RUPATADINE Oral solution Ref.[7356] Active ingredients: Rupatadine

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 10 kg up to less than 25 kg: 2.5 ml (2.5 mg 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).

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.

No case of overdose has been reported in adults and children. In a clinical safety study in adults rupatadine at daily dose of 100 mg during 6 days was well tolerated. The most common adverse reaction was somnolence. If accidental ingestion of very high doses occurs symptomatic treatment together with the required supportive measures should be given.

Shelf life: 30 months.

The shelf life after first opening is the same as the expiry date placed on the box and the bottle.

This medicinal product does not require any special storage conditions.

120 ml amber polyethylene terephthalate (PET) bottle with low density polyethylene (LDPE) perforated stopper closed with yellow high density polyethylene (HDPE) child-resistant closure in a cardboard box also containing 5 ml oral syringe (polypropylene, polyethylene) graduated at 0.25 ml.

No special requirements.

Any unused product or waste material should be disposed of in accordance with local requirements.