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Zyrtec

Cetirizine dihydrochloride

NAME OF THE MEDICINAL PRODUCT
Cetirizine dihydrochloride, 10 mg, film-coated tablets
Cetirizine dihydrochloride, 1 mg/ml, oral solution
Cetirizine dihydrochloride, 10 mg/ml, oral drops, solution

QUALITATIVE AND QUANTITATIVE COMPOSITION
Cetirizine dihydrochloride, 10 mg, film-coated tablets
Each film-coated tablet contains 10 mg of cetirizine dihydrochloride.
Cetirizine dihydrochloride, 1 mg/ml, oral solution
Each 1 ml contains 1 mg of cetirizine dihydrochloride.
Cetirizine dihydrochloride, 10 mg/ml, oral drops, solution
Each 1 ml contains 10 mg of cetirizine dihydrochloride.

Excipients
Cetirizine dihydrochloride, 10 mg, film-coated tablets
Microcrystalline cellulose, Lactose, Colloidal anhydrous silica, Magnesium stearate, Opadry Y-1-7000.
Cetirizine dihydrochloride, I mg/ml, oral solution
Sorbitol solution at 70 % (non crystallizing, Glycerol, Propylene glycol, Sodium soccharinate,
Methylparahydroxybenzoate, Propylparohydroxybenzoate, Banana flavour 54.330/A (Firmenich), Sodium Acetate, Glacial Acetic Acid, Purified water.
Cetirizine dihydrochloride, 10 mg/ml, oral drops, solution
Glycerol, Propylene glycol, Sodium saccharincte, Methylparahydroxybenzoate, Propylparahydroxybenzoate, Sodium acetate, Glacial acetic acid, Purified water.

PHARMACEUTICAL FORM
Cetirizine dihydrochloride, 10 mg, film-coated tablets
White, oblong, film-coated tablet, with breakline and Y-Y logo.
Cetirizine dihydrochloride, 1 mg/ml, oral solution
Clear and colourless liquid with slightly sweet taste and a banana flavour.
Cetirizine dihydrochloride, 10 mg/ml, oral drops, solution
Clear and colourless liquid with slightly sweet taste and a bitter flavour.

CLINICAL INFORMATION
Indications
Adults and children of 2 years and above: symptomatic treatment of seasonal allergic rhinitis, perennial allergic rhinitis and urticaria of allergic origin.

Dosage and Administration
The tablets need to be swallowed with a glass of liquid.
The drops have to be diluted in liquid, while the solution can be swallowed as such.

Route of Administration
For oral use.

Adults
10 mg (20 drops or 10 ml oral solution or 1 tablet) once daily.
A 5 mg starting dose (10 drops or 5 ml of oral solution or half of the tablet) may be proposed if this leads to satisfactory control of the symptoms.

Children
Children aged from 2 to 6 years
2.5 mg (5 drops or 2.5 ml of oral solution bid) twice daily.
Children aged from 6 to 12 years
5 mg (10 drops or 5 ml of oral solution or half of the tablet) twice daily.
Children over 12 years of age
10 mg j20 drops or 10 ml of oral solution or 1 tablet) once daily.

Elderly
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
The dosing intervals must be individualised 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:


Dosing adjustments for adult patients with impaired renal function

Group

Creatinine clearance (ml/min)

Dosage and frequency

Normal

≥80

10 mg once daily

Mild

50 - 79

10 mg once daily

Moderate

30 - 49

5 mg once daily

Severe

< 30

5 mg once every 2 days

End-stage renal disease -

Patients undergoing dialysis

< 10 Contra-indicated

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, his age and his body weight.

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

Patients with hepatic impairment and renal impairment
Dose adjustment is recommended (see Patients with renal impairment above).

Contraindications
Cetirizine is contraindicated in:
hypersensitivity to any of the constituents of this formulation, to hydroxyzine or to any piperazine derivatives.
patients with severe renal impairment at less than 10 ml/min creatinine clearance.

Warnings and Precautions
Alcohol

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.

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

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

Children
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. It is recommended to use a paediatric formulation of cetirizine.

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

Activities requiring mental alertness
In clinical trials, the occurrence of somnolence has been reported in some patients taking Zyrtec. Due caution should therefore be exercised when driving a car or operating potentially dangerous machinery.

Excipients
Lactose
Cetirizine dihydrochloride, 10 mg, film-coated tablets
These products contain lactose. Patients with rare hereditary problems of galactose intolerance, (the Lapp lactase deficiency or glucose-galactose malabsorption) should not take this medicine.

Sorbitol
Cetirizine dihydrochloride, 1 mg/ml, oral solution
This product contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Parabens
Cetirizine dihydrochloride, 1 mg/ml, oral solution
Cetirizine dihydrochloride, 10 mg/ml, oral drops, solution

These products contain methylparahydroxybenzoate or propylparahydroxybenzoate, which may cause allergic reactions (possibly delayed).

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