Storage:
active substance: desloratadine;
1 tablet contains desloratadine in terms of anhydrous 100% substance 5 mg;
excipients: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, lactose monohydrate, corn starch, hypromellose, calcium stearate, Opadry II 85F 30571 Blue (iron oxide red (E 172), polyvinyl alcohol, titanium dioxide (E 171), talc, indigo carmine (E 132), polyethylene glycol).
Medicinal form. Coated tablets.
The main physicochemical properties: round tablets with a biconvex surface, covered with a blue shell.
Pharmacotherapeutic group. Antihistamines for systemic use.
Clinical characteristics.
Indication.
Elimination of symptoms associated with:
– allergic rhinitis (see section “Pharmacological properties”);
– urticaria (see section “Pharmacological properties”).
Contraindication.
Hypersensitivity to the active substance or to any of the auxiliary substances of the drug or to loratadine.
Interaction with other medicinal products and other types of interactions.
In clinical studies of desloratadine in the form of tablets with the simultaneous use of erythromycin or ketoconazole, no clinically significant interactions were observed.
According to clinical and pharmacological studies, when using the drug together with alcohol, there was no increase in the negative effect of ethanol on psychomotor function. However, in the post-registration period, there were cases of alcohol intolerance and alcohol intoxication during the use of the drug. Therefore, it is necessary to be careful when drinking alcohol during treatment with Edem®
Method of application and dosage.
Adults and children over 12 years of age: 1 tablet 1 time per day, regardless of food intake, for the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria.
Therapy of intermittent allergic rhinitis (presence of symptoms less than 4 days a week or less than 4 weeks) must be carried out taking into account the anamnesis data: stop after the disappearance of symptoms and resume after their re-emergence.
With persistent allergic rhinitis (presence of symptoms more than 4 days a week or more than 4 weeks), it is necessary to continue the treatment during the entire period of contact with the allergen.
Children.
The effectiveness and safety of using Edem® tablets in children under 12 years of age has not been established.
Overdose.
In case of overdose, standard measures should be taken to remove unabsorbed active substance. Symptomatic and supportive treatment is recommended. In clinical studies, in which desloratadine was administered in doses of 45 mg (which was 9 times higher than recommended), clinically significant adverse reactions were not observed. Desloratadine is not removed by hemodialysis. The possibility of its removal during peritoneal dialysis has not been established.
Expiration date.
3 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions.
Store in the original packaging at a temperature not higher than 25 °C.
Keep out of the reach of children.
Packaging. 10 or 30 tablets in a blister. 1 blister in a pack.
Leave category. Without a prescription.
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