Mydocalm forte

Package leaflet: Information for the patient

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Mydocalm Forte (Mydocalm 150 mg)
150 mg, film-coated tablets
Tolperisoni hydrochloridum
Mydocalm Forte and Mydocalm 150 mg are different brand names of the same medicine.
Please read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What is Mydocalm Forte and what is it used for.
2. Important information before taking Mydocalm Forte.
3. How to take Mydocalm Forte.
4. Possible side effects.
5. How to store Mydocalm Forte.
6. Contents of the pack and other information.

1. What is Mydocalm Forte and what is it used for

Mydocalm Forte contains tolperisone as the active substance. Tolperisone is a centrally acting medicinal product. It is indicated for the treatment of pathologically increased skeletal muscle tone following stroke in adult patients.

2. Important information before using Mydocalm Forte

When not to use Mydocalm Forte

• if the patient is allergic to tolperisone or to eperisone-containing medicines or to any of the other ingredients of this medicine (listed in section 6).
• if the patient has myasthenia (an immunological disorder characterized by excessive muscle fatigue).
• during breastfeeding.

Warnings and precautions
Before starting treatment with Mydocalm Forte, discuss this with your doctor or pharmacist.
Hypersensitivity reactions
In the post-marketing period of medicinal products containing tolperisone (the active substance in Mydocalm Forte), the most frequently reported adverse reactions have been hypersensitivity reactions.
Hypersensitivity reactions ranged from mild skin reactions to severe systemic reactions (e.g. anaphylactic shock).
It appears that the risk of hypersensitivity reactions is increased in women, elderly patients, or patients concurrently using other medicines (mainly non-steroidal anti-inflammatory drugs - NSAIDs). Furthermore, an increased risk of hypersensitivity to this medicine may occur in patients with a history of drug allergy or allergic conditions (such as atopy, hay fever, asthma, atopic dermatitis with high serum IgE levels, urticaria), or in patients with concurrent viral infection.
Early signs of hypersensitivity include: hot flushes, rash, intense itching of the skin (with raised wheals), wheezing, difficulty breathing with or without swelling of the face, lips, tongue and/or throat, difficulty swallowing, increased heart rate, low blood pressure, rapid drop in blood pressure.
If the patient experiences any of these symptoms, treatment with this medicine must be stopped immediately and the patient should contact their doctor or the nearest hospital emergency department.
If the patient has ever had an allergic reaction to tolperisone, this medicine must not be used.
If the patient has a known allergy to lidocaine, they may be at increased risk of allergy to tolperisone. In such cases, consult your doctor before starting treatment.
Children and adolescents
The safety and efficacy of tolperisone in children have not been established.
Mydocalm Forte and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Tolperisone may enhance the effects of certain medicines such as thioridazine (an antipsychotic), tolterodine (used to treat urinary incontinence), venlafaxine (an antidepressant), atomoxetine (used to treat attention deficit hyperactivity disorder - ADHD), desipramine (an antidepressant), dextromethorphan (a cough suppressant), metoprolol (a beta-blocker used to treat high blood pressure, angina pectoris (chest pain)), nebivolol (a beta-blocker used to treat hypertension and heart failure), and perphenazine (an antipsychotic).
Although tolperisone acts on the central nervous system, its potential to cause drowsiness (reduced concentration) is low. However, when used concomitantly with other centrally acting muscle relaxants, the doctor may consider reducing the dose of tolperisone.
Mydocalm Forte enhances the effect of niflumic acid. Therefore, when used concomitantly, the doctor may consider reducing the dose of niflumic acid or other non-steroidal anti-inflammatory drugs, if used.
Mydocalm Forte with food and drink
The medicine should be taken after a meal, with a glass of water. Insufficient food intake may reduce the effect of tolperisone.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Mydocalm Forte should not be used during pregnancy (especially during the first trimester), unless the doctor decides to use it based on a benefit-risk assessment for the fetus.
Mydocalm Forte is contraindicated during breastfeeding.
Driving and operating machinery
Mydocalm Forte has no influence on the ability to drive or operate machinery.
However, patients who experience dizziness, drowsiness, concentration disturbances, epilepsy, visual disturbances, or muscle weakness while taking Mydocalm Forte should consult their doctor.
Mydocalm Forte contains monohydrate lactose (milk sugar) and titanium dioxide
Mydocalm Forte contains lactose (146.285 mg per coated tablet) and titanium dioxide as excipients.
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to use Mydocalm Forte

This medicine should always be used as directed by the physician. In case of doubt, consult your
doctor or pharmacist.
The recommended dose is:

• 1 tablet of Mydocalm Forte 150 mg, three times daily, according to individual patient needs and tolerance.

