Viagra: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

VIAGRA 25 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 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, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What VIAGRA is and what it is used for

VIAGRA 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
blood to flow into the penis during sexual stimulation. VIAGRA will help you achieve an erection
only if you are sexually stimulated.
VIAGRA 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 VIAGRA

Do not take VIAGRA
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 have any doubts, 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 Viagra 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 sudden vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking VIAGRA
if you have sickle cell anemia (an abnormality of red blood cells), leukemia (a blood cell cancer), or multiple myeloma (a bone marrow cancer).
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 intercourse.
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 VIAGRA and contact your doctor immediately.
Do not use VIAGRA together with other oral or topical treatments for erectile dysfunction.
Do not use VIAGRA together with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other phosphodiesterase type 5 (PDE5) inhibitor.
Do not take VIAGRA if you do not have erectile dysfunction.
Do not take VIAGRA 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
VIAGRA must not be given to individuals under 18 years of age.

Other medicines and VIAGRA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
VIAGRA 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 VIAGRA and when it was taken. Do not take VIAGRA with other medicines unless specifically authorized by your doctor.
Do not take VIAGRA if you are taking medicines called nitrates, as combining these medicines 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 VIAGRA 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 of VIAGRA (25 mg).
Some patients taking alpha-blockers for high blood pressure or enlarged prostate may experience dizziness or mild confusion, which may be caused by low blood pressure when sitting down or standing up quickly. Some patients have reported these symptoms when taking VIAGRA together with alpha-blockers. This is more likely to occur within 4 hours after taking VIAGRA. To reduce the risk of these symptoms, you should already be on a stable dose of an alpha-blocker before starting VIAGRA treatment. Your doctor may start you on a lower dose of VIAGRA (25 mg).
Inform your doctor or pharmacist if you are taking medicines containing sacubitril/valsartan, used to treat heart failure.

VIAGRA with food, drinks, and alcohol
VIAGRA can be taken with or without food. However, you may notice that the onset of VIAGRA's effect is 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 consuming large amounts of alcohol before using VIAGRA.

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

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

VIAGRA contains lactose
If your doctor has informed you of an intolerance to certain sugars, such as lactose, contact your doctor before taking VIAGRA.

VIAGRA contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially "sodium-free".

3. How to take VIAGRA

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.
VIAGRA must not be taken more than once a day.
Do not take VIAGRA film-coated tablets in combination with other medicinal products containing sildenafil, including VIAGRA orodispersible tablets or VIAGRA orodispersible films.
Take VIAGRA approximately one hour before anticipated sexual activity. Swallow the tablet whole with a glass of water.
If you feel that the effect of VIAGRA is too strong or too weak, consult your doctor or pharmacist.
VIAGRA will help you achieve an erection only if you are sexually stimulated. The time required for VIAGRA to take effect varies from person to person, but generally ranges from half an hour to one hour. The effect of VIAGRA may take longer if you have just eaten a heavy meal.
If VIAGRA 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 VIAGRA than you should:
You may experience an increase in the frequency and severity of adverse 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 how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

Allergic reaction – occurs with uncommon frequency (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 with uncommon frequency: 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 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 skin peeling and swelling, blisters in the mouth, 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 colour intensity 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, tinnitus, 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, epistaxis, 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 tightness in the throat, 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, 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 men who experienced these side effects, but not all, 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 VIAGRA.

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 at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store VIAGRA

Keep this medicine out of the sight and reach of children.
Store below 30 °C.
Do not use this medicine after the expiry date stated on the pack and blister after EXP. The expiry date refers to the last day of the month.
Keep in the original packaging to protect the medicine 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. Contents of the pack and other information

What VIAGRA contains
The active substance is sildenafil. Each tablet contains 25 mg of sildenafil (as citrate salt).
The other components are:

Core: microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), sodium croscarmellose (see section 2 “VIAGRA contains sodium”), magnesium stearate.
Coating: hypromellose, titanium dioxide (E171), lactose monohydrate (see section 2 “VIAGRA contains lactose”), triacetin, aluminium lake containing indigo carmine (E132).

Description of the appearance of VIAGRA and contents of the pack
The film-coated tablets (tablets) of VIAGRA are blue, film-coated and diamond-shaped with rounded corners. They are marked with “VIAGRA” on one side and “VGR 25” on the other. The tablets are available in blisters in pack sizes of 2, 4, 8 or 12 tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder
Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Netherlands.

