XYZAL FILM-COATED TABLET 5 MG

UCB FARCHIM SA - SWITZERLANDAESICA PHARMACEUTICALS S.R.L. (PRIMARY AND SECONDARY PACKAGER) (ITALY)🇸🇬 Health Sciences Authority

Approval Date: Oct 14, 2020
Approval ID: dc75488da9e454b6
Company: UCB FARCHIM SA - SWITZERLANDAESICA PHARMACEUTICALS S.R.L. (PRIMARY AND SECONDARY PACKAGER) (ITALY)
Type: Therapeutic

Approval Details

Approval Id: dc75488da9e454b6
Drug Name: XYZAL FILM-COATED TABLET 5 MG
Product Name: XYZAL FILM-COATED TABLET 5 MG
Approval Number: SIN16028P
Approval Date: 2020-10-14
Registrant: GLAXOSMITHKLINE PTE LTD
Licence Holder: GLAXOSMITHKLINE PTE LTD
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: TABLET, FILM COATED
Dosage: POSOLOGY AND METHOD OF ADMINISTRATION Film-coated tablet: it must be taken orally, swallowed whole with liquid and may be taken with or without food. Duration of use: Intermittent allergic rhinitis (symptoms <4 days/week or for less than 4 weeks a year) has to be treated according to the disease and its history; it can be stopped once the symptoms have disappeared and can be restarted again when symptoms reappear. In case of persistent allergic rhinitis (symptoms >4 days/week or for more than 4 weeks a year), continuous therapy can be proposed to the patient during the period of exposure to allergens. There is clinical experience with the use of levocetirizine for treatment periods of at least 6 months. For chronic urticaria and chronic allergic rhinitis, there is clinical experience of use of cetirizine (racemate) for up to one year. Route of Administration: For oral use. Adults and adolescents 12 years and above: The recommended dose is 5 mg once daily (1 film-coated tablet). Elderly: Adjustment of the dose is recommended in elderly patients with moderate to severe renal impairment (see Patients with renal impairment below). Children aged 6 to 12 years: The recommended dose is 5 mg once daily (1 film-coated tablet). Adult patients with renal impairment: The dosing intervals must be individualised according to renal function (eGFR – estimated Glomerular Filtration Rate). Refer to the following table and adjust the dose as indicated. <img src="/TGIF/Xyzal-Table1_270223.png" alt="Xyzal Dosage Table 1" /> In paediatric patients suffering from renal impairment, the dose will have to be adjusted on an individual basis taking into account the renal clearance of the patient and his body weight. Patients with hepatic impairment: No dose adjustment is needed in patients with solely hepatic impairment. In patients with hepatic impairment and renal impairment, adjustment of the dose is recommended (see Patients with renal impairment above).
Route Of Administration: ORAL
Indication Info: THERAPEUTIC INDICATIONS Levocetirizine is indicated for the symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) and chronic idiopathic urticaria.
Contraindications: CONTRAINDICATIONS Hypersensitivity to levocetirizine, to cetirizine, to hydroxyzine, to any piperazine derivatives, or to any of the excipients. Patients with end stage renal disease with estimated Glomerular Filtration Rate (eGFR) below 15 ml/min (requiring dialysis treatment). Due to the presence of lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take the tablet formulation.
Atc Code: R06A E09
Atc Item Name: xr 06 a e 09
Pharma Manufacturer Name: GLAXOSMITHKLINE PTE LTD
Company Detail Path: /organization/glaxosmithkline-pte-ltd

Active Ingredients

Levocetirizine dihydrochloride

5 mg

LEVOCETIRIZINE DIHYDROCHLORIDE

5 MG

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Oct 14, 2020

Approval ID

dc75488da9e454b6

Type

Therapeutic

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