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Mydocalm 150 mg film-coated tablets – tolperisone for post-stroke spasticity
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- Stock: Zabrana online prodaje
- Brand: GEDEON RICHTER
- Model: BR-6062165577
Mydocalm 150 mg is a prescription medicine containing the active substance tolperisone hydrochloride. Tolperisone acts on the central nervous system and is used for the symptomatic treatment of pathologically increased muscle tone, or spasticity, following a stroke in adults.
Mydocalm is available only with a medical prescription. The only approved indication for tolperisone in Serbia is the symptomatic treatment of post-stroke spasticity in adults. It is not approved for ordinary muscle cramps, back pain, a slipped disc, lumbago, spondylosis or recovery after orthopaedic surgery.
The current Serbian regulatory documentation confirms Mydocalm in the strength of 150 mg, in a pack of 30 film-coated tablets. A 50 mg strength should not be presented as a currently authorised Mydocalm pack without additional verification of the specific product.
Mydocalm 150 mg – approved use and administration
| Information | Details |
|---|---|
| Active substance | Tolperisone hydrochloride |
| Strength | 150 mg per film-coated tablet |
| Pack size | 30 film-coated tablets in three blisters of 10 |
| Approved indication | Symptomatic treatment of post-stroke spasticity in adults |
| Legal status | Prescription-only medicine |
What is spasticity?
Spasticity is an abnormal increase in muscle tone that may cause stiffness, restricted movement and reduced function of the affected limbs. In some patients, it develops as a result of damage to the central nervous system following a stroke.
Mydocalm may help reduce spasticity, but it does not treat the cause of the stroke and does not replace physiotherapy, occupational therapy, prescribed exercises, neurological follow-up or other prescribed treatment.
How is Mydocalm taken?
Take this medicine exactly as prescribed by the doctor. According to the official patient leaflet for Mydocalm 150 mg, the recommended dose is:
- one 150 mg tablet three times daily;
- take the tablet after a meal with a glass of water.
The Summary of Product Characteristics states a total oral daily dose of 150 to 450 mg, divided into three doses according to the patient’s needs and tolerance. The dose must not be changed without medical advice.
Insufficient food intake may reduce the bioavailability and effect of tolperisone. The medicine should therefore be taken consistently after meals.
Kidney or liver impairment
Patients with moderate kidney or liver impairment require individual dose adjustment and careful monitoring of their condition and organ function.
Tolperisone is not recommended in patients with severe kidney or liver impairment.
Who must not take Mydocalm?
- people allergic to tolperisone;
- people allergic to the chemically related substance eperisone;
- people allergic to any of the other ingredients;
- patients with myasthenia gravis;
- women who are breastfeeding;
- patients who have previously experienced a hypersensitivity reaction to tolperisone.
The safety and efficacy of tolperisone in children and adolescents have not been established.
Hypersensitivity reactions
Hypersensitivity is the most important safety risk associated with tolperisone. Reactions may range from mild skin symptoms to a serious systemic allergic reaction and anaphylactic shock.
The risk may be higher in women, older patients, people using several medicines, particularly non-steroidal anti-inflammatory medicines, and patients with a history of allergy, asthma, hay fever, atopic dermatitis or hives.
People allergic to lidocaine may have an increased risk of cross-hypersensitivity to tolperisone and should consult their doctor before treatment.
- redness, rash, hives or severe itching;
- swelling of the face, lips, tongue or throat;
- difficulty swallowing or breathing;
- wheezing;
- a rapid heartbeat;
- a marked fall in blood pressure, severe weakness or fainting.
Tolperisone must not be used again after a hypersensitivity reaction.
Interactions with other medicines
Tolperisone may increase the concentration or effect of certain medicines metabolised by CYP2D6, including:
- thioridazine and perphenazine;
- tolterodine;
- venlafaxine and desipramine;
- atomoxetine;
- dextromethorphan;
- metoprolol and nebivolol.
