Allergy Relief Antihistamine Tablets
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Allergy Relief Antihistamine Tablets Sainsbury’s Allergy Relief Antihistamine Tablets Asda Allergy Relief Antihistamine Tablets Morrisons Allergy Relief Antihistamine Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient mg per tablet
Chlorphenamine Maleate 4.0
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pale yellow tablet with breakline.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the symptomatic control of allergic conditions responsive to antihistamines e.g. hayfever, vasomotor rhinitis, urticaria, pruritus, angioneurotic oedema, food allergies, drug and serum reactions, and insect bites.
4.2 Posology and method of administration
For oral use.
Adults, the elderly and children 12 years and over:
One tablet every 4 to 6 hours. Do not take more than 4 tablets in 24 hours.
Children from 6 - 12 years:
Half a tablet every 4 to 6 hours. Do not give more than 4 half tablets (maximum 2 tablets) in 24 hours.
Do not give to children under 6 years of age.
4.3 Contraindications
Hypersensitivity to chlorphenamine, other antihistamines, or to any of the other tablet ingredients.
Chlorphenamine should be avoided in severe liver disease due to the sedative effect.
The anticholinergic properties of chlorphenamine are intensified by monoamine oxidase inhibitors (MAOIs) (see section 4.5).
4.4. Special warnings and precautions for use
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.
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 disease and thyrotoxicosis.
Children and the elderly are more likely to experience the neurological anticholinergic effects.
The effects of alcohol may be increased.
Chlorphenamine should be used with caution in urinary retention and/or pyloroduodenal obstruction.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorbtion should not take this medicine.
4.5 Interaction with other medicinal products and other forms of interaction
The anticholinergic properties of chlorphenamine are intensified by monoamine oxidase inhibitors (MAOIs), therefore chlorphenamine tablets should not be taken by patients who have been treated with MAOIs within the last fourteen days.
Chlorphenamine inhibits phenytoin metabolism due to its anticholinergic properties and this can lead to phenytoin toxicity, therefore concurrent use of phenytoin with chlorphenamine should be avoided.
Use chlorphenamine with caution when taking hypnotics or anxiolytics concurrently as this combination may potentiate drowsiness. Concurrent use of alcohol may have a similar effect.
4.6 Pregnancy and lactation
There is inadequate evidence of safety in human pregnancy so chlorphenamine tablets should only be used during pregnancy when clearly needed and when the potential benefits outweigh the potential unknown risks to the foetus. Use during the third trimester may result in reactions in the newborn or premature neonates.
Chlorphenamine maleate may inhibit lactation and may be secreted in breast milk, therefore use by nursing mothers requires that the therapeutic benefits of the drug should be weighed against the potential hazards to the mother and baby.
4.7 Effects on ability to drive and use machines
The antichlolinergic properties of chlorphenamine may cause drowsiness, dizziness, blurred vision and psychomotor impairment. If affected, patients should not drive or operate machinery.
4.8 Undesirable effects
The following list of adverse effects relates to those experienced with chlorphenamine at OTC doses for short-term use. In the treatment of chronic conditions, under long-term treatment, additional adverse effects may occur.
Cardiac disorders
Palpitation, tachycardia, arrythmias, chest tightness.
Blood and lymphatic system disorders Haemolytic anaemia and other blood dyscrasias.
Nervous system disorders
Sedation varying from slight drowsiness to deep sleep, headaches, dizziness, inability to concentrate, incoordination, lassitude.
Eye disorders Blurred vision.
Ear and labyrinth disorders Tinnitus.
Respiratory, thoracic and mediastinal disorders Thickening of bronchial secretions.
Gastrointestinal disorders
Dry mouth, dyspepsia, nausea, vomiting, diarrhoea and abdominal pain.
Renal and urinary disorders Urinary retention.
Skin and subcutaneous tissue disorders
Allergic reactions including exfoliative dermatitis, urticaria, photosensitivity.
Musculoskeletal and connective tissue disorders Muscular weakness, twitching.
Metabolism and nutrition disorders Anorexia
Vascular disorders Hypotension
Immune system disorders Allergic reactions
Hepatobiliary disorders Hepatitis, including jaundice.
Psychatric disorders
Depression, nightmares, irritability, paradoxical excitation in children and confusional psychosis in the elderly.
Points to Note
Possibility of nitrosamine formation when taken with dietary nitrite.
Children and the elderly are more likely to experience the neurological anticholinergic effects.
4.9. Overdose
(a) Symptoms
Symptoms and signs include sedation, paradoxical stimulation of CNS, toxic psychosis, seizures, apnoea, convulsions, anticholinergic effects, dystonic reactions and cardiovascular collapse including arrythmias.
(b) Management
Symptomatic and supportive measures should be provided with special attention to cardiac, respiratory, renal and hepatic functions, and fluid and electrolyte balance.
Management also includes:
(i) Treatment with intravenous phenytoin for CNS convulsions;
(ii) Hypotension and arrythmias should be treated vigorously
(iii) Haemoperfusion may be used in severe cases.
(iv) Severe respiratory depression may necessitate the use of mechanical ventilation.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic Group: Antihistamines for systemic use - substituted alkylamines
ATC code: R06AB04
Chlorphenamine is a potent antihistamine (Hi-antagonist). It antagonises various histamine-induced effects such as increased capillary permeability and dilation, the formation of oedema and the constriction of gastrointestinal and respiratory smooth muscle. It has weak antimuscarinic and moderate antiserotonin and local anaesthetic actions. It can cause CNS stimulation or depression. It is an alkylamine derivative and probably achieves its effect by occupying receptor sites in effector cells.
5.2 Pharmacokinetic properties
The drug is readily and rapidly absorbed from the G.I. tract. The effects develop within 30 minutes, are maximal within 1 to 2 hours and 4 to 6 hours. There is significant plasma protein binding. 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.
The drug is largely inactivated in the liver and excreted as metabolites in the urine.
5.3. Pre-clinical Safety Data
There is no pre-clinical data of relevance to a prescriber which is additional to that already included in other sections of the SmPC.
6.1 List of excipients
Lactose BP Potato Starch BP Magnesium Stearate BP
Anstead Dispersed Yellow 19248 (15% Quinoline Yellow E104) 6.2. Incompatibilities
None stated.
6.3. Shelf-Life
3 years
6.4. Special Precautions for Storage
Store below 25°C in a dry place.
6.5. Nature and Contents of Container
Chlorphenamine Tablets are available in blister packs of 28, 30 and 60 tablets.
Specification details of blister packs :
PVC (white, rigid, opaque) : 250 microns
Aluminium foil (hard tempered) 20 microns
Primer (nitrocellulose) : 1.5 -2.5 gsm
Heat seal lacquer : 6.5 - 8.5 gsm
They are also available in Securitainers and Tampertainers in packs of 100, 500 & 1000 tablets and Pill Packs of 28 tablets. All three containers are made up of High Density Polypropylene body and Low Density Polyethylene cap.
6.6. Instructions for Use, Handling and Disposal
Chlorphenamine Tablets BP 4mg should be taken orally with a drink of water. Always read instructions on the label / carton and the Patient Information Leaflet (PIL) enclosed.
Keep all medicines out of the reach of children.
Do not use after the expiry date.
7. MARKETING AUTHORISATION HOLDER
Wrafton Laboratories Ltd
Wrafton
Braunton
NortH Devon
EX33 2DL
United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 12063/0050
9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
17 November 2003
10 DATE OF REVISION OF THE TEXT
06/11/2010