Mydocalm forte

Package leaflet: Information for the user

WARNING: Keep the leaflet, information on the immediate packaging in a foreign language.
Mydocalm Forte (Mydocalm 150 mg), 150 mg, coated tablets
Tolperisoni hydrochloridum
Mydocalm Forte and Mydocalm 150 mg are different trade names for the same medicine.
Please read the entire 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 pass it on to others. The medicine may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Mydocalm Forte is and what it is 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 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 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 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
During the post-marketing period for medicinal products containing tolperisone (the active substance in Mydocalm Forte), the most frequently reported adverse reactions have been hypersensitivity reactions.
Hypersensitivity reactions have 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 reactions to this medicine may occur in patients with a history of drug allergy or in patients with past allergic conditions (such as atopy, hay fever, asthma, atopic dermatitis with high serum IgE concentration, 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 facial, lip, tongue, and/or throat swelling, 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.
If the patient has been diagnosed with an allergy to lidocaine, they may have an increased risk of allergy to tolperisone. In such a case, the patient should consult their 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 they plan to take.
Tolperisone may enhance the effects of certain medicines, such as thioridazine (an antipsychotic), tolterodine (used in the treatment of urinary incontinence), venlafaxine (an antidepressant), atomoxetine (used in the treatment of attention deficit hyperactivity disorder (ADHD)), desipramine (an antidepressant), dextromethorphan (a cough suppressant), metoprolol (a beta-adrenergic blocking agent used in the treatment of high blood pressure and angina pectoris (chest pain)), nebivolol (a beta-adrenergic blocking agent used in the treatment of 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 they are being 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 child, 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, based on a benefit-risk assessment, that the expected benefit outweighs the potential risk to the fetus.
Mydocalm Forte is contraindicated during breastfeeding.
Driving and operating machinery
Mydocalm Forte has no effect 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 lactose (milk sugar)
Mydocalm Forte contains lactose (146.285 mg per coated tablet) as an excipient.
If the patient has been previously diagnosed with an intolerance to certain sugars, the patient should consult their doctor before taking this medicinal product.

3. How to use Mydocalm Forte

This medicine should always be taken as directed by the physician. If in 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 should be performed, including frequent assessment of kidney function and general condition, as adverse reactions have been observed more frequently in this group of patients. If the 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 should be performed, including frequent assessment of liver function and general condition, as adverse reactions have been observed more frequently in this group of patients. If the 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, 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 package leaflet with you.
Missed dose of Mydocalm Forte
Take the next dose at the usual time.
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 cases, consult your doctor or pharmacist.
If you have any further questions about 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 disappear 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, 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 occur in up to 1 in 1000 people): allergic reactions (hypersensitivity) *, severe allergic reactions (anaphylactic reactions), reduced activity, depression, attention disorders, tremor, seizures, 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, flushing, breathing difficulties, nosebleeds, increased breathing 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 excessive amounts of 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, confusion, slowing of heart rate, slight decrease in bone density, chest discomfort, changes in laboratory test results (increased blood creatinine concentration).
* Since the medicine was placed on the market, the following symptoms have also been reported (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 a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C PL-02 222 Warsaw
Tel.: + 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 the 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 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 you no longer use. This will help protect the environment.

6. Contents of the packaging 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:
Monohydrate citric acid, anhydrous colloidal silicon dioxide, stearic acid, talc, microcrystalline cellulose, corn starch, monohydrate lactose (145.50 mg).
Coating:
Anhydrous colloidal silicon dioxide, titanium dioxide (E 171), monohydrate lactose (0.785 mg), macrogol 6000, hypromellose.

What Mydocalm Forte looks like and contents of the pack
White or almost white, round, biconvex, slightly shiny coated tablets, printed with "150" on one side. When broken, the coated tablet reveals a white cross-section.
The pack contains 30 coated tablets packed in PVC/Al blisters within a cardboard box.

For further detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing Authorization Holder in Bulgaria, 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:
PharmaVitae Sp. z o.o. sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna

Repackaged in:
Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warsaw
LABOR Przedsiębiorstwo Farmaceutyczno-Chemiczne Sp. z o.o., ul. Długosza 49, 51-162 Wrocław
Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź
CANPOLAND SPÓŁKA AKCYJNA, ul. Beskidzka 190, 91-610 Łódź
SHIRAZ PRODUCTIONS Sp. z o.o., ul. Tymiankowa 24/28, 95-054 Ksawerów

Marketing Authorization Number in Bulgaria, country of export: 9900289
Parallel Import Authorization Number: 528/12