Brand name Sildenafil Teva

Form tablets, film-coated

Active substance / Dosage

SILDENAFIL

Prescription type Prescription only

ATC code

G04BE03

Registration number 042088

Manufacturer TEVA B.V.

Table of Contents

Package leaflet: Information for the patient
Sildenafil Teva 25 mg film-coated tablets
1. What Sildenafil Teva is and what it is used for
2. What you need to know before taking Sildenafil Teva
3. How to take Sildenafil Teva
4. Possible side effects
5. How to store Sildenafil Teva
6. Package contents and other information
Patient information leaflet
Sildenafil Teva 50 mg film-coated tablets
1. What Sildenafil Teva is and what it is used for
2. What you need to know before taking Sildenafil Teva
3. How to take Sildenafil Teva
4. Possible side effects
5. How to store Sildenafil Teva
6. Package contents and other information
Patient Information Leaflet: Information for the patient
Sildenafil Teva 100 mg film-coated tablets
1. What Sildenafil Teva is and what it is used for
2. What you need to know before taking Sildenafil Teva
3. How to take Sildenafil Teva
4. Possible side effects
5. How to store Sildenafil Teva
6. Package contents and other information

Package leaflet: Information for the patient

Sildenafil Teva 25 mg film-coated tablets

sildenafil
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, pharmacist, or nurse.
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 could be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

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

Sildenafil Teva contains the active substance sildenafil, which belongs to a class of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It helps relax the blood vessels in the penis, allowing increased blood flow into the penis during sexual stimulation. Sildenafil Teva will help you achieve an erection only if you are sexually stimulated.
Sildenafil Teva 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 sufficient for sexual intercourse.

2. What you need to know before taking Sildenafil Teva

Do not take Sildenafil Teva

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 called nitrates, as this combination may cause a dangerous drop in blood pressure. Inform your doctor if you are taking any of these medicines, which are often used to relieve angina pectoris (or "chest pain"). If you are unsure, consult your doctor or pharmacist.
If you are taking medicines known as nitric oxide donors, such as amyl nitrite ("poppers"), because this combination may also cause a dangerous drop in blood pressure.
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 or liver problem.
If you have recently had a stroke or heart attack, or if you have low blood pressure.
If you have a rare inherited eye disease (such as retinitis pigmentosa).
If you have previously experienced vision loss caused by non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Sildenafil Teva.

If you have sickle cell anemia (an abnormality of red blood cells), leukemia (a blood cell tumor), or multiple myeloma (a bone marrow tumor).
If you have a penile deformity or Peyronie's disease.
If you have heart problems. Your doctor must carefully assess whether your heart condition allows you to tolerate the physical strain of sexual activity.
If you currently have a stomach ulcer or coagulation disorders (such as hemophilia).
If you experience a sudden decrease or loss of vision, stop taking Sildenafil Teva and contact your doctor immediately.

