Rupafin Special Precautions

Tablet: The administration of rupatadine with grapefruit juice is not recommended (see Interactions). 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 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 (see Pharmacology: Pharmacodynamics under Actions).
Regarding use in children less than 12 years old and in patients with renal or hepatic impairment, see Dosage & Administration.
Due to the presence of lactose monohydrate in rupatadine 10 mg tablets, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Oral solution: Safety of rupatadine oral solution in children aged less than 2 years have not been established.
The combination of rupatadine with potent CYP3A4 inhibitors should be avoided and with moderate CYP3A4 inhibitors should beadministered with caution (see Interactions).
Dose adjustment of sensitive CYP3A4 substrates (e.g. simvastatin, lovastatin) and CYP3A4 substrates with a narrow therapeutic index (e.g. cyclosporine, tacrolimus, sirolimus, everolimus, cisapride) could be required as rupatadine may increase plasma concentrations of these drugs (see Interactions).
The administration of rupatadine with grapefruit juice is not recommended (see Interactions).
Cardiac safety of rupatadine 10 mg tablets was assessed in a Thorough QT/QTc study in adults. 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.
Increases of blood creatine phosphokinase, alanine aminotransferase and aspartate aminotransferase, as well as abnormalities of liver function tests are uncommon adverse reaction reported with rupatadine 10 mg tablets in adults.
This medicinal product contains sucrose, so it may be harmful to the teeth. Patients with rare hereditary problems of fructose intolerance, glucose/galactose malabsorption or sucraseisomaltase insufficiency should not take this medicine.
This medicinal product contains methyl parahydroxybenzoate, may cause allergic reactions (possibly delayed).
Effects on the ability to drive and use machines: Rupatadine 10 mg had no influence on the ability to drive and use machines in a performed clinical trial. Nevertheless, care should be taken before driving or using machinery until the patient's individual reaction on rupatadine has been established.