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  • RUPAFIN TABLETS
    / Kamada


    Active Ingredient

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Tablets

    30

    not in the basket chart

    Dosage

    Adults and adolescents (over 12 years of age)
    The recommended dose is 10 mg (one tablet) once a day, with or without food.
    Elderly
    Rupatadine should be used with caution in elderly people.
    Paediatric patients
    Rupatadine 10 mg Tablets is not indicated for use in children below age 12.
    Patients with renal or hepatic insufficiency
    As there is no clinical experience in patients with impaired kidney or liver functions, the use of rupatadine 10 mg Tablets is at present not recommended in these patients.


    Indications

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

     


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients.


    Special Precautions

    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.
    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.
    Regarding use in children less than 12 years old and in patients with renal or hepatic impairment.
    Due to the presence of lactose monohydrate in rupatadine 10 mg tablets, patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
    See prescribing information for full details.


    Side Effects

    Somnolence, headache , dizziness , dry mouth, fatigue and asthenia.  See prescribing information for full details.


    Drug interactions

    Interaction studies have only been performed in adults and adolescents (over 12 years of age) with rupatadine 10 mg tablets.
    Effects of other drugs on rupatadine
    Co-administration with potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, voriconazole, posaconazole, HIV protease inhibitors, clarithromycin, nefazodone) should be avoided and co-medication with moderate CYP3A4 inhibitors (erythromycin, fluconazole, diltiazem) should be used with caution.
    The concomitant administration of rupatadine 20 mg and ketoconazole or erythromycin increases the systemic exposure to rupatadine 10 times and 2-3 times respectively. These modifications were not associated with an effect on the QT interval or with an increase of the adverse reactions in comparison with the drugs when administered separately.
    Interaction with grapefruit: The concomitant administration of grapefruit juice increased 3.5 times the systemic exposure of rupatadine. Grapefruit juice should not be taken simultaneously.
    Effects of rupatadine on other drugs
    Caution should be taken when rupatadine is co-administered with other metabolised drugs with narrow therapeutic windows since knowledge of the effect of rupatadine on other drugs is limited.
    Interaction with alcohol: After administration of alcohol, a dose of 10 mg of rupatadine produced marginal effects in some psychomotor performance tests although they were not significantly different from those induced by intake of alcohol only. A dose of 20 mg increased the impairment caused by the intake of alcohol.
    Interaction with CNS depressants:
    As with other antihistamines, interactions with CNS depressants cannot be excluded.
    Interaction with statins:
    Asymptomatic CPK increases have been uncommonly reported in rupatadine clinical trials. The risk of interactions with statins, some of which are also metabolised by the cytochrome P450 CYP3A4 isoenzyme, is unknown. For these reasons, rupatadine should be used with caution when it is coadministered with statins.
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy:
    There are limited amount of data from the use of rupatadine in pregnant women.
    See prescribing information for full details.

    Lactation:
    It is unknown whether rupatadine is excreted into breast milk.
    See prescribing information for full details.


    Overdose

    No case of overdose has been reported. In a clinical safety study 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.

     


    Manufacturer
    J. Uriach y Compañia., S.A., Barcelona, Spain
    Licence holder
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