PANTOFLUX Gastro-resistant tablet Ref.[49767] Active ingredients: Pantoprazole

Posology

Adults and adolescents 12 years of age and above

Reflux oesophagitis

One Pantoflux 40 mg gastro-resistant tablet per day. In individual cases the dose may be doubled (increase to 2 Pantoflux 40 mg 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 prescription of antibacterial agents. Depending upon the resistance pattern, the following combinations can be recommended for the eradication of H. pylori:

a) Pantoflux 40 mg gastro-resistant tablet twice daily one
+ twice daily 1000 mg amoxicillin
+ twice daily 500 mg clarithromycin

b) Pantoflux 40 mg gastro-resistant tablet twice daily
+ twice daily 400‑500 mg metronidazole (or 500 mg tinidazole)
+ twice daily 250‑500 mg clarithromycin

c) Pantoflux 40 mg gastro-resistant tablet twice daily
+ 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 Pantoflux 40 mg 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 Pantoflux monotherapy:

Treatment of gastric ulcer

One Pantoflux 40 mg gastro-resistant tablet per day. In individual cases the dose may be doubled (increase to 2 Pantoflux 40 mg tablets 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.

Treatment of duodenal ulcer

One Pantoflux 40 mg gastro-resistant tablet per day. In individual cases the dose may be doubled (increase to 2 Pantoflux 40 mg tablets 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.

Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions

For the long-term management of Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions patients should start their treatment with a daily dose of 80 mg (2 tablets of Pantoflux 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 hypersecretory conditions is not limited and should be adapted according to clinical needs.

Special populations

Paediatric population

Pantoflux is not recommended for use in children below 12 years of age due to limited data on safety and efficacy in this age group (see section 5.2).

Patients with hepatic impairment

A daily dose of 20 mg pantoprazole (1 tablet of Pantoflux 20 mg) should not be exceeded in patients with severe liver impairment. Pantoflux 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 Pantoflux in combination treatment of these patients (see section 4.4).

Patients with renal impairment

No dose adjustment is necessary in patients with impaired renal function. Pantoflux 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 Pantoflux in combination treatment for these patients (see section 5.2).

Elderly

No dose adjustment is necessary in elderly patients (see section 5.2).

Method of administration

Oral use

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 overdose with clinical signs of intoxication, apart from symptomatic and supportive treatment, no specific therapeutic recommendations can be made.

4 years.

Blister: This medicinal product does not require any special storage conditions.

Tablet container: Do not store above 30°C

Aluminium/aluminium blister pack.

Tablet container (HDPE) closed with PP cap with integrated desiccant.

Pack sizes:

Blister: 7, 14, 15, 20, 28, 30, 56, 60, 98, 100 tablets and 10 × 14 tablets (hospital pack)

Tablet container: 30, 100, 250 tablets.

Not all pack sizes may be marketed.

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.