PANOCID 40

pantoprazole

Film coated tablets, enteric, 40 mg

PACKAGE INSRT. INFORMATION FOR THE PATIENT

Please, read this package insert carefully before using the pteraration!

Keep this package insert. You may need to read it again.

If you have any additional questions, please, consult your doctor.

This preparation is indicated for you personally and should not be given to other individuals. Doing so may harm their health even if their symptoms are similar to yours.

Composition.

Active substance: pantoprazole;

1 tablet contains pantoprazole 40mg;

Auxiliary substances: mannitol, anhydrous sodium carbonate, hydroxipropylmethylcellulose, povodone, calcium stearate, colorant ІС-EN 350 yellow, colorant ІС-S-329.

Medicinal form. Film coated tablets, enteric.

Pharmacotherapeutical group. Drugs for treatment of peptic ulcer. Inhibitors of “proton pump”.

Pharmacological properties. Panocid 40 decreases basal and stimulated hydrochloric acid secretion. In duodenal ulcer, associated with Helicobaсter pylori, such decrease of gastric secretion enhances the susceptibility of the microorganism to antibiotics. Pantoprazole has antimicrobial action against Helicobaсter pylori and promotes antihelicobacterial effect of other preparations.

Indications. Peptic gastric and duodenal ulcer in acute state, gastroesophageal reflux disease, Zollinger-Ellison syndrome, eradication of Helicobacter pylori (in combination with antibacterial therapy), non-ulcer dyspepsia, chronic gastritis with increased acid-forming function of the stomach in the acute stage.

Contraindications. Hypersensitivity to preparation, severe renal insufficiency, hepatitis, liver cirrosis, pregnancy and lactation. It is not recommended to indicate the preparation to children under 15 years old.

Precautions at use. If you are pregnant or nursing mother, tell you doctor about it before using the preparation.

It is not recommended for treatment of hyperacid states associated with diet or other (alcohol, smoking) factors. Before starting pantoprazole treatment of the ulcer located in the stomach it is necessary to exclude the possibility of malignant disease as masking of its symptoms may lead to late diagnosis.

In elderly patients the dose should not exceed 40 mg a day.

Use with caution when driving and carrying out work that require attention.

Interaction with other drugs. If you receive any other medicinal preparations tell your doctor about it. At concomitant use it may alter the absorption of the preparations that depends on pH level (ketoconazole). Clinical interaction of pantoprazole with such preparations as diazepam, warfarin, theophylline, phenytoin, digoxin, as well as with oral contraceptives and anacid preparations, has not been established.

Way of introduction and doses

• peptic gastric ulcer –1 tablet (40 mg) twice a day for 2-6 weeks;
• peptic duodenal ulcer –1 tablet (40 mg) twice a day for 2-4 weeks;
• gastroesophageal reflux disease – 1 tablet (40 mg) twice a day for 4-8 weeks; supportive therapy for gastroesophageal reflux disease – 1 tablet (40 mg) once a day for up to 12 months;
• chronic gastritis with increased acid-forming function of the stomach in the acute stage – 1-2 tablets (40-80 mg) a day for 2-4 weeks;
• for eradication of Helicobacter pylori (in combination with antibacterial agents (amoxicilline, clarithromycin, tetracycline, furasolidone, metronidazole) and bismuth preparations)) –1 tablet (40 mg) twice a day for 7 days (maximum for up to 2 weeks);
• non-ulcer dyspepsia – 1-2 tablets (40-80 mg) a day for 2-3 weeks;

Zollinger-Ellison syndrome – the dose is adjusted individually according to the initial level of gastric secretion; the initial dose of the preparation is 3 tablets (120 mg) once a day for 2-8 weeks.

Overdose. There are no data about overdose of the preparation. If overdose is suspected, symptomatic therapy is carried out. Dialysis is not effective.

Side effects. In rare cases – nausea, diarrhea, constipation, meteorism, abdominal pain, headache, general weakness, skin rash, dizziness, depression, increased activity of transaminase in blood, sleepiness, insomnia, photophobia, paresthesia, sight disorders, tinnitus, hematuria, impotence, alopecia, acne, allergic reactions, fever, eosinophilia. In case of any of these or other adverse reactions discontinue the intake of the preparation and consult the doctor.

Shelf life. 3 years. Do not use the preparation after the expiary date indicated on the package.

Storage conditions. Keep out of the reach of children in dry protected from light place at temperature below 30ºC.

Packing. 10 tablets in a blister; 1or 3 blisters in a carton.

Terms of dispensing. On prescription.

Name and Address of the Manufacturer. Flamingo Pharmaceuticals Ltd. E-28, MIDS, Taloja, Mumbai – 410208, India.