VIAGRA 25 mg Коированная Таблетка

Содержание инструкции

1. VIAGRA 25 mg film-coated tablets
   1. What is VIAGRA and what is it used for
   2. What you need to know before taking VIAGRA
   3. How to take VIAGRA
   4. Possible side effects
   5. How to store VIAGRA
   6. Package contents and other information
2. VIAGRA 50 mg film-coated tablets
   1. What is VIAGRA and what is it used for
   2. What you need to know before taking VIAGRA
   3. How to take VIAGRA
   4. Possible side effects
   5. How to store VIAGRA
   6. Contents of the pack and other information
3. VIAGRA 100 mg film-coated tablets
   1. What is VIAGRA and what is it used for
   2. What you need to know before taking VIAGRA
   3. How to take VIAGRA
   4. Possible side effects
   5. How to store VIAGRA
   6. Contents of the pack and other information
4. VIAGRA 50 mg orodispersible tablets
   1. What is VIAGRA and what is it used for
   2. What you need to know before taking VIAGRA
   3. How to take VIAGRA
   4. Possible side effects
   5. How to store VIAGRA
   6. Package contents and other information
5. VIAGRA 50 mg film-coated orodispersible tablets
   1. What is VIAGRA and what is it used for
   2. What you need to know before taking VIAGRA
   3. How to take VIAGRA
   4. Possible side effects
   5. How to store VIAGRA
   6. Contents of the pack and other information

VIAGRA 25 mg film-coated tablets

sildenafil

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What VIAGRA is and what it is used for
• 2. What you need to know before you take VIAGRA
• 3. How to take VIAGRA
• 4. Possible side effects
• 5. How to store VIAGRA
• 6. Contents of the pack and other information

1. What is VIAGRA and what is it used for

VIAGRA contains the active ingredient sildenafil which belongs to the class of medicines called
phosphodiesterase type 5 (PDE5) inhibitors. It helps to relax the blood vessels in the penis, allowing
blood flow to the penis when it is sexually stimulated. VIAGRA will only help you to get an erection
if you are sexually stimulated.
VIAGRA is a treatment for adult men who experience erectile dysfunction, sometimes
called impotence. This condition occurs when a man cannot 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 any of the other ingredients of this medicine
(listed in section 6).
if you are taking medicines called nitrates, because this combination can cause a dangerous
drop in blood pressure. Tell 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, ask your doctor or pharmacist.
if you are taking any of the medicines known as nitric oxide donors, such as amyl nitrite (“poppers”), because this combination can 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 secondary to blood clots). It has been shown that PDE5 inhibitors, such as Viagra, increase the hypotensive effect
of this medicine. If you are taking riociguat or if you have any doubts, tell your doctor.
if you have a serious heart or liver problem.
if you have recently had a stroke or a heart attack, or if you have low blood pressure.
if you have a rare hereditary eye disease (such as retinitis pigmentosa).
if you have previously experienced loss of vision 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 (cancer of the blood cells), multiple myeloma (cancer of the bone marrow).
if you have a deformity of the penis or Peyronie's disease.
if you have heart problems. Your doctor should carefully check that your heart condition allows you to cope with the strain of sexual activity.
if you currently have a stomach ulcer, or problems with blood clotting (such as
hemophilia).
if you experience a sudden decrease or loss of vision, stop taking VIAGRA and
contact your doctor immediately.
You should not use VIAGRA together with other oral or topical treatments for erectile dysfunction.
You should not use VIAGRA together with treatments for pulmonary arterial hypertension (PAH)
containing sildenafil or any other type 5 phosphodiesterase (PDE5) inhibitor.
You should not take VIAGRA if you do not have erectile dysfunction.
You should not take VIAGRA if you are a woman.

Special precautions for patients with kidney or liver problems
If you have kidney or liver problems, you should tell your doctor. Your doctor may decide to
give you a lower dose.

Children and adolescents
VIAGRA should not be given to anyone under the age of 18.

Other medicines and VIAGRA
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
VIAGRA tablets can interact with some medicines, particularly those used for
treating chest pain. If you have a medical emergency, you should tell 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 authorised it.
You should not take VIAGRA if you are taking medicines called nitrates because the combination
of these medicines can cause a dangerous drop in blood pressure. Tell your doctor, the
pharmacist or nurse if you are taking any of these medicines which are often used for
relieving angina attacks (or “chest pain”).
You should not take VIAGRA if you are using any of the medicines known as nitric oxide
donors, such as amyl nitrite (“poppers”) because this combination can also cause a
dangerous drop in blood pressure.
Tell your doctor or pharmacist if you are already taking riociguat.
If you are taking medicines called protease inhibitors, for example medicines for the
treatment of HIV, your doctor may initially prescribe VIAGRA at the lowest dose (25 mg).
Some patients taking alpha-blockers for high blood pressure or
enlarged prostate may experience dizziness or lightheadedness which can be caused by low blood pressure when sitting or standing up quickly. Some patients
have reported these symptoms when they have taken VIAGRA together with alpha-blockers. This is more likely to happen within 4 hours of taking VIAGRA. To reduce the possibility that
these symptoms appear, you should be on a stable dose of your alpha-blocker before
starting treatment with VIAGRA. Your doctor may start you on a lower dose of VIAGRA (25 mg).
Tell 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
VIAGRA can be taken with or without food. However, you may notice that the onset of the effect
of VIAGRA may be delayed if you take it after a heavy meal.
Drinking alcohol can temporarily impair your ability to get
an erection. To get the most benefit from this medicine, it is advisable to avoid
drinking large amounts of alcohol before using VIAGRA.

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

Driving and using machines
VIAGRA can cause dizziness and can alter your vision. Before driving and using machines you must
be aware of how you react to VIAGRA.

VIAGRA contains lactose
If your doctor has told you that you have an intolerance to some 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, that is to say essentially
“sodium-free”.

3. How to take VIAGRA

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist. The recommended starting dose is 50 mg.

VIAGRA should not be taken more than once a day.
Do not take VIAGRA film-coated tablets in association with other medicines containing
sildenafil, including VIAGRA orodispersible tablets or VIAGRA orodispersible film.
You should take VIAGRA approximately one hour before the 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 only help you to achieve an erection if you are sexually stimulated. The time it takes 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 be delayed if you have
recently eaten a heavy meal.
If VIAGRA does not help you to 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 notice an increase in side effects and the severity of these effects. Higher doses than
100 mg do not increase efficacy.

