Muskomed 20s 4 mg capsule

The instruction for medical use of MUSKOMED medicine This medicine is subject to additional monitoring. It will allow to reveal new information on safety quickly. We appeal to health care providers to report about any suspected undesirable reactions. A trade name Muskomed Mezhdunarodnoye the unlicensed name Tiokolkhikozid Lekarstvennaya the form of the Structure One Capsule Capsule contains active agent - tiokolkhikozid 4 mg or 8 mg, excipients: lactoses monohydrate, starch corn, magnesium stearate, structure of the capsule: titan dioxide (E 171), gelatin. The description the Solid gelatin capsules, size No. 3, a lid and the body of opaque white color containing yellow powder (for a dosage of 4 mg). The solid gelatin capsules, size No. 2, a lid and the body of opaque white color containing yellow powder (for a dosage of 8 mg). Pharmacotherapeutic group Muscle relaxants of the central action others. Tiokolkhikozid the ATX M03BX05 Code the Pharmacological Pharmacokinetics Later properties of oral use tiokolkhikozid is quickly absorbed. The peak of concentration in blood plasma is reached in 15-45 min. The maximum concentration in plasma makes 61 ng/ml. Tiokolkhikozid has three metabolites. Two main forms in circulation: tiokolkhikozid aglikon and glyukuronidny derivative a tiokolkhikozida which is an active metabolite. Linking with proteins of blood plasma makes 13%. Tiokolkhikozid contacts albumine. Elimination half-life makes 2.5-5 h. In the course of metabolism 3 metabolites are formed, 2 of which are defined in blood serum – aglikon and active glyukuronizirovanny derivative a tiokolkhikozida. About 20% of the accepted dose are excreted with urine in the form of not changed metabolites, 75-81% are removed with excrements. The pharmacodynamics Muskomed as active agent contains tiokolkhikozid - the semi-synthetic muscle relaxant received from a natural glycoside of a kolkhikozid. Tiokolkhikozid shows selection affinity to piperidic acid (GAMK) and glycine receptors that causes effect of drug at various levels of nervous system, both at spasms of local character, and at spasms of the central origin. Tiokolkhikozid acting as the antagonist of the GAMK-receptor can have the effective myorelaxation effect by means of regulatory complex mechanisms at the supraspinal level, however, its glitsinergichesky mechanisms of action cannot be excluded. Muskomed has no kurarepodobny effect, does not cause paralysis and does not influence cardiovascular and respiratory systems. Indications Muskomed is shown at symptomatic treatment of painful muscular spasms. The route of administration and doses take the Drug Muskomed inside after a meal, washing down with enough water. The adult on 4-8 mg twice a day after a meal. Maximum single dose of 8 mg. Maximum daily dose of 16 mg. Duration of treatment is 5 – 7 days. Use in a combination with the anesthetizing physical therapy in 30-40 min. prior to the procedure renders more significant medical effect. The prevention/precaution When developing diarrhea can reduce a dose to 4 mg a day. Side effects Seldom - anaphylactic reactions as an itching, an urtikary and Quincke's disease - drowsiness - a vazovagalny syncope, hypotension - temporary confusion of consciousness, excitement - nausea, vomiting, diarrhea, a gastralgia Very seldom - an acute anaphylaxis - temporary confusion of consciousness, excitement, irritability of the Contraindication - hypersensitivity to the tiokolkhikozid or other substance which is a part of drug - hypotonia of muscles and sluggish paralysis / paresis - a concomitant use of anticoagulants and predisposition to hemorrhages - a hereditary lactose intolerance, deficiency of Lapp-lactases enzyme, glucose galactose malabsorption - the women of childbearing age who are not using contraception methods - pregnancy and the period of a lactation - children's age up to 18 years the Medicinal interactions of Data on medicinal interaction are not present. However it is recommended to be careful at a concomitant use with other muscle relaxants. Simultaneous use of the drug Muskomed and the drugs possessing the oppressing action on the central nervous system (including barbiturates, tranquilizers and antihistamines) and also alcohol, can lead to strengthening of this action. At simultaneous use with anticoagulants the risk of bleedings increases. Special instructions In an abnormal liver function the dose adjustment is not required as drug is not metabolized in a liver. In a renal failure low doses of drug are recommended. Muskomed can provoke an epileptic seizure at patients with epilepsy or with risk of an epileptic seizure. Preclinical trials showed that one of metabolites of a tiokolkhikozid (SL59.0955) causes an aneuploidy (unequal chromosome number during cell fission). The aneuploidy is risk factor of teratogenic influence on an embryo and also potential risk factor of developing cancer, decrease in genital potential at men. It is necessary to avoid use of drug in the doses exceeding the recommended doses and prolonged use. Patients have to be carefully informed on potential risk in case of pregnancy and need of use of effective methods of contraception. Drug contains lactose. To patients with rare hereditary problems of a lactose intolerance, a galactose, disturbance of absorption of lactose and a galactose does not recommend administration of drug. Pregnancy and the period of a lactation Muskomed is contraindicated at pregnancy and in the period of a lactation. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms Are absent data on impact of drug on ability of driving and operation of cars. Clinical trials showed what tiokolkhikozid does not influence psychomotor function. Nevertheless, exceptional cases of drowsiness therefore it is necessary to consider this potential side effect at control of vehicles or at operation of cars were registered. It is necessary to be careful at control of motor transport or the mechanisms demanding concentration of attention. The overdose Is not present data on overdose. Symptoms: strengthening of side effects is possible. Treatment: symptomatic and maintenance therapy. The form of release and packing On 10 capsules place in blister strip packaging from a film of polyvinylchloride and aluminum foil. On 1 and 2 blister strip packagings 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 above 25 °C. 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 the Producer UORLD of ILACh DIGNITY MEDICINE. VE TIDZh. A.Sh., TURKEY (Bagdzhylar Ilchesi, Gyuneshli, Evren Makhallesi, Dzhami Yolu Dzhad. No. 50 K. 1B Zemin 4-5-6, Istanbul) Owner of the registration certificate UORLD of ILACh DIGNITY MEDICINE. VE TIDZh. A.Sh., TURKEY the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products: RIN Pharm LLP, RK, Almaty, Suyunbaya Ave., 222 B Ph. / fax: +7 (727) 2529090 Address of the organization responsible for post-registration observation of safety of medicine: TROKA-S PHARMA LLP, RK, Almaty, Suyunbaya Ave., 222 B Cellular ph. +7 701 786 33 98, (24-hour access). e-mail: pvpharma@worldmedicine.kz