Viagra

Helstu upplýsingar

  • Heiti vöru:
  • Viagra
  • Lyf við lungum:
  • Mannfólk
  • Lyfjaform:
  • Allópatísk lyf

Skjöl

Staðsetning

  • Fáanlegt í:
  • Viagra
    Evrópusambandið
  • Tungumál:
  • enska

Meðferðarupplýsingar

  • Meðferðarhópur:
  • UROLOGICALS
  • Lækningarsvæði:
  • Erectile Dysfunction
  • Ábendingar:
  • Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for Viagra to be effective, sexual stimulation is required.,
  • Vörulýsing:
  • Revision: 33

Staða

  • Heimild:
  • EMA - European Medicines Agency
  • Leyfisstaða:
  • Authorised
  • Leyfisnúmer:
  • EMEA/H/C/000202
  • Leyfisdagur:
  • 12-09-1998
  • EMEA númer:
  • EMEA/H/C/000202
  • Síðasta uppfærsla:
  • 24-07-2019

Opinber matsskýrsla

30 Churchill Place

Canary Wharf

London E14 5EU

United Kingdom

An agency of the European Union

Telephone

+44 (0)20 3660 6000

Facsimile

+44 (0)20 3660 5555

Send a question via our website

www.ema.europa.eu/contact

© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

EMA/17073/2016

EMEA/H/C/000202

EPAR summary for the public

Viagra

sildenafil

This is a summary of the European public assessment report (EPAR) for Viagra. It explains how the

Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in

favour of granting a marketing authorisation and its recommendations on the conditions of use for

Viagra.

What is Viagra?

Viagra is a medicine that contains the active substance sildenafil. It is available as tablets (25, 50 or

100 mg) and as orodispersible tablets (50 mg). Orodispersible tablets are tablets that dissolve in the

mouth.

What is Viagra used for?

Viagra is used to treat adult men with erectile dysfunction (sometimes called impotence), when they

cannot get or keep a sufficiently hard penis (erection) for satisfactory sexual activity. For Viagra to be

effective, sexual stimulation is required.

The medicine can only be obtained with a prescription.

How is Viagra used?

The recommended dose of Viagra is 50 mg taken as needed about one hour before sexual activity. If

Viagra is taken with food, the onset of activity may be delayed compared with taking it without food.

The orodispersible tablets should be placed on the tongue and left to disintegrate before swallowing.

The dose may be increased to a maximum of 100 mg or decreased to 25 mg depending on the

effectiveness and side effects. Patients with liver problems or severe kidney problems should start

treatment with the 25 mg dose. The maximum recommended dosing frequency is once a day.

Viagra

EMA/17073/2016

Page 2/3

How does Viagra work?

The active ingredient in Viagra, sildenafil, belongs to a group of medicines called phosphodiesterase

type 5 (PDE5) inhibitors. It works by blocking the phosphodiesterase enzyme, which normally breaks

down a substance known as cyclic guanosine monophosphate (cGMP). During normal sexual

stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the

penis (the corpora cavernosa) to relax, allowing the flow of blood into the corpora, producing the

erection. By blocking the breakdown of cGMP, Viagra restores erectile function. Sexual stimulation is

still needed to produce an erection.

How has Viagra been studied?

Viagra has been studied in four main studies including 1,690 men aged 19 to 87 years, where it was

compared with placebo (a dummy treatment) for between 12 and 26 weeks. Two of these studies used

fixed doses (patients allocated to 25, 50 or 100 mg) and two studies were flexible (patients started on

25 mg and could be moved to 50 or 100 mg depending on their response). In addition, there were

studies in patients with spinal cord injury and with diabetes. The main measure of effectiveness was

based on the ability of the men to get and maintain an erection. This was recorded in a special

questionnaire completed at home using a scoring system on a five-point scale, where a score of 5

represents the best result.

What benefit has Viagra shown during the studies?

Viagra was significantly more effective than placebo in all studies. In the questionnaire, scores for the

question on how often the patient was able to achieve intercourse went from about 2 without

treatment to 3 or 4 with Viagra 50 mg. In the fixed-dose studies, the proportions of patients reporting

that treatment improved their erections were 62% (25 mg), 74% (50 mg) and 82% (100 mg),

compared with 25% on placebo.

What is the risk associated with Viagra?

The most common side effects with Viagra are headache, flushing, dyspepsia (indigestion), visual

disorders, including visual colour distortion and blurred vision, nasal congestion (blocked nose),

dizziness, nausea and hot flushes. For the full list of all side effects reported with Viagra, see the

package leaflet.

Viagra must not be used where sexual activity is inadvisable (e.g. men with severe heart disease such

as unstable angina or severe heart failure). It must also not be taken by patients who have ever had

loss of vision because of a problem with blood flow to the nerve in the eye (non-arteritic anterior

ischemic optic neuropathy or NAION). Viagra must not be taken with nitrates (medicines used to treat

angina) or medicines of the class ‘guanylate cyclase stimulators’ such as riociguat (used to treat

pulmonary hypertension [high blood pressure in the lungs]). Because Viagra has not been studied in

patients with severe liver disease, hypotension (low blood pressure), recent stroke or myocardial

infarction (heart attack), or a hereditary eye disease, such as retinitis pigmentosa, these patients must

not use it. For the full list of restrictions, see the package leaflet.

Viagra

EMA/17073/2016

Page 3/3

Why has Viagra been approved?

The CHMP decided that Viagra’s benefits are greater than its risks and recommended that it be given

marketing authorisation.

What measures are being taken to ensure the safe and effective use of

Viagra?

A risk management plan has been developed to ensure that Viagra is used as safely as possible. Based

on this plan, safety information has been included in the summary of product characteristics and the

package leaflet for Viagra, including the appropriate precautions to be followed by healthcare

professionals and patients.

Other information about Viagra

The European Commission granted a marketing authorisation valid throughout the European Union for

Viagra on 14 September 1998.

The full EPAR for Viagra can be found on the Agency’s website: ema.europa.eu/Find medicine/Human

medicines/European public assessment reports. For more information about treatment with Viagra,

read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 01-2016.

Upplýsingar um fylgiseðil sjúklinga: samsetning, vísbendingar, aukaverkanir, skammtar, milliverkanir, aukaverkanir, meðgöngu, brjóstagjöf

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

VIAGRA 25 mg film-coated tablets

Sildenafil

Read all of this leaflet carefully before you start taking this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or nurse.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

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

side effects not listed in this leaflet. See section 4.

What is in this leaflet

What VIAGRA is and what it is used for

What you need to know before you take 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 group of medicines called

phosphodiesterase type 5 (PDE5) inhibitors. It works by helping to relax the blood vessels in your

penis, allowing blood to flow into your penis when you get sexually excited. VIAGRA will only help

you to get an erection if you are sexually stimulated.

VIAGRA is a treatment for adult men with erectile dysfunction, sometimes known as impotence. This

is when a man cannot get, or keep a hard, erect penis suitable for sexual activity.

2.

What you need to know before you take VIAGRA

Do not take VIAGRA

If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section

If you are taking medicines called nitrates, as the combination may lead to a dangerous fall in

your blood pressure. Tell your doctor if you are taking any of these medicines which are often

given for relief of angina pectoris (or “chest pain”). If you are not certain, ask your doctor or

pharmacist.

If you are using any of the medicines known as nitric oxide donors such as amyl nitrite

(“poppers”), as the combination may also lead to a dangerous fall in your blood pressure.

If you are taking riociguat. This drug is used to treat pulmonary arterial hypertension (i.e., high

blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high

blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as Viagra have

been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or

are unsure tell your doctor.

If you have a severe heart or liver problem.

If you have recently had a stroke or a heart attack, or if you have low blood pressure.

If you have certain rare inherited eye diseases (such as retinitis pigmentosa).

If you have ever had loss of vision due to 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 blood

cells), multiple myeloma (cancer of bone marrow).

If you have a deformity of your penis or Peyronie’s Disease.

If you have problems with your heart. Your doctor should carefully check whether your heart

can take the additional strain of having sex.

If you currently have a stomach ulcer, or a bleeding problems (such as haemophilia).

If you experience sudden decrease or loss of vision, stop taking VIAGRA and contact your

doctor immediately.

You should not use VIAGRA with any other oral or local treatments for erectile dysfunction.

You should not use VIAGRA with treatments for pulmonary arterial hypertension (PAH) containing

sildenafil or any other PDE5 inhibitors.

You should not take VIAGRA if you do not have erectile dysfunction.

You should not take VIAGRA if you are a woman.

Special considerations for patients with kidney or liver problems

You should tell your doctor if you have kidney or liver problems. Your doctor may decide on a lower

dose for you.

Children and adolescents

VIAGRA should not be given to individuals 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 may interfere with some medicines, especially those used to treat chest pain. In the

event of a medical emergency, you should tell your doctor, pharmacist or nurse that you have taken

VIAGRA and when you did. Do not take VIAGRA with other medicines unless your doctor tells you

that you can.

You should not take VIAGRA if you are taking medicines called nitrates, as the combination of these

medicines may lead to a dangerous fall in your blood pressure. Always tell your doctor, pharmacist or

nurse if you are taking any of these medicines that are often used for the relief of 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”) as the combination may also lead to a dangerous fall in your blood

pressure.

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

If you are taking medicines known as protease inhibitors, such as for the treatment of HIV, your

doctor may start you on the lowest dose (25 mg) of VIAGRA.

Some patients who take alpha-blocker therapy for the treatment of high blood pressure or prostate

enlargement may experience dizziness or light-headedness, which may be caused by low blood

pressure upon sitting or standing up quickly. Certain patients have experienced these symptoms when

taking VIAGRA with alpha-blockers. This is most likely to happen within 4 hours after taking

VIAGRA. To reduce the chance that these symptoms might happen, you should be on a regular daily

dose of your alpha-blocker before you start VIAGRA. Your doctor may start you on a lower dose

(25 mg) of VIAGRA.

VIAGRA with food and drink and alcohol

VIAGRA can be taken with or without food. However, you may find that VIAGRA takes longer to

start working if you take it with a heavy meal.

Drinking alcohol can temporarily impair your ability to get an erection. To get the maximum benefit

from your medicine, you are advised not to drink excessive amounts of alcohol before taking

VIAGRA.

Pregnancy, breast-feeding and fertility

VIAGRA is not indicated for use by women.

Driving and using machines

VIAGRA can cause dizziness and can affect vision. You should be aware of how you react to

VIAGRA before you drive or use machinery.

VIAGRA contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, such as lactose,

contact your doctor before taking VIAGRA.

3.

How to take VIAGRA

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor

or pharmacist if you are not sure. The recommended starting dose is 50 mg.

You should not take VIAGRA more than once a day.

Do not take VIAGRA film-coated tablets in combination with VIAGRA orodispersible tablets.

You should take VIAGRA about one hour before you plan to have sex. Swallow the tablet whole with

a glass of water.

If you feel that the effect of VIAGRA is too strong or too weak, talk to your doctor or pharmacist.

VIAGRA will only help you to get an erection if you are sexually stimulated. The amount of time

VIAGRA takes to work varies from person to person, but it normally takes between half an hour and

one hour. You may find that VIAGRA takes longer to work if you take it with a heavy meal.

If VIAGRA does not help you to get an erection, or if your erection does not last long enough for you

to complete sexual intercourse you should tell your doctor.

If you take more VIAGRA than you should:

You may experience an increase in side effects and their severity. Doses above 100 mg do not

increase the efficacy.

You should not take more tablets than your doctor tells you to.

Contact your doctor if you take more tablets than you should.

If you have any further questions on 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 and of a short

duration.

If you experience any of the following serious side effects stop taking VIAGRA and seek

medical help immediately:

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

Symptoms include sudden wheeziness, difficulty in breathing or dizziness, swelling of the

eyelids, face, lips or throat.

Chest pains - this occurs uncommonly

If this occurs during or after intercourse

- Get in a semi-sitting position and try to relax.

- Do not use nitrates to treat your chest pain.

Prolonged and sometimes painful erections - this occurs rarely (may affect up to 1 in 1,000

people)

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

immediately.

A sudden decrease or loss of vision - this occurs rarely

Serious skin reactions - this occurs rarely

Symptoms may include severe peeling and swelling of the skin, blistering of the mouth,

genitals and around the eyes, fever.

Seizures or fits - this occurs rarely

Other side effects:

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

Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flush (symptoms include a

sudden feeling of heat in your upper body), indigestion, colour tinge to vision, blurred vision, visual

disturbance, stuffy nose and dizziness.

Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, bloodshot eyes /red

eyes, eye pain, seeing flashes of light, visual brightness, light sensitivity, watery eyes, pounding

heartbeat, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling sleepy,

reduced sense of touch, vertigo, ringing in the ears, dry mouth, blocked or stuffy sinuses,

inflammation of the lining of the nose (symptoms include runny nose, sneezing and stuffy nose),

upper abdominal pain, gastro-oesophageal reflux disease (symptoms include heartburn), presence of

blood in urine, pain in the arms or legs, nosebleed, feeling hot and feeling tired.

Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary

decreased blood flow to parts of the brain, feeling of tightening of the throat, numb mouth, bleeding at

the back of the eye, double vision, reduced sharpness of vision, abnormal sensation in the eye,

swelling of the eye or eyelid, small particles or spots in your vision, seeing halos around lights,

dilation of the pupil of the eye, discolouration of the white of the eye, penile bleeding, presence of

blood in semen, dry nose, swelling of the inside of the nose, feeling irritable and sudden decrease or

loss of hearing.

From post-marketing experience cases of unstable angina (a heart condition) and sudden death have

been reported rarely. Of note, most, but not all, of the men who experienced these side effects had

heart problems before taking this medicine. It is not possible to determine whether these events were

directly related to VIAGRA.

Reporting of side effects

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

effects not listed in this leaflet. You can also report side effects directly via the national reporting

system listed in Appendix V. By reporting side effects you can help provide more information on the

safety of this medicine.

5.

How to store VIAGRA

Keep this medicine out of the sight and reach of children.

Do not store above 30

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The

expiry date refers to the last day of that month.

Store in the original package, in order to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What VIAGRA contains

The active substance is sildenafil. Each tablet contains 25 mg of sildenafil (as the citrate salt).

The other ingredients are:

Tablet core:

microcrystalline cellulose, calcium hydrogen phosphate (anhydrous),

croscarmellose sodium, magnesium stearate,

Film coat:

hypromellose, titanium dioxide (E171), lactose monohydrate, triacetin, indigo

carmine aluminium lake (E132)

What VIAGRA looks like and contents of the pack

VIAGRA film-coated tablets are blue, with a rounded-diamond shape. They are marked “PFIZER” on

one side and “VGR 25” on the other side. The tablets are provided in blister packs containing 2, 4, 8

or 12 tablets. Some pack sizes may not be marketed in your country.

Marketing Authorisation Holder and Manufacturer

The marketing authorisation holder of VIAGRA is Pfizer Europe MA EEIG, Boulevard de la Plaine

17, 1050 Bruxelles, Belgium.

The manufacturer of VIAGRA is Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530

Pocé-sur-Cisse, France.

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

Authorisation Holder.

België /Belgique / Belgien

Pfizer S.A./ N.V.

Tél/Tel: +32 (0)2 554 62 11

Luxembourg/Luxemburg

Pfizer S.A.

Tél/Tel: +32 (0)2 554 62 11

България

Пфайзер Люксембург САРЛ, Клон България

Тел.: +359 2 970 4333

Magyarország

Pfizer Kft.

Tel.: + 36 1 488 37 00

Česká republika

Pfizer s.r.o.

Tel: +420-283-004-111

Malta

V.J. Salomone Pharma Ltd.

Tel: + 356 21 22 01 74

Danmark

Pfizer ApS

Tlf: +45 44 20 11 00

Nederland

Pfizer bv

Tel: +31 (0)10 406 43 01

Deutschland

Pfizer OFG Germany GmbH

Tel: +49 (0)800 5500634

Norge

Pfizer AS

Tlf: +47 67 52 61 00

Eesti

Pfizer Luxembourg SARL Eesti filiaal

Tel: +372 666 7500

Österreich

Pfizer Corporation Austria Ges.m.b.H.

Tel: +43 (0)1 521 15-0

Ελλάδα

Upjohn Hellas Ε.Π.Ε.,

Τηλ.: +30 210 67 85 800

Polska

Pfizer Polska Sp. z o.o.,

Tel.: +48 22 335 61 00

España

Pfizer GEP, S.L.

Tel: +34 91 490 99 00

Portugal

Laboratórios Pfizer, Lda.

Tel: +351 21 423 5500

France

Pfizer PFE France

Tél: +33 (0)1 58 07 34 40

România

Pfizer România S.R.L.

Tel: +40 (0)21 207 28 00

Hrvatska

Pfizer Croatia d.o.o.

Tel: + 385 1 3908 777

Slovenija

Pfizer Luxembourg SARL, Pfizer, podružnica za

svetovanje s področja farmacevtske dejavnosti,

Ljubljana

Tel: + 386(0)152 11 400

Ireland

Pfizer Healthcare Ireland

Tel: 1800 633 363 (toll free)

Tel: +44 (0)1304 616161

Slovenská republika

Pfizer Luxembourg SARL, organizačná zložka

Tel: +421–2–3355 5500

Ísland

Icepharma hf.

Sími: + 354 540 8000

Suomi/Finland

Pfizer Oy

Puh/Tel: +358(0)9 43 00 40

Italia

Pfizer Established Medicine Italy S.r.l.

Tel: +39 06 33 18 21

Sverige

Pfizer AB

Tel: +46 (0)8 550 520 00

Κύπρος

PFIZER ΕΛΛΑΣ Α.Ε. (CYPRUS BRANCH),

Τηλ: +357 22 817690

United Kingdom

Pfizer Limited

Tel: +44 (0)1304 616161

Latvija

Pfizer Luxembourg SARL filiāle Latvijā

Tel: +371 670 35 775

Lietuva

Pfizer Luxembourg SARL, filialas Lietuvoje

Tel. +3705 2514000

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

Other sources of information

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

http://www.ema.europa.eu.

Package leaflet: Information for the patient

VIAGRA 50 mg film-coated tablets

Sildenafil

Read all of this leaflet carefully before you start taking this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or nurse.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

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

side effects not listed in this leaflet. See section 4.

What is in this leaflet

What VIAGRA is and what it is used for

What you need to know before you take 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 group of medicines called

phosphodiesterase type 5 (PDE5) inhibitors. It works by helping to relax the blood vessels in your

penis, allowing blood to flow into your penis when you get sexually excited. VIAGRA will only help

you to get an erection if you are sexually stimulated.

VIAGRA is a treatment for adult men with erectile dysfunction, sometimes known as impotence. This

is when a man cannot get, or keep a hard, erect penis suitable for sexual activity.

2.

What you need to know before you take VIAGRA

Do not take VIAGRA

If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section

If you are taking medicines called nitrates, as the combination may lead to a dangerous fall in

your blood pressure. Tell your doctor if you are taking any of these medicines which are often

given for relief of angina pectoris (or “chest pain”). If you are not certain, ask your doctor or

pharmacist.

If you are using any of the medicines known as nitric oxide donors such as amyl nitrite

(“poppers”), as the combination may also lead to a dangerous fall in your blood pressure.

If you are taking riociguat. This drug is used to treat pulmonary arterial hypertension (i.e., high

blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high

blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as Viagra have

been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or

are unsure tell your doctor.

If you have a severe heart or liver problem.

If you have recently had a stroke or a heart attack, or if you have low blood pressure.

If you have certain rare inherited eye diseases (such as retinitis pigmentosa).

If you have ever had loss of vision due to 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 blood

cells), multiple myeloma (cancer of bone marrow).

If you have a deformity of your penis or Peyronie’s Disease.

If you have problems with your heart. Your doctor should carefully check whether your heart

can take the additional strain of having sex.

If you currently have a stomach ulcer, or a bleeding problems (such as haemophilia).

If you experience sudden decrease or loss of vision, stop taking VIAGRA and contact your

doctor immediately.

You should not use VIAGRA with any other oral or local treatments for erectile dysfunction.

You should not use VIAGRA with treatments for pulmonary arterial hypertension (PAH) containing

sildenafil or any other PDE5 inhibitors.

You should not take VIAGRA if you do not have erectile dysfunction.

You should not take VIAGRA if you are a woman.

Special considerations for patients with kidney or liver problems

You should tell your doctor if you have kidney or liver problems. Your doctor may decide on a lower

dose for you.

Children and adolescents

VIAGRA should not be given to individuals 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 may interfere with some medicines, especially those used to treat chest pain. In the

event of a medical emergency, you should tell your doctor, pharmacist or nurse that you have taken

VIAGRA and when you did. Do not take VIAGRA with other medicines unless your doctor tells you

that you can.

You should not take VIAGRA if you are taking medicines called nitrates, as the combination of these

medicines may lead to a dangerous fall in your blood pressure. Always tell your doctor, pharmacist or

nurse if you are taking any of these medicines that are often used for the relief of 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”) as the combination may also lead to a dangerous fall in your blood

pressure.

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

If you are taking medicines known as protease inhibitors, such as for the treatment of HIV, your

doctor may start you on the lowest dose (25 mg) of VIAGRA.

Some patients who take alpha-blocker therapy for the treatment of high blood pressure or prostate

enlargement may experience dizziness or light-headedness, which may be caused by low blood

pressure upon sitting or standing up quickly. Certain patients have experienced these symptoms when

taking VIAGRA with alpha-blockers. This is most likely to happen within 4 hours after taking

VIAGRA. In order to reduce the chance that these symptoms might happen, you should be on a

regular daily dose of your alpha-blocker before you start VIAGRA. Your doctor may start you on a

lower dose (25 mg) of VIAGRA.

VIAGRA with food and drink and alcohol

VIAGRA can be taken with or without food. However, you may find that VIAGRA takes longer to

start working if you take it with a heavy meal.

Drinking alcohol can temporarily impair your ability to get an erection. To get the maximum benefit

from your medicine, you are advised not to drink excessive amounts of alcohol before taking

VIAGRA.

Pregnancy, breast-feeding and fertility

VIAGRA is not indicated for use by women.

Driving and using machines

VIAGRA can cause dizziness and can affect vision. You should be aware of how you react to

VIAGRA before you drive or use machinery.

VIAGRA contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, such as lactose,

contact your doctor before taking VIAGRA.

3.

How to take VIAGRA

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor

or pharmacist if you are not sure. The recommended starting dose is 50 mg.

You should not take VIAGRA more than once a day.

Do not take VIAGRA film-coated tablets in combination with VIAGRA orodispersible tablets.

You should take VIAGRA about one hour before you plan to have sex. Swallow the tablet whole with

a glass of water.

If you feel that the effect of VIAGRA is too strong or too weak, talk to your doctor or pharmacist.

VIAGRA will only help you to get an erection if you are sexually stimulated. The amount of time

VIAGRA takes to work varies from person to person, but it normally takes between half an hour and

one hour. You may find that VIAGRA takes longer to work if you take it with a heavy meal.

If VIAGRA does not help you to get an erection, or if your erection does not last long enough for you

to complete sexual intercourse you should tell your doctor.

If you take more VIAGRA than you should:

You may experience an increase in side effects and their severity. Doses above 100 mg do not

increase the efficacy.

You should not take more tablets than your doctor tells you to.

Contact your doctor if you take more tablets than you should.

If you have any further questions on 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 and of a short

duration.

If you experience any of the following serious side effects stop taking VIAGRA and seek

medical help immediately:

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

Symptoms include sudden wheeziness, difficulty in breathing or dizziness, swelling of the

eyelids, face, lips or throat.

Chest pains - this occurs uncommonly

If this occurs during or after intercourse

- Get in a semi-sitting position and try to relax.

- Do not use nitrates to treat your chest pain.

Prolonged and sometimes painful erections - this occurs rarely (may affect up to 1 in 1,000

people)

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

immediately.

A sudden decrease or loss of vision - this occurs rarely

Serious skin reactions - this occurs rarely

Symptoms may include severe peeling and swelling of the skin, blistering of the mouth,

genitals and around the eyes, fever.

Seizures or fits - this occurs rarely

Other side effects:

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

Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flush (symptoms include a

sudden feeling of heat in your upper body), indigestion, colour tinge to vision, blurred vision, visual

disturbance, stuffy nose and dizziness.

Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, bloodshot eyes /red

eyes, eye pain, seeing flashes of light, visual brightness, light sensitivity, watery eyes, pounding

heartbeat, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling sleepy,

reduced sense of touch, vertigo, ringing in the ears, dry mouth, blocked or stuffy sinuses,

inflammation of the lining of the nose (symptoms include runny nose, sneezing and stuffy nose),

upper abdominal pain, gastro-oesophageal reflux disease (symptoms include heartburn), presence of

blood in urine, pain in the arms or legs, nosebleed, feeling hot and feeling tired.

Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary

decreased blood flow to parts of the brain, feeling of tightening of the throat, numb mouth, bleeding at

the back of the eye, double vision, reduced sharpness of vision, abnormal sensation in the eye,

swelling of the eye or eyelid, small particles or spots in your vision, seeing halos around lights,

dilation of the pupil of the eye, discolouration of the white of the eye, penile bleeding, presence of

blood in semen,dry nose, swelling of the inside of the nose, feeling irritable and sudden decrease or

loss of hearing.

From post-marketing experience cases of unstable angina (a heart condition) and sudden death have

been reported rarely. Of note, most, but not all, of the men who experienced these side effects had

heart problems before taking this medicine. It is not possible to determine whether these events were

directly related to VIAGRA.

Reporting of side effects

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

effects not listed in this leaflet. You can also report side effects directly via the national reporting

system listed in Appendix V. By reporting side effects you can help provide more information on the

safety of this medicine.

5.

How to store VIAGRA

Keep this medicine out of the sight and reach of children.

Do not store above 30

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The

expiry date refers to the last day of that month.

Store in the original package, in order to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What VIAGRA contains

The active substance is sildenafil. Each tablet contains 50 mg of sildenafil (as the citrate salt).

The other ingredients are:

Tablet core:

microcrystalline cellulose, calcium hydrogen phosphate (anhydrous),

croscarmellose sodium, magnesium stearate,

Film coat:

hypromellose, titanium dioxide (E171), lactose monohydrate, triacetin, indigo

carmine aluminium lake (E132)

What VIAGRA looks like and contents of the pack

VIAGRA film-coated tablets are blue, with a rounded-diamond shape. They are marked “PFIZER” on

one side and “VGR 50” on the other side. The tablets are provided in blister packs containing 2, 4, 8,

12 or 24 tablets in a carton or card packaging. Some pack sizes may not be marketed in your country.

Marketing Authorisation Holder and Manufacturer

The marketing authorisation holder of VIAGRA is Pfizer Europe MA EEIG, Boulevard de la Plaine

17, 1050 Bruxelles, Belgium.

The manufacturer of VIAGRA is Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530

Pocé-sur-Cisse, France.

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

Authorisation Holder.

België /Belgique / Belgien

Pfizer S.A./ N.V.

Tél/Tel: +32 (0)2 554 62 11

Luxembourg/Luxemburg

Pfizer S.A.

Tél/Tel: +32 (0)2 554 62 11

България

Пфайзер Люксембург САРЛ, Клон България

Тел.: +359 2 970 4333

Magyarország

Pfizer Kft.

Tel.: + 36 1 488 37 00

Česká republika

Pfizer s.r.o.

Tel: +420-283-004-111

Malta

V.J. Salomone Pharma Ltd.

Tel: + 356 21 22 01 74

Danmark

Pfizer ApS

Tlf: +45 44 20 11 00

Nederland

Pfizer bv

Tel: +31 (0)10 406 43 01

Deutschland

Pfizer OFG Germany GmbH

Tel: +49 (0)800 5500634

Norge

Pfizer AS

Tlf: +47 67 52 61 00

Eesti

Pfizer Luxembourg SARL Eesti filiaal

Tel: +372 666 7500

Österreich

Pfizer Corporation Austria Ges.m.b.H.

Tel: +43 (0)1 521 15-0

Ελλάδα

Upjohn Hellas Ε.Π.Ε.,

Τηλ.: +30 210 67 85 800

Polska

Pfizer Polska Sp. z o.o.,

Tel.: +48 22 335 61 00

España

Pfizer GEP, S.L.

Tel: +34 91 490 99 00

Portugal

Laboratórios Pfizer, Lda.

Tel: +351 21 423 5500

France

Pfizer PFE France

Tél: +33 (0)1 58 07 34 40

România

Pfizer România S.R.L.

Tel: +40 (0)21 207 28 00

Hrvatska

Pfizer Croatia d.o.o.

Tel: + 385 1 3908 777

Slovenija

Pfizer Luxembourg SARL, Pfizer, podružnica za

svetovanje s področja farmacevtske dejavnosti,

Ljubljana

Tel: + 386(0)152 11 400

Ireland

Pfizer Healthcare Ireland

Tel: 1800 633 363 (toll free)

Tel: +44 (0)1304 616161

Slovenská republika

Pfizer Luxembourg SARL, organizačná zložka

Tel: +421–2–3355 5500

Ísland

Icepharma hf.

Sími: + 354 540 8000

Suomi/Finland

Pfizer Oy

Puh/Tel: +358(0)9 43 00 40

Italia

Pfizer Established Medicine Italy S.r.l.

Tel: +39 06 33 18 21

Sverige

Pfizer AB

Tel: +46 (0)8 550 520 00

Κύπρος

PFIZER ΕΛΛΑΣ Α.Ε. (CYPRUS BRANCH),

Τηλ: +357 22 817690

United Kingdom

Pfizer Limited

Tel: +44 (0)1304 616161

Latvija

Pfizer Luxembourg SARL filiāle Latvijā

Tel: +371 670 35 775

Lietuva

Pfizer Luxembourg SARL, filialas Lietuvoje

Tel. +3705 2514000

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

Other sources of information

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

http://www.ema.europa.eu.

Package leaflet: Information for the patient

VIAGRA 100 mg film-coated tablets

Sildenafil

Read all of this leaflet carefully before you start taking this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or nurse.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

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

side effects not listed in this leaflet. See section 4.

What is in this leaflet

What VIAGRA is and what it is used for

What you need to know before you take 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 group of medicines called

phosphodiesterase type 5 (PDE5) inhibitors. It works by helping to relax the blood vessels in your

penis, allowing blood to flow into your penis when you get sexually excited. VIAGRA will only help

you to get an erection if you are sexually stimulated.

VIAGRA is a treatment for adult men with erectile dysfunction, sometimes known as impotence. This

is when a man cannot get, or keep a hard, erect penis suitable for sexual activity.

2.

What you need to know before you take VIAGRA

Do not take VIAGRA

If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section

If you are taking medicines called nitrates, as the combination may lead to a dangerous fall in

your blood pressure. Tell your doctor if you are taking any of these medicines which are often

given for relief of angina pectoris (or “chest pain”). If you are not certain, ask your doctor or

pharmacist.

If you are using any of the medicines known as nitric oxide donors such as amyl nitrite

(“poppers”), as the combination may also lead to a dangerous fall in your blood pressure.

If you are taking riociguat. This drug is used to treat pulmonary arterial hypertension (i.e., high

blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high

blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as Viagra have

been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or

are unsure tell your doctor.

If you have a severe heart or liver problem.

If you have recently had a stroke or a heart attack, or if you have low blood pressure.

If you have certain rare inherited eye diseases (such as retinitis pigmentosa).

If you have ever had loss of vision due to 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 blood

cells), multiple myeloma (cancer of bone marrow).

If you have a deformity of your penis or Peyronie’s Disease.

If you have problems with your heart. Your doctor should carefully check whether your heart

can take the additional strain of having sex.

If you currently have a stomach ulcer, or a bleeding problems (such as haemophilia).

If you experience sudden decrease or loss of vision, stop taking VIAGRA and contact your

doctor immediately.

You should not use VIAGRA with any other oral or local treatments for erectile dysfunction.

You should not use VIAGRA with treatments for pulmonary arterial hypertension (PAH) containing

sildenafil or any other PDE5 inhibitors.

You should not take VIAGRA if you do not have erectile dysfunction.

You should not take VIAGRA if you are a woman.

Special considerations for patients with kidney or liver problems

You should tell your doctor if you have kidney or liver problems. Your doctor may decide on a lower

dose for you.

Children and adolescents

VIAGRA should not be given to individuals 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 may interfere with some medicines, especially those used to treat chest pain. In the

event of a medical emergency, you should tell your doctor, pharmacist or nurse that you have taken

VIAGRA and when you did. Do not take VIAGRA with other medicines unless your doctor tells you

that you can.

You should not take VIAGRA if you are taking medicines called nitrates, as the combination of these

medicines may lead to a dangerous fall in your blood pressure. Always tell your doctor, pharmacist or

nurse if you are taking any of these medicines that are often used for the relief of 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”) as the combination may also lead to a dangerous fall in your blood

pressure.

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

If you are taking medicines known as protease inhibitors, such as for the treatment of HIV, your

doctor may start you on the lowest dose (25 mg) of VIAGRA.

Some patients who take alpha-blocker therapy for the treatment of high blood pressure or prostate

enlargement may experience dizziness or light-headedness, which may be caused by low blood

pressure upon sitting or standing up quickly. Certain patients have experienced these symptoms when

taking VIAGRA with alpha-blockers. This is most likely to happen within 4 hours after taking

VIAGRA. To reduce the chance that these symptoms might happen, you should be on a regular daily

dose of your alpha-blocker before you start VIAGRA. Your doctor may start you on a lower dose

(25 mg) of VIAGRA.

VIAGRA with food and drink and alcohol

VIAGRA can be taken with or without food. However, you may find that VIAGRA takes longer to

start working if you take it with a heavy meal.

Drinking alcohol can temporarily impair your ability to get an erection. To get the maximum benefit

from your medicine, you are advised not to drink excessive amounts of alcohol before taking

VIAGRA.

Pregnancy, breast-feeding and fertility

VIAGRA is not indicated for use by women.

Driving and using machines

VIAGRA can cause dizziness and can affect vision. You should be aware of how you react to

VIAGRA before you drive or use machinery.

VIAGRA contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, such as lactose,

contact your doctor before taking VIAGRA.

3.

How to take VIAGRA

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor

or pharmacist if you are not sure. The recommended starting dose is 50 mg.

You should not take VIAGRA more than once a day.

Do not take VIAGRA film-coated tablets in combination with VIAGRA orodispersible tablets.

You should take VIAGRA about one hour before you plan to have sex. Swallow the tablet whole with

a glass of water.

If you feel that the effect of VIAGRA is too strong or too weak, talk to your doctor or pharmacist.

VIAGRA will only help you to get an erection if you are sexually stimulated. The amount of time

VIAGRA takes to work varies from person to person, but it normally takes between half an hour and

one hour. You may find that VIAGRA takes longer to work if you take it with a heavy meal.

If VIAGRA does not help you to get an erection, or if your erection does not last long enough for you

to complete sexual intercourse you should tell your doctor.

If you take more VIAGRA than you should:

You may experience an increase in side effects and their severity. Doses above 100 mg do not

increase the efficacy.

You should not take more tablets than your doctor tells you to.

Contact your doctor if you take more tablets than you should.

If you have any further questions on 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 and of a short

duration.

If you experience any of the following serious side effects stop taking VIAGRA and seek

medical help immediately:

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

Symptoms include sudden wheeziness, difficulty in breathing or dizziness, swelling of the

eyelids, face, lips or throat.

Chest pains - this occurs uncommonly

If this occurs during or after intercourse

- Get in a semi-sitting position and try to relax.

- Do not use nitrates to treat your chest pain.

Prolonged and sometimes painful erections - this occurs rarely (may affect up to 1 in 1,000

people)

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

immediately.

A sudden decrease or loss of vision - this occurs rarely

Serious skin reactions - this occurs rarely

Symptoms may include severe peeling and swelling of the skin, blistering of the mouth,

genitals and around the eyes, fever.

Seizures or fits - this occurs rarely

Other side effects:

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

Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flush (symptoms include a

sudden feeling of heat in your upper body), indigestion, colour tinge to vision, blurred vision, visual

disturbance, stuffy nose and dizziness.

Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, bloodshot eyes /red

eyes, eye pain, seeing flashes of light, visual brightness, light sensitivity, watery eyes, pounding

heartbeat, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling sleepy,

reduced sense of touch, vertigo, ringing in the ears, dry mouth, blocked or stuffy sinuses,

inflammation of the lining of the nose (symptoms include runny nose, sneezing and stuffy nose),

upper abdominal pain, gastro-oesophageal reflux disease (symptoms include heartburn), presence of

blood in urine, pain in the arms or legs, nosebleed, feeling hot and feeling tired.

Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary

decreased blood flow to parts of the brain, feeling of tightening of the throat, numb mouth, bleeding at

the back of the eye, double vision, reduced sharpness of vision, abnormal sensation in the eye,

swelling of the eye or eyelid, small particles or spots in your vision, seeing halos around lights,

dilation of the pupil of the eye, discolouration of the white of the eye, penile bleeding, presence of

blood in semen, dry nose, swelling of the inside of the nose, feeling irritable and sudden decrease or

loss of hearing.

From post-marketing experience cases of unstable angina (a heart condition) and sudden death have

been reported rarely. Of note, most, but not all, of the men who experienced these side effects had

heart problems before taking this medicine. It is not possible to determine whether these events were

directly related to VIAGRA.

Reporting of side effects

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

effects not listed in this leaflet. You can also report side effects directly via the national reporting

system listed in Appendix V. By reporting side effects you can help provide more information on the

safety of this medicine.

5.

How to store VIAGRA

Keep this medicine out of the sight and reach of children.

Do not store above 30

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The

expiry date refers to the last day of that month.

Store in the original package, in order to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What VIAGRA contains

The active substance is sildenafil. Each tablet contains 100 mg of sildenafil (as the citrate salt).

The other ingredients are:

Tablet core:

microcrystalline cellulose, calcium hydrogen phosphate (anhydrous),

croscarmellose sodium, magnesium stearate,

Film coat:

hypromellose, titanium dioxide (E171), lactose monohydrate, triacetin, indigo

carmine aluminium lake (E132)

What VIAGRA looks like and contents of the pack

VIAGRA film-coated tablets are blue, with a rounded-diamond shape. They are marked “PFIZER” on

one side and “VGR 100” on the other side. The tablets are provided in blister packs containing 2, 4, 8,

12 or 24 tablets. Some pack sizes may not be marketed in your country.

Marketing Authorisation Holder and Manufacturer

The marketing authorisation holder of VIAGRA is Pfizer Europe MA EEIG, Boulevard de la Plaine

17, 1050 Bruxelles, Belgium.

The manufacturer of VIAGRA is Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530

Pocé-sur-Cisse, France.

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

Authorisation Holder.

België /Belgique / Belgien

Pfizer S.A./ N.V.

Tél/Tel: +32 (0)2 554 62 11

Luxembourg/Luxemburg

Pfizer S.A.

Tél/Tel: +32 (0)2 554 62 11

България

Пфайзер Люксембург САРЛ, Клон България

Тел.: +359 2 970 4333

Magyarország

Pfizer Kft.

Tel.: + 36 1 488 37 00

Česká republika

Pfizer s.r.o.

Tel: +420-283-004-111

Malta

V.J. Salomone Pharma Ltd.

Tel: + 356 21 22 01 74

Danmark

Pfizer ApS

Tlf: +45 44 20 11 00

Nederland

Pfizer bv

Tel: +31 (0)10 406 43 01

Deutschland

Pfizer OFG Germany GmbH

Tel: +49 (0)800 5500634

Norge

Pfizer AS

Tlf: +47 67 52 61 00

Eesti

Pfizer Luxembourg SARL Eesti filiaal

Tel: +372 666 7500

Österreich

Pfizer Corporation Austria Ges.m.b.H.

Tel: +43 (0)1 521 15-0

Ελλάδα

Upjohn Hellas Ε.Π.Ε.,

Τηλ.: +30 210 67 85 800

Polska

Pfizer Polska Sp. z o.o.,

Tel.: +48 22 335 61 00

España

Pfizer GEP S.L.

Tel: +34 91 490 99 00

Portugal

Laboratórios Pfizer, Lda.

Tel: +351 21 423 5500

France

Pfizer PFE France

Tél: +33 (0)1 58 07 34 40

România

Pfizer România S.R.L.

Tel: +40 (0)21 207 28 00

Hrvatska

Pfizer Croatia d.o.o.

Tel: + 385 1 3908 777

Slovenija

Pfizer Luxembourg SARL, Pfizer, podružnica za

svetovanje s področja farmacevtske dejavnosti,

Ljubljana

Tel: + 386(0)152 11 400

Ireland

Pfizer Healthcare Ireland

Tel: 1800 633 363 (toll free)

Tel: +44 (0)1304 616161

Slovenská republika

Pfizer Luxembourg SARL, organizačná zložka

Tel: +421–2–3355 5500

Ísland

Icepharma hf.

Sími: + 354 540 8000

Suomi/Finland

Pfizer Oy

Puh/Tel: +358(0)9 43 00 40

Italia

Pfizer Established Medicine Italy S.r.l.

Tel: +39 06 33 18 21

Sverige

Pfizer AB

Tel: +46 (0)8 550 520 00

Κύπρος

PFIZER ΕΛΛΑΣ Α.Ε. (CYPRUS BRANCH),

Τηλ: +357 22 817690

United Kingdom

Pfizer Limited

Tel: +44 (0)1304 616161

Latvija

Pfizer Luxembourg SARL filiāle Latvijā

Tel: +371 670 35 775

Lietuva

Pfizer Luxembourg SARL, filialas Lietuvoje

Tel. +3705 2514000

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

Other sources of information

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

http://www.ema.europa.eu.

Package leaflet: Information for the patient

VIAGRA 50 mg orodispersible tablets

Sildenafil

Read all of this leaflet carefully before you start taking this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or nurse.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

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

side effects not listed in this leaflet. See section 4.

What is in this leaflet

What VIAGRA is and what it is used for

What you need to know before you take 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 group of medicines called

phosphodiesterase type 5 (PDE5) inhibitors. It works by helping to relax the blood vessels in your

penis, allowing blood to flow into your penis when you get sexually excited. VIAGRA will only help

you to get an erection if you are sexually stimulated.

VIAGRA is a treatment for adult men with erectile dysfunction, sometimes known as impotence. This

is when a man cannot get, or keep a hard, erect penis suitable for sexual activity.

2.

What you need to know before you take VIAGRA

Do not take VIAGRA

If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section

If you are taking medicines called nitrates, as the combination may lead to a dangerous fall in

your blood pressure. Tell your doctor if you are taking any of these medicines which are often

given for relief of angina pectoris (or “chest pain”). If you are not certain, ask your doctor or

pharmacist.

If you are using any of the medicines known as nitric oxide donors such as amyl nitrite

(“poppers”), as the combination may also lead to a dangerous fall in your blood pressure.

If you are taking riociguat. This drug is used to treat pulmonary arterial hypertension (i.e., high

blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high

blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as Viagra have

been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or

are unsure tell your doctor.

If you have a severe heart or liver problem.

If you have recently had a stroke or a heart attack, or if you have low blood pressure.

If you have certain rare inherited eye diseases (such as retinitis pigmentosa).

If you have ever had loss of vision due to 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 blood

cells), multiple myeloma (cancer of bone marrow).

If you have a deformity of your penis or Peyronie’s Disease.

If you have problems with your heart. Your doctor should carefully check whether your heart

can take the additional strain of having sex.

If you currently have a stomach ulcer, or a bleeding problems (such as haemophilia).

If you experience sudden decrease or loss of vision, stop taking VIAGRA and contact your

doctor immediately.

You should not use VIAGRA with any other oral or local treatments for erectile dysfunction.

You should not use VIAGRA with treatments for pulmonary arterial hypertension (PAH) containing

sildenafil or any other PDE5 inhibitors.

You should not take VIAGRA if you do not have erectile dysfunction.

You should not take VIAGRA if you are a woman.

Special considerations for patients with kidney or liver problems

You should tell your doctor if you have kidney or liver problems. Your doctor may decide on a lower

dose for you.

Children and adolescents

VIAGRA should not be given to individuals 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 may interfere with some medicines, especially those used to treat chest pain. In the

event of a medical emergency, you should tell your doctor, pharmacist or nurse that you have taken

VIAGRA and when you did. Do not take VIAGRA with other medicines unless your doctor tells you

that you can.

You should not take VIAGRA if you are taking medicines called nitrates, as the combination of these

medicines may lead to a dangerous fall in your blood pressure. Always tell your doctor, pharmacist or

nurse if you are taking any of these medicines that are often used for the relief of 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”) as the combination may also lead to a dangerous fall in your blood

pressure.

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

If you are taking medicines known as protease inhibitors, such as for the treatment of HIV, your

doctor may start you on the lowest dose (25 mg film-coated tablets) of VIAGRA.

Some patients who take alpha-blocker therapy for the treatment of high blood pressure or prostate

enlargement may experience dizziness or light-headedness, which may be caused by low blood

pressure upon sitting or standing up quickly. Certain patients have experienced these symptoms when

taking VIAGRA with alpha-blockers. This is most likely to happen within 4 hours after taking

VIAGRA. To reduce the chance that these symptoms might happen, you should be on a regular daily

dose of your alpha-blocker before you start VIAGRA. Your doctor may start you on a lower dose

(25 mg film-coated tablets) of VIAGRA.

VIAGRA with alcohol

Drinking alcohol can temporarily impair your ability to get an erection. To get the maximum benefit

from your medicine, you are advised not to drink excessive amounts of alcohol before taking

VIAGRA.

Pregnancy, breast-feeding and fertility

VIAGRA is not indicated for use by women.

Driving and using machines

VIAGRA can cause dizziness and can affect vision. You should be aware of how you react to

VIAGRA before you drive or use machinery.

3.

How to take VIAGRA

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor

or pharmacist if you are not sure.

The recommended starting dose is 50 mg.

You should not take VIAGRA more than once a day.

Do not take VIAGRA orodispersible tablets in combination with film-coated tablets containing

sildenafil including VIAGRA film-coated tablets.

You should take VIAGRA about one hour before you plan to have sex. The amount of time VIAGRA

takes to work varies from person to person, but it normally takes between half an hour and one hour.

Place the orodispersible tablet in the mouth, on the tongue, where it will dissolve in seconds, then

swallow with saliva or water.

The orodispersible tablets should be taken on an empty stomach as you may find that it takes longer to

start working if you take it with a heavy meal.

If you require a second 50 mg orodispersible tablet to make a 100 mg dose, you should wait until the

first one has completely disintegrated and you have swallowed it before taking the second

orodispersible tablet.

If you feel that the effect of VIAGRA is too strong or too weak, talk to your doctor or pharmacist.

VIAGRA will only help you to get an erection if you are sexually stimulated.

If VIAGRA does not help you to get an erection, or if your erection does not last long enough for you

to complete sexual intercourse you should tell your doctor.

If you take more VIAGRA than you should:

You may experience an increase in side effects and their severity. Doses above 100 mg do not

increase the efficacy.

You should not take more tablets than your doctor tells you to.

Contact your doctor if you take more tablets than you should.

If you have any further questions on 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 and of a short

duration.

If you experience any of the following serious side effects stop taking VIAGRA and seek

medical help immediately:

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

Symptoms include sudden wheeziness, difficulty in breathing or dizziness, swelling of the

eyelids, face, lips or throat.

Chest pains - this occurs uncommonly

If this occurs during or after intercourse:

- Get in a semi-sitting position and try to relax.

- Do not use nitrates to treat your chest pain.

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

people)

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

immediately.

A sudden decrease or loss of vision - this occurs rarely

Serious skin reactions - this occurs rarely

Symptoms may include severe peeling and swelling of the skin, blistering of the mouth,

genitals and around the eyes, fever.

Seizures or fits - this occurs rarely

Other side effects:

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

Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flush (symptoms include a

sudden feeling of heat in your upper body), indigestion, colour tinge to vision, blurred vision, visual

disturbance, stuffy nose and dizziness.

Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, bloodshot eyes /red

eyes, eye pain, seeing flashes of light, visual brightness, light sensitivity, watery eyes, pounding

heartbeat, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling sleepy,

reduced sense of touch, vertigo, ringing in the ears, dry mouth, blocked or stuffy sinuses,

inflammation of the lining of the nose (symptoms include runny nose, sneezing and stuffy nose),

upper abdominal pain, gastro-oesophageal reflux disease (symptoms include heartburn), presence of

blood in urine, pain in the arms or legs, nosebleed, feeling hot and feeling tired.

Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary

decreased blood flow to parts of the brain, feeling of tightening of the throat, numb mouth, bleeding at

the back of the eye, double vision, reduced sharpness of vision, abnormal sensation in the eye,

swelling of the eye or eyelid, small particles or spots in your vision, seeing halos around lights,

dilation of the pupil of the eye, discolouration of the white of the eye, penile bleeding, presence of

blood in semen, dry nose, swelling of the inside of the nose, feeling irritable and sudden decrease or

loss of hearing.

From post-marketing experience cases of unstable angina (a heart condition) and sudden death have

been reported rarely. Of note, most, but not all, of the men who experienced these side effects had

heart problems before taking this medicine. It is not possible to determine whether these events were

directly related to VIAGRA.

Reporting of side effects

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

effects not listed in this leaflet. You can also report side effects directly via the national reporting

system listed in Appendix V. By reporting side effects you can help provide more information on the

safety of this medicine.

5.

How to store VIAGRA

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The

expiry date refers to the last day of that month.

This medicinal product does not require any special temperature storage conditions.

Store in the original package, in order to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What VIAGRA contains

The active substance is sildenafil. Each orodispersible tablet contains 50 mg of sildenafil (as

the citrate salt).

The other ingredients are:

microcrystalline cellulose, silica hydrophobic colloidal, croscarmellose sodium, magnesium

stearate, indigo carmine aluminium lake (E132), sucralose, mannitol, crospovidone, polyvinyl

acetate, povidone,

flavouring containing: maltodextrin and dextrin,

natural flavouring containing: maltodextrin, glycerol (E422) and propylene glycol (E1520),

lemon flavouring containing: maltodextrin and alpha-tocopherol (E307)).

What VIAGRA looks like and contents of the pack

VIAGRA orodispersible tablets are blue, diamond shape, marked “V50” on one side. The

orodispersible tablets are provided in blister packs containing 2, 4, 8 or 12 tablets. Some pack sizes

may not be marketed in your country.

Marketing Authorisation Holder and Manufacturer

The marketing authorisation holder of VIAGRA is Pfizer Europe MA EEIG, Boulevard de la Plaine

17, 1050 Bruxelles, Belgium.

The manufacturer of VIAGRA is Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530

Pocé-sur-Cisse, France.

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

Authorisation Holder.

België /Belgique / Belgien

Pfizer S.A./ N.V.

Tél/Tel: +32 (0)2 554 62 11

Luxembourg/Luxemburg

Pfizer S.A.

Tél/Tel: +32 (0)2 554 62 11

България

Пфайзер Люксембург САРЛ, Клон България

Тел.: +359 2 970 4333

Magyarország

Pfizer Kft.

Tel.: + 36 1 488 37 00

Česká republika

Pfizer s.r.o.

Tel: +420-283-004-111

Malta

V.J. Salomone Pharma Ltd.

Tel: + 356 21 22 01 74

Danmark

Pfizer ApS

Tlf: +45 44 20 11 00

Nederland

Pfizer bv

Tel: +31 (0)10 406 43 01

Deutschland

Pfizer OFG Germany GmbH

Tel: +49 (0)800 5500634

Norge

Pfizer AS

Tlf: +47 67 52 61 00

Eesti

Pfizer Luxembourg SARL Eesti filiaal

Tel: +372 666 7500

Österreich

Pfizer Corporation Austria Ges.m.b.H.

Tel: +43 (0)1 521 15-0

Ελλάδα

Upjohn Hellas Ε.Π.Ε.,

Τηλ.: +30 210 67 85 800

Polska

Pfizer Polska Sp. z o.o.,

Tel.: +48 22 335 61 00

España

Pfizer GEP, S.L.

Tel: +34 91 490 99 00

Portugal

Laboratórios Pfizer, Lda.

Tel: +351 21 423 5500

France

Pfizer PFE France

Tél: +33 (0)1 58 07 34 40

România

Pfizer România S.R.L.

Tel: +40 (0)21 207 28 00

Hrvatska

Pfizer Croatia d.o.o.

Tel: + 385 1 3908 777

Slovenija

Pfizer Luxembourg SARL, Pfizer, podružnica za

svetovanje s področja farmacevtske dejavnosti,

Ljubljana

Tel: + 386(0)152 11 400

Ireland

Pfizer Healthcare Ireland

Tel: 1800 633 363 (toll free)

Tel: +44 (0)1304 616161

Slovenská republika

Pfizer Luxembourg SARL, organizačná zložka

Tel: +421–2–3355 5500

Ísland

Icepharma hf.

Sími: + 354 540 8000

Suomi/Finland

Pfizer Oy

Puh/Tel: +358(0)9 43 00 40

Italia

Pfizer Established Medicine Italy S.r.l.

Tel: +39 06 33 18 21

Sverige

Pfizer AB

Tel: +46 (0)8 550 520 00

Κύπρος

PFIZER ΕΛΛΑΣ Α.Ε. (CYPRUS BRANCH),

Τηλ: +357 22 817690

United Kingdom

Pfizer Limited

Tel: +44 (0)1304 616161

Latvija

Pfizer Luxembourg SARL filiāle Latvijā

Tel: +371 670 35 775

Lietuva

Pfizer Luxembourg SARL, filialas Lietuvoje

Tel. +3705 2514000

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

Other sources of information

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

http://www.ema.europa.eu.