Hayleve
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT
Hayleve
Chlorphenamine Maleate 4 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains chlorphenamine maleate 4 mg.
Excipient with known effect: also contains lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet. The tablet can be divided into equal doses. Biconvex pale yellow scored (*).Odourless.
(*) Score is in the form of a cross break-line.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
The tablets are indicated for symptomatic control of all allergic conditions responsive to antihistamines, including urticaria, hayfever, food allergy, drug and serum reactions, insect bites, vasomotor rhinitis and angioneurotic oedema.
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 over 12 years: 1 tablet four to six hourly Maximum daily dose: 6 tablets (24 mg) 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: 1/2 tablet 4 to 6 hourly. Maximum daily dose: 3 tablets (12 mg) in any 24 hours.
Not recommended for children under the age of 6 years.
4.3 Contraindications
The tablets are contra-indicated in patients who are hypersensitive to antihistamines or to any of the tablet ingredients.
The anticholinergic properties of chlorphenamine are intensified by monoamine oxidase inhibitor (MAOIs). The tablets are therefore contra-indicted in patients who have been treated with MAOIs within the last 14 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; hepatic impairment, renal impairment, bronchitis, bronchiectasis or asthma severe hypertension or cardiovascular disease. Children and the elderly are more likely to experience the neurological anticholinergic effects and paradoxical excitation (eg.Increased energy, restlessness, nervousness).
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.
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.
Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Keep out of sight and reach of children.
4.5 Interaction with other medicinal products 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 leading to phenytoin toxicity.
The anticholinergic effects of chlorphenamine are intensified by MAOIs (see Contraindications).
4.6 Fertility, pregnancy and lactation
Pregnancy
There are no adequate data from the use of chlorphenamine maleate in pregnant women. The potential risk for human 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
Use by nursing mothers is not recommended because of the risks of adverse effects in the infant. Chlorphenamine maleate and other antihistamine 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 chlorphenamine may causes drowsiness, dizziness, blurred vision and psychomotor impairment, which can seriously hamper the patient's 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 reaction identified during postmarketing 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: palpitation, tachycardia, arrhythmias Vascular disorders:
Unknown: Hypotension
Respiratory, thoracic and mediastinal disorders:
Unknown: thickening of bronchial secretions Gastrointestinal disorders:
Common: nausea, dry mouth
Unknown: vomiting, diarrhoea, abdominal pain, dyspepsia Hepatobiliary disorders:
Unknown: hepatitis, jaundice.
Skin and subcutaneous disorders:
Unknown: exfoliative dermatitis, rash, photosensitivity, urticaria Musculoskeletal and connective tissue disorders:
Unknown: muscle 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 likely to experience the neurological anticholinergic effects and paradoxical excitation (eg. Increased energy, restlessness, nervousness).
Reporting of suspected adverse reactions
Reporting suspected adverse reaction 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 at www.mhra.gov.uk/yellowcard.
4.9 Overdose
Symptoms and signs
The estimated lethal dose of chlorphenamine is 25 to 50 mg/kg bodyweight. Symptoms and signs include sedation, paradoxic stimulation of the CNS, toxic psychosis, apnoea, convulsions, 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 IV diazepam. Haemoperfusion may be used in severe cases.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
ATC Code R06AB04
Chlorphenamine is a potent antihistamine (H1-antagonist).
Antihistamines diminish or abolish the actions of histamine in the body by competitive reversible blockade of histamine H1-receptor sites on tissues. Chlorphenamine also has anticholinergic activity.
Antihistamines act to prevent the release of histamine, prostaglandins and leukotrienes and have been shown to prevent the migration of inflammatory mediators. The actions of chlorphenamine include inhibition of histamine on smooth muscle, capillary 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 1 to 2 hours and last 4 to 6 hours. The plasma half-life has been estimated to 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. Only traces amounts have been found in the faeces.
5.3 Preclinical safety data
No additional data of relevance.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lactose Maize Starch Povidone K25 Quinoline yellow E104 Magnesium Stearate Sodium Starch Glycollate
6.2 Incompatibilities
Chlorphenamine is incompatible with alkaline substances which precipitate Chlorphenamine Base.
6.3 Shelf life
Plastic containers: 36 months
Blister-packs: 36 months
6.4 Special precautions for storage
Keep containers well closed. Protect from light. Store below 25°C.
6.5 Nature and contents of container
High density polystyrene with polythene lids and/or polypropylene containers with polypropylene or polythene lids and polyurethane or polythene inserts.
Pack sizes: 100, 500 and 1,000.
PVC/Aluminium foil blister packs.
Pack sizes: 10, 28, 30 and 60.
6.6 Special precautions for disposal
No special instructions.
7 MARKETING AUTHORISATION HOLDER
Chelonia Healthcare Limited 11 Boumpoulinas Street,
3rd Floor, 1060 Nicosia Cyprus
8 MARKETING AUTHORISATION NUMBER(S)
PL 33414/0140
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
19 July 2000
10 DATE OF REVISION OF THE TEXT
08/08/2016