Antaloc

POSOLOGY AND METHOD OF ADMINISTRATION

Method of administration

Oral use. Antaloc enteric-coated tablets should not be chewed or crushed and should be swallowed whole 1 hour before a meal with some water.

Posology

Adults and adolescents 12 years of age and above

Reflux oesophagitis

The recommended dose is one tablet 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 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 Antaloc enteric-coated tablet 

+ twice daily 1000 mg amoxicillin

+ twice daily 500 mg clarithromycin

b) twice daily, one Antaloc enteric-coated tablet 

+ twice daily 400 - 500 mg metronidazole (or 500 mg tinidazole)

+ twice daily 250 - 500 mg clarithromycin

c) twice daily, one Antaloc enteric-coated tablet 

+ twice daily 1000 mg amoxicillin

+ twice daily 400 - 500 mg metronidazole (or 500 mg tinidazole)

In combination with 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, other 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

The recommended dose is one tablet 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.

Treatment of duodenal ulcer

The recommended dose is one tablet 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.

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 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 hypersecretory conditions 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. 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.

Patients with renal Impairment

No dose adjustment is necessary for 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.

Older people

No dose adjustment is necessary for elderly patients.

Pediatric population

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.

CONTRAINDICATIONS

Hypersensitivity to pantoprazole, substituted benzimidazoles, or to any of the excipients

WARNINGS AND PRECAUTIONS

Hepatic Impairment

In patients with severe liver impairment, the liver enzymes should be monitored regularly during treatment with pantoprazole, particularly on long-term use. In the case of a rise in liver enzymes, the treatment should be discontinued.

Combination therapy

In the case of combination therapy, the summaries of product characteristics of the respective medicinal products should be observed.

Gastric malignancy

Symptomatic response to pantoprazole may mask the symptoms of gastric malignancy and may delay diagnosis. In the presence of any alarm symptom (e. g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis, anemia, or melaena) and when gastric ulcer is suspected or present, malignancy should be excluded.

Further investigation is to be considered if symptoms persist despite adequate treatment.

Co-administration with HIV protease inhibitors

Co-administration of pantoprazole is not recommended with HIV protease inhibitors for which absorption is dependent on acidic intragastric pH such as atazanavir, due to a significant reduction in their bioavailability.

Influence on vitamin B12 absorption

In patients with Zollinger-Ellison syndrome and other pathological hypersecretory conditions requiring long-term treatment, pantoprazole, as all acid-blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria. This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy or if respective clinical symptoms are observed.

Long term treatment

In long-term treatment, especially when exceeding a treatment period of 1 year, patients should be kept under regular surveillance.

Gastrointestinal infections caused by bacteria

Treatment with Pantoprazole may lead to a slightly increased risk of gastrointestinal infections caused by bacteria such as Salmonella and Campylobacter and C. difficile.

Hypomagnesaemia

Severe hypomagnesemia has been reported in patients treated with PPIs like pantoprazole for at least three months and in most cases for a year. Serious manifestations of hypomagnesemia such as fatigue, tetany, delirium, convulsions, dizziness, and ventricular arrhythmia can occur, but they may begin insidiously and be overlooked. In most affected patients, hypomagnesemia improved after magnesium replacement and discontinuation of the PPI.

For patients expected to be on prolonged treatment or who take PPIs with digoxin or medicinal products that may cause hypomagnesemia (e.g., diuretics), health care professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment.

Bone fractures

Proton pump inhibitors, especially if used in high doses and over long durations (>1 year), may modestly increase the risk of hip, wrist, and spine fracture, predominantly in the older people or in presence of other recognized risk factors. Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10–40%. Some of this increase may be due to other risk factors. Patients at risk of osteoporosis should receive care according to current clinical guidelines and they should have an adequate intake of vitamin D and calcium.

Subacute cutaneous lupus erythematosus (SCLE)

Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping Pantoprazole. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.

Interference with laboratory tests

Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumors. To avoid this interference, Pantoprazole treatment should be stopped for at least 5 days before CgA measurements (see section 5.1). If CgA and gastrin levels have not returned to the reference range after the initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment

SHELF-LIFE

36 months from the manufacturing date. Do not use after the expiry date

Box of 10 blisters x 07 enteric-coated tablets.