Sildenafil Ratiopharm: detailed information

Patient Information Leaflet

Sildenafil ratiopharm 25 mg film-coated tablets

sildenafil
Please 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful to them.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Sildenafil ratiopharm is and what it is used for
What you need to know before taking Sildenafil ratiopharm
How to take Sildenafil ratiopharm
Possible side effects
How to store Sildenafil ratiopharm
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 class of medicines
called phosphodiesterase type 5 (PDE5) inhibitors. This medicine helps maintain an erection long enough
for complete and satisfying sexual intercourse. It reduces the action of a natural chemical in the body
that prevents erection. Sildenafil ratiopharm will only work if you are sexually stimulated.
What Sildenafil ratiopharm is used for
Sildenafil ratiopharm is a treatment for adult men with erectile dysfunction, sometimes called impotence.
This condition occurs when a man is unable to achieve or maintain an erection suitable for sexual intercourse.

2. What you need to know before taking Sildenafil ratiopharm

DO NOT take Sildenafil ratiopharm

if you are allergic to sildenafil or to any of the other ingredients of this medicine (listed in section 6).
if you are taking medicines containing nitrates (e.g. glyceryl trinitrate) or nitric oxide donors (e.g. amyl nitrite, also known as "poppers"). These medicines are often used to relieve symptoms of chest pain (angina pectoris). Taking these medicines with Sildenafil ratiopharm could dangerously affect your blood pressure. Inform your doctor if you are taking any of these medicines. If you have any doubts, 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 due to blood clots). PDE5 inhibitors such as sildenafil have been shown to increase the blood pressure-lowering effect of this medicine. If you are taking riociguat or have any doubts, inform your doctor.
if you have a serious heart problem.
if you have recently had a heart attack or stroke.
if you have low blood pressure.
if you have a serious liver problem.
if you have a rare inherited eye disease (such as retinitis pigmentosa).
if you have previously experienced vision loss caused by a condition affecting the eyes known as "eye stroke" (non-arteritic ischemic optic neuropathy, NAION).

Warnings and precautions
Talk to your doctor or pharmacist before taking Sildenafil ratiopharm

if you have heart problems. In this case, your doctor must carefully assess whether your heart can tolerate the additional strain of sexual activity.
if you suffer from any of the following conditions or symptoms, as you may be more likely to experience side effects:
- an abnormality of red blood cells (sickle cell anemia);
- blood cancer (leukemia);
- bone marrow cancer (multiple myeloma);
- any disease or deformity of the penis.
if you suffer from any of the following conditions, inform your doctor, who will carefully evaluate whether this medicine is suitable for you:
- if you currently have a stomach ulcer.
- if you have a bleeding disorder (e.g. hemophilia).
if you have kidney or liver problems, you must inform your doctor. In such cases, your doctor may decide to prescribe a lower dose.

DO NOT take this medicine

if you are already taking other treatments for erectile dysfunction.
if you are already taking treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other phosphodiesterase type 5 (PDE5) inhibitor.
if you do not have erectile dysfunction.
if you are a woman.

If you experience a sudden decrease in vision, stop taking Sildenafil ratiopharm and contact your doctor immediately.

Children and adolescents
This medicine must not be administered to children and adolescents under 18 years of age.

Other medicines and Sildenafil ratiopharm
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In case of a medical emergency, inform those treating you that you are taking Sildenafil ratiopharm.
You must not take Sildenafil ratiopharm if you are taking medicines containing nitrates (e.g. glyceryl trinitrate) or nitric oxide donors (e.g. amyl nitrite, also known as "poppers"). These medicines are often used to relieve symptoms of chest pain (angina pectoris). Taking nitrates or nitric oxide donors together with Sildenafil ratiopharm can have dangerous effects on your blood pressure.
Inform your doctor or pharmacist if you are already taking riociguat.
Taking Sildenafil ratiopharm together with certain medicines may cause problems. Therefore, inform your doctor if you are taking any of the following medicines:

ritonavir or saquinavir (medicines used to treat HIV infections),
ketoconazole or itraconazole (medicines used to treat fungal infections),
erythromycin (an antibiotic),
cimetidine (a medicine used to treat heartburn and gastric ulcers),
alpha-blockers (a class of medicines used to treat high blood pressure or enlarged prostate [benign prostatic hyperplasia]). Some patients taking alpha-blockers may experience dizziness or a sensation of lightheadedness when standing up. These are symptoms of low blood pressure occurring when rising quickly from a sitting or lying position (postural hypotension). These symptoms generally occur within 4 hours after taking Sildenafil ratiopharm. To reduce the risk of these symptoms, you should already be on stable alpha-blocker therapy before starting Sildenafil ratiopharm.
medicines containing sacubitril/valsartan, used to treat heart failure. If you are taking any of these medicines, your doctor may start you on the lowest dose (25 mg) of Sildenafil ratiopharm. If you are taking ritonavir, you must not exceed a maximum dose of 25 mg of sildenafil within 48 hours.