You must not use Sildenafil Teva together with other oral or local treatments for erectile dysfunction.
You must not use Sildenafil Teva together with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other phosphodiesterase type 5 (PDE5) inhibitor.
You must not take Sildenafil Teva if you do not have erectile dysfunction.
You must not take Sildenafil Teva if you are a woman.
Special precautions for patients with kidney or liver problems
If you have kidney or liver problems, inform your doctor. Your doctor may decide to prescribe a lower dose.
Children and adolescents
Sildenafil Teva must not be administered to individuals under 18 years of age.
Other medicines and Sildenafil Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Sildenafil Teva tablets may interact with certain medicines, particularly those used to treat chest pain. In case of a medical emergency, you must inform the doctor, pharmacist, or nurse that you have taken Sildenafil Teva and when. Do not take Sildenafil Teva with other medicines unless authorized by your doctor.
Do not take Sildenafil Teva if you are taking medicines called nitrates, because the combination may cause a dangerous drop in blood pressure. Inform your doctor, pharmacist, or nurse if you are taking any of these medicines, which are often used to relieve angina pectoris (or "chest pain").
Do not take Sildenafil Teva if you are using medicines known as nitric oxide donors, such as amyl nitrite ("poppers"), because this combination may also cause a dangerous drop in blood pressure.
Inform your doctor or pharmacist if you are already taking riociguat.
If you are taking protease inhibitors, for example medicines used to treat HIV, your doctor may initially prescribe Sildenafil Teva at the lowest dose (25 mg).
Some patients taking alpha-blockers for high blood pressure or enlarged prostate may experience dizziness or mental confusion, possibly due to low blood pressure when sitting or standing up quickly. Some patients have reported these symptoms when taking Sildenafil Teva together with alpha-blockers. This is more likely to occur within 4 hours after taking Sildenafil Teva. To reduce the risk of these symptoms, you should already be on a stable dose of an alpha-blocker before starting treatment with Sildenafil Teva. Your doctor may start you on the lowest dose (25 mg) of Sildenafil Teva.
Inform your doctor or pharmacist if you are taking medicines containing sacubitril/valsartan, used to treat heart failure.
Sildenafil Teva with food, drinks, and alcohol
Sildenafil Teva can be taken with or without food. However, you may notice that the onset of action of Sildenafil Teva is slower if taken after a heavy meal.
Drinking alcohol may temporarily impair your ability to achieve an erection. To get the maximum benefit from this medicine, it is advisable to avoid consuming large amounts of alcohol before using Sildenafil Teva.
Pregnancy, breastfeeding, and fertility
Sildenafil Teva is not indicated for use in women.
Driving and using machines
Sildenafil Teva may cause dizziness and may affect vision. Before driving or operating machinery, make sure you know how you react to Sildenafil Teva.
Sildenafil Teva 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 Teva

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. The recommended starting dose is 50 mg.
Sildenafil Teva must not be taken more than once a day.
Do not take Sildenafil Teva film-coated tablets in combination with orodispersible tablets containing sildenafil.
Take Sildenafil Teva approximately one hour before planned sexual activity. Swallow the tablet whole with a glass of water.
If you feel that the effect of Sildenafil Teva is too strong or too weak, consult your doctor or pharmacist.
Sildenafil Teva will help you achieve an erection only if you are sexually stimulated. The time needed for Sildenafil Teva to take effect varies from person to person, but generally ranges from half an hour to one hour. The effect of Sildenafil Teva may take longer if you have just eaten a heavy meal.
If Sildenafil Teva 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 Teva than you should
You may experience an increase in the frequency and severity of side effects. Doses higher than 100 mg do not increase effectiveness.
Do not take more tablets than those prescribed by your doctor.
If you take more tablets than prescribed, contact your doctor.
If you have any questions about the use of 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 the use of Sildenafil Teva are usually mild to moderate in intensity and short in duration.
If you experience any of the following serious side effects, stop taking Sildenafil Teva 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 semi-upright 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 skin peeling and swelling, mouth blisters, blisters in the genital area and 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, stuffy nose 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 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 at 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, change in the white colour of the sclera (part of the eye), penile bleeding, presence of 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.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. 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 Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and packaging after EXP. The expiry date refers to the last day of the month.
Store in the original packaging to protect from moisture.
Do not dispose of any medicine 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 Teva contains
The active substance is sildenafil.
Each tablet contains 25 mg of sildenafil (as citrate salt).
The excipients are:
Inner core: microcrystalline cellulose, calcium hydrogen phosphate, croscarmellose sodium, magnesium stearate.
Coating: poly(vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc.