The medicine should be taken after meals, with a glass of water.
Renal function disorders
During treatment with Mydocalm Forte, regular monitoring tests should be performed, including
frequent monitoring of kidney function and general health status, as adverse reactions have been
observed more frequently in this group of patients. If a patient has severe kidney disease, they should
consult a doctor before taking this medicine, as Mydocalm Forte is not recommended for patients
with severe renal impairment.
Hepatic function disorders
During treatment with Mydocalm Forte, regular monitoring tests should be performed, including
frequent monitoring of liver function and general health status, as adverse reactions have been
observed more frequently in this group of patients. If a patient has severe liver disease, they should
consult a doctor before taking this medicine, as Mydocalm Forte is not recommended for patients
with severe hepatic impairment.
Use of a higher than recommended dose of Mydocalm Forte
Symptoms of overdose may include drowsiness, gastrointestinal symptoms (such as malaise,
vomiting, upper abdominal pain), rapid heartbeat, high blood pressure, slowed movements, and
dizziness. In severe cases, seizures, respiratory depression or arrest, and coma have been reported.
In case of overdose, seek immediate medical advice from a doctor, pharmacist, or emergency
department. Bring the patient information leaflet with you.
Missed dose of Mydocalm Forte
Take the next dose as usual.
Do not take a double dose to make up for a missed tablet.
Discontinuation of Mydocalm Forte
Do not stop taking the medicine even if you feel its effect is too strong or too weak. In such a case,
consult your doctor or pharmacist.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
They usually resolve after discontinuation of the medicine.
Uncommon adverse reactions (may occur in up to 1 in 100 people): loss of appetite, insomnia, sleep disturbances, headache, dizziness, somnolence, low blood pressure,
feeling of discomfort in the abdominal cavity, diarrhoea, dry mouth sensation, dyspepsia
(indigestion), nausea, muscle weakness, muscle pain, limb pain, fatigue, discomfort, weakness.
Rare adverse reactions (may occur in up to 1 in 1000 people): allergic (hypersensitivity) reactions*, severe allergic reactions (anaphylactic reactions), reduced activity, depression, attention disturbances, tremor, epilepsy, loss of sensation, unusual skin reactions (tingling, numbness, and pricking sensations), lethargy, blurred vision, spinning sensation, tinnitus, constricting chest pain (angina pectoris), rapid heartbeat, sensation of fast and irregular heartbeat, rashes, breathing difficulties, nosebleeds, accelerated respiration, abdominal pain, constipation, bloating, vomiting, mild liver damage, allergic skin reactions, itching, urticaria, rash, feeling of discomfort in limbs, sensation of being drunk, feeling of warmth, excessive sweating, inability to control urination and involuntary urination, presence of excessive protein in urine (detected in laboratory tests), feeling of warmth, thirst, restlessness, decreased blood pressure, changes in laboratory test results (increased bilirubin levels, changes in liver enzyme activity, decreased platelet count, increased white blood cell count).
Very rare adverse reactions (may occur in up to 1 in 10,000 people):
anaemia, unusual enlargement of lymph nodes, severe allergic reactions (anaphylactic shock), excessive thirst sensation, confusion, slowed heart rate, slight decrease in bone density, chest discomfort, changes in laboratory test results (increased blood creatinine concentration).
* The following symptoms have also been reported after the medicine was placed on the market (frequency unknown): sudden swelling of hands, feet, ankles, face, lips, tongue or throat. Difficulty in swallowing or breathing may also occur.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Mydocalm Forte

No special storage requirements apply.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Mydocalm Forte contains

• The active substance is tolperisone hydrochloride. Each coated tablet contains 150 mg of tolperisone hydrochloride.
• The other ingredients are: Core of the coated tablet: citric acid monohydrate, colloidal anhydrous silica, stearic acid, talc, microcrystalline cellulose, corn starch, lactose monohydrate. Coating: colloidal anhydrous silica, titanium dioxide (E 171), macrogol 6000, lactose monohydrate, hypromellose.

What Mydocalm Forte looks like and contents of the pack
White or almost white, round, biconvex, slightly shiny coated tablets with the imprint "150" on one side. When the coated tablet is broken, a white surface is visible.
For more detailed information, please contact the responsible entity or the parallel importer.
Marketing Authorisation Holder in Bulgaria, the country of export:
Gedeon Richter Plc.
Gyömrői út 19-21.
1103 Budapest
Hungary
Manufacturer:
Gedeon Richter Plc.
Gyömrői út 19-21.
1103 Budapest
Hungary
Parallel Importer:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Marketing Authorisation Number in Bulgaria, the country of export: 9900289
Parallel Import Licence Number: 309/19