LEREX

LEVOCETIRIZINE DIHYDROCHLORIDE

Levocetirizine Dihydrochloride is indicated in the treatment of symptoms associated with allergic conditions such as seasonal allergic rhinitis, perennial allergic rhinitis and chronic idiopathic urticaria.

Non-sedating antihistamines

Levocetirizine Dihydrochloride is a preparation of Levocetirizine Dihydrochloride. Levocetirizine is the active (levo) isomer of Cetirizine. It is a new highly effective and well-tolerated non-sedating antihistamine with potent antiallergic properties. It has a two-fold higher affinity for H1-receptors than Cetirizine. Levocetirizine has a rapid and long-lasting action, allowing once-a-day administration.

Adults and children 12 years of age and older: 5 mg once daily in the evening Children 6 to 11 years of age: 2.5 mg once daily in the evening Children 6 months to 5 years of age: 1.25 mg (1/2 teaspoon oral solution) once daily in the evening Renal Impairment: Adjust the dose in patients 12 years of age and older with decreased renal function

It is contraindicated in patients who are hypersensitive to this medication or to any of its ingredients.

The most common adverse reactions (rate 82% and > placebo) were somnolence, nasopharyngitis, fatigue, dry mouth, and pharyngitis in subjects 12 years of age and older, and pyrexia, somnolence, cough, and epistaxis in children 6 to 12 years of age. In subjects 1 to 5 years of age, the most common adverse reactions (rate 82% and > placebo) were pyrexia, diarrhea, vomiting, and otitis media. In subjects 6 to 11 months of age, the most common adverse reactions (rate 83% and > placebo) were diarrhea and constipation.

Pregnancy: The safety of Levocetirizine in pregnancy has not been established. Therefore, it should be used with caution during pregnancy and only if the potential benefits to the mother outweigh any risks to the foetus. Lactation: Levocetirizine passes into breast milk. So, it should be used with caution in nursing mothers and only if the expected benefit to the mother is greater than the risk to the nursing infant.

Symptoms: Drowsiness, agitation, restlessness, confusion, diarrhoea, dizziness, fatigue, headache, malaise, mydriasis, pruritus, sedation, somnolence, stupor, tachycardia, tremor and urinary retention. Management: Symptomatic and supportive treatment. Gastric lavage must be considered shortly following ingestion.

Epileptic patients and patients at risk of convulsions. Renal impairment. Pregnancy and lactation.

Store between 20-258C.