Trust the Original to help you turn it off.

Transcription

1 Trust the Original to help you turn it off.

2 Trust the Original to help you turn it off.

3 Trust the Original to help you turn it off.

4 Trust the Original to help you turn it off.

5 Trust the Original to help you turn it off.

6 Trust the Original to help you turn it off.

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8 , Trust the Original Levocetrizine Original Research Molecule The only levocetrizine brand used in maximum clinical trials Say NO to allergy. Say YES to the original. Montelukast International Standard Certificate of Suitability given # by EDQM # EDQM: European Directorate for the Quality of Medicines

9 , Trust the Original Say NO to allergy. Say YES to the original. Levocetrizine Montelukast

10 , Trust the Original Say NO to allergy. Say YES to the original. Levocetrizine Montelukast

11 , Trust the Original Say NO to allergy. Say YES to the original.

12 , Trust the Original Say NO to allergy. Say YES to the original. IRB* TECHNOLOGY * IRB: Immediate Release Bi-Layer Technology

13 Say NO to allergy. Say YES to the original. 1,2,3 For faster, longer and 24 hours efficacy, 1. J Investig Allergol Clin Immunol 2006; Vol. 16, Supplement 1: Comparative pharmacology of the H1 antihistamines. A del Cuvillo, J Mullol, J Bartra 2. British Journal of Clinical Pharmacology DOI: /j Allergy Asthma Proc Jul-Aug:30(4);366-76

14 , Say NO to allergy. Say YES to the original.

15 Say NO to allergy. Say YES to the original., Also Available

16 Name of Medicinal Product: Xyzal M tablets. Qualitative and Quantitative Composition: Each tablet contains: Levocetirizine dihydrochloride IP 5 mg and Montelukast sodium equivalent to Montelukast 10 mg. Pharmaceutical Form: White and light pink coloured, round, bilayered, flat faced, bevelled edge, noncoated tablet scored on one side and plain on the other side. Therapeutic Indications: For the treatment of allergic rhinitis in adults only. Posology and Method of Administration: The usual dose is Montelukast sodium 10mg and Levocetirizine dihydrochloride 5 mg given once a daily orally. Contra-Indications: Levocetirizine: The use of Levocetirizine is contra indicated in patients with known hypersensitivity to Levocetirizine or any other ingredients of Levocetirizine, or to cetirizine. The observed reactions range from urticaria to anaphylaxis. Levocetirizine is also contraindicated in patients with end-stage renal disease [CLCR<mL/ min] and patients undergoing haemodialysis. Montelukast: Hypersensitivity to any component of this product. Special Warnings and Precautions: Levocetirizine: Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness and motor coordination such as driving or operating machinery whe taking Levocetirizine. Avoid concurrent use of alcohol or other central nervous system depressants with Levocetirizine. Montelukast: Montelukast should not be used as monotherapy for the treatment and management of exercise induced bronchospasm. Patients who have exacerbations of asthma after exercise should continue to use their usual regimen of inhaled (beta)-agonist prophylaxis and have available for rescue a short acting inhaled (beta)-agonist. Patients with known aspirin sensitivity should continue avoidance of aspirin or non-steroidal anti-inflammatory agents while taking Montelukast. In Eosinophilic Conditions in rare cases, patients on therapy with Montelukast may present with systemic eosinophilia,sometimes presentingwith clinical features fo vasculitis consistent with Churg Strauss syndrome, a condition, which is often treated with systemic corticosteroid therapy. Undesirable Effects: The possible side effects of Levocetirizine are somnolence, nasopharyngitis, fatigue, dry mouth, and pharyngitis, and most wetre mild to moderate in intensity. Others like pyrexia, cough and epistaxis were also reported. The possible side effects of Montelukast are asthenia/fatigue, fever, abdominal pain, trauma, dyspepsia, gastroenteritis, infectious dental pain, dizziness, headache, nasal congestion, cough, influenza, rash, increase in ALTand AST levels, pyuria. Overdose: Levocetirizine: Symptoms of overdose may include drowsiness in adults and initially agitation and restlesness, followed by drowsiness in childrens. Montelukast: There have been reports of acute overdosage in postmarketing experience and clinical studies with Montelukast. These include reports in adults and children with a dose as higher as 1000mg. The clinical and laboratory findings observed were consistent with the safety profile in adults and paediatric patients. The most frequently occuring adverse experiences were consistent with safety profile of Montelukast and included abdominal pain, somnolence, thirst, headache, vomiting and psychomotor hyperactivity. Keep out of reach of children. Please refer to the full prescribing information before usage. Xyzal M Tablets Abbreviated version th Aug2013 GGI-CO-A2-GR-XM VA-F17-150