Omez DCP modified-release capsules 30mg+20mg, 30pcs

Composition

Each capsule contains: active ingredients:  omeprazole 20 mg (as part of granules with enteric coating 267 mg), domperidone 30 mg (as part of granules with prolonged release 100 mg); excipients: talcum powder 2 mg. Composition of omeprazole granules:  active substance:  omeprazole 20 mg; excipients: mannitol 137.86 mg, lactose monohydrate 9.66 mg, sodium lauryl sulfate 0.52 mg, sodium hydrophosphate 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: methacrylic acid and ethyl acrylate copolymer [1: 1] (methacrylic acid copolymer [type C]) 40.47 mg, sodium hydroxide 0.54 mg, macrogol 6000 4.85 mg, talc 4.05 mg, titanium dioxide 2.13 mg. Composition of domperidone granules: Active ingredient:  domperidone 30 mg; excipients:  nonpareil granulated sugar 58.98 mg, colloidal silicon dioxide 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, iron oxide red dye 0.04 mg, titanium dioxide 0.47 mg; extended release coating: hypromellose 5 cps 0.40 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 14.50%, sodium lauryl sulfate 0.08%. Composition of black ink for writing on the capsule cap: ethanol 29-33%, isopropanol 9-12%, butanol 4-7%, shellac 24-28%, iron oxide black dye (E 172) 24-28%, water ammonia 1-3%, propylene glycol 0.5-2%. Composition of red ink for writing on the capsule body: ethanol 21− 25%, isopropanol 12− 16%, butanol 7− 10%, shellac 22− 27%, the dye crimson [Ponceau 4R] (E 124) 18− 24%, titanium dioxide (E 171) 5− 9%, ammonia water 1− 3%, Polysorbate 80 0,5− 2%, propylene glycol 0,5− 2%.

Pharmacological action

pharmacodynamically the two active ingredients (domperidone and omeprazole) has a complex action on the main links in the pathogenesis of gastroesophageal reflux disease (GERD), dyspeptic disorders of different Genesis. Domperidone enhances and synchronizes physiological peristaltic waves, omeprazole reduces basal and stimulated hydrochloric acid secretion. Omeprazole Mechanism of action Omeprazole concentrates in the acidic environment of the secretory tubules of the parietal cells of the gastric mucosa, activates and inhibits the proton pump-the enzyme H+ / K+ – ATPase, which provides dose-dependent highly effective inhibition of basal and stimulated hydrochloric acid secretion, regardless of the stimulating factor. Effect on gastric acidthe maximum effect is achieved within 4 days of treatment. In patients with duodenal ulcer, omeprazole at a dose of 20 mg causes a steady decrease in 24-hour gastric acidity by at least 80%. In this case, the average maximum concentration of hydrochloric acid after stimulation with pentagastrin is reduced by 70% within 24 hours. In patients with duodenal ulcer, omeprazole 20 mg with daily oral use maintains an intragastric acidity value of pH≥3 for an average of 17 hours per day. Inhibition of hydrochloric acid secretion depends on the area under the concentration – time pharmacokinetic curve (AUC) of omeprazole, and not on the drug’s plasma concentration at a given time. Action on Helicobacter pylori Eradication of Helicobacter pylori when using omeprazole together with antibacterial agents is accompanied by rapid elimination of symptoms, a high degree of healing of defects in the mucous membrane of the gastrointestinal tract. long-term remission of peptic ulcer disease, which reduces the likelihood of complications such as bleeding, is just as effective as ongoing maintenance therapy. Other effectsthe reduced secretion of hydrochloric acid in the stomach leads to a slight increase in the risk of intestinal infections caused by Salmonella spp., Campylobacter spp. and Clostridium difficile. During treatment with drugs that lower the secretion of gastric glands, the concentration of gastrin in the blood serum increases. Due to a decrease in the secretion of hydrochloric acid, the concentration of chromogranin A increases (see the section “Special instructions”). Domperidone antagonist of dopamine, combines peripheral (gastrokinetic) action and antagonism to dopamine receptors in the trigger zone of the brain (central action), so it has an antiemetic effect, stimulates the release of prolactin from the pituitary gland and eliminates the inhibitory effect of dopamine on the motor function of the gastrointestinal tract. increases and synchronizes peristaltic waves, thereby accelerating the natural emptying of the stomach and increasing the pressure of the sphincter of the lower esophagus. Omeprazole pharmacokineticabsorption of omeprazole is high, the time to reach the maximum concentration in blood plasma (TCmax) is 0.5-1 hour. Bioavailability – 30-40%, after constant intake of 1 time a day increases to 60%. Distribution. Plasma protein binding is 90-95%. Volume of distribution 0.3 l / kg. Metabolism. Part of omeprazole undergoes presystemic hepatic metabolism involving more CYP2C19 than CYP3A4 with the formation of inactive metabolites. Omeprazole, which is not involved in the formation of active metabolites by parietal cells, is completely metabolized in the liver. The total plasma clearance is 0.3− 0.6 l/min. Output. The half-life (T1/2) of omeprazole is about 40 minutes. It is excreted by the kidneys (70-80%) and with bile (20-30%). When liver function is impaired, the bioavailability increases and the plasma clearance of omeprazole decreases. No changes in the bioavailability of omeprazole were observed in patients with impaired renal function or in elderly patients. Domperidone This dosage form provides a delayed release of the Active ingredient. In acidic dissolution tests, after 8 hours,75% to 83% of the nominal domperidone content in one capsule is determined, and after 12 hours-from 86% to 94%. Fasting absorption is fast. TCmax – 30-60 minutes. Low bioavailability (15%) is associated with first-pass metabolism in the intestinal wall and liver. Distribution. Plasma protein binding is 90%. Penetrates into various tissues, passes poorly through the blood-brain barrier. It is metabolized in the liver (including due to the first-pass effect) and in the intestinal wall (by hydroxylation and N-dealkylation) with the participation of isoenzymes CYP3A4, CYP1A2 and CYP2E1. Excretion: 66% through the intestine (unchanged-10%), kidneys-33% (unchanged-1%) in the form of glucuronides. With severe chronic renal failure, T1 / 2 is prolonged.