Description of the appearance of Sildenafil Teva and contents of the pack
Sildenafil Teva 25 mg are white, film-coated oval tablets, marked with 'S 25' on one side and smooth on the other.
Sildenafil Teva is available in blister packs containing 2, 4, 8 and 12 tablets, and in perforated unit-dose blisters containing 10 x 1 tablet.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva B.V.
Swensweg 5
2031GA Haarlem
The Netherlands

Manufacturers
TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13,
4042 Debrecen,
Hungary
Teva Pharma, S.L.U.
Polígono Industrial Malpica, calle C, no. 4
50016 Zaragoza
Spain
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80, 31-546 Kraków,
Poland

For further information about this medicine, please contact the local representative of the Marketing Authorization 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
TEVA GmbH Teva Nederland B.V.
Tel: +49 73140208 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 Teva Pharma - Produtos Farmacêuticos, Lda.
Tél: +33 155917800 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 Pharma Iceland ehf. TEVA Pharmaceuticals Slovakia s.r.o.
Sími: +354 5503300 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
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 medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu

Patient information leaflet

Sildenafil Teva 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, pharmacist or nurse.
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 could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

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

Sildenafil Teva contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It helps relax the blood vessels in the penis, allowing blood flow into the penis during sexual stimulation. Sildenafil Teva will help you get an erection only if you are sexually stimulated.
Sildenafil Teva 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 sufficient for sexual intercourse.

2. What you need to know before taking Sildenafil Teva

Do not take Sildenafil Teva

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 called nitrates, because this combination may cause a dangerous drop in blood pressure. Inform your doctor if you are taking any of these medicines, which are often used to relieve angina attacks (or “chest pain”). If you are unsure, consult your doctor or pharmacist.
if you are taking medicines known as nitric oxide donors, such as amyl nitrite (“poppers”), because this combination may also cause a dangerous drop in blood pressure.
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 or liver problem.
if you have recently had a stroke or heart attack, or if you have low blood pressure.
if you have a rare inherited eye disease (such as retinitis pigmentosa).
if you have previously experienced vision loss caused by non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Sildenafil Teva if you have sickle cell anemia (an abnormality of red blood cells), leukemia (a blood cell tumor), or multiple myeloma (a bone marrow tumor).
if you have a penile deformity or Peyronie's disease.
if you have heart problems. Your doctor must carefully assess whether your heart condition allows you to tolerate the physical strain of sexual activity.
if you currently have a stomach ulcer or bleeding disorders (such as hemophilia).
if you experience a sudden decrease or loss of vision, stop taking Sildenafil Teva and contact your doctor immediately.

You must not use Sildenafil Teva together with other oral or topical treatments for erectile dysfunction.
You must not use Sildenafil together with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or with any other phosphodiesterase type 5 (PDE5) inhibitors.
You must not take Sildenafil Teva if you do not have erectile dysfunction.
You must not take Sildenafil Teva if you are a woman.

Special precautions for patients with kidney or liver problems
If you have kidney or liver problems, you must inform your doctor. Your doctor may decide to prescribe a lower dose.

Children and adolescents
Sildenafil Teva must not be given to individuals under 18 years of age.

Other medicines and Sildenafil Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Sildenafil Teva tablets may interact with certain medicines, particularly those used to treat chest pain. In case of a medical emergency, you must inform the doctor, pharmacist, or nurse that you have taken Sildenafil Teva and when it was taken. Do not take Sildenafil Teva with other medicines unless authorized by your doctor.
Do not take Sildenafil Teva if you are taking medicines called nitrates, because the combination may cause a dangerous drop in blood pressure. Inform your doctor, pharmacist, or nurse if you are taking any of these medicines, which are often used to relieve angina attacks (or “chest pain”).
Do not take Sildenafil Teva if you are using medicines known as nitric oxide donors, such as amyl nitrite (“poppers”), because this combination may also cause a dangerous drop in blood pressure.
Inform your doctor or pharmacist if you are already taking riociguat.
If you are taking protease inhibitors, for example medicines used to treat HIV, your doctor may initially prescribe you the lowest dose (25 mg) of Sildenafil Teva.
Some patients taking alpha-blockers for high blood pressure or enlarged prostate may experience dizziness or mental confusion due to low blood pressure when sitting down or standing up quickly. Some patients have reported these symptoms when taking Sildenafil Teva together with alpha-blockers. This is most likely to occur within 4 hours after taking Sildenafil Teva. To reduce the risk of these symptoms, you should already be on a stable dose of an alpha-blocker before starting treatment with Sildenafil Teva. Your doctor may start you on the lowest dose (25 mg) of Sildenafil Teva.
Inform your doctor or pharmacist if you are taking medicines containing sacubitril/valsartan, used to treat heart failure.

