The instruction for medical use of TIOZID medicine Trade name ТИОЗИД® the International unlicensed name Tiokolkhikozid Lekarstvennaya a form Solution for intramuscular injections, 4 mg / 2 ml Structure of 2 ml of solution contain active agent – tiokolkhikozid 4 mg, excipients: sodium chloride, water purified. Description Transparent solution of yellow color. Pharmacotherapeutic group Muscle relaxants of the central action others. Tiokolkhikozid. The ATX M03BX05 code the Pharmacological Tiokolkhikozid Pharmacokinetics properties quickly resolves after intramuscular introduction and reaches the peak of concentration in plasma in 30 – 40 minutes. Elimination half-life of drug makes 2.5 – 5 hours of plasma. Linking of a tiokolkhikozid with serum protein makes 13%. Drug easily spreads in body tissue. 20% of the entered dose of drug are removed with urine in not changed look or in the form of its metabolites. 75 – 81% of the entered dose of drug are removed with a stake through a zhelchevydelitelny system. At long therapy the cumulative effect is observed therefore effect of substance continues within several days after the end of administration of drug. The pharmacodynamics Tiokolkhikozid is semi-synthetic substance derivative a kolkhikozida, with myorelaxation pharmacological effect (muscular relaxant). Tiozid reduces or eliminates muscular spasms of the central origin. Myorelaxation action is observed also on visceral muscles. Has no kurarepodobny effect. On the mechanism of action treats muscle relaxants of the central action, does not cause paralysis and decrease in amplitude of action potential of a trailer motive plate of a muscle. The selectivity of the central myorelaxation effect of a tiokolkhikozid as GABA agonist and glitsinergichesky receptors is established. Glitsinomimetichesky properties of a tiokolkhikozid cause action at various levels of nervous system that is important as at the reflex spasms arising in rheumatism or injuries, and at spasms of muscles of a cerebral etiology. Drug does not cause paralysis, does not affect a cardiovascular and respiratory system. Indications – symptomatic treatment of painful muscular spasms the Route of administration and doses For intramuscular introduction. Adults: The daily dose makes intramusculary on 2 ml (4 mg) 2 times a day. However the dosage can be adjusted during treatment. It is not recommended for long-term treatment of chronic diseases. The recommended term of treatment of 3 – 5 days. By preparation for physiotherapeutic procedures the period of relaxation of muscles is 30-40 minutes after an intramuscular injection. Side effects Assessment of possibility of side effects of drug corresponds to the following indicators: very often (≥ 1/10), it is frequent (≥ 1/100 to & lt, 1/10), infrequently (≥ 1/1.000 to & lt, 1/100), is rare (≥ 1/10.000 to & lt, 1/1.000), is very rare (& lt, 1/10.000), it is unknown (not enough data). Seldom: – disturbances from nervous system (drowsiness, confusion of consciousness, excitement) – disturbances from digestive tract (diarrhea, a gastralgia, nausea) – disturbance of activity of a cardiovascular system (hypotension) – disturbances from the immune system (allergic rash, anaphylactic reactions, including a Quincke’s disease) – allergic skin reactions Very seldom: – reaction of an anaphylaxis, including an acute anaphylaxis of the Contraindication – supersensitivity – a flaccid paralysis and a hypomyotonia – therapy by anticoagulants and predisposition to hemorrhages – pregnancy and the period of a lactation – children’s age up to 18 years Medicinal interactions of TIOZID can be applied to a tiokolkhikozid or auxiliary components of drug together with non-steroidal anti-inflammatory drugs (NPVS), phenylbutazone, analgeziruyushchy drugs, anabolic steroids, demulcents, barbiturates and suktsinilkholiny. Joint appointment with other muscular relaxants is not recommended as they can enhance effect of interaction considerably. It is not recommended to take the drug together with anticoagulants as the risk of bleedings increases. At simultaneous use with the drugs oppressing the central nervous system (CNS) including with alcohol, antihypertensive drugs, kurarepodobny drugs strengthening of muscle relaxation and oppression of central nervous system, development of hypotonia is possible. Special instructions to take at patients with allergic reactions in the anamnesis with caution. Tiokolkhikozid can cause epileptic attacks in the patients having epilepsy or entering into risk group. Safety and efficiency of use of TIOZIDA was not studied for the patients having a renal or liver failure and also for elderly patients. For these patients, especially advanced age, low doses of drug are recommended. Influence on reproductive function: Though metabolites of drug have anogenic activity, drug does not affect reproductive function. Metabolites of drug can have undesirable effect on male fertility and, therefore, use of drug it is not recommended at men with problems in the relation and it is necessary to consider the possibility of drug withdrawal. Period of pregnancy and lactation. Tiokolkhikozid is allocated in breast milk of mother therefore it is not recommended to use drug in the period of a lactation. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms Exact data on influence of drug on ability of driving of the car are absent. Clinical trials showed what tiokolkhikozid does not influence psychomotor functions. However drowsiness therefore it is necessary to adhere to special precaution when driving the car was in rare instances noted. Overdose of Data on overdose of drug are not known. Symptoms: strengthening of side effects is possible. Treatment: to provide clinical observation of the patient and also symptomatic and maintenance therapy. The form of release and packing On 2 ml of drug place in an ampoule from colourless transparent glass with the line for a break. Apply the text on an ampoule with method of an intaglio printing the fast fixed paint. On 6 ampoules in the plastic dividing separator together with the instruction for medical use in the state and Russian languages place in a pack from cardboard with the hologram of firm – producer. To Store storage conditions at a temperature not above 25 °C, in the place protected from light. To store out of children’s reach! 2 years not to apply a period of storage after an expiration date. Prescription status According to the prescription the Ilach Dolum Sanai Idol Producer ve A.Sh. Tidzharet, Turkey the Packer Idol Ilach Dolum Sanai ve A.Sh. Tidzharet, Turkey the Owner of the registration certificate of JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika the Republic of Kazakhstan the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods): JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika Republic of Kazakhstan, Almaty, Shevchenko St. 162 E.