Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Takeda UK Limited, Building 3, Glory Park, Glory Park Avenue, Wooburn Green, Bucks, HP10 0DF, UK
Pantoprazole is indicated for use in adults and adolescents 12 years of age and above for:
Pantoprazole is indicated in adults for:
One tablet of Pantoprazole per day. In individual cases the dose may be doubled (increase to 2 tablets Pantoprazole 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.
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 prescription of antibacterial agents. Depending upon the resistance pattern, the following combinations can be recommended for the eradication of H. pylori:
a) Twice daily one tablet Pantoprazole
+ twice daily 1000 mg amoxicillin
+ twice daily 500 mg clarithromycin
b) Twice daily one tablet Pantoprazole
+ twice daily 400-500 mg metronidazole (or 500 mg tinidazole)
+ twice daily 250-500 mg clarithromycin
c) Twice daily one tablet Pantoprazole
+ twice daily 1000 mg amoxicillin
+ twice daily 400-500 mg metronidazole (or 500 mg tinidazole)
In combination therapy for eradication of H. pylori infection, the second Pantoprazole tablet should be taken 1 hour before the evening meal. The combination therapy is implemented for 7 days in general and can be prolonged for a further 7 days to a total duration of up to two weeks. If, to ensure healing of the ulcers, further treatment with pantoprazole is indicated, the dose recommendations for duodenal and gastric ulcers should be considered.
If combination therapy is not an option, e.g. if the patient has tested negative for H. pylori, the following dose guidelines apply for Pantoprazole monotherapy:
Treatment of gastric ulcer
One tablet of Pantoprazole per day. In individual cases the dose may be doubled (increase to 2 tablets of Pantoprazole daily) especially when there has been no response to other treatment. A 4-week period is usually required for the treatment of gastric ulcers. If this is not sufficient, healing will usually be achieved within a further 4 weeks.
One tablet of Pantoprazole per day. In individual cases the dose may be doubled (increase to 2 tablets of Pantoprazole daily) especially when there has been no response to other treatment. 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.
For the long-term management of Zollinger-Ellison-Syndrome and other pathological hyper secretory conditions patients should start their treatment with a daily dose of 80 mg (2 tablets of Pantoprazole 40 mg). Thereafter, the dose can be titrated up or down as needed using measurements of gastric acid secretion to guide. With doses above 80 mg daily, the dose should be divided and given twice daily. A temporary increase of the dose above 160 mg pantoprazole is possible but should not be applied longer than required for adequate acid control.
Treatment duration in Zollinger-Ellison syndrome and other pathological hyper secretory conditions is not limited and should be adapted according to clinical needs.
A daily dose of 20 mg pantoprazole (1 tablet of 20 mg pantoprazole) should not be exceeded in patients with severe liver impairment. Pantoprazole must not be used in combination treatment 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 4.4).
No dose adjustment is necessary in patients with impaired renal function. Pantoprazole must not be used in combination treatment 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 (see section 5.2).
No dose adjustment is necessary in older people (see section 5.2).
Pantoprazole is not recommended for use in children below 12 years of age because of limited data on safety and efficacy in the age group (see section 5.2).
Oral use.
The tablets should not be chewed or crushed, and should be swallowed whole 1 hour before a meal with some water.
There are no known symptoms of overdose in man.
Systemic exposure with up to 240 mg administered intravenously over 2 minutes, were well tolerated.
As pantoprazole is extensively protein bound, it is not readily dialysable.
In the case of an overdose with clinical signs of intoxication, apart from symptomatic and supportive treatment, no specific therapeutic recommendations can be made.
Blister packs: 3 years.
Bottles:
Unopened: 3 years.
After first opening: 100 days.
This medicinal product does not require any special storage conditions.
HDPE bottles with LDPE screw cap closure.
7 gastro-resistant tablets
10 gastro-resistant tablets
14 gastro-resistant tablets
15 gastro-resistant tablets
24 gastro-resistant tablets
28 gastro-resistant tablets
30 gastro-resistant tablets
48 gastro-resistant tablets
49 gastro-resistant tablets
56 gastro-resistant tablets
60 gastro-resistant tablets
84 gastro-resistant tablets
90 gastro-resistant tablets
98 gastro-resistant tablets
98 (2x49) gastro-resistant tablets
100 gastro-resistant tablets
Hospital pack with:
50 gastro-resistant tablets
90 gastro-resistant tablets
100 gastro-resistant tablets
140 gastro-resistant tablets
140 (10x14) gastro-resistant tablets
150 (10x15) gastro-resistant tablets
700 (5x140) gastro-resistant tablets
Blister (ALU/ALU blister) without cardboard reinforcement.
Blister (ALU/ALU blister) with cardboard reinforcement (blister wallet).
7 gastro-resistant tablets
10 gastro-resistant tablets
14 gastro-resistant tablets
15 gastro-resistant tablets
24 gastro-resistant tablets
28 gastro-resistant tablets
30 gastro-resistant tablets
48 gastro-resistant tablets
49 gastro-resistant tablets
56 gastro-resistant tablets
60 gastro-resistant tablets
84 gastro-resistant tablets
90 gastro-resistant tablets
98 gastro-resistant tablets
98 (2x49) gastro-resistant tablets
100 gastro-resistant tablets
112 gastro-resistant tablets
168 gastro-resistant tablets
Hospital pack with:
50 gastro-resistant tablets
90 gastro-resistant tablets
100 gastro-resistant tablets
140 gastro-resistant tablets
140 (10x14) gastro-resistant tablets
150 (10x15) gastro-resistant tablets
700 (5x140) gastro-resistant tablets
Not all pack sizes may be marketed.
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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