REVATIO 20 MG FILM-COATED TABLET

Land: Malaysia

Språk: engelsk

Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiv ingrediens:

SILDENAFIL CITRATE

Tilgjengelig fra:

PFIZER (MALAYSIA) SDN. BHD.

INN (International Name):

SILDENAFIL CITRATE

Enheter i pakken:

90Tablet Tablets

Produsert av:

Fareva Amboise

Informasjon til brukeren

Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP_
_)_
REVATIO FILM-COATED TABLET
Sildenafil citrate (20 mg)
1
PLD TITLE
: Revatio
PLD DATE
: 27 June 2019
COUNTRY
: Malaysia
REFERENCE DOCUMENTS
: Revatio 20 mg, Film-coated Tablet, Malaysia LPD, Dated 29 January
2018
REASON FOR CHANGE
: Resubmission of document to incorporate changes requested by
officer.
Update as per current approved Malaysia LPD, Dated 19 April 2016.
Update PIL as per
BoH remarks.
Update to Section (Fertility, Pregnancy and Lactation) concerning the
detection of
sildenafil and its active metabolite in human breast milk and the
potential for impact on
the breastfed infant
To update PIL as per request by local BoH
To update PRH address
Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP_
_)_
REVATIO FILM-COATED TABLET
Sildenafil citrate (20 mg)
2
WHAT IS IN THIS LEAFLET
1.
What REVATIO is used for
2.
How REVATIO works
3.
Before you use REVATIO
4.
How to use REVATIO
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
REVATIO
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT REVATIO IS USED FOR
REVATIO is indicated to treat
adults with high blood pressure
in the blood vessels in the lungs
(pulmonary arterial
hypertension), to improve
exercise capacity.
HOW REVATIO WORKS
REVATIO belongs to a group of
medicines called
phosphodiesterase type 5 (PDE5)
inhibitors.
REVATIO brings down blood
pressure in the lungs by widening
the blood vessels in the lungs.
BEFORE YOU USE REVATIO
_- When you must not use it_
-
if you are allergic
(hypersensitive) to sildenafil or
any of the other ingredients of
this medicine (listed in section
“_Ingredients”_).
-
if you are taking medicines
containing nitrates or nitric
oxide donors.
REVATIO can cause a serious
increase in the low blood
pressure 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 have pulmonary
hypertension d

Preparatomtale

Pfizer Confidential 1
LPD Title : Sildenafil citrate
LPD Date : 29 January 2018
Country : Malaysia
Reference : EU SmPC (Dated 04 December 201 7), CDS version 1 1 (Dated 23 May 2017), USPI
(Dated July 2017) (Section 4.4- Paediatric warning)
Reasons of Change: The Revatio (sildenafil citrate) CDS is being updated to include a revised statement in Section 4.6 (Fertility, Pregnancy and Lactation) concerning the detection
of sildenafil and its active metabolite in human breast milk and t he potential for
impact on the breastfed infant.
PFIZER
REVATIO*
Sildenafil Citrate
1. NAME OF THE MEDICINAL PRODUCT
Revatio 20 mg film-coated tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film -coated tablet contains 20 mg of sildenafil (as citrate). Revatio tablets also contain lactose.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film -coated tablet:
White, round, biconvex film -coated tablets marked “PFIZER” on one side and “RVT 20”on the other.
4. CLINICAL PART ICULARS
4.1 Therapeutic indications
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 hype rtension associated with connective tissue disease.
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 i n spite of Revatio treatment,
alternative therapies should be considered.
Adults ( ≥18 years):
The recommended dose is 20 mg three times a day (TID). Physicians should advise patients who
forget to take Revatio 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.