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The instruction for medical use of Intanorm medicine This medicine is a subject of additional observation. It will allow to reveal new information on safety quickly. We ask doctors to report about any arising side reactions of drug. A trade name Intanorm Mezhdunarodnoye the unlicensed name Domperidon Lekarstvennaya a form of the Tablet of 10 mg Structure One tablet contains active agent – domperidon 10 mg, excipients: microcrystalline cellulose, calcium dihydrophosphate, magnesium stearate, talc, silicon dioxide colloidal. The description of the Tablet of white color, round shape, biconvex, with the line of a break on one party, flat on the other hand. Pharmacotherapeutic group Drugs for treatment of functional disorders of digestive tract. Stimulators of motility of digestive tract. Domperidon. The ATX A03FA03 code the Pharmacological Pharmacokinetics Domperidon properties is quickly absorbed at oral administration on an empty stomach. Time of achievement of the maximum concentration (Tmax) of a domperidon in blood plasma is 30-60 minutes after administration of drug. At administration of drug after a meal the absorption of a domperidon slows down, and the area under a ratio curve concentration time (AUC) increases. The Gipoatsidnost of gastric juice also reduces absorption of a domperidon and Tmax is about 90 minutes old. At the same time the maximum concentration (Cmax) equals 18ng/ml after single dose and 21 ng/ml at daily administration of drug on 30 mg a day within 2 weeks. Low absolute biological availability of a domperidon (about 15%) is caused by extensive primary metabolism in a wall of intestines and liver. Domperidon is metabolized in a liver by hydroxylation and N-dealkylation. Domperidon for 91-93% contacts proteins of blood plasma. Concentration of a domperidon in breast milk of the feeding women are 4 times lower, than the corresponding concentration in blood plasma. Domperidon badly gets through a blood-brain barrier. Plasma elimination half-life of blood after reception of a single dose makes 7-9 hours. Removal with urine and a stake makes 31 and 66% of an oral dose, respectively. Drug discharge in not changed look makes small percent (10% – with a stake and about 1% – with urine). Domperidon does not kumulirut and does not induce own exchange. At patients with a heavy renal failure (serumal creatinine & gt, 6 mg/100 ml, i.e. & gt, 0.6 mmol/l) elimination half-life of a domperidon increased from 7.4 to 20.8 o’clock, but concentration of drug in blood plasma were lower. The pharmacodynamics Active agent of the drug Intanorm – domperidon – is an antagonist of dopamine, possesses antiemetic action which is caused by a combination of peripheral (gastrokinetichesky) action and antagonism to dopamine receptors in a trigger zone of chemoceptors. Domperidon increases duration of reductions of antral and duodenal departments of a stomach, accelerates its depletion and increases pressure in a sphincter of a lower part of a gullet. Domperidon has no effect on gastric secretion. Intanorm’s use seldom is followed by extrapyramidal side effects, but stimulates prolactin secretion with a hypophysis which is out of a blood-brain barrier. Indications – symptomatic treatment of nausea and vomiting the Route of administration and doses Is recommended to use drug to food. In case of its reception after a meal the absorption can slow down. The patient should take the drug in due time. Adults and teenagers (12 years, weighing more than 35 kg are more senior) On 10 mg – no more than 3 times a day. Maximum daily dose of 30 mg. Duration of reception should not exceed one week. Abnormal liver functions Domperidon is contraindicated at heavy and moderate severity abnormal liver functions. Correction of the mode of dosing at easy degree of abnormal liver functions is not required. Use in a renal failure As very small percent of drug is removed by kidneys in not changed look, correction of a single dose with a renal failure is not required from patients. However at repeated prescribing of drug the frequency rate of administration of drug has to be reduced to one or two times a day. Side effects according to clinical trials the Undesirable reactions observed at ≥ by 1% of patients: a depression, alarm, decrease or lack of a libido, a headache, drowsiness, an akathisia, dryness in an oral cavity, diarrhea, rash, an itching, a galactorrhoea, a gynecomastia, pain and sensitivity in mammary glands, disturbances of a menstrual cycle and an amenorrhea, disturbance of a lactation, an asthenia. The undesirable reactions observed at & lt, 1% of patients: hypersensitivity, a small tortoiseshell, swelling and discharges from mammary glands. According to spontaneous messages about the undesirable phenomena Below the listed undesirable effects classified as follows: very frequent (≥ 10%), frequent (≥1%, but & lt, 10%), infrequent (≥ 