Sildenafil Aurovitas

Leaflet accompanying the packaging: information for the user

Sildenafil Aurovitas, 50 mg, film-coated tablets

Sildenafil Aurovitas, 100 mg, film-coated tablets

Sildenafil

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. The medicine works by supporting the relaxation of blood vessels in the penis, increasing blood flow to the penis during sexual stimulation. Sildenafil Aurovitas helps achieve an erection only if there is prior sexual stimulation.

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 concurrent use may lead to dangerous lowering of blood pressure. The patient should inform their doctor if they are taking any medicines from this group, which are often used to relieve symptoms of angina pectoris ("chest pain"). In case of doubt, consult a doctor or pharmacist.
• If the patient is taking medicines that release nitric oxide (such as amyl nitrite, so-called poppers), as their concurrent 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 blood clots blocking the pulmonary artery and/or its branches). It has been shown that PDE5 inhibitors, such as Sildenafil Aurovitas, enhance the hypotensive effect of this medicine. If the patient is taking riociguat or is unsure if they are taking it, they should tell their doctor.

If the patient has severe heart or liver disease.

• If the patient has recently had a stroke or heart attack, and in cases of low blood pressure.
• If the patient has hereditary degenerative retinal disorders, such as retinitis pigmentosa.
• If the patient has ever had a loss of vision due to non-inflammatory ischemic optic neuropathy (NAION).

Warnings and precautions

Before starting treatment with Sildenafil Aurovitas, the patient should discuss it with their doctor or pharmacist:

• if the patient has sickle cell anemia (a disorder affecting red blood cells), leukemia (a blood cancer), or multiple myeloma (a cancer of the bone marrow);
• if the patient has a penile deformity or Peyronie's disease;
• if the patient has heart problems. In this case, the doctor should assess whether the heart muscle condition allows for the additional effort associated with sexual activity;
• if the patient has stomach ulcers or bleeding disorders (such as hemophilia);
• if the patient experiences sudden vision loss or sudden loss of vision, they should stop taking the medicine and contact their doctor immediately.

Sildenafil Aurovitas should not be used concurrently with other oral or topical treatments for erectile dysfunction.

Sildenafil Aurovitas should not be used concurrently with treatments for pulmonary arterial hypertension (PAH) using sildenafil or other PDE5 inhibitors.

Sildenafil Aurovitas should not be used by patients who have not been diagnosed with erectile dysfunction.

Sildenafil Aurovitas is not intended for women.

Use of Sildenafil Aurovitas in patients with kidney or liver function disorders

Patients with kidney or liver function disorders should inform their doctor. The doctor may decide to administer a lower dose of the medicine.

Children and adolescents

The medicine should not be used in people under 18 years of age.

Sildenafil Aurovitas and other medicines

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

Medicines containing sacubitril with valsartan, used to treat heart failure.

Sildenafil Aurovitas may interact with some medicines, especially those used to treat chest pain. If the patient's condition worsens, they should inform their doctor or pharmacist about taking Sildenafil Aurovitas. The patient should not take Sildenafil Aurovitas concurrently with other medicines without their doctor's recommendation.

The patient should not use Sildenafil Aurovitas if they are taking nitrates, as their concurrent use may lead to dangerous lowering of blood pressure. The patient should always inform their doctor, pharmacist, or nurse if they are taking nitrates, which are used to treat angina pectoris ("chest pain").

The patient should not use Sildenafil Aurovitas if they are taking medicines that release nitric oxide (such as amyl nitrite, so-called poppers), as their concurrent use may also lead to dangerous lowering of blood pressure.

If the patient is already taking riociguat, they should tell their doctor or pharmacist.

In the case of taking protease inhibitors used to treat HIV infections, it is recommended to start treatment with the lowest dose (25 mg).

In some patients who are taking alpha-adrenergic blockers for high blood pressure or prostate enlargement, dizziness or lightheadedness may occur, which can be symptoms of orthostatic hypotension, characterized by a drop in blood pressure when standing up or sitting down quickly. Such symptoms occurred in some patients taking Sildenafil Aurovitas and alpha-adrenergic blockers concurrently. This is most likely to happen within 4 hours of taking Sildenafil Aurovitas. To reduce the risk of these symptoms, the patient should regularly take their fixed doses of alpha-adrenergic blockers before starting treatment with Sildenafil Aurovitas. The doctor may decide to use a lower initial dose (25 mg) of sildenafil.

Sildenafil Aurovitas with food, drink, and alcohol

Sildenafil Aurovitas can be taken with or without food.

Although taking Sildenafil Aurovitas while eating a large meal may prolong the time it takes for the medicine to start working.

The ability to achieve an erection may be temporarily impaired after consuming alcohol. To maximize the therapeutic effects of the medicine, the patient should not consume large amounts of alcohol before taking Sildenafil Aurovitas.

Pregnancy, breastfeeding, and fertility

Sildenafil Aurovitas is not intended for use by women.

Driving and using machines

Sildenafil Aurovitas may cause dizziness and vision disturbances. Patients should be aware of how they react to the medicine before driving or operating machinery.

Sildenafil Aurovitas contains lactose

Sildenafil Aurovitas, film-coated tablets, contain lactose monohydrate. If the doctor has informed the patient that they have an intolerance to some sugars, such as lactose, the patient should contact their doctor before taking the medicine.

