Piriteze Allergy Syrup

Each 1 ml of solution contains 1 mg of cetirizine hydrochloride.

For excipients, see 6.1.

Oral solution.

Clear colourless solution with a banana odour.

Adults and children 6 years and over:

Symptomatic treatment of allergic rhinitis (seasonal and perennial), and chronic idiopathic urticaria.

Adults and children aged 6 years and over: 2 x 5 ml once daily or 5ml taken twice daily (morning and evening).

If drowsiness occurs, the solution can be administered in the evening.

Children under 6 years:

Not recommended.

Cetirizine is contraindicated in patients with severe renal impairment. In patients with moderate renal impairment the dose should be adjusted to 5 ml. Caution should be exercised in patients with mild to moderate renal impairment or impaired liver function (see 4.4 Special warnings and precautions for use).

There is no evidence that the dose needs to be modified for healthy elderly patients. The duration of the treatment may vary depending on the symptoms.

Hypersensitivity to cetirizine hydrochloride and other piperazine-derivatives or to any of the excipients.

Patients with severe renal impairment (CL_cr: <10 ml/min).

In some patients, long term treatment with Cetirizine Solution may lead to an increased risk of caries due to mouth dryness. The patients should therefore be informed about the importance of oral hygiene.

In cases of impaired hepatic function and renal function, the elimination of cetirizine may be impaired. Caution should be exercised when administering cetirizine to these patients. (see section 4.2 posology and section 4.3 contraindications).

Cetirizine may potentiate the effects of alcohol. Therefore caution is recommended during concomitant use of alcohol.

Caution is recommended with concomitant use of CNS depressants.

Allergy testing: Use of cetirizine must be discontinued three days before allergy tests. Cetirizine may potentiate the effects of alcohol. Therefore caution is recommended during concomitant use of alcohol. Caution is recommended during concomitant use of CNS depressants.

Data on a limited number of exposed pregnancies indicate no adverse effects of cetirizine on pregnancy or on the health of the foetus/new born child. To date no other relevant epidemiological data are available.

Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or post natal development (see 5.3). Caution should be exercised when prescribing to pregnant women.

Breast feeding

No data concerning the excretion of cetirizine into human milk are available. Cetirizine should be avoided during lactation.

Cetirizine may have minor or moderate influence on the patient's ability to react. This should be considered when extra alertness is required e.g. when driving. Cetirizine may potentiate the effects of alcohol and CNS depressants.

In objective tests of psychomotor function the incidence of sedation with cetirizine was similar to placebo. There have been occasional reports of mild and transient side effects such as drowsiness, fatigue, headache, dizziness, agitation, dry mouth and gastrointestinal discomfort. If desired the dose might be taken as 5 mg in the morning and 5 mg in the evening.

Undesirable effects reported from the post-marketing experience are listed below. The frequency is defined as: very common (>10%); common (10% and>1%); uncommon (1% and>0.1%); rare (0.1% and>0.01%) and very rare (0.01% including isolated reports).

Blood and lymphatic disorders: Very rare: thrombocytopenia

Cardiac disorders: Rare: tachycardia, palpitations

Eye disorders: Very rare: accommodation disorder, blurred vision, oculogyric crisis

Gastrointestinal disorders: Uncommon: diarrhoea

General disorders and administration site conditions: Uncommon: asthenia, malaise; Rare: oedema

Immune system disorders: Rare: hypersensitivity; Very rare: anaphylactic shock

Hepatobiliary disorders: Rare: abnormal hepatic function (increased transaminases, alkaline phosphatase, γ-GT and bilirubin); Very rare: hepatitis

Investigations: Rare: weight increase

Nervous system disorders: Uncommon: paraesthesia; Rare: convulsions, movement disorders; Very rare: dysgeusia, syncope

Psychiatric disorders: Uncommon: agitation; Rare: aggression, confusion, depression, hallucinations, insomnia

Renal and urinary disorders: Very rare: dysuria, enuresis, micturition difficulties

Skin and subcutaneous tissue disorders: Uncommon: pruritus, rash; Rare: urticaria; Very rare: angioneurotic oedema, erythema multiforme.

Toxicity: Limited experience of overdosing. 20 mg to a 2 year old, 30 mg to a 3 year old and 40 mg to an 11 year old did not give any symptoms. 60 mg to a 4 year old gave mild intoxication, 400 mg to a 14 year old gave mild symptoms while 400-500 mg to an adult gave no symptoms at all.

Symptoms of overdosage reported with antihistamine substances: Somnolence, unconsciousness and/or excitation (principally in children). Ataxia, tremor, headache, hallucinations, seizures, dry mouth, flush, hyperthermia, mydriasis, urine retention tachycardia and in the case of massive doses, possible fall in blood pressure and arrhythmias. Nausea and vomiting. Also extrapyramidal symptoms are possible. Cetirizine has a low sedative and anticholinergic effect. Sedation can be a symptom of overdose, it can occur after a single dose of less than 50 mg.

Treatment: At the present time there is no specific antidote. Experience of overdosing is limited and no severe intoxication has been reported to date. Primary treatment should be gastric lavage, if justified and charcoal. Symptomatic treatment should be instituted in the case of acute intoxication, such as diazepam for seizures or acute dystonias.

ATC code: RO6AEO7

Pharmacotherapeutic group: Antihistamine piperazine derivatives.

Cetirizine hydrochloride is a racemate and an anti-allergic with specific histamine H₁ -receptor blocking characteristics.

Cetirizine inhibits cutaneous reactions in allergic individuals through VIP (Vasoactive Intestinal Polypeptide) and substance P, neuropeptides that are considered to be involved in the allergic reaction. Effect is reached within 2 hours with a maximum effect after 4 hours, and remains for at least 24 hours. In allergic individuals, cetirizine inhibits the recruitment of eosinophils after stimulation with allergens and non selective histamine liberators, by a mechanism that is not primarily explained by the H₁-receptor blocking characteristics of the pharmaceutical.

Cetirizine is absorbed with small inter-individual variations. Cetirizine has not been given intravenously, therefore the bioavailability, clearance and volume of distribution (Vd) are unknown. Maximum plasma concentration is achieved within 1 hour and the terminal half-life is about 10 hours in adults and 6 hours in children between the age of 6-12 years. The grade of protein binding in plasma is about 93%. Cetrizine is metabolised to a small extent with a known inactive main metabolite. 60% of a dose of cetirizine is eliminated in unchanged form via the kidneys within 96 hours. Repeated administration does not lead to any accumulation, nor is the absorption or elimination affected. In cases of impaired kidney function, the elimination is slower and the half-life is prolonged. Elimination will also be decreased in cases of hepatic impairment.

There is no evidence that the pharmacokinetics of cetirizine is altered in elderly patients unless renal or hepatic function is reduced.

Preclinical information has not been included because the safety profile of Cetirizine Hydrochloride 1mg/ml Oral Solution has been established after many years of clinical use. Please refer to section 4.

Glycerol

Propylene glycol

Sorbitol 70% solution

Methylparaben

Propylparaben

Sodium acetate

Acetic acid glacial

Saccharin sodium

Banana flavour

Purified water

Not applicable.

3 years.

No special precautions for storage.

70 ml fill bottles.

Amber glass bottle, with child-resistant polypropylene screw cap incorporating a tamper evident seal (yellow polyethylene).

Measuring device: 5 ml plastic PP measuring spoon graduated at 2.5 ml

No special requirements.

Teva UK Limited

Brampton Road

Hampden Park

Eastbourne

East Sussex BN22 9AG

PL 00289/0595

27 January 2004

08/01/2009