Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Mydocalm Forte (Mydocalm 150 mg), 150 mg, coated tablets
Tolperisone hydrochloride
Mydocalm Forte and Mydocalm 150 mg are different brand names for the same medicine.
Please read the entire leaflet before using the medicine, as it contains important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are identical.
If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Table of Contents:

What Mydocalm Forte is and what it is used for
Important information before taking Mydocalm Forte
How to take Mydocalm Forte
Possible side effects
How to store Mydocalm Forte
Contents of the pack and other information

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

Mydocalm Forte contains tolperisone as the active substance. Tolperisone is a centrally acting agent on the central nervous system. It is indicated in 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 drugs containing eperisone, or to any of the other ingredients of this medicine (listed in section 6).
If the patient has myasthenia gravis (an autoimmune 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
Since the market introduction of medicinal products containing tolperisone (the active substance in Mydocalm Forte), the most frequently reported adverse reactions have been hypersensitivity reactions. These 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 medications (mainly non-steroidal anti-inflammatory drugs - NSAIDs). Furthermore, an increased risk of hypersensitivity reactions to this drug may occur in patients with a history of drug allergy or allergic diseases or 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 bumps), wheezing, difficulty breathing with or without swelling of the face, lips, tongue and/or throat, difficulty swallowing, rapid heartbeat, low blood pressure, rapid drop in blood pressure.
If the patient experiences any of these symptoms, they should immediately stop taking this medicine and 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.

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 they plan to take.
Tolperisone may enhance the effects of certain drugs 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 arterial 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 (NSAIDs) if they are being used.

Mydocalm Forte with food and drink
This 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 after weighing the expected benefits against the potential risks to the fetus.
Mydocalm Forte is contraindicated during breastfeeding.

Driving and operating machinery
If the patient has previously been diagnosed with an allergy to lidocaine, they have an increased risk of allergy to tolperisone. In such cases, the patient should consult their doctor before starting treatment.
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)
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicinal product.

3. How to use Mydocalm Forte

This medicine should always be used exactly as directed by the doctor. 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 condition, as an increased frequency of adverse reactions has been observed in this group of patients. If the patient has severe kidney disease, they should consult a doctor before taking this medicine, because 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 condition, as an increased frequency of adverse reactions has been observed in this group of patients. If the patient has severe liver disease, they should consult a doctor before taking this medicine, because 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, slowed or stopped breathing, 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 scheduled.
Do not take a double dose to make up for a missed tablet.
Stopping 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 everybody will get them.
They usually disappear after discontinuation of the medicine.

Uncommon adverse reactions (may affect up to 1 in 100 people): loss of appetite, insomnia, sleep disturbances, headache, dizziness, drowsiness, low blood pressure, 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 affect up to 1 in 1,000 people): allergic (hypersensitivity) reactions*, severe allergic reactions (anaphylactic reactions), reduced activity, depression, attention disturbances, tremor, seizures, loss of sensation, unusual skin reactions (tingling, numbness, and prickling sensations), lethargy, blurred vision, sensation of spinning, tinnitus, angina-like chest pain (angina pectoris), rapid heartbeat, sensation of fast and irregular heartbeat, flushing, breathing difficulties, nosebleeds, increased respiratory rate, abdominal pain, constipation, bloating, vomiting, mild liver damage, allergic skin reactions, itching, urticaria, rash, discomfort in limbs, sensation of being drunk, feeling of warmth, excessive sweating, inability to control urination and involuntary urination, presence of excess protein in urine (detected in laboratory tests), feeling of warmth, thirst, restlessness, low 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 affect up to 1 in 10,000 people): anaemia, abnormal enlargement of lymph nodes, severe allergic reactions (anaphylactic shock), excessive thirst, confusion, slowing of heart rate, slight reduction in bone density, chest discomfort, changes in laboratory test results (increased blood creatinine concentration).

* After marketing authorization, the following symptoms have also been reported (frequency unknown): sudden swelling of hands, feet, ankles, face, lips, tongue or throat. Swallowing or breathing difficulties 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 also be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Mydocalm Forte

No special storage instructions are required.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box.
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 in use. This will help protect the environment.

6. Contents of the package and other information

What Mydocalm Forte contains

The active substance is tolperisone hydrochloride. Each coated tablet contains 150 mg of tolperisone hydrochloride.
Other components of the medicine are:

Tablet core:
citric acid monohydrate, colloidal anhydrous silica, stearic acid, talc, microcrystalline cellulose,
corn starch, lactose monohydrate.
Coating:
colloidal anhydrous silica, titanium dioxide (E 171), lactose monohydrate, macrogol 6000,
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.
The pack contains 30 coated tablets.
For more detailed information, please contact the Marketing Authorisation Holder or the parallel importer.

Marketing Authorisation Holder in Latvia, 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation number in Latvia, country of export: 97-0349
Parallel import authorisation number: 349/25