MONTEFARMACO, Irireos 10 mg/ml 10 MONTEFARMACO

“Composition
Active ingredients
1 ml of solution contains 10 mg of cetirizine dihydrochloride, one drop of solution contains 0.5 mg of cetirizine dihydrochloride. Single dose container contains: cetirizine dihydrochloride 10 mg. Irireos antihistamine 10 mg/ml oral drops, solution 20 ml bottle, excipients: 1 ml of solution contains 1.35 mg of methyl parahydroxybenzoate; 1 ml of solution contains 0.15 mg of propyl parahydroxybenzoate.
Excipients
Irireos Antihistamine 10 mg/ml drops for oral use, single dose solution: glycerin 85%, propylene glycol, sodium saccharin, sodium acetate trihydrate, glacial acetic acid, water per inch Irireos Antihistamine 10 mg/ml drops for oral use, solution 20 ml bottle: 85% glycerin, propylene glycol, sodium saccharin, sodium acetate trihydrate, glacial acetic acid, methyl p-hydroxybenzoate (E 218), propyl p-hydroxybenzoate (E 216), ppi water

Directions
Cetirizine dihydrochloride 10 mg/ml drops for oral use, solution is indicated for adults and children from 2 years of age: for the treatment of nasal and ocular symptoms of seasonal and year-round allergic rhinitis; for the symptomatic treatment of chronic idiopathic urticaria.

Method of administration and dosage
Dosage: 10 mg (20 drops) once daily. Elderly patients: Based on available data, no dosage reduction is necessary in elderly patients with normal renal function. Patients with moderate to severe renal impairment: There are no data to support the efficacy/safety ratio in patients with renal impairment. Since cetirizine is primarily eliminated by the kidneys, in cases where alternative treatments cannot be used, dosing intervals should be individualized based on renal function. Refer to the following list and adjust the dose as indicated. To use this dosing list, it is necessary to have an estimate of the patient’s creatinine clearance (CL cr), expressed in ml/min. CL cr (mL/min) can be estimated from serum creatinine (mg/dL) using the following formula: CL^cr = [140 – age (years)] x weight (kg) / 72 x serum creatinine (mg/dL) (x 0.85 for women). Dose adjustment for adults with renal impairment. Group: Normal; Creatinine clearance: >= 80 mL/min; Dosage and frequency: 10 mg once daily. Group: Mild; Creatinine clearance: 50 – 79 mL/min; Dosage and frequency: 10 mg once daily. Group: Moderate; Creatinine clearance: 30 – 49 mL/min; Dosage and frequency: 5 mg once daily. Group: Severe; Creatinine clearance: < 30 mL/min; Dosage and frequency: 5 mg once every 2 days. Group: ESRD – dialysis patients; creatinine clearance: < 10 ml/min; dosage and frequency: contraindicated. Patients with impaired liver function. No dose adjustment is required in patients with impaired liver function alone. Dose adjustment is recommended in patients with impaired liver and kidney function (see above “Patients with moderate to severe renal impairment”). Paediatrics. Children 2 to 6 years of age: 2.5 mg (5 drops) twice daily. Children 6 to 12 years of age: 5 mg (10 drops) twice daily. Adolescents over 12 years of age: 10 mg (20 drops) daily. In children with impaired renal function, the dose should be adjusted individually based on renal clearance, age and body weight of the patient. Method of administration: The drops should be placed on a spoon or diluted with water and taken orally. If dilution is used, it should be taken into account that the volume of water added to the drops should be in an amount that the patient can take, especially for pediatric use. The solution should be administered immediately.

Warnings
In therapeutic doses, no clinically significant interactions with alcohol have been identified (at a blood alcohol level of 0.5 g / l). However, caution is recommended when taking alcohol at the same time. Caution should be exercised in patients with factors predisposing to urinary retention (e.g. spinal cord injury, prostatic hyperplasia), since cetirizine may increase the risk of urinary retention. Caution is recommended in patients with epilepsy and in patients at risk of seizures. Methyl parahydroxybenzoate and propyl parahydroxybenzoate can cause allergic reactions (even delayed). The reaction to skin tests for allergy is suppressed by antihistamines and a washout period (3 days) is required before performing them. When cetirizine treatment is stopped, itching and/or urticaria may occur, even if such symptoms were not observed before treatment. In some cases, symptoms may be intense and it may be necessary to resume treatment. Symptoms should disappear when treatment is resumed. Paediatric population: use in infants and children under 2 years of age is not recommended.”