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RUPAFIN TABLET 10MG [SIN14087P]
Active ingredients: RUPAFIN TABLET 10MG
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Product Info
RUPAFIN TABLET 10MG
[SIN14087P]
Product information
Active Ingredient and Strength | RUPATADINE FUMARATE 12.8 MG EQV RUPATADINE - 10 MG |
Dosage Form | TABLET |
Manufacturer and Country | NOUCOR HEALTH S.A. - SPAIN |
Registration Number | SIN14087P |
Licence Holder | HYPHENS PHARMA PTE. LTD. |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | R06AX28 |
4.1 Therapeutic indications
Symptomatic treatment of allergic rhinitis and urticaria in adults and adolescents (12 years of age and above).
4.2 Posology and method of administration
Adults and adolescents (12 years of age and above)
The recommended dose is 10 mg (one tablet) once a day, with or without food.
Elderly
Rupatadine should be used with caution in elderly people (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Paediatric patients
Rupatadine 10 mg Tablets is not recommended for use in children below age 12 due to a lack of data on safety and efficacy.
Patients with renal or hepatic insufficiency
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.
4.3 Contraindications
Hypersensitivity to rupatadine or to any of the excipients.
