ICTERIN 7CPR RIV 10MG

TICERIN 10 MG COMPRESENT RIVES WITH FILM

active ingredients

Each film-coated tablet contains 10 mg of dichlorohydrate cetirizine. Excipient with known effect: Lactose monohydrate (64 mg). For the full list of excipients, see paragraph 6.1.

Excellent

Compressed core: Lactose monohydrate, Cellulosa microcrystalline, Croscarmellosa sodica, Silice colloidal anidra, Magnesium stearate. Coating of the tablet: Titanium Dioxide (E171), Ipromellose (E464), Macrogol.

Therapeutic indications

Ticerin is indicated in adults and pediatric patients aged 6: • 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 any derivative of piperazin. • Severe kidney damage with a creatinine clearance of less than 10 ml/min.

Population

Population Adults: 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 year: There are no data that documents the effectiveness/security ratio in patients with kidney damage. Since cetirizine is excreted mainly by renal (see paragraph 5.2), in cases where it is not possible to use an alternative treatment, the intervals between doses must be customized according to renal function. See the table below and adjust the dose as indicated. Using the table requires the estimate of creatinine clearance (CL)_cr) the patient in ml/min. The CL_cr (ml/min) can be obtained on the basis of the determination of sierica creatinine (mg/dl) according to the following formula:

CLcr =	[140 - età (anni)] x weight (kg)	(x 0,85) for women)
	72 x sierica creatinine (mg/dl)

Adaptation of dose for adult patients with kidney damage:

Group	Creatine clearance (ml/min)	Dose 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

Hepatic Comprogation: In patients with only hepatic impairment, no dosage adjustment is required. A dose adaptation is recommended in patients with liver impairment and kidney damage (see “Renal Damage”). Pediatric population. Children under the age of 6: The formulation in tablets should not be used in children under the age of 6 as it does not allow the necessary adjustments of the dose. Children aged between 6 and 12 years: 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 with kidney damage, the dose must be individually adapted, taking into account kidney clearance, age and body weight of the patient. Method of administration: The tablets should be swallowed with a glass of liquid. Indications to divide the tablets Put the tablet on a hard and flat surface (such as the top of a table or a dish) with the incision line up. Then press simultaneously with the fingers (inch or indexes) briefly but decided on the outer edges to the right and left of the engraving line, as shown in the figure below.

Conservation

This medicine does not require any special condition of conservation.

Warnings

Therapeutic doses have not been shown clinically significant interactions with alcohol (for blood levels of 0.5 g/l). However, in case of concomitant alcohol intake, caution is recommended. You should pay attention in patients with factors that are suitable for urinary retention (e.g. spinal cord injury, prostatic hyperplasia), since cetirizine can increase the risk of urinary retention. Caution is recommended in epileptic patients and patients at risk of seizures. The response to skin tests for allergies is inhibited by antihistamines, therefore before carrying out them a wash-out period is necessary (3 days). 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. Exciting. Lactose monohydrate: Patients suffering from rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose mal absorption should not take this medicine. Sodium: This medicine contains less than 1 mmol (23 mg) of sodium per tablet coated with film, i.e. essentially ‘without sodium’.

Interactions

For the pharmacokinetic, pharmacodynamic and tolerability profile of cetirizine, with this antihistamine there are no interactions. In drug-pharmaceutical interaction studies carried out, particularly with pseudo-phedrine or theophylline (400 mg/day), no significant interaction was reported either pharmacodynamic or pharmacocytic. The degree of absorption of cetirizine is not reduced by food intake although the absorption rate has decreased. In sensitive patients, the concomitant use of alcohol or other depressing agents, SNC can cause further attention reduction and performance impairment, although cetirizine does not enhance the effect of alcohol (hematic levels 0.5 g/l).

