Midocalm forte

Package Leaflet: Information for the User

Mydocalm Forte, 150 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 package 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.

Package Leaflet Contents:

• 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 medicine that acts on the central nervous system. It is indicated for the treatment of pathologically increased muscle tone in adult patients after a stroke.

2. Important information before taking Mydocalm Forte

When not to take Mydocalm Forte

• during breastfeeding.

Warnings and precautions

Before starting treatment with Mydocalm Forte, discuss it with your doctor or pharmacist.
Hypersensitivity reactions
After the introduction of tolperisone-containing medicinal products (the active substance of Mydocalm Forte) to the market, the most commonly 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 increased risk of hypersensitivity reactions occurs in women, elderly patients, or those taking other medicines (mainly non-steroidal anti-inflammatory drugs - NSAIDs). Additionally, it appears that the increased risk of hypersensitivity reactions to this medicine may occur 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.
Early symptoms of hypersensitivity are: hot flashes, rash, severe skin itching (with hives), wheezing, difficulty breathing with or without facial, lip, tongue, and/or throat swelling, difficulty swallowing, rapid heartbeat, low blood pressure, rapid blood pressure drop.
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 have an allergy to lidocaine, you are at greater risk of an allergy to tolperisone. In such a case, 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 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, angina pectoris), nebivolol (a beta-blocker used to treat hypertension and heart failure), and perphenazine (an antipsychotic).
Although tolperisone is a centrally acting medicine, its potential to cause drowsiness (reduced concentration) is low. In case of concomitant use with other centrally acting muscle relaxants, your doctor will consider reducing the dose of tolperisone.
Mydocalm Forte enhances the effect of niflumic acid. Therefore, in case of concomitant use, your doctor will consider reducing the dose of niflumic acid or other non-steroidal anti-inflammatory drugs, if they are used.

Mydocalm Forte with food and drink

Take the medicine after a meal, washing it down 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 Forte 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 Forte is contraindicated during breastfeeding.

Driving and using machines

Mydocalm Forte does not affect the ability to drive and use machines. However, if you experience dizziness, drowsiness, concentration disorders, have epilepsy, vision disorders, or muscle weakness while taking Mydocalm Forte, consult your doctor.
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Mydocalm Forte contains lactose (milk sugar)

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

3. How to take Mydocalm Forte

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 tablet of Mydocalm Forte 150 mg, three times a day, according to individual patient needs and tolerance.

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

Kidney function disorders

While taking Mydocalm Forte, 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 Forte is not recommended for patients with severe kidney function disorders.

Liver function disorders

While taking Mydocalm Forte, 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 Forte is not recommended for patients with severe liver function disorders.

Overdose of Mydocalm Forte

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, respiratory depression or arrest, 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 Forte

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

Stopping treatment with Mydocalm Forte

Do not stop taking the medicine even if you think its effect is too strong or too weak. In such a 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.
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, epilepsy, loss of sensation, atypical skin reactions (tingling, numbness, and prickling), lethargy, blurred vision, dizziness, tinnitus, angina pectoris (chest pain), rapid heartbeat, irregular heartbeat, rash, difficulty breathing, nosebleeds, rapid breathing, abdominal pain, constipation, bloating, vomiting, mild liver damage, allergic skin reactions, itching, urticaria, rash, discomfort in the limbs, feeling of being drunk, feeling hot, excessive sweating, urinary incontinence and involuntary urination, presence of excessive protein in the urine (detected in laboratory tests), feeling hot, 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 side effects(may affect up to 1 in 10,000 people): anemia, atypical lymph node enlargement, severe allergic reactions (anaphylactic shock), excessive thirst, confusion, slow heart rate, slight decrease in bone density, chest discomfort, changes in laboratory test results (increased creatinine levels in the blood).
* After the medicine was placed on the market, the following symptoms were also 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, 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 Forte

There are no special storage precautions.
Keep the medicine out of the sight and reach of children.
Do not use this medicine 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.
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6. Contents of the pack and other information

What Mydocalm Forte contains

• The active substance is tolperisone hydrochloride. Each film-coated tablet contains 150 mg of tolperisone hydrochloride.
• The other ingredients are:

Core:
Citric acid monohydrate, colloidal anhydrous silica, stearic acid, talc, microcrystalline cellulose, maize starch, lactose monohydrate (145.50 mg).
Coating:
Colloidal anhydrous silica, titanium dioxide, lactose monohydrate, macrogol 6000, hypromellose.

What Mydocalm Forte looks like and contents of the pack

White or almost white, round, biconvex, slightly shiny film-coated tablets with the inscription “150” 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 detailed 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 package leaflet:

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