Do not take a number of tablets greater than those prescribed by your doctor.
If you take a number of tablets greater than prescribed, contact your doctor.
If you have any questions about the use of this medicine, ask 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 in association with the use of VIAGRA are usually mild to moderate in severity 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 with a frequency of uncommon(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 a frequency of uncommon: If it occurs during or after sexual activity:
• Assume a semi-sitting position and try to relax.
• Do not use nitratesto 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 uninterrupted for more than 4 hours, contact your doctor immediately.
• Sudden reduction or loss of vision - occurs rarely.
• Severe skin reactions - occur rarely. Symptoms may include severe peeling and swelling of the skin, blisters in the mouth, on the genitals and around the eyes, fever.
• Convulsions or seizures - 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, flushing, hot flushes (symptoms include a sudden feeling of heat in the upper body), indigestion, increased color intensity of vision, blurred vision, visual disturbances, stuffy nose and dizziness.

Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, red eyes, eye pain, flashes of light, increased perception of light, light sensitivity, tearing, palpitations, fast heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sensitivity to touch, vertigo, ringing in the ears, dry mouth, obstructed or congested sinuses, inflammation of the nasal mucosa (symptoms include runny nose, sneezing and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn), blood in the urine, pain in the arms or legs, nosebleeds, feeling of heat and fatigue.

Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary reduction of blood flow to certain areas of the brain, feeling of constriction in the throat, numb mouth, bleeding in the back of the eye, double vision, reduced visual acuity, abnormal eye sensitivity, swelling of the eyes or eyelids, appearance of spots or corpuscles in your field of vision, seeing halos around lights, dilation of the pupils, alteration of the white color of the sclera (part of the eye), bleeding of the penis, presence of blood in the seminal fluid, dry nose, swelling of the nasal mucosa, irritability and sudden or loss of hearing.
Cases of unstable angina (a heart disease) and sudden death have been reported rarely from post-marketing experience. It should be noted that most men who experienced these side effects, but not all, had heart problems before using 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, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system listed in Annex V.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store VIAGRA

Keep this medicine out of the sight and reach of children.
Store at a temperature not exceeding 30 °C.
Do not use this medicine after the expiry date stated on the packaging and on the blister after
EXP. The expiry date refers to the last day of the month.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine in 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 ingredient is sildenafil. Each tablet contains 25 mg of sildenafil (as citrate salt).
The other ingredients 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
VIAGRA film-coated tablets (tablets) are blue, film-coated and have the
shape of a rounded diamond. They have “VIAGRA” embossed on one side and “VGR 25” on the other. The
tablets are available in blisters in packs of 2, 4, 8 or 12 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 medicine, contact the local representative of the marketing authorisation
holder.

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

Lietuva
Viatris UAB
Tel: +370 52051288

Luxembourg/Luxemburg
Viatris
Tél/Tel: +32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika
Viatris CZ s.r.o.
Tel: +420 222 004 400

България
Майлан ЕООД
Тел.: +359 2 44 55 400

Magyarország
Viatris Healthcare Kft.
Tel.: + 36 1 4 65 2100

Danmark
Viatris ApS
Tlf: +45 28 11 69 32

Malta
V.J. Salomone Pharma Limited
Tel: (+356) 21 200 174

Deutschland
Viatris Healthcare GmbH
Tel: +49 (0) 800 0700 800

Nederland
Mylan Healthcare BV
Tel: +31 (0) 20 426 3300

Eesti
Viatris OÜ
Tel: +372 6363 052

Norge
Viatris AS
Tlf: +47 66 75 33 00

Ελλάδα
Viatris Hellas Ltd
Τηλ: +30 2100 100 002

Österreich
Viatris Austria GmbH
Tel: +43 1 86390

España
Viatris Pharmaceuticals, S.L.
Tel: +34 900 102 712

Polska
Viatris Healthcare Sp. z o.o.,
Tel.: +48 22 546 64 00

France
Viatris Santé
Tél: +33 (0)4 37 25 75 00

Portugal
Viatris Healthcare, Lda.
Tel: +351 21 412 72 00

Hrvatska
Viatris Hrvatska d.o.o.
Tel: + 385 1 23 50 599

România
BGP Products SRL
Tel: +40 372 579 000

Ireland
Viatris Limited
Tel: + 353 1 8711600

Slovenija
Viatris d.o.o.
Tel: + 386 1 236 31 80

Ísland
Icepharma hf.
Sími: +354 540 8000

Slovenská republika
Viatris Slovakia s.r.o.
Tel: +421 2 32 199 100

Italia
Viatris Pharma S.r.l.
Tel: +39 02 612 46921

Suomi/Finland
Viatris Oy
Puh/Tel: +358 20 720 9555

Κύπρος
GPA Pharmaceuticals Ltd
Τηλ: +357 22863100

Sverige
Viatris AB
Tel: +46 (0)8 630 19 00

Latvija
Viatris SIA
Tel: +371 676 055 80

United Kingdom(Northern Ireland)
Mylan IRE Healthcare Limited
Tel: + 353 18711600

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

VIAGRA 50 mg film-coated tablets

sildenafil

Read this leaflet carefully before you start 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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What VIAGRA is and what it is used for
• 2. What you need to know before you take VIAGRA
• 3. How to take VIAGRA
• 4. Possible side effects
• 5. How to store VIAGRA
• 6. Contents of the pack and other information

1. What is VIAGRA and what is it used for

VIAGRA contains the active ingredient sildenafil which belongs to the class of medicines called
phosphodiesterase type 5 (PDE5) inhibitors. It helps to relax the blood vessels in the penis, allowing
blood flow to the penis when it is sexually stimulated. VIAGRA will only help you achieve an erection
if you are sexually stimulated.
VIAGRA is a treatment for adult men who experience erectile dysfunction, sometimes
called impotence. This condition occurs when a man cannot achieve or
maintain an erection adequate 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 can cause a dangerous
drop in blood pressure. Tell 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, ask your doctor or pharmacist.
if you are taking any of the medicines known as nitric oxide donors, such as amyl nitrite (“poppers”), because this combination can 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 secondary to blood clots). It has been shown that PDE5 inhibitors, such as Viagra, increase the hypotensive effect
of this medicine. If you are taking riociguat or if you have any doubts, tell your doctor.
if you have a serious heart or liver problem.
if you have recently had a stroke or a heart attack, or if you have low blood pressure.
if you have a rare hereditary eye disease (such as retinitis pigmentosa).
if you have previously experienced loss of vision caused by non-arteritic anterior ischaemic optic neuropathy (NAION).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking VIAGRA
if you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of the blood cells), multiple myeloma (cancer of the bone marrow).
if you have a deformity of the penis or Peyronie's disease.
if you have heart problems. Your doctor needs to carefully check that your heart condition allows you to cope with the exertion of sexual activity.
if you currently have a stomach ulcer, or problems with blood clotting (such as
haemophilia).
if you experience a sudden decrease or loss of vision, stop taking VIAGRA and
contact your doctor immediately.
You should not use VIAGRA together with other oral or local treatments for erectile dysfunction.
You should not use VIAGRA together with treatments for pulmonary arterial hypertension (PAH)
containing sildenafil or any other type 5 phosphodiesterase (PDE5) inhibitor.
You should not take VIAGRA if you do not have erectile dysfunction.
You should not take VIAGRA if you are a woman.

