Source: Υπουργείο Υγείας (CY) Revision Year: 2022 Publisher: Remedica Ltd., Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus
(a) Properties
Fixed combination of anti-histamine with anti-tussive activity and carminative.
(b) Indications for use
In the symptomatic relief of non-productive cough and of allergic conditions and reactions.
One or two 5 ml spoonfuls three to four times daily.
Not recommended for children under 12 years (see section 4.3).
For oral use.
Mild to Moderate Symptoms: Drowsiness, anticholinergic syndrome (hyperpyrexia, mydriasis, flushing, fever, dry mouth, urinary retention, decreased bowel sounds) tachycardia, mild hypertension, nausea and vomiting are common after overdose.
Agitation, confusion and hallucinations may develop with moderate poisoning.
Severe Symptoms: Effects may include delirium, psychosis, seizures, coma, hypotension, QRS widening, and ventricular dysrhythmias (including torsades de pointes), but are generally only reported in adults after large ingestions. Rhabdomyolysis and renal failure may rarely develop in patients with prolonged agitation, coma or seizures. Death may occur as a result of respiratory failure or circulatory collapse. With higher doses, and particularly in children, symptoms of CNS excitation including insomnia, nervousness, tremors, and epileptiform convulsions may appear; with massive doses, coma or cardiovascular collapse may follow.
Excessive use of menthol may lead to abdominal pain, vomiting, flushed face, dizziness, weakness, tachycardia, stupor and ataxia.
Treatment of overdose should be symptomatic and supportive. The benefit of gastric decontamination is uncertain. Consider activated charcoal (charcoal dose: 25 – 100 g for adults; 0.5 to 1 g/kg for children) only if the patient presents within 1 hour of ingestions of a potentially toxic amount.
The intravenous use of physostigmine may be efficacious in antagonizing severe anticholinergic symptoms.
3 years.
Store below 25°C with cap replaced tightly. Protect from light.
Cardboard box containing one amber glass bottle (type III) closed with a plastic child resistant closure. One measuring spoon of 5 ml (graduated every 2.5 ml) is also supplied with the pack.
Pack size of 100 ml syrup.
No special requirements.
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