{"product_id":"zyrtecset-allergy-cetirizine-10mg-7-tablets","title":"Zyrtecset Allergy Cetirizine 10mg 7 Tablets","description":"\u003cp data-pm-slice=\"1 1 []\"\u003e\u003cspan\u003eZyrtecset Allergy 10mg is an antihistamine medicine containing \u003c\/span\u003e\u003cstrong\u003e\u003cspan\u003ecetirizine dihydrochloride\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e. It is used to relieve symptoms associated with seasonal and year-round allergic rhinitis, including nasal and eye symptoms, and may also be used for symptoms of chronic urticaria (hives).\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eSuitable for adults and children from 6 years of age.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch2\u003e\u003cspan\u003eBenefits\u003c\/span\u003e\u003c\/h2\u003e\n\u003cul data-spread=\"false\"\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003eHelps relieve symptoms of seasonal allergic rhinitis\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003eHelps relieve year-round allergy symptoms\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003eHelps reduce allergic nasal and eye symptoms\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003eMay help relieve symptoms associated with chronic urticaria\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003eContains 10mg cetirizine dihydrochloride per tablet\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003eSuitable for adults and children from 6 years\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2\u003e\u003cspan\u003eActive Ingredient\u003c\/span\u003e\u003c\/h2\u003e\n\u003cp\u003e\u003cspan\u003eEach film-coated tablet contains:\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003eCetirizine Dihydrochloride – 10mg\u003c\/span\u003e\u003c\/strong\u003e\u003c\/p\u003e\n\u003ch2\u003e\u003cspan\u003eDirections\u003c\/span\u003e\u003c\/h2\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003eAdults and adolescents 12 years and older:\u003c\/span\u003e\u003c\/strong\u003e\u003cbr\u003e\u003cspan\u003eTake 1 tablet (10mg) once daily.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003eChildren 6 to 12 years:\u003c\/span\u003e\u003c\/strong\u003e\u003cbr\u003e\u003cspan\u003eTake ½ tablet (5mg) twice daily.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eFor people with moderate kidney impairment, the recommended dose may be reduced to 5mg once daily.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eIf you or your child has severe kidney disease, consult a healthcare professional before use.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch2\u003e\u003cspan\u003ePrecautions\u003c\/span\u003e\u003c\/h2\u003e\n\u003cp\u003e\u003cspan\u003eDo not use if you are allergic to cetirizine, hydroxyzine, piperazine derivatives, or any of the other ingredients.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eConsult a healthcare professional before use if you:\u003c\/span\u003e\u003c\/p\u003e\n\u003cul data-spread=\"false\"\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003eHave kidney problems\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003eHave a history of epilepsy or seizures\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003eAre pregnant or breastfeeding\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003eTake medicines that may cause drowsiness or affect the central nervous system\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cspan\u003eAvoid alcohol while taking this medicine.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eCetirizine may cause drowsiness or reduced alertness in some people. Use caution when driving or operating machinery until you know how the medicine affects you.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eDo not exceed the recommended dose.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch2\u003e\u003cspan\u003ePossible Side Effects\u003c\/span\u003e\u003c\/h2\u003e\n\u003cp\u003e\u003cspan\u003ePossible side effects may include:\u003c\/span\u003e\u003c\/p\u003e\n\u003cul data-spread=\"false\"\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003eDrowsiness\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003eHeadache\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003eDizziness\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003eFatigue\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003eDry mouth\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003eNausea\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003eDiarrhea\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003eRhinitis or sore throat\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cspan\u003eRarely, allergic reactions may occur, including swelling of the face or throat. Seek medical attention if you experience a serious allergic reaction.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eRefer to the package leaflet for the complete list of possible side effects and precautions.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch2\u003e\u003cspan\u003eIngredients\u003c\/span\u003e\u003c\/h2\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003eActive Ingredient:\u003c\/span\u003e\u003c\/strong\u003e\u003cbr\u003e\u003cspan\u003eCetirizine Dihydrochloride 10mg per film-coated tablet.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003eOther Ingredients:\u003c\/span\u003e\u003c\/strong\u003e\u003cbr\u003e\u003cspan\u003eMicrocrystalline Cellulose, Lactose Monohydrate, Colloidal Anhydrous Silica, Magnesium Stearate, Opadry Y-1-7000 (Hydroxypropyl Methylcellulose [E464], Titanium Dioxide [E171], Macrogol 400).