Manufacturer
Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, France or Mylan Hungary Kft., Mylan utca 1, Komárom, 2900 Hungary.

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

België/Belgique/Belgien Lietuva
Viatris Viatris UAB
Tél/Tel: +32 (0)2 658 61 00 Tel: +370 52051288

България Luxembourg/Luxemburg
Майлан ЕООД Viatris
Тел.: +359 2 44 55 400 Tél/Tel: +32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika Magyarország
Viatris CZ s.r.o. Viatris Healthcare Kft.
Tel: +420 222 004 400 Tel.: +36 1 465 2100

Danmark Malta
Viatris ApS V.J. Salomone Pharma Limited
Tlf: +45 28 11 69 32 Tel: (+356) 21 200 174

Deutschland Nederland
Viatris Healthcare GmbH Mylan Healthcare BV
Tel: +49 (0) 800 0700 800 Tel: +31 (0) 20 426 3300

Eesti Norge
Viatris OÜ Viatris AS
Tel: +372 6363 052 Tlf: +47 66 75 33 00

Ελλάδα Österreich
Viatris Hellas Ltd Viatris Austria GmbH
Τηλ: +30 2100 100 002 Tel: +43 1 86390

España Polska
Viatris Pharmaceuticals, S.L. Viatris Healthcare Sp. z o.o.
Tel: +34 900 102 712 Tel.: +48 22 546 64 00

France Portugal
Viatris Santé Viatris Healthcare, Lda.
Tél: +33 (0)4 37 25 75 00 Tel: +351 21 412 72 00

Hrvatska România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: +385 1 23 50 599 Tel: +40 372 579 000

Ireland Slovenija
Viatris Limited Viatris d.o.o.
Tel: +353 1 8711600 Tel: +386 1 236 31 80

Ísland Slovenská republika
Icepharma hf. Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: +421 2 32 199 100

Italia Suomi/Finland
Viatris Pharma S.r.l. Viatris Oy
Tel: +39 02 612 46921 Puh/Tel: +358 20 720 9555

Κύπρος Sverige
CPO Pharmaceuticals Limited Viatris AB
Τηλ: +357 22863100 Tel: +46 (0)8 630 19 00

Latvija
Viatris SIA
Tel: +371 676 055 80

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

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE PATIENT

VIAGRA 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 others, even if they have the same symptoms as you, because it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

1. What VIAGRA is and what it is used for

VIAGRA 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 to the penis during sexual stimulation. VIAGRA will help you achieve an erection
only if you are sexually stimulated.
VIAGRA 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 should know before taking VIAGRA

Do not take VIAGRA
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
decrease in blood pressure. Inform your doctor if you are taking any of these
medicines, which are often used to relieve angina pectoris attacks (or "chest pain"). If you have any doubts, 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 decrease
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 Viagra, have been shown to enhance 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 VIAGRA
if you have sickle cell anemia (an abnormality of red blood cells), leukemia (blood cell cancer), or multiple myeloma (a cancer of the bone marrow).
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 intercourse.
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 VIAGRA and
contact your doctor immediately.
Do not use VIAGRA together with other oral or local treatments for erectile dysfunction.
Do not use VIAGRA together with treatments for pulmonary arterial hypertension (PAH)
containing sildenafil or with any other phosphodiesterase type 5 (PDE5) inhibitor.
Do not take VIAGRA if you do not have erectile dysfunction.
Do not take VIAGRA 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
VIAGRA must not be administered to individuals under 18 years of age.

Other medicines and VIAGRA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.
VIAGRA tablets may interact with certain medicines, particularly those used for
chest pain. In case of a medical emergency, you must inform the doctor, pharmacist, or nurse that you have taken VIAGRA and when you took it. Do not take
VIAGRA with other medicines unless your doctor has authorized it.
Do not take VIAGRA if you are taking medicines called nitrates, because combining
these medicines 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 attacks (or "chest pain").
Do not take VIAGRA 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 of VIAGRA (25 mg).
Some patients taking alpha-blockers for high blood pressure or enlarged prostate may experience dizziness or mild confusion, possibly due to low blood pressure when sitting down or standing up quickly. Some patients have reported these symptoms when taking VIAGRA together with alpha-blockers. This is more likely to occur within 4 hours after taking VIAGRA. To reduce the risk of these symptoms, you should already be on a stable dose of an alpha-blocker before starting VIAGRA treatment. Your doctor may start you on a lower dose of VIAGRA (25 mg).
Inform your doctor or pharmacist if you are taking medicines containing sacubitril/valsartan, used to treat heart failure.

