MedPath logo

Rupafin Tablet 10mg

Prescription Only
Drug type: Therapeutic
ATC code: R06AX28
Dosage form: TABLET
Route of administration: ORAL
Active ingredient: Rupatadine Fumarate 12.8mg eqv Rupatadine; RUPATADINE FUMARATE 12.8 MG EQV RUPATADINE

4.1 Therapeutic indications

Symptomatic treatment of allergic rhinitis and urticaria in adults and adolescents (12 years of age and above).

4.3 Contraindications

Hypersensitivity to rupatadine or to any of the excipients.

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.

Registrant
HYPHENS PHARMA PTE. LTD.
Approval Date
2012-01-25
Approval Number
SIN14087P
Manufacturer
Noucor Health S.A.
Licence Holder
HYPHENS PHARMA PTE. LTD.