Anesthetics, Muscle relaxants / Painkillers and Antispasmodics

Mydocalm 30s 50 mg coated tablets

Brands: Gedeon Richter (Hungary)

$14.50

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Mydocalm 30s 50 mg coated tablets quantity

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b8509535b34a

Brands:: Gedeon Richter (Hungary)

Description

The instruction for medical use

of MIDOKALM® medicine

the Trade name
of Midokalm®

the International unlicensed

name Tolperisonum Dosage Form
of the Tablet, film coated 50 mg and 150 mg

Structure
One tablet contains
active agent – Tolperisonum a hydrochloride of 50 mg and 150 mg,
excipients: anhydrous citric acid, silicon dioxide colloidal, stearic acid, talc, cellulose microcrystalline, starch corn, lactoses monohydrate,
structure of a film cover: silicon dioxide colloidal anhydrous, titan dioxide (E 171), lactoses monohydrate, macrogoal 6000, gipromelloza.

The description
of the Tablet, film coated white or almost white color, round shape, with a biconvex surface, with an engraving 50 on one party, with a diameter about 7 mm and a characteristic smell (for a dosage of 50 mg).
Tablets, film coated white or almost white color, round shape, with a biconvex surface, with an engraving 150 on one party, with a diameter about 11 mm and a characteristic smell (for a dosage of 150 mg).
Pharmacotherapeutic group
Muscle relaxants. Muscle relaxants of the central action. Muscle relaxants of the central action others. Tolperisonum.
The ATX M03BX04 code

the Pharmacological

Pharmacokinetics Later properties of intake Tolperisonum is easily soaked up from a small intestine. The maximum concentration of Tolperisonum in blood plasma is reached 0.5-1 hour later, as a result of considerable presistemny metabolism the bioavailability is about 20%.
Tolperisonum is intensively metabolized in a liver and kidneys. It is removed by kidneys, generally (& gt, 99%) in the form of metabolites which pharmacological activity is unknown. After intake the elimination half-life makes about 1.5 h.
The pharmacodynamics
of Midokalm® is a muscle relaxant of the central action. The mechanism of effect of Tolperisonum is completely not found out. Has high affinity to nervous tissue, reaching the highest concentrations in a brain trunk, a spinal cord and peripheral nervous system.
The most significant effect of Tolperisonum is its braking action on the spinal reflex way. This effect together with inhibiting effect on the descending conduction paths, causes therapeutic advantage of Tolperisonum.
Tolperisonum possesses membrane stabilizing action, reduces electric excitability of motor neurons and primary afferent fibers. Tolperisonum dozozavisimo brakes activity potential – dependent natrium channels, amplitude and frequency of action potential respectively decreases.
The oppressing effect on potential – dependent calcium channels,
the secondary mechanism of action is proved, consists in blocking of release of the transmitter as a result of blockade of receipt of calcium ions in synapses.
Strengthens peripheric circulation. This effect is not connected with impact of drug on the central nervous system. It can be caused by weak spasmolytic and anti-adrenergic effect of Tolperisonum.

Indications
– urgent or long-term treatment patholologically the raised tone of skeletal muscles in organic neurologic diseases (damage of pyramidal ways, multiple sclerosis, cerebrovascular disturbances, a myelipathy, encephalomyelitis, etc.)
– treatment of a muscle hyper tone and the muscular spasms accompanying musculoskeletal system diseases (for example, a spondylosis, a spondylarthrosis, cervical and lumbar syndromes, arthroses of large joints
– recovery treatment after surgeries in orthopedics and traumatology
– treatment of obliterating diseases of vessels and also the syndromes arising owing to disturbance of an innervation of vessels (for example, a Crocq’s disease, an intermittent anginevrotichesky dysbasia)
– Littl’s disease and other encephalopathies at children which are followed by muscular dystonia

the Route of administration and doses
the Adult: the average daily dose depending on individual requirement and tolerance of drug the patient makes 150-450 mg, divided into 3 receptions.
To children: aged from 6 up to 14 years: daily 2-4 mg/kg of body weight, in three steps. Considering low daily doses, at treatment of children it is recommended to apply mg tablets Мидокалм® 50.
The drug should be taken after a meal, washing down with a glass of water.

Side effects
Infrequently (& gt, 1/1000 to & lt, 1/100)
– a headache, dizziness, drowsiness, insomnia, a sleep disorder
– an asthenia, a general malaise, fatigue
– anorexia
– arterial hypotension
– nausea, dyspepsia, dryness in a mouth, the feeling of discomfort in a stomach, diarrhea
– muscle weakness, myalgia, extremity pain
– is rare (& gt, 1/10000 to & lt, 1/1000)
– disturbance of attention, a tremor, epilepsy, hyposensitivity, decrease of the activity, a depression, a hypesthesia, a lethargy, paresthesia, pathological catalepsy, irritability, misting of sight
– sonitus
– stenocardia, tachycardia, heart consciousness, inflows
– dispnoe, a tachypnea, nasal bleeding
– allergic dermatitis, the enhanced perspiration, a skin itching, a small tortoiseshell, rashes, a pathological flush, reaction of hypersensitivity, anaphylactic reaction
– vomiting, pain in epigastriums, a constipation, a meteorism
– disturbances from a liver, increase in concentration of bilirubin of blood, change of activity of liver enzymes
– discomfort in extremities
– feeling of intoxication, feeling of heat, thirst, irritability
– enuresis, a proteinuria
– decrease in number of thrombocytes, increase in number of leukocytes
is Very rare (& lt, 1/10000)
– bradycardia
– anemia, a lymphadenopathy
– an acute anaphylaxis
– osteosinging
– discomfort in a thorax
– increase in content of creatinine of blood

of the Contraindication
– hypersensitivity to active agent or any of excipients
– a myasthenia
– pregnancy and the period of a lactation
– children’s age up to 6 years
– intolerance of a galactose, a lactose intolerance of Lapp or malabsorption of a glucose/galactose

Medicinal interactions
of Data on interaction with the medicines limiting use of Midokalma® no.
Despite the central mechanism of action, Midokalm® does not cause sedation therefore it can be appointed in a combination with sedative, sleeping medicines and tranquilizers. In case of combined use with other muscular relaxants operating on central nervous system it is recommended to lower Tolperisonum dose.
Tolperisonum does not strengthen effect of alcohol on the central nervous system.
Increases expressiveness of effect of niflumovy acid therefore at their simultaneous use it is recommended to lower a dose of niflumovy acid or other NPVS.

The special
instructions Pregnancy and the period of a lactation
because of lack of significant clinical data Midokalm® should not be applied at pregnancy (especially in the first trimester) except for cases when the expected advantage definitely justifies potential risk for a fruit.
As there are no data on Tolperisonum discharge with breast milk, use of Midokalma® is contraindicated when feeding by a breast.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Drug does not affect ability to control of motor transport and work with mechanisms.
To the patient who feels dizzy or muscle weakness, it is necessary to consult with the attending physician!

Overdose
Data on overdose are small. Drug possesses the wide therapeutic index, in literature the drug use inside in a dose of 600 mg at children’s age without emergence of serious toxic symptoms is described. In some cases, at reception by children of high
doses of drug (300-600 mg) observed irritability.
Symptoms: in preclinical trials on toxicity at high doses observed an ataxy, toniko-clonic spasms, dispnoe and an apnoea.
Treatment: symptomatic and maintenance therapy, there is no specific antidote.

The form of release and packing
On 10 tablets place in blister strip packaging from a film of polyvinylchloride and aluminum foil.
On 3 planimetric packs together with the instruction for medical use in the state and Russian languages put in a cardboard pack.

To Store storage conditions at a temperature from 15 of 0C do30 0C.
To store out of children’s reach!

A period of storage
3 years
not to take the drug after an expiration date.

Prescription status
According to the prescription

the Name and the country
of the JSC Gideon Richter manufacturing organization,
Hungary 1103 Budapest, Dyomryoi St., 19-21, Hungary

the Name and the country of the owner of the registration certificate
of JSC Gideon Richter, Hungary

the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products:
Representative office of JSC Gideon Richter in RK
E-mail:
Phone number: 8-(7272)-58-26-22, 8-(7272)-58-26-23

To develop info@richter.kz

Additional information