Afilon 100 mg, filmomhulde tablet

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

Afilon 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.

Do not take Afilon

• 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 (hypersensitive) to sildenafil or any of the other ingredients of Afilon.
• 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).

Take special care with Afilon

Tell your doctor

• 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 Afilon and contact your doctor immediately.

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

Special considerations for children and adolescents

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

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.

Taking other medicines:

Please tell your doctor or pharmacist if you are taking or have recently taken other medicines, including medicines obtained without prescription.

Afilon 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 Afilon and when you did. Do not take Afilon with other medicines unless your doctor tells you that you can.

You should not take Afilon 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 Afilon 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 Afilon.

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 Afilon with alpha-blockers. This is most likely to occur within 4 hours after taking Afilon. In order to reduce the likelihood that these symptoms occur, you should be on a regular daily dose of your alpha-blocker before you start Afilon. Your doctor may start you on a lower dose (25 mg) of Afilon.

Taking Afilon with food and drink

Afilon can be taken with or without food. However, you may find that Afilon 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 Afilon.

Pregnancy and Breast feeding

Afilon is not indicated for use by women.

Driving and using machines

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

Always take Afilon exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual starting dose is 50 mg.

You should not take Afilon more than once a day.

You should take Afilon 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 Afilon is too strong or too weak, talk to your doctor or pharmacist.

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

If Afilon 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 Afilon 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.

Like all medicines, Afilon can cause side effects although not everybody gets them. The side effects reported in association with the use of Afilon 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 Afilon can cause allergic reactions. You should contact your doctor immediately if you experience any of the following symptoms after taking Afilon: 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 Afilon. 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 Afilon and contact your doctor immediately.

The following frequencies are used to evaluate side effects:

very common: affects more than 1 user in 10

common: affects 1 to 10 users in 100

uncommon: affects 1 to 10 users in 1,000

rare: affects 1 to 10 users in 10,000

very rare: affects less than 1 user in 10,000

not known: frequency cannot be estimated from the available data

A very common side effect is headache.

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

Uncommon side effects 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, dry mouth, chest pain and feeling tired.

Rare side effects include: high blood pressure, low

blood pressure, fainting, stroke, nosebleed and sudden decrease or loss of hearing.

Additional side effects reported from post-marketing experience include: pounding heartbeat, chest pain, sudden death, 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 Afilon. 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 any of the side effects get serious, or if you notice any side effects not listed in this leaflet please tell your doctor.

Keep out of the reach and sight of children

This medicinal product does not require any special storage conditions.

Do not use Afilon after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Afilon contains

The active substance is sildenafil. Each tablet Afilon 25 mg/50 mg/100mg film-coated tablets contains sildenafil citrate equivalent to 25 mg/50 mg/100 mg sildenafil.

The other ingredients are: calcium hydrogen phosphate dihydrate, cellulose microcrystalline, magnesium stearate, silica, colloidal anhydrous, croscarmellose sodium, hypromellose, titanium dioxide (E-171), macrogol 6000, talc and indigo carmine aluminium lake (E-132).

What Afilon looks like and contents of the pack

Afilon 100 mg film-coated tablets are blue, enlongated. and marked with “100”.

Afilon 100 mg film-coated tablets are supplied in blister packs of 4 or 8 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Laboratorios LICONSA, S.A. Gran Vía Carlos III, 98, 7th floor 08028 Barcelona, SPAIN

Manufacturer:

LABORATORIOS NORMON, S.A. Ronda de Valdecarrizo, 6

28760 Tres Cantos – Madrid, SPAIN

LABORATORIOS LICONSA, S.A.

Avenida Miralcampo, 7. Polígono Industrial Miralcampo 19200 Azuqueca de Henares

Guadalajara – SPAIN

Nummer(s) van de vergunning voor het in de handel brengen

Afilon 100 mg, filmomhulde tablet is ingeschreven in het register onder RVG 104527

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

AT/H/301/01-03/DC

AT:Silchemo 25/50/100 mg, Filmtablette

BE: Silchemo 25/50/100 mg Comprimé pelliculé

DK: Silchemo 25/50/100 mg Filmovertrukket tablet

FI: Silchemo 25/50/100 mg Tabletti, kalvopäällysteinen

NL: Afilon 25/50/100 mg, filmomhulde tablet

NO: Silchemo 25/50/100 mg tabletter, filmdrasjerte

SE: Silchemo 25/50/100 mg Filmdragerad tablet

This leaflet was last approved in: mei 2013