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ZIRTEC*7CPR RIV 10MG

  • UCB Pharma S.p.A.
  • 026894042
Features:


Indicated in case of allergy.


Indicated in case of rhinitis, runny nose and urticaria.


Deductible over-the-counter drug.


From 6 years of age.


















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ZIRTEC*7CPR RIV 10MG

Therapeutic indications

Cetirizine dihydrochloride 10 mg film-coated tablets are indicated in adults and pediatric patients from 6 years of age: - for the treatment of nasal and ocular symptoms of seasonal and perennial allergic rhinitis. - for the symptomatic treatment of chronic idiopathic urticaria.

Dosage and method of use

Dosage10 mg once daily (1 tablet).Special populations Elderly peopleBased on available data, no dose reduction is necessary in elderly subjects with normal renal function.Renal impairmentThere are no data available documenting the efficacy/safety relationship in patients with renal impairment. Since cetirizine is predominantly excreted renally (see section 5.2), in cases where alternative treatments cannot be used, the interval between doses should be based on renal function. Refer to the following table and determine the dose as indicated. Dose adjustments in adult patients with impaired renal function

Group Estimated Glomerular Filtration Rate eGFR)(mL/min) Dose and frequency
Normal renal function ≥90 10 mg once daily
Mild impairment of renal function 60 -10 mg once daily
Moderate impairment of renal function 30 -5 mg once daily
Severe impairment of renal function 15-5 mg once every 2 days
Terminal stage of kidney disease Contraindicated
Hepatic impairment

Patients with only hepatic impairment do not require any dose adjustment. Dose adjustment is recommended in patients with hepatic and renal impairment (seeRenal impairment).Pediatric populationThe tablet formulation of the medicine should not be used in children under 6 years of age as it does not allow the necessary dose adjustments. Children between 6 and 12 years of age: 5 mg twice daily (half a tablet twice daily). Adolescents over 12 years of age: 10 mg once daily (1 tablet). In pediatric patients with renal impairment, the dose will need to be individually adapted, taking into account the renal clearance, age and body weight of the patient.Method of administrationThe tablets should be taken with a glass of liquid.

Contraindications

Hypersensitivity to the active substance, to any of the excipients listed in paragraph 6.1, to hydroxyzine or to any piperazine derivative. Patients with end-stage renal disease with eGFR (Estimated Glomerular Filtration Rate) less than 15 ml/min.

Side effects

Clinical studiesIn generalClinical studies have shown that cetirizine at the recommended dosage has minor CNS side effects, including drowsiness, fatigue, dizziness and headache. In some cases, paradoxical CNS stimulation has been reported. Although cetirizine is a selective H1peripheral and is relatively free of anticholinergic activity, isolated cases of difficulty in urination, visual accommodation disorders and dry mouth have been reported. Cases of abnormal liver function with elevations in liver enzyme levels accompanied by elevated bilirubin have been reported, most of which resolved following discontinuation of treatment with cetirizine dihydrochloride.•List of adverse reactionsIn double-blind controlled clinical trials comparing cetirizine to placebo or other antihistamines at the recommended dose (10 mg per day for cetirizine), for which quantitative safety data are available, they were exposed to cetirizine more of 3200 subjects. Based on these 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 (WHO-ART) Cetirizine 10 mg (n= 3260) Placebo (n = 3061)
General pathologies and conditions relating to the administration site    
Fatigue 1.63% 0.95%
Nervous system disorders    
Dizziness 1.10% 0.98%
Headache 7.42% 8.07%
Gastrointestinal disorders    
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, thoracic and mediastinal disorders    
Pharyngitis 1.29% 1.34%

Although statistically the incidence of drowsiness is more common than with placebo, this event was mild to moderate in severity in the majority of cases. Further studies in which objective tests were carried out demonstrated that usual daily activities are not impaired at the recommended daily dose in healthy young volunteers.Pediatric populationAdverse 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) Cetirizine (n=1656) Placebo (n =1294)
Gastrointestinal disorders    
Diarrhea 1.0% 0.6%
Psychiatric disorders    
Drowsiness 1.8% 1.4%
Respiratory, thoracic and mediastinal disorders    
Rhinitis 1.4% 1.1%
General pathologies and conditions relating to the administration site    
Fatigue 1.0% 0.3%
Post-marketing experience

