Aleze Tablet 10mg

Product Information

ALEZE

Aleze®(Loratadine)

Presentation

Aleze tablet: White, shield shaped, scored tablet, having engraved on one side; each tablet contains micronised Loratadine INN

10mg.

Aleze suspension: White, strawberry flavored suspension; each 5ml suspension contains Loratadine INN 5mg.

Indications

Aleze tablets and suspension are indicated in adults for the relief of symptoms associated with seasonal and perennial allergic

rhinitis, such as sneezing, nasal discharge and itching and ocular itching and burning. Nasal and ocular signs and symptoms are

relieved rapidly after oral administration. Aleze is also indicated for the relief of symptoms associated with idiopathic chronic

urticaria. In children over two years, Aleze suspension is indicated for the symptomatic treatment of seasonal allergic rhinitis

and allergic skin conditions such as idiopathic urticaria.

Dosage and administration

Adults, including the elderly, and children 12 years of age and over: Loratadine 10mg (one Aleze tablet or 10ml Aleze suspension)

once daily.

Children aged 6-12 years: Loratadine 10mg (10ml Aleze suspension) once daily.

Children aged 2-5 years: Loratadine 5mg (5ml Aleze suspension) once daily.

Safety and efficacy of loratadine below 2 years has not been established.

Contra-indication, warnings, etc.

Contra-indication: Loratadine is contra-indicated in patients who have shown hypersensitivity to loratadine.

Use in pregnancy and lactation: Loratadine should not be administered during pregnancy. There is no experience of the use of

loratadine in human pregnancy. In animal studies loratadine was not teratogenic; at high doses some embryotoxic effects were

observed. Since loratadine is excreted in breast milk it should not be administered to lactating women.

Side-effects: During controlled studies the incidence of adverse events, including sedation and anticholinergic effects, observed

with 10mg loratadine was comparable to that observed with placebo. Other events, fatigue, nausea and headache were reported

rarely. Tachycardia and syncope have been reported rarely.

Spontaneous adverse events reported rarely include:alopecia, anaphylaxis, abnormal hepatic function and supraventricular

tachyarrythmias.

Drug interactions: Concomitant use of loratadine with cimetidine, erythromycin or ketoconazole increased loratadine concentrations

in plasma, although no adverse effects, clinical or electrocardiographic, were observed.

Overdosage: In the event of overdosage, treatment which should be started immediately is symptomatic and supportive. The patient

should be induced to vomit, even if emesis has occured spontaneously (ipecacunha is preferred method), but not in patients with

impaired consciousness. Administration of activated charcoal as a slurry with water may be attempted following emesis. If vomiting

is unsuccessful or contra-indicated, gastric lavage should be performed. Loratadine is not dialisable to any appreciable extent.

After emergency treatment, the patient should continue to be under medical supervision.

Pharmaceutical precautions

Store in a cool and dry place, protected from light.

Packaging quantities

Aleze tablet: Cartons of 50 tablets in blister.

Aleze suspension: Bottles containing 60ml suspension