. Sildenafil Aurovitas helps achieve an erection only if sexual stimulation occurs beforehand.
Sildenafil Aurovitas is used to treat erectile dysfunction in adult men, also known as impotence. This condition occurs when a man cannot achieve or maintain a penile erection sufficient for sexual intercourse.

2. Important information before taking Sildenafil Aurovitas

When not to take Sildenafil Aurovitas:

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, as their concomitant use may lead to a dangerous drop in blood pressure. The patient should inform the doctor if they are taking any medicines from this group; these medicines are often used to relieve symptoms of angina (chest pain). If in doubt, consult a doctor or pharmacist.
If the patient is taking drugs that release nitric oxide (such as amyl nitrite, so-called "poppers"), because their simultaneous use may also cause dangerous lowering of blood pressure.
If the patient is taking riociguat. This medicine is 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 resulting from blockage of the pulmonary artery and/or its branches by blood clots). It has been shown that PDE5 inhibitors, such as Sildenafil Aurovitas, enhance the hypotensive effect of riociguat. If the patient is taking riociguat or is unsure whether they are taking it, they should inform their doctor.
If the patient has severe heart or liver disease.
If the patient has recently had a stroke or heart attack, or has low blood pressure.
If the patient has inherited degenerative retinal disorders, such as retinitis pigmentosa.
If the patient has ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Before starting treatment with Sildenafil Aurovitas, discuss the following with a doctor or pharmacist:

if the patient has sickle cell anemia (an abnormality affecting red blood cells), leukemia (a blood cancer), or multiple myeloma (a cancer of the bone marrow);
if the patient has anatomical deformity of the penis or Peyronie's disease;
if the patient has heart problems. In such cases, the doctor should assess whether the patient's cardiac condition allows for the additional strain associated with sexual activity;
if the patient has peptic ulcer disease or bleeding disorders (such as hemophilia);
if sudden vision deterioration or sudden vision loss occurs, the patient should stop taking the medicine immediately and contact a doctor without delay.

Sildenafil Aurovitas must not be used simultaneously with other oral or topical treatments for erectile dysfunction.
Sildenafil Aurovitas must not be used simultaneously with pulmonary arterial hypertension (PAH) therapies containing sildenafil or other PDE5 inhibitors.
Sildenafil Aurovitas should not be used by patients in whom erectile dysfunction has not been diagnosed.
Sildenafil Aurovitas is not intended for use in women.

Use of Sildenafil Aurovitas in patients with renal or hepatic impairment
Patients with impaired kidney or liver function should inform their doctor. The doctor may decide to prescribe a lower dose of the medicine.

Children and adolescents
This medicine must not be used in individuals under 18 years 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 sacubitril with valsartan, used in the treatment of heart failure.
Sildenafil Aurovitas may interact with certain medicines, especially those used to treat chest pain. If the patient's health deteriorates, inform the doctor or pharmacist that Sildenafil Aurovitas has been taken. Do not take Sildenafil Aurovitas with other medicines unless directed by a doctor.
Do not take Sildenafil Aurovitas if the patient is using nitrates, because their concomitant use may lead to a dangerous drop in blood pressure. Always inform the doctor, pharmacist, or nurse if the patient is taking nitrates, which are used to treat angina (chest pain).
Do not take Sildenafil Aurovitas if the patient is using drugs that release nitric oxide (such as amyl nitrite, so-called "poppers"), because their concomitant use may also lead to dangerous lowering of blood pressure.
If the patient is already taking riociguat, they should inform their doctor or pharmacist.
When taking protease inhibitors used in the treatment of HIV infection, it is recommended to start treatment with the lowest dose (25 mg).
Some patients taking α-adrenolytic agents for high blood pressure or benign prostatic hyperplasia may experience dizziness or lightheadedness, which may be symptoms of orthostatic hypotension (a drop in blood pressure upon standing up or sitting down quickly). Such symptoms have occurred in some patients taking Sildenafil Aurovitas together with α-adrenolytic agents. This is most likely within 4 hours after taking Sildenafil Aurovitas. To reduce the risk of these symptoms, the patient should be on a stable dose of their α-adrenolytic medicine before starting treatment with Sildenafil Aurovitas. The doctor may decide to use a lower starting dose (25 mg) of sildenafil.

Sildenafil Aurovitas with food, drink, and alcohol
Sildenafil Aurovitas can be taken with or without food. However, taking Sildenafil Aurovitas with a heavy meal may delay the onset of the medicine's effect.
The ability to achieve an erection may be temporarily impaired after alcohol consumption. To maximize the therapeutic effect of the medicine, significant amounts of alcohol should not be consumed before taking Sildenafil Aurovitas.

Pregnancy, breastfeeding, and fertility
Sildenafil Aurovitas is not intended for use in women.

Driving and operating machinery
Sildenafil Aurovitas may cause dizziness and visual disturbances. Patients should assess how they react to the medicine before driving or operating machinery.

Sildenafil Aurovitas contains lactose
Sildenafil Aurovitas, film-coated tablets, contain monohydrate lactose. If the doctor has informed the patient of an intolerance to certain sugars, such as lactose, the patient should consult their doctor before taking this medicine.