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

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

Driving and using machines
VIAGRA may cause dizziness and may affect vision. Before driving or operating machinery, you should be aware of how you react to VIAGRA.

VIAGRA contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, such as lactose, contact your doctor before taking VIAGRA.

VIAGRA contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

3. How to take VIAGRA

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.
VIAGRA must not be taken more than once a day.
Do not take VIAGRA film-coated tablets in combination with other medicinal products containing sildenafil, including VIAGRA orodispersible tablets or VIAGRA orodispersible films.
Take VIAGRA approximately one hour before anticipated sexual activity. Swallow the tablet whole with a glass of water.
If you feel that the effect of VIAGRA is too strong or too weak, consult your doctor or pharmacist.
VIAGRA will help you achieve an erection only if you are sexually stimulated. The time required for VIAGRA to take effect varies from person to person, but generally ranges from half an hour to one hour. The effect of VIAGRA may take longer if you have just eaten a heavy meal.
If VIAGRA 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 VIAGRA than you should:
You may experience an increase in the frequency and severity of adverse 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, pharmacist, or nurse.

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 VIAGRA are usually mild to moderate in intensity and short-lived.
If you experience any of the following serious side effects, stop taking
VIAGRA and contact your doctor immediately:

Allergic reaction – occurs with uncommon frequency (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 with uncommon frequency: If this occurs during or after sexual activity:
- 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 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 skin peeling and swelling, 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 colour intensity 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 touch sensitivity, 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, 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 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.

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

5. How to store VIAGRA

Keep this medicine out of the sight and reach of children.
Store below 30 °C.
Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month.
Keep in the original packaging to protect the medicine 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 VIAGRA contains
The active substance is sildenafil. Each tablet contains 50 mg of sildenafil (as citrate salt).
The other ingredients are:

Inner core: microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), sodium croscarmellose (see section 2 “VIAGRA contains sodium”), magnesium stearate.
Coating: hypromellose, titanium dioxide (E171), monohydrate lactose (see section 2 “VIAGRA contains lactose”), triacetin, aluminium lake containing indigo carmine (E132).

Description of the appearance of VIAGRA and package contents
The film-coated tablets (tablets) of VIAGRA are blue, film-coated and diamond-shaped with rounded edges. They are marked with “VIAGRA” on one side and “VGR 50” on the other.
The tablets are available in blisters packed in a carton box or secondary cardboard packaging containing 2, 4, 8, 12 or 24 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Netherlands.
Manufacturer
Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, France or Mylan Hungary Kft., Mylan utca 1, Komárom, 2900 Hungary.
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
België/Belgique/Belgien Lietuva
Viatris Viatris UAB
Tél/Tel: +32 (0)2 658 61 00 Tel: +370 52051288
България Luxembourg/Luxemburg
Майлан ЕООД Viatris
Тел.: +359 2 44 55 400 Tél/Tel: +32 (0)2 658 61 00
(Belgique/Belgien)
Česká republika Magyarország
Viatris CZ s.r.o. Viatris Healthcare Kft.
Tel: +420 222 004 400 Tel.: + 36 1 4 65 2100
Danmark Malta
Viatris ApS V.J. Salomone Pharma Limited
Tlf: +45 28 11 69 32 Tel: (+356) 21 220 174
Deutschland Nederland
Viatris Healthcare GmbH Mylan Healthcare BV
Tel: +49 (0) 800 0700 800 Tel: +31 (0) 20 426 3300
Eesti Norge
Viatris OÜ Viatris AS
Tel: +372 6363 052 Tlf: +47 66 75 33 00
Ελλάδα Österreich
Viatris Hellas Ltd Viatris Austria GmbH
Τηλ: +30 2100 100 002 Tel: +43 1 86390
España Polska
Viatris Pharmaceuticals, S.L. Viatris Healthcare Sp. z o.o.
Tel: +34 900 102 712 Tel.: +48 22 546 64 00
France Portugal
Viatris Santé Viatris Healthcare, Lda.
Tél: +33 (0)4 37 25 75 00 Tel: +351 21 412 72 00
Hrvatska România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: + 385 1 23 50 599 Tel: +40 372 579 000
Ireland Slovenija
Viatris Limited Viatris d.o.o.
Tel: + 353 1 8711600 Tel: + 386 1 236 31 80
Ísland Slovenská republika
Icepharma hf. Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: +421 2 32 199 100
Italia Suomi/Finland
Viatris Pharma S.r.l. Viatris Oy
Tel: +39 02 612 46921 Puh/Tel: +358 20 720 9555
Κύπρος Sverige
CPO Pharmaceuticals Limited Viatris AB
Τηλ: +357 22863100 Tel: +46 (0)8 630 19 00
Latvija
Viatris SIA
Tel: +371 676 055 80
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu .

PATIENT INFORMATION LEAFLET

VIAGRA 100 mg film-coated tablets

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

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

Contents of this leaflet

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

1. What VIAGRA is and what it is used for

VIAGRA 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 blood to flow into the penis when sexually stimulated. VIAGRA will help you achieve an erection only if you are sexually stimulated.
VIAGRA 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 should know before taking VIAGRA

Do not take VIAGRA
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
decrease in blood pressure. Inform your doctor if you are taking any of these
medicines, which are often used to relieve attacks of angina pectoris (or “chest
pain”). If you have any doubts, 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 decrease 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 Viagra, 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 VIAGRA
if you have sickle cell anemia (an abnormality of red blood cells), leukemia (a blood cell cancer), or multiple myeloma (a bone marrow cancer).
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 exertion 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 VIAGRA and
contact your doctor immediately.
You must not use VIAGRA together with other oral or local treatments for erectile dysfunction.
You must not use VIAGRA together with treatments for pulmonary arterial hypertension (PAH)
containing sildenafil or with any other phosphodiesterase type 5 (PDE5) inhibitor.
You must not take VIAGRA if you do not have erectile dysfunction.
You must not take VIAGRA 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
VIAGRA must not be administered to individuals under 18 years of age.

Other medicines and VIAGRA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
VIAGRA 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 VIAGRA and when you took it. Do not take VIAGRA with other medicines unless your doctor has authorized it.
You must not take VIAGRA if you are taking medicines called nitrates, because combining these medicines 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 attacks of angina pectoris (or “chest pain”).
You must not take VIAGRA 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 of VIAGRA (25 mg).
Some patients taking alpha-blockers for high blood pressure or enlarged prostate may experience dizziness or mild confusion, which may be caused by low blood pressure when sitting down or standing up quickly. Some patients have reported these symptoms when taking VIAGRA together with alpha-blockers. This is more likely to occur within 4 hours after taking VIAGRA. To reduce the likelihood of these symptoms, you should already be on a stable dose of an alpha-blocker before starting treatment with VIAGRA. Your doctor may start you on a lower dose of VIAGRA (25 mg).
Inform your doctor or pharmacist if you are taking medicines containing sacubitril/valsartan, used to treat heart failure.

VIAGRA with food, drinks and alcohol
VIAGRA may be taken with or without food. However, you may notice that the onset of VIAGRA’s effect may be delayed if you take it 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 consuming large amounts of alcohol before taking VIAGRA.

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

Driving and using machines
VIAGRA may cause dizziness and may affect vision. Before driving or operating machinery, you should be aware of how you react to VIAGRA.

VIAGRA contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, such as lactose, contact your doctor before taking VIAGRA.

VIAGRA contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take VIAGRA

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.
VIAGRA must not be taken more than once a day.
Do not take sildenafil-containing medicines together with VIAGRA film-coated tablets, including VIAGRA orodispersible tablets or VIAGRA orodispersible films.
Take VIAGRA approximately one hour before anticipated sexual activity. Swallow the tablet whole with a glass of water.
If you feel the effect of VIAGRA is too strong or too weak, consult your doctor or pharmacist.
VIAGRA will help you achieve an erection only if you are sexually stimulated. The time required for VIAGRA to take effect may vary from person to person, but generally ranges from half an hour to one hour. The effect of VIAGRA may take longer if you have just eaten a heavy meal.
If VIAGRA 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 VIAGRA 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, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects reported with VIAGRA are usually mild to moderate in intensity and short in duration.
If you experience any of the following serious side effects, stop taking VIAGRA 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 this 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 peeling and swelling of the skin, mouth blisters, genital or eye-area blisters, 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 colour intensity 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, ringing in the ears, dry mouth, blocked or stuffy nose, nasal mucosal inflammation (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 at 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, pupil dilation, change 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.

