Sildenafil ratiopharm 50 mg film-coated tablets

What Sildenafil ratiopharm is

Sildenafil ratiopharm belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Sildenafil ratiopharm allows an erection to last long enough for you to satisfactorily complete sexual activity. It reduces the action of the natural chemical in your body, which makes erections go away. Sildenafil ratiopharm will only work when you are sexually stimulated.

What Sildenafil ratiopharm is used for
Sildenafil ratiopharm 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 Sildenafil ratiopharm

• if you are allergic (hypersensitive) to sildenafil or any of the other ingredients of Sildenafil ratiopharm.
• if you are taking medicines that contain nitrates (e.g. glycerol trinitrate) or nitric oxide donors (e.g. amyl nitrite, also called ?poppers?). These medicines are often used to relieve the symptoms of chest pain (angina pectoris). Taking these medicines with Sildenafil ratiopharm could seriously affect your blood pressure. Tell your doctor if you are taking any of these medicines. If you are not certain, ask your doctor or pharmacist.
• if you have a severe heart problem.
• if you have recently had a stroke or a heart attack.
• if you have low blood pressure.
• if you have a severe liver problem.
• if you have certain rare inherited eye diseases (such as retinitis pigmentosa).
• if you have ever suffered from loss of vision due to an eye condition known as ?stroke of the eye? (non-arteritic anterior ischaemic optic neuropathy, NAION).

Take special care with Sildenafil ratiopharm

• 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 suffer from any of the following disorders or symptoms, as you may experience more side effects:
• an abnormality of the red blood cells (sickle cell anaemia);
• cancer of the blood (leukaemia);
• a cancer of the bone marrow (multiple myeloma);
• any disease or deformity of the penis.
• if you suffer from any of the following disorders, please tell your doctor who will check carefully whether this medicine is suitable for you:
• if you currently have a stomach ulcer;
• if you have a blood-clotting disorder (e.g. haemophilia).
• if you suffer from kidney or liver problems. Please tell your doctor about this. In this case, he/she may decide to give you a lower dose.

You should NOT take Sildenafil ratiopharm

• if you are already undergoing other treatments for erectile dysfunction.
• if you do not have erectile dysfunction.
• if you are a woman.

Sildenafil ratiopharm should NOT be given to children and adolescents under the age of 18.

If you experience sudden decrease or loss of vision, stop taking Sildenafil ratiopharm and contact your doctor IMMEDIATELY.

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

In a medical emergency, you must tell anyone treating you that you have taken Sildenafil ratiopharm.

Do NOT take Sildenafil ratiopharm if you are taking medicines that contain nitrates (e.g. glycerol trinitrate) or nitric oxide donors (e.g. amyl nitrite, also called ?poppers?). These medicines are often used to relieve the symptoms of chest pain (angina pectoris). Simultaneous intake of nitrates or nitric oxide donors with Sildenafil ratiopharm can have severe effects on your blood pressure.

Taking Sildenafil ratiopharm together with some medicines may lead to problems. Therefore, tell your doctor if you are taking any of the following medicines:

• ritonavir or saquinavir (medicines for the treatment of HIV infections);
• ketoconazole or itraconazole (medicines for the treatment of fungal infections);
• erythromycin (an antibiotic);
• cimetidine (medicine for the treatment of heartburn and peptic ulcers);
• alpha blockers (group of medicines for the treatment of high blood pressure or an enlarged prostate [benign prostatic hyperplasia]). Some patients taking alpha blockers may experience dizziness or light-headedness when getting up. These are symptoms of a fall in blood pressure upon rising quickly from sitting or lying (postural hypotension). These symptoms usually occur within 4 hours of taking Sildenafil ratiopharm. In order to reduce the probability of these symptoms occurring, you should start taking Sildenafil ratiopharm only when you are already well controlled on a regular daily dose of your alpha blocker. If you are taking one of these medicines, your doctor may start you on the lowest dose (25 mg) of Sildenafil ratiopharm. If you are taking ritonavir, you may not exceed a maximum dose of 25 mg sildenafil within a period of 48 hours.

UsingSildenafil ratiopharm with food and drink
When Sildenafil ratiopharm is taken with food, it may take a little longer for Sildenafil ratiopharm to work.

Alcoholic drink can make erection difficulties worse. In order to get the maximum benefit from your medicine, it is recommended that you avoid alcohol before intake of Sildenafil ratiopharm.

Driving and using machines
Sildenafil ratiopharm might make some people feel dizzy or affect their vision or hearing. If you feel dizzy, or if your vision or hearing is affected after taking Sildenafil ratiopharm, do not drive or operate any tools or machines.

Always take Sildenafil ratiopharm exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose is

Take 1 film-coated tablet of Sildenafil ratiopharm about 1 hour before sexual activity. Swallow the film-coated tablet whole with a glass of water.

You should not take more film-coated tablets than your doctor tells you to.

You should not take Sildenafil ratiopharm more than once a day.

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

If Sildenafil ratiopharm 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 ratiopharm than you should
Men who take too much Sildenafil ratiopharm may experience more side effects or may get severe muscle pain. If you take more Sildenafil ratiopharm than you should, tell your doctor.

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

Like all medicines, Sildenafil ratiopharm can cause side effects although not everybody gets them.

The following frequency conventions are used in the evaluation of side effects very common common uncommon rare very rare not known affects more than 1 user in 10 affects 1 to 10 users in 100 affects 1 to 10 users in 1,000 affects 1 to 10 users in 10,000 affects less than 1 user in 10,000 frequency cannot be estimated from the available data.

Important side effects:

• Chest pain: If you experience chest pain (uncommon) during or after sexual activity, you should NOT take any medicines that contain nitrates (e.g. glycerol trinitrate). Please contact a doctor IMMEDIATELY.
• Allergic reactions: Allergic reactions such as skin rash, raised areas of the skin that itch and severe allergic reactions with weakness, drop in blood pressure, difficulty breathing and swelling of the eyelids, face, lips or throat have been reported rarely. If you think you are having this type of reaction, you must stop taking Sildenafil ratiopharm and get medical help IMMEDIATELY.
• Visual disturbances: If you experience a sudden impairment or loss of vision (frequency not known), stop taking Sildenafil ratiopharm and contact your doctor IMMEDIATELY.
• Prolonged erections: Prolonged and sometimes painful erections have been reported after taking Sildenafil ratiopharm (frequency not known). If you have such an erection, which lasts continuously for more than 4 hours, you should contact a doctor IMMEDIATELY.

You may experience the following additional side effects:

• very common: headache;
• common: dizziness, altered vision (increased brightness of light or blurred vision), colour tinge to vision, flushing, stuffy nose, indigestion;
• uncommon: feeling sleepy, reduced sense of touch, bloodshot eyes, eye pain, watery eyes, abnormal sensation in the eye, vertigo, ringing in the ears, pounding heartbeat, faster heartbeat, vomiting, nausea, dry mouth, skin rash, muscle pain, feeling tired, measurement of faster heartbeat;
• rare: stroke, fainting, sudden impairment or loss of hearing, high blood pressure, low blood pressure, heart attack, irregular heartbeat, nosebleed;
• not known: temporary decreased blood flow to parts of the brain, seizure, recurrence of seizures, occlusion of blood vessels inside the eye, partial, sudden, temporary, or permanent impairment or loss of vision in one or both eyes, abnormal heartbeat, unstable angina (chest pain), sudden death, serious skin reactions characterised by rash, blisters, peeling skin and pain, which require immediate medical attention.

Most, but not all, of the men who experienced cardiovascular side effects already had cardiovascular problems before taking this medicine. It is not possible to determine whether these events were directly related to Sildenafil ratiopharm.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

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

This medicine does not require any special storage conditions.

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 Sildenafil ratiopharm contains

• The active substance is sildenafil. Each film-coated tablet contains 50 mg of sildenafil (as citrate).
• The other ingredients are: microcrystalline cellulose,hypromellose, croscarmellose sodium, magnesium stearate, calcium hydrogen phosphate anhydrous, talc, macrogol 6000, titanium dioxide, iron oxide red, indigo carmine aluminium lake.

What Sildenafil ratiopharm looks like and contents of the pack

Sildenafil ratiopharm are blue, oblong film-coated tablets with edge.

Sildenafil ratiopharm are supplied in packs of 1, 2, 4, 8 or 12 film-coated tablets in blisters. Not all pack sizes may be marketed.

Marketing Authorisation Holderratiopharm GmbH
Graf-Arco-Straße 3
89079 Ulm
Germany
info@ratiopharm.de

Manufacturer

Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren
Germany

HBM Pharma s.r.o.

Sklabinská 30

036 80 Martin

Slovak Republic

Medicamentos Internacionales, S.A.

c/ Solana, n°26

28850 Torrejón de Ardoz (Madrid)

Spain

Famar S.A.

7, Anthousas Avenue

15344 Anthousa, Attiki

Greece

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

BelgiëBelgiqueBelgien ratiopharm Belgium S.A. TélTel 32 2 761 10 11 LuxembourgLuxemburg ratiopharm S.A. Luxemburg TélTel 35 2 40 37 27

ratiopharm GmbH, Te 49 731 402 02 Magyarország ratiopharm Hungária Kft. Tel 36 1 273 2730

eská republika ratiopharm CZ s.r.o. Malta ratiopharm GmbH, Il ermanja

Tel 420 2 510 21 122 Tel 49 731 402 02

Danmark ratiopharm AS Tlf 45 45 46 06 60 Nederland ratiopharm Nederland bv Tel 31 23 7070 840

Deutschland ratiopharm GmbH Tel 49 731 402 02 Norge ratiopharm AS Tlf 47 66 77 55 90

Eesti ratiopharm Eesti büroo Tel 372 6838 006 Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel 43 1 97 007

ratiopharm GmbH, 49 731 402 02 Polska ratiopharm Polska Sp.z.o.o Tel 48 22 335 39 20

España ratiopharm España, S.A. Tel 34 91 567 29 70 Portugal ratiopharm, Comércio e Indústria de Produtos farmacêuticos Lda Tel 351 21 424 80 00

France Laboratoire ratiopharm S.A. Tél 33 1 42 07 97 04 România ratiopharm GmbH, Germania Tel 49 731 402 02

Ireland ratiopharm UK Ltd, United Kingdom Tel 44 239 238 6330 Slovenija ratiopharm GmbH, Nemija Tel 49 731 402 02

Ísland ratiopharm GmbH, skaland Sími 49 731 402 02 Slovenská republika ratiopharm Slovensko s.r.o. Tel 421 2 57 200 300

Italia ratiopharm Italia s.r.l. Tel 39 02 28 87 71 SuomiFinland ratiopharm Oy PuhTel 358 20 180 5900

ratiopharm GmbH, 49 731 402 02 Sverige ratiopharm AB Tel 46 42 37 0740

Latvija ratiopharm Latvijas prstvniecba Tel 371 67499110 United Kingdom ratiopharm UK Ltd Tel 44 239 238 6330

Lietuva
ratiopharm atstovas Lietuvoje
Tel: + 370 5 212 3295

This leaflet was last approved in {MM/YYYY}.