B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Sildenafil ratiopharm 25 mg film -coated tablets

sildenafil

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.

• – 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.

What is in this leaflet

• 1. What Sildenafil ratiopharm is and what it is used for

• 2. What you need to know before you take Sildenafil ratiopharm

• 3. How to take Sildenafil ratiopharm

• 4. Possible side effects

• 5. How to store Sildenafil ratiopharm

• 6. Contents of the pack and other information

1. What Sildenafil ratiopharm is and what it is used for

What Sildenafil ratiopharm is

Sildenafil ratiopharm contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. This medicine 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 adult 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.

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

Do NOT take Sildenafil ratiopharm

• – if you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).

• – 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 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 secondary to blood clots). PDE5 inhibitors, such as sildenafil, have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

• – 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).

Warnings and precautions

Talk to your doctor or pharmacist before taking 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 this medicine

• – if you are already undergoing other treatments for erectile dysfunction.

• – if you are already undergoing treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitors.

• – if you do not have erectile dysfunction.

• – if you are a woman.

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

Children and adolescents

This medicine should NOT be given to children and adolescents under the age of 18.

Other medicines and Sildenafil ratiopharm

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

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.

Tell your doctor or pharmacist if you are already taking riociguat.

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.

Sildenafil ratiopharm with food, drink and alcohol

When this medicine 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 this medicine.

Driving and using machines

This medicine 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.

Sildenafil ratiopharm contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.

3. How to take Sildenafil ratiopharm

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 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.

This medicine 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 this medicine takes longer to work if you take it with a heavy meal.

If this medicine 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects reported in association with the use of sildenafil are usually mild to moderate and of a short duration.

If you experience any of the following serious side effects stop taking Sildenafil ratiopharm and seek medical help immediately:

• – An allergic reaction – this occurs uncommonly (may affect up to 1 in 100 people).

Symptoms include sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat.

• – Chest pains – this occurs uncommonly. If this occurs during or after intercourse: Get in a semi-sitting position and try to relax.
• Do not use nitrates to treat your chest pain.

• – Prolonged and sometimes painful erections – this occurs rarely (may affect up to 1 in 1,000 people).

If you have an erection, which lasts for more than 4 hours, you should contact a doctor immediately.

• – A sudden decrease or loss of vision – this occurs rarely.

• – Serious skin reactions – this occurs rarely.

Symptoms may include severe peeling and swelling of the skin, blistering of the mouth, genitals and around the eyes, fever.

• – Seizures or fits – this occurs rarely.

Other side effects:

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

Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flush (symptoms include a sudden feeling of heat in your upper body), indigestion, colour tinge to vision, blurred vision, visual disturbance, stuffy nose and dizziness.

Uncommon (may affect up to 1 in 100 people): vomiting, skin rash eye irritation, bloodshot eyes/red eyes, eye pain, seeing flashes of light, visual brightness, light sensitivity, watery eyes, pounding heartbeat, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling sleepy, reduced sense of touch, vertigo, ringing in the ears, dry mouth, blocked or stuffy sinuses, inflammation of the lining of the nose (symptoms include runny nose, sneezing and stuffy nose), upper abdominal pain, gastro-oesophageal reflux disease (symptoms include heartburn), presence of blood in urine, pain in the arms or legs, nosebleed, feeling hot and feeling tired.

Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary decreased blood flow to parts of the brain, feeling of tightening of the throat, numb mouth, bleeding at the back of the eye, double vision, reduced sharpness of vision, abnormal sensation in the eye, swelling of the eye or eyelid, small particles or spots in your vision, seeing halos around lights, dilation of the pupil of the eye, discolouration of the white of the eye, penile bleeding, presence of blood in semen, dry nose, swelling of the inside of the nose, feeling irritable and sudden decrease or loss of hearing.

From post-marketing experience cases of unstable angina (a heart condition) and sudden death have been reported rarely. Of note, most, but not all, of the men who experienced these side effects had heart problems before taking this medicine. It is not possible to determine whether these events were directly related to Sildenafil ratiopharm.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible 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.

5. How to store Sildenafil ratiopharm

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 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.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Sildenafil ratiopharm contains

• – The active substance is sildenafil.

Each film-coated tablet contains sildenafil citrate equivalent to 25 mg of sildenafil.

