Ultratop capsules 20mg, No. 28

- Peptic ulcer of the stomach and duodenum (in the acute phase and anti-relapse treatment), incl. associated with Helicobacter pylori (as part of combination therapy);

- Gastroesophageal reflux disease (GERD), including reflux esophagitis and non-erosive forms of reflux disease (NERD);

- Erosive and ulcerative lesions of the stomach and duodenum associated with the intake of non-steroidal anti-inflammatory drugs (NSAIDs), stress ulcers;

- Zollinger-Ellison syndrome and other pathological conditions associated with increased gastric secretion.

Inside, before meals, with a small amount of water (the contents of the capsule cannot be chewed).

Duodenal ulcer in the acute phase: 20 mg per day for 2

- 4 weeks (in resistant cases up to 40 mg per day).

Peptic ulcer in the acute phase and erosive-ulcerative esophagitis: 20 - 40 mg per day for 4-8 weeks.

Gastroesophageal reflux disease (GERD): patients with moderate inflammation, 1 capsule 20 mg once a day in the morning, before breakfast for 4-8 weeks. To ensure the following dosing regimen, it is possible to take the drug in a different registered dosage (Ultop, 40 mg capsules). Patients with a severe course of GERD, resistant to conventional therapy: 40 mg (2 capsules of Ultopa 20 mg or 1 capsule of Ultopa 40 mg) once a day in the morning, before breakfast. The duration of the main course of treatment is usually 4-8 weeks. After healing of erosive esophagitis, maintenance treatment is indicated for 26-52 weeks, with severe esophagitis - for life. In cases of recurrence of severe GERD or resistant GERD disease, treatment may be extended up to 4 to 8 weeks.

Erosive and ulcerative lesions of the gastrointestinal tract caused by taking NSAIDs: 20 mg per day for 4-8 weeks.

Eradication of Helicobacter pylori: 20 mg 2 times a day for 7 or 14 days (depending on the treatment regimen used) in combination with antibacterial agents. Anti-relapse treatment of gastric ulcer and duodenal ulcer: 10-20 mg per day. To ensure the following dosing regimen, it is possible to take the drug in a different registered dosage (Ultop, 10 mg capsules).

Anti-relapse treatment for GERD: 20 mg per day for a long time. The safety and efficacy of 12 months maintenance therapy has been proven. Reception on demand is possible.

Zollinger-Ellison syndrome and other pathological conditions associated with increased gastric secretion: the dose is selected individually depending on the initial level of gastric secretion, usually starting from 60 mg per day. If necessary, the dose is increased to 80-120 mg per day, in this case it is divided into 2-3 doses.

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

1 capsule contains enteric granules (sucrose, corn starch), hyprolose, magnesium carbonate, heavy, sucrose, corn starch, sodium lauryl sulfate.

Shell pellets : methacrylic acid and pellets:

Pellet core:

Active ingredient: omeprazole 20.00 mg

Excipients:

sugar granules (sucrose, corn starch) 80.00 mg, hyprolose 4.80 mg, magnesium carbonate, heavy 20.00 mg, sucrose 32.20 mg, corn starch 26.50 mg, sodium lauryl sulfate 2.50 mg.

Pellet shell . methacrylic acid and ethyl acrylate copolymer (1: 1), 30% dispersion1 31.00 mg, talc 6.00 mg, macrogol 6000 3.10 mg, titanium dioxide 1.90, sodium hydroxide 0.21 mg.

1 presented as dry weight of polymer

Capsule shell composition:

BODY of the capsule: iron dye red oxide E172 0.0875%, titanium dioxide E171 3%, gelatin up to 100%. Capsule LID: iron dye red oxide E172 0.6153%, titanium dioxide E171 2%, gelatin up to 100%.

- Hypersensitivity to omeprazole or other components of the drug;

- Children's age (effectiveness and safety in children has not been proven);

- Pregnancy;

- Lactation period.

Carefully :

renal and / or hepatic impairment, hereditary fructose intolerance, glucose and / or galactose malabsorption syndrome, or sucrose / isomaltose deficiency.