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 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 VIAGRA.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store VIAGRA

6. Package contents and other information

What VIAGRA contains
The active substance is sildenafil. Each tablet contains 100 mg of sildenafil (as citrate salt).
The other components are:

Inner core: microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), sodium croscarmellose (see section 2 “VIAGRA contains sodium”), magnesium stearate.
Coating: hypromellose, titanium dioxide (E171), lactose monohydrate (see section 2 “VIAGRA contains lactose”), triacetin, aluminium lake containing indigo carmine (E132).

Description of the appearance of VIAGRA and pack contents
VIAGRA film-coated tablets (tablets) are blue, film-coated and diamond-shaped with rounded edges. They are marked with “VIAGRA” on one side and “VGR 100” on the other. The tablets are available in blister packs containing 2, 4, 8, 12 or 24 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, The Netherlands.
Manufacturer
Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, France or Mylan Hungary Kft., Mylan utca 1, Komárom, 2900 Hungary.
For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
België/Belgique/Belgien Lietuva
Viatris Viatris UAB
Tél/Tel: +32 (0)2 658 61 00 Tel: +370 52051288
България Luxembourg/Luxemburg
Майлан ЕООД Viatris
Тел.: +359 2 44 55 400 Tél/Tel: +32 (0)2 658 61 00
(Belgique/Belgien)
Česká republika Magyarország
Viatris CZ s.r.o. Viatris Healthcare Kft.
Tel: +420 222 004 400 Tel.: +36 1 465 2100
Danmark Malta
Viatris ApS V.J. Salomone Pharma Limited
Tlf: +45 28 11 69 32 Tel: (+356) 21 220 174
Deutschland Nederland
Viatris Healthcare GmbH Mylan Healthcare BV
Tel: +49 (0)800 0700 800 Tel: +31 (0)20 426 3300
Eesti Norge
Viatris OÜ Viatris AS
Tel: +372 6363 052 Tlf: +47 66 75 33 00
Ελλάδα Österreich
Viatris Hellas Ltd Viatris Austria GmbH
Τηλ: +30 2100 100 002 Tel: +43 1 86390
España Polska
Viatris Pharmaceuticals, S.L. Viatris Healthcare Sp. z o.o.
Tel: +34 900 102 712 Tel.: +48 22 546 64 00
France Portugal
Viatris Santé Viatris Healthcare, Lda.
Tél: +33 (0)4 37 25 75 00 Tel: +351 21 412 72 00
Hrvatska România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: +385 1 23 50 599 Tel: +40 372 579 000
Ireland Slovenija
Viatris Limited Viatris d.o.o.
Tel: +353 1 8711600 Tel: +386 1 236 31 80
Ísland Slovenská republika
Icepharma hf. Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: +421 2 32 199 100
Italia Suomi/Finland
Viatris Pharma S.r.l. Viatris Oy
Tel: +39 02 612 46921 Puh/Tel: +358 20 720 9555
Κύπρος Sverige
CPO Pharmaceuticals Limited Viatris AB
Τηλ: +357 22863100 Tel: +46 (0)8 630 19 00
Latvija
Viatris SIA
Tel: +371 676 055 80

Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

INSTRUCTION LEAFLET: INFORMATION FOR THE PATIENT

VIAGRA 50 mg orodispersible 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, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What VIAGRA is and what it is used for

VIAGRA 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
blood to flow into the penis when sexually stimulated. VIAGRA will help you achieve an erection
only if you are sexually stimulated.
VIAGRA 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 VIAGRA

Do not take VIAGRA
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
decrease in blood pressure. Inform your doctor if you are taking any of these
medicines, which are often used to relieve angina pectoris attacks (or "chest pain"). If you have any doubts, 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 decrease 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 Viagra, have been shown to increase the hypotensive effect of riociguat. 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 due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking VIAGRA
if you have sickle cell anemia (an abnormality of red blood cells), leukemia (a blood cell cancer), or multiple myeloma (a bone marrow cancer).
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 exertion of sexual intercourse.
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 VIAGRA and contact your doctor immediately.
Do not use VIAGRA together with other oral or topical treatments for erectile dysfunction.
Do not use VIAGRA together with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or with any other phosphodiesterase type 5 (PDE5) inhibitors.
Do not take VIAGRA if you do not have erectile dysfunction.
Do not take VIAGRA 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
VIAGRA must not be administered to individuals under 18 years of age.