Sildenafil ratiopharm with food, drinks and alcohol
Taking this medicine with food may delay the onset of the effect of Sildenafil ratiopharm.
Drinking alcohol may worsen the difficulty in achieving an erection. To get the maximum benefit from this medicine, it is advisable to avoid alcohol before taking this medicine.

Driving and using machines
This medicine may cause dizziness or affect your vision or hearing. If you experience dizziness or changes in vision or hearing after taking Sildenafil ratiopharm, do not drive and do not operate machinery.

Sildenafil ratiopharm contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially 'sodium-free'.

3. How to take Sildenafil ratiopharm

Take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is
Take 1 sildenafil orodispersible tablet approximately 1 hour before sexual activity.
Swallow the orodispersible tablet whole with a glass of water.
Do not take more orodispersible tablets than prescribed by your doctor.
Do not take Sildenafil ratiopharm more than once a day.
This medicine will help you achieve an erection only if you are sexually stimulated. The time
required for Sildenafil ratiopharm to take effect varies from person to person, but
usually ranges from half an hour to one hour. The effect of this medicine may take
longer if you have just eaten a heavy meal.
If this medicine does not help you achieve an erection or if the erection does not last long enough
to complete sexual intercourse, inform your doctor.
If you take more Sildenafil ratiopharm than you should
If you take too much Sildenafil ratiopharm, you may experience an increase in side effects and
the onset of severe muscle pain. If you take more Sildenafil ratiopharm than prescribed, inform
your doctor.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The side effects reported with sildenafil are usually mild to moderate and short-lived.
If you experience any of the following serious side effects, stop taking
Sildenafil ratiopharm and contact your doctor immediately:

Allergic reaction – occurs uncommonly (may affect up to 1 in 100 people). Symptoms include sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat.
Chest pain – occurs uncommonly. If it occurs during or after sexual intercourse:
- Sit in a semi-upright position and try to relax. Do not use nitrates to treat chest pain.
Prolonged and sometimes painful erections – occur rarely (may affect up to 1 in 1,000 people). If this type of erection lasts continuously for more than 4 hours, contact your doctor immediately.
Sudden decrease or loss of vision – occurs rarely.
Severe skin reactions – occur rarely. Symptoms may include severe peeling and swelling of the skin, blisters in the mouth, genital area or around the eyes, fever.
Seizures or convulsions – occur 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 flushes (symptoms include a sudden feeling of warmth in the upper part of the body), indigestion, increased intensity of colours in vision, blurred vision, visual disturbances, nasal congestion and dizziness.
Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye redness, eye pain, flashes of light, increased light perception, light sensitivity, tearing, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sensitivity to touch, vertigo, ringing in the ears, dry mouth, blocked or congested sinuses, inflammation of the nasal mucosa (symptoms include runny nose, sneezing and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn), blood in the urine, pain in arms or legs, nosebleeds, sensation of warmth and fatigue.
Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary reduction in blood flow to certain areas of the brain, sensation of throat tightness, numbness of the mouth, bleeding from the back of the eye, double vision, reduced visual acuity, abnormal eye sensitivity, swelling of the eyes or eyelids, appearance of spots or floaters in the visual field, seeing halos around lights, dilated pupils, changes in the white colour of the sclera (part of the eye), penile bleeding, blood in semen, dry nose, swelling of the nasal mucosa, irritability and sudden decrease or loss of hearing.
After marketing experience, rare cases of unstable angina (a heart condition) and sudden death have been reported. It should be noted that most, but not all, of the men who experienced these side effects already had pre-existing heart problems before taking this medicine. It is not possible to determine whether these events are directly related to the use of Sildenafil ratiopharm.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system referred to in Annex 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 packaging and on the
blister after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents 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 components are microcrystalline cellulose, hypromellose, sodium croscarmellose, magnesium stearate, calcium hydrogen phosphate, talc, macrogol 6000, titanium dioxide, iron oxide red.