0.1%, but & lt, 1%), rare (≥ 0.01%, but & lt, 0.1%) and very rare (& lt, 0.01%), including separate cases. Very seldom – anaphylactic reactions, including an acute anaphylaxis – excitement, nervousness – extrapyramidal disturbances, spasms (mainly at newborns and children) – lengthening of an interval of QT, a sudden cardiac death *, serious ventricular arrhythmias * – a Quincke’s edema, urticaria – an ischuria – increase in level of prolactin in plasma, deviations of laboratory indicators of function of a liver * In some epidemiological researches was shown that use of a domperidon can be connected with increase in risk of developing serious ventricular arrhythmias or sudden death. The risk of emergence of these phenomena is more probable at patients 60 years and at the patients taking the drug in a daily dose more than 30 mg are more senior. Use of a domperidon in the smallest effective dose at adults and children is recommended. Contraindications – hypersensitivity to a domperidon or any of fillers – heavy and moderate severity of abnormal liver functions – to patients with the diagnosed lengthening of intervals of warm conductivity, in particular QT, with considerable disturbances of electrolytic balance or heart diseases, such as stagnant heart failure – simultaneous use of other medicines with the known risk factor of lengthening of an interval of QT – simultaneous use with strong CYP3A4 inhibitors – prolactin-rileasing a tumor of a hypophysis (prolaktinom) – gastrointestinal bleeding – mechanical impassability or perforation at which stimulation of motive function of a stomach can be dangerous – pregnancy and the period of a lactation – children’s age up to 12 years Medicinal interactions Anticholinergic drugs can neutralize action of a domperidon. The bioavailability decreases at its reception after Cimetidinum or Natrii hydrocarbonas. It is not necessary to take the antiacid and anti-secretory drugs along with the drug Intanorm as they reduce its bioavailability after intake. The main way of metabolic transformations of a domperidon passes with participation of an isoenzyme of CYP3A4 of a system of P450 cytochrome therefore at the simultaneous use of a domperidon and medicines considerably inhibiting this isoenzyme the increase in level of a domperidon in blood plasma is possible. At use of a domperidon with the powerful CYP3A4 inhibitors capable to extend QT interval, clinically significant changes of an interval of QT were observed. Therefore use of a domperidon with certain drugs is contraindicated (see the section Contraindications). The increased risk of lengthening of an interval of QT owing to pharmakodinamichesky and/or pharmacokinetic interaction. Contraindicated simultaneous use with the following medicines: QT extending an interval: – antiarrhytmic the class IA (Disopyramidum, hydroquinidine, quinidine), – antiarrhytmic class III (for example, Amiodaronum, dofetilid, dronedaron, ibutilid, sotalol), – some neuroleptics (for example, a haloperidol, Pimozidum, sertindoly), – some antidepressants (for example, tsitalopramy, estsetalopramy), – some antibiotics (for example, erythromycin, levofloksatsiny, moksifloksatsiny Spheromycinum), – some antifungal (for example, pentamidine), – some antimalarial (in particular, galofantriny, lyumefantriny), – some gastrointestinal drugs (for example, tsizapridy, dolasetrony, prukalopridy), – some antihistaminic (for example, mekvitaziny, mizolastiny), – some drugs used for cancer therapy (for example, toremifeny, vandetaniby, Vincaminum), – some other drugs (for example, bepridily, difemanily, methadone). With strong CYP3A4 inhibitors (irrespective of their ability to extend QT interval): – protease inhibitors, – azolny antifungal drugs of systemic action, – some macroleads (erythromycin, klaritromitsin, telitromitsin). It is not recommended to accept at the same time with moderate CYP3A4 inhibitors, for example, diltiazem, verapamil and some macroleads (see the section Contraindications). It is required to be careful at simultaneous use of the following medicines at the inducing development of bradycardia and a hypopotassemia and also with macroleads azithromycin and roksitromitsiny, QT extending an interval (klaritromitsin it is contraindicated for use as strong CYP3A4 inhibitor). At simultaneous use with m cholinolytics and narcotic analgetika the influence of a domperidon on a motor evakuatornuyu activity of a stomach and intestines decreases. Simultaneous use with ketokonazoly, erythromycin or other potential CYP3A04 inhibitors can lead to lengthening of an interval of QT. At simultaneous use of a domperidon in a dose of 10 mg 4 times a day and a ketokonazol in a dose of 200 mg are twice a day observed lengthening of an interval of QT on 10-20 ms. At monotherapy domperidony as in similar doses, as well as at reception of a daily dose of 160 mg (that is twice higher than the maximum allowed daily