Dosage form:

enteric capsules

Composition :

1 capsule contains enteric granules (sucrose, corn starch), hyprolose, magnesium carbonate, heavy, sucrose, corn starch, sodium lauryl sulfate.

Shell pellets : methacrylic acid and pellets:

Pellet core:

Active ingredient: omeprazole 20.00 mg

Excipients:

sugar granules (sucrose, corn starch) 80.00 mg, hyprolose 4.80 mg, magnesium carbonate, heavy 20.00 mg, sucrose 32.20 mg, corn starch 26.50 mg, sodium lauryl sulfate 2.50 mg.

Pellet shell . methacrylic acid and ethyl acrylate copolymer (1: 1), 30% dispersion1 31.00 mg, talc 6.00 mg, macrogol 6000 3.10 mg, titanium dioxide 1.90, sodium hydroxide 0.21 mg.

1 presented as dry weight of polymer

Capsule shell composition:

BODY of the capsule: iron dye red oxide E172 0.0875%, titanium dioxide E171 3%, gelatin up to 100%. Capsule LID: iron dye red oxide E172 0.6153%, titanium dioxide E171 2%, gelatin up to 100%.

Description:

Two-color capsules: the capsule body is light pink, the capsule cap is brown pink. The capsules contain pellets from white to white with a yellowish or pinkish shade.

Pharmacotherapeutic group:

an agent that lowers the secretion of gastric glands - a proton pump inhibitor.

Pharmacodynamics:

Inhibits the enzyme H + K + ATP-ase ('proton pump') in the parietal cells of the stomach and thereby blocks the final stage of the synthesis of hydrochloric acid. This leads to a decrease in the level of basal and stimulated secretion, regardless of the nature of the stimulus. The drug is a prodrug and is activated in the acidic environment of the secretory tubules of parietal cells. After a single oral dose of the drug, the effect of omeprazole occurs within the first hour and lasts for 24 hours, the maximum effect is achieved after 2 hours.

After stopping the drug intake, secretory activity is fully restored after 3-5 days. Basal gastric secretion decreases to 94% after taking 40 mg of omeprazole. The acidity of gastric juice within 24 hours decreases by 80 - 97% when taking 20 mg of omeprazole and 92 - 94% when taking 40 mg. Inhibition of 50% of the maximum secretion lasts 24 hours.

Pharmacokinetics:

Omeprazole is rapidly absorbed from the gastrointestinal tract, the maximum plasma concentration is reached after 0.5-1 hour. Bioavailability is 30-40%. Bioavailability increases slightly in the elderly and patients with impaired liver function, and to a large extent in patients with chronic hepatic insufficiency (it can reach 100%). The connection with plasma proteins is about 90% - 95%.
Omeprazole is almost completely metabolized in the liver with the formation of 6 metabolites (hydroxyomeprazole, sulfide and sulfone derivatives, etc.), pharmacologically inactive. It is an inhibitor of the CYP2C19 enzyme system. The half-life is 0.5-1 hour. Excretion by the kidneys (70-80%) and with bile (20-30%). In chronic renal failure, excretion decreases in proportion to the decrease in creatinine clearance. In elderly patients, excretion is reduced. In liver failure, half-life

- 2 - 3 hours.

Total clearance - 500 - 600 ml / min.

Indications for use

- Peptic ulcer of the stomach and duodenum (in the acute phase and anti-relapse treatment), incl. associated with Helicobacter pylori (as part of combination therapy);

- Gastroesophageal reflux disease (GERD), including reflux esophagitis and non-erosive forms of reflux disease (NERD);

- Erosive and ulcerative lesions of the stomach and duodenum associated with the intake of non-steroidal anti-inflammatory drugs (NSAIDs), stress ulcers;

- Zollinger-Ellison syndrome and other pathological conditions associated with increased gastric secretion.

Contraindications

- Hypersensitivity to omeprazole or other components of the drug;

- Children's age (effectiveness and safety in children has not been proven);

- Pregnancy;

- Lactation period.

