Chlorphenamine 4mg tablets

Country: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Chlorphenamine maleate

Fáanlegur frá:

Boston Healthcare Ltd

ATC númer:

R06AB04

INN (Alþjóðlegt nafn):

Chlorphenamine maleate

Skammtar:

4mg

Lyfjaform:

Oral tablet

Stjórnsýsluleið:

Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 03040100

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Chlorphenamine 4 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4 mg Chlorphenamine Maleate.
Also contains lactose and sunset yellow (E110). For the full list of
excipients
see 6.1.
3
PHARMACEUTICAL FORM
Tablet.
Yellow, circular normal convex tablets with a breakline embossed C / 4
on one face
and PV on the reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The symptomatic control of allergic conditions which respond to anti-
histamines including hay fever, urticaria, vasomotor rhinitis,
angioneurotic
oedema, food allergies, drug and serum reactions, pruritis vulvae,
pruritis ani,
and insect bites.
Also indicated for the symptomatic relief of itch associated with
chickenpox.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral use
Adults and children over 12 years: 4mg (one tablet) every 4 to 6 hours
(maximum 24 mg daily).
Children: Aged 6 –12 years: 2mg (equivalent to half a tablet) every
4 to 6
hours
(Maximum 12mg daily)
Not recommended for children under 6 years of age.
Elderly: As for adults but such patients are prone to confusional
psychosis and
other neurological anticholinergic effects.
Consideration should be given to using a lower daily dose (e.g. a
maximum of
3 tablets (12mg in total) in any 24 hours, taken 1 tablet 4 to 6
hourly.
4.3
CONTRAINDICATIONS
1.
Use in patients hypersensitive to Chlorphenamine or any of the
excipients in the
tablet.
2.
Coma or pre-coma states.
3.
Known brain damage or epilepsy.
The anticholinergic properties of Chlorphenamine are intensified by
monoamine
oxidase inhibitors (MAOIs). Chlorphenamine is therefore
contraindicated in
patients who have been treated with MAOIs within the last fourteen
days.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The anticholinergic properties of Chlorphenamine may cause drowsiness,
dizziness, blurred vision and psychomotor impairment in some patients,
which
may seriously affect ability to drive and use machinery.
Chlorphenamine, in common wit