Febricol-RX Tablet

Երկիր: Մալայզիա

Լեզու: անգլերեն

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

Ակտիվ բաղադրիչ:

CHLORPHENIRAMINE MALEATE; Paracetamol; PHENYLEPHRINE HYDROCHLORIDE

Հասանելի է:

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

INN (Միջազգային անվանումը):

CHLORPHENIRAMINE MALEATE; Paracetamol; PHENYLEPHRINE HYDROCHLORIDE

Միավորները փաթեթում:

10Tablet Tablets; 60Tablet Tablets; 100Tablet Tablets; 30Tablet Tablets

Պատրաստված է:

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

Տեղեկատվական թերթիկ

RiMUP for both languages will be uploaded into E12.

Ապրանքի հատկությունները

D3 – NEW DRAFT PACKAGE INSERT
CLEAN COPY
Important information. Please read carefully.
_ _
_FEBRICOL-RX TABLET _
TABLET
COMPOSITION
Each capsule contains:
Paracetamol
500mg
Chlorpheniramine Maleate
2mg
Phenylephrine Hydrochloride
5mg
PHARMACODYNAMICS
Chlorpheniramine is a H
1
-blocker that reduces rhinorrhoea and sneezing. Phenylephrine is
used as a nasal and bronchial decongestant. It is a direct selective
alpha-adrenergic receptor
agonist,
and
thus
it
does
not
cause
the
release
of
endogenous
noradrenaline
like
pseudoephedrine does. Paracetamol has analgesic and antipyretic
actions similar to those of
aspirin. These actions are considered to be due to inhibition of the
biosynthesis of
prostaglandins.
PHARMACOKINETICS
Chlorpheniramine
is
well
absorbed
from
the
gastro-intestinal
tract,
following
oral
administration. It is extensively metabolised in the liver and
excreted mainly as metabolites
in the urine. Phenylephrine has reduced bioavailability from the
gastrointestinal tract owing
to irregular absorption and first-pass metabolism by monoamine oxidase
in the gut and
liver. Paracetamol is readily and effectively absorbed from the
gastrointestinal tract,
metabolised in the liver and excreted in the urine mainly as the
glucuronide and sulphate
conjugates.
INDICATIONS
Febricol-RX is indicated for the symptomatic relief of headache,
muscular ache, fever,
sneezing, nasal congestion, and itching and watery eyes, associated
with flu, common colds
and allergic rhinitis.
DOSAGE AND ADMINISTRATION
Febricol-RX is preferably taken after food.
Adults and Children over 12 years: 1 to 2 tablets every 4-6 hours.
Maximum 8 tablets per
day.
CONTRAINDICATIONS
Febricol-RX is contraindicated in patients taking monoamine oxidase
inhibitors or within
two weeks after stopping such treatment, patients with severe
hypertension or severe
coronary artery disease and in patients with known hypersensitivity to
any of the active
constituent.
WARNINGS AND PRECAUTIONS
This medicine may cause drowsiness. If affected, do not drive motor
vehicle