SILDENAFIL TORRENT 100 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

1. what sildenafil is and what it is used for

Sildenafil contains the active substance Sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by helping to relax the blood vessels in your penis, allowing blood to flow into your penis when you get sexually excited. Sildenafil will only help you to get an erection if you are sexually stimulated.

Sildenafil is a treatment for adult men with erectile dysfunction, sometimes known as impotence. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity.

2. what you need to know before you take sildenafil

Do not take Sildenafil

• if you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
• if you are taking medicines called nitrates, as the combination may lead to a dangerous fall in your

blood pressure. Tell your doctor if you are taking any of these medicines which are often given for relief of angina pectoris (or “chest pain”). If you are not certain, ask your doctor or pharmacist.

• if you are using any of the medicines known as nitric oxide donors such as amyl nitrite (“poppers”), as the combination may also lead to a dangerous fall in your blood pressure.
• if you are taking riociguat. This drug 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 secondary to blood clots). PDE5 inhibitors, such as Sildenafil have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.
• if you have a severe heart or liver problem.
• if you have recently had a stroke or a heart attack, or if you have low blood pressure.
• if you have certain rare inherited eye diseases (such as retinitis pigmentosa).
• if you have ever had loss of vision due to non-arteritic anterior ischaemic optic neuropathy (NAION).

Warnings and precautions

Talk to your doctor or pharmacist before taking Sildenafil

• if you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of blood cells), multiple myeloma (cancer of bone marrow).
• if you have a deformity of your penis or Peyronie’s Disease.
• if you have problems with your heart. Your doctor should carefully check whether your heart

can take the additional strain of having sex.

• if you currently have a stomach ulcer, or a bleeding problems (such as haemophilia).
• if you experience sudden decrease or loss of vision, stop taking Sildenafil and contact your doctor immediately.

You should not use Sildenafil with any other oral or local treatments for erectile dysfunction.

You should not use Sildenafil with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitors.

You should not take Sildenafil if you do not have erectile dysfunction.

You should not take Sildenafil if you are a woman.

Special considerations for patients with kidney or liver problems

You should tell your doctor if you have kidney or liver problems. Your doctor may decide on a lower dose for you.

Children and adolescents

Sildenafil should not be given to individuals under the age of 18.

Other medicines and Sildenafil

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Sildenafil tablets may interfere with some medicines, especially those used to treat chest pain. In the event of a medical emergency, you should tell your doctor or pharmacist that you have taken Sildenafil and when you did. Do not take Sildenafil with other medicines unless your doctor tells you that you can.

You should not take Sildenafil if you are taking medicines called nitrates, as the combination of these products may lead to a dangerous fall in your blood pressure. Always tell your doctor or pharmacist if you are taking any of these medicines that are often used for the relief of angina pectoris (or “chest pain”).

You should not take Sildenafil if you are using any of the medicines known as nitric oxide donors such as amyl nitrite (“poppers”) as the combination may also lead to a dangerous fall in your blood pressure.

Tell your doctor or pharmacist if you are already taking riociguat.

If you are taking medicines known as protease inhibitors, such as for the treatment of HIV, your doctor may start you on the lowest dose (25 mg) of Sildenafil.

Some patients who take alpha-blocker therapy for the treatment of high blood pressure or prostate enlargement may experience dizziness or light-headedness, which may be caused by low blood pressure upon sitting or standing up quickly. Certain patients have experienced these symptoms when taking Sildenafil with alpha-blockers. This is most likely to happen within 4 hours after taking Sildenafil. To reduce the chance that these symptoms might happen, you should be on a regular daily dose of your alpha-blocker before you start Sildenafil. Your doctor may start you on a lower dose (25 mg) of Sildenafil.

Sildenafil with food, drink and alcohol

Sildenafil can be taken with or without food. However, you may find that Sildenafil takes longer to start working if you take it with a heavy meal.

Drinking alcohol can temporarily impair your ability to get an erection. To get the maximum benefit from your medicine, you are advised not to drink excessive amounts of alcohol before taking Sildenafil.

Pregnancy and breast-feeding

Sildenafil is not indicated for use by women.

Driving and using machines

Sildenafil can cause dizziness and can affect vision. You should be aware of how you react to Sildenafil before you drive or use machinery.

