CETIRIZINE MY 7CPR RIV 10MG

CETIRIZATION MYLAN GENERICS 10 MG COMPRESENT RIVES WITH FILM

active ingredients

Each tablet coated with film contains 10 mg cetirizine dichloride. Excipient with known effects Each film-coated tablet contains 74.3 mg of lactose monohydrate. For the full list of excipients, see paragraph 6.1.

Excellent

Nucleus of the tablet: Monohydrate lactose, pregelatinized corn starch, Povidone K29/32, Magnesium stearate. Coating of the tablet: Talco, Titanium Dioxide (E171), Ipromellosa 5cP (E464), Macrogol 400.

Therapeutic indications

Cetirizina is indicated in adults and children from 6 years of age: - For treating nasal and eye symptoms of seasonal and perennial allergic rhinitis. - For symptomatic treatment of idiopathic chronic hives.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1 or hydroxyzine or any derivative of piperazin. Patients with severe impairment of kidney function with creatinine clearance less than 10 ml/min.

Population

Population. . Children aged 6 to 12 years: 5 mg twice daily (half a tablet twice daily). Adults and children over 12 years old: 10 mg once a day (one tablet). Seniors: data does not suggest the need to reduce dose, in older people with normal kidney function. Pediatric population: The use of the formulation in tablets coated with film is not recommended in children under the age of 6, because this formulation does not allow an adequate adaptation of the dose. Patients with impairment of moderate to severe kidney function: The intervals between doses must be customized according to the kidney function. Please refer to the following table and adjust the dose as indicated. To use this posological table, it is necessary to have an estimate of creatinine clearance (CLcr) of the patient expressed in ml/min. The CLcr (ml/min) can be obtained from the value of sierica creatinine (mg/dl) using the following formula: Adaptation of posology for adults with compromised kidney function.

Group	Creatine clearance (ml/min)	Dosage and frequency
Normal	≥80	10 mg once a day
Lie	50-79	10 mg once a day
Moderate	30-49	5 mg once a day
Grave		5 mg once every 2 days
Renal disease at the last stage - Patients in dialysis		Contraindicated

In pediatric patients with impairment of kidney function, the dose should be individually adapted, taking into account kidney clearance, age and body weight of the patient. Compromise of liver function: no dose adjustment is required in patients suffering only from impairment of liver function. Compromise of liver and kidney function: an adaptation of posology is recommended (see above “Pacients with impairment of moderate to severe kidney function”). 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 predisposition factors (such as spine injury, prostatic hyperplasia) since cetirizine can increase the risk of urinary retention. Caution is recommended in epileptic patients and patients at risk of seizures. Allergic skin tests are inhibited by antihistamines therefore a wash-out period (of 3 days) is required before carrying out them. Patients with rare hereditary problems of galactose intolerance, lactase lapp deficiency or glucose-galactose mal absorption should not take cetirizine tablets coated with movies.

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 pharmacokinetic interactions have been reported, particularly with pseudophedrine or theophylline (400 mg/die). The degree of absorption of cetirizine is not reduced by food intake, although the absorption rate is decreased.

Effects

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.BenchCetirizine is a selective inhibitor of peripheral H1 receptors and is relatively devoid of anti-linergical activity, rare cases of difficulty in urination, eye tampering disorders and dry mouth have been reported. Anomalous hepatic function has been reported with elevated hepatic enzymes accompanied by high bilirubin, most of which resolved following discontinuation of treatment with cetirizine dichloride. a) Clinical experiments: In the context of double-blind controlled clinical trials or clinical pharmacology studies, in which the effects of cetirizine have been compared to placebo or other antihistamines to the recommended dosage (10 mg per day for cetirizine) for which quantitative safety data are available, more than 3200 subjects have been treated with cetirizine. Based on this data, the following adverse events were reported in placebo controlled trials with an incidence equal to or greater than 1.0% with cetirizine 10 mg:

Adverse events(WHO-ART)	Cetirizina 10 mg (n= 3260)	Placebo (n = 3061)
Body as a whole - general pathologies
Fatigue	1.63%	0,95%
Central and peripheral nervous system pathologies
Heads	1.0%	0,98%
Cefa	7,42%	8,07%
Gastrointestinal system pathologies
Abdominal pain	0,98%	1,08%
Dry mouth	2,09%	0,82%
Nausea	1,07%	1.4%
Psychiatric disorders
Sleep	9,63%	5,00%
Diseases of the respiratory system
Pharisees	1.29%	1.34%

Although statistically the incidence of drowsiness with cetirizine was more common than with the placebo, this event resulted from small 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. Adverse reactions with an incidence of 1% in children aged between 6 months and 12 years, in clinical studies controlled at placebo or clinical pharmacology studies, are:

Adverse reactions (WHO-ART)	Cetirizina (n=1656)	Placebo (n =1294)
Gastro-intestinal system pathologies
Diarrea	1.0%	0,6%
Psychiatric disorders
Sleep	1.8%	1.4%
Diseases of the respiratory system
Rehabilitation	1.4%	1.1%
Body as a whole - general pathologies
Fatigue	1.0%	0.3%

b) Post-marketing experience: The adverse events encountered during the clinical studies listed in the previous paragraph should be added to the isolated cases of the following adverse reactions reported in the post-marketing experience. Undesirable effects are described according to the MedDRA organic systemic classification and the estimated frequency based on post-marketing experience. The frequencies are defined as follows: very common (≥1/10), common (≥1/100 to 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: agitation; Rare: aggression, confusion, depression, hallucinations, insomnia; Very rare: tic; Notable: suicide thoughts. Diseases of the nervous system. . Not common: paresthesia; Rare: seizures; Very rare: dysgeusia, dyskinesia, dystonia, syncope, tremor; Not known: amnesia, impairment of memory. Pathologies of the eye. . Very rare: acknowledgment disorder, blurred vision, oculorotation. Ear and maze pathologies. . Notable: dizziness. Heart disease . . Rare: tachycardia. Gastrointestinal diseases. . Not commonDiarrhea. Hepatobiliary diseases. . Rare: altered liver function (increasing transaminese, alkaline phosphatease _γ- GT and bilirubin. Pathologies of skin and subcutaneous tissue. . Not common: itching, rash; Rare: hives; Very rare: anjourotic edema, fixed eruption from drugs. Kidney and urinary pathologies. . Very rare: disuria, enuresis; Notable: urinary retention. Systemic pathologies and conditions for administration. . Not common: asthenia, malaise; RareEdema. Diagnostic examinations. . Rare: weight gain.Reporting of adverse reactions.Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

a) Symptoms 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. b) Treatment A specific antidote to cetirizine is not known. In case of overdose, symptomatic or support treatment is recommended. Following recent ingestion, gastric lavender is recommended. Cetirizine is not effectively removed by dialysis.

Pregnancy

: For cetirizine there are very few clinical data on pregnancies exposed to treatment. Animal studies show no direct or indirect harmful effects regarding pregnancy, embryo/ fetal development, childbirth or postnatal development. Prescription to pregnant women must be done with caution.

Food

: Cetirizine is excreted in breast milk at concentrations representing 0.25- 0.90 compared to those measured in plasma, depending on the sampling time after administration. Therefore, caution should be used in prescribing Cetirizina Mylan Generics to nursing women.

Source: Farmadati