nohydrate in Rupafin 10 mg tablets, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
4.5 Interaction with other medicinal products and other forms of interaction
Interaction studies have only been performed in adults and adolescents (over 12 years of age) with rupatadine 10 mg tablets.
Interaction with ketoconazole or erythromycin: 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. However, rupatadine should be used with caution when it is administered concomitantly with these drug substances and other inhibitors of the isozyme CYP3A4.
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.
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.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are limited amount of data from the use of rupatadine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). As a precautionary measure, it is preferable to avoid the use of rupatadine during pregnancy.
Breastfeeding
Rupatadine is excreted in animal milk. It is unknown whether rupatadine is excreted into breast milk. 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.
4.7 Effects on ability to drive and use machines
Rupatadine 10 mg had no influence on the ability to drive and use machines. Nevertheless, care should be taken before driving or using machinery until the patient's individual reaction on rupatadine has been established.
4.8 Undesirable effects
Rupatadine 10 mg has been administered to over 2025 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 (9.5%), headache (6.9%) and fatigue (3.2%).
The majority of adverse reactions observed in clinical trials were mild to moderate in severity and usually did not require cessation of therapy.
The frequencies of adverse reactions are assigned as follows:
• Common (≥ 1/100 to < |
