Arifil 100 mg filmomhulde tabletten

Arifil 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. Arifil will only help you to get an erection if you are sexually stimulated.

You should not take Arifil if you do not have erectile dysfunction. You should not take Arifil if you are a woman.

Arifil 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 Arifil

• If you are allergic (hypersensitive) to sildenafil or any of the other ingredients of Arifil.
• 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 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 Arifil

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 Arifil and contact your doctor immediately.

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

Special considerations for children and adolescents

Arifil 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.

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

You should not take Arifil 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 Arifil 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 Arifil.

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 Arifil with alpha-blockers. This is most likely to occur within 4 hours after taking Arifil. 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 Arifil]. Your doctor may start you on a lower dose (25 mg) of Arifil.

Taking Arifil with food and drink

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

Pregnancy and breast feeding

Arifil is not indicated for use by women.

Driving and using machines

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

Always take Arifil 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 Arifil more than once a day.

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

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

If Arifil 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 Arifil 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, Arifil can cause side effects although not everybody gets them. The side effects reported in association with the use of Arifil are usually mild to moderate and of a short duration.

If you have chest pain 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 Arifil can cause allergic reactions. You should contact your doctor immediately if you experience any of the following symptoms after taking Arifil: 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 Arifil. 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 Arifil 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
• 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

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 Arifil. 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 becomes 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.

Store in the original package in order to protect from light.

Do not use Arifil after the expiry date which is stated on the carton after “Exp”. 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 Arifil contains

The active substance is sildenafil.

Each tablet contains 100 mg of sildenafil (as the citrate salt).

The other ingredients are: Tablet core:

cellulose, microcrystalline; calcium hydrogen phosphate, anhydrous; croscarmellose sodium; magnesium stearate; povidone

Film coat:

hypromellose; cellulose, microcrystalline; titanium dioxide (E 171); brilliant blue FCF aluminium lake (E 133); macrogol stearate/polyoxyl 40 stearate; macrogol 6000

What Arifil looks like and contents of the pack

Arifil 100 mg are blue, oval and lentiform (biconvex) shaped film-coated tablets with break- marks. The tablets can be divided into equal halves.

The tablets are provided in blister packs containing 4, 10, 12 and 20 tablets.

Some pack sizes may not be marketed in your country.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Apocare Pharma GmbH

Hauptstr. 198

33647 Bielefeld

Duitsland

Manufacturer hameln rds a.s. Horna 36

900 01 Modra Slowakije

Apocare Pharma GmbH

Hauptstr. 198

33647 Bielefeld

Duitsland

For any further information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

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

Netherlands	Arifil 25 mg, 50 mg, 100 mg filmomhulde tabletten
Germany	Arifil 25 mg, 50 mg, 100 mg Filmtabletten
Slovak Republic	Arifil 25 mg, 50 mg, 100 mg filmom obalené tablety
Austria	Arifil 25 mg, 50 mg, 100 mg Filmtabletten

In het register ingeschreven onder:

RVG 104907

Deze bijsluiter is voor het laatst goedgekeurd in december 2012