Sildenafil Sanexcel

Leaflet attached to the packaging: patient information

Sildenafil SaneXcel, 100 mg, film-coated tablets

Sildenafil

You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should 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 you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Sildenafil SaneXcel and what is it used for
• 2. Important information before taking Sildenafil SaneXcel
• 3. How to take Sildenafil SaneXcel
• 4. Possible side effects
• 5. How to store Sildenafil SaneXcel
• 6. Contents of the pack and other information

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

Sildenafil SaneXcel 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 the blood vessels in the penis, increasing blood flow to the penis during sexual stimulation. Sildenafil SaneXcel helps to achieve an erection only if there is prior sexual stimulation.

Sildenafil SaneXcel is used to treat erectile dysfunction in adult men, which is defined as the inability to achieve or maintain an erection sufficient for sexual intercourse.

2. Important information before taking Sildenafil SaneXcel

When not to take Sildenafil SaneXcel:

• If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
• If you are taking nitrates, as their simultaneous intake may lead to a dangerous decrease in blood pressure. You should inform your doctor if you are taking any medicines from this group - these medicines are often used to relieve symptoms of angina pectoris ("chest pain"). In case of doubt, consult your doctor or pharmacist.
• If you are taking medicines that release nitric oxide (such as amyl nitrite, so-called poppers), as their simultaneous intake may also lead to a dangerous decrease in blood pressure.
• If you are taking riociguat. This is a medicine 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 SaneXcel, enhance the blood pressure-lowering effect of this medicine. If you are taking riociguat or are unsure, you should inform your doctor.

In severe heart or liver disease.

• Recently suffered a stroke or heart attack, as well as in cases of low blood pressure.
• Hereditary degenerative changes in the retina, such as retinitis pigmentosa.
• If you have ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Before starting to take Sildenafil SaneXcel, you should discuss it with your doctor, pharmacist, or nurse if:

• You have sickle cell anemia (a disorder affecting red blood cells), leukemia (a blood cancer), or multiple myeloma (a bone marrow cancer).
• You have anatomical deformation of the penis or Peyronie's disease.
• You have heart problems. In this case, your doctor should assess whether your heart condition allows for the additional strain associated with sexual activity.
• You have ulcers or bleeding disorders (such as hemophilia).
• If you experience sudden vision loss or sudden loss of vision, you should stop taking Sildenafil SaneXcel and contact your doctor immediately.

Sildenafil SaneXcel should not be taken simultaneously with other oral or topical treatments for erectile dysfunction.

Sildenafil SaneXcel should not be taken simultaneously with treatments for pulmonary arterial hypertension (PAH) using sildenafil or other PDE5 inhibitors.

Sildenafil SaneXcel should not be taken if you have not been diagnosed with erectile dysfunction.

Sildenafil SaneXcel is not intended for women.

Special considerations for patients with kidney or liver function disorders

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

Children and adolescents

The medicine should not be taken by persons under 18 years of age.

Sildenafil SaneXcel and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about medicines you plan to take.

Sildenafil SaneXcel may interact with some medicines, especially those used to treat chest pain. If your condition worsens and you need immediate medical attention, you should inform your doctor, pharmacist, or nurse about taking Sildenafil SaneXcel and the time of its intake. You should not take Sildenafil SaneXcel with other medicines without your doctor's advice.

You should not take Sildenafil SaneXcel if you are taking nitrate medicines, as their simultaneous use may lead to a dangerous decrease in blood pressure.

You should always inform your doctor, pharmacist, or nurse if you are taking nitrates, which are used to treat angina pectoris ("chest pain").

You should not take Sildenafil SaneXcel if you are taking medicines that release nitric oxide (such as amyl nitrite, so-called poppers), as their simultaneous use may also cause a dangerous decrease in blood pressure.

If you are already taking riociguat, you should inform your doctor or pharmacist.

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

In some patients taking alpha-adrenergic blockers for high blood pressure or prostate enlargement, dizziness or lightheadedness may occur, which can be symptoms of low blood pressure caused by a drop in blood pressure when standing up or sitting quickly.

Such symptoms have occurred in some patients taking sildenafil and alpha-adrenergic blockers. Their occurrence is most likely within 4 hours of taking Sildenafil SaneXcel. To reduce the possibility of these symptoms, the patient should regularly take their fixed dose of alpha-adrenergic blocker before starting to take Sildenafil SaneXcel. The doctor may decide to use a lower initial dose (25 mg) of sildenafil.

You should tell your doctor or pharmacist if you are taking medicines containing sacubitril with valsartan, used to treat heart failure.

Sildenafil SaneXcel with food, drink, and alcohol

Sildenafil SaneXcel can be taken with or without food.

Although taking Sildenafil SaneXcel during a large meal may prolong the time needed 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 Sildenafil SaneXcel, you should not consume large amounts of alcohol before taking the medicine.

Pregnancy, breastfeeding, and fertility

Sildenafil SaneXcel is not intended for use by women.

Driving and using machines

Sildenafil SaneXcel may cause dizziness and vision disturbances. Patients should find out how they react to Sildenafil SaneXcel before driving or operating machinery.

