ZIRTEK ALLERGY Film-coated tablet Ref.[6300] Active ingredients: Cetirizine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: UCB Pharma Ltd, 208 Bath Road, Slough, Berkshire, SL1 3WE

Therapeutic indications

Cetirizine dihydrochloride 10 mg film-coated tablets are indicated in adults and paediatric patients 6 years and above:

  • For the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
  • For the relief of symptoms of chronic idiopathic urticaria.

Posology and method of administration

Posology

10 mg once daily (1 tablet).

Special population

Elderly

Data do not suggest that the dose needs to be reduced in elderly subjects provided that the renal function is normal.

Renal impairment

There are no data to document the efficacy/safety ratio in patients with renal impairment. Since cetirizine is mainly excreted via renal route (see section 5.2), in cases no alternative treatment can be used, the dosing intervals must be individualized according to renal function. Refer to the following table and adjust the dose as indicated. To use this dosing table, an estimate of the patient’s creatinine clearance (CLcr) in ml/min is needed. The CLcr (ml/min) may be estimated from serum creatinine (mg/dl) determination using the following formula:

Clcr = [140 – age (years) x weight (kg)] / 72 x serum creatinine (mg/dl) (x 0.85 for women)

Dosing adjustments for adult patients with impaired renal function:

GroupCreatinine clearance (ml/min) Dosage and frequency
Normal≥8010 mg once daily
Mild50–7910 mg once daily
Moderate30–495 mg once daily
Severe<305 mg once every 2 days
End-stage renal disease – Patients undergoing dialysis<10Contraindicated

Hepatic impairment

No dose adjustment is needed in patients with solely hepatic impairment. In patients with hepatic impairment and renal impairment, adjustment of the dose is recommended (see Patients with moderate to severe renal impairment above).

Paediatric population

The tablet formulation should not be used in children under 6 years of age as it does not allow the necessary dose
adjustments.

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

Adolescents above 12 years: 10 mg once daily (1 tablet).

In paediatric patients suffering from renal impairment, the dose will have to be adjusted on an individual basis taking into account the renal clearance, age and body weight of the patient.

Method of administration

The tablets need to be swallowed with a glass of liquid.

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. Gastric lavage may be considered shortly after ingestion of the drug.

Cetirizine is not effectively removed by haemodialysis.

Shelf life

5 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

The tablets are enclosed in a transparent, colorless, inert PVC blister strip thermo-sealed with a lacquered aluminium foil. These blister strips are housed in a carton box.

Boxes of 1, 4, 5, 7, 10, 14, 15, 20, 21, 30, 40, 45, 50, 60, 90, 100 or 100 (10x10) tablets.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

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

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.