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SPC: REVATIO Film-coated tablets (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Revatio 20mg film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains 20mg of sildenafil (as citrate). Excipient(s) with known effect: ach tablet also contains 0.7mg of lactose. For the full list of excipients, see section 6.1.

Pharmaceutical form

Film-coated tablet. White, round, biconvex film-coated tablets marked PFIZER on one side and RVT 20 on the other.

Therapeutic indications

Adults Treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension ...

Posology and method of administration

Treatment should only be initiated and monitored by a physician experienced in the treatment of pulmonary arterial hypertension. In case of clinical deterioration in spite of Revatio treatment, alternative ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Co-administration with nitric oxide donors (such as amyl nitrite) or nitrates in any form due to the hypotensive ...

Special warnings and precautions for use

The efficacy of Revatio has not been established in patients with severe pulmonary arterial hypertension (functional class IV). If the clinical situation deteriorates, therapies that are recommended at ...

Interaction with other medicinal products and other forms of interaction

Effects of other medicinal products on sildenafil In vitro studies Sildenafil metabolism is principally mediated by the cytochrome P450 (CYP) isoforms 3A4 (major route) and 2C9 (minor route). Therefore, ...

Fertility, pregnancy and lactation

Women of childbearing potential and contraception in males and females Due to lack of data on effects of Revatio in pregnant women, Revatio is not recommended for women of childbearing potential unless ...

Effects on ability to drive and use machines

Revatio has moderate 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 might be ...

Undesirable effects

Summary of the safety profile In the pivotal placebo-controlled study of Revatio in pulmonary arterial hypertension, a total of 207 patients were randomized to and treated with 20mg, 40mg, or 80mg TID ...

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. At single doses of 200 mg the ...

Pharmacodynamic properties

Pharmacotherapeutic group: Urologicals, Drugs used in erectile dysfunction ATC code: G04BE03 Mechanism of action Sildenafil is a potent and selective inhibitor of cyclic guanosine monophosphate (cGMP) ...

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 and carcinogenic potential, toxicity to reproduction and ...

List of excipients

Tablet core: Microcrystalline cellulose Calcium hydrogen phosphate (anhydrous) Croscarmellose sodium Magnesium stearate Film coat: Hypromellose Titanium dioxide (E171) Lactose monohydrate Glycerol triacetate ...

Incompatibilities

Not applicable.

Shelf life

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

PVC/Aluminium blisters of 90 tablets. Pack size of 90 tablets in a carton. 90 1 tablets in PVC/Aluminium perforated unit dose blisters. PVC/Aluminium blisters of 300 tablets. Pack size of 300 tablets ...

Special precautions for disposal and other handling

No special requirements for disposal.

Marketing authorization holder

Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium

Marketing authorization number(s)

EU/1/05/318/001 EU/1/05/318/004 EU/1/05/318/005

Date of first authorization / renewal of the authorization

Date of first authorisation: 28 October 2005 Date of latest renewal: 23 September 2010

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