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

What Sildenafil ratiopharm looks like and contents of the pack

Sildenafil ratiopharm are white to off-white, 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 Holder

ratiopharm GmbH

Graf-Arco-StraBe 3

89079 Ulm

Germany

Manufacturer

Merckle GmbH

Ludwig-Merckle-StraBe 3

89143 Blaubeuren

Germany

Teva Operations Poland Sp. z o.o.

ul. Mogilska 80

31–546 Krakow

Poland

HBM Pharma s.r.o.

Sklabinska 30

036 80 Martin

Slovak Republic

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

België/Belgiqu­e/Belgien Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373	Lietuva UAB Teva Baltics Tel: +370 52660203
Efc^rapufl TeBa OapMa EAfl Ten: +359 24899585	Luxembourg/Lu­xemburg ratiopharm GmbH Allemagne/Deut­schland Tel/Tel: +49 73140202
Česká republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111	Magyarorszag Teva Gyogyszergyar Zrt. Tel: +36 12886400
Danmark Teva Denmark A/S Tlf: +45 44985511	Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407117
Deutschland ratiopharm GmbH Tel: +49 73140202	Nederland Teva Nederland B.V. Tel: +31 8000228400
Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801	Norge Teva Norway AS Tlf: +47 66775590
EXÀàôa Specifar A.B.E.E. Tql: +30 2118805000	Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070
España ratiopharm España, S.A. Tel: +34 915672970	Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300
France Teva Santé Tél: +33 155917800	Portugal ratiopharm – Comercio e Industria de Produtos Farmaceuticos, Lda. Tel: +351 214767550
Hrvatska Pliva Hrvatska d.o.o. Tel: +385 13720000	Romania Teva Pharmaceuticals S.R.L. Tel: +40 212306524
Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407117	Slovenija Pliva Ljubljana d.o.o. Tel: +386 15890390

Slovenská republika

TEVA Pharmaceuticals Slovakia s.r.o.

Tel: +421 257267911

Suomi/Finland

Teva Finland Oy

Puh/Tel: +358 201805900

United Kingdom (Northern Ireland)

Teva Pharmaceuticals Ireland

Ireland

Tel: +44 2075407117

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

Detailed information on this medicine is available on the European Medicines Agency web site:.

Package leaflet: Information for the patient

Sildenafil ratiopharm 50 mg film -coated tablets

sildenafil

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.

• – 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.

What is in this leaflet

• 1. What Sildenafil ratiopharm is and what it is used for

• 2. What you need to know before you take Sildenafil ratiopharm

• 3. How to take Sildenafil ratiopharm

• 4. Possible side effects

• 5. How to store Sildenafil ratiopharm

• 6. Contents of the pack and other information

1. What Sildenafil ratiopharm is and what it is used for

What Sildenafil ratiopharm is

Sildenafil ratiopharm contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. This medicine 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 adult 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.

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

Do NOT take Sildenafil ratiopharm

• – if you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).

• – 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 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 secondary to blood clots). PDE5 inhibitors, such as sildenafil, have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

• – 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).

Warnings and precautions

Talk to your doctor or pharmacist before taking 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 this medicine

• – if you are already undergoing other treatments for erectile dysfunction.

• – if you are already undergoing treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitors.

• – if you do not have erectile dysfunction.

• – if you are a woman.

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

Children and adolescents

This medicine should NOT be given to children and adolescents under the age of 18.

Other medicines and Sildenafil ratiopharm

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

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.

Tell your doctor or pharmacist if you are already taking riociguat.

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.

Sildenafil ratiopharm with food, drink and alcohol

When this medicine 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 this medicine.

Driving and using machines

This medicine 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.

Sildenafil ratiopharm contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.

3. How to take Sildenafil ratiopharm

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 dose is

Take 4 or 1 film-coated tablet of Sildenafil ratiopharm as prescribed by your doctor 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.

This medicine 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 this medicine takes longer to work if you take it with a heavy meal.

If this medicine 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects reported in association with the use of sildenafil are usually mild to moderate and of a short duration.

If you experience any of the following serious side effects stop taking Sildenafil ratiopharm and seek medical help immediately:

• – An allergic reaction – this occurs uncommonly (may affect up to 1 in 100 people).

Symptoms include sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat.

• – Chest pains – this occurs uncommonly. If this occurs during or after intercourse: Get in a semi-sitting position and try to relax.
• Do not use nitrates to treat your chest pain.

• – Prolonged and sometimes painful erections – this occurs rarely (may affect up to 1 in 1,000 people).

