Chlorantin-M tablets – Chlorpheniramine maleate

Composition

Active ingredient: Chlorpheniramine maleate 4mg / Tablet.

Inactive ingredients: Lactose monohydrate, Maize starch, Talc, Magnesium stearate, Gelatin.

Pharmaceutical form: Oral Tablets.

Therapeutic indications

Chlorantin-M tablets are indicated for symptomatic control of all allergic conditions responsive to antihistamines, including hay fever, vasomotor rhinitis, urticaria, angioneurotic oedema, food allergy, drug & serum reactions and insect bites. Also indicated for the symptomatic relief of itch associated with chickenpox.

Dose & administration

For Oral Administration only.

Do not exceed the stated dose or frequency of dosing.

Adults and children 12 years and over: 1 tablet 4 to 6 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 6 years.

Contraindications

Chlorantin-M tablets are contra-indicated in patients who are hypersensitive to antihistamines or to any of the tablet ingredients.

The anticholinergic properties of Chlorpheniramine are intensified by monoamine oxidase inhibitors (MAOIS). Chlorantin-M Tablets is therefore contraindicated in patients who have been treated with MAOIS within the last fourteen days.

Special warnings and precautions for use

Chlorpheniramine, in common with other drugs having anticholinergic effects, should be used with caution in epilepsy; raised intraocular pressure including glaucoma; prostatic hypertrophy; severe hypertension or cardiovascular disease; bronchitis, bronchiectasis or asthma; hepatic impairment.

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

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.

Interaction with other medicinal products and other forms of interaction

Concurrent use of Chlorpheniramine and hypnotics or anxiolytics may cause an increase in sedative effects; therefore medical advice should be sought before taking Chlorpheniramine concurrently with these medicines.

Chlorpheniramine inhibits phenytoin metabolism and can lead to phenytoin toxicity.

The anticholinergic effects of Chlorpheniramine are intensified by MAOIS (see Contra-indications).

Pregnancy and lactation

Pregnancy

There are no adequate data from the use of Chlorpheniramine maleate in pregnant women. The potentisl 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 essentially by a physician.

Lactation

Chlorpheniramine 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.

Effects on ability to drive and use machines

The anticholinergic properties of Chlorpheniramine may cause drowsiness, dizziness, blurred vision and psychomotor impairment, which can seriously hamper the patient’s ability to drive and use machinery.

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 greater than or equal to 1% to <10% of subjects) or very common (occurring in greater-than or equal to 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: haemolytic anaemia, blood dyscrasias.

Immune system disorders: Unknown: allergic reaction, angioedema, anaphylactic reactions.

Metabolism and nutritional disordrers: 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: palpitations, tachycardia, arrythmias.

Vascular disorders: Unknown: Hypotension.

Respiratory, thoracic and mediastinal disorders: Unknown: thickening of bronchial secretions.

Gastrointestinal disorders: Common: nausea, dry mouth. Unknown: vomiting, abdominal pain, diarrhoea, dyspepsia.

Hepatobiliary disorders: Unknown: hepatitis, including jaundice.

Skin and subcutaneous disorders: Unknown: exfoliative dermatitis, rash, urti- caria, photosensitivity.

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).

كلورانتين م أقراص فموية مضادة للحساسية – ٤ ميليجرام كلورفينيرامين ماليات

Chlorantin-M tablets produced by MISR PHARMACEUTICALS COMPANY, Cairo, Egypt. ATC code: R06AB04.