Sildenafil sanexcel

Package leaflet: Information for the patient

Sildenafil SaneXcel, 100 mg, film-coated tablets
Sildenafilum
Please read the entire leaflet carefully before taking this medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please 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 you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

1. What Sildenafil SaneXcel is and what it is 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 Sildenafil SaneXcel is and what it is 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 blood vessels in the penis, thereby increasing blood flow into the penis during sexual stimulation. Sildenafil SaneXcel helps achieve an erection only if the patient is sexually stimulated.
Sildenafil SaneXcel is used to treat erectile dysfunction in adult men, i.e. impotence defined as the inability to obtain or maintain a penile erection sufficient for sexual intercourse.

2. Important information before using Sildenafil SaneXcel

When not to use Sildenafil SaneXcel:

• 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 decrease 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 concomitant use may also lead to a dangerous decrease in blood pressure.

• If the patient is taking riociguat. This is a medicine 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 caused by blood clots). PDE5 inhibitors, such as Sildenafil SaneXcel, have been shown to enhance the blood pressure-lowering effect of this medicine. If the patient is taking riociguat or is unsure, they should inform their doctor.

• Severe heart or liver disease.

• Recent stroke or heart attack, and in cases of low blood pressure.

• Hereditary 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 SaneXcel, discuss with a doctor, pharmacist, or nurse if:

• The patient has sickle cell anemia (an abnormality of red blood cells), leukemia (a blood cancer), or multiple myeloma (a cancer of the bone marrow).
• The patient has been diagnosed with penile anatomical deformity or Peyronie's disease.
• The patient has heart-related conditions. In such cases, the doctor should assess whether the heart condition allows for the additional physical strain associated with sexual activity.
• The patient has peptic ulcers or bleeding disorders (such as hemophilia).
• If sudden vision loss or sudden decrease in vision occurs, the patient should stop taking Sildenafil SaneXcel and contact a doctor immediately.

Sildenafil SaneXcel should not be used concomitantly with other oral or topical treatments for erectile dysfunction.
Sildenafil SaneXcel should not be used together with pulmonary arterial hypertension (PAH) therapies containing sildenafil or other PDE5 inhibitors.
Sildenafil SaneXcel should not be taken if erectile dysfunction has not been diagnosed.
Sildenafil SaneXcel is not a medicine intended for use in women.

Special considerations for patients with kidney or liver 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 should not be used in individuals under 18 years of age.

Sildenafil SaneXcel and other medicines
Tell your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use.
Sildenafil SaneXcel may interact with certain medicines, especially those used to treat chest pain. In case of worsening health requiring immediate medical attention, inform the doctor, pharmacist, or nurse about taking Sildenafil SaneXcel and the time it was taken. Do not take Sildenafil SaneXcel with other medicines without medical advice.
Do not take Sildenafil SaneXcel if the patient is using nitrates, as 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 used to treat angina (chest pain).
Do not take Sildenafil SaneXcel if the patient is using drugs that release nitric oxide (such as amyl nitrite, so-called poppers), because their concomitant use may also cause a dangerous drop in blood pressure.
If the patient is already taking riociguat, inform the doctor or pharmacist.
For patients taking protease inhibitors used in the treatment of HIV infection, initiation of treatment with a lower dose (25 mg) of sildenafil is recommended.
Some patients taking alpha-blockers for high blood pressure or benign prostatic hyperplasia may experience dizziness or lightheadedness, which may be symptoms of low blood pressure caused by a drop in blood pressure upon rapid standing or sitting. Such symptoms have occurred in some patients taking sildenafil together with alpha-blockers. These are most likely to occur within 4 hours after taking Sildenafil SaneXcel. To reduce the risk of such symptoms, the patient should be on a stable dose regimen of their alpha-blocker before starting Sildenafil SaneXcel. The doctor may decide to initiate treatment with a lower starting dose (25 mg) of sildenafil.
Inform the doctor or pharmacist if the patient is taking medicines containing sacubitril and valsartan, used in the treatment of heart failure.

