Posology : מינונים

4.2      Posology and method of administration
Posology

Controloc 20 mg:
Adults and adolescents 12 years of age and above

Reflux oesophagitis and associated symptoms (e.g. heartburn, acid regurgitation, pain on swallowing).
The recommended oral dose is one Controloc 20 mg tablet per day. Symptom relief is generally accomplished within 2-4 weeks. If this is not sufficient, symptom relief will normally be achieved within a further 4 weeks. When symptom relief has been achieved, reoccurring symptoms can be controlled using an on-demand regimen of 20 mg once daily, taking one tablet when required. A switch to continuous therapy may be considered in case satisfactory symptom control cannot be maintained with on-demand treatment.

Long-term management and prevention of relapse in reflux oesophagitis For long-term management, a maintenance dose of one Controloc 20 mg tablet per day is recommended, increasing to 40 mg pantoprazole per day if a relapse occurs. Controloc 40 mg tablet is available for this case. After healing of the relapse the dose can be reduced again to Controloc 20 mg tablet.

Adults

Prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk with a need for continuous NSAID treatment The recommended oral dose is one Controloc 20 mg tablet per day.

Controloc 40 mg:

Adults and adolescents 12 years of age and above
Reflux oesophagitis
One tablet of Controloc 40 mg per day. In individual cases the dose may be doubled (increase to 2 tablets Controloc 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.


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) Twice daily one tablet Controloc 40 mg
+ twice daily 1000 mg amoxycillin
+ twice daily 500 mg clarithromycin b) Twice daily one tablet Controloc 40 mg
+ twice daily 400-500 mg metronidazole (or 500 mg tinidazole)
+ twice daily 250-500 mg clarithromycin c) Twice daily one tablet Controloc 40 mg
+ twice daily 1000 mg amoxycillin
+ twice daily 400-500 mg metronidazole (or 500 mg tinidazole)
In combination therapy for eradication of H. pylori infection, the second Controloc 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 Controloc 40 mg monotherapy:

Treatment of gastric ulcer
One tablet of Controloc 40 mg per day. In individual cases the dose may be doubled (increase to 2 tablets Controloc 40 mg 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 tablet of Controloc 40 mg per day. In individual cases the dose may be doubled (increase to 2 tablets of Controloc 40 mg 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
For the long-term management of Zollinger-Ellison-Syndrome patients should start their treatment with a daily dose of 80 mg (2 tablets of Controloc 40 mg). Thereafter, the dosage 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 is not limited and should be adapted according to clinical needs.
 special populations

Patients with hepatic impairment
A daily dose of 20 mg pantoprazole (1 tablet of 20 mg pantoprazole) should not be exceeded in patients with severe liver impairment. Controloc 40 mg 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 Controloc 40 mg 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. Controloc 40 mg 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 Controloc 40 mg in combination treatment for these patients (see section 5.2).

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

Children below 12 years of age
Pantoprazole 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).

Method of administration

Oral use
The tablets should not be chewed or crushed, and should be swallowed whole 1 hour before a meal with some water.