Omez DSR 30mg+20mg capsules 30
Women's clothing size
With your arms relaxed at your sides, measure around the fullest part of your chest.
Measure around the narrowest part of your natural waist, generally around the belly button. To ensure a comfortable fit, keep one finger between the measuring tape and your body.
30 mg+20 mg
Active substance: omeprazole (as enteric-coated granules)* 20 mg, domperidone (as prolonged-release granules)** 30 mg.
Excipients: talc - 2 mg.
*Excipients (as part of enteric-coated granules - 267 mg): mannitol - 137.86 mg, lactose monohydrate - 9.66 mg, sodium lauryl sulfate - 0.52 mg, sodium hydrogen phosphate - 0.89 mg, sucrose (25/30) - 24.35 mg; sucrose - 8.54 mg, hypromellose 6 cps - 0.14 mg; coating: hypromellose 6 cps - 13 mg; enteric coating: copolymer of methacrylic acid and ethyl acrylate [1:1] (copolymer of methacrylic acid [type C]) - 40.47 mg; sodium hydroxide - 0.54 mg; macrogol 6000 - 4.85 mg; talc - 4.05 mg; titanium dioxide - 2.13 mg.
**Excipients (as part of granules with prolonged release - 100 mg): sugar nib nonparel - 58.98 mg, silicon dioxide colloidal - 0.48 mg, talc - 4.51 mg, hypromellose 5 cps - 0.57 mg; coating: hypromellose 5 cps - 2.34 mg, talc - 0.71 mg, iron oxide yellow dye - 0.12 mg, red iron oxide dye - 0.04 mg, titanium dioxide - 0.47 mg; prolonged-release coating: hypromellose 5 cps – 0.4 mg; ethylcellulose 10 cps - 1.18 mg, triacetin - 0.12 mg; talc - 0.086 mg.
Composition of gelatin solid capsules No. 1: gelatin - 85.42%, water - 14.5%, sodium lauryl sulfate - 0.08%.
The composition of black ink for applying the inscription on the capsule lid: ethanol - 29-33%, isopropanol - 9-12%, butanol - 4-7%, shellac - 24-28%, iron dye black oxide (E172) - 24-28%, ammonia aqueous - 1-3%, propylene glycol - 0.5-2%.
Composition of red ink for inscription on the capsule body: ethanol - 21-25%, isopropanol - 12-16%, butanol - 7-10%, shellac - 22-27%, punch dye [Ponso 4R] (E124) - 18–24%, titanium dioxide (E171) - 5–9%, ammonia aqueous - 1–3%, polysorbate 80 - 0.5–2%; propylene glycol - 0.5-2%.
The combination of two active ingredients (domperidone and omeprazole) has a complex effect on the main links in the pathogenesis of gastroesophageal reflux disease (GERD), dyspeptic disorders of various genesis.
Domperidone enhances and synchronizes physiological peristaltic waves, omeprazole reduces basal and stimulated secretion of hydrochloric acid.
Indications for use
- dyspepsia, accompanied by delayed emptying of the stomach, gastroesophageal reflux, esophagitis (a feeling of overflow in the epigastrium, a feeling of bloating, pain in the upper abdomen; belching, flatulence; nausea, vomiting; heartburn with or without throwing gastric contents into the oral cavity);
- gastroesophageal reflux disease;
- nausea, vomiting, heartburn associated with gastroesophageal reflux disease, gastritis, peptic ulcer of the stomach and duodenum, incl. after eradication therapy.
- hypersensitivity to the components of the drug and benzimidazoles;
- prolactin-secreting pituitary tumor (prolactinoma);
- lactose intolerance, lactase deficiency, glucose-galactose malabsorption;
- deficiency of sucrase / isomaltase, fructose intolerance;
- simultaneous administration of erlotinib, posaconazole, nelfinavir, atazanavir, oral forms of ketoconazole, erythromycin or other CYP3A4 inhibitors that cause prolongation of the QT interval, such as fluconazole, voriconazole, clarithromycin, amiodarone and telithromycin;
- gastrointestinal bleeding, mechanical obstruction or perforation, i.e. when stimulation of the motility of the gastrointestinal tract can be dangerous;
- hepatic insufficiency of moderate and severe severity;
- the period of breastfeeding;
- age up to 18 years.
- in the presence of a stomach ulcer (or suspected stomach ulcer), previous surgery on the gastrointestinal tract;
- in the presence of "alarming" symptoms: a significant spontaneous decrease in body weight, repeated vomiting, vomiting with an admixture of blood, a change in the color of feces (tar-like stool - melena), impaired swallowing;
- with the appearance of new symptoms or a change in existing symptoms from the gastrointestinal tract;
- in the presence of severe electrolyte disorders or heart disease, such as heart failure).
