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Motinorm

Motinorm syrup 5 mg/5 ml 30 ml x1, ATX code: A03FA03 (Domperidone) Active substance: domperidone Rec.INN registered by WHO

Dosage form

MOTINORM

syrup 5 mg/5 ml: fl. 30 mlreg. No.: LSR-004219/09 from 05/28/09 - Indefinitely

Release form, composition and packaging

Syrup 5 ml

domperidone 5 mg, Clinical and pharmacological group: Antiemetic drug of central action, blocking dopamine receptors Pharmacotherapeutic group: Antiemetic drug - central dopamine receptor antagonist The scientific information provided is general and cannot be used to make a decision about the possibility of using a specific drug.

pharmachologic effect

Antiemetic. It has an antiemetic effect, soothes hiccups and eliminates nausea in some cases. The action is due to the blockade of central dopamine receptors. Thanks to this, the inhibitory effect of dopamine on the motor function of the gastrointestinal tract is eliminated and the evacuation and motor activity of the stomach increases.

Pharmacokinetics Absorption after oral administration, on an empty stomach is rapid (taking after meals, reduced acidity of gastric juice slows down and reduces absorption). Cmax is reached after 1 hour. Bioavailability is 15% (first pass effect through the liver). Plasma protein binding - 90%. Penetrates into various tissues and does not pass through the blood-brain barrier. Metabolized in the liver and in the intestinal wall (by hydroxylation and N-dealkylation). 66% is excreted through the intestines, 33% by the kidneys, incl. unchanged - 10% and 1%, respectively. T1/2 - 7-9 hours, with severe chronic renal failure - lengthens.

Indications Nausea, vomiting, hiccups of various origins (with toxemia, radiation therapy, diet disorders, taking certain medications (morphine), endoscopic and radiopaque studies, in the postoperative period). Postoperative hypotension and atony of the stomach and intestines, biliary dyskinesia, flatulence, reflux esophagitis, cholecystitis, cholangitis, various types of dyspepsia. Nausea and vomiting caused by dopaminomimetics. ICD-10 codes

Dosage regimen: Adults and children over 5 years old: 10 mg 3 times a day 15-30 minutes before meals, and if necessary, an additional 10 mg before bedtime. In acute cases of nausea and vomiting, severe dyspepsia - 20 mg 3-4 times a day. In case of renal failure, the frequency of use should be reduced.

Side effect

From the side of the central nervous system: rarely - increased excitability and/or extrapyramidal disorders, headache.

From the digestive system: spasms of smooth muscles of the gastrointestinal tract, dry mouth, thirst.

Allergic reactions: itching, rash, urticaria.

Other: increased plasma prolactin levels, galactorrhea, gynecomastia.

Contraindications for use Gastrointestinal bleeding, mechanical intestinal obstruction, perforation of the stomach or intestines, prolactinoma, children under 1 year of age (up to 5 years and children weighing up to 20 kg - for tablets), hypersensitivity to domperidone, pregnancy, lactation period (breastfeeding).

Use during pregnancy and breastfeeding

Domperidone is contraindicated for use during pregnancy and lactation.

Use for liver dysfunction Use with caution in liver dysfunction.

Use for impaired renal function Use with caution in case of impaired renal function. In case of renal failure, the frequency of use should be reduced.

Use in children Contraindicated in children under 1 year of age (under 5 years and children weighing up to 20 kg - for tablets).

Special instructions: Use with caution in case of impaired liver and kidney function.

Drug interactions

When used simultaneously with antacids, antisecretory drugs (including cimetidine, sodium bicarbonate), the bioavailability of domperidone decreases.

When used simultaneously with anticholinergic drugs, the effect of domperidone is inhibited.

Since domperidone is metabolized mainly with the participation of the CYP3A4 isoenzyme, it is believed that with the simultaneous use of domperidone and inhibitors of this isoenzyme (including antifungals of the azole group, macrolide antibiotics, HIV protease inhibitors, nefazodone), an increase in the level of domperidone in the blood plasma is possible .