Carefully :

renal and / or hepatic impairment, hereditary fructose intolerance, glucose and / or galactose malabsorption syndrome, or sucrose / isomaltose deficiency.

Pregnancy and lactation:

The safety of use during pregnancy and lactation, breastfeeding has not been studied. Therefore, it is not recommended to prescribe the drug during pregnancy. If necessary, the appointment of the drug during lactation should stop breastfeeding.

Method of administration and dosage

Inside, before meals, with a small amount of water (the contents of the capsule cannot be chewed).

Duodenal ulcer in the acute phase: 20 mg per day for 2

- 4 weeks (in resistant cases up to 40 mg per day).

Peptic ulcer in the acute phase and erosive-ulcerative esophagitis: 20 - 40 mg per day for 4-8 weeks.

Gastroesophageal reflux disease (GERD): patients with moderate inflammation, 1 capsule 20 mg once a day in the morning, before breakfast for 4-8 weeks. To ensure the following dosing regimen, it is possible to take the drug in a different registered dosage (Ultop, 40 mg capsules). Patients with a severe course of GERD, resistant to conventional therapy: 40 mg (2 capsules of Ultopa 20 mg or 1 capsule of Ultopa 40 mg) once a day in the morning, before breakfast. The duration of the main course of treatment is usually 4-8 weeks. After healing of erosive esophagitis, maintenance treatment is indicated for 26-52 weeks, with severe esophagitis - for life. In cases of recurrence of severe GERD or resistant GERD disease, treatment may be extended up to 4 to 8 weeks.

Erosive and ulcerative lesions of the gastrointestinal tract caused by taking NSAIDs: 20 mg per day for 4-8 weeks.

Eradication of Helicobacter pylori: 20 mg 2 times a day for 7 or 14 days (depending on the treatment regimen used) in combination with antibacterial agents. Anti-relapse treatment of gastric ulcer and duodenal ulcer: 10-20 mg per day. To ensure the following dosing regimen, it is possible to take the drug in a different registered dosage (Ultop, 10 mg capsules).

Anti-relapse treatment for GERD: 20 mg per day for a long time. The safety and efficacy of 12 months maintenance therapy has been proven. Reception on demand is possible.

Zollinger-Ellison syndrome and other pathological conditions associated with increased gastric secretion: the dose is selected individually depending on the initial level of gastric secretion, usually starting from 60 mg per day. If necessary, the dose is increased to 80-120 mg per day, in this case it is divided into 2-3 doses.

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

Side effect

In rare cases, the following, usually reversible, side reactions may occur:

From the digestive system: diarrhea or constipation, nausea, vomiting, flatulence, abdominal pain, heartburn, dry mouth, taste disturbances, stomatitis, pancreatitis (including fulminant), loss of appetite, discoloration of stool, esophageal candidiasis, atrophy of the mucous membrane of the tongue, a transient increase in the activity of 'liver' enzymes and bilirubin in plasma; in patients with previous severe liver disease - hepatitis (including jaundice), hepatic dysfunction or hepatic encephalopathy.

From the central or peripheral nervous system: headache,

dizziness, aggressiveness, apathy, nervousness, agitation, drowsiness, insomnia, tremor, vertigo, paresthesia, depression, hallucinations; in patients with severe concomitant somatic diseases, patients with previous severe liver disease - encephalopathy.

From the cardiovascular system: angina pectoris, tachycardia, bradycardia,

palpitations, arterial hypertension, vasculitis, peripheral edema.

From the genitourinary system: interstitial nephritis, urinary tract infections, leukocyturia, proteinuria, hematuria, glucosuria, increased serum creatinine concentration, gynecomastia, testicular pain.

From the musculoskeletal system: muscle weakness, myalgia, arthralgia, ossalgia (bone pain), muscle cramps.

From the hematopoietic system: pancytopenia, agranulocytosis, anemia (including hemolytic anemia), neutropenia, thrombocytopenia, leukocytosis, leukopenia.

