Midocalm Forte

Package Leaflet: Information for the Patient

Warning! Keep the leaflet, the 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 trade names for the same drug.

You should read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, you should tell your 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 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

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

Warnings and precautions

Before starting treatment with Mydocalm Forte, you should discuss it with your doctor or pharmacist.
Allergic reactions
After the introduction of tolperisone-containing medicines (the active substance of Mydocalm Forte) to the market, the most commonly reported adverse reactions were allergic reactions.
Allergic reactions ranged from mild skin reactions to severe systemic reactions (e.g., anaphylactic shock).
It seems that the risk of allergic reactions is increased in women, elderly patients, or those taking other medicines (mainly non-steroidal anti-inflammatory drugs - NSAIDs). Additionally, it seems that the risk of allergic reactions to this medicine may be increased in patients with a history of drug allergies or allergic conditions (such as atopy, hay fever, asthma, atopic dermatitis with high IgE levels in the serum, urticaria) or in those with a concurrent viral infection.
Early symptoms of hypersensitivity are: hot flashes, rash, severe 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 you feel that you are experiencing these symptoms, you should stop taking this medicine immediately and contact your doctor or the nearest emergency department.
If you have ever had an allergic reaction to tolperisone, you should not take this medicine.
If you have been diagnosed with an allergy to lidocaine, you are at a higher risk of being allergic to tolperisone. In such a case, you should discuss this with 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

You should tell your doctor or pharmacist about all the medicines you are currently 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 medicine), 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), and nebivolol (a beta-blocker used to treat high blood pressure and heart failure).
Although tolperisone is a centrally acting muscle relaxant, its potential to cause drowsiness (reduced concentration) is low. When used concomitantly with other centrally acting muscle relaxants, your doctor will consider reducing the dose of tolperisone.
Mydocalm Forte enhances the effect of niflumic acid. Therefore, when used concomitantly, 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

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

Driving and using machines

Mydocalm Forte 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 Forte, you should consult your doctor.

Mydocalm Forte contains lactose monohydrate (milk sugar) and titanium dioxide

Mydocalm Forte contains lactose (146.285 mg in one coated tablet) and titanium dioxide as excipients.
If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

3. How to take Mydocalm Forte

This medicine should always be taken as directed by your doctor. If you are unsure, you should consult 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.

The medicine should be taken after meals, with a glass of water.

Kidney function disorders

During treatment with 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, you should consult your doctor before taking this medicine, as Mydocalm Forte is not recommended for patients with severe kidney disorders.

Liver function disorders

During treatment with 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, you should consult your doctor before taking this medicine, as Mydocalm Forte is not recommended for patients with severe liver disorders.

Taking a higher dose of Mydocalm Forte than recommended

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, you should immediately consult your doctor, pharmacist, or emergency department. You should take the package leaflet with you.

Missing a dose of Mydocalm Forte

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

Stopping treatment with Mydocalm Forte

You should not stop taking the medicine even if you feel that its effect is too strong or too weak. In such a case, you should consult your doctor or pharmacist.
If you have any further doubts about taking this medicine, you should consult 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 (anaphylaxis), decreased activity, depression, attention disorders, tremors, epilepsy, loss of sensation, atypical skin reactions (tingling, numbness, and prickling), lethargy, blurred vision, vertigo, 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, 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, atypical 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 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 any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Mydocalm Forte

There are no special storage instructions.
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 month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Mydocalm Forte contains

• The active substance of the medicine is tolperisone hydrochloride. Each coated tablet contains 150 mg of tolperisone hydrochloride.
• The other ingredients are: Coated tablet core:citric acid monohydrate, colloidal silica anhydrous, stearic acid, talc, microcrystalline cellulose, corn starch, lactose monohydrate. Coating:colloidal silica anhydrous, 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 inscription "150" on one side. After breaking the coated tablet, a white surface is visible.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization 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 Street 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
Zbąszyńska Street 3
91-342 Łódź
Marketing authorization number in Bulgaria, the country of export: 9900289
Parallel import authorization number: 309/19

Date of leaflet approval: 06.08.2024

[Information about the trademark]