Motinorm 5 ml drops for oral administration

Instructions for medical use of the drug MOTINORM® Trade name MOTINORM® International nonproprietary name Domperidone Dosage form Drops for oral administration Composition 1 ml of solution contains the active substance - domperidone 10 mg, excipients: polysorbate 80, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sucrose, sorbitol solution 70% , propylene glycol, glycerin, xanthan gum, ponceau 4R (water soluble) (E124), citric acid monohydrate, sodium citrate, strawberry flavor, American ice cream flavor (MK: 14000), purified water Description Viscous pink solution with strawberry flavor Pharmacotherapeutic group Preparations for treatment of functional disorders of the gastrointestinal tract. Stimulants of gastrointestinal motility. Domperidone. ATC code A03FA03 Pharmacological properties Pharmacokinetics Domperidone is rapidly absorbed when taken orally on an empty stomach, the maximum plasma concentration (Cmax) is reached after approximately 60 minutes. The low absolute bioavailability of oral domperidone (approximately 15%) is due to extensive metabolism in the intestinal wall and liver. Although in healthy people the bioavailability of domperidone increases when taken after meals, patients with gastrointestinal complaints should take domperidone 15-30 minutes before meals. Reduced gastric acidity reduces the absorption of domperidone. The bioavailability of the drug when taken orally is reduced after prior administration of cimetidine or sodium bicarbonate. When the drug is taken orally after a meal, maximum absorption slows down slightly and the area under the curve (AUC) increases slightly. When taken orally, domperidone does not accumulate and does not induce its own metabolism; the maximum plasma level at 90 minutes (21 ng/mL) after two weeks of oral dosing at 30 mg per day was almost the same as after the first dose (18 ng/mL). Domperidone is 91–93% bound to plasma proteins. Domperidone slightly penetrates the blood-brain barrier. Domperidone is metabolized quickly and extensively in the liver by hydroxylation and N-dealkylation. In-vitro metabolism studies have shown that CYP3A4 is the main isoenzyme of cytochrome P-450, which is involved in the N-dealkylation of domperidone, and CYP3A4, together with CYP1A2 and CYP2E1, are involved in the aromatic hydroxylation of domperidone. Excretion in urine and feces is 31% and 66% of the oral dose, respectively. Excretion of the drug unchanged is a small percentage (10% in feces and approximately 1% in urine). The plasma half-life after taking a single dose is 7–9 hours in healthy people, but prolonged in patients with severe renal failure. Liver failure In patients with moderate liver failure (Child-Pugh score 7-9 or class B), the AUC and C max of domperidone are 2.9 and 1.5 times higher, respectively, than in healthy individuals. The level of unbound fraction increases by 25%, and the terminal half-life is extended from 15 to 23 hours. Patients with moderate hepatic impairment have slightly less systemic exposure than healthy subjects based on Cmax and AUC, with no changes in protein binding or half-life. The pharmacokinetics of domperidone in patients with severe hepatic impairment have not been studied. Motinorm® is contraindicated in patients with moderate or severe liver failure. Renal failure In patients with severe renal failure (creatinine clearance <30 ml/min/1.73 m2), the half-life of domperidone is increased from 7.4 to 20.8 hours, but plasma drug levels are lower than in healthy volunteers. Since very little unchanged drug (about 1%) is excreted through the kidneys, the need for dose adjustment with a single dose in patients with renal failure is unlikely. However, upon repeated administration, the frequency of use of the drug should be reduced to once or twice a day depending on the severity of the disorder, and a dose reduction may be necessary. Pharmacodynamics Domperidone is a dopamine antagonist that has an antiemetic effect. Its antiemetic effect may be due to a combination of peripheral (gastrokinetic) action and antagonism of dopamine receptors in the chemoreceptor trigger zone, which is located behind the blood-brain barrier in the zone postrema. Domperidone is rarely associated with extrapyramidal side effects, especially in adults, but domperidone stimulates the release of prolactin by the pituitary gland. In