Mydocalm tablet 50mg gedeon treats muscle spasticity after stroke (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Tolperisone hydrochloride

Ingredient

Composition information	Content
Tolperisone hydrochloride	50mg

Uses

Indications

Mydocalm medicine 50 mg is indicated in the following cases:

Treatment of muscle spasticity after an adult stroke. Tolperison's exact mechanism of operation is unknown.

By stabilizing the cell membrane and local anesthesia, the Mydocalm inhibits the transmission in the primary nerve fibers and the motor neurons, thereby inhibiting the Synap and Synap multi -single reflexes. On the other hand, according to a second mechanism, through the inhibition of Ca2+ line into the synap, it is thought that this substance inhibits the release of neurotransmitters. In the brain body, MyDocalm inhibits the spinal grid reflection line. On different animal models, this preparation can reduce muscle tone and spasms after brain loss.

Mydocalm improves peripheral circulation. The effects of improving circulation do not depend on the observation effects seen on the central nervous system, this effect may be related to the anti -light spasm and the Adrenergic resistance of Tolperison.

pharmacokinetics

When taken, Tolperison is well absorbed in the small intestine. Peak concentration in plasma is achieved from 0.5 - 1 hour after drinking. Due to the first strong metabolism, the bioavailability of the drug reaches about 20%. Fat -rich meals can increase the bioavailability of oral tolperison up to 100% and increase the peak of the serum about 45% compared to a snack, the peak concentration is reached after drinking about 30 minutes.

Tolperison is strongly metabolized by the liver and kidneys. It is excreted mainly through the kidney (over 99%) in the form of metabolites.

unknown activity of the metabolic substance.

Before taking Mydocalm tablet 50mg gedeon treats muscle spasticity after stroke (3 blisters x 10 tablets)

How to use

Take oral use.

Should take medicine during or after meals with a cup of water.

Tolperison's bioavailability decreases when not served with meals and increases when used with a fat -rich meal, so it is recommended to use the drug with a meal.

always follow the instructions for using the doctor's medicine. If not clear should ask the doctor or pharmacist.

Dosage

The usual oral dosage of the Mydocalm movie is 1 to 3 capsules x 3 times a day.

closely monitor the prescribed dose and treatment time.

Special patients

Patients with renal failure:

Information about the use of drugs in patients with renal impairment is limited, but it has recorded an increase in the occurrence of harmful events in this group of patients. Therefore, for patients renal failure average level, the dosage should be determined for each patient combined with closely monitor the condition and renal function. It is not recommended to use Tolperison in patients with severe renal failure.

For patients with liver failure:

Information about the use of drugs in patients with liver failure is limited, however, the increase in the ratio of harmful events in this group of patients. Therefore, for patients with medium degrees of liver failure, the dosage should be determined for each patient in combination with closely monitor the condition and liver function. It is not recommended to use Tolperison in patients with Hepatic failure severity.

For children:

Tolperison's safety and effectiveness in children has not been confirmed. Do not take medicine for children under 18 years old.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose? Mydocalm has a wide treatment range, literature has recorded cases of oral doses of 600 mg for children without any serious toxic symptoms.

There is an irritation after treatment for children with oral doses of 300 - 600 mg a day. In clinical toxic toxic studies, high doses of mydocalm can cause loss, convulsions - tremor, shortness of breath and respiratory paralysis.

Mydocalm has no specific antidote. When overdose, symptomatic treatment should be treated and supported.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Do not doubling the dose to compensate for the forgotten tablet.

Side Effects

When using mydocalm 50 mg , you may experience unwanted effects (ADR).

Most unwanted effects when using Tolperison are mainly manifestations on the skin, subcutaneous tissue, systemic disorders, neurological disorders and digestive disorders .

Hypersensitivity reactions: Most of these reactions are not serious and can recover. Very rare life -threatening hypersensitivity reactions.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Mydocalm 50 mg contraindicated in the following cases:

Hypersensitivity to Tolperison or substances with chemical structures similar to Eperison or excipients.

Severe muscle weakness (an immune disease combined with muscle weakness).

breastfeeding women.

Children under 18 years old (due to lack of data on this object).

Precautions when using

Hypersensitivity reactions:

After circulating on the market, the most harmful reaction reported about Tolperison is hypersensitivity reactions, manifested from mild skin reactions to heavy body reactions such as anaphylaxis. The possible manifestations include rash, redness, urticaria, itching, angioedema, fast vessels, hypotension, shortness of breath.

The risk of hypersensitivity reactions is usually higher than in women, patients with a history of allergies or a history of hypersensitivity to other drugs.

Be cautious when using Tolperison in patients sensitive to lidocaine due to cross -reactions.

Patients should be recommended for the possibility of hypersensitivity reactions when using Tolperison. When there is any hypersensory expression, stop the drug immediately and quickly consult a doctor.

No reuse Tolperison for patients who had been overconfigioned to Tolperison.

important information about mydocalm preparation:

Patients with lactose intolerance should be noted, in each component of each mydocalm tablet of 50 mg contains 48,892 mg lactose monohydrate. This preparation also contains Titanium Dioxid (E171).

The ability to drive and operate machinery

mydocalm does not affect the ability to drive and operate the machine.

If you encounter dizziness, dizziness, distraction, epilepsy, blurred vision, or muscle weakness when taking mydocalm, patients need to consult a doctor.

Pregnancy

Please consult a doctor or pharmacist before taking any drug.

Report to the doctor if you are pregnant or plan to get pregnant. Based on animal tests, Tolperison does not cause teratogenic. Because there is no equivalent data on humans, Tolperison should not be used for pregnant women (especially in the first 3 months) except for the case of maternal benefits greater than the potential risk for the fetus.

Breastfeeding period

Because it is not known whether Tolperison is secreted into breast milk or not. Hence do not use Tolperison during breastfeeding.

Drug interaction

Notice to the doctor or pharmacist the drugs you are taking or data recently, including those that are not prescribed.

Dynamic pharmacokinetic interactive studies on CYP2D6 metabolic enzyme with dextromethorphan substrate show that tolperison -use simultaneous use may increase the blood concentration of metabolic drugs mainly through CYP2D6 such as Thioridazin, Tolterodin, Venlafaxin, Atomoxetin, Desipramine, Dextromethan, Methtromethin, Methtromethin, Methtromethin, Methtromethine, Methtromethin, Methtromethine, Methtromethine, Methtromethine, Methtromethine, Methtromethine nebivolol and perphenazin.

In vitro studies on liver lobes and human liver cells do not show any inhibition or induction on other ISOENZYM CYP (CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP1A2, CYP3A4).

In contrast, the concentration of tolperison does not get damaged when used simultaneously with metabolic drugs through CYP2D6 because Tolperison can be metabolized through other roads.

Tolperison's bioavailability is reduced if not taking medicine at a meal, so it is recommended to take medicine with meals.

Tolperison is a central -acting muscle relaxant with little sedative effect. In case of simultaneous use of Tolperison along with other central -acting muscle relaxants, it is recommended to reduce the tolperison dose if necessary.

Mydocalm can increase the effect of niflumic acid, so it should be considered to reduce the dose of niflumic acid or other NSAIDs when used simultaneously with these drugs.

Storage

Store drugs in dry, temperatures not exceeding 300C.

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