If you have an erection, which lasts for more than 4 hours, you should contact a doctor immediately.

• – A sudden decrease or loss of vision – this occurs rarely.

• – Serious skin reactions -this occurs rarely.

Symptoms may include severe peeling and swelling of the skin, blistering of the mouth, genitals and around the eyes, fever.

• – Seizures or fits – this occurs rarely.

Other side effects:

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

Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flush (symptoms include a sudden feeling of heat in your upper body), indigestion, colour tinge to vision, blurred vision, visual disturbance, stuffy nose and dizziness.

Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, bloodshot eyes/red eyes, eye pain, seeing flashes of light, visual brightness, light sensitivity, watery eyes, pounding heartbeat, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling sleepy, reduced sense of touch, vertigo, ringing in the ears, dry mouth, blocked or stuffy sinuses, inflammation of the lining of the nose (symptoms include runny nose, sneezing and stuffy nose), upper abdominal pain, gastro-oesophageal reflux disease (symptoms include heartburn), presence of blood in urine, pain in the arms or legs, nosebleed, feeling hot and feeling tired.

Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary decreased blood flow to parts of the brain, feeling of tightening of the throat, numb mouth, bleeding at the back of the eye, double vision, reduced sharpness of vision, abnormal sensation in the eye, swelling of the eye or eyelid, small particles or spots in your vision, seeing halos around lights, dilation of the pupil of the eye, discolouration of the white of the eye, penile bleeding, presence of blood in semen, dry nose, swelling of the inside of the nose, feeling irritable and sudden decrease or loss of hearing.

From post-marketing experience cases of unstable angina (a heart condition) and sudden death have been reported rarely. Of note, most, but not all, of the men who experienced these side effects had heart problems before taking this medicine. It is not possible to determine whether these events were directly related to Sildenafil ratiopharm.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible 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.

5. How to store Sildenafil ratiopharm

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 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.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Sildenafil ratiopharm contains

• – The active substance is sildenafil.

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

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

What Sildenafil ratiopharm looks like and contents of the pack

Sildenafil ratiopharm are white to off-white, oblong film-coated tablets with edge and score line on one side. The tablet can be divided into equal doses.

Sildenafil ratiopharm are supplied 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-StraBe 3

89079 Ulm

Germany

Manufacturer

Merckle GmbH

Ludwig-Merckle-StraBe 3

89143 Blaubeuren

Germany

Teva Operations Poland Sp. z o.o.

ul. Mogilska 80

31–546 Krakow

Poland

HBM Pharma s.r.o.

Sklabinska 30

036 80 Martin

Slovak Republic

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

België/Belgiqu­e/Belgien Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373	Lietuva UAB Teva Baltics Tel: +370 52660203
Efc^rapufl TeBa OapMa EAfl Ten: +359 24899585	Luxembourg/Lu­xemburg ratiopharm GmbH Allemagne/Deut­schland Tel/Tel: +49 73140202
Česká republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111	Magyarorszag Teva Gyogyszergyar Zrt. Tel: +36 12886400
Danmark Teva Denmark A/S Tlf: +45 44985511	Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407117
Deutschland ratiopharm GmbH Tel: +49 73140202	Nederland Teva Nederland B.V. Tel: +31 8000228400
Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801	Norge Teva Norway AS Tlf: +47 66775590
EXÀàôa Specifar A.B.E.E. Tql: +30 2118805000	Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070
España ratiopharm España, S.A. Tel: +34 915672970	Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300
France Teva Santé Tél: +33 155917800	Portugal ratiopharm – Comercio e Industria de Produtos Farmaceuticos, Lda. Tel: +351 214767550
Hrvatska Pliva Hrvatska d.o.o. Tel: +385 13720000	Romania Teva Pharmaceuticals S.R.L. Tel: +40 212306524
Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407117	Slovenija Pliva Ljubljana d.o.o. Tel: +386 15890390

Slovenská republika

TEVA Pharmaceuticals Slovakia s.r.o.

Tel: +421 257267911

Suomi/Finland

Teva Finland Oy

Puh/Tel: +358 201805900

United Kingdom (Northern Ireland)

Teva Pharmaceuticals Ireland

Ireland

Tel: +44 2075407117

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

Detailed information on this medicine is available on the European Medicines Agency web site:.

Package leaflet: Information for the patient

Sildenafil ratiopharm 100 mg film -coated tablets

sildenafil

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.

