- Approval Id
- f72a1dc3583fd6b1
- Drug Name
- RUPAFIN ORAL SOLUTION 1mg/ml
- Product Name
- RUPAFIN ORAL SOLUTION 1mg/ml
- Approval Number
- SIN14868P
- Approval Date
- 2015-10-09
- Registrant
- HYPHENS PHARMA PTE. LTD.
- Licence Holder
- HYPHENS PHARMA PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- SOLUTION
- Dosage
- **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.
- Route Of Administration
- ORAL
- Indication Info
- **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_).
- Contraindications
- **4.3 Contraindications**
Hypersensitivity to rupatadine or to any of the excipients.
- Atc Code
- R06A X28
- Atc Item Name
- xr 06 a x 28
- Pharma Manufacturer Name
- HYPHENS PHARMA PTE. LTD.
- Company Detail Path
- /organization/hyphens-pharma-pte-ltd-singapore
