Mydocalm 150 Gedeon tablets treat skeletal muscle tone (3 blisters x 10 tablets)

Heavy institutions .

Caution when taking drugs

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.

The ability to drive and operate machinery

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

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

Pregnancy and lactation

Pregnant women

In animal tests, Tolperison does not cause teratogenic.

In rats and rabbits, toxicity with embryos appears after the dose of 500mg/kg body weight and 250mg/kg body weight in the corresponding sense. However, these doses are many times higher than the dose.

Due to the appropriate lack of clinical data, Tolperison should not be used for pregnant women (especially in the first 3 months of pregnancy) unless the effect is beneficial for the mother to exceed the risk of pregnancy.

breastfeeding women

It is unclear whether Tolperison is secreted into breast milk, so it is not used to use Tolperison during breastfeeding.

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 with average renal impairment, the dosage is needed for each patient in combination with closely monitor the condition and kidney function.

There is no recommendation to use Tolperison in patients with severe renal failure.

For patients with liver failure

Information about the use of drugs in patients with hepatic impairment is limited, but it has recorded an increase in the occurrence of harmful events in this group of patients.

Therefore, for patients with average liver failure, the dosage is needed for each patient in combination with closely monitoring the condition and liver function.

There is no recommendation to use Tolperison in patients with severe liver failure.

For children

Tolperison's safety and effectiveness in children has not yet been confirmed.

Lactose -intolered patients should be noted, in each component of 150mg each Mydocalm tablet contains 146,285mg lactose monohydrate. This preparation also contains Titanium Dioxid (E171).

Interactive drug

Notice to the doctor or pharmacist the drugs you are taking or have recently used even those that are not prescribed.

Studies of pharmacokinetic interaction on CYP2D6 metabolic enzyme with dextromethorphan substrate show that Tolperison's simultaneous use can increase the blood concentration of metabolic drugs mainly through CYP2D6 such as: Thioridazin , Tolterodin, venlafaxin , Atomoxetin, DesIPIPIN, DESIPIN, DesIPIPIN, DESIPIPIN, DESIPIPIN, DESIPOPIN, DESIPOPIN, DESIPOLETIN Dextromethorphan, metoprolol, nebivolol and perphenazin.

In vitro studies on liver lobes and liver cells do not show any inhibition or induction on other isoenzymes CYP (CYP2B0, CYP2C8, CYP2C9, CYP2C19, CYP1A2, CYP3A4).

In contrast, Tolperison concentration is not affected when used simultaneously with metabolic drugs through CYP2D6 because Tolperison can be metabolized through other roads.

Tolperison's bioavailability is reduced if not taken with a meal, should take medicine with meals or immediately after eating.

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, tolperison dose should be considered if necessary.

Mydocalm can increase the effect of niflumic acid , so it is important to consider reducing the dose of niflumic acid or other NSAIDs when used simultaneously with these drugs.