PROBITOR 20 mg. 30 tablets 

PROBITOR WHAT IS AND WHAT IT IS USED FOR?

Omeprazole is an inhibitor of the gastric proton pump, ie inhibits the enzyme responsible for the secretion of stomach acid.

Probitor be used in:

 Duodenal

 A stomach ulcer

Regurgitation of gastric contents into the esophagus

 Maintenance therapy of reflux esophagitis to prevent retsedivi

Syndrome Zollingen-Ellison / much increased production of stomach acid /

 Treatment of ulcers of the stomach and duodenum, the use of non-steroidal antirheumatic / anti-inflammatory medications, maintenance therapy to prevent the recurrence of ulcers of the stomach and duodenum, the use of non-steroidal antirheumatic / antiinflammatory drugs.

Symptomatic treatment of gastroesophageal reflux disease

 In combination therapy with appropriate antibacterial drugs for eradication of Helicobacter pylori in peptic ulcer patients with such infection.

BEFORE YOU USE PROBITOR

Do not use probitor:

 If you are allergic to omaprazol or any of the other ingredients of Probitor

In patients with impaired liver function should be given combination therapy with clarithromycin.

Take special care with Probitor

If appropriate, patients with gastric ulcer disease, respectively. duodenum should be performed to test the presence of the agent Helicobacter pylori. Patients who tested positive for Helicobacter pylori needs as early as possible to begin eradication therapy.

Suspected gastric ulcer disease before starting treatment with Probitor to exclude a possible malignancy, as treatment may improve symptoms and to impede diagnosis.

Diagnosis of reflux oesophagitis should be confirmed endoscopically.

Decreased gastric acidity due to various reasons, including proton pump inhibitors, increases the growth of bacteria normally present in the gastrointestinal tract. Treatment products inhibiting acid secretion leads to a slightly increased risk of gastrointestinal infections.

In patients with severe liver fanktsiya should regularly monitor liver enzymes during therapy Probitor.

Before treatment of ulcers associated with the use of NSAIDs, should seriously consider discontinuation of these drugs.

Maintenance treatment of ulcers associated with the use of nonsteroidal antirheumatic / anti-inflammatory agents should be limited to patients at risk.

In combination therapy and omeprazole, caution is required as they arise interactions. It is also necessary caution when applied to combination therapy in patients with impaired kidney or liver.

In severely ill patients, control of visual and auditory functions, as described isolated cases of blindness and deafness after administration of the injection form of omeprazole.

Probitor, especially at high doses, should be used with caution in elderly patients with liver and kidney disease.

PREGNANCY and BREAST-FEEDING:

Limited epidemiological studies have revealed adverse effects on pregnancy or increase the total number of defects. Overall no evidence of specific abnormalities. Omeprazole and its metabolites are excreted in rat milk. In humans there is insufficient data on the impact on infants. Omerparzol concentrations in breast milk reaches 6% of the maximum plasma concentration of the mother.

Use of omeprazole during pregnancy and lactation requires a careful evaluation of the benefit / risk ratio.

Use in children

Probitor should not be administered to infants and children under 2 years

Elderly:

Should be used with caution in elderly patients, especially need high doses.

HOW TO TAKE PROBITOR?

Gastro-resistant capsules should be swallowed whole with some liquid before meals or on an empty stomach.

Duodenal ulcer:

The usual dose is one capsule daily. Treatment continued for 2 to 4 weeks.

Gastric ulcer:

The usual dose is one capsule daily. Duration of treatment is 4-/6/-8 weeks.

Reflux oesophagitis:

The usual dose is one capsule daily. Treatment continued for 4 to 8 weeks.

Children over 2 years with severe reflux oesophagitis:

Probitor should only be used in children with severe reflux oesophagitis resistant to other therapies. Treatment should be carried out by the hospital pediatrician.

Recommended dosages are as follows:

In weighing 10 to 20 kg: 10 mg / day

With more than 20 mg: 20mg/dl

Treatment duration is usually 4 to 8 weeks and should not exceed 12 weeks due to lack of data from long-term use in this age group.

Maintenance treatment of reflux ezofigit to prevent retsediv:

Syndrome Zollinger-Ellison

Dosage should be individualized and the patient under supervision as clinically indicated.

The recommended starting dose is 60 mg once daily. When assigned dosage of 80 mg per day, it should be divided into two doses.

Treatment of gastric and duodenal ulcers associated with the use of NSAIDs:

The usual dose is 20 mg daily. The duration of treatment is 4 to 8 weeks.

Symptomatic treatment of gastroesophageal reflux disease:

The usual dose is 10-20 mg daily. The duration of treatment is 2-4 weeks.

POSSIBLE SIDE EFFECTS

Gastrointestinal disorders:

Common - diarrhea, constipation, flatulence, nausea and vomiting.

Rare - brown-black discoloration of the tongue during concomitant administration of clarithromycin and benign cysts of the glands

Very rare - dry mouth, sores in the mouth, fungi, or inflammation of the pancreas

Liver and gallbladder:

Uncommon - changes in liver enzymes

Very rare - hepatitis with or without jaundice, liver failure and encephalopathy in patients with pre-existing severe liver disease.

Disorders of the haematopoietic system:

Very rare - blood dyscrasia, reversible thrombocytopenia, leucopenia or pancytopenia and agranulocytosis

Rare - hipohromna mikrotsitna anemia in children

Skin and subcutaneous tissue disorders:

Uncommon - itching, skin rash, alopecia, multiforme or photosensitivity eriteam and increased sweating.

Musculo-skeletal system:

Rare - muscular weakness, myalgia and joint pain

Renal and urinary disorders:

Very rare - Jade

Nervous system disorders:

Common - drowsiness, sleep disturbances, dizziness and headache

Rare - tingling and mild confusion. Memory impairment and hallucinations occur predominantly in severely ill or elderly.

Very rare - anxiety and depressive reactions, predominantly in severely ill or elderly

Abnormal sensory organs:

Uncommon - visual disturbances and hearing disorders or taste.

Hypersensitivity reactions:

Very rare - hives, fever, angioedema, bronchospasm or anaphylactic shock, allergic vasculitis and fever

Other side effects:

Uncommon - peripheral edema

Very rare - hyponatremia, gynecomastia

ADDITIONAL INFORMATION

What Probitor:

The active ingredient is omeprazole. Each stamashno-resistant capsule contains 20 mg omeprazole

The other ingredients are: hypromellose, disodium phosphate dihydrate, talc, titanium dioxide, a copolymer of methacrylic acid and ethyl acrylate, sodium dodecyl sulfate, polysorbate 80, triethyl citrate, sucrose, corn starch, gelatin, purified water, black printing ink, sastsoyashto of shellac, ethyl alcohol, isopropyl alcohol, propylene glycol, N-butyl alcohol, ammonium hydroxide, potassium hydroxide, water, and black iron oxide.