Chlorphenamine 4mg tablets

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Indlægsseddel Indlægsseddel (PIL)
19-04-2019
Produktets egenskaber Produktets egenskaber (SPC)
17-03-2023

Aktiv bestanddel:

Chlorphenamine maleate

Tilgængelig fra:

Crescent Pharma Ltd

ATC-kode:

R06AB04

INN (International Name):

Chlorphenamine maleate

Dosering:

4mg

Lægemiddelform:

Oral tablet

Indgivelsesvej:

Oral

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 03040100; GTIN: 5017123094132

Produktets egenskaber

                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Chlorphenamine Tablets 4 mg
Numark Antihistamine and Allergy Relief 4mg Tablets
Allerief 4 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4.00 mg chlorphenamine maleate.
Excipient(s) of known effect: Lactose 105.0 mg per tablet.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Yellow, normal convex tablet engraved with company logo on one side,
and a
breakline and B094 on the other side.
4.1
THERAPEUTIC INDICATIONS
Chlorphenamine tablets are indicated for symptomatic control of all
allergic
conditions responsive to antihistamines, including hay fever,
vasomotor rhinitis,
urticaria, angioneurotic oedema, food allergy, drug and serum
reactions, pruritis and
vulvae, and insect bites.
Also indicated for the symptomatic relief of itch associated with
chickenpox.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS AND CHILDREN 12 YEARS AND OVER: 1 tablet every 4-6 hours.
Maximum daily
dose 24 mg (6 tablets) in any 24 hours.
ELDERLY: The elderly are more likely to experience neurological
anticholinergic
effects. Consideration should be given to using a lower daily dose
(e.g. a maximum
daily dose of 12mg (3 tablets) in any 24 hours).
CHILDREN AGED 6–12 YEARS: ½ tablet every 4-6 hours. Maximum daily
dose 12 mg (3
tablets) in any 24 hours.
CHILDREN UNDER 6 YEARS: Not recommended.
Method of administration:
Oral
Do not exceed the stated dose or frequency of dosing
Minimum dosing interval: 4 hours.
Do not use continuously for more than two weeks without consulting a
doctor
Populations
Patients with renal or hepatic impairment should seek doctor’s
advise prior to taking
this medicine. (See Section 4.4 Special warnings and precautions for
use).
4.3
CONTRAINDICATIONS
Hypersensitivity to other antihistamines, chlorphenamine maleate or
any of the
other tablet ingredients.
The
anticholinergic
properties
of
chlorphenamine
are
intensified
by
monoamine oxidase inhibitors (MAOIs). Chlorphenamine tablets are
t
                                
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