\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003eBrand:\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e Zyrtecset\u003c\/span\u003e\u003cbr\u003e\u003cstrong\u003e\u003cspan\u003eManufacturer:\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e UCB\u003c\/span\u003e\u003cbr\u003e\u003cstrong\u003e\u003cspan\u003eStrength:\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e 10mg\u003c\/span\u003e\u003cbr\u003e\u003cstrong\u003e\u003cspan\u003ePackage Size:\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e 7 Tablets\u003c\/span\u003e\u003cbr\u003e\u003cstrong\u003e\u003cspan\u003eProduct Type:\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e Antihistamine Allergy Medicine\u003c\/span\u003e\u003cbr\u003e\u003cstrong\u003e\u003cspan\u003eAge:\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e Adults and children from 6 years\u003c\/span\u003e\u003cbr\u003e\u003cstrong\u003e\u003cspan\u003eBarcode \/ EAN:\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e 3400936461680\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan style=\"color: rgb(255, 42, 0);\"\u003e\u003cstrong\u003ePlease read the following full disclosure before taking or purchasing this product.\u003c\/strong\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cul data-spread=\"false\" data-pm-slice=\"3 1 []\"\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003efor the treatment of nasal and ocular symptoms of seasonal and perennial allergic rhinitis;\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003efor the treatment of symptoms of chronic idiopathic urticaria.\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cspan\u003eMedical advice is recommended for chronic idiopathic urticaria.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan\u003e4.2 Posology and method of administration\u003c\/span\u003e\u003c\/h3\u003e\n\u003ch4\u003e\u003cspan\u003ePosology\u003c\/span\u003e\u003c\/h4\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003e10 mg once daily (1 tablet).\u003c\/span\u003e\u003c\/strong\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan\u003eSpecial populations\u003c\/span\u003e\u003c\/h3\u003e\n\u003ch4\u003e\u003cspan\u003eElderly patients\u003c\/span\u003e\u003c\/h4\u003e\n\u003cp\u003e\u003cspan\u003eNo dose adjustment is required in elderly patients with normal renal function.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch4\u003e\u003cspan\u003eRenal impairment\u003c\/span\u003e\u003c\/h4\u003e\n\u003cp\u003e\u003cspan\u003eAvailable data do not allow the benefit\/risk ratio to be adequately documented in patients with renal impairment.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eBecause cetirizine is primarily eliminated by the kidneys, if no alternative treatment can be used, the interval between doses should be adjusted according to renal function.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eDosage should be adjusted as follows:\u003c\/span\u003e\u003c\/p\u003e\n\u003ctable\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003cth\u003e\u003cspan\u003eGroup\u003c\/span\u003e\u003c\/th\u003e\n\u003cth\u003e\u003cspan\u003eGFR (mL\/min)\u003c\/span\u003e\u003c\/th\u003e\n\u003cth\u003e\u003cspan\u003eDose and Frequency\u003c\/span\u003e\u003c\/th\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cspan\u003eNormal renal function\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan\u003e≥ 90\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan\u003e10 mg once daily\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cspan\u003eMildly reduced renal function\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan\u003e60 to \u0026lt; 90\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan\u003e10 mg once daily\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cspan\u003eModerately reduced renal function\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan\u003e30 to \u0026lt; 60\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan\u003e5 mg once daily\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cspan\u003eSeverely reduced renal function, not requiring dialysis\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan\u003e15 to \u0026lt; 30\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan\u003e5 mg once every 2 days\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cspan\u003eEnd-stage renal failure requiring dialysis\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan\u003e\u0026lt; 15\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan\u003eContraindicated\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e\n\u003ch4\u003e\u003cspan\u003eHepatic impairment\u003c\/span\u003e\u003c\/h4\u003e\n\u003cp\u003e\u003cspan\u003eNo dose adjustment is necessary in patients with isolated hepatic impairment.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eIn patients with hepatic impairment associated with renal impairment, dose adjustment is recommended according to renal function.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan\u003ePediatric population\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp\u003e\u003cspan\u003eThe tablet form should not be used in children under 6 years of age because it does not allow appropriate dose adjustment.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003eChildren aged 6 to 12 years:\u003c\/span\u003e\u003c\/strong\u003e\u003cbr\u003e\u003cspan\u003e5 mg twice daily, corresponding to half a tablet twice daily.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003eAdolescents over 12 years:\u003c\/span\u003e\u003c\/strong\u003e\u003cbr\u003e\u003cspan\u003e10 mg once daily, corresponding to one tablet.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eIn children with renal impairment, the dose should be individually adjusted according to renal clearance, age, and body weight.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan\u003eMethod of administration\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp\u003e\u003cspan\u003eThe tablets should be swallowed with a drink.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch2\u003e\u003cspan\u003e4.3 Contraindications\u003c\/span\u003e\u003c\/h2\u003e\n\u003cul data-spread=\"false\"\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003eHypersensitivity to the active substance, any of the excipients listed in section 6.1, hydroxyzine, or piperazine derivatives.