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

3. How to take Sildenafil Aurovitas

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The recommended starting dose is 50 mg.
Sildenafil Aurovitas must not be taken more than once a day.
Do not take Sildenafil Aurovitas tablets in combination with another sildenafil product in the form of orally disintegrating tablets.
Sildenafil Aurovitas should be taken approximately one hour before planned sexual activity. Swallow the tablet whole with a glass of water.
If you feel that the effect of Sildenafil Aurovitas is too strong or too weak, consult your doctor or pharmacist.
Sildenafil Aurovitas enables an erection only in the presence of sexual stimulation. The time to onset of effect varies between patients, usually ranging from half an hour to one hour. The effect may occur later if the medicine is taken after a heavy meal.
Contact your doctor if, after taking Sildenafil Aurovitas, an erection does not occur or if the duration of erection is insufficient for sexual intercourse.
Taking a higher than recommended dose of Sildenafil Aurovitas
Unwanted effects may occur more frequently and may be more severe. Taking a dose higher than 100 mg does not increase the effectiveness of the medicine.
Do not take more tablets than prescribed by your doctor.
Contact your doctor if you have taken more tablets than recommended.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions reported with the use of Sildenafil Aurovitas are usually mild or moderate and transient.
If any of the following adverse reactions occur, stop taking Sildenafil Aurovitas and seek immediate medical help:

Allergic reaction – uncommon (may affect up to 1 in 100 people). Symptoms: sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat.
Chest pain – uncommon. If it occurs during or after sexual intercourse:
- adopt a semi-sitting position and try to relax,
- do not take nitrates to relieve chest pain.
Prolonged and sometimes painful erections – rare (may affect up to 1 in 1,000 people). If an erection lasts longer than 4 hours, contact a doctor immediately.
Sudden worsening or loss of vision – rare.
Severe skin reactions – rare. Symptoms may include severe peeling and swelling of the skin, blistering in the mouth, on the genitals and around the eyes, fever.
Seizures or convulsions – rare.

Other adverse reactions:
Very common (may affect more than 1 in 10 people):

Headache.

Common (may affect up to 1 in 10 people):

Nausea, sudden flushing of the face, hot flushes (symptoms include sudden feeling of warmth in the upper body), indigestion, coloured vision, blurred vision, visual disturbances, stuffy nose, dizziness.

Uncommon (may affect up to 1 in 100 people):

Vomiting, skin rash, eye irritation, eye redness, eye pain, seeing flashes of light, transient sensations of bright light, light sensitivity, tearing of the eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sense of touch, dizziness, ringing in the ears, dry mouth, sensation of blockage or stuffy sinuses, inflammation of the nasal mucosa (symptoms include runny nose, sneezing and blocked nose), upper abdominal pain, gastroesophageal reflux (symptoms include heartburn), presence of blood in urine, pain in arms or legs, nosebleeds, feeling of warmth, and feeling of fatigue.

Rare (may affect up to 1 in 1,000 people):

Fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow through certain parts of the brain, sensation of tightness in the throat, numbness of the lips, bleeding into the back of the eye, double vision, reduced visual acuity, abnormal sensations in the eye, swelling of the eye or eyelid, small particles or spots in the visual field, seeing halos around light sources, pupil dilation, discoloration of the sclera, bleeding from the penis, presence of blood in semen, dry nose, swelling inside the nose, irritability, and sudden hearing decrease or hearing loss.

Since sildenafil has been marketed, rare cases of unstable angina (heart disease) and sudden death have been reported. It should be noted that in most, but not all, men who experienced these adverse reactions, cardiac disorders were present before taking this medicine. It is not possible to determine whether these adverse reactions were related to the use of Sildenafil Aurovitas.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, tell your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration 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
Adverse reactions can also be reported to the marketing authorization holder.

5. How to store Sildenafil Aurovitas

Keep this medicine out of the sight and reach of children.
No special storage conditions are required for this medicine.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Sildenafil Aurovitas contains
The active substance is sildenafil.
Each tablet contains 50 mg of sildenafil (as citrate).
Each tablet contains 100 mg of sildenafil (as citrate).
The other ingredients are:

Tablet core: calcium hydrogen phosphate, microcrystalline cellulose (type-200), sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.
Tablet coating: lactose monohydrate, hypromellose (15 cp), titanium dioxide (E 171), triacetin.

What Sildenafil Aurovitas looks like and contents of the pack
Film-coated tablets
Sildenafil Aurovitas 50 mg, film-coated tablets
White or almost white, round (9.6 mm in diameter), biconvex film-coated tablets, embossed with "SL" on one side and "50" on the other side.
Sildenafil Aurovitas 100 mg, film-coated tablets
White or almost white, round (11.2 mm in diameter), biconvex film-coated tablets, embossed with "SL" on one side and "100" on the other side.
Pack sizes:
Sildenafil Aurovitas film-coated tablets are available in transparent PVC/PVDC/Aluminium blister packs containing 4, 8, 12, 24 or 48 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D, lok. 27
01-909 Warsaw
e-mail: [email protected]
Manufacturer/Importer:
APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Belgium: Sildenafil AB 25mg/50 mg/100 mg filmomhulde tabletten/comprimés pelliculés/Filmtabletten
Poland: Sildenafil Aurovitas
Portugal: Sildenafil Labesfal