Viagra

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

sildenafil

Available from:

Upjohn EESV

ATC code:

G04BE03

INN (International Name):

sildenafil

Therapeutic group:

Urologicals

Therapeutic area:

Erectile Dysfunction

Therapeutic indications:

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.

Product summary:

Revision: 45

Authorization status:

Authorised

Authorization date:

1998-09-13

Patient Information leaflet

65
B. PACKAGE LEAFLET
66
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
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 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
6).

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 amy

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
VIAGRA 25 mg film-coated tablets
VIAGRA 50 mg film-coated tablets
VIAGRA 100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains sildenafil citrate equivalent to 25,
50 or 100 mg of sildenafil.
Excipient with known effect
_VIAGRA 25 mg tablets _
Each film-coated tablet contains 0.9 mg lactose (as monohydrate).
_VIAGRA 50 mg tablets _
Each film-coated tablet contains 1.7 mg lactose (as monohydrate).
_VIAGRA 100 mg tablets _
Each film-coated tablet contains 3.5 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
VIAGRA 25 mg tablets
Blue, rounded diamond-shaped film-coated tablets, marked “PFIZER”
on one side and “VGR 25” on
the other.
VIAGRA 50 mg tablets
Blue, rounded, diamond-shaped film-coated tablets, marked “PFIZER”
on one side and “VGR 50” on
the other.
VIAGRA 100 mg tablets
Blue, rounded diamond-shaped film-coated tablets, marked “PFIZER”
on one side and “VGR 100” on
the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
VIAGRA is indicated in adult 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.
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Use in adults _
The recommended dose is 50 mg taken as needed approximately one hour
before sexual activity.
Based on efficacy and tolerability, the dose may be increased to 100
mg or decreased to 25 mg. The
maximum recommended dose is 100 mg. The maximum recommended dosing
frequency is once per
day. If VIAGRA is taken with food, the onset of activity may be
delayed compared to the fasted state
(see section 5.2).
Special populations
_ _
_Elderly _
Dose adjustments are not required in elderly patients (≥ 65 years
old).
_Renal impairment _
The dosing recommendations