Description of the appearance of Sildenafil ratiopharm and pack sizes
Sildenafil ratiopharm film-coated tablets are oblong, white to off-white, and have an inscription.
Sildenafil ratiopharm is available 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-Straße 3
89079 Ulm
Germany

Manufacturer
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
Slovak Republic

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./AG UAB Teva Baltics
Tél/Tel: +32 38207373 Tel: +370 52660203

България Luxembourg/Luxemburg
Тева Фарма ЕАД ratiopharm GmbH
Тел: +359 24899585 Allemagne/Deutschland
Tél/Tel: +49 73140202

Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251007111 Tel: +36 12886400

Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland
Tlf: +45 44985511 L-Irlanda
Tel: +44 2075407117

Deutschland Nederland
ratiopharm GmbH Teva Nederland B.V.
Tel: +49 73140202 Tel: +31 8000228400

Eesti Norge
UAB Teva Baltics Eesti filiaal Teva Norway AS
Tel: +372 6610801 Tlf: +47 66775590

Ελλάδα Österreich
Specifar Α.Β.Ε.Ε. ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 2118805000 Tel: +43 1970070

España Polska
Teva Pharma, S.L.U. Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +34 913873280 Tel: +48 223459300

France Portugal
Teva Santé ratiopharm - Comércio e Industria de Produtos
Tél: +33 155917800 Farmacêuticos, Lda.
Tel: +351 214767550

Hrvatska România
Pliva Hrvatska d.o.o. Teva Pharmaceuticals S.R.L.
Tel: +385 13720000 Tel: +40 212306524

Ireland Slovenija
Teva Pharmaceuticals Ireland Pliva Ljubljana d.o.o.
Tel: +44 2075407117 Tel: +386 15890390

Ísland Slovenská republika
Teva Finland Oy TEVA Pharmaceuticals Slovakia s.r.o.
Finnland Tel: +421 257267911
Sími: +358 201805900

Italia Suomi/Finland
Teva Italia S.r.l. Teva Finland Oy
Tel: +39 028917981 Puh/Tel: +358 201805900

Κύπρος Sverige
Specifar Α.Β.Ε.Ε. Teva Sweden AB
Ελλάδα Tel: +46 42121100
Τηλ: +30 2118805000

Latvija United Kingdom (Northern Ireland)
UAB Teva Baltics filiāle Latvijā Teva Pharmaceuticals Ireland
Tel: +371 67323666 Ireland
Tel: +44 2075407117

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu .

Patient Information Leaflet

Sildenafil ratiopharm 50 mg film-coated tablets

sildenafil
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Sildenafil ratiopharm is and what it is used for
What you need to know before taking Sildenafil ratiopharm
How to take Sildenafil ratiopharm
Possible side effects
How to store Sildenafil ratiopharm
Contents of the pack and other information

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

What Sildenafil ratiopharm is used for
Sildenafil ratiopharm is a treatment for adult men who have erectile dysfunction, sometimes called impotence.
This condition occurs when a man is unable to achieve or maintain an erection suitable for sexual intercourse.

2. What you should know before taking Sildenafil ratiopharm

Do NOT take Sildenafil ratiopharm

if you are allergic to sildenafil or to any of the other ingredients of this medicine (listed in section 6).
if you are taking medicines containing nitrates (e.g. glyceryl trinitrate) or nitric oxide donors (e.g. amyl nitrite, also known as "poppers"). These medicines are often used to relieve symptoms of chest pain (angina pectoris). Taking them with Sildenafil ratiopharm could dangerously affect your blood pressure. Inform your doctor if you are taking any of these medicines. If you have any doubts, 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 due to blood clots). PDE5 inhibitors such as sildenafil have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, inform your doctor.
if you have a serious heart problem.
if you have recently had a heart attack or heart-related problem.
if you have low blood pressure.
if you have a serious liver problem.
if you have a rare inherited eye disease (such as retinitis pigmentosa).
if you have previously experienced sudden vision loss caused by a condition affecting the eye known as "eye stroke" (non-arteritic ischemic optic neuropathy, NAION).