\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003eEnd-stage renal impairment with a glomerular filtration rate below 15 mL\/min.\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2\u003e\u003cspan\u003e4.4 Special warnings and precautions for use\u003c\/span\u003e\u003c\/h2\u003e\n\u003cp\u003e\u003cspan\u003eAt therapeutic doses, no clinically significant interaction has been demonstrated with alcohol at blood alcohol concentrations up to 0.5 g\/L. However, caution is recommended when alcohol is consumed at the same time.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eCaution should be exercised in patients with factors predisposing them to urinary retention, such as spinal cord injury or prostatic hyperplasia, because cetirizine may increase the risk of urinary retention.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eCetirizine should be administered with caution in patients with epilepsy or those at risk of seizures.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eAntihistamines inhibit responses to allergy skin testing. A treatment-free period of 3 days is required before such testing is performed.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003ePatients with galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption syndrome, which are rare hereditary disorders, should not take this medicine.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eItching and\/or urticaria may occur after cetirizine is discontinued, even when these symptoms were not present before treatment began. In some cases, symptoms may be severe and may require treatment to be restarted. Symptoms should resolve when treatment is resumed.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan\u003ePediatric population\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp\u003e\u003cspan\u003eUse of the film-coated tablet is not recommended in children under 6 years because this formulation does not allow appropriate dosage adjustment for this age group.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eA pediatric formulation of cetirizine is recommended instead.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch2\u003e\u003cspan\u003e4.5 Interaction with other medicinal products and other forms of interaction\u003c\/span\u003e\u003c\/h2\u003e\n\u003cp\u003e\u003cspan\u003eBased on the pharmacokinetic, pharmacodynamic, and tolerability profile of cetirizine, no interactions are expected with this antihistamine.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eTo date, no significant pharmacodynamic or pharmacokinetic interactions have been reported in drug-interaction studies, particularly with pseudoephedrine or theophylline at 400 mg\/day.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eThe extent of cetirizine absorption is not reduced by food, although the rate of absorption is slower.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eConcomitant use of alcohol or other central nervous system depressants may impair alertness or performance in sensitive patients, although cetirizine does not potentiate the effects of alcohol at a blood concentration of 0.5 g\/L.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch2\u003e\u003cspan\u003e4.6 Fertility, pregnancy and breastfeeding\u003c\/span\u003e\u003c\/h2\u003e\n\u003ch3\u003e\u003cspan\u003ePregnancy\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp\u003e\u003cspan\u003eProspective data collected on pregnancy outcomes following exposure to cetirizine do not suggest maternal or embryo-fetal toxicity greater than that observed in the general population.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eAnimal studies have shown no direct or indirect harmful effects on pregnancy, embryonic and fetal development, delivery, or postnatal development.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eCaution is recommended when prescribing cetirizine during pregnancy.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan\u003eBreastfeeding\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp\u003e\u003cspan\u003eCetirizine passes into breast milk.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eA risk of adverse effects in breastfed newborns cannot be excluded.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eCetirizine is excreted into human breast milk at concentrations ranging from approximately 25% to 90% of those measured in plasma, depending on the timing of sampling relative to administration.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eCaution is therefore recommended when prescribing cetirizine to breastfeeding women.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan\u003eFertility\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp\u003e\u003cspan\u003eHuman fertility data are limited, but no risk has been identified.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eAnimal data do not indicate a reproductive safety concern for humans.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch2\u003e\u003cspan\u003e4.7 Effects on ability to drive and use machines\u003c\/span\u003e\u003c\/h2\u003e\n\u003cp\u003e\u003cspan\u003eObjective measurements of driving ability, sleep onset, and assembly-line performance have not demonstrated clinically relevant effects at the recommended dose of 10 mg.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eHowever, patients who experience drowsiness should not drive, take part in potentially hazardous activities, or operate machinery.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eThey should not exceed the recommended dose and should take into account their individual response to the medicine.