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CETRINE

Information leaflet

                                                         Irish Medicines Board




                                   Summary of Product Characteristics
 1 NAME OF THE MEDICINAL PRODUCT

 Cetrine 10 mg Film-coated Tablets

 2 QUALITATIVE AND QUANTITATIVE COMPOSITION

 Each film-coated tablet contains Cetirizine Dihydrochloride 10 mg.

 Excipients: Also contains Lactose Monohydrate 81.8mg

 Fora full list of excipients, see section 6.1.

 3 PHARMACEUTICAL FORM

 Film-coated tablets
 White, oblong film-coated tablet, scored on one side.
 The scoreline is to allow the tablet to be divided into equal halves.

 4 CLINICAL PARTICULARS

 4.1 Therapeutic Indications
 In adults and paediatric patients 6 years and above:
  -   Cetirizine is indicated for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
  -   Cetirizine is indicated for the relief of symptoms of chronic idiopathic urticaria.

 4.2 Posology and method of administration

 Route of Administration: Oral.

 Recommended Dosage Schedule:

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

 Adults and adolescents over 12 years of age: 10 mg once daily (1 tablet).

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

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

 Patients with Moderate to severe 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 individualised according to renal function. Refer to the following
 table and adjust the dose as indicated. To use the 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)             (x 0.85 for women)
   72 x serum creatinine (mg/dl)




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Date Printed 06/02/2012                               CRN 2111380                                         page number: 1
                                                         Irish Medicines Board




 Dosing adjustments for adult patients with impaired renal function
  Group                            Creatinine Clearance (ml/min)             Dosage and frequency
  Normal                            80                                       10mg once daily
  Mild                             50 – 79                                   10mg once daily
  Moderate                         30 – 49                                   5mg once daily
  Severe                            30                                       5 mg once every 2 days
  End Stage Renal Disease –         10                                       Contraindicated
  Patients undergoing dialysis

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

 Patients with hepatic impairment: no dosage adjustment is required in patients with solely hepatic impairment.

 Patients with hepatic impairment and renal impairment: dose adjustment is recommended (see Patients with moderate
 to severe renal impairment above).

 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 of less than 10ml/min creatinine clearance.

 4.4 Special warnings and precautions for use
 At therapeutic doses, no clinically significant interactions have been demonstrated with alcohol (for a blood alcohol level of
 0.5g/L). Nevertheless, precaution is recommended if alcohol is taken concomitantly.

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

 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.

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

 Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
 should not take this medicine.

 4.5 Interaction with other medicinal products and other forms of interaction
 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 drug-drug
 interactions studies performed, notably with pseudoephedrine or theophylline (400mg/day).

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

 4.6 Fertility, pregnancy and lactation
 For cetirizine, very rare clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect
 harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see 5.3).
 Caution should be exercised when prescribing to pregnant women.

 Lactation
 Cetirizine is excreted in human milk at concentrations representing 0.25 to 0.90 those measured in plasma, depending on sampling
 time after administration. Therefore, caution should be exercised when prescribing cetirizine to lactating women.




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Date Printed 06/02/2012                               CRN 2111380                                         page number: 2
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