Warnings and precautions
Talk to your doctor or pharmacist before taking Sildenafil ratiopharm

if you have heart problems. In such cases, your doctor will need to carefully assess whether your heart can tolerate the additional strain of sexual activity.
if you suffer from any of the following disorders or symptoms, as you may be more likely to experience side effects:
- a red blood cell disorder (sickle cell anaemia);
- blood cancer (leukaemia);
- bone marrow cancer (multiple myeloma);
- any disease or deformity of the penis.
if you have any of the following conditions, inform your doctor, who will carefully evaluate whether this medicine is suitable for you:
- if you currently have a stomach ulcer.
- if you have bleeding disorders (e.g. haemophilia).
if you have kidney or liver problems, you must inform your doctor. In such cases, your doctor may decide to prescribe a lower dose.

You must NOT take this medicine

if you are already taking other treatments for erectile dysfunction.
if you are already taking treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other phosphodiesterase type 5 (PDE5) inhibitor.
if you do not have erectile dysfunction.
if you are a woman.

If you experience sudden vision loss, stop taking Sildenafil ratiopharm and contact your doctor immediately.

Children and adolescents
This medicine must not be administered to children and adolescents under 18 years of age.

Other medicines and Sildenafil ratiopharm
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In case of a medical emergency, inform anyone treating you that you are taking Sildenafil ratiopharm.
You must not take Sildenafil ratiopharm if you are taking medicines containing nitrates (e.g. glyceryl trinitrate) or nitric oxide donors (e.g. amyl nitrite, also known as "poppers"). These medicines are often used to relieve symptoms of chest pain (angina pectoris). Taking nitrates or nitric oxide together with Sildenafil ratiopharm can have dangerous effects on your blood pressure.
Inform your doctor or pharmacist if you are already taking riociguat.
Taking Sildenafil ratiopharm together with certain medicines may cause problems. Therefore, inform your doctor if you are taking any of the following medicines:

ritonavir or saquinavir (medicines used to treat HIV infections),
ketoconazole or itraconazole (medicines used to treat fungal infections),
erythromycin (an antibiotic),
cimetidine (a medicine used to treat heartburn and gastric ulcers),
alpha-blockers (a class of medicines used to treat high blood pressure or enlarged prostate [benign prostatic hyperplasia]). Some patients taking alpha-blockers may experience dizziness or a sensation of lightheadedness when standing up. These are symptoms of low blood pressure occurring when rising quickly from a sitting or lying position (postural hypotension). These symptoms usually occur within 4 hours after taking Sildenafil ratiopharm. To reduce the likelihood of these symptoms, you should already be on a stable dose of an alpha-blocker before starting Sildenafil ratiopharm.
medicines containing sacubitril/valsartan, used to treat heart failure. 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 must not exceed a maximum dose of 25 mg of sildenafil within 48 hours.

Sildenafil ratiopharm with food, drinks and alcohol
If you take this medicine with food, the onset of action of Sildenafil ratiopharm may be delayed.
Drinking alcohol may worsen difficulties in achieving an erection. To obtain the maximum benefit from this medicine, it is advisable to avoid alcohol consumption before using this medicine.

Sildenafil ratiopharm contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially 'sodium-free'.

3. How to take Sildenafil ratiopharm

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is
Take ½ or 1 film-coated tablet of Sildenafil ratiopharm as prescribed by your doctor, approximately 1
hour before sexual activity. Swallow the film-coated tablet whole with a glass of
water.
Do not take more film-coated tablets than prescribed by your doctor.
Do not take Sildenafil ratiopharm more than once a day.
This medicine will help you achieve an erection only if you are sexually stimulated. The
time required for Sildenafil ratiopharm to take effect varies from person to person, but
generally ranges from half an hour to one hour. The effect of this medicine may take
longer if you have just eaten a large meal.
If this medicine does not help you achieve an erection or if the erection does not last long
enough to complete sexual intercourse, inform your doctor.
If you take more Sildenafil ratiopharm than you should
If you take too much Sildenafil ratiopharm, you may experience an increase in unwanted effects and
the onset of severe muscle pain. If you take more Sildenafil ratiopharm than you should, inform your
doctor.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The side effects reported in association with sildenafil use are usually mild to moderate in intensity and short-lived.
If you experience any of the following serious side effects, stop taking
Sildenafil ratiopharm and contact your doctor immediately:

