Sildenafil Torrent 25 mg, filmomhulde tabletten

Sildenafil Torrent 25 mg, filmomhulde tabletten
Werkzame stof(fen)Sildenafil
Toelatingslandnl
VergunninghouderTorrent Pharma
ATC-codeG04BE03
Farmacologische groepenUrologische

Patiëntenbijsluiter

Wat is het en waarvoor wordt het gebruikt?

[product name] 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. [product name] will only help you to get an erection if you are sexually stimulated. You should not take [product name] if you do not have erectile dysfunction. You should not take [product name] if you are a woman.

[product name] is a treatment for 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 [product name]

Do not take [product name]

  • If you are taking medicines called nitrates, as the combination may cause a potentially dangerous decrease 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 drugs known as nitric oxide donors such as amyl nitrite (“poppers”), as the combination may also lead to a potentially dangerous decrease in your blood pressure.
  • If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
  • If you have a severe heart or liver problem.
  • If you have recently had a stroke or a heart attack.
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  • 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 [product name]

  • 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 in that case 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 [product name] and contact your doctor immediately.

You should not use [product name] with any other oral or local treatments for erectile dysfunction.

Children and adolescents

[product name] should not be given to individuals under the age of 18.

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.

Other medicines and [product name]

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

[product name] tablets may interfere with some medicines, especially those used to treat chest pain. In the event of a medical emergency, you should tell any health care professional treating your condition that you have taken [product name] and when you did. Do not take [product name] with other medicines unless your doctor tells you that you can.

You should not take [product name] if you are taking medicines called nitrates, as the combination of these products may cause a potentially dangerous decrease 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 [product name] if you are using any of the drugs known as nitric oxide donors such as amyl nitrite (“poppers”) as the combination may also lead to a potentially dangerous decrease in your blood pressure.

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 [product name].

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 [product name] with alpha-blockers. This is most likely to occur within 4 hours after taking [product name]. In order to reduce the likelihood that these symptoms occur, you should be on a

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regular daily dose of your alpha-blocker before you start [product name]. Your doctor may start you on a lower dose (25 mg) of [product name].

[product name] with food, drink and alcohol

[product name] can be taken with or without food. However, you may find that [product name] 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 [product name].

Pregnancy, breast-feeding and fertility

[product name] is not indicated for use by women.

Driving and using machines

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

Hoe wordt het gebruikt?

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 [product name] more than once a day.

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

If you have the impression that the effect of [product name] is too strong or too weak, talk to your doctor or pharmacist.

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

If [product name] 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 [product name] 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.

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Wat zijn mogelijke bijwerkingen?

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

If you have chest pains during or after intercourse:

  • Get in a semi-sitting position and try to relax.
  • Do not use nitrates to treat your chest pain.
  • Contact your doctor immediately.

All medicines including [product name] can cause allergic reactions. You should contact your doctor immediately if you experience any of the following symptoms after taking [product name]: sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat.

Prolonged and sometimes painful erections have been reported after taking [product name]. If you have an erection which lasts for more than 4 hours, you should contact a doctor immediately.

If you experience a sudden decrease or loss of vision, stop taking [product name] and contact your doctor immediately.

A very common side effect (likely to occur in more than 1 in 10 patients) is:

  • headache.

Common side effects (likely to occur in 1 to 10 patients in 100) include:

  • facial flushing,
  • indigestion,
  • effects on vision (including colour tinge to vision, light sensitivity, blurred vision or reduced sharpness of vision),
  • stuffy nose,
  • dizziness.

Uncommon side effects (likely to occur in 1 to 10 patients in 1000) include:

  • vomiting,
  • skin rash,
  • bleeding at the back of the eye,
  • eye irritation,
  • bloodshot eyes /red eyes,
  • eye pain,
  • double vision,
  • abnormal sensation in the eye,
  • irregular or rapid heartbeat,
  • muscle pain,
  • feeling sleepy,
  • reduced sense of touch,
  • vertigo,
  • ringing in the ears,
  • nausea,
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  • dry mouth,
  • chest pain,
  • feeling tired.

Rare side effects (likely to occur in 1 to 10 patients in 10000) include:

  • high blood pressure,
  • low blood pressure,
  • fainting,
  • stroke,
  • nosebleed
  • sudden decrease or loss of hearing
  • Hypersensitivity reactions.

Additional side effects reported from post-marketing experience include:

  • sudden death,
  • pounding heartbeat,
  • chest pain,
  • heart attack or temporary decreased blood flow to parts of the brain.

Most, but not all, of these men had heart problems before taking this medicine. It is not possible to determine whether these events were directly related to [product name].

Cases of convulsions or seizures and serious skin reactions characterised by rash, blisters, peeling skin and pain which require immediate medical attention have also been reported.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Hoe moet het worden bewaard?

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 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.

Verdere informatie

What [product name] contains

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

The other ingredients are:

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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 [product name] looks like and contents of the pack

[product name] 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.

[product name] 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.

[product name] 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.

[AT/H/0408/001-003/DC] Pack size: 4, 8 or 12 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Torrent Pharma GmbH

Südwestpark 50

90449 Nürnberg

Duitsland

Nummer van de vergunning voor het in de handel brengen

25 mg: RVG 109605

50 mg: RVG 109606

100 mg: RVG 109607

Deze bijsluiter is voor het laatst goedgekeurd in september 2012

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Laatst bijgewerkt op 24.08.2023

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