SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Cetirizine Dihydrochloride 10mg Film-coated Tablets Bell's Healthcare Allergy and Hayfever Relief 10 mg Tablets Alexander’s Hayfever and Allergy Relief 10 mg Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film-coated tablet contains 10 mg of Cetirizine Dihydrochloride

Excipients: one film-coated tablet contains 100.2 mg of lactose monohydrate (see section 4.4).

For a full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Film-coated tablet (tablets). The diameter of each tablet is 8mm.

White coloured, circular, biconvex film coated tablets, marked with ‘A’ on one side and a breakline score on the other.

The tablet can be divided into equal halves.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Cetirizine is indicated for the symptomatic treatment of perennial rhinitis, seasonal allergic rhinitis and chronic idiopathic urticaria.

4.2    Posology and method of administration

Children aged from 6 to 12 years: 10mg once daily (1 tablet).

Adults and children over 12 years of age: 10 mg once daily (1 tablet). The tablets need to be swallowed with a glass of liquid.

Elderly subjects: At present there is no data to_suggest that the dose needs to be reduced in elderly subjects provided that the renal function is normal.

Patients with renal insufficiency: the dosage should be reduced to half the usual recommended daily dose.

Patients with hepatic impairment: no dose adjustment is needed in patients with solely hepatic impairment.

4.3 Contraindications

Hypersensitivity to the active substance, to any of the excipients, to hydroxyzine or to any piperazine derivatives.

Patients with severe renal impairment at less than 10 ml/min creatinine clearance.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption should not take cetirizine film-coated tablet.

4.4 Special warnings and precautions for use

The use of the film-coated tablet formulation is not recommended in children aged less than 6 years since this formulation does not allow for appropriate dose adaptation.

Do not exceed the stated dose. If symptoms persist consult your doctor.

4.5 Interaction with other medicinal products and other forms of interaction

To date there have been no known interactions with other drugs. Studies with diazepam and cimetidine revealed no evidence of interactions. As with other antihistamines, it is advisable to avoid excessive alcohol consumption.

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.

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

4.6 Fertility, Pregnancy and lactation

No adverse effects have been reported from animal studies. There has been little or no clinical experience of cetirizine in pregnancy. As with other drugs the use of cetirizine in pregnancy should be avoided. Cetirizine is contraindicated in lactating women as it is excreted in breast milk.

4.7 Effects on ability to drive and use machines

Antihistamines can cause drowsiness in some patients. Although this has not been reported with cetirizine at the recommended dose, please be cautious whilst driving or operating machinery.

4.8 Undesirable effects

Clinical studies have shown that cetirizine at the recommended dosage has minor undesirable effects on the CNS, including somnolence, fatigue, dizziness and headache. In some cases, paradoxical CNS stimulation has been reported.

Although cetirizine is a selective antagonist of peripheral H1-receptors and is relatively free of anticholinergic activity, isolated cases of micturition difficulty, eye accommodation disorders and dry mouth have been reported.

Instances of abnormal hepatic function with elevated hepatic enzymes accompanied by elevated bilirubin have been reported. Mostly this resolves upon discontinuation of the treatment with cetirizine dihydrochloride.

Post-marketing experience

The following adverse drug reactions have been reported from postmarketing experience.

Very common (>1/10); common (>1/100 to <1/10); uncommon (>1/1,000 to <1/100); rare (>1/10,000 to <1,000); very rare (<1/10,000), not known, cannot be estimated from available data.