• – 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.

What is in this leaflet

• 1. What Sildenafil ratiopharm is and what it is used for

• 2. What you need to know before you take Sildenafil ratiopharm

• 3. How to take Sildenafil ratiopharm

• 4. Possible side effects

• 5. How to store Sildenafil ratiopharm

• 6. Contents of the pack and other information

1. What Sildenafil ratiopharm is and what it is used for

What Sildenafil ratiopharm is

Sildenafil ratiopharm contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. This medicine 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 adult 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.

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

Do NOT take Sildenafil ratiopharm

• – if you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).

• – 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 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 secondary to blood clots). PDE5 inhibitors, such as sildenafil, have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

• – if you have a severe heart problem.

• – if you have recently had a stroke or a heart attack.

• – if you have low blood pressure.

Warnings and precautions

Talk to your doctor or pharmacist before taking 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 this medicine

• – if you are already undergoing other treatments for erectile dysfunction.

• – if you are already undergoing treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitors.

• – if you do not have erectile dysfunction.

• – if you are a woman.

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

Children and adolescents

This medicine should NOT be given to children and adolescents under the age of 18.

Other medicines and Sildenafil ratiopharm

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

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.

Tell your doctor or pharmacist if you are already taking riociguat.

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.

Sildenafil ratiopharm with food, drink and alcohol

When this medicine 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 this medicine.

Driving and using machines

This medicine 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.

Sildenafil ratiopharm contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.

3. How to take Sildenafil ratiopharm

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 dose is

Take 4 or 1 film-coated tablet of Sildenafil ratiopharm as prescribed by your doctor 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.

This medicine 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 this medicine takes longer to work if you take it with a heavy meal.

If this medicine 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects reported in association with the use of sildenafil are usually mild to moderate and of a short duration.

If you experience any of the following serious side effects stop taking Sildenafil ratiopharm and seek medical help immediately:

• – An allergic reaction – this occurs uncommonly (may affect up to 1 in 100 people).

Symptoms include sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat.

• – Chest pains – this occurs uncommonly. If this occurs during or after intercourse: Get in a semi-sitting position and try to relax.
• Do not use nitrates to treat your chest pain.

• – Prolonged and sometimes painful erections – this occurs rarely (may affect up to 1 in 1,000 people).

If you have an erection, which lasts for more than 4 hours, you should contact a doctor immediately.

• – A sudden decrease or loss of vision – this occurs rarely.

• – Serious skin reactions – this occurs rarely.

Symptoms may include severe peeling and swelling of the skin, blistering of the mouth, genitals and around the eyes, fever.

• – Seizures or fits – this occurs rarely.

Other side effects:

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

Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flush (symptoms include a sudden feeling of heat in your upper body), indigestion, colour tinge to vision, blurred vision, visual disturbance, stuffy nose and dizziness.

Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, bloodshot eyes/red eyes, eye pain, seeing flashes of light, visual brightness, light sensitivity, watery eyes, pounding heartbeat, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling sleepy, reduced sense of touch, vertigo, ringing in the ears, dry mouth, blocked or stuffy sinuses, inflammation of the lining of the nose (symptoms include runny nose, sneezing and stuffy nose), upper abdominal pain, gastro-oesophageal reflux disease (symptoms include heartburn), presence of blood in urine, pain in the arms or legs, nosebleed, feeling hot and feeling tired.

Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary decreased blood flow to parts of the brain, feeling of tightening of the throat, numb mouth, bleeding at the back of the eye, double vision, reduced sharpness of vision, abnormal sensation in the eye, swelling of the eye or eyelid, small particles or spots in your vision, seeing halos around lights, dilation of the pupil of the eye, discolouration of the white of the eye, penile bleeding, presence of blood in semen, dry nose, swelling of the inside of the nose, feeling irritable and sudden decrease or loss of hearing.

From post-marketing experience cases of unstable angina (a heart condition) and sudden death have been reported rarely. Of note, most, but not all, of the men who experienced these side effects had heart problems before taking this medicine. It is not possible to determine whether these events were directly related to Sildenafil ratiopharm.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible 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.

5. How to store Sildenafil ratiopharm

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 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.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Sildenafil ratiopharm contains

• – The active substance is sildenafil.

Each film-coated tablet contains sildenafil citrate equivalent to 100 mg of sildenafil.

