Midocalm Forte

Package Leaflet: Information for the User

WARNING: Keep the leaflet, the information on the immediate packaging is in a foreign language.

Mydocalm Forte (Mydocalm 150 mg),150 mg, film-coated tablets
Tolperisone hydrochloride
Mydocalm Forte Mydocalm 150 mgare different trade names for the same medicine.

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 give it to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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

• during breastfeeding.

Warnings and precautions

Before starting treatment with Mydocalm Forte, the patient should discuss it with their doctor or pharmacist.
Hypersensitivity reactions
After the marketing of medicinal products containing tolperisone (the active substance of Mydocalm Forte), 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 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 allergic conditions (such as atopy, hay fever, asthma, atopic dermatitis with high IgE levels in serum, urticaria) or in those with concurrent viral infections.
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 the patient feels that they are experiencing these symptoms, they should stop taking the medicine immediately and contact their doctor or the nearest emergency department.
If the patient has ever had an allergic reaction to tolperisone, they should not take this medicine.
If the patient has been diagnosed with an allergy to lidocaine, they are at a higher risk of an allergy to tolperisone. In such cases, 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

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they 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), nebivolol (a beta-blocker used to treat high blood pressure and heart failure) and perphenazine (an antipsychotic medicine).
Although tolperisone is a centrally acting medicine, its potential to cause drowsiness (reduced concentration) is low. In cases of concomitant use with other centrally acting muscle relaxants, the doctor will consider reducing the dose of tolperisone.
Mydocalm Forte enhances the effect of niflumic acid. Therefore, in cases of concomitant use, the 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Mydocalm Forte should not be used during pregnancy (especially during the first trimester) unless the 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, patients who experience dizziness, drowsiness, concentration disorders, have epilepsy, vision disorders, or muscle weakness while taking Mydocalm Forte should consult their doctor.

Mydocalm Forte contains lactose (milk sugar)

Mydocalm Forte contains lactose (146.285 mg in one film-coated tablet) as an excipient.
If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicinal product.

3. How to take Mydocalm Forte

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The recommended dose is:

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

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 group of patients. If the patient has severe kidney disease, they should consult their doctor before taking this medicine, as Mydocalm Forte is not recommended for patients with severe kidney function 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 group of patients. If the patient has severe liver disease, they should consult their 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, slowed or stopped breathing, and coma have been reported.
In case of overdose, the patient should immediately consult their doctor, pharmacist, or emergency department. They should take the package leaflet with them.

Missed dose of Mydocalm Forte

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

Stopping treatment with Mydocalm Forte

The patient should not stop taking the medicine even if they feel that its effect is too strong or too weak. In such cases, the patient should consult their doctor or pharmacist.
If the patient has any further doubts about taking this medicine, they should consult their 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, 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, 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, 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 the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Mydocalm Forte

There are no special precautions for storage.
The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 film-coated tablet contains 150 mg of tolperisone hydrochloride.
• The other ingredients of the medicine are:

Tablet core:
Citric acid monohydrate, colloidal anhydrous silica, stearic acid, talc, microcrystalline cellulose, corn starch, lactose monohydrate (145.50 mg).
Coating:
Colloidal anhydrous silica, titanium dioxide (E 171), lactose monohydrate (0.785 mg), 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 imprint "150" on one side. After breaking the film-coated tablet, a white surface is visible.
The pack contains 30 film-coated tablets packaged in PVC/Al blisters in a cardboard box.
For more detailed information, the patient 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:

PharmaVitae Sp. z o.o. sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna

Repackaged by:

Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warsaw
LABOR Pharmaceutical-Chemical Enterprise Sp. z o.o., ul. Długosza 49, 51-162 Wrocław
Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź
CANPOLAND JOINT-STOCK COMPANY, ul. Beskidzka 190, 91-610 Łódź
SHIRAZ PRODUCTIONS Sp. z o.o., ul. Tymiankowa 24/28, 95-054 Ksawerów
Marketing authorization number in Bulgaria, the country of export:9900289
Parallel import authorization number:528/12
Date of leaflet approval: 06.09.2022
[Information about the trademark]