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch2\u003e\u003cspan\u003e4.8 Undesirable effects\u003c\/span\u003e\u003c\/h2\u003e\n\u003ch3\u003e\u003cspan\u003eClinical trials\u003c\/span\u003e\u003c\/h3\u003e\n\u003ch4\u003e\u003cspan\u003eSummary\u003c\/span\u003e\u003c\/h4\u003e\n\u003cp\u003e\u003cspan\u003eMild adverse effects involving the central nervous system, including drowsiness, fatigue, dizziness, and headache, were observed during clinical trials using cetirizine at the recommended dose.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eIn some cases, a paradoxical stimulating effect on the central nervous system was observed.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eDespite its selective antagonistic action on peripheral H1 receptors and relatively low anticholinergic activity, isolated cases of difficulty urinating, accommodation disorders, and dry mouth have been reported.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eAbnormal liver function, including elevated liver enzymes associated with increased bilirubin, has also been reported. In most cases, these abnormalities resolved after cetirizine dihydrochloride was discontinued.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan\u003eAdverse reactions reported during clinical trials\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp\u003e\u003cspan\u003eMore than 3,200 subjects exposed to cetirizine were included in double-blind controlled clinical trials comparing cetirizine at the recommended dose of 10 mg\/day with placebo or other antihistamines.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eThe following adverse reactions occurred with cetirizine 10 mg at an incidence of 1.0% or greater:\u003c\/span\u003e\u003c\/p\u003e\n\u003ctable\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003cth\u003e\u003cspan\u003eAdverse Reaction\u003c\/span\u003e\u003c\/th\u003e\n\u003cth\u003e\u003cspan\u003eCetirizine 10 mg (n=3260)\u003c\/span\u003e\u003c\/th\u003e\n\u003cth\u003e\u003cspan\u003ePlacebo (n=3061)\u003c\/span\u003e\u003c\/th\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cspan\u003eFatigue\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan\u003e1.63%\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan\u003e0.95%\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cspan\u003eDizziness\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan\u003e1.10%\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan\u003e0.98%\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cspan\u003eHeadache\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan\u003e7.42%\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan\u003e8.07%\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cspan\u003eAbdominal pain\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan\u003e0.98%\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan\u003e1.08%\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cspan\u003eDry mouth\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan\u003e2.09%\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan\u003e0.82%\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cspan\u003eNausea\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan\u003e1.07%\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan\u003e1.14%\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cspan\u003eDrowsiness\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan\u003e9.63%\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan\u003e5.00%\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cspan\u003ePharyngitis\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan\u003e1.29%\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan\u003e1.34%\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e\n\u003cp\u003e\u003cspan\u003eDrowsiness occurred significantly more often than with placebo, but in most cases it was mild to moderate.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eObjective testing, supported by other studies, showed that normal daily activities were not affected in healthy young volunteers taking the recommended daily dose.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan\u003ePediatric population\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp\u003e\u003cspan\u003eThe following adverse reactions were reported with an incidence of 1% or greater in children aged 6 months to 12 years participating in placebo-controlled clinical trials:\u003c\/span\u003e\u003c\/p\u003e\n\u003ctable\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003cth\u003e\u003cspan\u003eAdverse Reaction\u003c\/span\u003e\u003c\/th\u003e\n\u003cth\u003e\u003cspan\u003eCetirizine (n=1656)\u003c\/span\u003e\u003c\/th\u003e\n\u003cth\u003e\u003cspan\u003ePlacebo (n=1294)\u003c\/span\u003e\u003c\/th\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cspan\u003eDiarrhea\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan\u003e1.0%\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan\u003e0.6%\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cspan\u003eDrowsiness\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan\u003e1.8%\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan\u003e1.4%\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cspan\u003eRhinitis\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan\u003e1.4%\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan\u003e1.1%\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cspan\u003eFatigue\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan\u003e1.0%\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan\u003e0.3%\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e\n\u003ch3\u003e\u003cspan\u003eAdverse reactions reported after marketing\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp\u003e\u003cspan\u003eIn addition to adverse reactions reported during clinical trials, the following reactions have been reported since the product was marketed.