Chlorphenamine Elixir 2 mg/5 ml
Lloydspharmacy Allergy Relief Syrup
Each 5ml contains Chlorphenamine Maleate BP 2.0mg
For a full list of excipients, see section 6.1.
Sugar free syrup in bottles of 150ml
Colourless syrup
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
For oral administration
Do not exceed the stated dose or the frequency of dosing
Adults and children 12 years and over: 10ml (4mg) every 4 - 6 hourly. Maximum daily dose: 60ml (24mg) 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: 5ml (2mg) every 4 - 6 hourly. Maximum daily dose: 30ml (12mg) in 24 hours.
Children aged 2 - 6 years: 2.5ml (1mg) every 4 - 6 hourly. Maximum daily dose: 15ml (6mg) in 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
Chlorphenamine is contraindicated in patients who are hypersensitive to antihistamines or any other ingredients in the syrup.
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.
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.
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).
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.
As with all antihistamines, dizziness, drowsiness, blurred vision and psychomotor impairment may occur. Extreme caution should be advised when driving or operating machinery.
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 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, 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 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)
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.
ATC Code R06AB02
Chlorphenamine is a potent H1 - 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 chlorphenmine 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.
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.
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
The shelf-life of this product is 36 months
Store below 25°C. Protected from light
Amber glass or PET bottles with HDPE, EPE wadded, tamper evident child resistant closure.
Sandoz Ltd
Frimley Business Park,
Frimley,
Camberley,
Surrey,
GU16 7SR.
United Kingdom