animal studies, domperidone was found in low concentrations in the brain, indicating a predominantly peripheral effect of domperidone on dopamine receptors. Human studies have shown that oral administration of domperidone increases pressure in the lower esophageal resting zone, improves antroduodenal motility and accelerates gastric emptying, while domperidone does not affect gastric secretion. The effect of domperidone on QT was studied in two active-control and placebo studies in healthy subjects receiving up to 80 mg per day (10 or 20 mg x 4 times daily) of domperidone for 4 days. It was found that the maximum difference in the QTc interval when taking domperidone 20 mg x 4 times a day and placebo with an average initial value of 3.4 ms (from 1.0 to 5.9 ms) does not exceed 10 ms. Clinically significant QTc effects were not observed when domperidone was used at a dose of 80 mg/day (i.e., more than twice the maximum recommended daily dose). However, two studies showed some evidence of QTc prolongation with domperidone monotherapy (10 mg 4 times daily). The mean maximum QTcF difference between domperidone and placebo was 5.4 ms (95% CI: -1.7 to 12. 4) and 7.5 ms (95% CI: 0.6 to 14.4), respectively. Indications for use - symptomatic treatment of nausea and vomiting Method of administration and dosage Domperidone should be used in the minimum effective dose for the shortest time necessary to combat nausea and vomiting. Domperidone is recommended to be taken before meals. If taken after a meal, absorption of the drug occurs with some delay. Patients should take each additional dose at the prescribed time. If the dosage time is missed, then the next dose is taken according to the usual dosing schedule, without compensating for the missed dose in order to avoid double dosing. The maximum duration of treatment should not exceed one week. Motinorm® in syrup form is recommended for use in pediatric practice (especially for children under 5 years of age). The drug is prescribed orally over 15-30 minutes. before meals. The bottle of syrup should be shaken before use. Adults and adolescents (12 years and older and weighing 35 kg or more) 1 ml (10 mg) up to three times daily. The maximum daily dose is 3 ml (30 mg). Children aged 1 to 12 years and weighing up to 35 kg: 0.25 mg/kg body weight 3 times a day. The maximum daily dose is 0.75 mg/kg. In case of renal failure, it is recommended to increase the interval between taking the drug. In patients with severe renal impairment (serum creatinine > 6 mg/100 ml, i.e. > 0.6 mmol/l), the half-life of domperidone increased from 7.4 to 20.8 hours. The frequency of dosing should be reduced to once or twice daily, and it may be necessary to reduce the dose. Side effects Based on clinical studies Adverse reactions observed in ≥ 1% of patients: depression, anxiety, decreased or absent libido, headache, drowsiness, akathisia, dry mouth, diarrhea, rash, itching, galactorrhea, gynecomastia, pain and tenderness in the area of the mammary glands, menstrual irregularities and amenorrhea, lactation disorders, asthenia. Adverse reactions observed in <1% of patients: hypersensitivity, urticaria, swelling and discharge from the mammary glands. Based on spontaneous reports of adverse events, side effects are given with a distribution by frequency and organ system. The frequency of side effects was classified as follows: very common (>1/10), common (>1/100, <1/10) and uncommon (>1/1000, <1/100), rare (>1/10,000, <1/1000) and very rarely (<1/10,000, including isolated cases). Rarely: - gastrointestinal disorders - increased plasma prolactin levels due to the fact that the pituitary gland is located outside the blood-brain barrier, in rare cases this hyperprolactinemia can stimulate the appearance of neuro-endocrine phenomena such as galactorrhea, gynecomastia and amenorrhea very rarely: - transient spasms intestines - itching, rash - extrapyramidal syndrome (very rarely occur in children and in isolated cases in adults, they are completely reversible and disappear immediately after stopping the drug), convulsions, drowsiness, headache. - prolongation of the QT interval, sudden cardiac death*, serious ventricular arrhythmias* - agitation, nervousness. Side effects such as convulsions, drowsiness and agitation are very rare and occur mainly in children and newborns - anaphylactic reactions, including anaphylactic