HAYLEVE, CHLORPHENAMINE MALEATE 4 MG TABLETS - summary of medicine 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 post- marketing use is unknown.

Blood and lymphatic system disorders:

Unknown:   haemolytic anaemia, blood

dyscrasias

Unknown: allergic reaction, angioedema, anaphylactic reactions

Unknown: anorexia

Unknown: confusion*, excitation*, irritability*, nightmares , depression

Nervous system disorders:

Very Common: sedation, somnolence

Common: disturbance in attention, abnormal coordination, dizziness headache

Common: blurred vision

Unknown: tinnitus

Unknown: palpitation, tachycardia, arrhythmias

Unknown: Hypotension

Respiratory, thoracic and mediastinal

disorders: Unknown: thickening of bronchial

Common: nausea, dry mouth

Unknown: vomiting, diarrhoea, abdominal pain, dyspepsia

Unknown: hepatitis, jaundice.

Unknown: exfoliative dermatitis, rash, photosensitivity, urticaria Musculoskeletal and connective tissue

Unknown: muscle twitching, muscle weakness

Unknown: urinary retention

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

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:               48 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

Hualan Pharmaceuticals Limited

16/17 College Green

Dublin

D02 V078

Ireland

8 MARKETING AUTHORISATION NUMBER(S)

PL 52104/0017

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

19 July 2000