Piriton Allergy 4mg Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
04-01-2024
Summary of Product characteristics
(SPC)
04-01-2024
Active ingredient:
Chlorpheniramine maleate
Available from:
Haleon Ireland Limited
ATC code:
R06AB; R06AB04
INN (International Name):
Chlorpheniramine maleate
Dosage:
4 milligram(s)
Pharmaceutical form:
Tablet
Prescription type:
Product not subject to medical prescription
Therapeutic area:
Substituted alkylamines; chlorphenamine
Authorization status:
Marketed
Authorization date:
1985-06-10
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR USER
PIRITON ALLERGY 4MG TABLETS
Chlorphenamine Maleate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription, but you still need to
use Piriton tablets carefully to get
the best results from them. Always use this medicine exactly as
described in this leaflet or as your
pharmacist 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. 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.
•
If you have any questions, or if there is anything you do not
understand, ask your pharmacist.
IN THIS LEAFLET:
1. What Piriton tablets do and what they are used for
2. What you need to know before you take Piriton tablets
3. How to take Piriton tablets
4. Possible side effects
5. How to store Piriton tablets
6. Contents of the pack and other information
1.
WHAT PIRITON TABLETS DO AND WHAT THEY ARE USED FOR
PIRITON TABLETS ARE USED TO TREAT THE ALLERGIC SYMPTOMS OF HAY FEVER
AND OTHER ALLERGIES. The active
ingredient is chlorphenamine maleate, an antihistamine which can help
to relieve the symptoms of
some allergies and itchy skin rashes. They can be used to treat the
itchiness, redness, swelling,
tenderness and irritation that can be caused by:
•
hay fever and other allergies e.g. pet, house dust mite and mould
spore allergies
•
nettle rash and hives
•
skin allergies
•
reactions to food, food additives or medicines
•
insect bites and stings
•
chickenpox
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PIRITON TABLETS
DO NOT TAKE PIRITON TABLETS:
•
IF YOU HAVE EVER HAD AN ALLERGIC REACTION to chlorphenamine, any other
antihistamines or any of
the other ingredients (listed in Section 6).
•
if you are taking or have taken in
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
04 January 2024
CRN00DY6J
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Piriton Allergy 4mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4mg Chlorphenamine maleate.
Excipients: contains lactose monohydrate 94.5mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Yellow, circular, biconvex tablets with a breakline on both sides.
They are engraved with a “P” to one side of the breakline, on
one face.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The tablets are indicated for symptomatic control of allergic
conditions responsive to antihistamines, including hay fever,
vasomotor rhinitis, urticaria, food allergy, drug and serum reactions,
insect bites. Also indicated for the symptomatic relief of
itch associated with chickenpox.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral use.
ADULTS AND CHILDREN 12 YEARS AND OVER:
The usual dose is 1 tablet every 4 - 6 hours (maximum of 6 tablets in
24 hours).
IN THE ELDERLY:
The usual dose is 1 tablet every 4 - 6 hours (maximum of 3 tablets in
24 hours).
Dosage should be as low as possible in view of greater susceptibility
to anticholinergic central nervous system effects with a
maximum of 12mg (3 tablets) in 24 hours.
CHILDREN 6 - 12 YEARS:
The usual dose is 0.1mg/kg or ½ a tablet every 4 - 6 hours (maximum
of 6 half tablets in 24 hours).
CHILDREN UNDER 6 YEARS:
Not recommended for children under the age of 6 years.
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.
Patients with severe renal or hepatic impairment should seek
doctor’s advice prior to taking this medicine. (See Section 4.4
Special warnings and precautions for use).
4.3 CONTRAINDICATIONS
1. Use in patients hypersensitive to the active ingredient or any
other constituents.
2. Pre-coma states.
3. Use in patients who have been
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