Sildenafil Teva 20 mg Film-coated Tablets

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Sildenafil

Disponible desde:

Teva B.V.

Código ATC:

G04BE; G04BE03

Designación común internacional (DCI):

Sildenafil

Dosis:

20 milligram(s)

formulario farmacéutico:

Film-coated tablet

tipo de receta:

Product subject to prescription which may not be renewed (A)

Área terapéutica:

Drugs used in erectile dysfunction; sildenafil

Estado de Autorización:

Marketed

Fecha de autorización:

2016-12-02

Información para el usuario

Sildenafil, DE/H/4461/001, 11-05-22
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SILDENAFIL TEVA 20 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 or pharmacist.
-
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 or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Sildenafil Teva is and what it is used for
2.
What you need to know before you take Sildenafil Teva
3.
How to take Sildenafil Teva
4.
Possible side effects
5.
How to store Sildenafil Teva
6.
Contents of the pack and other information
1.
WHAT SILDENAFIL TEVA IS AND WHAT IT IS USED FOR
Sildenafil Teva contains the active substance sildenafil which belongs
to a group of medicines called
phosphodiesterase type 5 (PDE5) inhibitors.
Sildenafil Teva brings down blood pressure in the lungs by widening
the blood vessels in the lungs.
Sildenafil Teva is used to treat adults and children and adolescents
from 1 to 17 years old with high blood
pressure in the blood vessels in the lungs (pulmonary arterial
hypertension).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SILDENAFIL TEVA
DO NOT TAKE SILDENAFIL TEVA
-
if you are allergic to sildenafil or any of the other ingredients of
this medicine (listed in section 6).
-
if you are taking medicines containing nitrates (such as nicorandil),
or nitric oxide donors such as
amyl nitrite (“poppers”). These medicines are often given for
relief of chest pain (or “angina
pectoris”). Sildenafil Teva can cause a serious increase in the
effects of these medicines. Tell your
doctor if you are taking any of these medicines. If you are not
certain, ask your doctor or pharmacist.
-
if you are t

Ficha técnica

Health Products Regulatory Authority
09 February 2023
CRN00DDH5
Page 1 of 20
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sildenafil Teva 20 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg of sildenafil (as citrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to off white, approx. 6.5 mm, biconvex circular film-coated
tablets debossed with “20” on one side and plain on the other
side.
4 CLINICAL PARTICULARS
4.1 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 and pulmonary hypertension associated with
connective tissue disease.
Paediatric population
Treatment of paediatric patients aged 1 year to 17 years old with
pulmonary arterial hypertension. Efficacy in terms of
improvement of exercise capacity or pulmonary haemodynamics has been
shown in primary pulmonary hypertension and
pulmonary hypertension associated with congenital heart disease (see
section 5.1).
4.2 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 Sildenafil
Teva treatment, alternative therapies should be considered.
Posology
_Adults_
The recommended dose is 20 mg three times a day (TID). Physicians
should advise patients who forget to take Sildenafil Teva
to take a dose as soon as possible and then continue with the normal
dose. Patients should not take a double dose to
compensate for the missed dose.
_Paediatric population (1 year to 17 years)_
For paediatric patients aged 1 year to 17 years old, the recommended
dose in patients ≤ 20 kg is 10 mg three times a day and
for patients > 20 kg is 20 mg three times a day. Higher than
recommended doses should not be used in paed