Other medicines and VIAGRA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
VIAGRA 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 VIAGRA and when you took it. Do not take VIAGRA with other medicines unless authorized by your doctor.
Do not take VIAGRA if you are taking medicines called nitrates, because combining these medicines 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 attacks (or "chest pain").
Inform your doctor or pharmacist if you are already taking riociguat.
Do not take VIAGRA 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.
If you are taking protease inhibitors, for example medicines used to treat HIV, your doctor may initially prescribe you the lowest dose of VIAGRA (film-coated tablets of 25 mg).
Some patients taking alpha-blockers for the treatment of high blood pressure or enlarged prostate may experience dizziness or mild confusion, which may be caused by low blood pressure when sitting down or standing up quickly. Some patients have reported these symptoms when taking VIAGRA together with alpha-blockers. This is more likely to occur within 4 hours after taking VIAGRA. To reduce the risk of these symptoms, you should already be on a stable dose of an alpha-blocker before starting VIAGRA treatment. Your doctor may start you on a lower dose of VIAGRA (film-coated tablets of 25 mg).
Inform your doctor or pharmacist if you are taking medicines containing sacubitril/valsartan, used for the treatment of heart failure.

VIAGRA with food, drinks, and alcohol
Drinking alcohol may temporarily impair your ability to get an erection. To get the maximum benefit from this medicine, it is advisable to avoid consuming large amounts of alcohol before taking VIAGRA.

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

Driving and using machines
VIAGRA may cause dizziness and may affect vision. Before driving or operating machinery, you should be aware of how you react to VIAGRA.

VIAGRA contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

3. How to take VIAGRA

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.
VIAGRA must not be taken more than once a day.
Do not take VIAGRA orodispersible tablets in combination with other medicinal products containing
sildenafil, including VIAGRA film-coated tablets or VIAGRA orodispersible films.
Take VIAGRA approximately one hour before anticipated sexual activity. The time required
for VIAGRA to take effect may vary from person to person, but generally ranges from half an hour to
one hour.
Place the orodispersible tablet on the tongue, where it will dissolve within a few seconds, then
swallow it with saliva or water.
Orodispersible tablets should be taken on an empty stomach, as the effect may be delayed after a heavy
meal.
If a second orodispersible tablet of 50 mg is needed to achieve a dose of 100 mg, you must wait until the first tablet has completely dissolved in the mouth and has been swallowed
before taking the second orodispersible tablet.
If you feel that the effect of VIAGRA is too strong or too weak, consult your doctor or
pharmacist.
VIAGRA will help you achieve an erection only if you are sexually stimulated.
If VIAGRA 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 VIAGRA than you should:
You may experience an increase in the frequency and severity of adverse 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, pharmacist, or
nurse.

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 VIAGRA are usually mild to moderate and
short-lived.
If you experience any of the following serious side effects, stop taking
VIAGRA and contact your doctor immediately:

Allergic reaction – occurs with uncommon frequency (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 with uncommon frequency: 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, mouth blisters, genital or eye area blisters, 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, light flashes, increased light perception, light sensitivity, tearing, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced touch sensitivity, 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 (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, numb 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 your 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.
Rare cases of unstable angina (a heart condition) and sudden death have been reported during post-marketing experience. It should be noted that most, but not all, of the men who experienced these side effects already had pre-existing heart problems before using this medicine. It is not possible to determine whether these events are directly related to the use of VIAGRA.

5. How to store VIAGRA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of that month. This medicine does not require any special storage temperature.
Store in the original packaging to protect the medicine 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 VIAGRA contains
The active substance is sildenafil. Each orodispersible tablet contains 50 mg of sildenafil
(as citrate salt).
The excipients are:
microcrystalline cellulose, hydrophobic colloidal silica, sodium croscarmellose (see
section 2 “VIAGRA contains sodium”), magnesium stearate, aluminium lake containing
indigo carmine (E132), sucralose, mannitol, crospovidone, polyvinyl acetate, povidone.
Flavourings contained: maltodextrins, dextrins.
Natural flavourings contained: maltodextrins, glycerol (E422), propylene glycol (E1520).
Lemon flavourings: maltodextrins, alpha-tocopherol (E307).

