Seasoneze 10 mg FC tablets.

Allergic processes responding to a histamine H 1 receptor antagonist.

• Respiratory: Allergic rhinitis, hay fever.
• Cutaneous: Allergic skin conditions associated with pruritus e.g. urticaria.

Adults and children 12 years of age or older: one 10 mg tablet daily.

Children aged 6 to 12 years: 10 mg (one tablet) once daily or 5 mg (half a tablet) twice daily.

Special populations:

• Elderly patients: At present there are no data to suggest that the dose needs to be reduced in elderly patients with normal renal function.
• Dosage in renal impairment: In patients with renal insufficiency (creatinine clearance less than 40 mL/min), the dosage should be reduced to half the usual recommended dose.
• Dosage in hepatic impairment: Half the recommended daily dose should be used in patients with moderate to severe hepatic impairment.

Method of administration: Oral administration.

Missed dose: Doctors should advise patients who forget to take SEASONEZE to take a dose as soon as possible and then to continue with the normal dose. Patients should not take a double dose to compensate for the missed dose.

Paediatric population: Not suitable for children less than 6 years of age.

• Hypersensitivity to cetirizine, to any of the excipients (see section 6.1), to hydroxyzine or to any piperazine derivatives.
• Patients with severe renal impairment at less than 30 mL/min creatinine clearance.
• Asthma, as it may cause airway obstruction in patients who have previously experienced adverse reactions to antihistamines.
• Pregnancy and lactation, as safety has not been established.
• Children under the age of two years, as safety and efficacy have not been demonstrated.

Caution should be taken in patients with predisposition factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia) as SEASONEZE may increase the risk of urinary retention.

Porphyria: Use with caution.

SEASONEZE lacks significant sedative effects. Patients should be warned however that a small number of individuals may experience sedation.

At therapeutic doses, no clinically significant interactions have been demonstrated with alcohol (for a blood alcohol level of 0,5 g/L). Nevertheless, precaution is recommended if alcohol is taken concomitantly.

Caution is recommended when SEASONEZE is used in epileptic patients and patients at risk of convulsions.

Response to allergy skin tests is inhibited by antihistamines and a wash-out period (of 3 days) is required before performing them.

Pruritus and/or urticaria may occur when SEASONEZE is stopped, even if those symptoms were not present before treatment initiation. In some cases, the symptoms may be intense and may require treatment to be restarted. The symptoms should resolve when the treatment is restarted.

SEASONEZE contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take SEASONEZE.

Paediatric population: The use of SEASONEZE is not recommended in children aged less than 6 years since this formulation does not allow for appropriate dose adaptation. It is recommended to use a paediatric formulation of cetirizine.

Due to the pharmacokinetic, pharmacodynamic and tolerance profile of cetirizine, no interactions are expected with this antihistamine.

Actually, neither pharmacodynamic nor significant pharmacokinetic interaction was reported in interactions studies performed, notably with pseudoephedrine or theophylline (400 mg/day).

The extent of absorption of cetirizine is not reduced with food, although the rate of absorption is decreased.

In sensitive patients, the concurrent use of alcohol or other central nervous system (CNS) depressants may cause additional reductions in alertness and impairment of performance, although cetirizine does not potentiate the effect of alcohol (0,5 g/L blood levels) (see section 4.4).

Pregnancy: Safety and efficacy in pregnancy and lactation has not been established (see section 4.3). Prospectively collected data on pregnancy outcomes do not suggest potential for maternal or foetal/embryonic toxicity above background rates. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development. SEASONEZE should not be used during pregnancy.

Breastfeeding: Cetirizine is excreted in breast milk. Cetirizine is excreted in human milk at concentrations representing 25 % to 90 % those measured in plasma, depending on sampling time after administration. SEASONEZE should not be used when breastfeeding.

Fertility: Limited data is available on human fertility, but no safety concern has been identified. Animal data show no safety concern for human reproduction.

Patients should be warned that some individuals may experience sedation. It is therefore advisable to determine individual response before driving a vehicle or operating machinery. This effect may be compounded by the simultaneous intake of alcohol or other central nervous system depressants (see section 4.5).

SEASONEZE at the recommended dosage has minor adverse effects on the CNS, including somnolence, fatigue, dizziness and headache. In some cases, paradoxical CNS stimulation has been reported.

SEASONEZE is a selective antagonist of peripheral H 1 -receptors and is relatively free of anticholinergic activity. Nevertheless, cases of micturition difficulties, eye accommodation disorders and dry mouth have been reported following the use of SEASONEZE.

Instances of abnormal hepatic function with elevated hepatic enzymes accompanied by elevated bilirubin have been reported following the use of SEASONEZE. This may resolve upon discontinuation of the medicine.

Clinical trials: Double blind controlled clinical trials comparing cetirizine to placebo or other antihistamines at the recommended dosage (10 mg daily for cetirizine), of which quantified safety data are available, included more than 3 200 subjects exposed to cetirizine. The following adverse reactions were reported:

• Blood and the lymphatic system disorders: Less frequent: leucopenia, haemolytic anaemia, agranulocytosis
• Psychiatric disorders: Frequent: somnolence
• Nervous system disorders: Frequent: dizziness, headache
• Ear and labyrinth disorders: Less frequent: tinnitus
• Cardiac disorders: Less frequent: palpitations, dysrhythmias
• Vascular disorders: Less frequent: hypotension
• Respiratory, thoracic and mediastinal disorders: Frequent: pharyngitis, rhinitis, thickening of mucous, bronchospasm
• Gastrointestinal disorders: Frequent: dry mouth, nausea; Less frequent: abdominal pain, constipation
• Hepato-biliary disorders: Less frequent: jaundice
• Skin and subcutaneous tissue disorders: Less frequent: photosensitivity, hair loss, sweating
• General disorders and administration site conditions: Frequent: fatigue

Somnolence was mild to moderate in the majority of cases. Objective tests as demonstrated by other studies have demonstrated that usual daily activities are unaffected at the recommended daily dose in healthy young volunteers.

Symptoms of overdose: Symptoms observed after an overdose of SEASONEZE are mainly associated with CNS effects or with effects that could suggest an anticholinergic effect. Adverse events reported are: confusion, diarrhoea, dizziness, fatigue, headache, malaise, mydriasis, pruritis, restlessness, sedation, somnolence, stupor, tachycardia, tremor, and urinary retention.

Management: There is no known specific antidote to SEASONEZE. Should overdose occur, symptomatic or supportive treatment is recommended. SEASONEZE is not effectively removed by dialysis.