Effects

Clinical studies. In 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 a 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, disorders of eye and dry mouth. Cases of alteration of liver function have been reported, with increased liver enzymes accompanied by high bilirubin. Most of these cases are resolved by the discontinuation of treatment with cetirizine dichloride. List of adverse reactions: Double-blind controlled clinical trials were carried out, which compared the cetirizine to placebo or other antihistamines to the recommended dose (10 mg per day of cetirizine), for which there are quantitative safety data, on more than 3200 subjects exposed to cetirizine. Based on this data, the following adverse reactions were reported in placebo controlled trials with an incidence equal to or greater than 1.0% with cetirizine 10 mg:

Adverse reactions	Cetirizine 10 mg	Placebo
(WHO-ART)	(n= 3260)	(n=3061)
Systemic pathologies and conditions for administration
Tired	1.63%	0,95%
Diseases of the nervous system
Chief Minister	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 with cetirizine has been more common than with the placebo, this event has been a mild to moderate entity in most cases. As demonstrated in other studies, objective tests have shown that in healthy young volunteers, the recommended daily dose of the drug does not affect normal daily activities. Pediatric population Adverse reactions with an incidence of 1% in children aged between 6 months and 12 years, in placebo controlled clinical trials are:

Adverse reactions	Cetirizine	Placebo
(WHO-ART)	(n= 1656)	(n=1294)
Gastrointestinal disorders
Diarrea	1.0%	0,6%
Psychiatric disorders
Sleep	1.8%	1.4%
Respiratory, chest and mediastinic pathologies
Rehabilitation	1.4%	1.1%
Systemic pathologies and conditions for the administration site
Tired	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 (from ≥1/100 to Emolinfopoietic system pathologies. Very rare: thrombocytopenia. Immune disorders. Rare: hypersensitivity; Very rare: anaphylactic shock. Disorders of metabolism and nutrition. Frequency not known: increased appetite. Psychiatric disorders. Not common: agitation; Rare: aggression, confusion, depression, hallucinations, insomnia; Very rare: tic; Notable frequency: suicidal idea, nightmare. Nervous system pathologies. Not common: parestesia; Rare: convulsions; Very rare: dysgeusia, syncope, tremors, dystonia, dyskinesia; Frequency not known: amnesia, impairment of memory. Pathologies of the eye. Very rare: ailments of eye-catchingness, blurring vision, oculogira crisis. Ear and labyrinth pathologies. Frequency not known: vertigo. Heart disease. Rare: tachycardia. Gastrointestinal disease. Not common: diarrhea. Hepatobile pathologies. Rare: abnormal liver function (increasing transaminase, alkaline phosphatease, γ-GT and bilirubin). Pathologies of skin and subcutaneous tissue. Not common: itching, rash; Rare: hives; Very rare: angioneurotic edema, fixed eruption by drug; Not known: generalized acute exantematic pustolosis. Diseases of the musculoskeletal system and connective tissue. Not known: artralgia. Kidney and urinary pathologies. Very rare: disuria, enurei; Frequency not known: retention of urine. Systemic pathologies and conditions for administration. Not common: asthenia, malaise; Rare: edema. Diagnostic exams. Rare: increased weight. Description of selected adverse reactions: After the interruption of the cetirizine, itching (intensive paints) and/or hives were reported. 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 through the national reporting system: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Overdosing

Symptoms Symptoms observed as a result of a cetirizine overdose are mainly associated with SNC load effects or effects that may suggest an anti-linergical effect. 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, numbness, tachycardia, tremors and urine retention. Treatment It is not known a specific antidote for cetirizine. 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 drug. Cetirizine is not effectively removed by hemodialysis.

Pregnancy:

Perspective data collected for cetirizine on pregnancy outcomes do not suggest potential toxicity to the mother or fetus/embry above the basic values. Animal studies have shown no direct or indirect harmful effects on pregnancy, embryo/fetal development, birth or postnatal development. Precaution is needed in prescribing the product to pregnant women.

Nursing:

Cetirizine is excreted in breast milk, at concentrations between 25% and 90% of that measured in plasma, depending on sampling times from administration. It is therefore necessary to prescribe the product to nursing women.

Fertility:

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

Source: Farmadati