Rhineton Non Drowsy 10 mg Tablets

RHINETON NON DROWSY are indicated in adults for the relief of symptoms associated with perennial and /or seasonal allergic rhinitis, chronic urticaria and other allergic skin disorders.

Posology

Adults

One RHINETON NON DROWSY orally once daily.

Special populations

Use in patients with hepatic failure or renal impairment: In patients with hepatic failure or renal impairment, an initial dose of 5 mg once daily or 10 mg on alternate days is recommended.

Use in elderly patients: Safety of RHINETON NON DROWSY in the elderly has not been established (see section 4.3).

Paediatric population

Safety and efficacy of RHINETON NON DROWSY in children under two years of age have not been established (see section 4.3).

Method of administration

RHINETON NON DROWSY are for oral administration. RHINETON NON DROWSY can be taken with or without meal.

Hypersensitivity or idiosyncratic reaction to loratadine or to any of the excipients listed in section 6.1. Safety of RHINETON NON DROWSY 10 in the elderly has not been established. Safety and efficacy of RHINETON NON DROWSY 10 in children under two years of age have not been established. RHINETON NON DROWSY are contraindicated in pregnancy and lactation as the safety has not been established (see section 4.6).

RHINETON NON DROWSY lack significant sedative effects. Patients should, however be warned that a small number of individuals may experience sedation. It is therefore advisable to determine individual response before driving or performing complicated tasks. This effect may be compounded by the simultaneous intake of alcohol or other central nervous system depressants.

RHINETON NON DROWSY should be administered with caution in patients with severe hepatic impairment because they may have a reduced clearance of loratadine. A lower initial dose of 5 mg once daily or 10 mg every other day is recommended in such patients.

RHINETON NON DROWSY should be discontinued at least two days (48 hours) prior to skin testing procedures, since it may prevent or diminish otherwise positive reactions to dermal reactivity indicators.

The use of RHINETON NON DROWSY has been associated with the risk of weight gain (see section 4.8).

Important information about excipients: Lactose RHINETON NON DROWSY contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Medicine/laboratory test interactions

RHINETON NON DROWSY should be discontinued about two days prior to skin testing procedures, since it may prevent or diminish otherwise positive reactions to dermal reactivity indicators (see section 4.4). When administered concurrently with alcohol, RHINETON NON DROWSY have no potentiating effects. However, concomitant consumption of excessive amounts of alcohol should be avoided (see section 4.4).

Caution should be exercised when other medicines known to inhibit hepatic microsomal enzymes are co-administered with RHINETON NON DROWSY. Medicines known to inhibit either P450 3A4 or P450 2D6 are quinidine, fluconazole or fluoxetine.

An increase in plasma concentrations of loratadine have been reported after concomitant use with ketoconazole, erythromycin or cimetidine in controlled clinical trials, but without clinically significant changes (including electrocardiographic). Other medicines known to inhibit hepatic metabolism should be co-administered with caution together with RHINETON NON DROWSY until definitive interaction studies can be completed or in the absence of formal interaction studies.

Contraindicated in pregnancy and lactation (see section 4.3).

Fertility

There is no fertility data available.

RHINETON NON DROWSY lack significant sedative effects. However, a few patients treated with non-sedating antihistamines such as RHINETON NON DROWSY have experienced drowsiness. Therefore, it is prudent that caution should be exercised before driving or operating machinery; the effect of RHINETON NON DROWSY on a particular patient can be ascertained after the first few doses. This effect may be compounded by the simultaneous intake of alcohol or other central nervous system depressants.

Tabulated list of adverse reactions

MedDRA System organ class Frequency Adverse reactions

Blood and lymphatic system disorders Less frequent Thrombocytopenia.

Immune system disorders Less frequent Hypersensitivity reactions (including skin rash, bronchospasm, angioedema and anaphylaxis) and cross sensitivity.

Psychiatric disorders Frequent Insomnia, nervousness. Less frequent Depression.

Nervous system disorders Frequent Headache, somnolence. Less frequent Dizziness, convulsions, sweating, paraesthesias, extrapyramidal effects, tremor, sleep disturbances.

Cardiac disorders Less frequent Tachycardia, palpitations and dysrythmias, including ventricular and supraventricular dysrythmias; hypotension.

Ear and labyrinth disorders Less frequent Tinnitus.

Gastrointestinal disorders Frequent Increased appetite Less frequent Nausea, vomiting, diarrhoea, dry mouth, gastritis, or epigastric pain, anorexia.

Hepato-biliary disorders Less frequent Abnormal hepatic functions, including jaundice and hepatitis.

Skin and subcutaneous tissue disorders Less frequent Rash, alopecia.

Musculoskeletal and connective tissue disorders Less frequent Myalgia.

General disorders and administration site conditions Frequent Fatigue.

Investigations Frequency unknown Weight increase.

Overdosage with loratadine may manifest in any of the symptoms described under section 4.8. There is no specific antidote for loratadine. In case of overdosage, treatment which is symptomatic and supportive should be started immediately. Consider standard measures to remove any unabsorbed medicine in the stomach, such as adsorption by activated charcoal administered as a slurry with water. The administration of gastric lavage should be considered. 0,9 % Sodium chloride solution is the lavage solution of choice, particularly in children. In adults tap water can be used; however, as much as possible of the amount administered should be removed before the next instillation. Sodium chloride or saline cathartics draw water into the bowel by osmosis and therefore, may be valuable for their action in rapid dilution of bowel content. Loratadine is not dialysable. After emergency treatment, the patient should continue to be under medical supervision.