Sildenafil Teva 20mg, film-coated Tablet

Country: Malta

Lingwa: Ingliż

Sors: Medicines Authority

Ingredjent attiv:

SILDENAFIL CITRATE

Disponibbli minn:

Teva B.V. Swensweg 5, 2031 GA Haarlem, Netherlands

Kodiċi ATC:

G04BE03

INN (Isem Internazzjonali):

SILDENAFIL CITRATE 20 mg

Għamla farmaċewtika:

FILM-COATED TABLET

Kompożizzjoni:

SILDENAFIL CITRATE 20 mg

Tip ta 'preskrizzjoni:

POM

Żona terapewtika:

UROLOGICALS

L-istatus ta 'awtorizzazzjoni:

Withdrawn

Data ta 'l-awtorizzazzjoni:

2019-03-28

Fuljett ta 'informazzjoni

Page 1 of 6
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 is and what it is used for
2.
What you need to know before you take Sildenafil
3.
How to take Sildenafil
4.
Possible side effects
5.
How to store Sildenafil
6.
Contents of the pack and other information
1.
WHAT SILDENAFIL IS AND WHAT IT IS USED FOR
Sildenafil contains the active substance sildenafil which belongs to a
group of medicines called
phosphodiesterase type 5 (PDE5) inhibitors.
Sildenafil brings down blood pressure in the lungs by widening the
blood vessels in the lungs.
Sildenafil 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
DO NOT TAKE SILDENAFIL:
-
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, or nitric oxide
donors such as amyl nitrate
(“poppers”). These medicines are often given for relief of chest
pain (or “angina pectoris”).
Sildenafil 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 taking riociguat. This drug is used to treat pulmonary
arterial hypertension (i.e., high
blood pressur

Karatteristiċi tal-prodott

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 embossed 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 paediatric patients with PAH (see also sections
4.4 and 5.1). The 20 mg tabl