shock, angioedema, allergic reactions, urticaria. *Some epidemiological studies have suggested that domperidone may be associated with an increased risk of serious ventricular arrhythmias or sudden death. The risk of these events is more likely in patients over 60 years of age 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. Contraindications - hypersensitivity to the components of the drug - gastrointestinal bleeding - mechanical obstruction or perforation, in which stimulation of the motor function of the stomach can be dangerous - prolactin-secreting tumor of the pituitary gland (prolactinoma) - simultaneous use of oral forms of ketoconazole, erythromycin and other powerful inhibitors of the CYP3A4 isoenzyme that cause QT prolongation, such as fluconazole, voriconazole, clarithromycin, amiodarone, and telithromycin - patients with current or history of conduction disturbances, particularly QT prolongation on ECG - patients with severe electrolyte disturbances or serious cardiac disease (eg, congestive heart failure) - pregnancy and lactation - children under 1 year of age - moderate to severe liver dysfunction With caution: - renal dysfunction Drug interactions Increased risk of developing QT interval prolongation as a result of pharmacodynamic and / or pharmacokinetic interactions Simultaneous use of Motinorm® with QTc-prolonging drugs is contraindicated. QTc-prolonging drugs: - Class IA antiarrhythmics (eg, disopyramide, hydroxyquinidine, quinidine) - Class III antiarrhythmics (eg, amiodarone, dofetilide dronedarone, ibutilide, sotalol) - some antipsychotics (eg, haloperidol, pimozide, sertindole) - some antidepressants (for example, citalopram, escitalopram) - some antibiotics (for example, erythromycin, levofloxacin, moxifloxacin, spiramycin) - some antifungals (for example, pentamidine) - some antimalarials (for example, halofantrine, lumefantrine) - some drugs used for gastrointestinal diseases (for example, cisapride, dolasetron, prucalopride) - some antihistamines (for example, mequitazine, mizolastine) - cancer drugs (for example, toremifene, vandetanib, vincamine) - some other drugs (for example, bepridil, difemanil , methadone). The main role in the metabolism of domperidone is played by the CYP3A4 isoenzyme. In vitro studies and clinical experience indicate that concomitant use of drugs that significantly inhibit this isoenzyme may cause increased plasma concentrations of domperidone. Motinorm® is contraindicated for use with strong inhibitors of the CYP3A4 isoenzyme (regardless of their QT effects): azole antifungals (imidazoles), macrolide antibiotics (erythromycin, clarithromycin, telithromycin), HIV protease inhibitors, antidepressants (nefazodone) because they can block the metabolism of domperidone, which leads to increased plasma concentrations. Concomitant use with moderate CYP3A4 inhibitors (diltiazem, verapamil and some macrolides) is not recommended. Concomitant use with the following substances requires caution - drugs that induce bradycardia and hypokalemia; - macrolides that prolong the QT interval: azithromycin and roxithromycin (clarithromycin is contraindicated as a potent inhibitor of CYP3A4). The above list of substances with which use or prescription with caution is not recommended is approximate and not completely exhaustive. Separate pharmacokinetic/pharmacodynamic studies of the interaction of domperidone with oral ketoconazole or erythromycin in healthy subjects confirmed the marked inhibition of CYP3A4-mediated first pass metabolism of domperidone by these drugs. With simultaneous administration of 10 mg of domperidone 4 times a day and 200 mg of ketoconazole 2 times a day, a prolongation of the QT interval was observed by an average of 9.8 ms during the entire observation period, at certain points the changes varied from 1.2 to 17.5 ms. With simultaneous administration of 10 mg of domperidone 4 times a day and 500 mg of erythromycin 3 times a day, there was an increase in the QT interval by an average of 9.9 ms during the entire observation period, at certain points the changes varied from 1.6 to 14.3 ms. In each of these studies, the Cmax and AUC of domperidone were increased approximately threefold (see Contraindications section). It is currently unknown how elevated plasma concentrations of domperidone contribute to changes in the QT interval. In these studies, domperidone monotherapy (10 