Indications

• Dyspepsia, accompanied by delayed gastric emptying, gastroesophageal reflux, esophagitis (a feeling of fullness in the epigastrium, feeling of bloating, pain in the upper part of the stomach; belching, bloating; nausea, vomiting; heartburn from reflux or no reflux of gastric contents into the mouth);
• gastroesophageal reflux disease;
• nausea, vomiting, heartburn associated with gastroesophageal reflux disease, gastritis, gastric ulcer and duodenal ulcer, including after the eradication therapy.

Use during pregnancy and lactation

The use of Omez ® DSR during pregnancy and lactation is contraindicated.

Contraindications

Hypersensitivity to omeprazole, substituted benzimidazoles or other components of the drug. Sucrose/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption (due to the presence of sucrose in the preparation). Concomitant use with erlotinib, posaconazole, nelfinavir and atazanavir. Omeprazole is contraindicated in children, except for the following indications: gastroesophageal reflux disease for children over 2 years of age and duodenal ulcer caused by Helicobacter pylori for children over 4 years of age (see the section “Dosage and use”). Before using the drug, you should consult your doctor in the following cases: :

• in the presence of a previously diagnosed peptic ulcer of the stomach; severe liver disease, accompanied by hepatic insufficiency; renal failure; jaundice; previous surgery on the gastrointestinal tract;
• in the presence of “alarm” symptoms: significant spontaneous reduction of body weight, repeated vomiting, vomiting blood, change in color of stool (black, tar-like stool – melena), impaired swallowing;
• the appearance of new symptoms or modification of already existing symptoms of the gastrointestinal tract;
• while the use of one or more of the following drugs: clopidogrel, digoxin, ketoconazole, Itraconazole, warfarin, Cilostazol, diazepam, phenytoin, saquinavir, tacrolimus, clarithromycin, voriconazole, rifampin, St. John’s wort preparations (see section “Interaction with other medicines”).

