Midocalm

Package Leaflet: Information for the User

Mydocalm, 50 mg, Film-Coated Tablets

Tolperisone hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Mydocalm and what is it used for

Mydocalm contains tolperisone as the active substance. Tolperisone is a medicine that acts on the central nervous system. It is used to treat pathological increased muscle tone of skeletal muscles after a stroke in adult patients.

2. Important information before taking Mydocalm

When not to take Mydocalm

• if you are allergic to tolperisone or other eperisone-containing medicines or to any of the other ingredients of this medicine (listed in section 6).
• if you have myasthenia (an immune system disorder characterized by excessive muscle fatigue).
• during breastfeeding.

Warnings and precautions

Before taking Mydocalm, discuss it with your doctor or pharmacist.
Hypersensitivity reactions
After the marketing of tolperisone-containing medicinal products (the active substance of Mydocalm), the most frequently reported adverse reactions were 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 those taking other medicines (mainly non-steroidal anti-inflammatory drugs - NSAIDs). Additionally, it appears that the risk of hypersensitivity reactions to this medicine may be increased in patients with a history of drug allergies or patients with allergic diseases or conditions (such as atopy, hay fever, asthma, atopic dermatitis with high IgE levels in serum, urticaria) or those with a concurrent viral infection.
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Early symptoms of hypersensitivity are: hot flashes, rash, severe itching of the skin (with hives), 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 you experience these symptoms, stop taking this medicine immediately and contact your doctor or the nearest emergency department.
If you have ever had an allergic reaction to tolperisone, do not take this medicine.
If you are allergic to lidocaine, you are at greater risk of being allergic to tolperisone. In this case, consult your doctor before starting treatment.

Children and adolescents

The safety and efficacy of tolperisone in children have not been established.

Mydocalm and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Tolperisone may enhance the effects of certain medicines, such as thioridazine (an antipsychotic), tolterodine (a medicine used to treat urinary incontinence), venlafaxine (an antidepressant), atomoxetine (a medicine 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 and angina pectoris), nebivolol (a beta-blocker used to treat high blood pressure and heart failure), and perphenazine (an antipsychotic).
Although tolperisone is a centrally acting medicine, its potential to cause drowsiness (reduced concentration) is low. When taken with other centrally acting muscle relaxants, your doctor will consider reducing the dose of tolperisone.
Mydocalm enhances the effect of niflumic acid. Therefore, when taken together, your doctor will consider reducing the dose of niflumic acid or other non-steroidal anti-inflammatory drugs, if they are used.

Mydocalm with food and drink

Take the medicine after a meal, with a glass of water. Insufficient food intake may reduce the effect of tolperisone.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Mydocalm should not be used during pregnancy (especially in the first trimester) unless your doctor decides to use it based on the balance of expected benefits and potential risk to the fetus.
Mydocalm is contraindicated during breastfeeding.

Driving and using machines

Mydocalm does not affect the ability to drive or use machines. However, if you experience dizziness, drowsiness, concentration disorders, have epilepsy, vision disorders, or muscle weakness while taking Mydocalm, consult your doctor.

Mydocalm contains lactose (milk sugar)

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If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicinal product.

3. How to take Mydocalm

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is:

• 1 to 3 Mydocalm tablets, three times a day, according to individual patient needs and tolerance.

Take the medicine after meals, with a glass of water.

Kidney function disorders

While taking Mydocalm, regular check-ups should be performed, including frequent monitoring of kidney function and overall condition, as a higher frequency of adverse reactions has been observed in this patient group. If you have severe kidney disease, consult your doctor before taking this medicine, as Mydocalm is not recommended for patients with severe kidney function disorders.

Liver function disorders

While taking Mydocalm, regular check-ups should be performed, including frequent monitoring of liver function and overall condition, as a higher frequency of adverse reactions has been observed in this patient group. If you have severe liver disease, consult your doctor before taking this medicine, as Mydocalm is not recommended for patients with severe liver function disorders.

Overdose of Mydocalm

Symptoms of overdose may include drowsiness, gastrointestinal symptoms (such as malaise, vomiting, abdominal pain), rapid heartbeat, high blood pressure, slow movements, and dizziness. In severe cases, seizures, slowed or stopped breathing, and coma have been reported.
In case of overdose, contact your doctor, pharmacist, or emergency department immediately. Take the package leaflet with you.

Missed dose of Mydocalm

Take the next dose as usual.
Do not take a double dose to make up for a forgotten tablet.

Stopping Mydocalm treatment

Do not stop taking the medicine even if you think its effect is too strong or too weak. In this case, consult your doctor or pharmacist.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
They usually disappear after stopping the medicine.
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Uncommon side effects(may affect up to 1 in 100 people): loss of appetite, insomnia, sleep disorders, headache, dizziness, drowsiness, low blood pressure, discomfort in the abdominal cavity, diarrhea, dry mouth, dyspepsia (indigestion), nausea, muscle weakness, muscle pain, limb pain, fatigue, discomfort, weakness.
Rare side effects(may affect up to 1 in 1,000 people): allergic reactions (hypersensitivity) *, severe allergic reactions (anaphylactic reactions), decreased activity, depression, attention disorders, tremors, seizures, loss of sensation, unusual skin reactions (tingling, numbness, and prickling), lethargy, blurred vision, dizziness, ringing in the ears, angina pectoris (chest pain), rapid heartbeat, irregular heartbeat, rash, difficulty breathing, rapid breathing, nosebleeds, abdominal pain, constipation, bloating, vomiting, mild liver damage, allergic skin reactions, excessive sweating, itching, urticaria, rash, urinary incontinence and involuntary urination, presence of excessive protein in the urine (detected in laboratory tests), discomfort in the limbs, feeling of being drunk, feeling of heat, thirst, agitation, 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 side effects(may affect up to 1 in 10,000 people): anemia, unusual lymph node enlargement, severe allergic reactions (anaphylactic shock), excessive thirst, confusion, slowed heart rate, slight decrease in bone density, chest discomfort, changes in laboratory test results (increased creatinine levels in the blood).
* After the marketing of the medicine, the following symptoms have also been reported (frequency not known): sudden swelling of the hands, feet, ankles, face, lips, tongue, or throat. Difficulty swallowing or breathing may also occur.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Mydocalm

There are no special precautions for storage. Keep the medicine out of sight and reach of children.
Do not use Mydocalm after the expiry date stated on the carton after: "EXP". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

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What Mydocalm contains

• The active substance of Mydocalm is tolperisone hydrochloride. Each film-coated tablet contains 50 mg of tolperisone hydrochloride.
• The other ingredients are:

Tablet core:
Citric acid monohydrate, colloidal anhydrous silica, stearic acid, talc, microcrystalline cellulose, maize starch, lactose monohydrate.
Coating:
Colloidal anhydrous silica, titanium dioxide, lactose monohydrate, macrogol 6000, hypromellose.

What Mydocalm looks like and contents of the pack

White or almost white, round, biconvex, slightly shiny film-coated tablets with the inscription "50" on one side. After breaking the film-coated tablet, a white surface is visible.

Marketing authorization holder and manufacturer

Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary

For more information, please contact:

GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Phone: +48 (22)755 96 48
[email protected]
Fax: +48 (22) 755 96 24
Date of last revision of the leaflet:
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