1. Name Of The Medicinal Product
Chlorphenamine Elixir BP
Rhino-Syrup Allergy
Pollenase Allergy Syrup
Lloyds Pharmacy Allergy Relief Syrup
2. Qualitative And Quantitative Composition
Each 5ml contains Chlorphenamine Maleate BP 2.0mg
3. Pharmaceutical Form
Sugar free syrup in bottles of 150ml
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.
4.2 Posology And Method Of Administration
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4.3 Contraindications
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.
4.4 Special Warnings And Precautions For Use
Chlorphenamine produces anticholinergic effects such as drowsiness, dizziness, blurred vision and psychomotor impairment. This may cause serious problems when the patient is driving or using machinery.
Due to the anticholinergic effect of the drug caution is advised in patients who have epilepsy, raised intra-ocular pressure including glaucoma, prostatic hypertrophy, severe hypertension or cardiovascular disease, bronchitis, bronchiectasis and asthma, hepatic disease and thyrotoxicosis. The neurological anticholinergic effects are more likely in the elderly and children.
The effects of alcohol are likely to be increased.
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
Safety in pregnancy has not been established. The use of chlorphenamine in pregnancy should be assessed and only used when the possible benefits outweigh the possible risks to the foetus. Effects on the neonate have been seen when chlorphenamine is used in the third trimester of pregnancy.
There may be some inhibition of lactation by chlorphenamine and some of the drug may be secreted into the breast milk. Therefore the risk to the mother and child should be assessed against the possible benefits of using chlorphenamine when breast feeding.
4.7 Effects On Ability To Drive And Use Machines
As with all antihistamines, dizziness and drowsiness may occur. Extreme caution should be advised when driving or operating machinery.
4.8 Undesirable Effects
Undesirable effects include sedation, which varies from slight drowsiness to deep sleep.
There have been occasional reports of the following: lassitude, inability to concentrate, blurred vision, hepatitis including jaundice, urinary retention, headaches, dry mouth, dizziness, palpitations, tachycardia, arrhythmias, hypotension, chest tightness, thickening of the bronchial secretions, haemolytic anaemia and other blood dyscrasias, tinnitus, depression, irritability, nightmares, twitching, muscular weakness and incoordination.
Gastrointestinal disturbances have been reported occasionally including, nausea, vomiting, diarrhoea, dyspepsia, abdominal pain and anorexia.
Allergic reactions have been observed and include exfoliative dermatitis, photosensitivity and urticaria.
Paradoxical excitation in children and confusional psychosis in the elderly can occur.
4.9 Overdose
The estimated lethal dose of Chlorphenamine Maleate is 25-50mg per kg bodyweight. Symptoms of overdose include sedation, paradoxical stimulation of the CNS, toxic psychosis, seizures, apnoea, convulsions, anticholinergic effects, dystonic reactions and cardiovascular collapse including arrhythmias.
Treatment should include gastric lavage for massive overdosage or induced emesis using syrup of Ipecacuanha. Following this activated charcoal and cathartics may be administered to minimise absorption.
Symptomatic and supportive measures should be given, with particular attention paid to the cardiac, respiratory, renal and hepatic functions and fluid and electrolyte balance. Hypotension and arrhythmias should be treated vigorously. If convulsions occur sedate with intramuscular paraldehyde, or i.v. diazepam or phenytoin Haemoperfusion may be used in severe cases.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Chlorphenamine is a potent H1– blocking drug. It antagonises the pharmacological actions of histamine released by antigen-antibody reaction in allergic diseases, thus providing symptomatic relief.
Chlorphenamine alone is less effective when pollen counts are high, allergen exposure is prolonged and nasal congestion has become prominent.
5.2 Pharmacokinetic Properties
Chlorphenamine Elixir is an immediate release liquid containing the well established active ingredient Chlorphenamine Maleate.
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
6.4 Special Precautions For Storage
Store below 25°C. Protected from light
6.5 Nature And Contents Of Container
Amber glass or PET bottles with HDPE, EPE wadded, tamper evident child resistant closure.
6.6 Special Precautions For Disposal And Other Handling
None Stated
ADMINISTRATIVE DATA
7. Marketing Authorisation Holder
Sandoz Ltd
Woolmer Way
Bordon
Hampshire GU35 9QE
United Kingdom
8. Marketing Authorisation Number(S)
PL 4416/0368
9. Date Of First Authorisation/Renewal Of The Authorisation
7th March 2000
10. Date Of Revision Of The Text
July 2004
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