Mioriks 14s 15 mg sustained release capsules

The instruction for medical use of MIORIKS® medicine the Trade name of Mioriks® the International unlicensed name Tsiklobenzaprin Lekarstvennaya the Capsule form with the prolonged release of 15 mg and 30 mg Structure One capsule contains active agent: tsiklobenzaprina hydrochloride of 15 mg and 30 mg excipients: a sugar krupka of 20-25 mesh, Opadry® Clear YS-1-7006, (patent mix of a gipromelloza and polyethyleneglycol), ethyl cellulose, diethyl phthalate, acetone, water the cleaned cover of the capsule of 15 mg: ferrous oxide red (E172), ferrous oxide yellow (E172), FD&C Blue No. 2, aluminum varnish, titan dioxide (E171), gelatin, traces of TekPrint™ SB-6018 Blue ink * cover of the capsule of 30 mg: FD&C Blue No. 2, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, titan dioxide (E 171), gelatin, traces of Opacode® White S-1-7085 ink ** * composition of Opacode® White S-1-7085 dye: % Shellac Glaze-45 in SD-45 alcohol, the titan FSSA dioxide *, 2 FSSA propyl alcohol *, 28% hydroxide ammonium solution, NF propylene glycol *, NF butanol * and simetikon FSSA *, ** composition of TekPrint™ SB-6018 Blue dye: Shellac NF *, ethanol anhydrous FSSA *, 2 FSSA propyl alcohol *, NF butanol *, NF propylene glycol *, ammonia solution the concentrated NF *, FD&C Blue No. 2 the aluminum YaF varnish * (E132). The description Solid gelatin capsules of No. in size 4 with the opaque body of orange-brown color, with an inscription of blue 1002-15 color and an opaque lid of orange-brown color with an inscription of blue EUR color. Contents of capsules – spherical granules from white till yellow color (for a dosage of 15 mg). Solid gelatin capsules of No. in size 4 with the opaque body from blue till blue-green color, with an inscription of white 1002-30 color and an opaque lid from red till red-orange color with an inscription of white EUR color. Contents of capsules – spherical granules from white till yellow color (for a dosage of 30 mg). Pharmacotherapeutic group Drugs for treatment of a musculoskeletal system. Muscle relaxants. Muscle relaxants of the central action. Muscle relaxants of the central action others. Tsiklobenzaprin. The ATX M03BX08 code the Pharmacological Pharmacokinetics Absorption Pharmacokinetic Parameters Mioriksa®, Cmax, AUC0-168h and AUC0-properties ∞, are dose-dependent and grow in direct ratio to a dose of the taken drug. At single dose of drug in doses of 15 and 30 mg the maximum concentration of a tsiklobenzaprin in plasma (Tmax) is reached in 7-8 h. Influences of meal, healthy adult volunteers at use of a single dose of drug Миорикс® 30 have a mg, showed significant increase in bioavailability with meal in comparison with reception on an empty stomach. 35% increase in peak concentration of a tsiklobenzaprin in plasma (Cmax) and 20% increase in influence (AUC0-168ch and AUC0-∞) with meal were observed. However no influence on maximum (Tmax), or on average concentration of a tsiklobenzaprin in plasma concerning time profile was revealed. The first concentration of a tsiklobenzaprin in plasma appear in 1.5 hours as with reception from food, and on an empty stomach. Multiple dose of drug Миорикс® 30 of mg (within 7 days once a day) leads to 2.5-fold increase in level of a tsiklobenzaprin in blood plasma at healthy faces. Metabolism and excretion Tsiklobenzaprin is substantially metabolized and excreted through kidneys first of all in the form of glucuronides. P-450 3A4, 1A2 cytochromes, to a lesser extent 2D6, participate in metabolism by means of N-dimetilirovaniya (one of oxidizing ways of metabolism of a tsiklobenzaprin). Elimination half-life of a tsiklobenzaprin 32 hours (range of 8-37 hours), the general clearance after reception of a single dose of drug Миорикс® 0.7 of l/min. Special groups of patients Elderly elderly patients age had more than 65 years no essential differences in pharmacokinetic parameters (Cmax or Tmax) in comparison with younger patients age of 18-45 years, however AUC of a tsiklobenzaprin at elderly people in plasma increases by 40% and elimination half-life of a tsiklobenzaprin in blood plasma is longer (32 hours at 18-45 years and till 50 o'clock at elderly). Pharmacokinetic indicators of a tsiklobenzaprin after reception of repeated