mg four times daily) prolonged the QT interval by 1.6 ms (ketoconazole study) and 2.5 ms (erythromycin study), whereas ketoconazole monotherapy (200 mg twice daily) and erythromycin (500 mg three times daily) led to a prolongation of the QT interval by 3.8 and 4.9 ms, respectively, during the entire observation period. Special instructions Motinorm® should not be prescribed together with anticholinergics, antacids or antisecretory drugs. In patients with diabetes mellitus, adjustment of the insulin dose is necessary when administered simultaneously with Motinorm®. Epidemiological studies have shown that use of domperidone was associated with an increased risk of serious ventricular arrhythmias or sudden cardiac death. A higher risk was observed in patients over 60 years of age, in patients taking daily doses greater than 30 mg, and in patients concomitantly taking drugs that prolong the QT interval or CYP3A4 inhibitors. Domperidone should be used at the minimum effective dose in adults and children. Domperidone is contraindicated in patients with known existing cardiac impairment, particularly QT prolongation, and in patients with significant electrolyte imbalance (hypokalemia, hyperkalemia, hypomagnesemia) or bradycardia, or in patients with underlying cardiac disease such as congestive heart failure from - for an increased risk of ventricular arrhythmia. Electrolyte disturbances (hypokalemia, hyperkalemia, hypomagnesemia) or bradycardia are known to increase the risk of abnormal heart rhythms. Domperidone treatment should be discontinued if signs or symptoms that may be related to cardiac arrhythmias occur. Patients should be advised to promptly report any heart symptoms to their physician. Use of Motinorm® in pediatrics in rare cases may cause neurological side effects. In children in the first months of life, metabolic functions and the blood-brain barrier are not fully developed, and therefore they have an increased risk of unwanted neurological effects in the form of extrapyramidal disorders and seizures. In this regard, it is not recommended to prescribe domperidone to newborns and infants under 1 year of age, and you should also very accurately calculate the dose of Motinorm® for children of early preschool age and strictly adhere to this dose. Neurological adverse effects can be caused by overdose of the drug in children, but other possible causes of such effects must be taken into account. The drug contains sorbitol, so it should not be taken by patients intolerant to sorbitol. The drug contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, which can cause allergic reactions (possibly delayed action). Use for liver diseases Considering the high degree of metabolism of domperidone in the liver, Motinorm® should be prescribed with caution to patients with mild liver failure. Use in kidney disease In patients with severe renal failure (serum creatinine > 6 mg/100 ml, i.e. > 0.6 mmol/l), the half-life of domperidone increased from 7.4 to 20.8 hours. The frequency of dosing should be reduced to once or twice daily, and it may be necessary to reduce the dose. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous machinery Caution should be exercised. Overdose Symptoms: drowsiness, disorientation, extrapyramidal disorders. Treatment: taking activated carbon; for extrapyramidal disorders - anticholinergic drugs, antiparkinsonian drugs or antihistamines with anticholinergic properties. Release form and packaging 5 ml of the drug is placed in an orange glass bottle, sealed with a screw-on aluminum cap with a gasket and first opening control. 1 bottle, along with a calibrated pipette and instructions for use in the state and Russian languages, is placed in a cardboard box. Storage conditions Store at a temperature not exceeding 25ºС. Keep out of the reach of children! Shelf life: 3 years Do not use the drug after the expiration date. Conditions for dispensing from pharmacies By prescription Manufacturer Medley Pharmaceuticals Ltd, India Medley House, D2, MIDS area, Andheri (E), Mumbai-400 093, India. Telephone, fax, E-mail 91-22-56959800/28204453 Address of the organization that accepts claims from consumers on the quality of products (products) in the Republic of Kazakhstan Representative office of Medley Pharmaceuticals Ltd. in the Republic of Kazakhstan Almaty, st. Kurmangazy, 48A, office 11 phone/fax: 7 (727) 2 61 51 41

