RUPAFIN ORAL SOLUTION 1mg/ml

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.

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.