RHINETON Tablet Ref.[51191] Active ingredients: Chlorphenamine

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2023  Publisher: RANBAXY PHARMACEUTICALS (PTY) LTD., 14 LAUTRE ROAD, STORMILL EXT.1, ROODEPOORT 1724, SOUTH AFRICA

4.1. Therapeutic indications

RHINETON is indicated for symptomatic treatment of perennial and seasonal allergic rhinitis, vasomotor rhinitis, allergic conjunctivitis and mild, uncomplicated allergic skin manifestations of urticaria and angioedema. RHINETON is also indicated as therapy for anaphylactic reactions adjunctive to adrenaline and other standard measures after the acute manifestations have been controlled. Skin conditions such as allergic eczema, atopic dermatitis, insect bites and drug reactions are often relieved by RHINETON.

4.2. Posology and method of administration

Posology

Adults and children 12 years or older

One 4 mg RHINETON tablet every 4 to 6 hours, up to a maximum of 24 mg in 24 hours.

Children 6 to 12 years

2 mg (Half a RHINETON tablet) every 4 to 6 hours, up to a maximum of 12 mg in 24 hours.

Children up to 6 years

Use is not recommended.

4.9. Overdose

Symptoms include drowsiness or paradoxical excitement, ataxia, tremors, athetosis, hallucinations and convulsions; hyperpyrexia may also occur. Fixed dilated pupils with a flushed face, sinus tachycardia, dyspnoea, urinary retention, dry mouth and fever. Terminally there may be deepening coma and cardiorespiratory collapse.

Central excitatory effects constitute the greatest danger, particularly in children who are more likely to exhibit central nervous system stimulation. Adults more frequently exhibit central nervous system depression and the aged are particularly prone to experience hypotension.

Treatment

In the event of overdosage, emergency treatment should be started immediately. The stomach should be emptied by emesis. There is no specific antidote and treatment is symptomatic and supportive. Stimulants (analeptic agents) should not be used.

Hyperpyrexia, especially in children, may require treatment with tepid water, sponge baths or hypothermic blanket.

6.3. Shelf life

24 months.

6.4. Special precautions for storage

Store below 25°C. Protect from light.

6.5. Nature and contents of container

Containers of 30, 100 and 1000 tablets.

Patient ready packs of different pack sizes.

6.6. Special precautions for disposal and other handling

No special requirements for disposal.

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