Source: Marketing Authorisation Holder Revision Year: 2021 Publisher: Manufacturer tablets: UCB Farchim S.A., Z.I. de Planchy, 10 Chemin de Croix Blanche, CH-1630 Bulle, Switzerland Packager: Aesica Pharmaceuticals S.r.l., Via Praglia 15, I 10044 Pianezza, Italy
Zyrtec-D is indicated for the treatment of symptoms associated with seasonal and perennial allergic rhinitis with nasal congestion, and hypersecretion, nose and/or eye itching and watery eyes.
It should be administered when both the anti-allergic properties of cetirizine dihydrochloride and the nasal decongestant activity of pseudoephedrine hydrochloride are desired.
The tablet should be swallowed whole with some liquid, and must not be broken, chewed or crushed. It may be taken with or without food.
After consultation with the doctor, duration of treatment should not exceed the period of acute symptoms, and should not exceed 2 to 3 weeks. After improvement of nasal symptoms, treatment should be continued only with cetirizine, where appropriate.
For oral use.
One tablet twice daily (morning and evening).
Zyrtec-D is contraindicated in children under 12 years of age (see Sections Contraindications; Warnings and Precautions).
Zyrtec-D should be used with caution in patients over 50 years of age. The dose should be reduced to one tablet daily for patients ≥77 years old.
The dose should be reduced to one tablet daily in patients with mild to moderate renal insufficiency. Zyrtec-D is contraindicated in severe renal insufficiency (see Section Contraindications).
The dose should be reduced to one tablet daily in patients with mild to moderate hepatic insufficiency.
Symptoms observed after an overdose of cetirizine are mainly associated with CNS effects or with effects that could suggest an anti-cholinergic effect.
In large doses, sympathomimetics may induce a toxic psychosis with delusions and hallucinations. Some patients may develop cardiac arrhythmias, circulatory collapse, convulsions, coma, and respiratory failure, which can be fatal.
Acute overdosage with Zyrtec-D may cause vomiting, diarrhoea, dizziness, fatigue, headache, malaise, mydriasis, urinary retention, tachycardia, cardiac arrhythmia, arterial hypertension, signs of CNS depression (sedation, apnoea, unconsciousness, cyanosis and cardiovascular collapse) or stimulation (insomnia, hallucinations, tremor, seizures) which could be fatal.
Treatment, preferably in hospital, should be symptomatic and supportive. Consideration should be given to the possible concomitant ingestion of other drugs.
No antidote is known. Sympathomimetic amines should not be used. Hypertension and tachycardia can be controlled with use of alpha-blockers and/or beta-blockers. Epileptic seizures can be treated with diazepam intravenously (or by the rectal route in children).
Cetirizine and pseudoephedrine are poorly eliminated by haemodialysis.
Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
As registered locally.
Store in original packaging, below 30°C in a dry place.
Keep out of the reach and sight of children.
Do not use after the expiry date stated on the carton box and blister.
The tablets are packed in PVC-Aclar Rx 160/Aluminium foil blisters or child resistant OPA/Alu/PVCAlu/Paper blisters placed in a cardboard box containing 10 and 50 tablets.
There are no special requirements for use or handling of this product.
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