Description of the appearance of VIAGRA and package contents
VIAGRA orodispersible tablets are blue and diamond-shaped. They are marked with
“V50” on one side. The orodispersible tablets are available in blisters in pack sizes of 2, 4, 8 or 12
tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder
Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, The Netherlands.

Manufacturer
Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, France or Mylan
Hungary Kft. Mylan utca 1 Komárom, 2900 Hungary.

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

België/Belgique/Belgien Lietuva
Viatris Viatris UAB
Tél/Tel: +32 (0)2 658 61 00 Tel: +370 52051288

България Luxembourg/Luxemburg
Майлан ЕООД Viatris
Тел.: +359 2 44 55 400 Tél/Tel: +32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika Magyarország
Viatris CZ s.r.o. Viatris Healthcare Kft.
Tel: +420 222 004 400 Tel.: + 36 1 4 65 2100

Danmark Malta
Viatris ApS V.J. Salomone Pharma Limited
Tlf: +45 28 11 69 32 Tel: (+356) 21 220 174

Deutschland Nederland
Viatris Healthcare GmbH Mylan Healthcare BV
Tel: +49 (0) 800 0700 800 Tel: +31 (0) 20 426 3300

Eesti Norge
Viatris OÜ Viatris AS
Tel: +372 6363 052 Tlf: +47 66 75 33 00

Ελλάδα Österreich
Viatris Hellas Ltd Viatris Austria GmbH
Τηλ: +30 2100 100 002 Tel: +43 1 86390

España Polska
Viatris Pharmaceuticals, S.L. Viatris Healthcare Sp. z o.o.,
Tel: +34 900 102 712 Tel.: +48 22 546 64 00

France Portugal
Viatris Santé Viatris Healthcare, Lda.
Tél: +33 (0)4 37 25 75 00 Tel: +351 21 412 72 00

Hrvatska România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: + 385 1 23 50 599 Tel: +40 372 579 000

Ireland Slovenija
Viatris Limited Viatris d.o.o.
Tel: + 353 1 8711600 Tel: + 386 1 236 31 80

Ísland Slovenská republika
Icepharma hf. Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: +421 2 32 199 100

Italia Suomi/Finland
Viatris Pharma S.r.l. Viatris Oy
Tel: +39 02 612 46921 Puh/Tel: +358 20 720 9555

Κύπρος Sverige
CPO Pharmaceuticals Limited Viatris AB
Τηλ: +357 22863100 Tel: +46 (0)8 630 19 00

Latvija
Viatris SIA
Tel: +371 676 055 80

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

PATIENT LEAFLET: INFORMATION FOR THE PATIENT

VIAGRA 50 mg orodispersible films

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, consult your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What VIAGRA is and what it is used for

VIAGRA 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
blood flow into the penis when sexually stimulated. VIAGRA will help you achieve an erection
only if you are sexually stimulated.
VIAGRA 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 need to know before taking VIAGRA

Do not take VIAGRA

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 pectoris (or “chest pain”). If you have any doubts, 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 VIAGRA, 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 severe 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 VIAGRA
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 exertion 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 VIAGRA and contact your doctor immediately.
Do not use VIAGRA together with other oral or topical treatments for erectile dysfunction.
Do not use VIAGRA together with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or with any other phosphodiesterase type 5 (PDE5) inhibitor.
Do not take VIAGRA if you do not have erectile dysfunction.
Do not take VIAGRA 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
VIAGRA must not be administered to individuals under 18 years of age.

