Please see the Rupatadine 10mg tablets Patient Information Leaflet here
For the treatment of allergic rhinitis (irritation of the nose, nasal passages etc) caused by allergens such as pollen or other substances eg house dust mite. Also recommended for ezcema and psoriasis to reduce irritation and urge to scratch the affected areas.
Adults over age of 18: take ONE tablet DAILY
If you are taking statin medication eg simvastatin or some immuno-suppressive medication eg tacrolimus then please speak to your pharmacist before taking this medication.
Active - ingredient: Rupatadine 10mg per tablet
Excipients (other non-active parts of the tablets)
Pregelatinised maize starch
Microcrystalline cellulose
Red iron oxide (E-172)
Yellow iron oxide (E-172)
Lactose monohydrate
Magnesium stearate
Keep the blister in the outer carton in order to protect from light.
Not to be taken if you are hypersensitivity to the active substance or any of the excipients listed in the Ingredients section
Do not take with grapefruit juice
Rupatadine 10 mg Tablets should be used with caution in elderly patients (65 years and older). Although no overall differences in effectiveness or safety were observed in clinical trials, higher sensitivity of some older individuals cannot be excluded due to the low number of elderly patients enrolled
Cardiac safety of rupatadine was assessed in a Thorough QT/QTc study. Rupatadine up to 10 times therapeutic dose did not produce any effect on the ECG and hence raises no cardiac safety concerns. However, rupatadine should be used with caution in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, patients with ongoing proarrhythmic conditions, such as clinically significant bradycardia, acute myocardial ischemia.
Rupatadine 10 mg tablets has been administered to over 2043 adult and adolescent patients in clinical studies, 120 of whom received rupatadine for at least 1 year.
The most common adverse reactions in controlled clinical studies were somnolence (9.4%), headache (6.9%),fatigue (3.1%), asthenia (1.5%), dry mouth (1.2%) and dizziness (1.03%).
The majority of the adverse reactions observed in clinical trials were mild to moderate in severity and they usually did not require cessation of therapy.