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eFrequencies are defined as:\u003c\/span\u003e\u003c\/p\u003e\n\u003cul data-spread=\"false\"\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003eVery common: ≥ 1\/10\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003eCommon: ≥ 1\/100 to \u0026lt; 1\/10\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003eUncommon: ≥ 1\/1,000 to \u0026lt; 1\/100\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003eRare: ≥ 1\/10,000 to \u0026lt; 1\/1,000\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003eVery rare: \u0026lt; 1\/10,000\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003eFrequency not known: cannot be estimated from available data\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch4\u003e\u003cspan\u003eBlood and lymphatic system disorders\u003c\/span\u003e\u003c\/h4\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003eVery rare:\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e thrombocytopenia.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch4\u003e\u003cspan\u003eImmune system disorders\u003c\/span\u003e\u003c\/h4\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003eRare:\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e hypersensitivity.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003eVery rare:\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e anaphylactic shock.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch4\u003e\u003cspan\u003eMetabolism and nutrition disorders\u003c\/span\u003e\u003c\/h4\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003eFrequency not known:\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e increased appetite.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch4\u003e\u003cspan\u003ePsychiatric disorders\u003c\/span\u003e\u003c\/h4\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003eUncommon:\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e agitation.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003eRare:\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e aggression, confusion, depression, hallucinations, insomnia.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003eVery rare:\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e tics.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003eFrequency not known:\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e suicidal thoughts, nightmares.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch4\u003e\u003cspan\u003eNervous system disorders\u003c\/span\u003e\u003c\/h4\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003eUncommon:\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e paresthesia.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003eRare:\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e seizures.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003eVery rare:\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e dysgeusia, syncope, tremor, dystonia, dyskinesia.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003eFrequency not known:\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e amnesia, memory impairment.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch4\u003e\u003cspan\u003eEye disorders\u003c\/span\u003e\u003c\/h4\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003eVery rare:\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e accommodation disorder, blurred vision, oculogyric crisis.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch4\u003e\u003cspan\u003eEar and labyrinth disorders\u003c\/span\u003e\u003c\/h4\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003eFrequency not known:\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e vertigo.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch4\u003e\u003cspan\u003eCardiac disorders\u003c\/span\u003e\u003c\/h4\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003eRare:\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e tachycardia.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch4\u003e\u003cspan\u003eGastrointestinal disorders\u003c\/span\u003e\u003c\/h4\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003eUncommon:\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e diarrhea.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch4\u003e\u003cspan\u003eHepatobiliary disorders\u003c\/span\u003e\u003c\/h4\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003eRare:\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e abnormal liver function tests, including increased transaminases, alkaline phosphatase, gamma-GT, and bilirubin.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003eFrequency not known:\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e hepatitis.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch4\u003e\u003cspan\u003eSkin and subcutaneous tissue disorders\u003c\/span\u003e\u003c\/h4\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003eUncommon:\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e itching, rash.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003eRare:\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e urticaria.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003eVery rare:\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e angioedema, fixed drug eruption.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003eFrequency not known:\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e acute generalized exanthematous pustulosis.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch4\u003e\u003cspan\u003eMusculoskeletal and connective tissue disorders\u003c\/span\u003e\u003c\/h4\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003eFrequency not known:\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e joint pain, muscle pain.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch4\u003e\u003cspan\u003eRenal and urinary disorders\u003c\/span\u003e\u003c\/h4\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003eVery rare:\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e painful urination, bedwetting.