Other medicines and VIAGRA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
VIAGRA may interact with certain medicines, particularly those used to treat chest pain. If a medical emergency occurs, you must inform the doctor, pharmacist, or nurse that you have taken VIAGRA and when you took it. Do not take VIAGRA together with other medicines unless authorized by your doctor.
Do not take VIAGRA 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 VIAGRA 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 the lowest dose of VIAGRA (film-coated tablets 25 mg).
Some patients taking alpha-blockers for the treatment of high blood pressure or prostate enlargement may experience dizziness or mild confusion, which may be caused by low blood pressure when sitting down or standing up quickly. Some patients have reported these symptoms when taking VIAGRA together with alpha-blockers. This is most likely to occur within 4 hours after taking VIAGRA. To reduce the likelihood of these symptoms, you should already be on a stable dose of an alpha-blocker before starting VIAGRA treatment. Your doctor may start you on a lower dose of VIAGRA (film-coated tablets 25 mg).
Inform your doctor or pharmacist if you are taking medicines containing sacubitril/valsartan, used for the treatment of heart failure.

VIAGRA and alcohol
Drinking alcohol may temporarily impair your ability to get an erection. To get the maximum benefit from this medicine, it is advisable to avoid consuming large amounts of alcohol before taking VIAGRA.

Pregnancy, breast-feeding and fertility
VIAGRA is not indicated for use in women.

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

3. How to take VIAGRA

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.
VIAGRA must not be taken more than once a day.
Do not take VIAGRA orodispersible films in combination with other medicinal products containing sildenafil,
including VIAGRA film-coated tablets or VIAGRA orodispersible tablets.
Take VIAGRA approximately one hour before anticipated sexual activity. The time required
for VIAGRA to take effect varies from person to person, but generally ranges from half an hour to
one hour.
Carefully open the aluminum sachet with dry hands, without cutting it. Remove the orodispersible
film with a dry finger and immediately place the orodispersible film on the tongue, where
it will dissolve within a few seconds, with or without water. During dissolution, saliva may be swallowed,
but do not swallow the film itself.
The orodispersible film must be taken on an empty stomach, as its effect may be delayed
after a heavy meal.
If a second orodispersible film of 50 mg is needed to reach a dose of 100 mg, you must
wait until the first film has completely dissolved in the mouth and has been swallowed before
taking the second orodispersible film.
If you feel that the effect of VIAGRA is too strong or too weak, consult your doctor or
pharmacist.
VIAGRA will help you achieve an erection only if you are sexually stimulated.
If VIAGRA 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 VIAGRA than you should
You may experience an increase in the frequency and severity of adverse effects. Doses higher than
100 mg do not increase efficacy.
Do not take more films than prescribed by your doctor.
If you take more films than prescribed, contact your doctor.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The side effects reported with VIAGRA are usually mild to moderate in intensity and of short duration.
If you experience any of the following serious side effects, stop taking
VIAGRA 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-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, 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, 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, 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 particles in your visual field, seeing halos around lights, pupil dilation, changes 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.

Following 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 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 VIAGRA.

5. How to store VIAGRA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack and sachet after
Exp./EXP. The expiry date refers to the last day of that month. This medicine does not
require any special storage conditions.
Do not dispose of any medicine 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 VIAGRA contains
The active substance is sildenafil. Each orodispersible film contains 50 mg of sildenafil (as citrate salt).
The other components are hydroxypropylcellulose (E463), macrogol, crospovidone (E1202), povidone (E1201), sucralose (E955), poly(vinyl alcohol) grafted with macrogol copolymer, levomenthol, hypromellose (E464), titanium dioxide (E171), iron oxide red (E172).

Description of the appearance of VIAGRA and contents of the pack
Each orodispersible film is individually packaged in an aluminium sachet.
Packs contain 2, 4, 8 or 12 sachets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, The Netherlands.

Manufacturer
LTS Lohmann Therapie-Systeme AG, Lohmannstrasse 2, Andernach, Rhineland-Palatinate, 56626, Germany.

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

België/Belgique/Belgien Lietuva
Viatris Viatris UAB
Tél/Tel: +32 (0)2 658 61 00 Tel: +370 52051288

България Luxembourg/Luxemburg
Майлан ЕООД Viatris
Тел.: +359 2 44 55 400 Tél/Tel: +32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika Magyarország
Viatris CZ s.r.o. Viatris Healthcare Kft.
Tel: +420 222 004 400 Tel.: +36 1 465 2100

Danmark Malta
Viatris ApS V.J. Salomone Pharma Limited
Tlf: +45 28 11 69 32 Tel: (+356) 21 220 174

Deutschland Nederland
Viatris Healthcare GmbH Mylan Healthcare BV
Tel: +49 (0)800 0700 800 Tel: +31 (0)20 426 3300