Motinorm 10 mg No. 30 tablet.

Instructions for medical use of the drug MOTINORM® Trade name Motinorm® International nonproprietary name Domperidone Dosage form Tablets 10 mg Composition One tablet contains the active substance: domperidone 10 mg, excipients: lactose, corn starch, methyl para-hydroxybenzoate, propyl parahydroxybenzoate, magnesium stearate. Description White or almost white round tablets with a score on one side and engraved “Medley” on the other. Pharmacotherapeutic group Gastrointestinal motility stimulants Code ATX A03FA03 Pharmacological properties Pharmacokinetics Absorption Domperidone is rapidly absorbed when taken orally on an empty stomach. The maximum concentration (Cmax) in blood plasma is reached within approximately 30 minutes. The low absolute bioavailability of domperidone when taken orally (approximately 15%) is due to extensive first-pass metabolism in the intestinal wall and liver. The bioavailability of domperidone increases when taken after a meal, but patients with complaints from the gastrointestinal tract (GIT) should take domperidone 15-30 minutes before meals. Hypoacidity of gastric juice reduces the absorption of domperidone. Distribution When taken orally, domperidone does not accumulate or induce its own metabolism. Cmax in plasma 90 minutes after dosing, equal to 21 ng/ml, after 2 weeks of dosing at 30 mg/day, was almost the same as after taking the first dose (18 ng/ml). Domperidone is 91-93% bound to plasma proteins. Concentrations of domperidone in breast milk of lactating women are 4 times lower than the corresponding concentrations in plasma. Metabolism The drug is metabolized in the liver by hydroxylation and N-dealkylation. When metabolizing the drug, CYP3A4 is the main isoenzyme of the cytochrome P450 system involved in the process of N-dealkylation of domperidone, while CYP3A4, CYP1A2 and CYP2E1 are involved in the process of aromatic hydroxylation of domperidone. Excretion Excreted unchanged in feces - 10% and in urine - approximately 1%. The half-life (T1/2) from plasma after taking a single dose is 7-9 hours. In patients with severe renal failure, T1/2 increases to 20.8 hours. Pharmacodynamics Antiemetic drug, stimulant of gastrointestinal motility (GIT). Domperidone is a dopamine antagonist that, similar to metoclopramide and some antipsychotics, has antiemetic properties. However, unlike these drugs, domperidone does not penetrate the blood-brain barrier well. Domperidone is rarely associated with extrapyramidal side effects, especially in adults, but domperidone stimulates the release of prolactin from the pituitary gland. Its antiemetic effect is due to a combination of peripheral (gastrokinetic) action and antagonism to dopamine receptors in the chemoreceptor trigger zone. When administered orally, domperidone increases the duration of antral and duodenal contractions, accelerates gastric emptying - the release of liquid and semi-solid fractions in healthy people and solid fractions in patients, which this process was slowed down, and increases the pressure of the sphincter of the lower esophagus in healthy people. Domperidone has no effect on gastric secretion. Indications for use - nausea, vomiting, a complex of dyspeptic symptoms caused by delayed gastric emptying, gastroesophageal reflux, esophagitis (feeling of fullness of the stomach, belching, flatulence, heartburn) - nausea and vomiting of functional or organic origin (including infections, errors in diet, drug or radiation therapy) - nausea and vomiting caused by dopamine agonists (levodopa and bromocriptine). Method of administration and dosage: Adults are prescribed 10-20 mg (1-2 tablets) 2-3 times a day 30 minutes before meals. Children aged 6 to 12 years (with a body weight of more than 35 kg) are prescribed a dose of 0.2 - 0.4 mg/kg body weight (5 mg - ½ tablet, 10 mg - 1 tablet), 2 - 3 times a day. day 30 minutes before meals or, if necessary, before bed. The duration of the course of therapy is determined by the doctor individually for