In addition to the adverse reactions encountered during clinical trials, listed in the previous paragraph, the following side effects have been reported during post-marketing experience. Undesirable effects are described according to MedDRA by system organ class and in accordance with the frequency defined based on post-marketing experience. Frequencies are defined as follows: very common (≥1/10); common (≥1/100, Blood and lymphatic system disorders: Very rare: thrombocytopeniaImmune system disorders:Rare: hypersensitivity Very rare: anaphylactic shockMetabolism and nutrition disorders:Not known: increased appetitePsychiatric disorders:Uncommon: agitation Rare: aggression, confusion, depression, hallucinations, insomnia Very rare: tics Not known: suicidal ideation, nightmareNervous system disorders: Uncommon: paraesthesia Rare: convulsions Very rare: dysgeusia, syncope, tremor, dystonia, dyskinesia Not known: amnesia, memory impairmentEye pathologies: Very rare: accommodation disorder, blurred vision, oculogyric crisisEar and labyrinth disorders:Not known: dizzinessCardiac diseases: Rare: tachycardiaGastrointestinal disorders: Uncommon: diarrheaHepatobiliary disorders: Rare: impaired liver function (elevation of transaminases, alkaline phosphatase, γ-GT and bilirubin) Not known: hepatitisPathologies of the skin and subcutaneous tissue: Uncommon: pruritus, rash Rare: urticaria Very rare: angioneurotic edema, fixed drug eruption Not known: acute generalized exanthematous pustulosisMusculoskeletal system and connective tissue disorders:Not known: arthralgia, myalgiaRenal and urinary disorders: Very rare: dysuria, enuresis Not known: urinary retentionGeneral pathologies and conditions relating to the administration site:Uncommon: asthenia, malaise Rare: edemaDiagnostic tests: Rare: weight gain.Description of selected adverse reactionsPruritus (intense tingling) and/or urticaria have been reported after discontinuation of cetirizine treatment.Reporting of suspected adverse reactionsReporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous 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.

Special warnings

At therapeutic doses, no clinically significant interactions with alcohol have been demonstrated (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 recommended in epileptic patients and in patients at risk of seizures. The response to allergy skin tests is inhibited by antihistamines and a wash-out period (3 days) is required before performing them. Patients suffering from rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine. Itching and/or hives may occur when treatment with cetirizine is stopped, even if such symptoms were not present before starting treatment. In some cases, symptoms may be intense and treatment may need to be restarted. Symptoms should resolve when treatment is restarted.Pediatric populationThe use of the film-coated tablet formulation is not recommended in children under 6 years of age, as this formulation does not allow appropriate dose adaptation. It is recommended to use a pediatric formulation of cetirizine.

Pregnancy and breastfeeding

PregnancyProspective pregnancy outcome data collected for cetirizine do not suggest potential toxicity to the mother or fetus/embryo above baseline values. Animal studies do not show direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development. Prescribing to pregnant women should be done with caution.Feeding timeCetirizine passes into breast milk. A risk of side effects in breast-fed infants cannot be excluded. 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, prescribing to breastfeeding women should be done with caution.FertilityLimited human fertility data are available but no safety concerns have been identified. Animal data do not show any reproductive safety concerns in humans.

Expiration and conservation

This medicine does not require any special storage conditions.

Interactions with other drugs

Due to 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 intake, although the rate of absorption is decreased. In sensitive patients, the simultaneous intake of cetirizine with alcohol or other substances with a depressant action on the CNS can cause a further decrease in alertness and alteration of performance, although cetirizine does not potentiate the effect of alcohol (0.5 g/L blood levels).

Overdose

SymptomsSymptoms observed following an overdose of cetirizine are mainly associated with central nervous system effects or effects that might suggest anticholinergic activity. Following intake of a dose equal to at least 5 times the recommended daily dose, the following adverse events have been reported: confusion, diarrhoea, dizziness, fatigue, headache, malaise, mydriasis, itching, restlessness, sedation, drowsiness, stupor, tachycardia, tremor and urinary retention.TreatmentThere is no known specific antidote to cetirizine. In case of overdose, symptomatic or supportive treatment is recommended. Gastric lavage may be considered if a short time has passed since ingestion of the medicine. Cetirizine is not effectively removed by hemodialysis.

Active principles

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

Excipients

- Microcrystalline cellulose - Lactose monohydrate - Colloidal anhydrous silica - Magnesium stearate - Opadry Y-1-7000 which consists of:- Hydroxypropyl methylcellulose (E 464) - Titanium dioxide (E 171) - Macrogol 400.

026894042

Data sheet

Packaging
10 mg 7 film-coated tablets
Product Type
HUMAN DRUG
ATC code
R06AE07
ATC description
Cetirizine
Therapeutic Group
Anti-allergic antihistamines
Active principle
cetirizine dihydrochloride (FU)
Class
C.
Pharmaceutical form
coated tablet
coated tablets
Type of Administration
oral
Container
blister
Quantity
7 coated tablets
Quantity of the Active Ingredient
10MG
Recipe required
SOP - non-prescription medicine
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