Allergic reaction – occurs uncommonly (may affect up to 1 in 100 people). Symptoms include sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat.
Chest pain – occurs uncommonly. If it occurs during or after sexual activity:
- Sit semi-reclined and try to relax.
- Do not use nitrates to treat chest pain.
Prolonged and sometimes painful erections – occur rarely (may affect up to 1 in 1,000 people). If this type of erection persists continuously for more than 4 hours, contact your doctor immediately.
Sudden decrease or loss of vision – occurs rarely.
Severe skin reactions – occur rarely. Symptoms may include severe peeling and swelling of the skin, mouth blisters, genital or eye-area blisters, fever.
Seizures or fits – occur 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 flushes (symptoms include a sudden feeling of warmth in the upper body), indigestion, increased intensity of colours in vision, blurred vision, visual disturbances, nasal congestion, and dizziness.
Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye redness, eye pain, light flashes, increased light perception, light sensitivity, tearing, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sensitivity to touch, vertigo, tinnitus, dry mouth, blocked or congested nasal sinuses, nasal mucosal inflammation (symptoms include runny nose, sneezing and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn), blood in urine, pain in arms or legs, epistaxis, feeling of warmth and fatigue.
Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary reduction in blood supply to certain areas of the brain, sensation of throat tightness, numbness of the mouth, bleeding from the back of the eye, double vision, reduced visual acuity, abnormal eye sensitivity, swelling of the eyes or eyelids, appearance of spots or particles in the visual field, seeing halos around lights, pupil dilation, changes in the white colour of the sclera (part of the eye), penile bleeding, blood in semen, dry nose, swelling of the nasal mucosa, irritability and sudden decrease or loss of hearing.

From post-marketing experience, rare cases of unstable angina (a heart condition) and sudden death have been reported. It should be noted that most, but not all, of the men who experienced these side effects already had pre-existing heart problems before taking this medicine. It is not possible to determine whether these events are directly related to the use of Sildenafil ratiopharm.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex 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 packaging and on the
blister after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents 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 components are microcrystalline cellulose, hypromellose, sodium croscarmellose, magnesium stearate, calcium hydrogen phosphate, talc, macrogol 6000, titanium dioxide, iron oxide red.

Description of the appearance of Sildenafil ratiopharm and contents of the pack
Sildenafil ratiopharm film-coated tablets are oblong, white to off-white in colour, with an indentation and a division line on one side. The tablet can be divided into equal parts.
Sildenafil ratiopharm is 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-Straße 3
89079 Ulm
Germany

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

België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./AG UAB Teva Baltics
Tél/Tel: +32 38207373 Tel: +370 52660203

България Luxembourg/Luxemburg
Тева Фарма ЕАД ratiopharm GmbH
Тел: +359 24899585 Allemagne/Deutschland
Tél/Tel: +49 73140202

Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251007111 Tel: +36 12886400

Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland
Tlf: +45 44985511 Ireland
Tel: +44 2075407117

Deutschland Nederland
ratiopharm GmbH Teva Nederland B.V.
Tel: +49 73140202 Tel: +31 8000228400

Eesti Norge
UAB Teva Baltics Eesti filiaal Teva Norway AS
Tel: +372 6610801 Tlf: +47 66775590

Ελλάδα Österreich
Specifar Α.Β.Ε.Ε. ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 2118805000 Tel: +43 1970070

España Polska
Teva Pharma, S.L.U. Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +34 913873280 Tel: +48 223459300

France Portugal
Teva Santé ratiopharm - Comércio e Industria de Produtos
Tél: +33 155917800 Farmacêuticos, Lda.
Tel: +351 214767550

Hrvatska România
Pliva Hrvatska d.o.o. Teva Pharmaceuticals S.R.L.
Tel: +385 13720000 Tel: +40 212306524

Ireland Slovenija
Teva Pharmaceuticals Ireland Pliva Ljubljana d.o.o.
Tel: +44 2075407117 Tel: +386 15890390

Ísland Slovenská republika
Teva Finland Oy TEVA Pharmaceuticals Slovakia s.r.o.
Finland Sími: +358 201805900
Tel: +421 257267911

Italia Suomi/Finland
Teva Italia S.r.l. Teva Finland Oy
Tel: +39 028917981 Puh/Tel: +358 201805900

Κύπρος Sverige
Specifar Α.Β.Ε.Ε. Teva Sweden AB
Greece Τηλ: +30 2118805000
Tel: +46 42121100

Latvija United Kingdom (Northern Ireland)
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More detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu .

Patient Information Leaflet

Sildenafil ratiopharm 100 mg film-coated tablets

sildenafil
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Sildenafil ratiopharm is and what it is used for
What you need to know before taking Sildenafil ratiopharm
How to take Sildenafil ratiopharm
Possible side effects
How to store Sildenafil ratiopharm
Contents of the pack and other information

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

2. What you need to know before taking Sildenafil ratiopharm

DO NOT take Sildenafil ratiopharm

if you are allergic to sildenafil or to any of the other ingredients of this medicine (listed in section 6).
if you are taking medicines containing nitrates (e.g. glyceryl trinitrate) or nitric oxide donors (e.g. amyl nitrite, also known as "poppers"). These medicines are often used to relieve symptoms of chest pain (angina pectoris). Taking these medicines with Sildenafil ratiopharm could dangerously affect your blood pressure. Inform your doctor if you are taking any of these medicines. If you have any doubts, 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 due to blood clots). PDE5 inhibitors such as sildenafil have been shown to increase the hypotensive effect of this drug. If you are taking riociguat or have any doubts, inform your doctor.
if you have a serious heart condition.
if you have recently had a heart attack or stroke.
if you have low blood pressure.
if you have a severe liver problem.
if you have a rare inherited eye disease (such as retinitis pigmentosa).
if you have previously experienced sudden vision loss caused by a condition affecting the eye known as "eye stroke" (non-arteritic ischemic optic neuropathy, NAION).

Warnings and precautions
Talk to your doctor or pharmacist before taking Sildenafil ratiopharm

if you have heart problems. In this case, your doctor will need to carefully assess whether your heart can tolerate the additional strain of sexual activity.
if you suffer from any of the following conditions or symptoms, as you may be at higher risk of side effects:
- a red blood cell disorder (sickle cell anaemia);
- blood cancer (leukaemia);
- bone marrow cancer (multiple myeloma);
- any disease or deformity of the penis.
if you have any of the following conditions, inform your doctor, who will carefully evaluate whether this medicine is suitable for you:
- if you currently have a stomach ulcer.
- if you have bleeding disorders (e.g. haemophilia).
if you have kidney or liver problems, you must inform your doctor. In such cases, your doctor may decide to prescribe a lower dose.

DO NOT take this medicine

if you are already taking other treatments for erectile dysfunction.
if you are already taking treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other phosphodiesterase type 5 (PDE5) inhibitor.
if you do not have erectile dysfunction.
if you are a woman.

If you experience sudden vision loss, stop taking Sildenafil ratiopharm and contact your doctor immediately.

Children and adolescents
This medicine must not be administered to children and adolescents under 18 years of age.

Other medicines and Sildenafil ratiopharm
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In case of a medical emergency, inform the healthcare provider that you are taking Sildenafil ratiopharm.
You must not take Sildenafil ratiopharm if you are taking medicines containing nitrates (e.g. glyceryl trinitrate) or nitric oxide donors (e.g. amyl nitrite, also known as "poppers"). These medicines are often used to relieve symptoms of chest pain (angina pectoris). Taking nitrates or nitric oxide together with Sildenafil ratiopharm can have dangerous effects on your blood pressure.
Inform your doctor or pharmacist if you are already taking riociguat.
Taking Sildenafil ratiopharm together with certain medicines may cause problems. Therefore, inform your doctor if you are taking any of the following medicines:

ritonavir or saquinavir (medicines used to treat HIV infections),
ketoconazole or itraconazole (medicines used to treat fungal infections),
erythromycin (an antibiotic),
cimetidine (a medicine used to treat heartburn and gastric ulcers),
alpha-blockers (a class of medicines used to treat high blood pressure or enlarged prostate [benign prostatic hyperplasia]). Some patients taking alpha-blockers may experience dizziness or a sensation of lightheadedness when standing up. These are symptoms of low blood pressure occurring when rising quickly from a sitting or lying position (postural hypotension). These symptoms generally occur within 4 hours after taking Sildenafil ratiopharm. To reduce the likelihood of these symptoms, you should already be on a stable dose of an alpha-blocker before starting Sildenafil ratiopharm.
medicines containing sacubitril/valsartan, used to treat heart failure. If you are taking any of these medicines, your doctor may start you on the lowest dose (25 mg) of Sildenafil ratiopharm. If you are taking ritonavir, you must not exceed a maximum dose of 25 mg of sildenafil within 48 hours.

