Midokalm - instructions for use, dose, side effects, contraindications

Excipients: citric acid monohydrate 0.730 mg and 2.190 mg; silicon dioxide colloid 0,800 mg and 2,400 mg; stearic acid 1,700 mg and 5,100 mg; talc 4,500 mg and 13,500 mg; cellulose microcrystalline 14,000 mg and 42,000 mg; corn starch 29.770 mg and 89.310 mg; lactose monohydrate 48,500 mg and 145,500 mg.

Composition of the film shell: silicon dioxide colloid 0.045 mg and 0.089 mg; titanium dioxide (color of Ind. 77891, E 171) 0.244 mg and 0.487 mg; lactose monohydrate 0.392 mg and 0.785 mg; macrogol 6000 0.392 mg and 0.785 mg; hypromellose 3.927 mg and 7.844 mg.

Description:

50 mg tablets: tablets covered with a film coating of white or almost white color, round, biconvex, with a weak characteristic odor with engraving "50" on one side. Tablets on a break of white or almost white color.

150 mg tablets: tablets covered with a film shell of white or almost white color are round, biconvex, with a weak characteristic odor with engraving "150" on one side.Tablets on a break of white or almost white color.

Pharmacotherapeutic group:Miorelaxant of central action

ATX: & nbsp

M.03.B.X Other muscle relaxants of central action

M.03.B.X.04 Tolmoreyson

Pharmacodynamics:

Miorelaxant of central action. The mechanism of action is not fully understood. Has a membrane-stabilizing, local anesthetic effect, inhibits the conductivity of pulses in the primary afferent fibers and motor neurons, which leads to blockage of spinal mono- and polysynaptic reflexes. It also probably inhibits the release of mediators again by inhibiting the entry of Ca2 + into the synapses. In the brain stem eliminates the ease of carrying out excitation along the reticulospinal path. It enhances peripheral blood flow regardless of the influence of the central nervous system. In the development of this effect, the weak spasmolytic and adrenoblocking effect of tolperisone plays a role.

Pharmacokinetics:

After taking tolperisone well absorbed from the gastrointestinal tract. The maximum concentration is achieved after 0.5-1 hour, bioavailability is about 20%.

Tolperisone is metabolized in the liver and kidneys.It is excreted in the urine in the form of metabolites (more than 99%).

Pharmacological activity of metabolites is unknown.

Indications:

Treatment of pathologically increased tone and spasms of the striated musculature arising from organic diseases of the central nervous system (affection of pyramidal pathways, multiple sclerosis, cerebral stroke, myelopathy, encephalomyelitis, etc.).

Treatment of increased tonus and muscle spasms, muscle contractures accompanying diseases of the movement organs (for example, spondylosis, spondyloarthrosis, cervical and lumbar syndromes, arthrosis of large joints).

Restorative treatment after orthopedic and traumatological operations.

In the combination therapy of obliterating vascular diseases (obliterating atherosclerosis, diabetic angiopathy, obliterating thromboangiitis, Raynaud's disease, diffuse scleroderma), diseases arising from the disorder of vascular innervation (acrocyanosis, intermittent angioedema dysbasia).

Litgl's disease (infantile cerebral palsy) and other encephalopathies accompanied by muscular dystonia.

Contraindications:

Hypersensitivity to any of the components of the drug. Myasthenia gravis, children under 3 years old.

Due to the lack of data on use during pregnancy and breastfeeding, the use of Miodocalm® during these periods is not recommended.

Dosing and Administration:

Inside after eating, not liquid, squeezed a little water.

Adults and children from 14 years of age: usually starting at 50 mg 2-3 times a day, gradually increasing the dose to 150 mg 2-3 times a day.

For children: children aged 3 to 6 years Mydocalm® is administered orally at a daily dose of 5 mg / kg (in 3 divided doses during the day); at the age of 7-14 years - in a daily dose of 2-4 mg / kg (in 3 divided doses during the day).

Side effects:

Muscle weakness, headache, arterial hypotension, nausea, vomiting, a feeling of discomfort in the abdomen. With a decrease in the dose, side effects usually go away.

In rare cases, there are allergic reactions (skin itch, erythema, urticaria, angioedema, anaphylactic shock, bronchospasm).

Overdose:

Data on an overdose of Medocamma® do not come.

There is no specific antidote, with an overdose of the drug recommended gastric lavage symptomatic therapy.

Interaction:

Data on the interactions that limit the use of the drug Midokalm®, is not available.

Although tolperisone has an effect on the central nervous system, it does not cause sedation, so it can be used in combination with sedatives, hypnotics and drugs containing alcohol.

Does not affect the effect of alcohol on the central nervous system.

Tol- perisone enhances the action of niflumic acid, while simultaneous use of these drugs may require a reduction in the dose of niflumic acid.

Means for general anesthesia, peripheral muscle relaxants, psychotropic drugs, clonidine - enhance the effect of tolperisone.

Special instructions:

Use strictly according to the doctor's prescription to avoid complications!

Effect on the ability to drive transp. cf. and fur:

Studies have not been carried out, but for many years of practice the drug has not received such information.

Form release / dosage:

Film-coated tablets, 50 mg and 150 mg.

Packaging:

For 10 tablets in a blister of PVC / A1. For 3 blisters in a cardboard bundle with the attached instructions for use.

Storage conditions:

In a dry place at a temperature of 15 to 30 ° C.

Keep out of the reach of children!

Shelf life:

3 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:P N002409 / 01

Date of registration:09.10.2008 / 14.11.2013

Expiration Date:Unlimited

The owner of the registration certificate:GEDEON RICHTER-RUS, CJSC GEDEON RICHTER-RUS, CJSC Russia

Manufacturer: & nbsp

GEDEON RICHTER OJSC Hungary

GEDEON RICHTER-RUS, CJSC Russia

Representation: & nbspGEDEON RICHTER-RUS CJSCGEDEON RICHTER-RUS CJSCRussia

Information update date: & nbsp24.04.2018

Illustrated instructions

Instructions

Midokalm® (Mydocalm®)