When it is taken with another centrally acting muscle relaxant, the doctor may consider reducing the dose.
Tolperisone may increase the effect of niflumic acid. Dose adjustment of niflumic acid or another NSAID may be required when they are used together.
Pregnancy and breastfeeding
Due to insufficient clinical data, tolperisone should not be used during pregnancy, particularly during the first trimester, unless the doctor determines that the expected benefit clearly outweighs the potential risk to the unborn child.
Mydocalm must not be used during breastfeeding.
Driving and using machines
Tolperisone has a low potential to cause sedation. However, do not drive or operate machinery if dizziness, drowsiness, impaired attention, blurred vision, a seizure or muscle weakness occurs during treatment. Contact your doctor.
Possible side effects
Uncommon side effects may include loss of appetite, sleep disorders, dizziness, drowsiness, headache, low blood pressure, nausea, diarrhoea, dry mouth, abdominal discomfort, muscle weakness, muscle pain, pain in the limbs, weakness and fatigue.
Rare effects include hypersensitivity reactions, impaired attention, tremor, abnormal skin sensations, seizures, blurred vision, tinnitus, a rapid or irregular heartbeat, breathing difficulties, vomiting, constipation, rash, itching, hives and changes in liver laboratory tests.
Very rare effects include anaemia, enlarged lymph nodes, anaphylactic shock, confusion, a slow heartbeat and increased blood creatinine.
Overdose and missed dose
Symptoms of overdose may include drowsiness, nausea, vomiting, upper abdominal pain, a rapid heartbeat, high blood pressure, slowed movement and dizziness. Seizures, slowing or stopping of breathing and coma have been reported in severe cases.
Seek urgent medical attention if too much medicine has been taken. There is no specific antidote.
Do not take a double dose to make up for a forgotten tablet. Take the next dose at the usual time.
Mydocalm should not be used as a general medicine for cramps, a stiff neck or back pain. Its approved use is limited to post-stroke spasticity in adults. In these patients, it should form only one part of a wider treatment plan supervised by a neurologist and rehabilitation team. Pay particular attention to rash, itching, swelling or breathing difficulties, because tolperisone must not be used again after an allergic reaction.
Ljubica Barbulović, Master of Pharmacy
Availability and price
Similar medicine containing tolperisone
Myderison also contains tolperisone. Medicines containing the same active substance must not be exchanged without consulting a doctor or pharmacist.
Composition and packaging
Each film-coated tablet contains 150 mg of tolperisone hydrochloride.
The medicine contains lactose. Each tablet contains 146.285 mg of lactose monohydrate. The tablets are white or almost white, round and biconvex, with “150” marked on one side.
The pack contains 30 film-coated tablets in three blisters of 10 tablets.
Marketing authorisation holder: Representative Office of Richter Gedeon Nyrt., Belgrade.
Manufacturer: Gedeon Richter Plc, Budapest, Hungary.
Storage
Keep out of the sight and reach of children. Mydocalm does not require special storage conditions. Do not use the medicine after the expiry date stated on the pack.
Frequently asked questions
Can Mydocalm be used for back pain?
Back pain is not an approved indication for tolperisone. In Serbia, Mydocalm is approved for the symptomatic treatment of post-stroke spasticity in adults.
Should Mydocalm be taken before or after food?
Take it after a meal with a glass of water. Taking it without sufficient food may reduce its effect.
Does Mydocalm cause drowsiness?
Tolperisone has a low potential to cause sedation, although some patients may experience drowsiness, dizziness or impaired attention.
Can treatment be stopped as soon as symptoms improve?
Do not stop treatment or change the dose without consulting the prescribing doctor.
Official sources:
ALIMS – Patient Information Leaflet |
ALIMS – Summary of Product Characteristics.
Marketing authorisation number: 515-01-00382-23-001, dated 11 December 2023. Content updated: July 2026.
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