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

What Sildenafil ratiopharm looks like and contents of the pack

Sildenafil ratiopharm are white to off-white, 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 Holder

ratiopharm GmbH

Graf-Arco-StraBe 3

89079 Ulm

Germany

Manufacturer

Merckle GmbH

Ludwig-Merckle-StraBe 3

89143 Blaubeuren

Germany

Teva Operations Poland Sp. z o.o.

ul. Mogilska 80

31–546 Krakow

Poland

HBM Pharma s.r.o.

Sklabinska 30

036 80 Martin

Slovak Republic

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

België/Belgiqu­e/Belgien Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373	Lietuva UAB Teva Baltics Tel: +370 52660203
Efc^rapufl TeBa OapMa EAfl Ten: +359 24899585	Luxembourg/Lu­xemburg ratiopharm GmbH Allemagne/Deut­schland Tel/Tel: +49 73140202
Česká republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111	Magyarorszag Teva Gyogyszergyar Zrt. Tel: +36 12886400
Danmark Teva Denmark A/S Tlf: +45 44985511	Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407117
Deutschland ratiopharm GmbH Tel: +49 73140202	Nederland Teva Nederland B.V. Tel: +31 8000228400
Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801	Norge Teva Norway AS Tlf: +47 66775590
EXÀàôa Specifar A.B.E.E. Tql: +30 2118805000	Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070
España ratiopharm España, S.A. Tel: +34 915672970	Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300
France Teva Santé Tél: +33 155917800	Portugal ratiopharm – Comercio e Industria de Produtos Farmaceuticos, Lda. Tel: +351 214767550
Hrvatska Pliva Hrvatska d.o.o. Tel: +385 13720000	Romania Teva Pharmaceuticals S.R.L. Tel: +40 212306524
Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407117	Slovenija Pliva Ljubljana d.o.o. Tel: +386 15890390

Slovenská republika

TEVA Pharmaceuticals Slovakia s.r.o.

Tel: +421 257267911

Suomi/Finland

Teva Finland Oy

Puh/Tel: +358 201805900

United Kingdom (Northern Ireland)

Teva Pharmaceuticals Ireland

Ireland

Tel: +44 2075407117

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

Detailed information on this medicine is available on the European Medicines Agency web site:.

Package leaflet: Information for the patient

Sildenafil ratiopharm 50 mg film -coated tablets

sildenafil

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.

• – 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.

What is in this leaflet

• 1. What Sildenafil ratiopharm is and what it is used for

• 2. What you need to know before you take Sildenafil ratiopharm

• 3. How to take Sildenafil ratiopharm

• 4. Possible side effects

• 5. How to store Sildenafil ratiopharm

• 6. Contents of the pack and other information

1. What Sildenafil ratiopharm is and what it is used for

What Sildenafil ratiopharm is

Sildenafil ratiopharm contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. This medicine 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 adult 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.

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

Do NOT take Sildenafil ratiopharm

• – if you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).

• – 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 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 secondary to blood clots). PDE5 inhibitors, such as sildenafil, have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

• – 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).

Warnings and precautions

Talk to your doctor or pharmacist before taking 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 this medicine

• – if you are already undergoing other treatments for erectile dysfunction.

• – if you are already undergoing treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitors.

• – if you do not have erectile dysfunction.

• – if you are a woman.

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

Children and adolescents

This medicine should NOT be given to children and adolescents under the age of 18.

Other medicines and Sildenafil ratiopharm

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

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.

Tell your doctor or pharmacist if you are already taking riociguat.

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.

Sildenafil ratiopharm with food, drink and alcohol

When this medicine 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 this medicine.

Driving and using machines

This medicine 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.

Sildenafil ratiopharm contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.

3. How to take Sildenafil ratiopharm

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 dose is

Take 4 or 1 film-coated tablet of Sildenafil ratiopharm as prescribed by your doctor 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.

This medicine 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 this medicine takes longer to work if you take it with a heavy meal.

If this medicine 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects reported in association with the use of sildenafil are usually mild to moderate and of a short duration.

If you experience any of the following serious side effects stop taking Sildenafil ratiopharm and seek medical help immediately:

• – An allergic reaction – this occurs uncommonly (may affect up to 1 in 100 people).

Symptoms include sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat.

• – Chest pains – this occurs uncommonly. If this occurs during or after intercourse: Get in a semi-sitting position and try to relax.
• Do not use nitrates to treat your chest pain.

