📌 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 does not induce sedation or behavioural changes at pharmacologically 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 cutaneous allergic reactions. Cetirizine also markedly reduces bronchial hyperreactivity to histamine in asthmatic patients. It also reduces 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 2-6 years. Cetirizine is strongly bound to plasma proteins, and plasma levels are linear with the dose given. Cumulative urinary excretion represents about two‑thirds of the dose given.

📌 INDICATIONS

• Symptomatic treatment of seasonal rhinitis and conjunctivitis, as well as perennial allergic rhinitis, such as sneezing, runny nose, itchy nose, red, itchy or watery eyes.
• Treatment of pruritus and urticaria of allergic origin.

📌 DOSAGE & ADMINISTRATION

• Adults and children over 6 years: In most cases, the recommended dose is 10 mg (one tablet or 10 ml syrup) once daily. It is recommended to take the drug during the evening meal. In patients affected by side effects, the dose may be taken as 5 mg (half a 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 1-2 years: The recommended dose is 2.5 mg (2.5 ml syrup or 0.25 ml oral drops) once daily. The dose may be increased to a maximum of 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, a reduction of the dosage of Cetirizine to half the usual daily dose is recommended.

📌 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 patients.

Use in Pregnancy (Category B) and Lactation

There are no well‑adequate studies on pregnant women. As a precaution, Zertan should not be administered during the first three months of pregnancy. Zertan passes into breast milk, so it is not recommended to be administered during lactation.

📌 DRUG INTERACTIONS

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

📌 ADVERSE EFFECTS

There are mild and transient side effects such as headache, drowsiness, dizziness, agitation, dry mouth, nausea, increased appetite and gastrointestinal discomfort.

📌 OVERDOSAGE

• Symptoms: Drowsiness can be a symptom of administration of 50 mg as a single dose.
• Treatment of overdosage: No specific antidote exists to date, but in the case of massive overdosage, gastric lavage should be applied as a primary treatment, with regular monitoring of all vital parameters.

📌 STORAGE INSTRUCTIONS

• Tablets: Store below 30°C in a dry place. Protect from light.
• Syrup: Store below 30°C in a tightly closed container. Protect from light.
• Oral drops: Store below 30°C in a tightly closed container. Protect from light.

📌 PHARMACEUTICAL FORMS

• 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.