ZENTIVA Cetirizine Zentiva, Cetirizina Zentiva 7x10Mg ZENTIVA

“Composition
Active ingredients
Cetirizine dihydrochloride.
Excipients
Tablet core: lactose monohydrate; corn starch; povidone 30; magnesium stearate. Tablet coating: hypromellose 2910/5 (E464); macrogol 6000; talc; titanium dioxide (E171); simethicone emulsion SE 4.

Directions
Cetirizine Zentiva 10 mg is indicated for adults and children aged 6 years and over:
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.

Method of administration and dosage
Children aged 6 to 12 years: 5 mg twice daily (half a tablet twice daily). Adults and adolescents over 12 years: 10 mg once daily (1 tablet).
Tablets should be taken with a glass of liquid.
Elderly patients: Based on the available data, no dose reduction is necessary in elderly patients with normal renal function. Patients with moderate and severe renal impairment: There are no data to support the balance between efficacy and safety in patients with renal impairment. Since cetirizine is eliminated primarily by the kidneys, in cases where alternative treatment methods cannot be used, the dosage intervals should be individualized based on renal function. >> Dosage adjustment for adults with renal impairment. normal creatinine clearance >=80 (ml/min): 10 mg once daily; mild creatinine clearance 50–79 (ml/min): 10 mg once daily; Moderate creatinine clearance 30 – 49 (ml/min): 5 mg once daily; Marked clearance 30 (ml/min): 5 mg once every 2 days; End-stage renal disease – patients on dialysis 10 (ml/min): Contraindicated. In children with renal insufficiency, the dose should be individualized taking into account renal clearance, age and body weight of the patient. Patients with impaired liver function: No dose adjustment is required for patients with impaired liver function. Patients with impaired liver and kidney function: Dose adjustment is recommended.

Warnings
No clinically significant interactions with alcohol have been observed when used in therapeutic doses (at a blood alcohol level of 0.5 g/l). However, caution is recommended when taking alcohol concomitantly. Caution should be exercised when administering the drug to patients with predisposing factors for urinary retention (e.g. spinal cord injury, prostatic hyperplasia) since cetirizine may increase the risk of urinary retention. Caution should be exercised in patients with epilepsy and in patients at risk of seizures. The results of skin allergy tests are inhibited by antihistamines, therefore it is recommended to wait a washout period (3 days) before testing. Paediatric population: the use of the drug in the form of film-coated tablets is not recommended for children under 6 years of age, since this form of release does not allow for appropriate dose adjustment. Cetirizine contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.”

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