Special precautions for patients with kidney or liver problems
If you have kidney or liver problems, you must tell your doctor. Your doctor may decide to
give you a lower dose.
Children and adolescents
VIAGRA should not be given to anyone under 18 years of age.

Other medicines and VIAGRA
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
VIAGRA tablets can interact with certain medicines, especially those used for
treating chest pain. If you should experience a medical emergency, you must tell the
doctor, pharmacist or nurse that you have taken VIAGRA and when you took it. Do not take
VIAGRA together with other medicines unless your doctor has authorised it.
You should not take VIAGRA if you are taking medicines called nitrates because the combination
of these medicines can cause a dangerous drop in blood pressure. Tell your doctor, the
pharmacist or nurse if you are taking any of these medicines which are often used for
relieving angina attacks (or “chest pain”).
You should not take VIAGRA if you are using any of the medicines known as nitric oxide donors, such as amyl nitrite (“poppers”) because this combination can also cause a
dangerous drop in blood pressure.
Tell your doctor or pharmacist if you are already taking riociguat.
If you are taking medicines called protease inhibitors, for example medicines for the
treatment of HIV, your doctor may initially prescribe VIAGRA at the lowest dose (25 mg).
Some patients taking alpha-blockers for high blood pressure or
enlarged prostate may experience dizziness or lightheadedness which can be caused by low blood pressure when sitting or standing up quickly. Some patients
have reported these symptoms when they have taken VIAGRA together with alpha-blockers. This is more likely to happen within 4 hours of taking VIAGRA. To reduce the possibility that
these symptoms appear, you should be on a stable dose of your alpha-blocker before starting treatment with VIAGRA. Your doctor may start you on a lower dose of VIAGRA (25 mg).
Tell 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
VIAGRA can be taken with or without food. However, you may find that the onset of the effect
of VIAGRA may be delayed if you take it after a heavy meal.
Drinking alcohol can temporarily impair your ability to get
an erection. To get the most benefit from this medicine, it is advisable to avoid
drinking large amounts of alcohol before using VIAGRA.

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

Driving and using machines
VIAGRA can cause dizziness and can alter your vision. Before driving and using machines you must
be aware of how you react to VIAGRA.

VIAGRA contains lactose
If your doctor has told you that you have an intolerance to some 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, that is to say essentially
“sodium-free”.

3. How to take VIAGRA

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist. The recommended starting dose is 50 mg.

VIAGRA should not be taken more than once a day.
Do not take VIAGRA film-coated tablets in association with other medicines containing
sildenafil, including VIAGRA orodispersible tablets or VIAGRA orodispersible film.
You should take VIAGRA approximately one hour before the 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 only help you to achieve an erection if you are sexually stimulated. The time it takes 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 be delayed if you have
recently eaten a heavy meal.
If VIAGRA does not help you to 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 notice an increase in unwanted effects and the severity of these effects. Higher doses of
100 mg do not increase efficacy.

Do not take a number of tablets greater than those prescribed by your doctor.
If you take a number of tablets greater than those prescribed, contact your doctor.
If you have any doubts 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 in severity 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 with a not commonfrequency (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 a not commonfrequency): If it occurs during or after sexual activity:
• Assume a semi-sitting position and try to relax.
• Do not use nitratesto 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 uninterrupted for more than 4 hours, contact your doctor immediately.
• Sudden reduction or loss of vision - occurs rarely.
• Severe skin reactions - occur rarely. Symptoms may include severe peeling and swelling of the skin, blisters in the mouth, on the genitals and around the eyes, fever.
• Convulsions or seizures - 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, flushing, hot flushes (the
symptoms include a sudden feeling of heat in the upper part of the body), indigestion,
increased intensity of colors to the sight, blurred vision, visual disturbances, stuffy nose and
dizziness.

Not common (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, red eyes, eye pain, flashes of light, increased perception of light, sensitivity
to light, tearing, palpitations, fast heartbeat, high blood pressure,
low blood pressure, muscle pain, drowsiness, reduced sensitivity to touch, vertigo, ringing
in the ears, dry mouth, blocked or congested sinuses, inflammation of the nasal mucosa
(symptoms include runny nose, sneezing and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn), blood in the urine, pain to the
arms or legs, nosebleeds, feeling of heat and fatigue.

Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary reduction of blood flow to certain areas of the brain, feeling
of constriction in the throat, numb 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 corpuscles in your field of vision, seeing halos around lights, dilation
of the pupils, alteration of the white color of the sclera (part of the eye), bleeding of the penis,
presence of blood in the seminal fluid, dry nose, swelling of the nasal mucosa, irritability and
sudden or loss of hearing.
Cases of unstable angina (a heart disease) and sudden death have been reported from post-marketing experience. It should be noted that most men
who experienced these side effects, but not all, had heart problems before
using 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, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly through 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 VIAGRA

Keep this medicine out of the sight and reach of children.
Store at a temperature not exceeding 30 °C.
Do not use this medicine after the expiry date stated on the packaging and on the blister after
EXP. The expiry date refers to the last day of the month.
Store in the original package to protect the medicine from moisture.
Do not dispose of any medicine in 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 ingredient is sildenafil. Each tablet contains 50 mg of sildenafil (as citrate salt).
The other excipients are:

• Core: microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), sodium croscarmellose (see section 2 “VIAGRA contains sodium”), magnesium stearate.
• Film 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
VIAGRA film-coated tablets (tablets) are blue, film-coated and have the
shape of a rounded diamond. They have “VIAGRA” embossed on one side and “VGR 50” on the other. The
tablets are available in blisters in a carton or in secondary packaging in
packs of 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, contact the local representative of the marketing
authorisation holder.

