PANTOPRAZOLE SANDOZ GASTRO RESISTANT TABLETS 40MG [SIN14775P]

Product Info

PANTOPRAZOLE SANDOZ GASTRO RESISTANT TABLETS 40MG

[SIN14775P]

4.1 Therapeutic Indications

• In combination with two appropriate antibiotics (see Dosage) for the eradication of H. pylori in patients with peptic ulcers with the objective of reducing the recurrence of duodenal and gastric ulcers caused by this microorganism.

• Duodenal ulcer

• Gastric ulcer

• Moderate and severe reflux oesophagitis

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.

Reflux oesophagitis
One tablet of Pantoprazole 40 mg per day. In individual cases, the dose may be doubled (increase to 2 tablets Pantoprazole 40 mg 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.

Eradication of Helicobacter pylori in combination with two appropriate antibiotics
In Helicobacter 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 prescription of antibacterial agents. Depending upon the resistance pattern, the following combinations can be recommended for the eradication of Helicobacter pylori:

1. twice daily one tablet Pantoprazole 40 mg
   + twice daily 1000 mg amoxicillin
   + twice daily 500 mg clarithromycin

2. twice daily one tablet Pantoprazole 40 mg
   + twice daily 500 mg metronidazole
   + twice daily 500 mg clarithromycin

3. twice daily one tablet Pantoprazole 40 mg
   + twice daily 1000 mg amoxicillin
   + twice daily 500 mg metronidazole

In combination therapy for eradication of Helicobacter pylori infection, the second Pantoprazole 40 mg tablet should be taken before the evening meal. The combination therapy is implemented for 7 days in general and can be prolonged to up to 2 weeks maximum. If, to ensure healing of the ulcers, further treatment with pantoprazole is indicated, the dosage recommendations for duodenal and gastric ulcers should be considered. A duodenal ulcer generally heals within 2 weeks. If a 2‐week period of treatment is not sufficient, healing will be achieved in almost all cases within a further 2 weeks. A 4-week period is usually required for the treatment of gastric ulcers and reflux esophagitis. If this is not sufficient, healing will usually be achieved within a further 4 weeks.

Treatment of gastric ulcer and duodenal ulcer
If combination therapy is not an option, e.g. if the patient has tested negative for Helicobacter pylori, the following dosage guidelines apply for Pantoprazole 40 mg monotherapy:

For the treatment of gastric and duodenal ulcer and reflux esophagitis, one tablet of Pantoprazole 40 mg per day. In individual cases, the dose may be doubled (increase to 2 tablets Pantoprazole 40 mg daily) especially when there has been no response to other treatment.

Special Patient Populations
Pediatric patients
The experience in children is limited. Pantoprazole 40 mg tablet is not recommended for use in children below 12 years of age due to limited data on safety and efficacy in this age group.

Impaired hepatic function
A daily dose of pantoprazole 20 mg should not be exceeded in patients with severe liver impairment (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

In addition, pantoprazole 40 mg tablet must not be used in combination treatment (e.g. amoxicillin, clarithromycin,) for eradication of H. pylori in patients with moderate to severe hepatic dysfunction since currently no data are available on the efficacy and safety of pantoprazole in combination treatment of these patients (see section 4.3).

Impaired renal function
No dose adjustment is necessary in patients with impaired renal function.

In addition, pantoprazole 40 mg tablet must not be used in combination treatment (e.g. amoxicillin, clarithromycin) for eradication of H. pylori in patients with impaired renal function, since currently no data are available on the efficacy and safety of pantoprazole in combination treatment for these patients.

Elderly patients
Generally, no dose adjustment is necessary in elderly patients. However, the daily dose of 40 mg should not be exceeded in treatment of gastric or duodenal ulcer.

4.3 Contraindications
Pantoprazole should generally not be used in cases of known hypersensitivity to one of the other constituents of Pantoprazole 40mg tablet or of the combination partners.

Pantoprazole 40 mg must not be used in combination treatment for eradication of H. pylori in patients with moderate to severe liver or kidney function disturbances since currently no clinical data are available on the efficacy and safety of Pantoprazole 40 mg in combination treatment for these patients.

Pantoprazole, like other PPIs, should not be co-administered with atazanavir (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).