Rosytona 100 mg, kauwtabletten

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

Rosytona 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.

You must talk to a doctor if you do not feel better or if you feel worse.

Do not take Rosytona :

• 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, 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 Rosytona

• 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 Rosytona and contact your doctor immediately.

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

Children and adolescents

Special considerations for children and adolescents

Rosytona 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.

Other medicines and Rosytona

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

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

You should not take Rosytona 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 Rosytona 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 Rosytona.

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

Rosytona with food, drink and alcohol

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

Pregnancy, breast-feeding and fertility

Rosytona is not indicated for use by women.

Driving and using machines

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

Rosytona contains aspartame and lactose

Rosytona chewable tablets contain aspartame, a source of phenylalanine. If you suffer from phenylketonuria (a rare, hereditary disorder of the metabolism) you should take this into account. Rosytona chewable tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

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 Rosytona more than once a day.

You should take Rosytona about one hour before you plan to have sex. The tablet should be chewed whole.

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

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

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

Very common (may affect more than 1 in 10 people):

Headache.

Common (may affect up to 1 in 10 people) 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 (may affect up to 1 in 100 people) 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, watery eyes, irregular or rapid heartbeat, muscle pain, feeling sleepy, reduced sense of touch, vertigo, ringing in the ears, nausea, dry mouth, chest pain, feeling tired, blood in the urine, penile bleeding and presence of blood in the semen.

Rare (may affect up to 1 in 1,000 people) include:

High blood pressure, low blood pressure, fainting, stroke, heart attack, nosebleed and sudden decrease or loss of hearing.

Not know ( frequency cannot be estimated from the available data)

Pounding heartbeat, chest pain, sudden death, 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 Rosytona.

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.

Reporting of side effects

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

this leaflet. You can also report side effects directly via the national reporting system listed in Appendix

V. By reporting side effects you can help provide more information on the safety of this medicine.

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 and on the blister after EXP. The expiry date refers to the last day of that month.

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

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.

What Rosytona contains

• The active substance is sildenafil. Each tablet contains 25 mg, 50 mg or 100 mg sildenafil.
• The other ingredients are: polacrilin potassium, silica colloidal anhydrous, lactose monohydrate, povidone K-30, aspartame (E951), croscarmellose sodium, peppermint flavour, magnesium stearate, potassium hydroxide (for pH adjustment) or hydrochloric acid (for pH adjustment).

What Rosytona looks like and contents of the pack

25 mg: White, triangular, biconvex, embossed with “25” on one side. 50 mg: White, triangular, biconvex, embossed with “50” on one side.

100 mg: White, triangular, biconvex, embossed with “100” on one side

Blisters in packages of:

1, 2, 4, 8, 12 chewable tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Actavis Group PTC ehf Reykjavikurvegur 76-78, 220 Hafnarfjordur IJsland

Manufacturer

Genepharm S.A.

18th km Marathon Avenue, 15351 Pallini Griekenland

Cemelog BRS Ltd

2040 Budaörs, Vasút u. 13. Hongarije

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park, Paola PLA 3000

Malta

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

{Name of the Member State} {Name of the medicinal product} {Name of the Member State} {Name of the medicinal product}

In het register ingeschreven onder:

25 mg: RVG 110279

50 mg: RVG 110280

100 mg: RVG 110281

Deze bijsluiter is voor het laatst goedgekeurd in oktober 2013