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

Lietuva
Viatris UAB
Tel: +370 52051288

България
Майлан ЕООД
Тел.: +359 2 44 55 400

Luxembourg/Luxemburg
Viatris
Tél/Tel: +32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika
Viatris CZ s.r.o.
Tel: +420 222 004 400

Magyarország
Viatris Healthcare Kft.
Tel.: + 36 1 4 65 2100

Danmark
Viatris ApS
Tlf: +45 28 11 69 32

Malta
V.J. Salomone Pharma Limited
Tel: (+356) 21 220 174

Deutschland
Viatris Healthcare GmbH
Tel: +49 (0) 800 0700 800

Nederland
Mylan Healthcare BV
Tel: +31 (0) 20 426 3300

Eesti
Viatris OÜ
Tel: +372 6363 052

Norge
Viatris AS
Tlf: +47 66 75 33 00

Ελλάδα
Viatris Hellas Ltd
Τηλ: +30 2100 100 002

Österreich
Viatris Austria GmbH
Tel: +43 1 86390

España
Viatris Pharmaceuticals, S.L.
Tel: +34 900 102 712

Polska
Viatris Healthcare Sp. z o.o.,
Tel.: +48 22 546 64 00

France
Viatris Santé
Tél: +33 (0)4 37 25 75 00

Portugal
Viatris Healthcare, Lda.
Tel: +351 21 412 72 00

Hrvatska
Viatris Hrvatska d.o.o.
Tel: + 385 1 23 50 599

România
BGP Products SRL
Tel: +40 372 579 000

Ireland
Viatris Limited
Tel: + 353 1 8711600

Slovenija
Viatris d.o.o.
Tel: + 386 1 236 31 80

Ísland
Icepharma hf.
Sími: +354 540 8000

Slovenská republika
Viatris Slovakia s.r.o.
Tel: +421 2 32 199 100

Italia
Viatris Pharma S.r.l.
Tel: +39 02 612 46921

Suomi/Finland
Viatris Oy
Puh/Tel: +358 20 720 9555

Κύπρος
GPA Pharmaceuticals Ltd
Τηλ: +357 22863100

Sverige
Viatris AB
Tel: +46 (0)8 630 19 00

Latvija
Viatris SIA
Tel: +371 676 055 80

United Kingdom(Northern Ireland)
Mylan IRE Healthcare Limited
Tel: + 353 18711600

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 .

VIAGRA 100 mg film-coated tablets

sildenafil

Read this leaflet carefully before you start 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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What VIAGRA is and what it is used for
• 2. What you need to know before you take VIAGRA
• 3. How to take VIAGRA
• 4. Possible side effects
• 5. How to store VIAGRA
• 6. Contents of the pack and other information

1. What is VIAGRA and what is it used for

VIAGRA contains the active ingredient sildenafil which belongs to the class of medicines called
phosphodiesterase type 5 (PDE5) inhibitors. It helps to relax the blood vessels in the penis, allowing
blood flow to the penis when it is sexually stimulated. VIAGRA will only help you to achieve an
erection if you are sexually stimulated.
VIAGRA is a treatment for adult men who experience erectile dysfunction, sometimes
called impotence. This condition occurs when a man cannot 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 can cause a dangerous
drop in blood pressure. Tell 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, ask your doctor or pharmacist.
if you are taking any of the medicines known as nitric oxide donors, such as amyl nitrite (“poppers”), because this combination can also cause a dangerous drop
in blood pressure.
if you are taking riociguat. This medicine is used to treat pulmonary hypertension
(i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs secondary to blood clots). It has been shown that PDE5 inhibitors, such as Viagra, increase the hypotensive effect
of this medicine. If you are taking riociguat or if you have any doubts, tell your doctor.
if you have a serious heart or liver problem.
if you have recently had a stroke or a heart attack, or if you have low blood pressure.
if you have a rare hereditary eye disease (such as retinitis pigmentosa).
if you have previously experienced loss of vision caused by a 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 (cancer of the blood cells), multiple myeloma (cancer of the bone marrow).
if you have a deformity of the penis or Peyronie's disease.
if you have heart problems. Your doctor must carefully check that your heart condition allows you to cope with the effort of sexual intercourse.
if you currently have a stomach ulcer, or problems with blood clotting (such as
hemophilia).
if you experience a sudden decrease or loss of vision, stop taking VIAGRA and
contact your doctor immediately.
You should not use VIAGRA together with other oral or local treatments for erectile dysfunction.
You should not use VIAGRA together with treatments for pulmonary arterial hypertension (PAH)
containing sildenafil or any other type 5 phosphodiesterase (PDE5) inhibitor.
You should not take VIAGRA if you do not have erectile dysfunction.
You should not take VIAGRA if you are a woman.

Special precautions for patients with kidney or liver problems
If you have kidney or liver problems, you must tell your doctor. Your doctor may decide to
give you a lower dose.
Children and adolescents
VIAGRA should not be given to anyone under 18 years of age.

Other medicines and VIAGRA
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
VIAGRA tablets can interact with some medicines, particularly those used for
treating chest pain. If you should experience 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 together with other medicines unless your doctor has authorized it.
You should not take VIAGRA if you are taking medicines called nitrates because the combination
of these medicines can cause a dangerous drop in blood pressure. Tell your doctor, the
pharmacist or nurse if you are taking any of these medicines which are often used for
relieving angina attacks (or “chest pain”).
You should not take VIAGRA if you are using any of the medicines known as nitric oxide donors, such as amyl nitrite (“poppers”) because this association can also cause a
dangerous drop in blood pressure.
Tell your doctor or pharmacist if you are already taking riociguat.
If you are taking medicines called protease inhibitors, for example medicines for the
treatment of HIV, your doctor may initially prescribe VIAGRA at the lowest dose (25 mg).
Some patients taking alpha-blockers for high blood pressure or
enlarged prostate may experience dizziness or lightheadedness which may be caused by low blood pressure when sitting or standing up quickly. Some patients
have reported these symptoms when they have taken VIAGRA together with alpha-blockers. This is more likely to happen within 4 hours of taking VIAGRA. To reduce the possibility that
these symptoms appear, you should be on a stable dose of your alpha-blocker before
starting treatment with VIAGRA. Your doctor may start you on a lower dose of VIAGRA (25 mg).
Tell 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
VIAGRA can be taken with or without food. However, you may notice that the onset of the effect
of VIAGRA may be delayed if you take it after consuming a heavy meal.
Drinking alcohol can temporarily impair the 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 VIAGRA.

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

Driving and using machines
VIAGRA can cause dizziness and can alter your vision. Before driving and using machines you must
be aware of how you react to VIAGRA.

