VIAGRA Film-coated tablet (2022)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
VIAGRA 25 mg film-coated tablets. VIAGRA 50 mg film-coated tablets. VIAGRA 100 mg film-coated tablets.
Qualitative and quantitative composition
Each tablet contains sildenafil citrate equivalent to 25, 50 or 100 mg of sildenafil. <u>Excipient with known effect:</u> VIAGRA 25 mg tablets: Each tablet contains 0.9 mg lactose (as monohydrate). VIAGRA ...
Pharmaceutical form
Film-coated tablet. <u>VIAGRA 25 mg tablets:</u> Blue, rounded diamond-shaped tablets, marked PFIZER on one side and VGR 25 on the other. <u>VIAGRA 50 mg tablets:</u> Blue, rounded, diamond-shaped tablets, ...
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, ...
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 ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Consistent with its known effects on the nitric oxide/cyclic guanosine monophosphate (cGMP) pathway (see section ...
Special warnings and precautions for use
A medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes, before pharmacological treatment is considered. Cardiovascular ...
Interaction with other medicinal products and other forms of interaction
Effects of other medicinal products on sildenafil <em>In vitro</em> studies Sildenafil metabolism is principally mediated by the cytochrome P450 (CYP) isoforms 3A4 (major route) and 2C9 (minor route). ...
Fertility, pregnancy and lactation
VIAGRA is not indicated for use by women. There are no adequate and well-controlled studies in pregnant or breast-feeding women. No relevant adverse effects were found in reproduction studies in rats and ...
Effects on ability to drive and use machines
VIAGRA may have a minor influence on the ability to drive and use machines. As dizziness and altered vision were reported in clinical trials with sildenafil, patients should be aware of how they react ...
Undesirable effects
Summary of the safety profile The safety profile of VIAGRA is based on 9,570 patients in 74 double-blind placebo-controlled clinical studies. The most commonly reported adverse reactions in clinical studies ...
Overdose
In single dose volunteer studies of doses up to 800 mg, adverse reactions were similar to those seen at lower doses, but the incidence rates and severities were increased. Doses of 200 mg did not result ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Urologicals; Drugs used in erectile dysfunction <b>ATC Code:</b> G04BE03 Mechanism of action Sildenafil is an oral therapy for erectile dysfunction. In the natural setting, ...
Pharmacokinetic properties
Absorption Sildenafil is rapidly absorbed. Maximum observed plasma concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted state. The mean absolute oral bioavailability ...
Preclinical safety data
Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction ...
List of excipients
<u>Tablet core:</u> Microcrystalline cellulose Calcium hydrogen phosphate (anhydrous) Croscarmellose sodium Magnesium stearate <u>Film coat:</u> Hypromellose Titanium dioxide (E171) Lactose monohydrate ...
Incompatibilities
Not applicable.
Shelf life
5 years.
Special precautions for storage
Do not store above 30°C. Store in the original package in order to protect from moisture.
Nature and contents of container
VIAGRA 25 mg film-coated tablets: PVC/Aluminium blisters in cartons of 2, 4, 8 or 12 tablets. VIAGRA 50 mg film-coated tablets: PVC/Aluminium blisters in cartons or secondary heat sealed card packaging ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Netherlands
Marketing authorization number(s)
<u>VIAGRA 25 mg film-coated tablets:</u> EU/1/98/077/002-004 EU/1/98/077/013 <u>VIAGRA 50 mg film-coated tablets:</u> EU/1/98/077/006-008 EU/1/98/077/014 EU/1/98/077/016-019 EU/1/98/077/024 <u>VIAGRA 100 ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 14 September 1998 Date of latest renewal: 14 September 2008
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