Medicinal Products

PANTOPRAZOLE ZYDUS FRANCE 40 mg

Generic drug of the therapeutic class: Gastro-Entero-Hepatology
active ingredients: Pantoprazole
laboratory: Zydus France

Gastroresistant tablet
Box of 28
All forms

Indication

· In combination with antibiotic therapy, eradication of Helicobacter pylori in case of peptic ulcer disease.

· Progressive duodenal ulcer.

· Evolutionary gastric ulcer.

· Esophagitis by gastro-oesophageal reflux.

· Long-term treatment of Zollinger-Ellison syndrome.

Dosage PANTOPRAZOLE ZYDUS FRANCE 40 mg Gastroresistant tablet Box of 28

The tablets will not be crunched or crushed, but swallowed whole with a little water before a meal.

Eradication of Helicobacter pylori in case of peptic ulcer disease:

The following dosing regimens are recommended:

· 1 tablet of pantoprazole 40 mg morning and evening with clarithromycin 500 mg morning and evening and amoxicillin 1000 mg morning and evening for 7 days;

· 1 tablet of pantoprazole 40 mg morning and evening with clarithromycin 500 mg morning and evening and metronidazole or tinidazole 500 mg morning and evening for 7 days;

· Alternatively to the above regimens, 1 tablet of pantoprazole 40 mg morning and evening combined with amoxicillin 1000 mg morning and evening and metronidazole or tinidazole 500 mg morning and evening for 7 days.

The effectiveness of treatment depends on compliance with the dosing regimen, including taking the therapy for 7 days.

Evolutionary duodenal ulcer

1 tablet daily for 4 weeks.

Evolutionary gastric ulcer

1 tablet daily for 4 to 8 weeks.

Gastroesophageal reflux esophagitis

1 tablet daily for 4 weeks with a possible second period of 4 weeks at the same dosage.

Long-term treatment of Zollinger-Ellison syndrome

The initial dosage is 2 tablets per day (ie 80 mg).

This can be increased or decreased depending on the needs, depending on the results of the acid flow measurements. In the case of a dosage higher than 80 mg / day, the dose will be divided into two doses. A temporary increase in dosage above 160 mg per day is possible but should not exceed the time required to control acid secretion.

Against indications

Known hypersensitivity to pantoprazole and / or any of the other ingredients.

Side effects Pantoprazole Zydus France

Frequency
Organ system

Frequent
(> 1/100 - <1/10)

Rare
(> 1 / 1, 000 - <1/100)

Rare
(1 / 10.000)

Very rare
(<1 / 10, 000 including isolated cases)

Blood and lymphatic system disorders

Leukopenia, thrombocytopenia

Gastrointestinal disorders

Abdominal pain, diarrhea, constipation, flatulence

Nausea, vomiting

Oral dryness

General disorders and administration site conditions

Peripheral edema

Hepatobiliary disorders

Severe cytolytic and icteric liver injury with or without hepatocellular insufficiency

Immune system disorders

Anaphylactic reactions, including anaphylactic shock

investigations

Elevation of liver enzymes (transaminases, gamma-glutamyltranspeptidases), elevation of triglycerides, hyperthermia, hyponatremia in the elderly

Musculoskeletal and systemic disorders

arthralgia

myalgia

Nervous system disorders

headaches

Dizziness, disturbed vision (blurred vision)

Psychiatric disorders

Depression, hallucination, disorientation and confusion especially in predisposed patients and worsening of these symptoms, if pre-existing

Renal and urinary disorders

Interstitial nephritis

Skin and subcutaneous tissue disorders

Allergic reactions with pruritus and skin rash.

Urticaria, angioedema, severe skin reactions such as Stevens-Johnson syndrome, erythema multiforme, Lyell's syndrome, photosensitivity

Other

gynecomastia

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