Irireos 10 mg/ml - oral antihistamine 10 single-dose vials

Product Description

Antihistamines for systemic use, piperazine derivatives.

Indications

Cetirizine dihydrochloride 10 mg/ml oral drops, solution is indicated in adults and pediatric patients from 2 years of age: for the treatment of nasal and ocular symptoms of seasonal and perennial allergic rhinitis; for the symptomatic treatment of chronic idiopathic urticaria.

Composition

Active ingredients

1 ml of solution contains 10 mg of cetirizine dihydrochloride, one drop of solution contains 0.5 mg of cetirizine dihydrochloride. One single-dose container contains: 10 mg of cetirizine dihydrochloride. 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 oral drops, single-dose solution: glycerol 85%, propylene glycol, sodium saccharin, sodium acetate trihydrate, glacial acetic acid, water for injections. Irireos Antihistamine 10 mg/ml oral drops, solution 20 ml bottle: glycerol 85%, propylene glycol, sodium saccharin, sodium acetate trihydrate, glacial acetic acid, methyl p-hydroxybenzoate (E 218), propyl p-hydroxybenzoate (E 216), water for injections.

Directions for use and Dosage

Dosage: 10 mg (20 drops) once a day. Elderly patients: based on available data, no dose reduction is necessary in elderly subjects with normal renal function. Patients with moderate to severe renal impairment: no data are available to document the efficacy/safety relationship in patients with renal impairment. Since Cetirizine is predominantly excreted renally. In cases where alternative treatments cannot be used, dosing intervals should be individualized based on renal function. Refer to the following dosing list and adjust the dose as indicated. To use this dosing list, an estimate of the patient's creatinine clearance (CLcr) expressed in ml/min is required. CLcr (ml/min) can be calculated from the serum creatinine value (mg/dl) using the following formula: CLcr = [140 - age (years)] x weight (kg) / 72 x serum creatinine (mg/dl) (x 0.85 for women). Dosage adjustment for adults with impaired renal function. 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: end-stage renal disease - dialysis patients; creatinine clearance: < 10 ml/min; dosage and frequency: contraindicated. Patients with hepatic impairment: Patients with only hepatic impairment do not require any dose adjustment. Dose adjustment is recommended in patients with both hepatic and renal impairment (see "Patients with moderate to severe renal impairment" above). Paediatric population. Children aged 2 to 6 years: 2.5 mg (5 drops) twice daily. Children aged 6 to 12 years: 5 mg (10 drops) twice daily. Adolescents over 12 years of age: 10 mg (20 drops) daily. In pediatric patients with renal impairment, the dose should be adjusted individually, taking into account the patient's renal clearance, age, and body weight. Method of administration: The drops should be placed on a spoon or diluted in water and taken orally. If dilution is used, it should be considered that the volume of water added to the drops must be sufficient to be able to be swallowed by the patient, especially for pediatric administration. The solution should be administered immediately.

Warnings

At therapeutic doses, no clinically significant interactions with alcohol have been observed (for blood alcohol levels of 0.5 g/l). However, caution is recommended when taking alcohol concomitantly. Caution should be exercised in patients with predisposing factors for urinary retention (e.g. spinal cord injury, prostatic hyperplasia) since urinary retention may be a sign of increased urinary retention. Cetirizine may increase the risk of urinary retention. Caution is advised in epileptic patients and patients at risk of seizures. Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed). The response to allergy skin tests is inhibited by antihistamines, and a washout period (3 days) is required before performing them. Itching and/or urticaria may occur when cetirizine treatment is stopped, even if these symptoms were not present before starting treatment. In some cases, symptoms may be severe, and restarting treatment may be necessary. Symptoms should resolve when treatment is restarted. Paediatric population: The use of the medicinal product is not recommended in infants and children under 2 years of age.

Contraindications

Hypersensitivity to the active substance, to any of the excipients listed, to hydroxyzine or to any piperazine derivative. Patients with severe renal insufficiency with creatinine clearance less than 10 ml/min.

