Chlorphenamine 4mg tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Chlorphenamine maleate

Dostopno od:

Bristol Laboratories Ltd

Koda artikla:

R06AB04

INN (mednarodno ime):

Chlorphenamine maleate

Odmerek:

4mg

Farmacevtska oblika:

Oral tablet

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 03040100; GTIN: 5060013943140

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Health
Boots Own Brand
Seasonal Healthcare
10-17-551 10-17-578
N/A
3
Leaflet
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1
No
WBA-1866-Allergy Relief 4mg Tablets Chlorphenamine
Maleate-1017551 1017578
PACK MOCK UP
ARTWORK TEXT SIZE
MAIN HEADINGS:
15pt
SUB HEADINGS:
12pt
BODY HEADINGS:
8pt
VERSION
NO.
DATE
ISSUED
REASON FOR CHANGE
2
02/08/2021
Amendments
3
12/11/2021
RFI - Changes requested by the MAH.
PL 17907/0349
MHRA approved v1
20/12/2018 WBAG315580 D
Internally approved
30 or 60 tablets
Boots Allergy Relief 4 mg
Tablets
PRODUCT NAME:
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PACK SIZE:
Blister pack PVC: 250
microns, Aluminium foil
20 microns
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Elderly:
Talk to your doctor or pharmacist before you
take this medicine as you may be more likely to
get side effects including confusion and you may
need to take a lower daily dose. Maximum daily
dose: 3 tablets (12 mg) in any 24 hours.
If you are elderly your doctor or pharmacist may
advise you to take fewer tablets. If this applies to
you follow their instructions.
Swallow the tabl

Lastnosti izdelka

1
NAME OF THE MEDICINAL PRODUCT
Chlorphenamine 4mg Tablets
Boots Allergy Relief 4 mg Tablets
Lloydspharmacy Allergy Relief 4 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4 mg of Chlorphenamine maleate.
Excipient with known effect: Also contains 109 mg of Lactose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Pale, yellow, uncoated, biconvex tablet with debossed “B”
breakline “L” on
one side and “4” on the other side.
The tablet can be divided into two equal doses.
4
CLINICAL PARTICULARS
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 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 OVER 12 YEARS:
1 tablet (4mg) every 4 to 6 hourly.
Maximum daily dose: 6 tablets (24mg) 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 of
12 mg in any 24 hours).
CHILDREN AGED 6 - 12 YEARS:
½ tablet (2mg) 4 to 6 hourly.
Maximum daily dose: 3 tablets (12mg) in any 24 hours.
NOT RECOMMENDED FOR CHILDREN UNDER THE AGE OF 6 YEARS.
POPULATIONS
Patients with renal or hepatic impairment should seek doctor’s
advice prior to
taking this medicine. (See Section 4.4 Special warnings and
precautions for
use).
Method of administration
For oral administration only
Do not exceed the stated dose or frequency of dosing.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance or to any of the excipients
listed
in section 6.1
•
The anticholinergic properties of chlorphenamine are intensified by
monoamine oxidase inhibitors (MAOIs). The tablets are therefore
contra-
indicated in patients who have been treated with M