Sildenafil Aurovitas contains sodium

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

3. How to take Sildenafil Aurovitas

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.

The recommended initial dose is 50 mg.

Sildenafil Aurovitas should not be taken more than once a day.

The patient should not take Sildenafil Aurovitas in the form of film-coated tablets in combination with another sildenafil in the form of orodispersible tablets.

Sildenafil Aurovitas should be taken about an hour before planned sexual activity. The tablet should be swallowed whole with a glass of water.

If the patient feels that the effect of Sildenafil Aurovitas is too strong or too weak, they should consult their doctor or pharmacist.

Sildenafil Aurovitas allows for an erection only if there is prior sexual stimulation. The time it takes for the medicine to start working varies from person to person, usually ranging from half an hour to one hour. The effect may occur later if the medicine is taken after a large meal.

The patient should contact their doctor if, after taking Sildenafil Aurovitas, they do not achieve an erection or if the duration of the erection is not sufficient for sexual intercourse.

Taking a higher dose of Sildenafil Aurovitas than recommended

In this case, the patient may experience more frequent side effects, and they may be more intense. Taking a dose higher than 100 mg does not increase the efficacy of the medicine.

The patient should not take more tablets than prescribed by their doctor.

The patient should contact their doctor if they have taken more tablets than recommended.

In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Sildenafil Aurovitas can cause side effects, although not everybody gets them.

Side effects reported in connection with the use of Sildenafil Aurovitas are usually mild or moderate and short-lived.

In case of any of the following side effects, the patient should stop taking Sildenafil Aurovitas and seek medical help immediately:

• An allergic reaction occurs uncommonly(may affect 1 in 100 people) Symptoms: sudden wheezing, difficulty breathing, or dizziness, swelling of the eyelids, face, lips, or throat.
• Chest pain - occurs uncommonlyIf it occurs during or after sexual intercourse:
• the patient should sit half-up and try to relax,
• not take nitratesto relieve chest pain.
• Prolonged and sometimes painful erections - occur rarely(may affect 1 in 1,000 people) If the erection lasts for more than 4 hours, the patient should contact their doctor immediately.
• Sudden vision loss or sudden loss of vision - occurs rarely.
• Severe skin reactions - occur rarely. Symptoms may include severe skin peeling and swelling, blistering in the mouth, on the genitals, and around the eyes, fever.
• Seizures or convulsions - occur rarely.

Other side effects:

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

• Headache.

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

• Nausea, sudden flushing, hot flashes (symptoms include a sudden feeling of heat in the upper body), indigestion, seeing a colored glow, blurred vision, visual disturbances, stuffy nose, dizziness.

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

• Vomiting, skin rash, eye irritation, conjunctivitis, eye pain, seeing flashes of light, temporary sensations of intense light, sensitivity to light, tearing, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, decreased sensitivity to touch, dizziness, ringing in the ears, dry mouth, feeling of nasal congestion or blocked sinuses, nasal inflammation (symptoms include runny nose, sneezing, and blocked nose), upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn), blood in the urine, pain in the arms or legs, nosebleeds, feeling of heat, and feeling of fatigue.

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

• Fainting, stroke, heart attack, irregular heartbeat, transient reduction of blood flow to parts of the brain, feeling of tightness in the throat, numbness of the lips, bleeding in the back of the eye, double vision, decreased sharpness of vision, abnormal sensations in the eye, swelling of the eye or eyelid, small particles or spots in the field of vision, seeing halos around light sources, dilation of the pupil, discoloration of the white of the eye, bleeding from the penis, blood in the semen, dry nose, swelling of the nasal passages, and irritability, as well as sudden hearing loss or loss of hearing.

After the introduction of sildenafil to the market, rare cases of unstable angina (heart disease) and sudden death have been reported. It is worth noting that in most, but not all, men who experienced these side effects, heart function disorders existed before taking the medicine. It is not possible to determine whether these side effects were related to the use of Sildenafil Aurovitas.

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 Monitoring of Adverse Reactions to Medicinal Products, 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

Side effects can also be reported to the marketing authorization holder.

5. How to store Sildenafil Aurovitas

The medicine should be stored out of sight and reach of children.

There are no special precautions for storing the medicine.

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Sildenafil Aurovitas contains

The active substance of the medicine is sildenafil.

Each tablet contains 50 mg of sildenafil (in the form of citrate).

Each tablet contains 100 mg of sildenafil (in the form of citrate).

Other ingredients are:

• Core: calcium hydrogen phosphate, microcrystalline cellulose (type-200), sodium carboxymethylcellulose, colloidal anhydrous silica, magnesium stearate.
• 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), convex, film-coated tablets with "SL" embossed on one side and "50" on the other.

Sildenafil Aurovitas, 100 mg, film-coated tablets

White or almost white, round (11.2 mm in diameter), convex, film-coated tablets with "SL" embossed on one side and "100" on the other.

Pack sizes:

Sildenafil Aurovitas film-coated tablets are available in transparent blisters made of PVC/PVDC/Aluminum, containing 4, 8, 12, 24, or 48 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.

ul. Sokratesa 13D lokal 27

01-909 Warsaw

e-mail: medicalinformation@aurovitas.pl

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 authorized 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

Date of last revision of the leaflet: 12/2022