- with osteoporosis;
- with renal failure.
Use in pregnancy and lactation Breast
Use of Omez ® JEM during pregnancy and during breastfeeding is contraindicated.
Use in case of impaired liver function
Contraindicated use in liver failure of moderate and severe severity.
With mild violations of liver function, correction of the dosing regimen is not required.
Use in renal dysfunction
With caution, the drug should be prescribed for renal failure.
Use in children
Contraindicated use under the age of 18 years.
Use in elderly patients
In elderly patients, correction of the dosage regimen is not required.
Omeprazole granules contain lactose, so do not use Omez ® DSM in patients with lactose intolerance, galactosemia and malabsorption of glucose and galactose.
It has been shown that the use of domperidone may be associated with an increased risk of ventricular arrhythmias or sudden coronary death, which is more likely for patients older than 60 years with a daily dose of domperidone of more than 30 mg.
The use of domperidone and other drugs that lead to a prolongation of the QT interval requires caution in patients with existing conduction disorders with QT prolongation, a pronounced electrolyte imbalance or congestive heart failure.
Patients at risk of developing osteoporosis or fractures on its background should be under appropriate clinical supervision, although the causal relationship of the use of omeprazole with fractures against the background of osteoporosis has not been established.
There are reports of severe hypomagnesemia in patients receiving therapy with proton pump inhibitors, including omeprazole, for more than one year.
Patients receiving omeprazole therapy for a long time, especially in combination with digoxin or other drugs that reduce the magnesium content in the blood plasma (diuretics), require regular monitoring of the magnesium content.
Effects on laboratory tests
An increase in the concentration of chromogranin A (CgA) due to a decrease in the secretion of hydrochloric acid may affect the results of examinations for the detection of neuroendocrine tumors.
To prevent this effect, therapy with proton pump inhibitors should be suspended 5 days before the study of the concentration of CgA.
Influence on the ability to drive vehicles and control mechanisms
During treatment with Omez ® JEM should be used with caution when driving motor transport and the performance of other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.
Dosage and Administration
Capsules are taken orally whole, without breaking or chewing. The recommended dose for adults and children over 16 years of age is 1 capsule 1 time per day 1 hour before meals. The course of treatment is not more than 7 days.
Symptoms: dizziness, confusion, apathy, drowsiness, headache, visual impairment, vascular dilatation, tachycardia, nausea, vomiting, flatulence, diarrhea, increased sweating, dry mouth. With an increase in the dose, the rate of elimination of the drug did not change.
Treatment: activated charcoal inside, gastric lavage; if necessary, symptomatic therapy and careful monitoring. Anticholinergics, drugs used to treat parkinsonism, or antihistamines may be effective in the event of extrapyramidal reactions. Hemodialysis is not effective enough.
- diarrhea, constipation, abdominal pain, nausea, vomiting, flatulence, dry mouth, stomatitis, gastrointestinal candidiasis, changes in taste
- headache, dizziness, paresthesia, drowsiness, insomnia; in some cases - a state of anxiety, depression, hallucinations, confusion, agitation, nervousness;
- arthralgia, myalgia, muscle laxity;
- leukopenia, pancytopenia, agranulocytosis, thrombocytopenia
- increase in the level of liver enzymes; in patients who have previously suffered severe liver disease, symptoms of hepatitis, encephalopathy, hepatic insufficiency may occur;
- fever, bronchospasm, interstitial nephritis, increased sweating;
- blurred vision;
- peripheral edema.
- anaphylactic reactions, including anaphylactic shock, photosensitivity, erythema multiforme, alopecia, angioedema;
- extrapyramidal phenomena, convulsions;
- prolongation of the QT interval, ventricular arrhythmia*, sudden coronary death*;
- Quincke's edema, urticaria;
- urinary retention;
- deviations in laboratory indicators of liver function, an increase in the level of blood prolactin.
* In some epidemiological studies, it has been shown that the use of domperidone may be associated with an increased risk of developing serious ventricular arrhythmias or sudden death.
The risk of these phenomena is more likely in patients older than 60 years and in patients taking the drug in a daily dose of more than 30 mg. It is recommended to use domperidone in the lowest effective dose in adults and children.
The drug should be stored out of the reach of children at a temperature not exceeding 25 ° C. Do not use after the expiration date indicated on the package.
- Dr. Reddy`s laboratories Ltd
- Dosage form
- Domperidone+Omeprazole Dosage 30 mg+20 mg
- Number of tablets
- INN Russian
- Russian title
- Омез ДСР