Osteoporosis. Although a causal relationship between omeprazole use and osteoporotic fractures has not been established, patients at risk of developing osteoporosis or osteoporotic fractures should be under appropriate clinical supervision.

Side effects

Possible side effects are listed below by body system and frequency of occurrence for omeprazole and domperidone: very common (>1/10); common (≥1/100, ><1/10); uncommon (≥1/1000, <1/100); rare (≥1/10000, <1/1000); very rare (Disorders of the blood and lymphatic systemo Meprazole-rare: leukopenia, thrombocytopenia; very rare: agranulocytosis, pancytopenia, eosinophilia. Immune system disorders Omeprazole – rare: hypersensitivity reactions: fever, angioedema, anaphylactic reaction / anaphylactic shock. Domperidone – very rare: anaphylactic reaction / anaphylactic shock, angioedema. Metabolic and nutritional disorders Omeprazole-rare: hyponatremia; frequency unknown: hypomagnesemia, which in severe cases can lead to hypocalcemia, hypokalemia. Mental disorders Omeprazole – infrequently: insomnia; rarely: increased excitability, depression, reversible confusion; very rarely: aggression, hallucinations. Domperidone – very rare: agitation, nervousness, increased excitability and irritability. Disorders of the nervous systemo Meprazole-often: headache; infrequently: dizziness, paresthesia, drowsiness; rarely: taste disorders. Domperidone – very rare: extrapyramidal events, convulsions, drowsiness, headache. Visual disturbances Omeprazole – infrequently: visual disturbances, including decreased visual fields, decreased visual acuity and clarity (usually disappear after discontinuation of therapy). Hearing disorders and labyrinth disorders Omeprazole – infrequently: auditory perception disorders, including “tinnitus” (usually disappear after stopping therapy), vertigo (feeling of whirling of one’s own body or surrounding objects). Disorders of the cardiovascular system:Domperidone – very rare: prolongation of the QT interval, ventricular tachycardia of the “pirouette” type, sudden coronary death (more likely for patients over 60 years of age taking more than 30 mg per day). Respiratory, thoracic and mediastinal disorders:Omeprazole-rare: bronchospasm. Disorders of the gastrointestinal tract Omeprazole-often: abdominal pain, constipation, diarrhea, flatulence, nausea, vomiting; rarely: dryness of the oral mucosa, stomatitis, gastrointestinal candidiasis, microscopic colitis, discoloration of the tongue to brown – black and the appearance of benign salivary gland cysts when used simultaneously with clarithromycin (the phenomena are reversible after discontinuation of therapy); isolated cases: formation of gastric glandular cysts and during long-term treatment with concomitant use with clarithromycin (a consequence of inhibition of hydrochloric acid secretion, is benign, reversible). Liver and biliary tract Disordersomeprazole – infrequently: increased activity of “liver” enzymes and alkaline phosphatase (reversible); rarely: hepatitis (with or without jaundice), liver failure, encephalopathy in patients with previous severe liver diseases. Skin and subcutaneous tissue disorders Omeprazole-infrequently: dermatitis, pruritus, skin rash, urticaria; rarely: alopecia, photosensitivity reactions in the form of redness of the skin after UV radiation, erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome (severe erythema characterized by the appearance of spots and blisters on the skin and mucous membranes against a background of high fever and joint pain). Domperidone – very rare: angioedema, urticaria. Musculoskeletal and connective tissue disorders Omeprazole-infrequently: vertebral fractures, wrist bones, femoral head associated with osteoporosis; rarely: arthralgia, myalgia, muscle weakness. Renal and urinary tract Disordersomeprazole-rare: interstitial nephritis. Domperidone – very rare: urinary retention. Disorders of the genitals and mammary gland Omeprazole-rare: gynecomastia. General disorders of Omeprazole-infrequently: malaise; rarely: increased sweating, peripheral edema. Laboratory and instrumental Datamperidone – very rare: changes in liver function tests, increased blood prolactin levels. In case of side effects that are not specified in these instructions, you should immediately inform your doctor.