Sildenafil Teva with food, drinks and alcohol
Sildenafil Teva can be taken with or without food. However, you may notice that the onset of action of Sildenafil Teva may be slower if taken after a heavy meal.
Drinking alcohol may temporarily impair your ability to get an erection. To get the maximum benefit from this medicine, it is advisable to avoid drinking large amounts of alcohol before using Sildenafil Teva.

Pregnancy, breastfeeding and fertility
Sildenafil Teva is not indicated for use in women.

Driving and using machines
Sildenafil Teva may cause dizziness and may affect vision. Before driving or operating machinery, make sure you know how you react to Sildenafil Teva.

Sildenafil Teva 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 Teva

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. The recommended starting dose is 50 mg.
Sildenafil Teva must not be taken more than once a day.
Do not take Sildenafil Teva film-coated tablets in combination with orodispersible tablets containing sildenafil.
You should take Sildenafil Teva approximately one hour before anticipated sexual activity. Swallow the tablet whole with a glass of water.
If you feel that the effect of Sildenafil Teva is too strong or too weak, consult your doctor or pharmacist.
Sildenafil Teva will help you achieve an erection only if you are sexually stimulated. The time needed for Sildenafil Teva to take effect may vary from person to person, but generally ranges from half an hour to one hour. The effect of Sildenafil Teva may take longer if you have recently eaten a heavy meal.
If Sildenafil Teva 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 Teva than you should
You may experience an increase in the frequency and severity of side effects. Doses higher than 100 mg do not increase effectiveness.
Do not take more tablets than prescribed by your doctor.
If you take more tablets than prescribed, contact your doctor.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them. The side effects reported in association with the use of Sildenafil Teva are usually mild to moderate in intensity and of short duration.
If you experience any of the following serious side effects, stop taking
Sildenafil Teva 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:
- Adopt a semi-sitting 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 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, blisters on the genitals and 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, 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 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 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 floating particles in the visual field, seeing halos around lights, pupil dilation, change in the white colour of the sclera (part of the eye), bleeding from the penis, presence of blood in semen, dry nose, swelling of the nasal mucosa, irritability, sudden decrease or loss of hearing.

Rare cases of unstable angina (a heart condition) and sudden death have been reported following marketing experience. It should be noted that most, but not all, of the men who experienced these side effects 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.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system detailed in Annex V*.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sildenafil Teva

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and packaging after EXP. The expiry date refers to the last day of that month.
Store in the original packaging to protect from moisture.
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 Teva contains
The active substance is sildenafil.
Each tablet contains 50 mg of sildenafil (as citrate salt).
The excipients are:
Core: microcrystalline cellulose, calcium hydrogen phosphate, croscarmellose sodium, magnesium stearate.
Coating: poly(vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc.

Description of the appearance of Sildenafil Teva and contents of the pack
Sildenafil Teva 50 mg are white, film-coated oval tablets with ‘S 50’ printed on one side and smooth on the other.
Sildenafil Teva is available in blister packs containing 2, 4, 8, 12 and 24 tablets, and in unit-dose perforated blisters containing 10 x 1 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva B.V.
Swensweg 5
2031GA Haarlem
The Netherlands

Manufacturer
TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13
4042 Debrecen
Hungary
Teva Pharma, S.L.U.
Polígono Industrial Malpica, Calle C, No. 4
50016 Zaragoza
Spain
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80, 31-546 Kraków
Poland