• – Prolonged and sometimes painful erections – this occurs rarely (may affect up to 1 in 1,000 people).

If you have an erection, which lasts for more than 4 hours, you should contact a doctor immediately.

• – A sudden decrease or loss of vision – this occurs rarely.

• – Serious skin reactions -this occurs rarely.

Symptoms may include severe peeling and swelling of the skin, blistering of the mouth, genitals and around the eyes, fever.

• – Seizures or fits – this occurs rarely.

Other side effects:

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

Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flush (symptoms include a sudden feeling of heat in your upper body), indigestion, colour tinge to vision, blurred vision, visual disturbance, stuffy nose and dizziness.

Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, bloodshot eyes/red eyes, eye pain, seeing flashes of light, visual brightness, light sensitivity, watery eyes, pounding heartbeat, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling sleepy, reduced sense of touch, vertigo, ringing in the ears, dry mouth, blocked or stuffy sinuses, inflammation of the lining of the nose (symptoms include runny nose, sneezing and stuffy nose), upper abdominal pain, gastro-oesophageal reflux disease (symptoms include heartburn), presence of blood in urine, pain in the arms or legs, nosebleed, feeling hot and feeling tired.

Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary decreased blood flow to parts of the brain, feeling of tightening of the throat, numb mouth, bleeding at the back of the eye, double vision, reduced sharpness of vision, abnormal sensation in the eye, swelling of the eye or eyelid, small particles or spots in your vision, seeing halos around lights, dilation of the pupil of the eye, discolouration of the white of the eye, penile bleeding, presence of blood in semen, dry nose, swelling of the inside of the nose, feeling irritable and sudden decrease or loss of hearing.

From post-marketing experience cases of unstable angina (a heart condition) and sudden death have been reported rarely. Of note, most, but not all, of the men who experienced these side effects had heart problems before taking this medicine. It is not possible to determine whether these events were directly related to Sildenafil ratiopharm.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible 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.

5. How to store Sildenafil ratiopharm

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 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.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Sildenafil ratiopharm contains

• – The active substance is sildenafil.

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

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

What Sildenafil ratiopharm looks like and contents of the pack

Sildenafil ratiopharm are white to off-white, oblong film-coated tablets with edge and score line on one side. The tablet can be divided into equal doses.

Sildenafil ratiopharm are supplied 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-StraBe 3

89079 Ulm

Germany

Manufacturer

Merckle GmbH

Ludwig-Merckle-StraBe 3

89143 Blaubeuren

Germany

Teva Operations Poland Sp. z o.o.

ul. Mogilska 80

31–546 Krakow

Poland

HBM Pharma s.r.o.

Sklabinska 30

036 80 Martin

Slovak Republic

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

België/Belgiqu­e/Belgien Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373	Lietuva UAB Teva Baltics Tel: +370 52660203
Efc^rapufl TeBa OapMa EAfl Ten: +359 24899585	Luxembourg/Lu­xemburg ratiopharm GmbH Allemagne/Deut­schland Tel/Tel: +49 73140202
Česká republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111	Magyarorszag Teva Gyogyszergyar Zrt. Tel: +36 12886400
Danmark Teva Denmark A/S Tlf: +45 44985511	Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407117
Deutschland ratiopharm GmbH Tel: +49 73140202	Nederland Teva Nederland B.V. Tel: +31 8000228400
Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801	Norge Teva Norway AS Tlf: +47 66775590
EXÀàôa Specifar A.B.E.E. Tql: +30 2118805000	Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070
España ratiopharm España, S.A. Tel: +34 915672970	Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300
France Teva Santé Tél: +33 155917800	Portugal ratiopharm – Comercio e Industria de Produtos Farmaceuticos, Lda. Tel: +351 214767550
Hrvatska Pliva Hrvatska d.o.o. Tel: +385 13720000	Romania Teva Pharmaceuticals S.R.L. Tel: +40 212306524
Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407117	Slovenija Pliva Ljubljana d.o.o. Tel: +386 15890390

Slovenská republika

TEVA Pharmaceuticals Slovakia s.r.o.

Tel: +421 257267911

Suomi/Finland

Teva Finland Oy

Puh/Tel: +358 201805900

United Kingdom (Northern Ireland)

Teva Pharmaceuticals Ireland

Ireland

Tel: +44 2075407117

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

Detailed information on this medicine is available on the European Medicines Agency web site:.

