SILDENAFIL RATIOPHARM 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Sildenafilo ratiopharm 50mg film-coated tablets EFG

sildenafilo

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.,keep this leaflet. You may need to read it again.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Sildenafilo ratiopharm and what is it used for
2. What you need to know before you take Sildenafilo ratiopharm
3. How to take Sildenafilo ratiopharm
4. Possible side effects
5. Storage of Sildenafilo ratiopharm
6. Contents of the pack and further information

1. What it is and what it is used for

2. What you need to know before you take Sildenafilo ratiopharm

Do not take Sildenafilo ratiopharm

• if you are allergic to sildenafilo or any of the other ingredients of this medicine (listed in section 6).
• if you are taking medicines that contain nitrates (e.g. glyceryl trinitrate) or nitric oxide donors (e.g. amyl nitrite, also known as "poppers"). These medicines are often used to relieve the symptoms of angina pectoris (chest pain). If you take these medicines with Sildenafilo ratiopharm, your blood pressure may be seriously affected. Tell your doctor if you are taking any of these medicines. If you are not sure, consult your doctor or pharmacist.
• if you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs caused by blood clots). PDE5 inhibitors, such as sildenafilo, have shown that they increase the hypotensive effect of this medicine. If you are taking riociguat or are not sure, consult your doctor.
  • if you have a serious heart problem.
  • if you have recently had a stroke or heart attack.
  • if you have low blood pressure.
  • if you have severe liver problems.
  • if you have certain rare inherited eye diseases (such as retinitis pigmentosa)
  • if you have ever had loss of vision due to a condition known as "eye stroke" (non-arteritic anterior ischemic optic neuropathy, NAION)

Warnings and precautions

Consult your doctor or pharmacist before starting to take Sildenafilo ratiopharm.

• if you have heart problems. In this case, your doctor should carefully check if

your heart is able to withstand the extra strain of having sexual intercourse.

• if you suffer from any of the following diseases or symptoms, as you may experience more side effects:
  • a red blood cell anomaly (sickle cell anemia);
  • blood cancer (leukemia)
  • bone marrow cancer (multiple myeloma);
  • any disease or deformation of the penis.

• if you suffer from any of the following diseases, inform your doctor, who will carefully check if this medicine is suitable for you:

• if you currently have a stomach ulcer;
• if you have a blood clotting disorder (e.g. hemophilia)

• if you have kidney or liver problems. Inform your doctor about them. In this case, it is possible that the doctor will decide to administer a lower dose.

DO NOT take this medicine

• if you are already using another treatment for erectile dysfunction.
• if you are already using treatments for pulmonary arterial hypertension (PAH) that contain sildenafilo or any other PDE5 inhibitor.
• if you do not have erectile dysfunction
• if you are a woman.

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

Children and adolescents

This medicine MUST NOT be given to children and adolescents under 18 years.

Taking Sildenafilo ratiopharm with other medicines

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

In case of a medical emergency, you must inform any healthcare professional who treats you that you have taken Sildenafilo ratiopharm.

DO NOT take Sildenafilo ratiopharm if you are taking medicines that contain nitrates (e.g. glyceryl trinitrate) or nitric oxide donors (e.g. amyl nitrite, also known as "poppers"). These medicines are often used to relieve the symptoms of angina pectoris (chest pain). Taking nitrates or nitric oxide donors with Sildenafilo ratiopharm can have serious effects on your blood pressure.

Tell your doctor or pharmacist if you are taking riociguat.

If you take Sildenafilo ratiopharm with certain medicines, you may have problems. Therefore, tell your doctor if you are taking any of the following medicines:

• ritonavir or saquinavir (medicines to treat HIV infections);
• ketoconazole or itraconazole (medicines to treat fungal infections)
• erythromycin (an antibiotic)
• cimetidine (a medicine to treat acidity and peptic ulcers)
• alpha-blockers (a group of medicines to treat high blood pressure or enlarged prostate (benign prostatic hyperplasia)). Some patients who take alpha-blockers may experience dizziness or lightheadedness when standing up. These are symptoms of a drop in blood pressure when standing up quickly from a sitting or lying position (postural hypotension). These symptoms usually occur within 4 hours of taking Sildenafilo ratiopharm. To reduce the likelihood of these symptoms, you should start taking Sildenafilo ratiopharm only when you are already well controlled on a regular daily dose of your alpha-blocker.

• medicines that contain sacubitril/valsartan, used to treat heart failure.

If you are taking any of these medicines, it is possible that your doctor will indicate that you should start with the lowest dose (25 mg) of Sildenafilo ratiopharm. If you are taking ritonavir, you must not exceed a maximum dose of 25 mg of sildenafilo in a 48-hour period.

Taking Sildenafilo ratiopharm with food, drinks and alcohol

If this medicine is taken with food, it may take a little longer to work.

Alcoholic drinks may worsen erectile dysfunction. To get the maximum benefit from your medicine, it is recommended that you avoid drinking alcohol before taking this medicine.

Driving and using machines

This medicine may make some people feel dizzy or have difficulties with their vision or hearing. Do not drive or use tools or machines if you feel dizzy or if your vision or hearing is affected after taking Sildenafilo ratiopharm.

Sildenafilo ratiopharm contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is essentially "sodium-free".

3. How

4. Possible side effects

5. Storage of

6. Contents of the pack and further information

Composition of Sildenafilo ratiopharm

• The active substance is sildenafilo.

Each film-coated tablet contains sildenafilo citrate equivalent to 50 mg of sildenafilo.

• The other ingredients are: microcrystalline cellulose, hypromellose, croscarmellose sodium, magnesium stearate, calcium hydrogen phosphate, talc, macrogol 6000, titanium dioxide, red iron oxide.

Appearance and packaging

Sildenafilo ratiopharm is presented as white to off-white, elongated, film-coated tablets with a score line on one side. The tablet can be divided into equal doses.

Sildenafilo ratiopharm is presented in packs of 1, 2, 4, 8, 12 or 24 film-coated tablets, in blisters. Not all pack sizes may be marketed.

Marketing authorisation holder

ratiopharm GmbH

Graf-Arco-Straße 3

89079 Ulm

Germany

Manufacturers

Merckle GmbH

Ludwig-Merckle-Straße 3

89143 Blaubeuren

Germany

Teva Operations Poland Sp. z o.o.

ul. Mogilska 80

31-546 Kraków

Poland

HBM Pharma s.r.o.

Sklabinská 30

036 80 Martin

Slovakia

You can obtain more information on this medicine by contacting the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:{MM/AAAA}.

Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu.