Instruction for use: Mydocalm

Active substance: Tolperisone

ATX Code

M03BX04 Tolperisone

Pharmacological group

Miorelaxant of central action [n-cholinolytics (muscle relaxants)]

The nosological classification (ICD-10)

G04 Encephalitis, myelitis and encephalomyelitis

Disseminated acute encephalomyelitis, Leukoencephalitis, Meningomielitis, Myelitis, Acute encephalitis, Acute encephalomyelitis, Chronic encephalitis, Chronic encephalomyelitis, Encephalitis, Encephalomyelitis, Inflammation of meninges

G24 Dystonia

Violation of muscle tone

G24.8.0 * Muscle hypertonicity

Increased muscle tone, The spasm of the striated muscles due to organic diseases of the CNS, muscle Spasticity, Painful muscle spasms in spinal diseases, Increased skeletal muscle tone

G25.9 Extrapyramidal and movement disorder, unspecified: bradykinesia; Restlessness; Movement disorders; Meiji syndrome; Muscle rigidity Muscle spasticity; Muscle tension; Pyramidal disorder; The defeat of the pyramidal tract; The rigidity of the muscles; Extrapyramidal syndrome; Spastic paralysis; Extrapyramidal hyperkinesia.

G35 Multiple sclerosis

Disseminated sclerosis, multiple sclerosis, Relapsing Multiple Sclerosis, Secondary progressive multiple sclerosis, Exacerbation of multiple sclerosis, Mixed forms of multiple sclerosis

G80.0 Spastic Cerebral Palsy

Little's disease, Spastic Pallas, Little disease

G93.4 Unspecified encephalopathy

Bilirubin encephalopathy, Lacunar status, Tremor in portal-systemic encephalopathy, Latent hepatic encephalopathy, Atherosclerotic encephalopathy, Hypertonic encephalopathy, Hypoxic encephalopathy, Dysmetabolic encephalopathy, Encephalopathy,Defeat of the brain, Porto-caval encephalopathy, Vascular encephalopathy, Traumatic encephalopathy, Encephalopathy, Encephalopathy of secondary origin, Encephalopathy dyscirculatory, Encephalopathy portocaval, Epileptic encephalopathy, Syndrome of hemorrhagic shock and encephalopathy, Subacute spongiform encephalopathy

G99.2 Myelopathy in diseases classified elsewhere

Myelopathy, Chronic myelopathy

I64 Stroke, not specified as hemorrhage or infarction

Primary stroke, Stroke, Stroke in the course of, microstroke, stroke, The completed stroke

I70.2 Atherosclerosis of the arteries of the extremities

Arteriosclerosis obliterans, Arteriosclerosis of peripheral arteries, Atherosclerosis of lower limb arteries, Atherosclerosis of peripheral arteries, Atherosclerosis of the vessels of the extremities, Obliterating disease of lower extremities, Obliterating atherosclerosis, Obliterating arteriosclerosis of lower limb arteries, Obliterating arteriosclerosis of the vessels of the upper limbs, Obliterating atherosclerosis of vessels of lower extremities, Atherosclerosis of the arteries of the extremities,Arteriopathy of the extremities, Obliterating atherosclerosis of the vessels of the extremities, Obliterating arteriosclerosis

I73.0 Raynaud's Syndrome

Reynaud-Lerish syndrome, Raynaud's disease, Raynaud phenomenon, Reynaud-Lerish syndrome, Raynaud's disease, Reynaud's syndrome with trophic disorders, Peripheral angiopathy

I73.1 Obliterating thromboangiitis [Buerger's disease]

Berger's disease, Thromboangiitis obliterans, Thromboangiitis, Obliterating thromboangiitis

I73.8 Other specified peripheral vascular diseases

Intermittent claudication syndrome, Endarteritis obliterans, Acrocyanosis, Peripheral angiospasm, Obliterating endarteritis, Intermittent claudication, Disorders of innervation of blood vessels, Spasm of peripheral arteries, Arterial angiopathy, Venous insufficiency and its complications, Spasm of peripheral vessels, Spasm of the coronary vessels, Endarteritis, Cooling of the feet, Occlusion disorders of peripheral circulation, Occlusion of peripheral vessels

I79.2 Peripheral angiopathy in diseases classified elsewhere

Diabetic angiopathy, Angiopathy in diabetes mellitus, Diabetic arteriosclerosis, Pain in peripheral nerve lesions, Diabetic angiopathy, Diabetic microangiopathy, Diabetic vascular injury, Intermittent angioedema dysbasia, Macroangiopathy in diabetes mellitus, Microangiopathies, Microangiopathy, Microangiopathy in diabetes mellitus, Tingling sensation in the arms and legs, Sensation of coldness in the extremities, Peripheral Angiopathy, Peripheral artery disease, Sclerosis of Menkeberg, Chronic obliterating diseases of the arteries

M19.9 Arthrosis, unspecified

Change in brush with osteoarthritis, Osteoarthritis, Osteoarthrosis, Arthrosis of large joints, Pain syndrome in osteoarthritis, Pain syndrome in acute inflammatory diseases of the musculoskeletal system, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Deforming arthrosis, Deforming osteoarthritis, Deforming osteoarthritis of joints, Osteoarthritis in the acute stage, Osteoarthritis of large joints, Acute pain syndrome with osteoarthritis, Post-traumatic osteoarthritis, Rheumatic osteoarthritis, Spondylarthrosis, Chronic osteoarthritis

M34.0 Progressive systemic sclerosis

M47 Spondylosis

Spondyloarthrosis, spondylarthrosis, Diseases of the spinal column, spondylosis

M47.8 Other spondylosis

Bamboo spine, Cervical spondylosis, Spondylosis of the cervical deforming, Cervical spondylosis

M54.4 Lumbago with sciatica

Pain in the lumbosacral spine, Lumbago, Sciatica, Lumbar syndrome

M62.4 Contracture of muscle

Neurological contractures with spasms, Muscular contracture

R25.2 Cramp and spasm

Muscle spasms in tetanus, Pain smooth muscle spasm, Pain spasm of smooth muscles (renal and biliary colic, intestinal spasms, dysmenorrhea),Pain spasm of smooth muscles of internal organs, Pain spasm of smooth muscles of internal organs (kidney and biliary colic, intestinal spasms, dysmenorrhea), Painful muscle spasm, mimic spasm, spasticity, Muscle spasms, Muscle spasms of central origin, Muscle spasms, Neurological contracture with spasms, Night cramps in the extremities, Night leg cramps, Symptomatic convulsive state, West syndrome, Smooth muscle spasm, Spasm of vascular smooth muscle, muscle spasm, The spasm of the striated muscles due to organic diseases of the CNS, Skeletal muscle spasm, The spasms of smooth muscles of internal organs, The spasms of skeletal muscles, Spastic condition of striated muscle, Spastic pain, Spasmodic state of smooth muscle, Spasticity skeletal muscle, muscle cramps, convulsions, Leg cramps, Seizures of central origin, convulsive states, Spastic syndrome, Convulsive status in children, Tonic seizures, Cerebral spastic syndrome, Phenomenon jackknife

R26.2 Difficulty walking, not elsewhere classified

Intermittent angioedema dysbasia

Z100 * CLASS XXII Surgical practice

Abdominal surgery, adenomectomy, Amputation, Coronary angioplasty, Angioplasty of the carotid arteries, Antiseptic skin treatment for wounds, Antiseptic Hand, Appendectomy, atherectomy, Balloon coronary angioplasty, Vaginal hysterectomy, The coronary bypass, Interventions in the vagina and cervix, Interventions on the bladder, Intervention in the mouth, Restoration and reconstructive surgery, Hand hygiene of medical personnel, Gynecologic surgery, Gynecological intervention, Gynecological surgery, Hypovolemic shock during operations, Disinfection of purulent wounds, Disinfection of wounds edges, Diagnostic intervention, Diagnostic procedures, Cervical Diathermocoagulation, Long-surgery, Replacing the fistula catheters, Infection in orthopedic surgery, Artificial heart valve, cystectomy, Short-term outpatient surgery, Short-term operation, Short surgical procedures, Krikotireotomiya, Blood loss during surgery, Bleeding during surgery and in the postoperative period, Kuldotsentez, laser photocoagulation, laser coagulation, retinal laser coagulation, Laparoscopy, Laparoscopy in Gynecology, CSF fistula, Small gynecological operations, Small surgical procedures, Mastectomy and subsequent plastic, mediastinotomy, Microsurgical operations on the ear, Mukogingivalnye operation, suturing, Minor surgery, neurosurgical operation, Immobilization of the eyeball in ophthalmic surgery, testectomy, pancreatectomy, Perikardektomiya, The period of rehabilitation after surgery, The period of, convalescence after surgery, Percutaneous transluminal coronary angioplasty, Pleural thoracentesis, Pneumonia postoperative and posttraumatic, Preparation for surgical procedures, Preparation for surgery, Preparation of the surgeon's hands before surgery, Preparation of the colon for surgical procedures, Postoperative aspiration pneumonia in neurosurgical and thoracic surgery, Postoperative nausea, Postoperative bleeding, postoperative granuloma, postoperative shock, The early postoperative period, myocardial revascularization, Radiectomy, gastric Resection, bowel resection, uterine Resection, liver Resection, enterectomy, Resection of part of the stomach, Reocclusion of the operated vessel, Bonding tissues during surgical procedures, Removal of sutures, Condition after eye surgery, Condition after surgery, Condition after surgery in the nasal cavity, Condition after gastrectomy, Status after resection of the small intestine, Condition after tonsillectomy, Condition after removal of the duodenum, Condition after phlebectomy, Vascular surgery, Splenectomy, Sterilization of surgical instruments, Sterilization of surgical instruments, sternotomy, Dental surgery, Dental intervention in periodontal tissues, strumectomy, Tonsillectomy, Thoracic surgery, total gastrectomy, Transdermal intravascular coronary angioplasty, Transurethral resection, Turbinektomiya, Removal of a tooth, cataract surgery, Removal of cysts, tonsillectomy, Removal of fibroids, Removing the mobile primary teeth, Removing polyps, Removing broken tooth, Removal of the uterus body, Removal of sutures, Urethrotomy, Fistula likvoroprovodyaschih ways, Frontoetmoidogaymorotomiya, Surgical infection, Surgical treatment of chronic limb ulcersm, Surgery, The surgery in the anal area, The surgery on the colon, Surgical practice, The surgical procedure, Surgical interventions, Surgery on the gastrointestinal tract, Surgical procedures on the urinary tract, Surgical procedures on the urinary system, Surgical intervention of the genitourinary system, Surgical procedures on the heart, Surgical manipulation, surgery, Surgery on the veins, Surgical intervention, Vascular surgery, Surgical treatment of thrombosis, cholecystectomy, Partial gastric resection, transabdominal hysterectomy, Percutaneous transluminal coronary angioplasty, Percutaneous transluminal angioplasty, Coronary artery bypass, tooth Extirpation, Extirpation of milk teeth, pulpectomy, pulsative cardiopulmonary bypass, tooth Extraction, teeth Extraction, cataract extraction, Electrocoagulation, endourological intervention, episiotomy, Etmoidotomiya, Complications after tooth extraction

Z54.0 recovery period after surgery

Conditions after brain surgery, Status after removal of gallstones, Conditions after surgery, The recovery period after surgery, The period of convalescence after surgery, The rehabilitation period after surgery, The period of rehabilitation after surgery, The period of convalescence after surgery, The period of convalescence after surgery, Convalescence in the postoperative period, The period of recovery after surgery on the eyes, The period after hemorrhoidectomy, The period after the surgery, The period of postoperative rehabilitation, The period of rehabilitation after injury

Composition

Tablets, coated with a film membrane 1 tab.

active substance:

Tolperisone hydrochloride 50 mg\ 150 mg

Auxiliary substances: citric acid monohydrate - 0.73 / 2.19 mg; Silicon dioxide colloidal - 0.8 / 2.4 mg; Stearic acid - 1.7 / 5.1 mg; Talc - 4,5 / 13,5 mg; MCC - 14/42 mg; Corn starch - 29.77 / 89.31 mg; Lactose monohydrate 48.5 / 145.5 mg

Membrane film: silicon dioxide colloid - 0.045 / 0.089 mg; Titanium dioxide (E171 - 77891) - 0.244 / 0.447 mg; Lactose monohydrate 0.392 / 0.785 mg; Macrogol 6000 - 0.392 / 0.785 mg; Hypromellose - 3.927 / 7.844 mg

Description of dosage form

Tablets of 50 mg: covered with a film coat of white or almost white color, round, biconcave, with a weak characteristic odor, with an engraving "50" on one side.

Tablets of 150 mg: film-coated white or almost white, round, biconvex, with a weak characteristic odor, engraved "150" on one side.

On the fracture: white or almost white.

pharmachologic effect

Pharmacological action - Muscle relaxant.

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 results in blocking 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 ingestion, Tolperisone is well absorbed from the digestive tract. Cmax 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%). The pharmacological activity of metabolites is unknown.

Indications

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

Treatment of increased tonus and muscle spasms, muscle contractures accompanying diseases of the movement organs (including 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, thromboangiitis obliterans, Raynaud's disease, diffuse scleroderma), diseases arising from the disorder of vascular innervation (acrocyanosis, intermittent angioedema dysbasia);

Little's disease (children's cerebral palsy) and other encephalopathies, accompanied by muscular dystonia.

Contraindications

Hypersensitivity to any of the components of the drug;

Myasthenia gravis;

Children's age till 3 years.

pregnancy and lactation

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

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 itching, erythema, urticaria, angioedema, anaphylactic shock, bronchospasm).

Interaction

Data on the interactions that limit the use of the drug Midocalm® are 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 preparations 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.

Dosing and Administration

Inside, after eating, without chewing, squeezed a little water.

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

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

Overdose

Data on the overdose of the drug Midokalm® was not received.

Treatment: recommended gastric lavage, symptomatic therapy. There is no specific antidote.

special instructions

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

Influence on the ability to drive vehicles and mechanisms. Studies have not been carried out, but for many years of practice, no such information has been received.

Relies Form

Film coated tablets, 50 mg and 150 mg. In the blister of PVC / aluminum, 10 pcs. 3 blisters in a cardboard box.

Conditions of supply of pharmacies

On prescription.

storage Conditions

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

Keep out of the reach of children.

Shelf life

3 years.

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