Pharmentis Cetirizine Pharmentis Antihistamine 7 Tablets

NAME
CETIRIZINE RATIOPHARM 10 MG

PHARMACOTHERAPEUTIC CATEGORY
Antihistamines for systemic use.

ACTIVE PRINCIPLES
Cetirizine dihydrochloride.

EXCIPIENTS
Core: lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate. Coating: titanium dioxide (E171), hypromellose 5cP (E464), macrogol 400.

INDICATIONS
Adults and pediatric patients from 6 years of age: treatment of nasal and ocular symptoms of seasonal and perennial allergic rhinitis; symptomatic treatment of chronic idiopathic urticaria.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity to the active substance, to any of the excipients, to hydroxyzine or to any derivative of piperazine; patients with severe renal insufficiency with creatinine clearance of less than 10 ml / min.

DOSAGE
Children aged 6 to 12 years: 5 mg twice a day (half tablet twice a day). Adults and children over 12 years of age: 10 mg once daily (1 tablet). The tablets should be taken with a glass of liquid. Elderly patients: based on available data, no dose reduction is required in elderly subjects with normal renal function. Patients with moderate to severe renal insufficiency: the intervals between doses should be individualized according to renal function. Refer to the following table and adjust the dose as indicated. To use this posology, it is necessary to have an estimate of the patient's creatinine clearance (CLcr) in ml / min. CLcr (ml / min) can be obtained starting from the serum creatinine value (mg / dl) using the following formula: clcr equals [140 - age (years)] x weight (kg) divided by 72 x serum creatinine (mg / dl) (x 0.85 for women). >> Dosage adjustment for adults with impaired renal function. Clcr> = 80 ml / min: 10 mg once a day; mild clcr 50 -79 ml / min: 10 mg once daily; moderate clcr 30 -49 ml / min: 5 mg once daily; severe <30 ml / min: 5 mg once every two days; End-stage renal disease - Dialysis patients: contraindicated. In pediatric patients with renal insufficiency, the dose will have to be individually adjusted, taking into account the renal clearance and the patient's body weight. Patients with hepatic insufficiency: Patients with hepatic insufficiency only do not require any dosage adjustments. Patients with hepatic and renal insufficiency: dose adjustment is recommended.

STORAGE
This medicine does not require any special storage conditions.

WARNINGS
At therapeutic doses, there was no evidence of clinically significant interactions with alcohol (for blood alcohol levels of 0.5 g / l). However, caution is advised in case of concomitant alcohol intake. Caution is advised in epileptic patients and in patients at risk for seizures. The use of the film-coated tablet formulation is not recommended in children younger than 6 years, as this formulation does not allow for appropriate dose adjustment. Skin tests for allergy diagnosis are inhibited by antihistamines and a washout period of 3 days is required before undergoing tests. The medicinal product must not be used in patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

INTERACTIONS
For the pharmacokinetic, pharmacodynamic and tolerability profile of cetirizine, no interactions with this antihistamine are expected. In drug-drug interaction studies, in fact, neither pharmacodynamic nor significant pharmacokinetic interactions were reported, in particular with pseudoephedrine or theophylline (400 mg / day). The degree of absorption of cetirizine is not reduced by food; although the rate of absorption decreased.

SIDE EFFECTS
Clinical studies have shown that cetirizine at the recommended dosage has minor CNS undesirable effects, including somnolence, fatigue, dizziness and headache. In some cases, paradoxical CNS stimulation has been reported. Although cetirizine is a selective inhibitor of peripheral H1 receptors and is relatively devoid of anticholinergic activity, rare cases of micturition difficulty, eye accommodation disturbances and dry mouth have been reported. There have been reports of abnormal liver function with liver enzyme elevations accompanied by elevated bilirubin, most of which resolved following discontinuation of cetirizine dihydrochloride. In double-blind controlled clinical trials or clinical pharmacology studies comparing cetirizine versus placebo or other antihistamines at the recommended dosage (10 mg per day for cetirizine), for which quantitative safety data are available, more than 3200 subjects were treated with cetirizine. Based on these data, the following adverse events were reported with an incidence of 1.0% or greater with cetirizine 10 mg in placebo-controlled trials. Body as a whole - general pathologies: fatigue. Central and peripheral nervous system disorders: dizziness, headache. Gastrointestinal system disorders: abdominal pain, dry mouth, nausea. Psychiatric disorders: sleepiness. Respiratory system disorders: pharyngitis. Although statistically the incidence of somnolence with cetirizine was more common than with placebo, this event was mild to moderate in severity in the majority of cases. Further studies in which objective tests have been carried out have shown that usual daily activities are not compromised at the recommended daily dose in young healthy volunteers. Adverse reactions with an incidence of 1% or greater in children aged 6 months to 12 years, in placebo-controlled clinical trials or clinical pharmacology studies. Disorders of the gastrointestinal system: diarrhea. Psychiatric disorders: sleepiness. Respiratory system disorders: rhinitis. Body as a whole - general pathologies: fatigue. >> Post-marketing experience. For these less frequently reported undesirable effects, the estimated frequencies (uncommon:> = 1/1000, <1/100; rare:> = 1 / 10,000, <1/1000; very rare: <1 / 10,000; not known: the frequency cannot be estimated from the available data) were based on post-marketing experience. Disorders of the blood and lymphatic system. Very rare: thrombocytopenia. Disorders of the immune system. Rare: hypersensitivity '; very rare: anaphylactic shock Psychiatric disorders. Uncommon: agitation; rare: aggression, confusion, depression, hallucinations, insomnia; very rare: tic. Nervous system disorders. Uncommon: paraesthesia; rare: convulsions; very rare: dysgeusia, dyskinesia, dystonia, syncope, tremor; not known: amnesia, memory disturbances. Eye disorders. Very rare: accommodation disorder, blurred vision, oculogyration. Cardiac pathologies. Rare: tachycardia. Gastrointestinal disorders. Uncommon: diarrhea. Hepatobiliary disorders. Rare: impaired liver function (elevation of transaminases, alkaline phosphatase, gamma GT and bilirubin). Skin and subcutaneous tissue disorders. Uncommon: pruritus, rash; rare: urticaria; very rare: angioneurotic edema, fixed drug eruption. Renal and urinary disorders. Very rare: dysuria, enuresis. General disorders and administration site conditions. Uncommon: asthenia, malaise; rare: edema. Diagnostic tests. Rare: weight gain.

PREGNANCY AND BREASTFEEDING
Very few clinical data on treatment-exposed pregnancies are available for cetirizine. Animal studies do not show direct or indirect harmful effects with respect to pregnancy, embryonic / fetal development, parturition or postnatal development. Caution should be used when prescribing the medicine to pregnant women. Cetirizine is excreted in breast milk in concentrations representing 0.25-0.90 of those measured in plasma, based on the sampling time after administration. Therefore, care should be taken when prescribing cetirizine to women who are breastfeeding.