Ticerin 10mg Cetirizin Dichlorohydrate Antihistamine 7 Coated Tablets

Therapeutic indications

Adults and pediatric patients from 6 years of age: • Cetirizine is indicated for the treatment of nasal and ocular symptoms of seasonal and perennial allergic rhinitis • Cetirizine is indicated for the symptomatic treatment of chronic idiopathic urticaria.

Dosage

Children aged 6 to 12 years : 5 mg twice a day (half tablet twice a day). Adults and adolescents over 12 years of age : 10 mg once daily (1 tablet) Elderly patients : Based on available data, no dose reduction is required in elderly subjects with normal renal function. Patients with moderate to severe renal impairment : No data are available documenting the efficacy / safety ratio in patients with renal impairment. Since cetirizine is mainly excreted via the kidney (see section 5.2), in cases where alternative treatment is not possible, the intervals between doses should be individualized according to renal function. Refer to the table below and adjust the dose as indicated. Use of the table requires an estimate of the patient's creatinine clearance (CL _cr ) in ml / min. CL _cr (ml / min) can be obtained on the basis of the determination of serum creatinine (mg / dl) according to the following formula:

CL cr =	[140 - age (years)] x weight (kg)	(x 0.85 for women )
	72 x serum creatinine (mg / dL)

Dosage adjustment for adult patients with renal impairment:

Group	Creatinine clearance (ml / min)	Dose and frequency
Normal	≥ 80	10 mg once a day
Mild	50–79	10 mg once a day
Moderate	30–49	5 mg once a day
Serious	<30	5 mg once every 2 days
End-stage renal disease - dialysis patients	<10	Contraindicated

In pediatric patients with renal impairment, the dose should be individually adjusted taking into account the patient's renal clearance and body weight. Patients with hepatic impairment : No dosage adjustment is required in patients with hepatic impairment alone. Patients with hepatic and renal impairment : dose adjustment is recommended (see "Patients with moderate to severe renal impairment"). Method of administration The tablets should be swallowed with a glass of water. Instructions for dividing the tablets Place the tablet on a hard, flat surface (such as a table top or plate) with the score line facing up. Then press at the same time with your fingers (thumbs or index fingers) shortly but firmly on the outer edges to the right and left of the score line.

Overdose

Symptoms Symptoms observed following an overdose of cetirizine are mainly associated with CNS effects or effects that may suggest an anticholinergic effect. Following a dose of at least 5 times the recommended daily dose, the following adverse events have been reported: confusion, diarrhea, dizziness, fatigue, headache, malaise, mydriasis, pruritus, restlessness, sedation, somnolence, drowsiness, tachycardia , tremors and urinary retention. Treatment There is no known antidote for cetirizine. In the event of an overdose, symptomatic or supportive treatment is recommended. Following recent ingestion, gastric lavage is recommended. Cetirizine is not effectively removed by hemodialysis.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or to hydroxyzine or to any derivative of piperazine. Patients with severe renal impairment, with creatinine clearance less than 10 ml / min.

Side effects

Clinical studies have shown that cetirizine at the recommended dosage has minor CNS side effects, including somnolence, fatigue, dizziness and headache. Paradoxical CNS stimulation has been reported in some cases. Although cetirizine is a selective peripheral H ₁ receptor antagonist and is relatively free of anticholinergic activity, isolated cases of micturition difficulty, eye accommodation disturbances and dry mouth have been reported. There have been reports of abnormal liver function, with elevation of liver enzymes accompanied by elevated bilirubin. Most of these cases resolve upon discontinuation of cetirizine dichlorohydrate treatment. Clinical trials Double-blind controlled clinical trials or clinical pharmacology studies have been performed, comparing cetirizine versus placebo or other antihistamines at the recommended dose (cetirizine 10 mg / days), for which quantitative safety data are available, based on over 3200 subjects exposed to cetirizine. Based on these data, the following adverse events were reported in placebo-controlled trials with an incidence of 1.0% or greater with cetirizine 10 mg:

Adverse Events (WHO – ART)	Cetirizine 10 mg (n = 3260)	Placebo (n = 3061)
Organism as a whole - systemic pathologies
Fatigue	1.63%	0.95%
Central and peripheral nervous system disorders
Dizziness	1.10%	0.98%
Headache	7.42%	8.07%
Disorders of the gastrointestinal system
Abdominal pain	0.98%	1.08%
Dry mouth	2.09%	0.82%
Nausea	1.07%	1.14%
Psychiatric disorders
Drowsiness	9.63%	5.00%
Respiratory system disorders
Pharyngitis	1.29%	1.34%

