Each tablet contains: 10 mg of rupatadine (as fumarate) Excipients: lactose

Tablet. Round, light salmon coloured tablets.

Symptomatic treatment of allergic rhinitis and chronic idiopathic 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.

Paediatric patients

Rupafin 10 mg Tablets is not recommended for use in children below age 12 due to a lack of data on safety and efficacy.

Patients with renal or hepatic insufficiency

As there is no clinical experience in patients with impaired kidney or liver functions, the use of Rupafin 10 mg Tablets is at present not recommended in these patients.

Rupafin should be used with caution in elderly people.

Hypersensitivity to rupatadine or to any of the excipients.

The administration of Rupafin with grapefruit juice is not recommended.

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 pro-arrhythmic conditions, such as clinically significant bradycardia, acute myocardial ischemia.

Rupafin 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.

Due to the presence of lactose monohydrate 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.

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.

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 are summarised according to the following scheme:

System Organ Class	Common ( 1/100 to < 1/10)	Uncommon ( 1/1000 to < 1/100)
Investigations		Blood creatine phosphokinase increased, Alanine aminotransferase increased, Aspartate aminotransferase increased, Liver function test abnormal, Weight increased
Nervous system disorders	Somnolence, Headache, Dizziness	Disturbance in attention
Respiratory, thoracic and mediastinal disorders		Epistaxis, Nasal dryness, Pharyngitis, Cough, Dry throat, Pharyngolaryngeal pain, Rhinitis
Gastrointestinal disorders	Dry mouth	Nausea, Abdominal pain upper, Diarrhoea, Dyspepsia, Vomiting, Abdominal pain, Constipation
Skin and subcutaneous tissue disorders		Rash
Musculoskeletal and connective tissue disorders		Back pain, Arthralgia, Myalgia
Metabolism and nutrition disorders		Increased appetite
General disorders and administration site conditions	Fatigue, Asthenia	Thirst, Malaise, Pyrexia
Psychiatric disorders		Irritability

GlaxoSmithKline UK