On the part of the skin: itching, skin rash; in some cases - photosensitivity, exudative erythema multiforme, hair loss, alopecia, petechiae, dry skin, epidermal necrosis, Stevens-Johnson syndrome.

Respiratory system: cough, nosebleeds.

From the senses: ringing in the ears, perversion of taste, unexpressed visual and hearing impairment.

Allergic reactions: urticaria, angioedema, bronchospasm,

interstitial nephritis, anaphylactic shock, fever.

Laboratory indicators: hypoglycemia, hyponatremia.

Others: back pain, blurred vision, peripheral edema, increased sweating, gynecomastia; rarely - the formation of gastric glandular cysts during long-term treatment (a consequence of inhibition of the secretion of hydrochloric acid, is benign, reversible), increased sweating, general fatigue, general weakness, weight gain.

Overdose:

Symptoms: abdominal pain, drowsiness, headache, dizziness, dry mouth, tachycardia, arrhythmia, blurred vision, agitation, confusion, increased sweating, nausea; in rare cases: convulsions, shortness of breath, hypothermia.

Treatment is symptomatic. There is no specific antidote. Hemodialysis is ineffective.

Interaction

Long-term use of omeprazole at a dose of 20 mg 1 time per day in combination with caffeine, theophylline, digoxin, amoxicillin, piroxicam, diclofenac, naproxen, metoprolol, propranolol, ethanol, lidocaine, quinidine and estradiol did not lead to a change in their plasma concentration.

There was no interaction with concomitantly taken antacids.

May reduce the absorption of ampicillin esters, iron salts, itraconazole and ketoconazole (
omeprazole raises the pH of the stomach). Being an inhibitor of cytochrome P450, it can increase the concentration and reduce the excretion of diazepam, indirect anticoagulants, phenytoin, nifedipine, warfarin and disulfiram, which in some cases may require a reduction in the doses of these drugs.

The effectiveness of prednisone and cyclosporine may be reduced, which in some cases may require a dose adjustment of cyclosporine.

When taken simultaneously, the absorption of omeprazole and clarithromycin is enhanced, which leads to an increase in their concentration in plasma.

Special instructions :

Before starting therapy, it is necessary to exclude the presence of a malignant process (especially with a stomach ulcer), since treatment, masking the symptoms, can delay the correct diagnosis.

Eating slows down the absorption of omeprazole, so the drug is recommended to be taken before meals.

In special cases, if you have difficulty swallowing a whole capsule, you can swallow its contents after opening or resorption of the capsule, and you can also mix the contents of the capsule with a slightly acidified liquid (juice, yogurt) and use the resulting suspension within 30 minutes.

— осторожностью необходимо принимать ”льтоп у пациентов с циррозом печени; суточна¤ доза не должна превышать 20 мг.

“ак же с осторожностью необходимо принимать ”льтоп у пациентов с почечной недостаточностью. ” пациентов, наход¤щихс¤ на диализе, фармакокинетические параметры омепразола не измен¤ютс¤.

”льтоп содержит сахарозу, поэтому препарат не рекомендуетс¤ примен¤ть пациентам с синдромом мальабсорбции глюкозы и/или галактозы, или дефицитом сахарозы/изомальтозы.

 апсулу гидросорбента, впа¤нную в крышку флакона, не следует проглатывать!

¬ли¤ние на способность управл¤ть транспортным средством :

в обычных дозировках препарат не оказывает вли¤ни¤ на скорость психомоторных реакций и концентрацию внимани¤.

‘орма выпуска :

 апсулы кишечнорастворимые 20 мг.

ѕри производстве на јќ ' – ј, д.д., Ќово место', —ловени¤:

”паковка :

14 or 28 capsules are placed in a polyethylene case with a polypropylene screw cap with a first opening control and a hydrosorbent capsule.

1 pencil case in a cardboard box along with instructions for use.

Storage conditions :

List B.

In a dry place, at a temperature not exceeding 25 ? C.

Keep out of the reach of children.

Shelf life :

3 years.

Do not use after the expiration date.

Terms of dispensing from pharmacies:

On prescription