Chlorphenamine 4mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Chlorphenamine maleate

Available from:

Actavis 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

Patient Information leaflet

PATIENT INFORMATION LEAFLET
CHLORPHENAMINE 4MG TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in
this leaflet or as your doctor or pharmacist or
nurse has told you.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more
information or advice.
•
If you get any side effects, talk to your doctor or
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet.
See section 4
•
You must talk to a doctor if you do not feel
better or if you feel worse.
IN THIS LEAFLET:
1. What Chlorphenamine is and what it is used for
2. What you need to know before you take
Chlorphenamine
3. How to take Chlorphenamine
4. Possible side effects
5. How to store Chlorphenamine
6. Contents of the pack and other information
1. WHAT CHLORPHENAMINE IS AND WHAT IT IS
USED FOR
This medicine contains Chlorphenamine maleate
which belongs to a group of medicines called
antihistamines, which act to relieve the symptoms
of allergies.
It can be used to relieve the symptoms of allergic
reactions including hayfever, raised, red itchy skin
(symptoms of urticaria, which is often known as
hives or nettle rash), allergic reactions to foods or
medicines, insect bites, runny nose and swelling
of the face or throat due to fluid build up and
itching caused by chickenpox.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
CHLORPHENAMINE
DO NOT TAKE CHLORPHENAMINE IF YOU:
•
are allergic to Chlorphenamine or any other
antihistamines or any of the other ingredients of
this medicine (listed in section 6). This
medicine contains sunset yellow E110 and can
cause allergic type reaction, including asthma
(allergy tends to be more common in people
who are sensitive to aspirin)
•
have taken monoamine oxidase inhibitor
(MAOI) antidepressant treatment in the past 14
days
•
have known brain damage or epilepsy
•
are comatose or in pre-comatose state
WARNINGS AND PRECAUTIONS
Talk

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 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