Panadol Actifast Caplet

Country: Malaysia

Language: English

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

Active ingredient:

Paracetamol

Available from:

GLAXOSMITHKLINE CONSUMER HEALTHCARE SDN. BHD.

INN (International Name):

Paracetamol

Units in package:

20 Tablets; 100 Tablets; 10 Tablets; 10 Tablets; 30 Tablets

Manufactured by:

GLAXOSMITHKLINE DUNGARVAN LTD

Patient Information leaflet

_Consumer Medication Information Leaflet (RiMUP) _
PANADOL
ACTIFAST TABLET
Paracetamol 500mg
1
WHAT IS IN THIS LEAFLET
1.
What Panadol Actifast
Tablet 500mg is used for
2.
How Panadol Actifast
Tablet works
3.
Before you use Panadol
Actifast Tablet
4.
How to use Panadol
Actifast Tablet
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Panadol Actifast Tablet
8.
Product Description
9.
Manufacturer & Product
Registration Holder
10.
Date of revision
WHAT PANADOL ACTIFAST TABLET
IS USED FOR
Relief of fever and the relief
from mild to moderate pain
including: headache, migraine,
backache, musculoskeletal
pain, period pain, pain of
osteoarthritis, toothache, pain
after dental procedures/ tooth
extraction, pain after
vaccination and the discomfort
from colds, influenza and sore
throats.
HOW PANADOL ACTIFAST
TABLET WORKS
Paracetamol is an analgesic and
antipyretic. Its mechanism of
action is believed to include
inhibition of prostaglandin
synthesis, primarily within the
central nervous system.
BEFORE YOU USE PANADOL
ACTIFAST TABLET
_- When you must not use it _
Do not use if you are allergic to
paracetamol or any of the other
ingredients in the product.
Do not take Panadol Actifast
Tablet if you are pregnant,
trying to get pregnant or think
you may be pregnant.
Ask your doctor or pharmacist
for advice before taking any
medicine.
_- Before you start to use it _
Check with your doctor before
use if:

you have liver or kidney
problems.

are underweight or
malnourished.

regularly drink alcohol.
You may need to avoid using
this product altogether or limit
the amount of paracetamol that
you take.
Check with your doctor before
use if:

you have a severe infection
as this may increase the
risk of metabolic
acidosis.Signs of
metabolic acidiosis
include: deep, rapid,
difficult breathing, feeling
sick (nausea), being sick
(vomiting), loss of
appetite. Contact a doctor
immediately if you get a
combination of these
symptoms.
Please see your doctor if your
symptoms do not improve.
ALLERGY ALERT:
Paraceta

Summary of Product characteristics

Setiap kaplet
mengandungi
500mg Paracetamol,
_sodium bicarbonate,_
_maize_
_starch,_
_pregelatinized_
_starch,_
_povidone,_
_sodium starch glycolate,_
_colloidal_
_anhydrous silica, magnesium stearate, microcrystalline_
_cellulose, carnauba wax, opadry II white._
DESKRIPSI PRODUK
Tablet bersalut lapisan licin putih ke putih pudar
yang berbentuk kapsul
dengan tepi rata. Tablet
ditanda dengan “P” pada satu permukaan dan “--”
di permukaan satu lagi.
KEGUNAAN
Untuk kelegaan demam dan kelegaan sakit daripada
ringan hingga sederhana termasuk:
sakit
kepala,
migrain,
sakit belakang,
sakit muskuloskeletal,
sakit
senggugut,
sakit
osteoarthritis,
sakit
gigi,
sakit
selepas prosedur
pergigian/pencabutan gigi,
sakit
selepas
vaksinasi
dan
ketidakselesaan
akibat
selesema dan sakit tekak.
DOS YANG DISYORKAN
ORANG DEWASA (TERMASUK WARGA TUA) DAN KANAK-
KANAK BERUSIA 12 TAHUN KE ATAS:
500mg-1000mg paracetamol (1-2 kaplet),
setiap 4-6
jam bila perlu.
KANAK-KANAK DI BAWAH UMUR 12 TAHUN:
Tidak disyorkan untuk kanak-kanak di bawah umur 12 tahun.
• Jangan melebihi dos yang disyorkan.
• Dos
paling rendah yang dapat
memberi
keberkesanan dan
tempoh rawatan yang paling singkat harus digunakan.
• Pengambilan secara oral sahaja.
• Selang antara dos minimum: 4 jam.
• Dos harian maksimum: 4000mg (8 kaplet)
Kemerosotan buah pinggang:
Pesakit
yang didiagnosis mengalami
masalah buah pinggang
mesti mendapatkan nasihat perubatan sebelum mengambil ubat
ini.
Batasan yang berkaitan dengan penggunaan produk-produk
paracetamol
pada
pesakit
dengan masalah buah pinggang
adalah akibat daripada kandungan paracetamol dalam ubat (sila
rujuk kepada Seksyen Amaran dan Perhatian)
Kemerosotan hati:
Pesakit
yang
didiagnosis
mengalami
masalah
hati
mesti
mendapatkan nasihat perubatan sebelum mengambil
ubat ini.
Batasan yang berkaitan dengan penggunaan produk-produk
paracetamol
pada pesakit
dengan masalah hati
adalah akibat
daripada kandungan paracetamol dalam ubat (sila rujuk kepada
Seksyen Amaran dan Perhatian).
CARA PENGAMBILAN
Oral
KONTRAINDIKASI