COMPOSITION

Each f/c tablet contains : Cetirizine hydrochloride 10 mg.

Each 5 ml (teaspoonful) contains : Cetirizine hydrochloride 5 mg.

Each 1 ml (oral drops) contains : Cetirizine hydrochloride 10 mg.

DESCRIPTION :

Zertan contains (Cetirizine hydrochloride) which is an antihistamine (H1 receptor) devoid of any anticholinergic or antiserotonin

effects and it doesn’t induce neither sedation nor behavioral changes at the pharmacological active doses. This may be explained

by the fact that Cetirizine does not cross the blood brain barrier. Cetirizine also inhibits the histamine-mediated “early” phases of

the cutaneous allergic reactions. Also Cetirizine markedly reduces bronchial hyperreactivity to histamine in the asthmatic patients.

It also reduces the allergic reactions induced by specific allergens. Peak blood levels are reached within one hour after oral

administration of Cetirizine. The plasma half life is approximately 10 hours in adults, 6 hours in children aged 6 to 12 years and 5

hours in children aged 2 to 6 years. Cetirizine is strongly bound to plasma proteins and the plasma levels are linear with dose given.

The cumulative urinary excretion represents about two third of the dose given.

INDICATIONS :

Zertan is indicated for :

- Symptomatic treatment of seasonal rhinitis and conjunctivitis as well as perennial allergic rhinitis such as sneezing, runny nose,

itchy nose, red, itchy or watery eye.

- Treatment of pruritis and urticaria of allergic origin.

DOSAGE & ADMINISTRATION :

- Adults and children over 6 years : In most cases, the recommended dose is 10mg ( one tablet or 10 ml syrup ) once daily, it is

recommended to take the drug during evening meal. In patients affected by side effects, the dose may be taken as 5 mg (half tablet

or 5 ml syrup) in the morning and in the evening.

- Children from 2 - 6 years : The recommended dose is 5 mg (5 ml syrup or 0.5 ml oral drops) once daily or 2.5 mg ( 2.5 ml syrup

or 0.25 ml oral drops ) in the morning and in the evening.

- Children from 1 year - 2 years : The recommended dose is 2.5 mg ( 2.5 ml syrup or 0.25 ml oral drops) once daily. The dose can

be increased maximum to 2.5 mg ( 2.5 ml syrup or 0.25 ml oral drops) twice daily ( every 12 hours ).

* In patients with hepatic or renal impairment : Reduction of dosage of Cetirizine is recommended to half the usual daily dose.

RESTRICTIONS ON USE :

Contraindications

Hypersensitivity to Cetirizine hydrochloride.

Effect on the capacity to drive vehicles or use machines

Studies of administration of 20 - 25 mg per day of Cetirizine, have not revealed any effects on alertness, but in rare cases a dose of

10 mg can reduce alertness in the patients.

Use in pregnancy (category B) and lactation

There are no well-adequate studies on pregnant woman. As a precaution Zertan should not be administered during first three months

of pregnancy. Zertan pass through breast milk, so it is not recommended to be administered during lactation.

DRUG INTERACTIONS :

Caution is recommended if sedatives (CNS depressants) or alcohol or theophylline are also being taken with Cetirizine.

ADVERSE REACTIONS :

There are mild and transient side effects such as headache, drowsiness, dizziness, agitation, dry mouth, nausea, increase the

appetite and gastro-intestinal discomfort.

OVERDOSAGE :

Symptoms : Drowsiness can be symptom of administration of 50 mg as a single dose.

Treatment of overdosage : No specific antidote till now, but in case of massive overdosage, gastric lavage should be applied as a

primary treatment with regular monitor of all vital parameters.

STORAGE INSTRUCTIONS :

Tablets : Store below 30oC, in a dry place . Protect from light.

Syrup : Store below 30oC, in a tightly closed container . Protect from light.

Oral Drops : Store below 30oC, in a tightly closed container . Protect from light.

PRESENTATIONS :

Zertan Tablets : Pack of 20 tablets and hospital packs of different sizes.

Zertan Syrup : Bottle of 100 ml.

Zertan Oral Drops : Bottle of 20 ml