ZIRTEC 7CPR RIV 10MG

ZIRTEC 10 MG FILM-COATED TABLETS

active ingredients

Each tablet coated with film contains 10 mg of cetirizine dichloride. Excipients with known effects: Each film-coated tablet contains 66.40 mg of lactose monohydrate. For the full list of excipients, see paragraph 6.1.

Excellent

- Cellulose microcrystalline - Lactose monohydrate - Silice anidra colloidal - Magnesium stearate - Opadry Y-1-7000 which consists of: - Hydroxypropylmethylcellulose (E 464) - Titanium oxide (E 171) - Macrogol 400.

Therapeutic indications

10 mg cetirizine tablets coated with film are indicated in adults and pediatric patients aged 6 years: - for the treatment of nasal and eye symptoms of seasonal and perennial allergic rhinitis. - for symptomatic treatment of idiopathic chronic hives.

Contraindications

Hypersensitivity to the active ingredient, to any of the excipients listed in paragraph 6.1, to hydroxyzine or to any derivative of piperazine. Patients with kidney disease in terminal phase with eGFR (Estimate Glomerular Filtration Speed) less than 15 ml/min.

Population

Population 10 mg once a day (1 tablet). Special popularity Seniors On the basis of the available data, in elderly individuals with normal kidney function no reduction of the dose is necessary. Renal Compromise There are no available data that documents the effectiveness/security ratio in patients with renal impairment. Since cetirizine is mainly excreted by renal (see paragraph 5.2), in cases where alternative treatments cannot be used, the interval between doses must be identified according to kidney function. Refer to the following table and establish the dose as indicated. Dose adjustments in adult patients with renal impairment

Group	Estimated Glomerular Filtration Speed eGFR)(mL/min)	Dose and frequency
Normal kidney function	≥90	10 mg once a day
Low renal functionality compromise	60 -	10 mg once a day
Moderate compromise of renal functionality	30 -	5 mg once a day
Severe impairment of kidney function	15-	5 mg once every 2 days
Terminal phase of kidney disease		Contraindicated

Epathetic Comprogation Patients suffering only from liver impairment do not need any dose adjustment. A dose adaptation is recommended in patients with liver and kidney impairment (see Renal Compromise). Pediatric population The formulation of the drug in tablets should not be used in children under 6 years of age as it does not allow the necessary adjustments of the dose. Children between 6 and 12 years old: 5 mg twice a day (half compressed twice a day). Adolescents over 12 years of age: 10 mg once a day (1 tablet). In pediatric patients suffering from renal impairment, the dose should be individually adapted, taking into account kidney clearance, age and body weight of the patient. Method of administration Tablets should be taken with a glass of liquid.

Conservation

This medicine does not require any special condition of conservation.

Warnings

At therapeutic doses, clinically significant interactions with alcohol were not highlighted (for blood levels of 0.5 g/l). However, caution is recommended in case of concomitant alcohol intake. Caution should be given in patients with urinary retention factors (such as spinal cord injury, prostatic hyperplasia) since cetirizine may increase the risk of urinary retention. Caution is recommended in epileptic patients and patients at risk of seizures. The response to skin tests for allergy is inhibited by antihistamines and a wash-out period (of 3 days) is required before performing them. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose mal absorption, should not take this medicine. Itching and/or hives may occur when the treatment with cetirizine is interrupted, even if such symptoms were not present before the start of treatment. In some cases, symptoms can be intense and you may need to start treatment again. Symptoms should resolve when you start treatment again. Pediatric population The use of the formulation in tablets coated with film is not recommended in children under 6 years of age, since this formulation does not allow an appropriate adaptation of the dose. It is recommended to use a pediatric formulation of cetirizine.

Interactions

For the pharmacokinetic, pharmacodynamic and tolerability profile of cetirizine, there are no interactions with this antihistamine. In drug-pharmaceutical interaction studies, in fact, no significant pharmacodynamic interactions or pharmacocinetic interactions have been reported, particularly with pseudophedrine or theophylline (400 mg/day). The degree of absorption of cetirizine is not reduced by food intake, although the absorption rate is decreased. In sensitive patients, the simultaneous intake of cetirizine with alcohol or other substances with depressing action on SNC may cause further decrease in the state of alertness and alteration of performance, although cetirizine does not enhance the effect of alcohol (0,5 g/L of blood levels).

