PLENDIL 2.5MG ER TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

FELODIPINE

Boleh didapati daripada:

ASTRAZENECA SDN. BHD.

INN (Nama Antarabangsa):

FELODIPINE

Unit dalam pakej:

30 Tablet Tablets

Dikeluarkan oleh:

AstraZeneca Pharmaceutical Co. Ltd.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
PLENDIL
®
_ _
TABLET
FELODIPINE (2.5MG, 5MG & 10MG)
1
WHAT IS IN THIS LEAFLET
1.
What Plendil is used for
2.
How Plendil works
3.
Before you use Plendil
4.
How to use Plendil
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
Plendil
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT PLENDIL IS USED FOR
Plendil is used for the treatment of
high blood pressure and vascular
cramp in the heart (angina
pectoris).
HOW PLENDIL WORKS
Plendil lowers the blood pressure
by dilating the blood vessels. This
results in the blood passing more
easily through the vessels, and the
blood pressure falls.
Plendil affects neither the ability
of the heart to contract, nor the
pulse. High blood pressure often
occurs as a result of the blood
having difficulty in passing
through the blood vessels.
In cases of vascular cramps in the
heart, the work of the heart is
facilitated as a result of the blood
vessels being widened.
BEFORE YOU USE PLENDIL
-
_When you must not use it _
_ _
Plendil must not be used:
•
in cases of untreated heart
failure
•
in cases of acute myocardial
infarction (heart attack)
•
in cases of unstable angina
pectoris
•
during pregnancy
•
if you are hypersensitive
(allergic) to any of the
ingredients contained in the
tablet
-
_Before you start to take it_
Talk to your doctor before starting
to take Plendil if you have any of
the following conditions:
•
narrowing of the aortic valve in
the heart (aortic stenosis)
•
impaired liver function
•
heart failure
•
low blood pressure
•
Plendil contains lactose. If you
are allergic to some sugars,
consult your doctor before
taking this medicine.
-
_Taking other medicines_
Tell your doctor if you are taking
ther medicines at the same time as
you are taking Plendil. Some
medicines can affect or be
affected by the treatment with
Plendil.
Grapefruit juice can potentiate the
effect of Plendil, and should
therefore be avoided.
HOW TO TAKE PLENDIL
-
_How m

Ciri produk

PLENDIL
® 2.5 MG, 5 MG AND 10 MG
_felodipine _
TABLETS
COMPOSITION
Felodipine 2.5 mg, 5 mg and 10 mg
PHARMACEUTICAL FORM
Film-coated extended-release tablets based on the hydrophilic gel
matrix principle.
The Plendil 2.5 mg tablet is yellow, circular, biconvex, engraved A/FL
on one side and 2.5 on
the other side, with a diameter of 8.5 mm.
The Plendil 5 mg tablet is pink, circular, biconvex, engraved A/Fm on
one side and 5 on the
other side, with a diameter of 9 mm.
The Plendil 10 mg tablet is reddish-brown, circular, biconvex,
engraved A/FE on one side
and 10 on the other side, with a diameter of 9 mm.
THERAPEUTIC INDICATIONS
Hypertension
Stable angina pectoris
POSOLOGY AND METHOD OF ADMINISTRATION
The tablets should be taken in the morning, be swallowed with water
and must not be
divided, crushed or chewed. The tablets can be administered without
food or following a light
meal not rich in fat or carbohydrate.
_ _
_Hypertension _
The dose should be adjusted individually. Treatment should be started
with 5 mg once daily.
If necessary the dose may be further increased or another
antihypertensive agent added. The
usual maintenance doses are 5 mg to 10 mg once daily. In elderly
patients initial treatment
with 2.5 mg daily should be considered.
_Stable angina pectoris_
The dose should be adjusted individually. Treatment should be started
with 5 mg once daily,
increasing to 10 mg once daily if needed.
_ELDERLY PATIENTS _
Initial treatment with 2.5mg daily dose should be considered.
_IMPAIRED RENAL FUNCTION _
Impaired renal function does not affect plasma concentrations of
felodipine. No dose adjustment
is required. However, Plendil should be used with caution in patients
with severely impaired renal
function (see Pharmacokinetic Properties)
_ _
_IMPAIRED HEPATIC FUNCTION_
_ _
Patients with impaired hepatic function may have elevated plasma
concentrations of felodipine
and may respond to treatment at lower doses
(see Special Warnings & Precautions for Use).
_ _
_PAEDIATRIC PATIENTS _
Due to limited clinical experience