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003eFrequency not known:\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e urinary retention.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch4\u003e\u003cspan\u003eGeneral disorders and administration site conditions\u003c\/span\u003e\u003c\/h4\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003eUncommon:\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e weakness, malaise.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003eRare:\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e edema.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch4\u003e\u003cspan\u003eInvestigations\u003c\/span\u003e\u003c\/h4\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003eRare:\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e weight gain.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan\u003eDescription of selected adverse reactions\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp\u003e\u003cspan\u003eCases of itching, including severe itching, and\/or urticaria have been reported after stopping cetirizine.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan\u003eReporting suspected adverse reactions\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp\u003e\u003cspan\u003eReporting suspected adverse reactions after authorization of the medicinal product is important because it allows continuous monitoring of the benefit\/risk balance.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eHealthcare professionals should report suspected adverse reactions through the French national reporting system operated by the \u003c\/span\u003e\u003cstrong\u003e\u003cspan\u003eAgence nationale de sécurité du médicament et des produits de santé (ANSM)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e and the Regional Pharmacovigilance Centers.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch2\u003e\u003cspan\u003e4.9 Overdose\u003c\/span\u003e\u003c\/h2\u003e\n\u003ch3\u003e\u003cspan\u003eSymptoms\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp\u003e\u003cspan\u003eSymptoms observed following cetirizine overdose are mainly associated with central nervous system effects or effects suggesting anticholinergic activity.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eAdverse effects reported after taking a dose at least five times greater than the recommended daily dose include:\u003c\/span\u003e\u003c\/p\u003e\n\u003cul data-spread=\"false\"\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003econfusion\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003ediarrhea\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003edizziness\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003efatigue\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003eheadache\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003emalaise\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003edilated pupils\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003eitching\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003eagitation\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003esedation\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003edrowsiness\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003estupor\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003etachycardia\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003etremor\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003eurinary retention\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch3\u003e\u003cspan\u003eManagement\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp\u003e\u003cspan\u003eThere is no known specific antidote for cetirizine.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eIn the event of overdose, symptomatic treatment and supportive measures are recommended.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eGastric lavage may be considered if ingestion occurred recently.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eCetirizine is not effectively removed by hemodialysis.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch1\u003e\u003cspan\u003e5. PHARMACOLOGICAL PROPERTIES\u003c\/span\u003e\u003c\/h1\u003e\n\u003ch2\u003e\u003cspan\u003e5.1 Pharmacodynamic properties\u003c\/span\u003e\u003c\/h2\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003ePharmacotherapeutic group:\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e Antihistamines for systemic use, piperazine derivatives.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003eATC code:\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e R06AE07.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan\u003eMechanism of action\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp\u003e\u003cspan\u003eCetirizine, a human metabolite of hydroxyzine, is a potent and selective antagonist of peripheral H1 receptors.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eIn vitro receptor-binding studies have shown no measurable affinity for receptors other than H1 receptors.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan\u003ePharmacodynamic effects\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp\u003e\u003cspan\u003eIn addition to its anti-H1 effects, cetirizine has demonstrated antiallergic activity.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eWhen administered at a dose of 10 mg once or twice daily, it inhibits the late-phase recruitment of eosinophils in the skin and conjunctiva of atopic individuals subjected to allergen challenge testing.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan\u003eClinical efficacy and safety\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp\u003e\u003cspan\u003eStudies in healthy volunteers have shown that cetirizine at doses of 5 mg and 10 mg strongly inhibits wheal-and-flare reactions induced by very high concentrations of histamine in the skin.