Proxium tablets

Adults and children ages 12 and up.

• Reflux esophagitis.

Adults.

• Eradication of Helicobacter pylori (H. pylori) in patients with H. pylori ‒ associated gastric and duodenal ulcers in combination with appropriate antibiotics.
• Duodenal ulcer.
• Stomach ulcer.
• Zollinger‒Ellison syndrome and other hypersecretory pathological conditions.

Proxium®, gastro-resistant tablets, should be taken 1 hour before meals whole, not chewed or ground, washed with water.

Recommended dosage.

Adults and children ages 12 and up.

Treatment of reflux esophagitis.

The recommended dose is 1 tablet of Proxium® 40 mg daily. In some cases, the dose can be doubled (2 tablets of Proxium® 40 mg daily), especially in the absence of the effect of other drugs for the treatment of reflux esophagitis. It usually takes 4 weeks to treat reflux esophagitis. If this is not enough, healing can be expected within the next 4 weeks.

Adults.

Eradication of H. pylori in combination with two antibiotics.

In adult patients with gastric and duodenal ulcer and H. pylori positive result, eradication of the microorganism by combination therapy should be achieved. Local data on bacterial resistance and national guidelines for the use and administration of appropriate antibacterial agents should be considered. Depending on the sensitivity, the following therapeutic combinations may be prescribed for H. pylori eradication in adults:

a) 1 tablet of Proxium® 40 mg twice daily

    + 1000 mg amoxicillin 2 times a day

    + 500 mg clarithromycin 2 times a day;

b) 1 tablet of Proxium® 40 mg twice daily

    + 400-500 mg metronidazole (or 500 mg tinidazole) 2 times a day

    + 250-500 mg clarithromycin 2 times a day;

c) 1 tablet of Proxium® 40 mg 2 times a day

    + 1000 mg amoxicillin 2 times a day

    + 400-500 mg metronidazole (or 500 mg tinidazole) 2 times a day.

When using combination therapy for the eradication of H. pylori, the second tablet of Proxium® 40 mg should be taken in the evening 1 hour before meals. The treatment period is 7 days and can be extended for another 7 days with a total duration of treatment of no more than two weeks. If further treatment with pantoprazole is indicated for ulcer healing, dosage recommendations for gastric and duodenal ulcers should be considered. If combination therapy is not indicated, for example, in patients with a negative result on H. pylori, Proxium® 40 mg is used for monotherapy in the dosage below.

Treatment of gastric ulcer.

1 tablet of Proxium® 40 mg daily. In some cases, the dose can be doubled (2 tablets of Proxium® 40 mg daily), especially in the absence of the effect of other drugs.

It usually takes 4 weeks to treat stomach ulcers. If this is not enough, ulcer healing can be expected within the next 4 weeks.

Treatment of duodenal ulcer.

1 tablet of Proxium® 40 mg daily. In some cases, the dose can be doubled (2 tablets of Proxium® 40 mg daily), especially in the absence of the effect of other drugs.

It usually takes 2 weeks to treat duodenal ulcer. If this is not enough, ulcer healing can be expected within the next 2 weeks.

Treatment of Zollinger's and Ellison's syndrome and other hypersecretory pathological conditions.

For long-term treatment of Zollinger-Ellison syndrome and other pathological hypersecretory conditions, the initial daily dose is 80 mg (2 tablets of Proxium® 40 mg). If necessary, the dose can then be titrated, increasing or decreasing, depending on the acidity of gastric juice. The dose in excess of 80 mg per day should be divided into two doses. A temporary dose increase of more than 160 mg pantoprazole is possible, but the duration of administration should only be limited by the period required for adequate acidity control.

The duration of treatment for Zollinger ‒ Ellison syndrome and other pathological conditions is not limited and depends on clinical need.

Patients with impaired liver function. Patients with severe hepatic impairment should not exceed the daily dose of 20 mg (1 tablet of Proxium® 20 mg). Proxyum® should not be used to eradicate H. pylori in combination therapy for patients with moderate and severe hepatic impairment, as there is currently no evidence of the efficacy and safety of such use in this category of patients.

Patients with impaired renal function. No dose adjustment is required for patients with impaired renal function. Proxyum® should not be used to eradicate H. pylori in combination therapy for patients with impaired renal function, as there is currently no evidence of the efficacy and safety of such use for this category of patients.

Elderly patients do not need a dose adjustment.

Children. Proxium 40 mg is indicated for children aged 12 years for the treatment of reflux oesophagitis. The drug is not recommended for use in children under 12 years of age, because data on the safety and efficacy of this drug are limited in this category.

Hypersensitivity to the active substance, benzimidazole derivatives and any drug component.

Active substance: pantoprazole;

1 tablet contains pantoprazole sodium sesquihydrate equivalent to pantoprazole 40 mg.

Excipients: anhydrous sodium carbonate, attracts (E 421), croscarmellose sodium, sodium starch (type A), magnesium stearate, colloidal silicon dioxide.

Shell composition: propylene glycol, yellow iron oxide (E172), titanium dioxide (E 171), hypromellose, triethyl citrate, methacrylate copolymer (type A).

8 tablets in a blister, 4 blisters in a carton.

Store in the original package in a place out of the reach of children.

Laboratorios Normon SA, Ronda de Valdecarriso, 6, Tres Cantos, 28760 Madrid, Spain.

№ 1860 dated 08/21/2019

Registration Certificate UA/13996/01/01