SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Chlorphenamine Elixir 2 mg/5 ml Lloydspharmacy Allergy Relief Syrup

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Each 5ml contains Chlorphenamine Maleate BP 2.0 mg.

For the full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Sugar free syrup in bottles of 150ml Colourless syrup

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the relief of symptoms caused by allergic conditions such as hayfever, allergic rhinitis, perennial rhinitis, vasomotor rhinitis, urticaria and skin rashes, angioneurotic oedema, drug and serum reactions, food allergy, insect bites etc, which are responsive to antihistamines. Indicated for the symptomatic relief of itch associated with chickenpox.

4.2    Posology and method of administration

Posology

Do not exceed the stated dose or the frequency of dosing.

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

Elderly: The elderly are more likely to experience neurological anticholinergic effects. A lower daily dose is recommended (e.g. a maximum of 12 mg in any 24 hours).

Children aged 6 - 12 years: 5 ml (2 mg) every 4 - 6 hourly. Maximum daily dose: 30 ml (12 mg) in 24 hours.

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

Children aged 1 - 2 years: 2.5 ml (1 mg) twice daily. The minimum interval between the doses should be 4 hours. Maximum daily dose: 5 ml (2 mg) in any 24 hours.

Not recommended for children below 1 year

Method of administration For oral administration.

4.3 Contraindications

Chlorphenamine is contraindicated in patients who are hypersensitive to antihistamines or any of the excipients in the syrup listed in section 6.1. Chlorphenamine is contraindicated in patients who have had treatment with monoamine Oxidase Inhibitors (MAOI’s) within the last 14 days as the anticholinergic properties of chlorphenamine are intensified by MAOI’s.

4.4 Special warnings and precautions for use

Chlorphenamine has an anticholinergic effects and should be used with caution in patients with epilepsy, raised intra-ocular pressure including glaucoma, prostatic hypertrophy, severe hypertension, cardiovascular disease, bronchitis, bronchiectasis, asthma, hepatic impairment. Children and the elderly patients are more likely to experience the neurological anticholinergic effects and paradoxical excitation (e.g. increased energy, restlessness, nervousness).

The effects of alcohol may be increased and therefore should be avoided. Chlorphenamine should not be used with other antihistamine containing products such as antihistamine containing cough and cold medicines.

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

4.5    Interaction with other medicinal products and other forms of interaction

Alcoholic drinks and certain other central nervous system depressants such as anxiolytics or hypnotics can potentiate the sedative effects of chlorphenamine.

Phenytoin metabolism is inhibited by chlorphenamine and this can cause phenytoin toxicity.

The anticholinergic effects of chlorphenamine are intensified by the use of other anticholinergic drugs such as atropine, tricyclic antidepressants and MAOI’s (see contraindications).

4.6    Pregnancy and lactation Pregnancy

There are no adequate data for the use of chlorphenamine in pregnant women, the potential risk in humans is unknown. Use during the third trimester may result in reactions in the newborn or premature neonates, therefore it should 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 into the breast milk. Should not to be used during lactation unless considered essential by a physician.

4.7 Effects on ability to drive and use machines

As with all antihistamines, dizziness, drowsiness, blurred vision and psychomotor impairment may occur. Extreme caution should be advised when driving or operating machinery.

4.8 Undesirable effects

Adverse reactions which have been observed in clinical trials 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 nutrition 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, arrhythmias

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 tissue 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 (e.g. 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 (www.mhra.gov.uk/yellowcard).

4.9 Overdose

Symptoms and signs

The estimated lethal dose of chlorphenamine is 25 - 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 and arrhythmias.

Treatment

Symptomatic and supportive measures giving special attention to cardiac, respiratory, renal and hepatic functions and fluid and electrolyte balance. If overdose occurs by the oral route treat with activated charcoal should be considered, provided there are no contraindications for use and the overdose has been taken recently (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 Hi - blocking drug. Antihistamines diminish or abolish the actions of histamine in the body by competitive reversible blockade of the histamine H₁-receptor sites in tissues. Chlorphenamine also has an 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 chlorphenamine include the inhibition of histamine on smooth muscle, capillary permeability and therefore reduction of oedema and wheal in hypersensitivity reactions such as allergy and anaphylaxis.

5.2    Pharmacokinetic properties

Chlorphenamine maleate is absorbed relatively slowly from the gastrointestinal tract and peak plasma concentrations occur between 2.5 and 6 hours after oral administration. It is reported that only 25 to 50% of an oral dose is absorbed as it appears that chlorphenamine undergoes considerable first pass metabolism. Metabolites include desmethyl- and didesmethylchlorphenamine. Chlorphenamine distributes widely in the body and penetrates into the CNS. In the circulation, about 70% of chlorphenamine is bound to plasma proteins.

Excretion of unchanged drug and metabolites is mainly via the urine and is dependent on urinary pH and flow rate. The elimination half-life is widely variable and has been reported to range from 2 to 43 hours. However, the duration of action is only 4-6 hours which is shorter than might be predicted.

It is reported that in children, absorption is faster and more extensive, and there is a quicker clearance with a shorter half-life.

5.3    Preclinical safety data

None provided

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Maltitol Solution USP Citric Acid Monohydrate Ph. Eur Sodium Citrate Ph. Eur Sodium Benzoate Ph. Eur Carmellose Sodium Ph. Eur Strawberry Flavour C9987 Purified Water Ph. Eur

6.2    Incompatibilities

None Stated

6.3    Shelf life

The shelf-life of this product is 36 months