PIRITON SYRUP

Active substance: CHLORPHENAMINE MALEATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Piriton 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
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. The minimum interval
between the doses should be 4 hours. Maximum daily dose: 5ml (2mg) in any 24
hours.
Not recommended for children below 1 year

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 or asthma; hepatic impairment. Children
and the elderly are more likely to experience the neurological anticholinergic
effects and paradoxical excitation (eg. Increased energy, restlessness,
nervousness).
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.
Piriton syrup contains 6.3% v/v ethanol. 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 Medicaments and other forms of Interaction
Concurrent use of chlorphenamine and hypnotics or anxiolytics may cause an
increase in sedative effects, 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

Pregnancy and Lactation
Pregnancy
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.
Lactation
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
Specific estimation of the frequency of adverse events for OTC products is
inherently difficult (particularly numerator data). Adverse reactions which have

been observed in clinical trails and which are considered to be common
(occurring in ≥1% to <10% of subjects) or very common (occurring in ≥10% of
subjects) are listed below by MedDRA System Organ Class. The frequency of
other adverse events identified during post-marketing use is unknown.
Blood and lymphatic system disorders:
Unknown: haemolytic anaemia, blood dyscrasias
Immune system disorders:
Unknown: allergic reaction, angioedema, anaphylactic reactions
Metabolism and nutritional disorders:
Unknown: anorexia
Psychiatric disorders:
Unknown: confusion*, excitation*, irritability*, nightmares*, depression
Nervous system disorders*:
Very common: sedation, somnolence
Common: disturbance in attention, abnormal coordination, dizziness, headache
Eye disorders:
Common: blurred vision
Ear and labyrinth disorders:
Unknown: tinnitus
Cardiac disorders:
Unknown: palpitations, tachycardia, arrythmias
Vascular disorders:
Unknown: Hypotension
Respiratory, thoracic and Mediastinal disorders:
Unknown: thickening of bronchial secretions

Gastrointestinal disorders:
Common: nausea, dry mouth

Unknown: vomiting, abdominal pain, diarrhoea, dyspepsia
Hepatobiliary disorders:
Unknown: hepatitis including jaundice
Skin and subcutaneous disorders:
Unknown: exfoliative dermatitis, rash, urticaria, photosensitivity,
Musculoskeletal and connective tissue disorders:
Unknown: muscular twitching, muscle weakness.
Renal and Urinary disorders:
Unknown: Urinary retention
General disorders and administration site conditions:
Common: fatigue
Unknown: chest tightness
*Children and the elderly are more susceptible to neurological anticholinergic
effects and paradoxical excitation (eg increased energy, restlessness,
nervousness)

4.9

Overdose
Symptoms 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.

Treatment
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
Syrup
Glycerol
Ethanol
Tingle flavour
Peppermint oil
Nipasept

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

Instruction for use, handling and disposal
For detailed instructions for use refer to the Patient Information Leaflet in
every pack.

7

MARKETING AUTHORISATION HOLDER
Stafford Miller Limited
980 Great West Road
Brentford
Middlesex
TW8 9GS
UNITED KINGDOM

Trading as: GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS,
UK.

8.

MARKETING AUTHORISATION NUMBER
PL 00036/0088

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
27/10/2005

10

DATE OF REVISION OF THE TEXT
24/05/2010

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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