Rupaxine 10 mg Tablet.

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

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 (see section 4.4).

Paediatric population RUPAXINE is not recommended for use in children below age 12, see section 4.4.

Patients with renal or hepatic insufficiency As there is no clinical experience in patients with impaired kidney or liver functions, the use of RUPAXINE is not recommended in these patients, see section 4.4.

Method of administration For oral use.

Hypersensitivity to the active substances or to any of the excipients. RUPAXINE is not recommended for use in children below 12 years of age. Pregnancy and lactation

Renal and hepatic impairment: Patients with impaired kidney or liver functions, the use of RUPAXINE is not recommended in these patients (see section 4.2).

Paediatric patients: RUPAXINE is not recommended for use in children under 12 years as safety is not established (see sections 4.2 and 4.3).

The administration with grapefruit juice is not recommended (see section 4.5).

The combination of rupatadine with potent CYP3A4 inhibitors should be avoided and with moderate CYP3A4 inhibitors should be administered with caution (see section 4.5).

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 medicines (see section 4.5).

RUPAXINE should be used with caution in patients with known prolongation of the QT interval, patients with uncorrected hypokalaemia, patients with ongoing prodysrhythmic conditions, such as clinically significant bradycardia, acute myocardial ischemia. RUPAXINE should be used with caution in elderly patients (65 years and older). Although no overall differences in effectiveness or safety were observed, higher sensitivity of some older individuals cannot be excluded due to the low number of elderly patients enrolled (see section 5.2).

Contains lactose monohydrate. Patients with rare hereditary conditions of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

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.

Interactions with ketoconazole or erythromycin: The concomitant administration of RUPAXINE and ketoconazole or erythromycin increases the systemic exposure to rupatadine 10 times and 2 u2013 3 times respectively. Caution is recommended in case of concomitant administration of rupatadine and these medicines or other CYP3A4 isoenzyme inhibitors (see section 4.4).

Interaction with grapefruit: The concomitant administration of grapefruit juice with RUPAXINE increased the systemic exposure of rupatadine by 3,5 times. It is recommended to avoid intake of grapefruit juice along with RUPAXINE.

Interaction with alcohol: RUPAXINE should be used with caution when administered with alcohol.

Interaction with CNS depressants: Interactions with other CNS depressants has not been established. No interactions have been observed with fluoxetine.

Interaction with statins: Asymptomatic CPK increases have been uncommonly reported in rupatadine. The risk of interactions with statins, some of which are also metabolised by the cytochrome P450 CYP3A4 isoenzyme, is unknown. Rupatadine should be used with caution when it is co-administered with statins.

Pregnancy H 1 antihistamines cross the placenta. The use of RUPAXINE in pregnancy is contraindicated (see section 4.3).

Breastfeeding RUPAXINE is excreted in animal milk. Due to potential harmful effects in neonates, the use of RUPAXINE is contraindicated during breastfeeding (see section 4.3).

Fertility There are no clinical data on fertility. Studies in animals have shown a significant reduction of fertility at exposure levels higher than those observed in humans at the maximum therapeutic dose.

This medicine lacks significant sedative effects. At the recommended dosage, RUPAXINE is not expected to have an effect on the ability to drive and use machines. Nevertheless, caution is recommended before driving or using a machine until the patientu2019s individual reaction to rupatadine has been determined.

a. Summary of the safety profile The most frequent adverse reactions are somnolence, headache and fatigue. The majority of adverse reactions observed were mild to moderate in severity and usually did not require cessation of therapy.

b. Tabulated list of adverse reactions presented in system organ class and frequency System organ class Undesirable effect Frequency Infections and Infestations Pharyngitis, Rhinitis Less Frequent Metabolism and nutrition disorders Increase appetite Less Frequent Psychiatric disorders Irritability Less Frequent Nervous system Disorders Dizziness Headache Somnolence Disturbance in Attention Frequent Less Frequent Cardiac disorders Tachycardia, palpitations Less frequent Respiratory, thoracic and mediastinal disorders Cough, Dry Throat Epistaxis, Nasal Dryness, Oropharyngeal Pain, Upper respiratory disorders Less Frequent Gastrointestinal Disorders Dry Mouth Abdominal Pain , Upper Abdominal Pain , Diarrhoea , Dyspepsia , Nausea , Vomiting , Constipation Frequent Less Frequent Skin and subcutaneous tissue disorders Rash Less Frequent Musculoskeletal, connective tissues, and bone disorders Arthralgia, Back Pain, Myalgia Less Frequent General disorders and administration site conditions Asthenia, Fatigue Malaise, Pyrexia, Thirst Frequent Less Frequent Investigations Alanine aminotransferase , Increased Aspartate aminotransferase , Increased Blood Creatine Phosphokinase , Increased Liver Function Test Abnormal, Weight increase Less Frequent Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. May also report to Adcock Ingram Limited using the following email: [email protected]

Should overdose occur, treatment should be symptomatic or supportive, taking into account any concomitantly ingested medications.