COLDKRIS Capsule Ref.[115642] Active ingredients: Chlorphenamine

In common with other drugs having anticholinergic effects, chlorphenamine should be used with caution in conditions such as epilepsy, raised intra-ocular pressure including glaucoma, prostatic hypertrophy, severe hypertension or cardiovascular disease, bronchitis, bronchiectasis or asthma, hepatic impairment, renal impairment.

Children and the elderly are more likely to experience the neurological anticholinergic effects and paradoxical excitation (e.g 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.

Excipients

Contains lactose. Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Keep out of the 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 and can lead to phenytoin toxicity.

The anticholinergic effects of chlorphenamine are intensified by MAOIs (see Contra-indications).

Pregnancy

There are no adequate data from the use of chlorphenamine maleate in pregnant women. The potential risk for humans 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

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 cause drowsiness, dizziness, blurred vision and psychomotor impairment in some patients which may seriously affect 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 trials 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 reactions identified during post-marketing use is unknown.

Blood and lymphatic system disorders

Unknown: Blood dyscrasias including haemolytic anaemia

Immune system disorders

Unknown: Hypersensitivity, angioedema, anaphylactic reactions

Metabolism and nutrition disorders

Unknown: Anorexia

Psychiatric disorders

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

Nervous system disorders*

Very common: sedation, somnolence

Common: disturbance in attention, headache, dizziness, abnormal co-ordination,

Eye disorders

Common: Blurred vision

Ear and labyrinth disorders

Unknown: Tinnitus

Cardiac disorders

Unknown: Tachycardia, palpitations, cardiac arrhythmias

Vascular disorders

Unknown: Hypotension

Respiratory, thoracic or mediastinal disorders

Unknown: thickening of bronchial secretions

Gastrointestinal disorders

Common: Nausea, Dry mouth,

Unknown: dyspepsia, vomiting, diarrhoea, abdominal pain

Hepatobiliary disorders

Unknown: Hepatitis, jaundice

Skin and subcutaneous disorders

Unknown: Skin rash, urticaria, exfoliative dermatitis, photosensitivity

Musculoskeletal and connective tissue disorders

Unknown: Muscle twitching, muscular weakness

Renal and urinary disorders

Unknown: Urinary retention

General disorders

Common: Fatigue

Unknown: Chest tightness

^* Children and the elderly are more likely to experience neurological anticholinergic effects and paradoxical excitation (e.g. increased energy, restlessness, nervousness).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

NA.