VIAGRA contains lactose
If your doctor has told you that you have an intolerance to some 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, that is to say essentially
“sodium-free”.

3. How to take VIAGRA

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist. The recommended starting dose is 50 mg.

VIAGRA should not be taken more than once a day.
Do not take VIAGRA film-coated tablets in association with other medicines containing
sildenafil, including VIAGRA orodispersible tablets or VIAGRA orodispersible film.
You should take VIAGRA approximately one hour before the 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 only help you to achieve an erection if you are sexually stimulated. The time it takes 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 be delayed if you have
recently consumed a heavy meal.
If VIAGRA does not help you to 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 notice an increase in undesirable effects and the severity of these effects. Higher doses of
100 mg do not increase efficacy.

Do not take a number of tablets greater than those prescribed by your doctor.
If you take a number of tablets greater than those 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 will experience them.
The side effects reported in association with the use of VIAGRA are usually mild to moderate in
severity 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 with a frequency of uncommon(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 a frequency of uncommon: If it occurs during or after sexual activity:
• Assume a semi-sitting position and try to relax.
• Do not use nitratesto 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 uninterrupted for more than 4 hours, contact your doctor immediately.
• Sudden reduction or loss of vision - occurs rarely.
• Severe skin reactions - occur rarely. Symptoms may include severe peeling and swelling of the skin, blisters in the mouth, on the genitals and around the eyes, fever.
• Convulsions or seizures - 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, flushing, hot flushes (the
symptoms include a sudden feeling of warmth in the upper part of the body), indigestion,
increased intensity of colors to the sight, blurred vision, visual disturbances, stuffy nose and
dizziness.

Uncommon(may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, red eyes, eye pain, flashes of light, increased perception of light, sensitivity
to light, tearing, palpitations, fast heartbeat, high blood pressure,
low blood pressure, muscle pain, drowsiness, reduced sensitivity to touch, vertigo, ringing
in the ears, dry mouth, blocked or congested sinuses, inflammation of the nasal mucosa (symptoms include runny nose, sneezing and nasal congestion), upper abdominal pain,
gastroesophageal reflux disease (symptoms include heartburn), blood in the urine, pain
in the arms or legs, nosebleeds, feeling of heat and fatigue.

Rare(may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular
heartbeat, temporary reduction of blood flow to certain areas of the brain, feeling
of constriction in the throat, numb 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 corpuscles in your visual field, seeing halos around lights, dilation
of the pupils, alteration of the white color of the sclera (part of the eye), bleeding of the penis,
presence of blood in the seminal fluid, dry nose, swelling of the nasal mucosa, irritability and
sudden or loss of hearing.
Cases of unstable angina (a heart disease) and sudden death have been reported from post-marketing experience. It should be noted that most men
who experienced these side effects, but not all, had heart problems before
using 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, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects
directly through the national reporting system as detailed in Annex V.
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 sight and reach of children.
Store at a temperature not exceeding 30 °C.
Do not use this medicine after the expiry date stated on the packaging and on the blister after
EXP. The expiry date refers to the last day of the month.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine in 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 ingredient is sildenafil. Each tablet contains 100 mg of sildenafil (as citrate salt).
The other ingredients are:

• Core: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium croscarmellose (see section 2 “VIAGRA contains sodium”), magnesium stearate.
• Film 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
VIAGRA film-coated tablets (tablets) are blue, film-coated and have the
shape of a rounded diamond. They have “VIAGRA” embossed on one side and “VGR 100” on the other. The
tablets are available in blisters in packs of 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 on this medicinal product, contact the local representative of the marketing
authorisation holder.

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

Lietuva
Viatris UAB
Tel: +370 52051288

България
Майлан ЕООД
Тел.: +359 2 44 55 400

Luxembourg/Luxemburg
Viatris
Tél/Tel: +32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika
Viatris CZ s.r.o.
Tel: +420 222 004 400

Magyarország
Viatris Healthcare Kft.
Tel.: + 36 1 4 65 2100

Danmark
Viatris ApS
Tlf: +45 28 11 69 32

Malta
V.J. Salomone Pharma Limited
Tel: (+356) 21 220 174

Deutschland
Viatris Healthcare GmbH
Tel: +49 (0) 800 0700 800

Nederland
Mylan Healthcare BV
Tel: +31 (0) 20 426 3300

Eesti
Viatris OÜ
Tel: +372 6363 052

Norge
Viatris AS
Tlf: +47 66 75 33 00

Ελλάδα
Viatris Hellas Ltd
Τηλ: +30 2100 100 002

Österreich
Viatris Austria GmbH
Tel: +43 1 86390

España
Viatris Pharmaceuticals, S.L.
Tel: +34 900 102 712

Polska
Viatris Healthcare Sp. z o.o.,
Tel.: +48 22 546 64 00

France
Viatris Santé
Tél: +33 (0)4 37 25 75 00

Portugal
Viatris Healthcare, Lda.
Tel: +351 21 412 72 00

Hrvatska
Viatris Hrvatska d.o.o.
Tel: + 385 1 23 50 599

România
BGP Products SRL
Tel: +40 372 579 000

Ireland
Viatris Limited
Tel: + 353 1 8711600

Slovenija
Viatris d.o.o.
Tel: + 386 1 236 31 80

Ísland
Icepharma hf.
Sími: +354 540 8000

Slovenská republika
Viatris Slovakia s.r.o.
Tel: +421 2 32 199 100

Italia
Viatris Pharma S.r.l.
Tel: +39 02 612 46921

Suomi/Finland
Viatris Oy
Puh/Tel: +358 20 720 9555

Κύπρος
GPA Pharmaceuticals Ltd
Τηλ: +357 22863100

Sverige
Viatris AB
Tel: +46 (0)8 630 19 00

Latvija
Viatris SIA
Tel: +371 676 055 80

United Kingdom(Northern Ireland)
Mylan IRE Healthcare Limited
Tel: + 353 187116600

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.

VIAGRA 50 mg orodispersible tablets

sildenafil

Read this leaflet carefully before you start 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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What VIAGRA is and what it is used for
• 2. What you need to know before you take VIAGRA
• 3. How to take VIAGRA
• 4. Possible side effects
• 5. How to store VIAGRA
• 6. Contents of the pack and other information

1. What is VIAGRA and what is it used for

VIAGRA contains the active ingredient sildenafil which belongs to the class of medicines known as
phosphodiesterase type 5 (PDE5) inhibitors. It helps to relax the blood vessels in the penis, allowing
blood flow to the penis when it is sexually stimulated. VIAGRA will only help you to achieve an erection
if you are sexually stimulated.
VIAGRA is a treatment for adult men who experience erectile dysfunction, sometimes
called impotence. This condition occurs when a man cannot achieve or
maintain an erection adequate for sexual intercourse.

