What RABIOXIN® is and what it is used for:

RABIOXIN® rabeprazole which belongs to a group of drugs called proton pump inhibitors.

 RABIOXIN®

Rabeprazole sodium

RABIOXIN® works by reducing the production of gastric acid. This prevents irritation of the stomach’s mucosa, so that the gastric ulcer can heal. This relieves pain and discomfort caused by ulcers.

RABIOXIN® is used for:

  • duodenal ulcers;
  • benign gastric ulcers;
  • pain or discomfort caused by gastric acid that flows back into the oesophagus (the tube from the mouth to the stomach). This action can irritate the oesophagus, causing heartburn and other symptoms;
  • once the symptoms disappear, RABIOXIN® may also be used to prevent the recurrence of the disease;
  • elimination of Helicobacter pylori (bacteria that infects the stomach) in patients with benign gastric ulcers (peptic ulcers) in combination with antibiotics;
  • Zollinger-Ellison Syndrome (disorder that causes tumors in the pancreas and duodenum and ulcers in the stomach and duodenum);

How to take RABIOXIN®:

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Taking this medicine:

RABIOXIN® gastro-resistant tablets must not be chewed, divided or crushed. They are to be swallowed whole with some water.

When administering RABIOXIN® once daily, it should preferably be taken in the morning before breakfast.

Dosage:

  • For duodenal ulcers or benign gastric ulcers: the recommended dose is 20 mg once daily;
  • For pain or discomfort caused by gastric acid that flows back into the oesophagus (the tube from the mouth to the stomach). This action can irritate the oesophagus causing heartburn and other symptoms. Sometimes there will be an active ulcer in addition sometimes there will be no active ulcer;
  • When there is an active ulcer: the recommended dose is 20 mg once daily for 4-8 weeks;
  • When there is no active ulcer: the recommended dose is 10 mg once daily. If the symptoms continue after four weeks your doctor may carry out certain tests. Once the symptoms are gone, any reappearing symptoms may be controlled by taking 10 mg once daily as needed;
  • To prevent the recurrence of the disease: your doctor will prescribe 10 mg or 20 mg once daily depending on your personal need;
  • For eliminating Helicobactor pylori (bacteria that infects the stomach): the following treatment is frequently recommended for 7 days: RABIOXIN® 20 mg twice daily + clarithromycin 500 mg twice daily and amoxicillin 1 g twice daily;
  • For Zollinger-Ellison syndrome: the recommended dose is 60 mg once daily. The dose may be increased to 60 mg twice daily. Single daily doses up to 100 mg/day may be given.

Duration of treatment:

  • For duodenal ulcers: Usually for 4 weeks, but afterwards your doctor may decide to continue the treatment for another 4 weeks;
  • For benign gastric ulcers: Usually for 6 weeks, but afterwards your doctor may decide to continue the treatment for another 6 weeks;
  • For pain or discomfort caused by gastric acid that flows back into the oesophagus with an active ulcer: 4 – 8 weeks;
  • For pain or discomfort caused by gastric acid that flows back into the oesophagus without active ulcer: Usually 4 weeks;
  • To prevent the recurrence of the disease: Your doctor will tell you how long the tablets should be taken;
  • For eliminating Helicobactor pylori: Usually 7 days;
  • For Zollinger-Ellison Syndrome: As long as the condition requires treatment.

What RABIOXIN® contains:

The active substance is rabeprazole sodium.

Each RABIOXIN® 20 mg gastro-resistant tablet contains 20 mg Rabeprazole sodium.

The other ingredients are:

Tablet core: mannitol, heavy magnesium oxide, hydroxypropyl cellulose, magnesium Stearate.

Intermediate layer: ethylcellulose, heavy magnesium oxide.

Tablet coating: hypromellose phthalate, dibutyl sebacate, yellow iron oxide (only RABIOXIN® 20 mg gastro-resistant tablets), red iron oxide (only RABIOXIN® 10 mg gastro-resistant tablets), titanium dioxide, talc.

What RABIOXIN® looks like and contents of the pack:

RABIOXIN® 20 mg gastro-resistant tablets: Yellow, film-coated, biconvex tablets.

The tablets are supplied in blister packs of 14 tablets.

Marketing Authorisation Holder:

Inbiotech Ltd.

5A Triaditsa Str.

Sofia 1000

Bulgaria

RABIOXIN® 20 mg 14 gastro-resistant tablets Rabeprazole sodium