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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 organ-
ic 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 moderately 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 excep-
tion of diarrhoea. Packs and prices: Country-specific. Note: Before prescribing, please read full product information.
References:
1. American College of Gastroenterology Functional Gastrointestinal Disorders Task Force. Evidence-based position statement on
the management of irritable bowel syndrome. Am J Gastroenterol. 2002;97 (suppl):S1-S27.
2. Data on file, Annotated Package insert. a Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
3. Schmitt C, et al. The 5HT4 partial agonist, tegaserord, a partial 5H4 agonist improves abdominal/pain and altered bowel function
in irritable bowel syndrome. Gut 1999;45 (Suppl.V):A260
4. Muller-Lissner SA, et al. Tegaserod , a 5 HT4 receptor partial agonist, relieves symptoms in irritable bowel syndrome patients with
abdominal pain, bloating and constipation. Aliment Pharmacol Ther 2001,15:1655-1666
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
ZELDF01/04ME+Ae

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Folder zelmac

  • 1.
  • 2.
  • 3.
  • 4. 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 organ- ic 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 moderately 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 excep- tion of diarrhoea. Packs and prices: Country-specific. Note: Before prescribing, please read full product information. References: 1. American College of Gastroenterology Functional Gastrointestinal Disorders Task Force. Evidence-based position statement on the management of irritable bowel syndrome. Am J Gastroenterol. 2002;97 (suppl):S1-S27. 2. Data on file, Annotated Package insert. a Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA. 3. Schmitt C, et al. The 5HT4 partial agonist, tegaserord, a partial 5H4 agonist improves abdominal/pain and altered bowel function in irritable bowel syndrome. Gut 1999;45 (Suppl.V):A260 4. Muller-Lissner SA, et al. Tegaserod , a 5 HT4 receptor partial agonist, relieves symptoms in irritable bowel syndrome patients with abdominal pain, bloating and constipation. Aliment Pharmacol Ther 2001,15:1655-1666 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 ZELDF01/04ME+Ae