each patient. When re-prescribing the drug to patients with severe renal impairment, the frequency of administration should not exceed 1-2 times during the day. Side effects are rare - intestinal spasms, dry mouth, thirst, diarrhea - increased levels of prolactin in the blood plasma; galactorrhea, gynecomastia, amenorrhea very rarely - extrapyramidal disorders, headache, nervousness - rash, urticaria - prolongation of the QT interval, ventricular arrhythmias Contraindications - hypersensitivity to the drug - gastrointestinal bleeding - obstruction of the stomach or intestines - perforation of the stomach or intestines - prolactin- secreting pituitary tumor - simultaneous use of oral forms of ketoconazole, erythromycin or other strong inhibitors of the CYP3A4 isoenzyme that cause prolongation of the QTc interval (fluconazole, voriconazole, clarithromycin, amiodarone and telithromycin) - hereditary intolerance to galactose, lactose, malabsorption syndrome, glucosemia, galactosemia - children's age up to 12 years (with body weight <35 kg) - pregnancy and lactation. Drug interactions Simultaneous use of the drug with opioid analgesics and anticholinergic drugs can neutralize the effect of Motinorm. When used simultaneously with Motinorm, antacid and antisecretory drugs reduce its bioavailability. When used simultaneously with Motinorm drugs that significantly inhibit the CYP3A4 enzyme (antifungals of the azole group, antibiotics from the macrolide group, HIV protease inhibitors, the antidepressant nefazodone), an increase in the level of domperidone in plasma may be observed. Domperidone does not affect the level of paracetamol in the blood. Motinorm may reduce the bioavailability of digoxin, the dose of which must be adjusted. Motinorm may affect the absorption of drugs with sustained release of the active substance or enteric-coated drugs used simultaneously orally. Phenothiazine, when taken simultaneously with the drug, can cause extrapyramidal symptoms. Concomitant use of bromocriptine with Motinorm leads to hyperprolactinemia. Special instructions Prescribe the drug with caution to patients with severe liver dysfunction. Long-term use of the drug requires regular medical supervision. The rapid movement of food through the gastrointestinal tract necessitates adjustment of insulin dosage in diabetics. In patients with severe renal failure, the half-life of the drug increases, which requires, when re-prescribing the drug, a reduction in the frequency of administration to once or twice a day. Features of the effect on the ability to drive vehicles and potentially dangerous mechanisms The drug does not affect the ability to drive vehicles and potentially dangerous mechanisms. Overdose Symptoms: drowsiness, disorientation, extrapyramidal disorders. Treatment: careful observation, taking activated carbon; in case of extrapyramidal disorders, the use of anticholinergic drugs used to treat parkinsonism or antihistamines with anticholinergic properties. Release form and packaging 10 tablets in a blister pack made of printed aluminum foil. 1 and 3 contour packages together with instructions for medical use in the state and Russian languages are placed in a cardboard box. Storage conditions: In a dry place, protected from light, at a temperature not exceeding 25 ºС. Keep out of the reach of children! Shelf life: 4 years Do not use the drug after the expiration date. Conditions for dispensing from pharmacies By prescription Manufacturer Medley Pharmaceuticals Ltd, India Medley House, D2, MIDS area, Andheri (E), Mumbai-400 093, India. Owner of the registration certificate Madeley Pharmaceuticals Ltd., India Address of the organization that accepts claims from consumers regarding the quality of products (products) in the territory of the Republic of Kazakhstan Representative office of Madeley Pharmaceuticals Ltd. Almaty, st. Kurmangazy 48 "a", office 9 Zip code 050000 Phone number (727) 2729871, 2615141 Fax number (727) 2614466 Email address

Motinorm syrup 5 mg/5 ml 30 ml x1