Interaction

Omeprazole: * The possibility of interaction of omeprazole with other drugs is severely limited. However, since omeprazole slows down the microsomal metabolism of drugs carried out by the liver cytochrome P 450 enzyme system, the elimination of other drugs that require the participation of this enzyme system, or high activity of the excretory function of the liver, may decrease with simultaneous use of omeprazole. This effect can reduce the rate of elimination of substances, increase the concentration of diazepam, phenytoin, anticoagulants, such as warfarin, in plasma (monitoring the concentration of drugs in plasma, the prothrombin index for anticoagulants is necessary for individual dose selection during treatment with omeprazole). * Omeprazole, acting on the acid-peptic factor, can affect the bioavailability of drugs whose absorption depends on pH, and omeprazole can also prevent the destruction of drugs that are sensitive to acid. Concomitant use of intraconazole or ketoconazole and omeprazole may reduce the rate of absorption of other drugs. • Omeprazole has no effect on cytochrome P isomers, which is confirmed by the absence of metabolic reactions with substrates CYP1A2 (caffeine, phenacetin, theophylline), CYP2C9 (S-warfarin, piroxicam, diclofenac, naproxen), CYP2D6 (metoprolol, propranolol), CYP2E (ethanol), CYP3A (cyclosporine, lidocaine, quinidine, estradiol, erythromycin, budesonide). Domperidone:* Anticholinergic drugs may neutralize the effects of domperidone. * Antacids and antisecretory medications may reduce the bioavailability of domperidone when taken simultaneously. * Domperidone may reduce bromocriptine-induced hypoprolactinemia. * Concomitant use of domperidone with drugs that inhibit the cytochrome C 450 CYP3A4 isoenzyme (azole-type antifungal drugs, macrolide antibiotics, HIV protease inhibitors) may significantly increase the concentration of domperidone in the blood.

How to take, course of use and dosage

Omez ® DSR is taken orally on an empty stomach,20-30 minutes before meals (the contents of the capsule should not be chewed), washed down with a small amount of water. Omez ® DSR is taken one capsule once a day in the morning. The maximum daily dose is 1 capsule of Omez ® DSR, which corresponds to 20 mg of omeprazole and 30 mg of domperidone. Use in patients with impaired liver function. No dosage adjustment is required for mild hepatic impairment. Use in patients with impaired renal function. No single dose adjustment is required. Use in the elderly. No dosage adjustment is required.

Overdose

Symptoms:An overdose of domperidone can be manifested by drowsiness, disorientation, and extrapyramidal disorders. There is no sufficient information about deliberate overdose of omeprazole. Studies using an intravenous dose of up to 270 mg per day and up to 650 mg for three days showed that there were no adverse reactions associated with taking the drug. Treatment: in case of overdose, supportive and symptomatic therapy is recommended; in case of extrapyramidal disorders, anticholinergic agents used to treat Parkinsonism can be used.

Special instructions

Omeprazole lactogranules contain lactose, so Omez ® DSR should not be used in patients with lactose intolerance, galactosemia, and glucose and galactose malabsorption. Cardiovascular system Domperidone use has been shown to be associated with an increased risk of ventricular arrhythmias or sudden coronary death, which is more likely in patients over 60 years of age with a daily dose of domperidone greater than 30 mg. The use of domperidone and other drugs that lead to prolongation of the QT interval requires caution in patients with existing conduction disorders with prolonged QT, severe electrolyte imbalance or congestive heart failure). Osteoporosis Patients at risk of developing osteoporosis or fractures associated with it should be under appropriate clinical supervision, although a causal relationship between the use of omeprazole and fractures associated with osteoporosis has not been established. Hypomagnesemia Severe hypomagnesemia has been reported in patients treated 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 content of magnesium in blood plasma (diuretics), need regular monitoring of magnesium content. During treatment with Omez® DSR, caution should be exercised when driving vehicles and performing other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Storage conditions

At a temperature not exceeding 25 °C. Keep out of reach of children!

Shelf

life is 2 years.

Active ingredient

Omeprazole, Domperidol

Conditions of release from pharmacies

By prescription

Dosage form

Capsules

Purpose

For adults as directed by your doctor

Indications

for Reflux esophagitis