Silcarfil 20 mg film-coated tablets

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Sildenafil citrate

Verfügbar ab:

Rowex Ltd

ATC-Code:

G04BE; G04BE03

INN (Internationale Bezeichnung):

Sildenafil citrate

Dosierung:

20 milligram(s)

Darreichungsform:

Film-coated tablet

Verschreibungstyp:

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

Therapiebereich:

Drugs used in erectile dysfunction; sildenafil

Berechtigungsstatus:

Marketed

Berechtigungsdatum:

2016-11-25

Gebrauchsinformation

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SILCARFIL 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 Silcarfil is and what it is used for
2.
What you need to know before you take Silcarfil
3.
How to take Silcarfil
4.
Possible side effects
5.
How to store Silcarfil
6.
Contents of the pack and other information
1.
WHAT SILCARFIL IS AND WHAT IT IS USED FOR
Silcarfil contains the active substance sildenafil which belongs to a
group of medicines called
phosphodiesterase type 5 (PDE5) inhibitors.
Silcarfil brings down blood pressure in the lungs by widening the
blood vessels in the lungs. Silcarfil
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 SILCARFIL
DO NOT TAKE SILCARFIL:
•
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”). Silcarfil 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 pressure in the lu

Fachinformation

Health Products Regulatory Authority
04 January 2024
CRN00DVC5
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Silcarfil 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, round (diameter: 7.1 mm), biconvex film-coated tablet with
debossment "20" on one 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
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 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)