2. What you need to know before taking VIAGRA

Do not take VIAGRA
if you are allergic to sildenafil or any of the other ingredients of this medicine
(listed in section 6).
if you are taking medicines called nitrates, because this combination can cause a dangerous
drop in blood pressure. Tell 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, ask your doctor or pharmacist.
if you are taking any of the medicines known as nitric oxide donors, such as amyl nitrite (“poppers”), because this combination can 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 secondary to blood clots). It has been shown that PDE5 inhibitors, such as Viagra, increase the hypotensive effect
of this medicine. If you are taking riociguat or if you are unsure, tell your doctor.
if you have a serious heart or liver problem.
if you have recently had a stroke or a heart attack, or if you have low blood pressure.
if you have a rare hereditary eye disease (such as retinitis pigmentosa).
if you have previously experienced loss of vision 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 (cancer of the blood cells), multiple myeloma (cancer of the bone marrow).
if you have a deformity of the penis or Peyronie's disease.
if you have heart problems. Your doctor needs to carefully check that your heart condition allows you to cope with the exertion of sexual activity.
if you currently have a stomach ulcer, or problems with blood clotting (such as
hemophilia).
if you experience a sudden decrease or loss of vision, stop taking VIAGRA and
contact your doctor immediately.
You should not use VIAGRA together with other oral or local treatments for erectile dysfunction.
You should not use VIAGRA together with treatments for pulmonary arterial hypertension (PAH)
containing sildenafil or any other type 5 phosphodiesterase (PDE5) inhibitor.
You should not take VIAGRA if you do not have erectile dysfunction.
You should not take VIAGRA if you are a woman.

Special precautions for patients with kidney or liver problems
If you have kidney or liver problems, you should tell your doctor. Your doctor may decide to
give you a lower dose.

Children and adolescents
VIAGRA should not be given to anyone under the age of 18.

Other medicines and VIAGRA
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
VIAGRA tablets can interact with some medicines, particularly those used for
the treatment of chest pain. If you should experience 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 authorised it.
You should not take VIAGRA if you are taking medicines called nitrates because the combination
of these medicines can cause a dangerous drop in blood pressure. Tell your doctor, the
pharmacist or nurse if you are taking any of these medicines which are often used for
relieving angina attacks (or “chest pain”).
Tell your doctor or pharmacist if you are already taking riociguat.
You should not take VIAGRA if you are using any of the medicines known as nitric oxide donors, such as amyl nitrite (“poppers”) because this combination can also cause a
dangerous drop in blood pressure.
If you are taking medicines called protease inhibitors, for example medicines for the
treatment of HIV, your doctor may initially prescribe VIAGRA at the lowest dose
(film-coated tablets 25 mg).
Some patients taking alpha-blockers for high blood pressure or
enlarged prostate may experience dizziness or lightheadedness which can be caused by low blood pressure when sitting or standing up quickly. Some patients
have reported these symptoms when they have taken VIAGRA together with alpha-blockers. This is more likely to happen within 4 hours of taking VIAGRA. To reduce the possibility that
these symptoms appear, you should be on a regular dose of the alpha-blocker before
starting treatment with VIAGRA. Your doctor may start you on a lower dose of VIAGRA (film-coated tablets 25 mg).
Tell 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 can temporarily impair the ability to get
an erection. To get the most benefit from this medicine, it is advisable to avoid
drinking large amounts of alcohol before using VIAGRA.

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

Driving and using machines
VIAGRA can cause dizziness and can alter your vision. Before driving and using machines 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, that is to say essentially
“sodium-free”.

3. How to take VIAGRA

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The recommended initial dose is 50 mg.

VIAGRA should not be taken more than once a day.
Do not take VIAGRA orodispersible tablets in association with other medicines containing
sildenafil, including VIAGRA film-coated tablets or VIAGRA orodispersible film.
You should take VIAGRA approximately one hour before the anticipated sexual activity. The time needed
for VIAGRA to take effect varies from person to person, but generally ranges from half an hour to
one hour.
Place the orodispersible tablet in your mouth, on your tongue, where it will dissolve in 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 you need a second 50 mg orodispersible tablet to reach a 100 mg dose,
you should wait until the first tablet has completely dissolved in your 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, contact your doctor or
pharmacist.
VIAGRA will only help you to achieve an erection if you are sexually stimulated.
If VIAGRA does not help you to 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 notice an increase in the undesirable effects and the severity of these effects. Higher doses than
100 mg do not increase efficacy.

Do not take a number of tablets greater than those prescribed by your doctor.
If you take a number of tablets greater than those prescribed, contact your doctor.
If you have any doubts about the use of this medicine, ask 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 in
severity 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 with a frequency of uncommon(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 a frequency of uncommon: If it occurs during or after sexual activity:
• Assume a semi-sitting position and try to relax.
• Do not use nitratesto 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 uninterrupted for more than 4 hours, contact your doctor immediately.
• Sudden reduction or loss of vision - occurs rarely.
• Severe skin reactions - occur rarely. Symptoms may include severe peeling and swelling of the skin, blisters of the mouth, genitals and around the eyes, fever.
• Convulsions or seizures - 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, flushing, hot flushes (the
symptoms include a sudden feeling of warmth in the upper part of the body), indigestion,
increased intensity of colors to the sight, blurred vision, visual disturbances, stuffy nose and
dizziness.

Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, red eyes, eye pain, flashes of light, increased perception of light, sensitivity
to light, tearing, heart palpitations, fast heartbeat, high blood pressure,
low blood pressure, muscle pain, drowsiness, reduced sensitivity to touch, vertigo, ringing
in the ears, dry mouth, blocked or congested sinuses, inflammation of the nasal mucosa (symptoms include runny nose, sneezing and nasal congestion), upper abdominal pain,
gastroesophageal reflux disease (symptoms include heartburn), blood in the urine, pain
in the arms or legs, nosebleeds, feeling of heat and fatigue.

Rare(may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular
heartbeat, temporary reduction of blood flow to some areas of the brain, feeling
of constriction in the throat, numb 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 corpuscles in your field of vision, seeing halos around lights, dilation
of the pupils, alteration of the white color of the sclera (part of the eye), bleeding of the penis,
presence of blood in the seminal fluid, dry nose, swelling of the nasal mucosa, irritability and
sudden or loss of hearing.
Cases of unstable angina (a heart disease) and sudden death have been reported after marketing. It should be noted that most men
who experienced these side effects, but not all, had heart problems before
using 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, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly through 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 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 particular storage temperature.
Store in the original package to protect the medicine from moisture.
Do not dispose of any medicine in 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 ingredient 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
indigotine (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 contents of the pack
VIAGRA orodispersible tablets are blue and diamond-shaped. They have “V50” imprinted
on one side. The orodispersible tablets are available in blisters in packs of 2, 4, 8 or 12
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, contact the local representative of the marketing
authorisation holder.

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

Lietuva
Viatris UAB
Tel: +370 52051288

България
Майлан ЕООД
Тел.: +359 2 44 55 400

Luxembourg/Luxemburg
Viatris
Tél/Tel: +32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika
Viatris CZ s.r.o.
Tel: +420 222 004 400

Magyarország
Viatris Healthcare Kft.
Tel.: + 36 1 4 65 2100

Danmark
Viatris ApS
Tlf: +45 28 11 69 32

Malta
V.J. Salomone Pharma Limited
Tel: (+356) 21 220 174

Deutschland
Viatris Healthcare GmbH
Tel: +49 (0) 800 0700 800

Nederland
Mylan Healthcare BV
Tel: +31 (0) 20 426 3300

Eesti
Viatris OÜ
Tel: +372 6363 052

Norge
Viatris AS
Tlf: +47 66 75 33 00

Österreich
Viatris Austria GmbH
Tel: +43 1 86390

España
Viatris Pharmaceuticals, S.L.
Tel: +34 900 102 712

Ελλάδα
Viatris Hellas Ltd
Τηλ: +30 2100 100 002

Polska
Viatris Healthcare Sp. z o.o.,
Tel.: +48 22 546 64 00

France
Viatris Santé
Tél: +33 (0)4 37 25 75 00

Portugal
Viatris Healthcare, Lda.
Tel: +351 21 412 72 00

Hrvatska
Viatris Hrvatska d.o.o.
Tel: + 385 1 23 50 599

România
BGP Products SRL
Tel: +40 372 579 000

Ireland
Viatris Limited
Tel: + 353 1 8711600

Slovenija
Viatris d.o.o.
Tel: + 386 1 236 31 80

Ísland
Icepharma hf.
Sími: +354 540 8000

Slovenská republika
Viatris Slovakia s.r.o.
Tel: +421 2 32 199 100

Italia
Viatris Pharma S.r.l.
Tel: +39 02 612 46921

Suomi/Finland
Viatris Oy
Puh/Tel: +358 20 720 9555

Κύπρος
GPA Pharmaceuticals Ltd
Τηλ: +357 22863100

Sverige
Viatris AB
Tel: +46 (0)8 630 19 00

Latvija
Viatris SIA
Tel: +371 676 055 80

United Kingdom(Northern Ireland)
Mylan IRE Healthcare Limited
Tel: + 353 18711600

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 .

VIAGRA 50 mg film-coated orodispersible tablets

sildenafil

Read this 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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What VIAGRA is and what it is used for
• 2. What you need to know before you take VIAGRA
• 3. How to take VIAGRA
• 4. Possible side effects
• 5. How to store VIAGRA
• 6. Contents of the pack and other information

1. What is VIAGRA and what is it used for

VIAGRA contains the active ingredient sildenafil which belongs to the class of medicines called
phosphodiesterase type 5 (PDE5) inhibitors. It helps to relax the blood vessels in the penis, allowing
blood flow to the penis when it is sexually stimulated. VIAGRA will only help you to achieve an
erection if you are sexually stimulated.
VIAGRA is a treatment for adult men who experience erectile dysfunction, sometimes
called impotence. This condition occurs when a man cannot achieve or
maintain an erection adequate 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 can cause a dangerous
drop in blood pressure. Tell 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, ask your doctor or pharmacist.
if you are taking any of the medicines known as nitric oxide donors, such as amyl nitrite (“poppers”), because this combination can 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 caused by blood clots). It has been shown that PDE5 inhibitors, such as VIAGRA, increase the hypotensive effect
of this medicine. If you are taking riociguat or if you are unsure, tell your doctor.
if you have a severe heart or liver problem.
if you have recently had a stroke or a 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 loss of vision caused by non-arteritic anterior ischaemic optic neuropathy (NAION).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking VIAGRA
if you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of the blood cells), multiple myeloma (cancer of bone marrow).
if you have a deformity of the penis or Peyronie’s disease.
if you have heart problems. Your doctor needs to carefully check that your heart condition allows you to cope with the exertion of sexual activity.
if you currently have a stomach ulcer, or problems with blood clotting (such as
haemophilia).
if you experience a sudden decrease or loss of vision, stop taking VIAGRA and
contact your doctor immediately.
You should not use VIAGRA together with other oral or local treatments for erectile dysfunction.
You should not use VIAGRA together with treatments for pulmonary arterial hypertension (PAH)
containing sildenafil or any other type 5 phosphodiesterase (PDE5) inhibitor.
You should not take VIAGRA if you do not have erectile dysfunction.
You should not take VIAGRA if you are a woman.

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

Children and adolescents
VIAGRA should not be given to anyone under the age of 18.

Other medicines and VIAGRA
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
VIAGRA can interact with some medicines, particularly those used to treat
chest pain. If you have a medical emergency, you should tell the doctor, the
pharmacist or the nurse that you have taken VIAGRA and when you took it. Do not take VIAGRA
with other medicines unless your doctor has authorised it.
You should not take VIAGRA if you are taking medicines called nitrates because the combination
of these medicines can cause a dangerous drop in blood pressure. Tell your doctor, the
pharmacist or the nurse if you are taking any of these medicines which are often used to
relieve angina pectoris (or “chest pain”).
You should not take VIAGRA if you are using any of the medicines known as nitric oxide
donors, such as amyl nitrite (“poppers”) because this combination can also cause a
dangerous drop in blood pressure.
Tell your doctor or pharmacist if you are already taking riociguat.
If you are taking medicines called protease inhibitors, for example medicines for the
treatment of HIV, your doctor may initially prescribe you VIAGRA at the lowest dose
(film-coated tablets 25 mg).
Some patients taking alpha-blockers for high blood pressure or
enlarged prostate may experience dizziness or lightheadedness which can be caused by low blood pressure when sitting or standing up quickly. Some patients
have reported these symptoms when taking VIAGRA together with alpha-blockers. This is more likely to happen within 4 hours of taking VIAGRA. To reduce the possibility that
these symptoms appear, you should be on a stable dose of your alpha-blocker before starting treatment with VIAGRA. Your doctor may start you on a lower dose of VIAGRA (film-coated tablets 25 mg).
Tell your doctor or pharmacist if you are taking medicines containing sacubitril/valsartan, used
for the treatment of heart failure.

VIAGRA with alcohol
Drinking alcohol may temporarily impair your ability to get an
erection. To get the most benefit from this medicine, it is advisable to avoid
drinking large amounts of alcohol before using VIAGRA.

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

Driving and using machines
VIAGRA can cause dizziness and can alter your vision. Before driving and using machines you must
be aware of how you react to VIAGRA.

3. How to take VIAGRA

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended starting dose is 50 mg.

VIAGRA should not be taken more than once a day.
Do not take VIAGRA orodispersible films in association with other medicines containing sildenafil,
including VIAGRA film-coated tablets or VIAGRA orodispersible tablets.
You should take VIAGRA approximately one hour before the anticipated sexual activity. The time
needed for VIAGRA to take effect varies from person to person, but generally ranges from half an
hour to one hour.
Carefully open the aluminum blister with dry hands, without cutting it. Extract the film
orodispersible with a dry finger and immediately place the orodispersible film on your tongue, where
it will dissolve in a few seconds with or without water. During dissolution, saliva may be swallowed,
but without swallowing the film.
The orodispersible film should be taken on an empty stomach, as the effect may be delayed
after a heavy meal.
If you need a second 50 mg orodispersible film to reach a dose of 100 mg, you should
wait until the first film has completely dissolved in your 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 only help you to achieve an erection if you are sexually stimulated.
If VIAGRA does not help you to 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 notice an increase in side effects and the severity of these effects. Higher doses of
100 mg do not increase efficacy.

Do not take a number of films higher than those prescribed by your doctor.
If you take a number of films higher than those prescribed, contact your doctor.
If you have any doubts about the use of this medicine, ask 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 in severity 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 with a frequency of uncommon(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 a frequency of uncommon: If it occurs during or after sexual activity:
• Assume a semi-sitting position and try to relax.
• Do not use nitratesto 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 uninterrupted for more than 4 hours, contact your doctor immediately.
• Sudden reduction or loss of vision - occurs rarely.
• Severe skin reactions - occur rarely. Symptoms may include severe peeling and swelling of the skin, blisters of the mouth, genitals and around the eyes, fever.
• Convulsions or seizures - 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, flushing, hot flushes (the
symptoms include a sudden feeling of warmth in the upper part of the body), indigestion,
increased intensity of colours to vision, blurred vision, visual disturbances, stuffy nose and
dizziness.

Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, red eyes, eye pain, flashes of light, increased perception of light, sensitivity
to light, tearing, heart palpitations, fast 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,
gastro-oesophageal reflux disease (symptoms include heartburn), blood in urine, pain
in the arms or legs, nosebleeds, feeling of heat and fatigue.

Rare(may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary reduction of blood flow to some areas of the brain, feeling
of constriction in the throat, numb 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 corpuscles in your field of vision, seeing halos around lights, dilation
of the pupils, alteration of the white colour of the sclera (part of the eye), bleeding of the penis,
presence of blood in the seminal fluid, dry nose, swelling of the nasal mucosa, irritability and
sudden or loss of hearing.
Cases of unstable angina (a heart condition) and sudden death have been reported from post-marketing experience. It should be noted that most men
who experienced these side effects, but not all, had heart problems before
using 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, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system listed in Annex V. By reporting side
effects you can help provide more information on the safety of this medicine.

5. How to store VIAGRA

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

Description of the appearance of VIAGRA and contents of the pack
Each orodispersible film is packaged in a single aluminium blister.
They are supplied in packs containing 2, 4, 8 or 12 blisters.
Not all pack sizes may be marketed.

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

Manufacturer
LTS Lohmann Therapie-Systeme AG, Lohmannstrasse 2, Andernach, Rhineland-Palatinate, 56626,
Germany.
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder.

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

Lietuva
Viatris UAB
Tel: +370 52051288

България
Майлан ЕООД
Тел.: +359 2 44 55 400

Luxembourg/Luxemburg
Viatris
Tél/Tel: +32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika
Viatris CZ s.r.o.
Tel: +420 222 004 400

Magyarország
Viatris Healthcare Kft.
Tel.: + 36 1 4 65 2100

Danmark
Viatris ApS
Tlf: +45 28 11 69 32

Malta
V.J. Salomone Pharma Limited
Tel: (+356) 21 220 174

Deutschland
Viatris Healthcare GmbH
Tel: +49 (0) 800 0700 800

Nederland
Mylan Healthcare BV
Tel: +31 (0) 20 426 3300

Eesti
Viatris OÜ
Tel: +372 6363 052

Norge
Viatris AS
Tlf: +47 66 75 33 00

Ελλάδα
Viatris Hellas Ltd
Τηλ: +30 2100 100 002

Österreich
Viatris Austria GmbH
Tel: +43 1 86390

España
Viatris Pharmaceuticals, S.L.
Tel: +34 900 102 712

Polska
Viatris Healthcare Sp. z o.o.,
Tel.: +48 22 546 64 00

France
Viatris Santé
Tél: +33 (0)4 37 25 75 00

Portugal
Viatris Healthcare, Lda.
Tel: +351 21 412 72 00

Hrvatska
Viatris Hrvatska d.o.o.
Tel: + 385 1 23 50 599

România
BGP Products SRL
Tel: +40 372 579 000

Ireland
Viatris Limited
Tel: + 353 1 8711600

Slovenija
Viatris d.o.o.
Tel: + 386 1 236 31 80

Ísland
Icepharma hf.
Sími: +354 540 8000

Slovenská republika
Viatris Slovakia s.r.o.
Tel: +421 2 32 199 100

Italia
Viatris Pharma S.r.l.
Tel: +39 02 612 46921

Suomi/Finland
Viatris Oy
Puh/Tel: +358 20 720 9555

Κύπρος
GPA Pharmaceuticals Ltd
Τηλ: +357 22863100

Sverige
Viatris AB
Tel: +46 (0)8 630 19 00

Latvija
Viatris SIA
Tel: +371 676 055 80

United Kingdom(Northern Ireland)
Mylan IRE Healthcare Limited
Tel: + 353 18711600

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 .