Tiozid 8 mg (10 tablets)

The instruction for medical use



of medicine ТИОЗИД® 4 ТИОЗИД® 8
the Trade name

ТИОЗИД® 4 ТИОЗИД® 8

International unlicensed


name Tiokolkhikozid Lekarstvennaya a form
of the Tablet, 4 mg and 8 mg

Structure
One tablet contains
active agent – tiokolkhikozid 4 mg and 8 mg,
excipients: kollidon (VA 64), lactoses monohydrate, starch prezhelatinizirovanny, the PH 102 microcrystalline cellulose, silicon dioxide colloidal, sodium stearit fumarating.

The description
Round, biconvex tablets of yellow color (for a dosage of 4 mg).
Round tablets of yellow color, with a flat surface, with a bilateral facet and with risky on one party (for a dosage of 8 mg).

Pharmacotherapeutic group
Muscle relaxants of the central action others. Tiokolkhikozid.
ATX M03BX05 code

Pharmacological

Pharmacokinetics Absorption properties: At intake of TIOZID it is quickly distributed in blood, the peak of concentration in blood plasma is reached in 15-45 min. The maximum concentration in plasma makes 61 ng/ml.
Distribution: Linking with proteins of blood plasma makes 13%. Tiokolkhikozid contacts albumine.
Metabolism: 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.
Removal: About 20% of the accepted dose are excreted with urine in the form of not changed metabolites, 75-81% are removed with excrements.

TIOZID pharmacodynamics - the semi-synthetic muscular relaxant received from a natural glycoside of a kolkhikozid.
Drug shows selection affinity to piperidic acid (GAMK) and glitsinergichesky receptors. The proof of activity of this muscular relaxant can be considered result of direct activation of receptors of GAMK at the level of a spinal cord.
The Glitsinomimetichesky effect of TIOZIDA can be observed at various levels of nervous system, both at spasms of local character, and at spastic spasms of the central origin.
Drug has no kurarepodobny impact, does not cause paralysis and breath does not oppress. Besides, drug has no impact on a cardiovascular system.

Indications
of TIOZID it is shown at symptomatic treatment of painful muscular spasms

the Route of administration and doses
to Adults
on 4-8 mg twice a day after a meal.
Maximum single dose of 8 mg.
Maximum daily dose of 16 mg.
The recommended course of therapy of 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


the hypersensitivity to the tiokolkhikozid or other substance which is a part of drug

hypotonia of muscles both sluggish paralysis / paresis

a concomitant use of anticoagulants and predisposition to hemorrhages

a hereditary lactose intolerance, deficiency of Lapp-lactases enzyme, glucose galactose malabsorption

pregnancy and the period of a lactation

children's age up to 18 years

Medicinal interactions
of Data on medicinal interaction is not present. However it is recommended to be careful at a concomitant use with the drugs having the same therapeutic action.
Simultaneous use of drug TIOZID 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 of dose adjustment TIOZIDA it is not required as drug is not metabolized in a liver.
In a renal failure low doses of drug are recommended.
Tiozid can provoke an epileptic seizure at patients with epilepsy or with risk of an epileptic seizure.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
needs to be careful at control of motor transport or the mechanisms demanding concentration of attention.

Overdose
of Cases of overdose at drug use it is not registered so far. It is possible to assume that toxic effects from digestive tract would be the main manifestations of overdose.
Treatment: symptomatic. Specific antidotes do not exist.

The form of release and packing
On 10 tablets place in blister strip packaging from a film of white opaque PVH/PE/PVDH and printing aluminum foil.
On 1, 2 or 3 planimetric packs together with the instruction for medical use in the state and Russian languages place in a pack cardboard with the hologram of firm – producer


to Store Storage conditions at a temperature not over 25 of 0C, in the dry, protected from light place.
To store out of children's reach!


2 years
not to apply a period of storage after expiry date.

Prescription status
According to the prescription



Republic of Kazakhstan JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika Producer,