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

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: ½ tablet 4 to 6 hourly. Maximum daily dose: 3 tablets (12mg) in any 24 hours

 

Not recommended for children under 6 years.

Zistan 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 inhibitors (MAOIs). Zistan Tablets is therefore contra-indicated in patients who have been treated with MAOIs within the last fourteen days.

§ Chlorphenamine, in common with other drugs having anticholinergic effects, should be used with caution in 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 (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 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 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

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, which can seriously hamper the patients' 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 Sytem 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 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: palpitations, tachycardia, arrhythmias

 

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, urticaria, 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)

 

To report any side effect(s):

·   Saudi Arabia:

The National Pharmacovigilance and Drug Safety Centre (NPC) § Fax: +966-11-205-7662 § Call NPC at: +966-11-2038222, Ext.: 2317-2356-2353-2354-2334-2340. § Toll free phone: 8002490000 § E-mail: npc.drug@sfda.gov.sa § Website: www.sfda.gov.sa/npc

Symptoms and signs

The estimated lethal dose of chlorphenamine is 25 to 50 mg/kg body weight. Symptoms and signs include sedation, paradoxical excitation of the CNS, toxic psychosis, convulsions, apnoea, 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 i.v. diazepam. Haemoperfusion may be used in severe cases.

ATC Code: R06AB02

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.

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 be 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

No additional data of relevance.

Lactose monohydrate

Maize starch

Povidone K-25

Aerosil 200

Talc powder

Magnesium stearate

None reported.

5 years from the manufacturing date. The expiry date refers to the last day of the month.

§ Keep in a safe place, out of the reach and sight of children.

§ Store below 30º C

Zistan Tablets are available in PVC blisters & supplied in a carton of 20 tablets.

No special requirements.