Package leaflet: Information for the patient

Sildenafil ratiopharm 100 mg film -coated tablets

sildenafil

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.

• – 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.

What is in this leaflet

• 1. What Sildenafil ratiopharm is and what it is used for

• 2. What you need to know before you take Sildenafil ratiopharm

• 3. How to take Sildenafil ratiopharm

• 4. Possible side effects

• 5. How to store Sildenafil ratiopharm

• 6. Contents of the pack and other information

1. What Sildenafil ratiopharm is and what it is used for

What Sildenafil ratiopharm is

Sildenafil ratiopharm contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. This medicine 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 adult 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.

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

Do NOT take Sildenafil ratiopharm

• – if you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).

• – 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 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 secondary to blood clots). PDE5 inhibitors, such as sildenafil, have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

• – if you have a severe heart problem.

• – if you have recently had a stroke or a heart attack.

• – if you have low blood pressure.

Warnings and precautions

Talk to your doctor or pharmacist before taking 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 this medicine

• – if you are already undergoing other treatments for erectile dysfunction.

• – if you are already undergoing treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitors.

• – if you do not have erectile dysfunction.

• – if you are a woman.

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

Children and adolescents

This medicine should NOT be given to children and adolescents under the age of 18.

Other medicines and Sildenafil ratiopharm

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

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.

Tell your doctor or pharmacist if you are already taking riociguat.

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.

Sildenafil ratiopharm with food, drink and alcohol

When this medicine 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 this medicine.

Driving and using machines

This medicine 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.

Sildenafil ratiopharm contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.

3. How to take Sildenafil ratiopharm

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 dose is

Take 4 or 1 film-coated tablet of Sildenafil ratiopharm as prescribed by your doctor 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.

This medicine 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 this medicine takes longer to work if you take it with a heavy meal.

If this medicine 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects reported in association with the use of sildenafil are usually mild to moderate and of a short duration.

If you experience any of the following serious side effects stop taking Sildenafil ratiopharm and seek medical help immediately:

• – An allergic reaction – this occurs uncommonly (may affect up to 1 in 100 people).

Symptoms include sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat.

• – Chest pains – this occurs uncommonly. If this occurs during or after intercourse: Get in a semi-sitting position and try to relax.
• Do not use nitrates to treat your chest pain.

• – Prolonged and sometimes painful erections – this occurs rarely (may affect up to 1 in 1,000 people).

If you have an erection, which lasts for more than 4 hours, you should contact a doctor immediately.

• – A sudden decrease or loss of vision – this occurs rarely.

• – Serious skin reactions – this occurs rarely.

Symptoms may include severe peeling and swelling of the skin, blistering of the mouth, genitals and around the eyes, fever.

• – Seizures or fits – this occurs rarely.

Other side effects:

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

Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flush (symptoms include a sudden feeling of heat in your upper body), indigestion, colour tinge to vision, blurred vision, visual disturbance, stuffy nose and dizziness.

Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, bloodshot eyes/red eyes, eye pain, seeing flashes of light, visual brightness, light sensitivity, watery eyes, pounding heartbeat, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling sleepy, reduced sense of touch, vertigo, ringing in the ears, dry mouth, blocked or stuffy sinuses, inflammation of the lining of the nose (symptoms include runny nose, sneezing and stuffy nose), upper abdominal pain, gastro-oesophageal reflux disease (symptoms include heartburn), presence of blood in urine, pain in the arms or legs, nosebleed, feeling hot and feeling tired.

Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary decreased blood flow to parts of the brain, feeling of tightening of the throat, numb mouth, bleeding at the back of the eye, double vision, reduced sharpness of vision, abnormal sensation in the eye, swelling of the eye or eyelid, small particles or spots in your vision, seeing halos around lights, dilation of the pupil of the eye, discolouration of the white of the eye, penile bleeding, presence of blood in semen, dry nose, swelling of the inside of the nose, feeling irritable and sudden decrease or loss of hearing.

From post-marketing experience cases of unstable angina (a heart condition) and sudden death have been reported rarely. Of note, most, but not all, of the men who experienced these side effects had heart problems before taking this medicine. It is not possible to determine whether these events were directly related to Sildenafil ratiopharm.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible 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.

5. How to store Sildenafil ratiopharm

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 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.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Sildenafil ratiopharm contains

• – The active substance is sildenafil.

Each film-coated tablet contains sildenafil citrate equivalent to 100 mg of sildenafil.

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