PANTOPRAZOLE RANBAXY
Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Tabia za bidhaa
(SPC)
07-06-2024
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Viambatanisho vya kazi:
PANTOPRAZOLE
Inapatikana kutoka:
Ranbaxy (UK) Limited
Kipimo:
40 Milligram
Dawa fomu:
Tablets Gastro-Resistant
Idhini ya tarehe:
2009-03-13
Tabia za bidhaa
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pantoprazole Ranbaxy 40 mg gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 40 mg Pantoprazole (as pantoprazole sodium sesquihydrate 45.2 mg).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet.
Yellow enteric coated oval shaped, biconvex tablets imprinted with ‘IV’ on one side and plain on other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adults and adolescents 12 years of age and above
-
reflux oesophagitis
Adults
-
Eradication of Helicobacter pylori (H. pylori) in combination with appropriate antibiotic therapy in patients with _H._
_pylori _associated ulcers.
-
Gastric and Duodenal ulcer
-
Zollinger-Ellison syndrome and other pathological hypersecretory conditions
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Tablets should not be chewed or crushed, and should be swallowed whole 1 hour before a meal with some
water.
Recommended dose
Adults and adolescents 12 years of age and above
Reflux oesophagitis
One gastro-resistant tablet Pantoprazole 40 mg per day. In individual cases the dose may be doubled (increase to 2
tablets daily) especially when there has been no response to other treatment. A 4-week period is usually required for the
treatment of reflux oesophagitis. If this is not sufficient, healing will usually be achieved within a further 4 weeks.
Adults:
Eradication of H. pylori in combination with two appropriate antibiotics
In H. pylori positive patients with gastric and duodenal ulcers, eradication of the germ by a combination therapy should
be achieved. Considerations should be given to official local guidance (e.g. national recommendations) regarding
bacterial resistance and the appropriate use and
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