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eHowever, a direct correlation between these observations and clinical effectiveness has not been established.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eIn a six-week placebo-controlled study involving 186 patients with allergic rhinitis and mild to moderate asthma, cetirizine 10 mg once daily improved rhinitis symptoms without affecting pulmonary function.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eThis study demonstrates the safe use of cetirizine in allergic patients with mild to moderate asthma.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eIn a placebo-controlled study, cetirizine administered at a high daily dose of 60 mg for 7 days did not cause a statistically significant prolongation of the QT interval.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eAt the recommended dose, improved quality of life has been demonstrated in patients with perennial and seasonal allergic rhinitis treated with cetirizine.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan\u003ePediatric population\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp\u003e\u003cspan\u003eIn a 35-day study in children aged 5 to 12 years, no reduction in the antihistamine effect of cetirizine was observed.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eAfter discontinuation following repeated administration, skin reactivity to histamine returned within 3 days.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch2\u003e\u003cspan\u003e5.2 Pharmacokinetic properties\u003c\/span\u003e\u003c\/h2\u003e\n\u003ch3\u003e\u003cspan\u003eAbsorption\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp\u003e\u003cspan\u003eAt steady state, peak plasma concentrations are approximately 300 ng\/mL and are reached after approximately \u003c\/span\u003e\u003cstrong\u003e\u003cspan\u003e1.0 ± 0.5 hours\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eThe distribution of measured pharmacokinetic parameters, including peak plasma concentration and area under the curve, is unimodal.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eThe bioavailability of cetirizine is not altered by food, although the rate of absorption is reduced.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eCetirizine bioavailability is equivalent when administered as a solution, capsule, or tablet.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan\u003eDistribution\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp\u003e\u003cspan\u003eThe apparent volume of distribution is \u003c\/span\u003e\u003cstrong\u003e\u003cspan\u003e0.50 L\/kg\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003ePlasma protein binding of cetirizine is \u003c\/span\u003e\u003cstrong\u003e\u003cspan\u003e93 ± 0.3%\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eCetirizine does not alter the protein binding of warfarin.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan\u003eBiotransformation\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp\u003e\u003cspan\u003eCetirizine does not undergo significant first-pass hepatic metabolism.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan\u003eElimination\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp\u003e\u003cspan\u003eThe terminal plasma half-life of cetirizine is approximately \u003c\/span\u003e\u003cstrong\u003e\u003cspan\u003e10 hours\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eNo accumulation of cetirizine occurs after daily administration of 10 mg for 10 days.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eApproximately two-thirds of the administered dose is excreted unchanged in the urine.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan\u003eLinearity \/ non-linearity\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp\u003e\u003cspan\u003eCetirizine pharmacokinetics are linear over the dose range of \u003c\/span\u003e\u003cstrong\u003e\u003cspan\u003e5 to 60 mg\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan\u003eRenal impairment\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp\u003e\u003cspan\u003eCetirizine pharmacokinetics were similar in patients with mild renal impairment, defined as creatinine clearance greater than 40 mL\/min, and in healthy volunteers.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eIn patients with moderate renal impairment, the half-life was increased threefold and clearance was reduced by 70% compared with healthy volunteers.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eIn hemodialysis patients with creatinine clearance below 7 mL\/min, the half-life was increased threefold and clearance was reduced by 70% after a single oral 10 mg dose.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eCetirizine was only minimally removed by hemodialysis.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eDose adjustment is required in patients with moderate or severe renal impairment.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan\u003eHepatic impairment\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp\u003e\u003cspan\u003eIn patients with chronic liver disease, including hepatocellular, cholestatic, and biliary cirrhosis, receiving a single dose of 10 or 20 mg of cetirizine, the half-life increased by approximately 50% and clearance decreased by approximately 40% compared with healthy subjects.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eDose adjustment is required in patients with hepatic impairment only when renal impairment is also present.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan\u003eElderly patients\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp\u003e\u003cspan\u003eAfter a single oral dose of 10 mg cetirizine in 16 elderly subjects, the half-life increased by approximately 50% and clearance decreased by approximately 40% compared with younger subjects.