Loratadine tablets are indicated for the symptomatic treatment of chronic idiopathic urticaria and allergic rhinitis.
Active substance: loratadine;
1 tablet contains loratadine in terms of 100% substance (0.01 g) 10 mg;
Excipients: potato starch, lactose monohydrate, povidone, calcium stearate.
The preparation is contraindicated in patients with hypersensitivity to the active substance or to any other component of the preparation.
Orally. The tablets can be used with or without food.
Adults and children over 12 years old should take 1 tablet (10 mg loratadine) 1 time per day.
For children from 2 to 12 years old, the dosage depends on body weight. With a body weight of more than 30 kg: 10 mg (1 tablet) 1 time per day. For children weighing less than 30 kg, use loratadine in the form of a syrup.
Pregnant
There are very few data on the use of loratadine in pregnant women. Animal studies have shown no direct or indirect adverse effects related to reproductive toxicity. It is advisable, as a safety measure, to avoid the use of Loratadine during pregnancy.
Children
The efficacy and safety of using loratadine in children under 2 years of age has not been established. The preparation Loratadin, tablets, is prescribed for children weighing more than 30 kg.
Drivers
In general, the preparation does not or insignificantly affect the reaction rate when driving or operating other mechanisms.
Nevertheless, the patient must be informed that very rarely cases of drowsiness have been reported, which may affect the ability to drive vehicles or work with other mechanisms.
Loratadine overdose increases the incidence of anticholinergic symptoms. In overdose, drowsiness, tachycardia, and headache have been reported. In case of overdose, symptomatic and supportive treatment is recommended for the required period of time. It is possible to use activated carbon in the form of an aqueous suspension. Gastric lavage can also be performed. Loratadine is not excreted from the body during hemodialysis; the effectiveness of peritoneal dialysis in removing the preparation is unknown. After emergency treatment, the patient should remain under medical supervision.
In clinical studies involving adults and adolescents, when using loratadine at the recommended dose of 10 mg per day for indications including allergic rhinitis and chronic idiopathic urticaria, adverse reactions were reported in 2% of patients (which is higher than in patients who received placebo). The adverse reactions reported more frequently than with placebo were drowsiness (1.2%), headache (0.6%), increased appetite (0.5%), and insomnia (0.1%). In clinical studies in children from 2 to 12 years old, there were such adverse events as headache (2.7%), nervousness (2.3%) or fatigue (1%).
When used simultaneously with alcohol, the effects of loratadine are not enhanced, which is confirmed by studies of psychomotor function.
A potential interaction can occur with the use of all known inhibitors of CYP3A4 or CYP2D6, which leads to an increase in loratadine levels, and this, in turn, may cause an increase in the incidence of adverse reactions.
An increase in plasma concentrations of loratadine was reported after simultaneous use with ketoconazole, erythromycin and cimetidine, which was not accompanied by clinically significant changes (including on the ECG).
Store in its original packaging at a temperature not exceeding 25 ° C.
Keep out of the reach of children.
Shelf life is 4 years.
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