doses of the drug Mioriks® at elderly were not estimated. Disturbances from a liver Data of researches of pharmacokinetic indicators at patients from the slight and moderated by severity hepatic dysfunction (on classification of Child Pugh) showed increase approximately twice in AUC and Cmax in comparison with indicators in healthy control group. The pharmacokinetics of a tsiklobenzaprin at patients with heavy abnormal liver functions was not studied. The pharmacodynamics Tsiklobenzaprin eliminates a local spasm of skeletal muscles without direct intervention in their function. It was shown that tsiklobenzaprin it is not effective at the muscular spasms caused by damage of the central nervous system. Tsiklobenzaprin does not influence neuromuscular synapses or directly skeletal muscles. Tsiklobenzaprin acts, first of all, at the level of a brain trunk, and only the secondary effect is gained at the level of a spinal cord though action on the last can make a contribution to the systemic relaxing effect of drug on skeletal muscles. Effect of a tsiklobenzaprin is reduction of the tonic somatic physical activity influencing both gamma (γ-) and on alpha (α-) motor systems. The similarity of effects of a tsiklobenzaprin and structurally related tricyclic antidepressants, including antagonistic effect in relation to reserpine, potentiation of effect of Norepinephrinum, strong peripheral and central anticholinergic effects and also sedation is revealed. Indications of Mioriks® it is shown for elimination of the muscular spasm which is followed by acute pain from the musculoskeletal system as addition to the mode of limited physical activity and physiotherapy exercises. Improvement is shown by elimination of muscular spasms and the related signs and symptoms, namely: pains, hypersensitivity and restriction of the movement. A route of administration and doses the Recommended dose for most of adult patients makes 15 mg once a day. The dose of 30 mg/days accepted in the form of one capsule (Миорикс® 30 mg) once a day or in the form of two capsules (Миорикс® 15 mg) can be required by some patients once a day. It is recommended to accept doses approximately at the same time day. It is recommended to use the drug Mioriks® during the short spans (up to 2 or 3 weeks). Side effects the Most widespread side reactions (≥ 3%): - drowsiness - dizziness - fatigue - nausea - constipations - dyspepsia Side reactions with a frequency of 1-3%: - fatigue - drowsiness - an asthenia - unpleasant taste - turbidity of sight - a headache - nervousness - confusion of consciousness Side reactions with a frequency & lt, 1% the General symptomatology: faints, indisposition, stethalgia, hypostasis. Cardiovascular system: tachycardia, arrhythmia, vazodilatation, heartbeat, hypotension, hypertensia, myocardial infarction, warm blockade, stroke. Digestive system: vomiting, anorexia, diarrhea, gastrointestinal pain, gastritis, thirst, meteorism, paraglossa, abnormal liver function and rare messages about hepatitis, jaundice, cholestasia, paralytic intestinal impassability, decolouration of language, stomatitis, swelling of parotid glands. Endocrine system: syndrome of inadequate secretion of antidiuretic hormone. Hematologic and lymphatic disturbances: hemorrhagic rash, suppression of activity of marrow, leukopenia, eosinophilia, thrombocytopenia. Hypersensitivity: acute anaphylaxis, Quincke's disease, itching, face edema, small tortoiseshell, rash. From the immune system, metabolism and food: increase and lowering of the level of sugar in blood, increase or loss of body weight. Disturbances from a skeletal and muscular system: local weakness, myalgia. Nervous system and mental state: spasms, ataxy, dizziness, dysarthtia, trembling, hypertension, convulsions, twitching of muscles, orientation disturbance, insomnia, suppressed mood, abnormal sensitivity, alarm, excitement, psychosis, pathological thinking and dreams, hallucinations, contagious excitation, paresthesias, diplopia, serotoninovy syndrome, malignant antipsychotic syndrome, reduction or increase in a libido, atypical gait, nonsense, agressive behavior, paranoia, peripheral neuropathy, paralysis Bella, disturbance of EEG, extrapyramidal symptoms. Respiratory system: asthma. Skin: perspiration, photosensitization, alopecia. Sense bodys: loss of flavoring sensitivity, sonitus. Urogenital system: frequent urination and/or an ischuria, the broken urination, stretching of urinary tract, impotence, testicular swellings, a gynecomastia, increase in a breast, a galactorrhoea. Contraindications - hypersensitivity to any component of this drug. It can be shown in the form of anaphylactic reaction, a small tortoiseshell, swelling of the person and/or language or an itching. At suspicion on reaction of hypersensitivity stop administration of drug of Mioriks® - combined use of monoamine oxidase inhibitors (MAO) or use within 14 days after the termination of their reception - a sharp phase of a myocardial infarction, arrhythmia, blockade of the carrying-out system of heart, disturbance of conductivity or stagnant heart failure - a hyper thyroidism - children's age up to 18 years Medicinal interactions based on structural similarity with tricyclic antidepressants, the drug Mioriks® can have life-threatening interactions with MAO inhibitors, can also strengthen effect of alcohol, barbiturates and other depressants of central nervous system. Can increase risk of developing spasms at the patients accepting tramadol, can also block antihypertensive action of a guanetidin and the same way the operating connections. There were cases of a serotoninovy syndrome, during the combined use of a tsiklobenzaprin and other medicines, such as selective serotonin reuptake inhibitors, selective serotonin reuptake inhibitors and noradrenaline, tricyclic antidepressants, tramadol, bupropion, trimeperidine, verapamil or MAO inhibitors. The special instructions Drug Mioriks® it is not effective in treatment of the spasticity connected with cerebral diseases of a brain. The Serotoninovy syndrome there Were cases potentially life-threatening a serotoninovy syndrome at use of a tsiklobenzaprin in a combination with other medicines, such as selective serotonin reuptake inhibitors (SSRI), selective serotonin reuptake inhibitors and noradrenaline (SNRI), tricyclic antidepressants (TCA), tramadol, bupropion, trimeperidine, verapamil or MAO inhibitors. Symptoms of a serotoninovy syndrome can include changes of a mental state (for example: confusion of consciousness, excitement, hallucinations), instability of the autonomic nervous system (for example: diaforez, tachycardia, instability blood pressure, hyperthermia), nervnomyshechny deviations (for example: tremor, ataxy, hyperreflexia, clonic spasms, muscle tension) and/or gastrointestinal symptoms (for example: nausea, vomiting, diarrhea). At development given above reactions the Mioriks® drug treatment and any accompanying serotonergic means it has to be immediately stopped, and symptomatic treatment has to be initiated. If the accompanying Mioriks® drug treatment and other serotonergic means is clinically justified, then careful observation is recommended, especially during an initiation of treatment or increase in a dose of drug. Similar effects to tricyclic Tsiklobenzaprin antidepressants it is structurally related to tricyclic antidepressants, for example, to amitriptyline and Imipraminum. Tricyclic antidepressants cause the arrhythmias, sinus tachycardia, increases in time of carrying out an impulse leading to a myocardial infarction and a stroke. The drug Mioriks® can enhance effects of alcohol, barbiturates and other depressants of the central nervous system. At development clinical significant symptoms on central nervous system, it is necessary to consider the termination of the Mioriks® drug treatment. Elderly patients Owing to 40% of increase in level of a tsiklobenzaprin in plasma, and 56% of increase in elimination half-life elderly patients have special groups of patients, in comparison with younger patients, it is not recommended to use the drug Mioriks® at elderly people. Use at patients with abnormal liver functions Owing to double increase in levels of a tsiklobenzaprin in plasma and because of a limited possibility of change of doses of drug, use of the drug Mioriks® at patients with slight, moderate or heavy abnormal liver functions is not recommended. Atropinopodobny action Due to existence of atropinopodobny action the drug Mioriks® should be used with care at patients who