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eThe reduction in cetirizine clearance in these elderly volunteers appears to be related to impaired renal function.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan\u003ePediatric population\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp\u003e\u003cspan\u003eThe cetirizine half-life is approximately:\u003c\/span\u003e\u003c\/p\u003e\n\u003cul data-spread=\"false\"\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003e6 hours in children aged 6 to 12 years\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003e5 hours in children aged 2 to 6 years\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003e3.1 hours in infants and young children aged 6 to 24 months\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2\u003e\u003cspan\u003e5.3 Preclinical safety data\u003c\/span\u003e\u003c\/h2\u003e\n\u003cp\u003e\u003cspan\u003eNon-clinical data from conventional studies of safety pharmacology, repeated-dose toxicity, genotoxicity, carcinogenicity, and reproductive and developmental toxicity revealed no particular hazard for humans.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch1\u003e\u003cspan\u003e6. PHARMACEUTICAL PARTICULARS\u003c\/span\u003e\u003c\/h1\u003e\n\u003ch2\u003e\u003cspan\u003e6.1 List of excipients\u003c\/span\u003e\u003c\/h2\u003e\n\u003cul data-spread=\"false\"\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003eMicrocrystalline cellulose\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003eLactose monohydrate\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003eColloidal anhydrous silica\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003eMagnesium stearate\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003eOpadry Y-1-7000, composed of:\u003c\/span\u003e\u003c\/p\u003e\n\u003cul data-spread=\"false\"\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003eHydroxypropyl methylcellulose (E464)\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003eTitanium dioxide (E171)\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cspan\u003eMacrogol 400\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2\u003e\u003cspan\u003e6.2 Incompatibilities\u003c\/span\u003e\u003c\/h2\u003e\n\u003cp\u003e\u003cspan\u003eNot applicable.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch2\u003e\u003cspan\u003e6.3 Shelf life\u003c\/span\u003e\u003c\/h2\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003e5 years.\u003c\/span\u003e\u003c\/strong\u003e\u003c\/p\u003e\n\u003ch2\u003e\u003cspan\u003e6.4 Special precautions for storage\u003c\/span\u003e\u003c\/h2\u003e\n\u003cp\u003e\u003cspan\u003eThis medicinal product does not require any special storage conditions.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch2\u003e\u003cspan\u003e6.5 Nature and contents of container\u003c\/span\u003e\u003c\/h2\u003e\n\u003cp\u003e\u003cspan\u003ePVC\/aluminum blister packs.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eBoxes containing \u003c\/span\u003e\u003cstrong\u003e\u003cspan\u003e7 tablets\u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003e.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch2\u003e\u003cspan\u003e6.6 Special precautions for disposal and other handling\u003c\/span\u003e\u003c\/h2\u003e\n\u003cp\u003e\u003cspan\u003eNo special requirements.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eAny unused medicinal product or waste material should be disposed of in accordance with applicable regulations.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch1\u003e\u003cspan\u003e7. MARKETING AUTHORIZATION HOLDER\u003c\/span\u003e\u003c\/h1\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003eUCB PHARMA\u003c\/span\u003e\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eTour Emblem\u003c\/span\u003e\u003cbr\u003e\u003cspan\u003e7 Allée de l’Arche\u003c\/span\u003e\u003cbr\u003e\u003cspan\u003e92400 Courbevoie\u003c\/span\u003e\u003cbr\u003e\u003cspan\u003eFrance\u003c\/span\u003e\u003c\/p\u003e\n\u003ch1\u003e\u003cspan\u003e8. MARKETING AUTHORIZATION NUMBER\u003c\/span\u003e\u003c\/h1\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003e34009 364 616 8 0\u003c\/span\u003e\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e7 scored film-coated tablets in a PVC\/aluminum blister pack.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch1\u003e\u003cspan\u003e9. DATE OF FIRST AUTHORIZATION \/ RENEWAL OF AUTHORIZATION\u003c\/span\u003e\u003c\/h1\u003e\n\u003cp\u003e\u003cspan\u003eTo be completed subsequently by the marketing authorization holder.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch1\u003e\u003cspan\u003e10. DATE OF REVISION OF THE TEXT\u003c\/span\u003e\u003c\/h1\u003e\n\u003cp\u003e\u003cspan\u003eTo be completed subsequently by the marketing authorization holder.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch1\u003e\u003cspan\u003e11. DOSIMETRY\u003c\/span\u003e\u003c\/h1\u003e\n\u003cp\u003e\u003cspan\u003eNot applicable.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch1\u003e\u003cspan\u003e12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS\u003c\/span\u003e\u003c\/h1\u003e\n\u003cp\u003e\u003cspan\u003eNot applicable.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch1\u003e\u003cspan\u003eCONDITIONS OF PRESCRIPTION AND SUPPLY\u003c\/span\u003e\u003c\/h1\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan\u003eMedicinal product not subject to medical prescription.\u003c\/span\u003e\u003c\/strong\u003e\u003c\/p\u003e","brand":"Pharmarcie.com","offers":[{"title":"Default Title","offer_id":47598508605612,"sku":"P3400936461680","price":19.95,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0604\/4047\/7868\/files\/dess_6cdffdfb-c230-45ee-b1ff-82ea3a43418f.png?v=1791574960","url":"https:\/\/pharmarcie.com\/products\/zyrtecset-allergy-cetirizine-10mg-7-tablets","provider":"Pharmarcie.com","version":"1.0","type":"link"}