| a) Generic Name |
Loratadine INN
|
| b) Trade/Brand Name |
To be submitted at the time of inclusion.
|
| a) Presentation |
Film Coated Tablet.
Each tablet contains Loratadine INN 10 mg.
|
| b) Indications |
Seasonal allergic rhinitis, perennial allergic rhinitis, skin allergies including chronic urticaria.
|
| c) Dosage & administration |
Adults and children over 30 kg of body weight, 10 mg once daily; children under 30 kg or under 5 years of age, 5 mg once daily; children under 2 years, not recommended.
|
| d) Contraindications |
Hypersensitivity or idiosyncrasy to its components.
|
| e) Side Effects |
Side effects of loratadine are generally mild. Fatigue, dizziness, dry mouth, headache, sedation, nausea and pruritus may be reported.
|
| f) Warnings & Precautions
|
Severe hepatic impairment alters the pharmacokinetics of loratadine and dose adjustment is required. Drowsiness can occur rarely and patients should be informed that it might affect skilled tasks.
|
| g) Drug Interactions |
There are no reports of potentially hazardous interactions with other drugs.
|
| h) Use in Pregnancy & Lactation |
The safe use of loratadine during pregnancy and lactation has not been established and therefore, this should be used only if the potential benefit justifies the potential risk to foetus.
|
| l) Package Quantity |
To be submitted at the time of inclusion.
|