Although statistically the incidence of somnolence was more common with cetirizine than with placebo, it was mild to moderate in the majority of cases. As demonstrated in other studies, objective tests showed that in healthy young volunteers, the drug did not affect normal daily activities at the recommended daily dose. Adverse drug reactions with incidence of 1% or greater in children aged 6 months to 12 years, included in placebo-controlled clinical trials or clinical pharmacology studies, are:

Adverse event (WHO – ART)	Cetirizine 10 mg (n = 1656)	Placebo (n = 1294)
Disorders of the gastrointestinal system
Diarrhea	1.0%	0.6%
Psychiatric disorders
Drowsiness	1.8%	1.4%
Respiratory system disorders
Rhinitis	1.4%	1.1%
Organism as a whole systemic pathologies
Exhaustion	1.0%	0.3%

Post-marketing experience To the adverse events reported during clinical trials and listed in the previous paragraph, isolated cases of the following adverse reactions reported in post-marketing experience should be added. For these less frequently reported undesirable effects, the estimated frequencies are: Very common (≥1 / 10); common (≥1 / 100 to <1/10); uncommon (≥1 / 1000 to <1/100); rare (≥1 / 10,000 to <1 / 1,000); very rare (<1 / 10,000), frequency not known (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 Frequency not known: increased appetite Psychiatric disorders Uncommon: agitation Rare: aggression, confusion, depression, hallucinations, insomnia Very rare: tic Frequency not known: suicidal ideation Nervous system disorders Uncommon: paraesthesia Rare: convulsions Very rare: dysgeusia, dyskinesia, dystonia, syncope, tremors Frequency not known: amnesia, memory impairment Eye disorders Very rare: Eye accommodation disorders, vision blurred, oculogyrinth Ear and labyrinth disorders Frequency not known: dizziness Cardiac disorders Rare: tachycardia Gastrointestinal disorders Uncommon: diarrhea Hepatobiliary disorders Rare: abnormal liver function (increased transaminases, alkaline phosphatase , γ – GT and bilirubin ) skin and subcutaneous tissue Uncommon: pruritus, rash Rare: urticaria Very rare: angioneurotic edema, fixed drug eruption Renal and urinary disorders Very rare: dysuria, enuresis Frequency not known: urinary retention General disorders and administration site conditions Uncommon: asthenia, malaise Rare: edema Investigations Rare: weight gain Reporting of adverse reactions Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the drug. medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system: www.agenziafarmaco.gov.it/it/responsabili

Pregnancy and breastfeeding

Pregnancy Very few clinical data on exposed pregnancies are available for cetirizine. Animal studies did not indicate direct or indirect harmful effects with respect to pregnancy, embryonal / fetal development, parturition or postnatal development. Caution should be exercised when prescribing the product to pregnant women. Breastfeeding Cetirizine is excreted in breast milk at concentrations ranging from 0.25 to 0.90 of that measured in plasma, depending on the sampling times from administration. Therefore, caution should be exercised when prescribing the product to lactating women.

Special warnings

At therapeutic doses, no clinically significant interactions with alcohol were shown (for blood alcohol levels of 0.5 g / L). However, caution is recommended in case of concomitant alcohol intake. Caution should be exercised in patients with predisposing factors for urinary retention (e.g. spinal cord injury, prostatic hyperplasia), as cetirizine may increase the risk of urinary retention. Caution is advised in epileptic patients and in patients at risk for seizures. Use of the film-coated tablet formulation is not recommended in children below 6 years of age as this formulation does not allow for appropriate dose adjustment. Allergy skin tests are inhibited by antihistamines, therefore a wash-out period (3 days) is required before performing them. Pediatric population Use of the film-coated tablet formulation is not recommended in children below 6 years of age as this formulation does not allow for appropriate dose adjustment. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Expiry and Retention

This medicine does not require any special storage conditions.

Active principles

Each film-coated tablet contains 10 mg of cetirizine dichlorohydrate. Excipient with known effect: lactose monohydrate (66 mg). For the full list of excipients, see section 6.1.

Excipients

Core : Lactose monohydrate Microcrystalline cellulose Colloidal anhydrous silica Magnesium stearate Coating : Titanium dioxide (E171) Hypromellose (E464) Macrogol