Sildenafil SaneXcel contains sodium

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

3. How to take Sildenafil SaneXcel

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist. The recommended starting dose is 50 mg.

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

You should not take Sildenafil SaneXcel with other medicines containing sildenafil.

Sildenafil SaneXcel should be taken about an hour before planned sexual activity.

The tablet should be swallowed whole with a glass of water.

If you feel that the effect of Sildenafil SaneXcel is too strong or too weak, you should consult your doctor or pharmacist.

Sildenafil SaneXcel allows for an erection only if there is prior sexual stimulation.

The time it takes for Sildenafil SaneXcel to work varies from person to person, usually between half an hour to one hour. The effect may occur later if the medicine is taken after a large meal.

You should contact your doctor if, after taking Sildenafil SaneXcel, you do not achieve an erection or if the duration of the erection is not sufficient for sexual intercourse.

Taking a higher dose of Sildenafil SaneXcel than recommended:

The patient may experience more frequent side effects, and they may be more severe. Taking a dose higher than 100 mg does not mean an increase in the effectiveness of the medicine.

You should not take more tablets than prescribed by your doctor.

You should contact your doctor if you have taken more tablets than prescribed.

If you have any further doubts about the use of this medicine, you should consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

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

If you experience any of the following side effects, you should stop taking Sildenafil SaneXcel and seek medical attention immediately:

• An allergic reaction - occurs uncommonly(may occur in 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:
• you should sit half-up and try to relax,
• do not take nitratesto relieve chest pain.
• Prolonged and sometimes painful erections - occur rarely(may occur in 1 in 1,000 people). If an erection lasts for more than 4 hours, you should contact your doctor immediately.
• Sudden vision loss or sudden loss of vision - occur rarely
• Severe skin reactions - occur rarelySymptoms may include severe peeling and swelling of the skin, blistering in the mouth, on the genitals, and around the eyes, fever.
• Seizures or convulsions - occur rarely

Other side effects:

Very common(may occur in more than 1 in 10 people): headache.

Common(may occur in 1 in 10 people): nausea, sudden flushing, hot flashes (symptoms include a feeling of heat in the upper part of the body), indigestion, seeing a blue tinge, blurred vision, disturbances in vision, stuffy nose, dizziness.

Uncommon(may occur in 1 in 100 people): vomiting, skin rash, eye irritation, conjunctivitis, eye pain, seeing flashes of light, increased sensitivity to light, tearing, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, somnolence, decreased sensation, dizziness, ringing in the ears, dry mouth, blocked or stuffy sinuses, inflammation of the nasal mucosa (symptoms include runny nose, sneezing, and stuffy nose), stomach pain, gastroesophageal reflux disease (symptoms include heartburn), blood in urine, pain in arms or legs, nosebleeds, feeling hot and feeling tired.

Rare(may occur in 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to part of the brain, feeling of constriction 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 eyes or eyelids, small particles or spots in the field of vision, seeing halos around light sources, dilated pupils, abnormal discoloration of the white of the eye, bleeding from the penis, presence of blood in semen, dry nose, swelling inside the nose, feeling irritable, and sudden loss of hearing.

After the medicine was placed on the market, rare cases of unstable angina (heart disease) and sudden death have been reported. It is important that most, but not all, men who experienced these side effects had pre-existing heart disease before taking this medicine. It is not possible to determine whether these side effects were related to the use of sildenafil.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sildenafil SaneXcel

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

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month stated.

There are no special precautions for storing the medicine.

Medicines should not be disposed of via wastewater or household waste. You should ask your 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 SaneXcel contains

• The active substance of the medicine is sildenafil. Each film-coated tablet contains 100 mg of sildenafil (as citrate).
• The other ingredients are: Tablet core: microcrystalline cellulose, calcium phosphate anhydrous, sodium croscarmellose, magnesium stearate. Tablet coating (Opadry II, 85F20464 Blue): polyvinyl alcohol, macrogol 3350, titanium dioxide (E 171), talc, indigo carmine, aluminum lake (E 132).

What Sildenafil SaneXcel looks like and contents of the pack

Sildenafil SaneXcel 100 mg film-coated tablets are elliptical, blue, film-coated tablets with a "+" sign embossed on one side, with a length of 16.2 mm ± 0.2 mm, width of 8.2 mm ± 0.2 mm, and thickness of 5.7 mm ± 0.2 mm, available in blisters containing 4, 8, or 16 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

J.J. Bishop Health a.s.

Rybná 682/14, Staré Město

110 00 Prague 1

Czech Republic

e-mail: pharmacovigilance@jjbishop.eu

Manufacturer:

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua de Tapada Grande 2, Abrunheira

2710-228 Sintra

Portugal

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

Bulgaria:

Силденафил SaneXcel 100 mg филмирани таблетки

Czech Republic:

Sildenafil SaneXcel

Poland:

Sildenafil SaneXcel

Portugal:

Sildenafil SaneXcel

Romania:

Sildenafila SaneXcel

Slovakia:

Sildenafil SaneXcel

Date of last revision of the leaflet: