Download PACKAGE INSERT – DIRECTIONS FOR USE Viagra 100 mg coated

PACKAGE INSERT – DIRECTIONS FOR USE
Viagra 100 mg coated tablets
Sildenafil citrate
Read this package insert carefully before you start taking this drug.
- Keep this package insert in case you need to read it again in the future.
- Address any questions to your doctor or pharmacist.
- This drug has been prescribed to you. Do not share it with anybody else. Administration
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of this drug to someone else could be dangerous even if the person has the same
symptoms.
If you experience any serious side effects or side effects not described in this package
insert, please inform your doctor or pharmacist.
Contents of this package insert:
1. Description of VIAGRA and indications for its use.
2. Things to pay attention to before you take VIAGRA.
3. Directions for VIAGRA use.
4. Possible side effects.
5. Storage of VIAGRA.
6. Additional information
1. DESCRIPTION OF VIAGRA AND INDICATIONS FOR ITS USE.
VIAGRA is a phosphodiesterase-5 inhibitor. Following its administration and in case of adequate
sexual stimulation, smooth muscles regulating the blood flow to the penis relax thus increasing
the blood flow to this organ. VIAGRA can help you achieve erection, but only in case of sexual
stimulation. You should not use this drug if you are not suffering from erectile dysfunction. This
drug should not be used by women.
VIAGRA is used for the treatment of men with erectile dysfunction. This condition is also
referred to as sexual impotence. This is a situation when the penis does not become erect during
sexual stimulation or does not become erect enough to allow for sexual activities.
2. THINGS TO PAY ATTENTION TO BEFORE YOU TAKE VIAGRA.
Do not take VIAGRA if:
you use any drugs containing nitrates or drugs that cause the release of nitric oxide, such
as isoamyl-nitrite. These drugs are most commonly used for the relief of angina pectoris
(chest pain). VIAGRA can significantly enhance the effect of these drugs. Always inform
your doctor that you take any of these drugs. In case of any doubts, always ask your
doctor or pharmacist.
you are allergic (hypersensitive) to sildenafil or any other ingredient of VIAGRA.
you are suffering from a serious heart or liver disease.
you have a recent history of stroke or heart attack or if you have low blood pressure.
you are suffering from a rare inherited retinal disorder (such as retinitis pigmentosa)
you have lost your sight as a result of non-arteritic anterior ischemic optic neuropathy
(NAION).
VIAGRA must be used with particular caution in the following cases:
Please tell your doctor if:
you are suffering from sickle cell anemia (disorder of red blood cells), leukemia (white
blood cell malignancy), multiple myeloma (bone marrow malignancy) or any disease or
deformity of your penis. Special care may be required when administering drugs that treat
erectile dysfunction to patients with the above disorders.
you have a heart disorder. In this case, your doctor should carefully consider if your heart
can withstand the increased workload associated with sexual intercourse.
you have peptic ulcer disease of bleeding disorder (such as hemophilia).
you experience sudden vision impairment or complete loss of sight. Stop using VIAGRA
and immediately seek the attention of your doctor.
Do not combine VIAGRA with any other treatment for erectile dysfunction.
Children
VIAGRA is not indicated for individuals below 18 years of age.
Patients with renal or hepatic disorder
Individuals with renal or hepatic disorder should discuss the suitability of VIAGRA treatment
with their doctor. He/she will determine whether the dosage of VIAGRA needs to be adjusted.
Interactions with other medicinal products:
Please inform your doctor or pharmacist of all drugs you are taking or have been taking recently,
including any over-the-counter drugs.
VIAGRA can interfere with other drugs, particularly those used to treat cardiac chest pain. In
case of sudden health complications, you should tell the attending physician that you have taken
VIAGRA. Do not take VIAGRA along with other drugs unless approved by your doctor.
VIAGRA can significantly enhance the effect of drugs containing nitrates or drugs that cause the
release of nitric oxide, such as isoamyl-nitrite. These drugs are often used for the relief of angina
pectoris (chest pain). You may not take VIAGRA in case you are using any of the above drugs.
If you are taking protease inhibitors (used for example for the treatment of AIDS), your doctor
will usually initiate the treatment with the lowest dose VIAGRA, i.e. 25mg.
Some patients using alpha-blockers for the treatment of high blood pressure or prostatic disorders
may experience dizziness or lightheadedness on standing up. These are the symptoms of postural
(orthostatic) hypotension presenting with low blood pressure on sitting up or standing up too
quickly. Some patients experienced these symptoms when using VIAGRA along with alphablockers. Symptoms of postural hypotension present most commonly within 4 hours of sildenafil
administration. You should use your daily dose of alpha-blocker regularly before you start taking
VIAGRA in order to reduce the risk of these symptoms. The doctor may initiate your treatment
with VIAGRA 25mg.
Administration of VIAGRA with meal and beverages
If you take VIAGRA with a meal, the effect of the drug may me slightly delayed.
Pregnancy and lactation
VIAGRA is not indicated for use in women
Effects on the ability to drive and use machines
VIAGRA can cause dizziness and impair vision. You should be aware of how you react
to VIAGRA before you drive or operate machinery.
Important details regarding some of VIAGRA ingredients
If you have ever been informed by the doctor of any sugar (such as lactose) intolerance, please
talk to your doctor before you start taking VIAGRA.
3. DIRECTIONS FOR VIAGRA USE
Always use VIAGRA exactly according to your doctor’s instructions. If you are not sure of
correct dosage, ask your doctor or pharmacist. The usual dosage is 50 mg.
Take VIAGRA approximately 1 hour before the anticipated sexual activity. Swallow the pill
without chewing and rinse it down with a sip of water.
If you have a feeling that the effect of VIAGRA is either insufficient or too strong, see your
doctor or pharmacist.
VIAGRA can help you achieve erection only if you are sexually stimulated. The time after which
the effect presents is highly individual, but usually ranges from 30 minutes to one hour. Taking
VIAGRA with a heavy meal can delay the effect of the drug.
Consumption of alcoholic beverages can temporarily impair your ability to achieve erection. To
allow for the best effect, it is recommended not to drink large amounts of alcohol prior to the
administration of VIAGRA.
If you do not achieve erection following the administration of VIAGRA or if the erection does
not last long enough to complete the sexual intercourse, see your doctor.
Do not use more than one tablet of VIAGRA daily.
If you take more than the recommended dosage of VIAGRA:
Dosage higher than 100 mg does no longer improve efficacy. It can however increase the
incidence and severity of side effects.
Do not take more tablets than recommended.
See you doctor if you take more tablets than recommended.
Should you have any questions regarding the use of this drug, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS.
Like other drugs, VIAGRA can cause side effects. Side effects are usually mild to moderate and
do not always present in all patients.
The most common side effects described in controlled clinical studies include headache, redness
of face (facial flushing). Other common side effects included indigestion, dizziness, nasal
congestion (stuffy nose), palpitations, impaired vision (including altered color perception,
increased brightness and blurred vision).
The following side effects have been reported in men taking VIAGRA after its introduction to the
market: vomiting, allergic reactions, skin rash, red eyes, eye tenderness, increased heart rate, nose
bleeds. Partial, sudden, temporary or permanent impairment or loss of vision affecting one or
both eyes has also been reported. Prolonged and sometimes painful erection has been reported in
association with VIAGRA treatment. If you experience erection that lasts for more than 4 hours
you should seek medical attention immediately.
The following side effects have also been reported: high blood pressure, low blood pressure,
dizziness, stroke, irregular heartbeats, chest pain, sudden death, heart attack or localized transient
cerebral ischemia. The majority of men (however not all of them) had already suffered from a
heart disorder before taking VIAGRA. It is not possible to determine whether these side affect
can be directly attributed to the administration of VIAGRA.
If you experience chest pain during or after the intercourse, do not take nitrates under any
circumstances. Instead, seek medical attention immediately.
If VIAGRA is used more than once daily, muscle pain may occur.
If you experience serious form of any of the above side effects or if you experience side effects
that are not mentioned in this package insert, please inform your doctor or pharmacist.
5. STORAGE OF VIAGRA
Keep out of reach and sight of children.
Store at temperatures below 30°C.
Keep VIAGRA in the original package in order to protect it from moisture.
VIAGRA may not be used after the expiration date printed on the package. Expiration date refers
to the last day of the month shown on the package.
Medicinal products may not be disposed of in household waste or sewage water. Your pharmacist
will tell you how to dispose of unused drugs. These precautions help to protect the environment.
6. ADDITIONAL INFORMATION
What is the composition of Viagra
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Sildenafil is the active ingredient of VIAGRA. One tablet contains 100 mg of sildenafil
in the form of sildenafil citrate.
Excipients:
Tablet: microcrystalline cellulose, calcium hydrogenphosphate, natrium croscarmellose,
magnesium stearate
Coating: hypromellose, titanium dioxide (E171), lactose monohydrate, triacetin, indigo
carmine aluminium lake (E132).
Identification and of VIAGRA and contents of this package
VIAGRA 100 mg tablets are blue coated, diamond-shape tablets marked “PFIZER” on one side
and “VGR 100” on the other. VIAGRA is provided in blister packs containing 1, 4, 8 and 12
tablets. Some package sizes may not be available.
Registration decision holder and manufacturer
Registration of VIAGRA is held by Pfizer Limited, Sandwich, Kent, CT13 9NJ, Great Britain.
VIAGRA is manufactured by VIAGRA je Pfizer PGM, Zone Industrielle, 29 Route des
Industries, 37530, Pocé-sur-Cisse, France
For further information regarding this product contact local representative of the registration
decision 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
eská republika
Pfizer s.r.o.
Tel: +420-283-004-111
Magyarország
Pfizer Kft.
Tel.: + 36 1 488 37 00
Danmark
Pfizer ApS
Tlf: +45 44 20 11 00
Malta
V.J. Salomone Pharma Ltd.
Tel: + 356 21 22 01 74
Deutschland
Pfizer Pharma GmbH
Tel:+49 (0)721 6101 9000
Nederland
Pfizer bv
Tel: +31 (0)10 406 42 00
Eesti
Pfizer Luxembourg SARL, Eesti filiaal
Tel: +372 6 405 328
Norge
Pfizer AS
Tlf: +47 67 52 61 00
Pfizer Hellas A.E.
: +30 210 6785800
Österreich
Pfizer Corporation Austria Ges.m.b.H.
Tel: +43 (0)1 521 15-0
España
Pfizer S.A.
Tel: +34 91 490 99 00
Polska
Pfizer Polska Sp. z o.o.,
Tel.: +48 22 335 61 00
France
Pfizer
Tél: +33 (0)1 58 07 34 40
Portugal
Laboratórios Pfizer, Lda.
Tel:+351 21 423 5500
Ireland
Pfizer Healthcare Ireland
Tel: +353 1800 633 363
Slovenija
Pfizer Luxembourg SARL, Pfizer, podružnica za
svetovanje s podro ja farmacevtske dejavnosti,
Ljubljana
Tel: + 386/1/52 11 400
Ísland
Vistor hf.
Tel: + 354 535 7000
Slovenská republika
Pfizer Luxembourg SARL, organiza ná zložka
Tel: +421–2–5941 8500
Italia
Pfizer Italia S.r.l.
Tel: +39 06 33 18 21
Suomi/Finland
Pfizer Oy
Puh/Tel: +358(0)9 43 00 40
GEO. PAVLIDES & ARAOUZOS LTD,
: +35722818087
Sverige
Pfizer AB
Tel: +46 (0)8 550 520 00
Latvija
Pfizer Luxembourg SARL fili le Latvij
Tel: +371 70 35 775
United Kingdom
Pfizer Limited
Tel: +44 (0)1737 331111
Lietuva
Pfizer Luxembourg SARL, filialas Lietuvoje
Tel. +3705 2514000
Date of last revision of this package insert: June 8, 2006.
Detailed information on this medicinal product is available on the European Agency for
the Evaluation of Medicinal Products (EMEA) web site: http://www.emea.eu.int/