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HSA Approval

RUPAFIN ORAL SOLUTION 1mg/ml

SIN14868P

RUPAFIN ORAL SOLUTION 1mg/ml

RUPAFIN ORAL SOLUTION 1mg/ml

October 9, 2015

HYPHENS PHARMA PTE. LTD.

HYPHENS PHARMA PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantHYPHENS PHARMA PTE. LTD.
Licence HolderHYPHENS PHARMA PTE. LTD.

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

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.

ORAL

Medical Information

**4.1 Therapeutic indications** Rupafin 1 mg/ml oral solution is indicated for the symptomatic treatment of: - Allergic rhinitis (including persistent allergic rhinitis) in children aged 2 to 11 years (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - Urticaria in children aged 2 to 11 years (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).

**4.3 Contraindications** Hypersensitivity to rupatadine or to any of the excipients.

R06A X28

xr 06 a x 28

Manufacturer Information

HYPHENS PHARMA PTE. LTD.

ITALFARMACO, S.A.

Active Ingredients

Rupatadine fumarate 1.280 mg eqv rupatadine

1.00 mg/ml

Rupatadine

Documents

Package Inserts

Rupafin oral solution PI.pdf

Approved: March 6, 2017

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RUPAFIN ORAL SOLUTION 1mg/ml - HSA Approval | MedPath