HAYLEVE Tablet Ref.[49960] Active ingredients: Chlorphenamine

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.

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).

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.

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.

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

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

Chlorphenamine is incompatible with alkaline substances which precipitate Chlorphenamine Base.