PIRITON CHILDRENS ALLERGY SYRUP, PIRITON SYRUP - summary of medicine characteristics

Piriton Syrup

Piriton Children’s Allergy Syrup

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

A colourless syrup containing 2mg of chiorphenamine maleate in 5ml

3 PHARMACEUTICAL FORM

Syrup

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Piriton Syrup is 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, insect bites.

Also indicated for the symptomatic relief of itch associated with chickenpox.

4.2 Posology and method of administration

Oral administration only

Do not exceed the stated dose or frequency of dosing

The minimum interval between the doses should be 4 hours.

Do not use continuously for more than two weeks without consulting a doctor.

Adults and children 12 years and over: 10ml (4mg) every 4 to 6 hourly. Maximum daily dose: 60ml (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: 5ml (2mg) every 4 to 6 hourly. Maximum daily dose: 30ml (12mg) in any 24 hours.

Children aged 2 – 6 years: 2.5ml (1mg) every 4 to 6 hourly. Maximum daily dose: 15ml (6mg) in any 24 hours.

Children aged 1 – 2 years: 2.5ml (1mg) twice daily. Maximum daily dose: 5ml (2mg) in any 24 hours.

Not recommended for children below 1 year

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).

4.3 Contraindications

Piriton Syrup is contra-indicated in patients who are hypersensitive to antihistamines or to any of the syrup ingredients.

The anticholinergic properties of chlorphenamine are intensified by monoamine oxidase inhibitors (MAOIs). Piriton Syrup is therefore contraindicated in patients who have been treated with MAOIs within the last fourteen days.

4.4 Special warnings and precautions for use

Chlorphenamine, in common with other drugs having anticholinergic effects, should be used with caution in epilepsy; raised intra-ocular pressure including glaucoma; prostatic hypertrophy; severe hypertension or cardiovascular disease; bronchitis, bronchiectasis and asthma; hepatic impairment; renal impairment. Children and the elderly are more likely to experience the neurological anticholinergic effects and paradoxical excitation (eg. Increased energy, restlessness, nervousness). Avoid use in elderly patients with confusion.

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 therefore concurrent use should be avoided.

Should not be used with other antihistamine containing products, including antihistamine containing cough and cold medicines.

Concurrent use with drugs which cause sedation such as anxiolytics and hypnotics may cause an increase in sedative effects, therefore medical advice should be sought before taking chlorphenamine concurrently with these medicines.

Piriton syrup contains 6.3% v/v ethanol (alcohol), i.e., up to 497 mg per 10 ml (4 mg), equivalent to 12.6 ml beer, 5.3 ml wine per dose. This should be taken into consideration as it is harmful for those suffering from alcoholism. To be taken into account in pregnant and breast feeding women, children and high risk groups such as patients with liver disease or epilepsy.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.

Piriton Syrup contains 2.36 g of sucrose per 5 ml. This should be taken into account in patients with diabetes mellitus.

Long term use increases the risk of dental caries and it is essential that adequate dental hygiene is maintained.

Methyl, ethyl and propyl hydroxybenzoates (E218, E214 and E216) may cause allergic reactions (possibly delayed).

Keep out of the reach and sight of children.

4.5 Interaction with other medicinal products and other forms of interaction Concurrent use of chlorphenamine and hypnotics or anxiolytics may cause an increase in sedative effects, concurrent use of alcohol may have a similar effect therefore medical advice should be sought before taking chlorphenamine concurrently with these medicines.

Chlorphenamine inhibits phenytoin metabolism and can lead to phenytoin toxicity.

The anticholinergic effects of chlorphenamine are intensified by MAOIs (see Contra-indications).

4.6 Fertility, Pregnancy and lactationPregnancy

There are no adequate data from the use of chlorphenamine in pregnant women. The potential risk for humans is unknown, Use during the third trimester may result in reactions in the newborn or premature neonates. Not to be used during pregnancy unless considered essential by a physician.

Chlorphenamine maleate and other antihistamines may inhibit lactation and may be secreted in breast milk. Not to be used during lactation unless considered essential by a physician.

4.7 Effects on ability to drive and use machines

The anticholinergic properties of chiorphenamine may cause drowsiness, dizziness, blurred vision and psychomotor impairment, which can seriously hamper the patients’ ability to drive and use machinery.

4.8 Undesirable effects

The following convention has been utilised for the classification of the frequency of adverse reactions: very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1000 to <1/100), rare (>1/10,000 to <1/1000) and very rare (<1/10,000), not known (cannot be estimated from available data).

Adverse reactions identified during post-marketing use with chlorphenamine are listed below. As these reactions are reported voluntarily from a population of uncertain size, the frequency of some reactions is unknown but likely to be rare or very rare:

*Children and the elderly are more susceptible to neurological anticholinergic effects and paradoxical excitation (eg increased energy, restlessness, nervousness)

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 OverdoseSymptoms and signs

The estimated lethal dose of chlorphenamine is 25 to 50mg/kg body weight. Symptoms and signs include sedation, paradoxical excitation of the CNS, toxic psychosis, convulsions, apnoea, anticholinergic effects, dystonic reactions and cardiovascular collapse including arrhythmias.

Management should be as clinically indicated or as recommended by the national poisons centres where available. Symptomatic and supportive measures should be provided with special attention to cardiac, respiratory, renal and hepatic functions and fluid and electrolyte balance. If overdosage is by the oral route, treatment with activated charcoal should be considered provided there are no contraindications for use and the overdose has been taken recently (treatment is most effective if given within an hour of ingestion). Treat hypotension and arrhythmias vigorously. CNS convulsions may be treated with i.v. diazepam. Haemoperfusion may be used in severe cases.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

ATC Code R06AB02

Chlorphenamine is a potent antihistamine (H1-antagonist).

Antihistamines diminish or abolish the actions of histamine in the body by competative reversible blockade of histamine H1-receptor sites on tissues. Chlorphenamine also has anticholinergic activity.

Antihistamines act to prevent the release of histamine, prostaglandins and leukotrines and have been shown to prevent the migration of inflammatory mediators. The actions of chlorphenmine include inhibition of histamine on smooth muscle, cappillary permeability and hence reduction of oedema and wheal in hypersensitivity reactions such as allergy and anaphylaxis.

5.2 Pharmacokinetic properties

Chlorphenamine is well absorbed from the gastro-intestinal tract, following oral administration. The effects develop within 30 minutes, are maximal within I to 2 hours and last 4 to 6 hours. The plasma half-life has been estimated to be 12 to 15 hours.

Chlorphenamine is metabolised to the monodesmethyl and didesmethyl derivatives. About 22% of an oral dose is excreted unchanged in the urine.

5.3 Preclinical safety data

No additional data of relevance.

6 PHARMACEUTICAL PARTICULARS

6.1 List of Excipients

Sucrose, liquid

Glycerol

Ethanol

Tingle Flavour

Peppermint oil

Mixture of methyl, ethyl and propyl hydroxybenzoates (E 218, E 214, E 216) Purified Water

6.2 Incompatibilities

None known

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Store below 25°C. Protect from light

6.5 Nature and contents of container

Amber glass bottle containing 150ml Piriton Syrup. Supplied with a measuring spoon or

Amber plastic bottle containing 150ml Piriton Syrup. Supplied with a measuring spoon

6.6 Special precautions for disposal

For detailed instructions for use refer to the Patient Information Leaflet in every pack.

7 MARKETING AUTHORISATION HOLDER

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, 980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 44673/0094

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION

14/02/1997 / 27/10/2005