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C zelmac a4
1.
2. ZELMAC®
6 mg tablets
Presentation: Tegaserod. Tablets: 6 mg tegaserod as hydrogen maleate. Indications/Potential uses: Symptomatic treatment of female patients with abdominal pain
and constipation associated with irritable bowel syndrome. An organic origin of such symptoms must be ruled out by means of appropriate investigations. Dosage: 6 mg
twice daily prior to a meal for a maximum of 12 weeks. Contraindications: Hypersensitivity to tegaserod hydrogen maleate and/or to any of the excipients. Precautions:
Diarrhoea and/or patients with recurrent diarrhoea associated with IBS. Caution is required in patients in whom increased gastrointestinal motility could have negative
effects. Use of Zelmac cannot be recommended in patients with severe hepatic impairment or severe renal failure. Caution is required in patients with mild to moderate-
ly severe renal or hepatic failure. Interactions: No drug interactions of clinical relevance. Adverse reactions: The overall incidence of adverse events in clinical trials
was comparable with that of placebo, with exception of diarrhoea. Packs and prices: Country-specific. Note: Before prescribing, please read full product information.
References:
1. Drossman DA, Corazziari E, Talley NJ, Thompson WG, Whitehead WE, eds. Rome II: The functional Gastrointestinal Disorders. 2nd ed. McLean, VA: Degnon
Associates, 2000:360-361. 2. American College of Gastroenterology Functional Gastrointestinal Disorders Task Force. Evidence-based position statement on the man-
agement of irritable bowel syndrome. Am J Gastroenterol. 2002;97 (suppl):S1-S27. 3. Silk DB. Impact of irritable bowel syndrome on personal relationships and working
practices. Eur J Gastroenterol & Hepatol 2001; 13:1327-1332. 4. Beglinger C. Tegaserod: A novel, selective 5-HT4 receptor partial agonist for irritable bowel syndrome.
IJCP 2002;56:47-51. 5. Novick J, et al. A randomized, double-blind, placebo-controlled trial of tegaserod in female patients suffering from irritable bowel syndrome with
constipation. Aliment Pharmacol Ther 2002; 16:1877-1888 6. Krumholz S, et al.The 5HT4 partial agonist, tegaserod, improves abdominal bloating and altered stool con-
sistency in Irritable bowel syndrome (IBS). Gut 1999;45 (Suppl V):A260
ZelDC301/04ME+Ae
