Midocalm forte

Leaflet attached to the packaging: information for the user

Note! Keep the leaflet! Information on the immediate packaging 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 medicine.

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

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness 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 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 packaging 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 skeletal muscles after a stroke in adult patients.

2. Important information before taking Mydocalm Forte

When not to take Mydocalm Forte

• If the patient is allergic to tolperisone or medicines containing eperisone or any of the other ingredients of this medicine (listed in section 6).
• If the patient has myasthenia (an immune disorder 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.
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 seems 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 seems 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.

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 medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Tolperisone may enhance the effect 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-adrenergic blocker used to treat high blood pressure, angina pectoris (chest pain)), nebivolol (a beta-adrenergic blocker used to treat hypertension and heart failure) and perphenazine (an antipsychotic medicine).
Although tolperisone is a centrally acting substance, its potential to cause drowsiness (reduced concentration) is low. In the case 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 the case 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, washed down 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 she may be pregnant, or plans to have a child, she should consult her 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

Early symptoms of hypersensitivity are: hot flashes, rash, severe itching of the skin (with hives), wheezing, difficulty breathing with or without facial swelling, lips, tongue, and/or throat swelling, difficulty swallowing, rapid heartbeat, low blood pressure, rapid drop in blood pressure.
If the patient feels that these symptoms are occurring, they should stop taking the medicine immediately and contact their doctor or the nearest hospital 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 a case, they should consult their doctor before starting treatment.
Mydocalm Forte does not affect the ability to drive and 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)

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicinal product.

3. How to take Mydocalm Forte

This medicine should always be taken according to the doctor's recommendations. In case of doubts, you should consult a 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, washed down 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 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 patient group. 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.

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 contact a 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 the 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.
In case of any further doubts regarding the use of 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 (anaphylactic reactions), decreased activity, depression, attention disorders, tremors, epilepsy, loss of sensation, unusual 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 of heat, excessive sweating, inability to control urination and involuntary urination, presence of excessive protein in the urine (detected in laboratory tests), 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 medicine was introduced to 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 side effects not listed in this leaflet, you should tell 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, 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, you can help provide more information on the safety of this medicine.

5. How to store Mydocalm Forte

Store in a temperature below 30°C, in the original packaging.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton.
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 used. This will help protect the environment.

6. Contents of the packaging 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 of the medicine are:

Tablet core:
citric acid, colloidal anhydrous silica, stearic acid, talc, microcrystalline cellulose, corn starch, lactose monohydrate.
Coating:
colloidal anhydrous silica, titanium dioxide (E 171), lactose monohydrate, macrogol 6000, hypromellose.

What Mydocalm Forte looks like and what the packaging contains

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.
The packaging contains 30 coated tablets.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:

Gedeon Richter România S.A.
Str. Cuza Vodă Nr. 99-105
540306 Târgu-Mureş
Romania

Manufacturer:

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

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Romania, the country of export:7643/2015/01
7643/2015/02
Parallel import authorization number:3/09
Date of leaflet approval:09.02.2024
[Information about the trademark]