Sildenafil ratiopharm with food, drinks and alcohol
Taking this medicine with food may delay the onset of Sildenafil ratiopharm's effect.
Drinking alcohol may worsen difficulties in achieving an erection. To get the maximum benefit from this medicine, it is advisable to avoid alcohol before using this medicine.

Driving and using machines
This medicine may cause dizziness or affect your vision or hearing. If you feel dizzy or if your vision or hearing is impaired after taking Sildenafil ratiopharm, do not drive and do not operate machinery.

Sildenafil ratiopharm contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially 'sodium-free'.

3. How to take Sildenafil ratiopharm

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Recommended dose
Take ½ or 1 film-coated tablet of Sildenafil ratiopharm as prescribed by your doctor, approximately 1
hour before sexual activity. Swallow the film-coated tablet whole with a glass of water.
Do not take more film-coated tablets than prescribed by your doctor.
Do not take Sildenafil ratiopharm more than once a day.
This medicine will help you achieve an erection only if you are sexually stimulated. The time required
for Sildenafil ratiopharm to take effect varies from person to person, but generally ranges from half
an hour to one hour. The effect of this medicine may take longer if you have just eaten a heavy meal.
If this medicine does not help you achieve an erection or if the erection does not last long enough to
complete sexual intercourse, inform your doctor.
If you take more Sildenafil ratiopharm than you should
If you take too much Sildenafil ratiopharm, you may experience an increase in adverse effects and
the onset of severe muscle pain. If you take more Sildenafil ratiopharm than prescribed, inform your
doctor.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. The side effects reported in association with sildenafil use are usually mild to moderate and short-lived.
If you experience any of the following serious side effects, stop taking
Sildenafil ratiopharm and contact your doctor immediately:

Allergic reaction – occurs uncommonly (may affect up to 1 in 100 people). Symptoms include sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat.
Chest pain – occurs uncommonly. If it occurs during or after sexual intercourse:
- Sit in a semi-upright position and try to relax.
- Do not use nitrates to treat chest pain.
Prolonged and sometimes painful erections – occur rarely (may affect up to 1 in 1,000 people). If this type of erection lasts continuously for more than 4 hours, contact your doctor immediately.
Sudden decrease or loss of vision – occurs rarely.
Severe skin reactions – occur rarely. Symptoms may include severe peeling and swelling of the skin, blisters in the mouth, genital area or around the eyes, fever.
Seizures or convulsions – occur 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 flushes (symptoms include a sudden feeling of warmth in the upper body), indigestion, increased intensity of colours in vision, blurred vision, visual disturbances, nasal congestion and dizziness.
Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye redness, eye pain, flashes of light, increased light perception, light sensitivity, tearing, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sensitivity to touch, vertigo, ringing in the ears, dry mouth, blocked or congested nasal sinuses, inflammation of the nasal mucosa (symptoms include runny nose, sneezing and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (including heartburn), blood in urine, pain in arms or legs, nosebleeds, feeling of warmth and fatigue.
Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary reduction in blood flow to certain areas of the brain, sensation of throat tightness, numbness of the mouth, bleeding from the back of the eye, double vision, reduced visual acuity, abnormal eye sensitivity, swelling of the eyes or eyelids, appearance of spots or floaters in the visual field, seeing halos around lights, dilated pupils, change in the white colour of the sclera (part of the eye), bleeding from the penis, blood in semen, dry nose, swelling of the nasal mucosa, irritability and sudden decrease or loss of hearing.
After marketing experience, rare cases of unstable angina (a heart condition) and sudden death have been reported. It should be noted that most, but not all, men who experienced these side effects already had pre-existing heart problems before taking this medicine. It is not possible to determine whether these events are directly related to the use of Sildenafil ratiopharm.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex 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 packaging and on the
blister after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents 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 components are microcrystalline cellulose, hypromellose, sodium croscarmellose, magnesium stearate, calcium hydrogen phosphate, talc, macrogol 6000, titanium dioxide, iron oxide red.

Description of the appearance of Sildenafil ratiopharm and contents of the pack
Sildenafil ratiopharm film-coated tablets are oblong, white to off-white in colour, with an indentation and a dividing line on one side. The tablet may be divided into equal parts.
Sildenafil ratiopharm is available in packs containing 1, 2, 4, 8, 12, 24 or 48 film-coated tablets in blisters. Not all pack sizes may be marketed.

Marketing Authorisation Holder
ratiopharm GmbH
Graf-Arco-Straße 3
89079 Ulm
Germany

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder: