Plendil 5 mg prolonged-release tablets

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Felodipine

Tersedia dari:

AstraZeneca UK Limited

Kode ATC:

C08CA; C08CA02

INN (Nama Internasional):

Felodipine

Dosis:

5 milligram(s)

Bentuk farmasi:

Prolonged-release tablet

Jenis Resep:

Product subject to prescription which may be renewed (B)

Area terapi:

Dihydropyridine derivatives; felodipine

Status otorisasi:

Marketed

Tanggal Otorisasi:

1993-05-18

Selebaran informasi

BARCODES
TYPE
NUMBER
EAN 13
5000456027076
Profile
Braille
Technical Info
612091-A01
10-02-18
PS12933
AZC7061/D
5682
N/A
NZ
Black
P259
P130
P269
Plendil 5mg Carton IE/MT
BODY TEXT SIZE
7.0 pt
SMALLEST TEXT SIZE
6.0 pt
EXP
Lot
For oral use as directed by a physician.
The tablet must not be divided, crushed or chewed. The tablets should
be
swallowed with water.
Read the package leaflet before use. Oral use
Keep out of the sight and reach of children.
POM
Each tablet contains 5 mg felodipine. Contains lactose and
macrogolglycerol hydroxystearate.
See leaflet for further information. Trade Marks herein are the
property of the AstraZeneca group
© AstraZeneca 2018
AstraZeneca UK Ltd., 600 Capability Green, Luton, LU1 3LU, UK is the
Marketing Authorisation Holder in Ireland.
AstraZeneca AB, Gartunavagen, S-151 85 Södertälje, Sweden is the
Marketing Authorisation Holder in Malta.
PA 970/49/2
MA 046/00201
Plendil
®
5 mg prolonged-release tablets
felodipine
Plendil
®
5 mg
prolonged-release tablets
felodipine
28 tablets (calendar blister pack)
28 tablets
(calendar blister pack)
5 000456 027076
plendil #5 mg
plendil #5 mg
plendil #5 mg
BRAILLE EXPLANATIONS AND TRANSLATIONS
PS12933

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Plendil 5 mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg felodipine
Excipients with known effect:
Each tablet contains 28 mg lactose and 5 mg macrogolglycerol
hydroxystearate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet
Plendil 5 mg: The tablet is pink, circular, biconvex engraved A/Fm on
one side and 5 on the other side, with a diameter
of 9 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension
Stable angina pectoris
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Hypertension_
The dose should be adjusted individually. Treatment can be started
with 5 mg once daily. Depending on the patient’s
response, the dosage can, where applicable be decreased to 2.5 mg or
increased to 10 mg daily. If necessary another
antihypertensive agent may be added. The standard maintenance dose is
5 mg once daily.
_Angina pectoris_
The dose should be adjusted individually. Treatment should be
initiated with 5 mg once daily and, if needed, increased
to 10 mg once daily.
_Elderly population_
Initial treatment with lowest available dose should be considered.
_Renal impairment_
Dose adjustment is not needed in patients with impaired renal
function.
_Hepatic impairment_
Patients with impaired hepatic function may have elevated plasma
concentrations of felodipine and may respond to
lower doses (see section 4.4).
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