have in the anamnesis an ischuria, closed-angle glaucoma, the increased intraocular pressure and at the patients taking the anticholinergic drugs. Pregnancy and a lactation Pregnancy - category B: there are no adequate and properly controlled researches of drug on pregnant women. In this regard use at pregnancy is possible, only when the advantage of use of drug exceeds potential risk for a fruit and the newborn. It is unknown whether this drug in milk of the person is excreted. As tsiklobenzaprin blizkorodstvenen tricyclic antidepressants some of which, as we know, are excreted in milk of the person at administration of drug by the feeding women should be careful. Overdose Symptoms: the most widespread effects connected with overdose tsiklobenzapriny are drowsiness and tachycardia. Less frequent manifestations include: tremor, nervousness, coma, ataxy, hypertensia, illegible speech, confusion of consciousness, dizziness, nausea, vomiting and hallucinations. Rare, but potentially important manifestations of overdose are cardiac arrest, a stethalgia, cardiac arrhythmias, heavy hypotension, spasms and a malignant antipsychotic syndrome. Changes of the electrocardiogram, in particular the QRS complex, are clinically significant indicators of toxicity of a tsiklobenzaprin. Treatment: Removal from digestive tract All patients with suspicion on overdose by the drug Mioriks® need to carry out gastric lavage by the large volume of water with the subsequent intake of activated carbon. If consciousness is broken, then before gastric lavage the airways have to be protected and calling of vomiting is contraindicated. The cardiovascular system the Maximum duration of the QRS complex of 0.10 seconds can be the best indicator of weight of overdose. For patients with arrhythmias and/or expanded QRS alkaline solutions about pH 7.45-7.55 (Natrii hydrocarbonas) have to be entered in the intravenous way and also the hyperventilation is carried out. pH higher than 7.60 or pCO2 lower than 20 mm of a mercury column are undesirable. Arrhythmias which do not respond to treatment with a Natrii hydrocarbonas / hyperventilation can be sensitive to lidocaine, a bretylium or Phenytoinum. Antiarrhythmic means, for example skhinidin, Disopyramidum and procaineamide (means of type 1A and 1C), are usually contraindicated. Central nervous system At patients from suppressed central nervous system is recommended an early intubation because of a possibility of sharp aggravation of symptoms. Spasms should be controlled benzodiazepines, or if they are inefficient, other anticonvulsants (for example, phenobarbital, Phenytoinum). Physostigmine is not recommended, except for cases of treatment life-threatening symptomatology which did not respond to other treatment, and only after detailed consultation with poison control center. The subsequent observation of a mental state As a condition of overdose often is the deliberate phenomenon, patients can try to commit suicide other means at a restoration stage. Thereof the direction to the psychiatrist can be required. Treatment of children the Principles of treatment of overdose of children and adults are identical. To the doctor it is strongly recommended to contact local poison control center concerning specific pediatric treatment. The form of release and packing On 14 capsules place in blister strip packaging from PVC
of a lenka and aluminum foil. On the 1 or 2 blister strip packaging together with the instruction for medical use in the state and Russian languages place in a cardboard pack. To Store storage conditions at a temperature not higher than 25 wasps. To store out of children's reach! 4 years not to apply a period of storage after an expiration date! Prescription status According to the prescription the Producer Adare Pharmasyyutikals, INK., Vandaliya, the State of Ohio, the USA the Owner of the registration certificate of Takeda GmbH, Konstants, Germany Packer Takeda of JV .z Pharm of the lake oh, to Lyshkovitsa, Poland the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) and responsible for post-registration observation of safety of medicine of Takeda Kazakhstan LLP Almaty, Shashkin St. 44 Phone number (727) 2444004 Fax number (727) 2444005
To Develop the e-mail address of DSO-KZ@takeda.com