Rupatadine STELLA 10 mg

Rx

Indications

• Symptomtic treatment of allergic rhinitis and urticaria in adults and adolescents (over 12 years of age).

Dosage

• Adults and adolescents (over 12 years of age): 10 mg (one tablet) once a day.
• Rupatadine should be used with caution in elderly people.
• Children below age 12 should not use rupatadine.
• Patients with renal or hepatic insufficiency are not recommended using Rupatadine STELLA 10 mg.

Usage

• Rupatadine STELLA 10 mg is administered orally, with or without food.

• Hypersensitivity to rupatadine or to any of the excipients.

• Dizziness, headache, somnolence,
• Dry mouth,
• Asthenia, fatigue.

• The administration of rupatadine with grapefruit juice is not recommended.
• The combination of rupatadine with potent CYP3A4 inhibitors should be avoided and with moderate CYP3A4 inhibitors should be administered with caution.
• Dose adjustment of sensitive CYP3A4 substrates (e.g. simvastatin, lovastatin) and CYP3A4 substrates with a narrow therapeutic index (e.g. ciclosporin, tacrolimus, sirolimus, everolimus, cisapride) could be required as rupatadine may increase plasma concentrations of these drugs.
• 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 STELLA 10 mg should be used with caution in elderly patients (65 years and older).
• Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
• It is preferable to avoid the use of rupatadine during pregnancy.
• A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from rupatadine therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
• Rupatadine STELLA 10 mg had no influence on the ability to drive and use machines. Nevertheless, care should be taken.