Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: J. Uriach y Compañía, S.A., Av. Camí Reial, 51-57, 08184 Palau-solità i Plegamans (Spain)
Symptomatic treatment of allergic rhinitis and urticaria in adults and adolescents (over 12 years of age).
The recommended dose is 10 mg (one tablet) once a day, with or without food.
Rupatadine should be used with caution in elderly people (see section 4.4).
Rupatadine 10 mg Tablets is not recommended for use in children below age 12. In children aged 2 to 11 years, the administration of rupatadine 1 mg/ml oral solution is recommended.
As there is no clinical experience in patients with impaired kidney or liver functions, the use of rupatadine 10 mg Tablets is at present not recommended in these patients.
No case of overdose has been reported. In a clinical safety study rupatadine at daily dose of 100 mg during 6 days was well tolerated. The most common adverse reaction was somnolence. If accidental ingestion of very high doses occurs symptomatic treatment together with the required supportive measures should be given.
Shelf life: 3 years.
Keep the blister in the outer carton in order to protect from light.
PVC/PVDC/aluminium blister.
Packs of 3, 7, 10, 15, 20, 30, 50 and 100 tablets. Not all pack sizes may be marketed.
No special requirements.
Any unused product or waste material should be disposed of in accordance with local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
