Omisak, 20 mg 30 pcs.

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Indications

Peptic ulcer disease of the stomach and duodenum (including.

Peptic ulcer disease (including prevention of recurrence),

Reflux esophagitis,

Hypersecretory conditions (Zollinger-Ellison syndrome, stress ulcers of the GI tract, polyendocrine adenomatosis, systemic mastocytosis),

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NSAID gastropathy,

Eradication of Helicobacter pylori in infected patients with peptic ulcer disease of the stomach and duodenum (as part of combination therapy).

Active ingredient

Composition

Each capsule is enteric-soluble and contains:

The active ingredient: omeprazole (in the form of enteric-coated pellets) 20 mg.

Auxiliary ingredients in omeprazole pellets: mannitol, sucrose, sodium hydrophosphate, sodium lauryl sulfate, lactose monohydrate, calcium carbonate, hypromellose (E-15), propylene glycol, methacrylic acid and ethyl acrylate copolymer [1:1], polysorbate-80, diethyl phthalate, sodium hydroxide, cetyl alcohol, corn starch.

The composition of the empty hard gelatin capsule: cap: gelatin, purified water, methyl parahydroxybenzoate, propyl parahydroxybenzoate, brilliant blue dye, iron oxide yellow dye, titanium dioxide, azorubin dye; body: gelatin, purified water, methyl parahydroxybenzoate, propyl parahydroxybenzoate, titanium dioxide.

The composition of the ink for marking the capsule shell: black ink: shellac, dehydrated alcohol, isopropanol, butanol, propylene glycol, black iron oxide dye (E 172), purified water; white ink: shellac, dehydrated alcohol, isopropanol, butanol, propylene glycol, titanium dioxide (E 171), polysorbate 80.

How to take, the dosage

Overly with a small amount of water (the contents of the capsule must not be chewed) before meals.

Penal ulcer in the acute phase – 20 mg per day for 2-4 weeks (in resistant cases up to 40 mg per day).

Peptic ulcer disease in the phase of exacerbation and erosive-ulcerous esophagitis – 20-40 mg per day for 4-8 weeks.

Errotic ulcerative lesions of the gastrointestinal tract caused with taking NSAIDs – 20 mg per day for 4-8 weeks.

Eradication of Helicobacter pylori – 20 mg 2 times per day for 7 or 14 days (depending on the regimen used) in combination with antibacterial agents.

For prevention of recurrence of peptic ulcer disease of the stomach and duodenum – 20 mg per day.

For the prevention of recurrence of reflux esophagitis – 20 mg per day for a long time (up to 6 months). Administration on demand (symptomatic treatment).

Zollinger-Ellison syndrome – the dose is adjusted individually depending on the initial level of gastric secretion, usually starting at 60 mg per day. If necessary, the dose is increased to 80-120 mg per day, in which case it is divided into 2 doses.

In patients with severe hepatic insufficiency, the daily dose should not exceed 20 mg.

Interaction

Special Instructions

Before starting therapy, the presence of a malignant process (especially with gastric ulcers) should be ruled out, since treatment, by masking symptoms, can delay the correct diagnosis.

Taking at the same time with food does not affect its effectiveness.

In special cases if it is difficult to swallow the whole capsule, the contents may be swallowed after opening or disgorging the capsule, or the capsule contents may be mixed with a slightly acidified liquid (juice, yogurt) and the resulting suspension may be used within 30 minutes.

Contraindications

Hypersensitivity to the drug, childhood, lactation.

Hepatic and/or renal insufficiency.

Side effects

In rare cases, the following usually reversible adverse reactions may occur. The frequency of adverse effects is classified according to the incidence of the case: very frequently over 1/10, frequently over 1/100 and less than 1/10, infrequently over 1/1000 and less than 1/100, rarely over 1/10000 and less than 1/1000, very rarely less than 1/10000, including isolated cases. Within each frequency class, adverse effects are presented in decreasing order of severity.

Blood and lymphatic system disorders: rare – leukopenia, thrombocytopenia; very rare – agranulocytosis, pancytopenia.

Allergic reactions: rare – hypersensitivity reactions, including fever, angioedema and anaphylactic reactions (including anaphylactic shock).

Metabolism and nutrition: rarely – hyponatremia, very rarely – hypomagnesemia.

Mental disorders: infrequent – insomnia, rarely – agitation; confusion, depression; very rare – aggression, hallucinations.

Nervous system disorders: often – headache; infrequent – dizziness, paresthesia, somnolence; rarely – taste disorders.

An organ of vision: rarely – blurred vision.

Hearing and balance disorders: infrequent – vertigo.

Gastrointestinal tract: frequently – diarrhea or constipation, nausea, vomiting, flatulence, abdominal pain; rarely – dry mouth, stomatitis, candidiasis of the mucous membrane of the gastrointestinal tract,

Hepatic and biliary tract disorders: infrequent – increased activity of “liver” enzymes; rare – in patients with previous severe liver disease – hepatitis (including with jaundice), very rare – liver failure, including.including with the development of encephalopathy (in patients with liver disease in anamnesis).

Skin disorders: infrequent dermatitis, pruritus, rash, urticaria, rarely alopecia, photosensitization; very rarely erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Musculoskeletal system: rare – arthralgia, myalgia; very rare – muscle weakness.

Allergic reactions: urticaria, angioneurotic edema, bronchospasm, interstitial nephritis, anaphylactic shock, fever.

Urogenital system disorders: rarely – interstitial nephritis.

Gender and mammary system disorders: very rare – gynecomastia.

Others: infrequent – malaise, peripheral edema; rarely – bronchospasm, increased sweating.

Overdose

Pregnancy use

The use of omeprazole during pregnancy is possible only if the expected therapeutic benefit exceeds the potential risk to the fetus.

In lactation, it is necessary to decide whether to stop breastfeeding or to discontinue the drug.

Similarities