Sildenafil contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dosage unit>, that is to say essentially ‘sodium-free’.

3. how to take sildenafil

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended starting dose is 50 mg.

You should not take Sildenafil more than once a day.

Do not take sildenafil film-coated tablets in combination with sildenafil orodispersible tablets

You should take Sildenafil about one hour before you plan to have sex. Swallow the tablet whole with a glass of water.

If you feel that the effect of Sildenafil is too strong or too weak, talk to your doctor or pharmacist.

Sildenafil will only help you to get an erection if you are sexually stimulated. The amount of time Sildenafil takes to work varies from person to person, but it normally takes between half an hour and one hour. You may find that Sildenafil takes longer to work if you take it with a heavy meal.

If Sildenafil does not help you to get an erection, or if your erection does not last long enough for you to complete sexual intercourse you should tell your doctor.

If you take more Sildenafil than you should

You may experience an increase in side effects and their severity. Doses above 100 mg do not increase the efficacy.

_____ You should not take more tablets than your doctor tells you to.

Contact your doctor if you take more tablets than you should.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine can cause side effects although not everybody gets them. The side effects reported in association with the use of sildenafil are usually mild to moderate and of a short duration.

If you experience any of the following serious side effects stop taking Sildenafil and seek medical help immediately:

• An allergic reaction – this occurs uncommonly (may affect up to 1 in 100 people) Symptoms include sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat
• Chest pains – this occurs uncommonly

If this occurs during or after intercourse

• – Get in a semi-sitting position and try to relax.

• - Do not use nitrates to treat your chest pain.

• Prolonged and sometimes painful erections – this occurs rarely (may affect up to 1 in 1,000 people)

If you have an erection which lasts for more than 4 hours, you should contact a doctor immediately.

• A sudden decrease or loss of vision – this occurs rarely
• Serious skin reactions – this occurs rarely

Symptoms may include severe peeling and swelling of the skin, blistering of the mouth, genitals and around the eyes, fever.

• Seizures or fits – this occurs rarely

5. how to store sildenafil

Keep this medicine out of the sight and reach of children

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

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Sildenafil contains

The active substance is sildenafil. Each tablet contains 25 mg, 50mg or 100mg of sildenafil (as the citrate salt).

The other ingredients are:

Tablet core : microcrystalline cellulose, croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, sodium stearyl fumarate.

Film coat : hypromellose, titanium dioxide (E171), triacetin, indigo carmine aluminium lake (E132).

What Sildenafil looks like and contents of the pack

Sildenafil 25 mg film-coated tablets are blue, round (diameter approx. 7.1 mm), biconvex, film coated tablets debossed with ‘86’on one side and plain on the other side.

Sildenafil 50 mg film-coated tablets are blue, round (diameter approx. 9.6 mm), biconvex, film coated tablets, debossed with ‘8’ Bisect ‘7’ on one side and plain on the other side. The tablet can be divided into equal doses.

Sildenafil 100 mg film-coated tablets are blue, round (diameter approx. 12.3 mm), biconvex, film coated tablets, debossed with ‘8’ Bisect ‘8’ on one side and plain on the other side. The tablet can be divided into equal doses.

Sildenafil 25mg is available in packs of 4, 8 or 12 tablets.

Sildenafil 50mg, 100mg are available in packs of 4, 8, 12 or 24, 48, 60, 90 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Torrent Pharma (UK) Ltd.

3rd Floor, Nexus Building,

4 Gatwick Road,

Crawley,

West Sussex,

RH10 9BG,

United Kingdom

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria: Sildenafil Torrent 25/50/100mg Filmtabletten

Germany: Sildenafil Heumann 25/50/100 mg Filmtabletten

Italy: Sildenafil ABC

Lithuania: Sildenafil Torrent 25/50/100mg plevele dengtos tabletes

Malta: Sildenafil Torrent 25/50/100mg film-coated tablets

Netherlands: Sildenafil Torrent 25/50/100mg filmomhulde tabletten

Romania: Sildenafil Torrent 25/50/100mg comprimate filmate

United Kingdom: Sildenafil 25/50/100mg Film-Coated Tablets

This leaflet was last revised in 07/2021.

8084315–7803

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