Sildenafil Amneal 20 mg filmomhulde tabletten

Land: Nederländerna

Språk: nederländska

Källa: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Aktiva substanser:

SILDENAFILCITRAAT SAMENSTELLING overeenkomend met ; SILDENAFIL

Tillgänglig från:

Amneal Pharma Europe Limited

ATC-kod:

G04BE03

INN (International namn):

SILDENAFILCITRAAT COMPOSITION corresponding to ; SILDENAFIL

Läkemedelsform:

Filmomhulde tablet

Sammansättning:

CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

Administreringssätt:

Oraal gebruik

Terapiområde:

Sildenafil

Tillstånd datum:

2018-07-11

Bipacksedel

Sildenafil Citrate 20 mg Tablets
1.3.1-package-leaflet
Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
SILDENAFIL AMNEAL 20 MG FILMOMHULDE TABLETTEN
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 is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
contains the active substance sildenafil which belongs
to a group of
medicines called phosphodiesterase type 5 (PDE5) inhibitors.
brings down blood pressure in the lungs by widening
the blood vessels in the
lungs.
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
DO NOT TAKE :

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”).
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
pharm

Produktens egenskaper

Sildenafil Citrate 20 mg
1.3.1-Summary-of-Product-Characteristics
16-March-2017
Page 1 of 21
SUMMARY OF PRODUCT CHARACTERISTICS:
1
NAME OF THE MEDICINAL PRODUCT
Sildenafil Amneal 20 mg filmomhulde tabletten
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, round shaped film-coated tablets, around 6.7 mm
with debossing ‘AN 1017’
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
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 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) _
Sildenafil Citrate 20 mg
1.3.1-Summary-of-Product-Characteristics
16-March-2017
Page 2 of 21
For paediatric patients aged 1 year to 17 years old, the recommended
dose in patients ≤ 20 kg is
10