Blood and lymphatic disorders:

Very rare: thrombocytopenia

Immune system disorders:

Rare: hypersensitivity Very rare: anaphylactic shock

Psychiatric disorders:

Uncommon: agitation

Rare: aggression, confusion, depression, hallucination, insomnia Very rare: tic

Nervous system disorders:

Uncommon: paraesthesia

Rare: convulsions, movements disorders

Very rare: dysgeusia, syncope, tremor, dystonia, dyskinesia

Eye disorders:

Very rare: accommodation disorder, blurred vision, oculogyration

Cardiac disorders:

Rare: tachycardia

Gastro-intestinal disorders:

Uncommon: diarrhoea

Hepatobiliary disorders:

Rare: abnormal hepatic function (increased transaminases, alkaline phosphatase, y-GT and bilirubin)

Skin and subcutaneous tissue disorders:

Uncommon: pruritus, rash Rare: urticaria

Very rare: angioneurotic oedema, fixed drug eruption, erythema multiforme

Renal and urinary disorders:

Very rare: dysuria, enuresis, micturition difficulties

General disorders and administration site conditions:

Uncommon: asthenia, malaise

Rare: oedema Investigations:

Rare: weight increased

4.9 Overdose

Symptoms

Symptoms observed after an overdose of cetirizine are mainly associated with CNS effects or with effects that could suggest an anticholinergic effect.

Adverse events reported after an intake of at least 5 times the recommended daily dose are: confusion, diarrhoea, dizziness, fatigue, headache, malaise, mydriasis, pruritus, restlessness, sedation, somnolence, stupor, tachycardia, tremor, and urinary retention.

Management

There is no known specific antidote to cetirizine.

Should overdose occur, symptomatic or supportive treatment is recommended. The patient should be kept under clinical observation for at least 4 hours after ingestion, and his blood pressure, heart rate and vital signs monitored until stable. In symptomatic cases ECG should be performed. The benefit of gastric lavage is uncertain. Oral activated charcoal (50g for an adult, 10-15g for a child) should be considered if more than 2.5mg/kg cetirizine has been ingested within 1 hour. Cetirizine is not effectively removed by dialysis.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Piperazine derivatives, ATC code: R06A E07

Cetirizine is a potent antihistamine with a low potential for drowsiness at normal therapeutic doses which has additional anti-allergic properties. It is a selective H1 antagonist with negligible effects on other receptors and so is virtually free from anti-cholinergic and anti-serotonin effects. Cetirizine inhibits the histamine-mediated early phase of the allergic-reaction and also reduces the migration of certain inflammatory cells and the release of certain mediators associated with the late allergic response.

5.2 Pharmacokinetic properties

Peak blood levels of the order of 0.3micrograms/ml are reached between 30 and 60 minutes after oral administration of a 10mg dose of cetirizine. The terminal half-life is approximately ten hours in adults, approximately six hours in children aged between 6 to12 years and approximately 5 hours in children 2-6years.

This is consistent with the urinary excretion half life of the drug. The cumulative urinary excretion represents about two thirds of the administered dose for both adults and children.

The apparent plasma clearance in children is higher than that measured in adults. A high proportion of cetirizine is bound to human plasma proteins.

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Microcrystalline Cellulose (Avicel PH 102) Lactose monohydrate for DC (Tabletose 80) Colloidal anhydrous silica (Aerosil)

Maize Starch Purified Talc Magnesium Stearate

Film Coating:

Opadry White 31F58914

-    Hypromellose 15cP

-    Lactose monohydrate

-    Titanium dioxide

-    Macrogol /

-    Sodium citrate

6.2    Incompatibilities

Not applicable.

6.3    Shelf life

3 years

6.4    Special precautions for storage

This medicinal product does not require any special temperature storage conditions. Keep the blister in the outer carton in order to protect from light.

6.5 Nature and contents of container

Aluminium/PVC clear blister strips, containing 4, 5, 7, 14 or 30 tablets. Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.

Any unused product or waste material should be disposed of in accordance with local requirements.

7    MARKETING AUTHORISATION HOLDER

Cipla (EU) Limited,

Hillbrow House,

Hillbrow Road,

Esher,

Surrey,

KT10 9NW

8    MARKETING AUTHORISATION NUMBER(S)

PL 36390/0127

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

09/06/2011 14/05/2014