Rupatadine fumarate has been approved for the treatment of allergic rhinitis and chronic urticaria in adults and children over 12 years. The defined daily dose (DDD) is 10 mg orally.

Rupatadine is a second generation, non-sedating, long-acting histamine antagonist with selective peripheral H1 receptor antagonist activity. It further blocks the receptors of the platelet-activating factor (PAF) according to in vitro and in vivo studies.

Rupatadine possesses anti-allergic properties such as the inhibition of the degranulation of mast cells induced by immunological and non-immunological stimuli, and inhibition of the release of cytokines, particularly of the TNF in human mast cells and monocytes.

Rupatadine is a once-daily, non-sedating, selective and long-acting new drug with a strong antagonist activity towards both histamine H(1) receptors and platelet-activating factor receptors. The use of rupatadine is indicated in adult and adolescent patients (> 12 years of age) suffering from intermittent and persistent allergic rhinitis and chronic idiopathic urticaria. In the treatment of these diseases, rupatadine is at least as effective as ebastine, cetirizine, loratadine and desloratadine. A very good safety profile of rupatadine has been evidenced in various studies, including a long-term (1-year) safety study.

Headache, drowsiness, weakness, fatigue and dizziness.

Like all medicines, Rupafin can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people) are sleepiness, headache, dizziness, dry mouth,

sensation of weakness and fatigue. Uncommon side effects (may affect up to 1 in 100 people) are

increased appetite, irritability, difficulty concentration, nosebleed, nasal dryness, sore throat, cough,

dry throat, rhinitis, nausea, abdominal pain, diarrhoea, indigestion, vomiting, constipation, rash, back

pain, joint pain, muscle pain, thirst, general discomfort, fever, abnormal liver function test and

increased weight.

Rare side effects (may affect up to 1 in 1,000 people are palpitations and increased heart rate.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please

tell your doctor or pharmacist.