dose), clinically significant changes of an interval of QT were not observed. Digoxin or paracetamol at a concomitant use of a domperidon does not influence the level of these drugs in blood. Intanorm it is also possible to combine with neuroleptics which action he does not strengthen, agonists of dopaminergic receptors (Bromocriptinum, L-finish singing) which undesirable peripheral effects, such as digestion disturbance, nausea, vomiting, he suppresses, without neutralizing their main properties. The special instructions Intanorm, it is not recommended to use for the purpose of motion desease relief of symptoms. Influence on the cardiovascular Use of a Domperidon system is connected with lengthening of an interval of QT on the ECG. During post-marketing observation very rare messages about cases of lengthening of an interval of QT, Torsades de pointes at the patients accepting domperidon are received. These cases included patients with the mixed risk factors, disturbances of electrolytic balance and the accompanying therapy which, perhaps, were the promoting factors. Epidemiological researches showed that use of a domperidon is connected with the increased risk of developing ventricular arrhythmias and a sudden cardiac death. Higher risk was observed at patients 60 years which are daily accepting more than 30 mg of a domperidon which are at the same time accepting other medicines with the known risk factor of lengthening of an interval of QT or strong CYP3A4 inhibitors are more senior. Intanorm it is necessary to accept in a minimal effective dose at adults and children. Intanorm is contraindicated to patients with the diagnosed lengthening of intervals of warm conductivity, in particular QT, with considerable disturbances of electrolytic balance (hypopotassemia, a hyperpotassemia, a hypomagnesiemia) or bradycardia, at patients with heart diseases, such as stagnant heart failure owing to the increased risk of developing ventricular arrhythmia. Disturbances of electrolytic balance (hypopotassemia, a hyperpotassemia, a hypomagnesiemia), bradycardia, are the factors increasing pro-arrhythmic risk. Treatment domperidony needs to be stopped if at the patient signs or symptoms which can be associated with cardiac arrhythmia are observed. The patient should consult with the doctor. The patient needs to recommend to tell immediately the doctor about development any warm symptoms. Renal failures Elimination half-life of a domperidon is extended in heavy renal failures. At repeated use the frequency of reception needs to be reduced to 1-2 times a day depending on weight of disturbances. The dose decline can be required. When assigning antiacid or anti-secretory means together with Intanorm it is necessary to observe an interval of 2 hours between intake of these drugs or to accept Intanorm in 30 min. prior to food, and antiacid and anti-secretory drugs in 30 min. after a meal. Considering high extent of metabolism of a domperidon in a liver, it is necessary to appoint with care Intanorm the patient from easy and moderate severity of a liver failure. At long therapy by Intanorm the patients with a renal failure have to be under regular observation. Pregnancy and the period of a lactation are Not enough data on use of a domperidon during pregnancy and a lactation. Features of influence of medicine on ability to run the vehicle or potentially dangerous by mechanisms Considering possible side effect from nervous system, patients need to be attentive at control of motor transport or work with other mechanisms. Overdose Symptoms: drowsiness, a disorientation and extrapyramidal reactions, especially at children. Treatment: use of activated carbon and careful observation is recommended. At emergence of extrapyramidal reactions it is possible to appoint anticholinergics, the antihistaminic drugs, drugs used for treatment of parkinsonism. Forms of release and packing On 10 tablets place in blister strip packaging from aluminum foil. On 1 blister strip packaging together with the instruction for medical use in the state and Russian languages put in a pack from cardboard. To Store storage conditions in the dry, protected from light place at a temperature not over 30 of 0C. To store out of children’s reach! 3 years not to apply a period of storage after an expiration date. Prescription status According to the prescription Lincoln Pharmaceuticals Ltd Producer, India the Owner of the registration certificate of Interpharma 902, Vikram Touyer, 16, Ranzhendra Place, New Delhi – 110008, India of E-mail. the Name, the address and a contact information (phone, the fax, e-mail) of the organization in the territory of the Republic of Kazakhstan responsible for post-registration observation of safety of medicine: KazEvroFarm LLP Almaty, Kurmangaza St. 48 and, office 9 050000 Phone number Index (727) 2729871, 2615141 Fax number (727) 2614466 E-mail:
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