Undesirable effects

Clinical studies. In general: Clinical studies have shown that cetirizine at the recommended dosage has minor CNS adverse effects, including drowsiness, fatigue, dizziness, and headache. In some cases, paradoxical CNS stimulation has been reported. Although cetirizine is a selective antagonist of peripheral H1 receptors and is relatively free of anticholinergic activity, isolated cases of difficulty urinating, disturbances of ocular accommodation, and dry mouth have been reported. Cases of abnormal liver function with elevated liver enzymes accompanied by elevated bilirubin have been reported, most of which resolved following discontinuation of cetirizine dihydrochloride treatment. List of adverse reactions: In double-blind, controlled clinical trials or clinical pharmacology studies comparing the effects of cetirizine to placebo or other antihistamines at the recommended dosage (10 mg daily for cetirizine), for which quantitative safety data are available, more than 3,200 subjects were treated with cetirizine. Based on these pooled data, the following adverse reactions have been reported in placebo-controlled trials with an incidence of 1.0% or greater with cetirizine 10 mg. Systemic disorders and administration site conditions: fatigue. Nervous system disorders: dizziness, headache. Gastrointestinal disorders: abdominal pain, dry mouth, nausea. Psychiatric disorders: somnolence. Respiratory, thoracic, and mediastinal disorders: pharyngitis. Although statistically more common than with placebo, the majority of somnolence was mild to moderate. Further studies with objective evidence have shown that normal daily activities are not affected at the recommended daily dose in healthy young volunteers. Paediatric population: Adverse reactions with an incidence of 1.0% or greater in children aged 6 months to 12 years in placebo-controlled clinical trials are as follows: Gastrointestinal disorders: diarrhea. Psychiatric disorders: somnolence. Respiratory, thoracic, and mediastinal disorders: rhinitis. General disorders and administration site conditions: fatigue. Post-marketing experience: In addition to the adverse reactions observed in clinical studies, the following adverse reactions have been reported during post-marketing experience. Adverse reactions are described according to MedDRA system organ classification and in accordance with the frequency defined on the basis of post-marketing experience. Frequencies are defined as follows: very common (>=1/10); common (>=1/100, <1/10); uncommon (>=1/1,000, <1/100); rare (>=1/10,000, <1/1,000); very rare (<1/10,000), not known (frequency cannot be estimated from the available data). Blood and lymphatic system disorders: Very rare: thrombocytopenia. Immune system disorders: Rare: hypersensitivity; very rare: anaphylactic shock. Metabolism and nutrition disorders: Not known: increased appetite. Psychiatric disorders: Uncommon: agitation; rare: aggression, confusion, depression, hallucinations, insomnia; very rare: tics; not known: suicidal ideation. Nervous system disorders: Uncommon: paraesthesia; rare: convulsions; very rare: dysgeusia, syncope, tremor, dystonia, dyskinesia; not known: amnesia, memory impairment. Eye disorders: Very rare: accommodation disorder, blurred vision, oculistrotation. Ear and labyrinth disorders: vertigo. Cardiac disorders: Rare: tachycardia. Gastrointestinal disorders: Uncommon: diarrhoea. Hepatobiliary disorders: Rare: abnormal liver function (increased transaminases, alkaline phosphatase, gamma-GT and bilirubin). Skin and subcutaneous tissue disorders: Uncommon: pruritus, rash; rare: urticaria; very rare: angioneurotic oedema, fixed drug eruption. Renal and urinary disorders: Very rare: dysuria, enuresis; not known: urinary retention. General disorders and administration site conditions. Uncommon: asthenia, malaise; rare: edema. Investigations. Rare: weight gain. Description of selected adverse reactions: Pruritus (intense itching) and/or urticaria have been reported after discontinuation of cetirizine treatment. Reporting of suspected adverse reactions. Reporting suspected adverse reactions after authorisation of the medicinal product is important as it allows continued monitoring of the benefit/risk balance of the medicinal product.

Pregnancy and breastfeeding

Pregnancy: Prospective data collected for cetirizine on pregnancy outcomes do not suggest potential maternal toxicity or the fetus/embryo above baseline values. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/fetal development, parturition, or postnatal development. Prescribing to pregnant women should be undertaken with caution. Breastfeeding: Cetirizine is excreted in breast milk at concentrations ranging from 25% to 90% of those measured in plasma, depending on the sampling time after administration. Therefore, prescribing to breastfeeding women should be done with caution. Fertility: Limited data on fertility in humans are available, but no safety concerns have been identified. Animal data do not reveal safety concerns for human production.

Format

10 single-dose containers