RUPAFIN ORAL SOLUTION 1mg/ml

HYPHENS PHARMA PTE. LTD.

HYPHENS PHARMA PTE. LTD.

Therapeutic

Prescription Only

SOLUTION

**4.2 Posology and method of administration** Children aged 2 to 11 years. _Dosage in children weighing equal or more than 25 kg:_ 5 ml (5 mg of rupatadine) of oral solution once a day, with or without food. _Dosage in children weighing equal or more than 10kg up to less than 25kg:_ 2.5ml (2.5mg of rupatadine) of oral solution once a day, with or without food. The administration of the product to children aged under 2 years is not recommended due to the lack of data in this population (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). In adults and adolescents (over 12 years of age), the administration of rupatadine 10 mg tablets is more appropriate. Patients with renal or hepatic insufficiency: As there is no clinical experience in patients with impaired kidney or liver functions, the use of rupatadine is at present not recommended in these patients. _Instructions of use:_ - To open the bottle press the cap and turn it anticlockwise. - Take the syringe and put it in the perforated stopper and turn the bottle upside down. - Fill the syringe with the prescribed dose. - Administer directly from the dosing syringe. - Wash the syringe after use.