Effects

Clinical studies • General Clinical studies have shown that cetirizine at the recommended dosage has minor side effects at SNC level, which include drowsiness, fatigue, dizziness and headache. In some cases, paradox stimulation of the SNC was reported. Although cetirizine is a selective antagonist of H receptors₁ peripheral and relatively devoid of anti-linergical activity, isolated cases of difficulty in urination, disturbances of visual accomodation and dry mouth have been reported. Anomalous hepatic function has been reported with elevated hepatic enzyme levels accompanied by high bilirubin, most of which solved following discontinuation of treatment with cetirizine dichloride. • List of adverse reactions In the context of double-blind controlled clinical trials, in which cetirizine was compared to placebo or other antihistamines at the recommended dose (10 mg per day per cetirizine), for which there are quantitative safety data, more than 3200 subjects have been exposed to cetirizine. Based on this data, the following adverse reactions with an incidence equal to or greater than 1.0% with cetirizine 10 mg were reported in placebo tests:

Adverse reactions (WHO-ART)	Cetirizina 10 mg (n= 3260)	Placebo (n = 3061)
General pathologies and conditions for administration
Fatigue	1.63%	0,95%
Diseases of the nervous system
Heads	1.0%	0,98%
Cefa	7,42%	8,07%
Gastrointestinal diseases
Abdominal pain	0,98%	1,08%
Dry mouth	2,09%	0,82%
Nausea	1,07%	1.4%
Psychiatric disorders
Sleep	9,63%	5,00%
Respiratory, chest and mediastinic pathologies
Pharisees	1.29%	1.34%

Although statistically the incidence of drowsiness is more common than with placebo, this event has resulted from mild to moderate entities in most cases. Further studies in which objective tests have been carried out have shown that the usual daily activities are not compromised at the recommended daily dose, in healthy young volunteers. Pediatric population Adverse reactions with an incidence equal to or greater than 1.0% in children aged between 6 months and 12 years, in placebo controlled clinical trials are:

Adverse reactions (WHO-ART)	Cetirizina (n=1656)	Placebo (n =1294)
Gastrointestinal diseases
Diarrea	1.0%	0,6%
Psychiatric disorders
Sleep	1.8%	1.4%
Respiratory, chest and mediastinic pathologies
Rehabilitation	1.4%	1.1%
General pathologies and conditions for administration
Fatigue	1.0%	0.3%

Post-marketing experience In addition to adverse reactions found during clinical trials, listed in the previous paragraph, the following side effects were reported during post-marketing experience. The side effects are described according to MedDRA by classification for systems and organs and according to the frequency defined on the basis of post-marketing experience. The frequencies are defined as follows: very common (≥1/10); common (≥1/100, pathologies of the emolinfopoietic system: Very rare: trombocytopenia Immune system disorders: Rare: hypersensitivity Very rare: anaphylactic shock Disorders of metabolism and nutrition: Notable: increased appetite Psychiatric disorders: Not common: Rare agitation: aggressiveness, confusion, depression, hallucinations, insomnia Very rare: tic Notable: suicidal idea, nightmare Diseases of the nervous system: Not common: parestesia Raro: convulsioni Very rare: disgeusia, sincope, tremor, distonia, discinesia Not known: amnesia, impairment of memory Pathologies of the eye: Very rare: ailment disorder, blurred vision, oculogira crisis Ear and labyrinth pathologies: Notable: vertigo Heart disease: Rare: tachycardia Gastrointestinal diseases: Not common: diarrhea Hepatobiliary diseases: Rare: altered liver function (increasing transaminese, alkaline phosphatease, γ-GT and bilirubin) Notable: hepatitis Pathologies of skin and subcutaneous tissue: Not common: itching, rash Rare: hives Very rare: angioneurotic edema, fixed eruption by drugs Notable: generalized acute exantematic pustolosis Diseases of musculoskeletal system and connective tissue: Notable: artralgia, mialgia Kidney and urinary pathologies: Very rare: disuria, enurei Not known: urinary retention General conditions and conditions relating to the administration office: Not common: asthenia, Rare malaise: edema Diagnostic examinations: Rare: weight gain. Description of selected adverse reactions Itching and/or hives have been reported, after discontinuation of the treatment of cetirizine. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Synonyms Symptoms observed as a result of a cetirizine overdose are mainly associated with effects on the central nervous system or effects that may suggest anti-linergic activity. As a result of taking a dose of at least 5 times the recommended daily dose, the following adverse events were reported: confusion, diarrhea, dizziness, fatigue, headache, malaise, midriasis, itching, restlessness, sedation, drowsiness, astonishment, tachycardia, tremor and urinary retention. Treatment A specific antidote to cetirizine is not known. In case of overdose, symptomatic or support treatment is recommended. The gastric lavender can be taken into account in the event that a short time has passed since the ingestion of the medicinal product. Cetirizine is not effectively removed for hemodilysis.

Pregnancy

Perspective data collected for cetirizine on pregnancy outcomes do not suggest a potential toxicity for the mother or for the fetus/embry above the basic values. Animal studies show no direct or indirect harmful effects regarding pregnancy, embryo/fetal development, childbirth or post-natal development. Prescription to pregnant women must be done with caution.

Food

Cetirizina passes into breast milk. It is not possible to exclude a risk of undesirable effects in infants breast milked. Cetirizine is excreted in breast milk at concentrations representing 25% to 90% of those measured in plasma, depending on the sampling time after administration. Therefore the prescription to nursing women must be carried out with caution.

Fertility

Limited human fertility data are available, but safety issues have not been identified. Animal data shows no safety issues for human reproduction.

Source: Farmadati