Chlorphenamine 4mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Chlorphenamine maleate

Available from:

Strides Pharma UK Ltd

ATC code:

R06AB04

INN (International Name):

Chlorphenamine maleate

Dosage:

4mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03040100; GTIN: 5031676002444

Patient Information leaflet

3.
HOW TO TAKE CHLORPHENAMINE TABLETS
For oral use. The tablets should be swallowed with
a drink of water. You should take your medicine
as directed by your doctor. The pharmacist's label
should tell you how much to take and how often.
If it does not or if you are not sure ask your doctor
or pharmacist.
The usual doses are as follows:
ADULTS AND THE ELDERLY: One tablet (4 mg) every
four to six hours (maximum of 6 tablets daily).
CHILDREN AND ADOLESCENTS
Children 6-12 years of age: Half a tablet (2 mg) every
four to six hours (maximum of 3 tablets daily).
Not recommended for children under 6 years of age.
The dose prescribed by your doctor may be different
to the usual dose given above; always follow your
doctor's
or
pharmacist's
instructions
for taking
medicines.
IF YOU HAVE TAKEN MORE THAN YOU SHOULD:
If you or anyone else has taken too many tablets you
should
contact
your
doctor
or nearest
hospital
casualty department immediately. Do not attempt to
drive. Symptoms in children include hallucinations,
excitement and convulsions. In adults symptoms
include drowsiness, coma and convulsions.
IF YOU FORGET TO TAKE A DOSE OF CHLORPHENAMINE
TABLETS
Do not take a double dose to make up for forgotten
individual doses.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Children
and
older
people
are
more
prone
to
side effects.
•
The most common side effect is drowsiness.
This can be helpful if symptoms are particularly
troublesome at night.
Stop taking this product and consult your doctor
if you:
•
Experience
allergic
reaction
which
can
be
severe.
Signs include raised and itchy skin,
swelling of the face or mouth causing difficulty
breathing.
•
Experience liver problems.
•
Experience anaemia or unexplained bleeding or
bruising.
•
Experience difficulty passing water.
•
Collapse.
The following side effects may occur:
•
Difficulty concentrating, feeling tired, dizziness,
headache or blurred vision.
•
Loss of appetite,
indigestion, feeling or bei

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Chlorphenamine 4 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Chlorphenamine Maleate 4 mg
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Yellow uncoated convex tablet with a breakline on one side
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
The
symptomatic
control
of
allergic
conditions
which
respond
to
anti-
histamines including hay fever, urticaria, vasomotor rhinitis, food
allergy, drug
and serum reactions, pruritis vulvae, pruritis ani, and insect bites.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
The route of administration for chlorphenamine tablets is oral.
ADULTS AND THE ELDERLY
4 mg every 4-6 hours (maximum of 24mg daily).
CHILDREN
6 - 12 years: 2mg every 4-6 hours (maximum of 12mg daily).
Not recommended for use in children under 6 years of age.
4.3
CONTRAINDICATIONS
The tablets are contraindicated in patients who are hypersensitive to
antihistamines or
any of the other tablet ingredients.
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
In common with other drugs having anticholinergic effects,
chlorphenamine should
be used with caution in conditions such as epilepsy, raised
intra-ocular pressure
including glaucoma, prostatic hypertrophy, severe hypertension or
cardiovascular
disease, bronchitis, bronchiectasis or asthma, hepatic impairment,
renal impairment.
Children and the elderly are more likely to experience the
neurological anticholinergic
effects and paradoxical excitation (e.g increased energy,
restlessness, nervousness).
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.
The effects of alcohol may be increased and