Sildenafil SaneXcel with food, drink, and alcohol
Sildenafil SaneXcel can be taken with or without food. However, taking Sildenafil SaneXcel 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 Sildenafil SaneXcel, significant amounts of alcohol should not be consumed before taking the medicine.

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

Driving and operating machinery
Sildenafil SaneXcel may cause dizziness and visual disturbances. Patients should understand how they react to Sildenafil SaneXcel before driving or operating machinery.

Sodium content of Sildenafil SaneXcel
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 SaneXcel

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 SaneXcel must not be taken more than once a day.
Do not take Sildenafil SaneXcel together with other medicines containing sildenafil.
Sildenafil SaneXcel should be taken approximately one 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, consult your
doctor or pharmacist.
Sildenafil SaneXcel enables an erection only in the presence of sexual stimulation.
The time it takes for Sildenafil SaneXcel to take 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 SaneXcel, an erection does not occur or
if the duration of erection is insufficient for sexual intercourse.
Taking a higher than recommended dose of Sildenafil SaneXcel:
Adverse effects may occur more frequently and be more severe. Taking a dose higher than 100 mg
does not result in increased 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, pharmacist, or nurse.

4. Possible adverse effects

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

• 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 uncommonly. 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 – occurs rarely (may occur in 1 in 1,000 people). If an erection lasts longer than 4 hours, contact a doctor immediately.
• Sudden worsening or loss of vision – occurs rarely
• Serious skin reactions – occurs rarely. Symptoms may include severe peeling and swelling of the skin, blistering in the mouth, genital area and around the eyes, fever.
• Seizures or fits – occurs rarely

Other adverse effects:
Very common (may affect more than 1 in 10 people): headache.
Common (may affect 1 in 10 people): nausea, sudden flushing of the face, hot flushes (symptoms include feeling of warmth in the upper body), indigestion, vision with coloured tinge, blurred vision, visual disturbances, stuffy nose, dizziness.
Uncommon (may affect 1 in 100 people): vomiting, skin rash, eye irritation, eye redness, eye pain, seeing flashes of light, bright vision, light sensitivity, tearing of the eyes, palpitations, rapid heartbeat, hypertension, hypotension, muscle pain, drowsiness, reduced sense of touch, dizziness, ringing in the ears, dry mouth, blocked or stuffy sinuses, nasal mucositis (symptoms include runny nose, sneezing and blocked nose), upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn), blood in urine, pain in hands or feet, nosebleeds, feeling of warmth and feeling of fatigue.
Rare (may affect 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to part of the brain, sensation of throat tightness, lip numbness, bleeding into the back of the eye, double vision, reduced visual acuity, abnormal sensations inside the eye, swelling of the eyes or eyelids, small particles or spots in the field of vision, seeing halos around light sources, pupil dilation, abnormal discoloration of the sclera, bleeding from the penis, presence of blood in semen, dry nose, swelling inside the nose, feeling of irritation, and sudden hearing loss or deafness.

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

Reporting of adverse effects
If any adverse effects occur, including those 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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Sildenafil SaneXcel

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

6. Contents of the pack and other information

What Sildenafil SaneXcel contains

• The active substance is sildenafil. Each coated tablet contains 100 mg of sildenafil (as citrate).
• Other ingredients are:
  Tablet core: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate.
  Tablet coating (Opadry II, 85F20464 Blue): polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide (E 171), talc, indigo carmine, aluminium 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 imprinted with a "+"\ symbol on one side, measuring 16.2 mm ± 0.2 mm in length, 8.2 mm ± 0.2 mm in width, and 5.7 mm ± 0.2 mm in thickness.
They are available in blisters containing 4, 8, or 16 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
J.J. Bishop Health a.s.
Rybná 682/14, Staré Město
110 00 Prague 1
Czech Republic
e-mail: [email protected]

Manufacturer:
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua de Tapada Grande 2, Abrunheira
2710-228 Sintra
Portugal

This medicinal product is authorised for marketing 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