Mydocalm

Package leaflet: Information for the user

Mydocalm, 50 mg, coated tablets
tolperisone hydrochloride
Please read the entire leaflet carefully before taking this medicine, as it contains important information for the patient.

• Keep this leaflet to be able to read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

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

1. What Mydocalm is and what it is used for
Mydocalm contains tolperisone as the active substance. Tolperisone is a centrally-acting medicinal product. It is indicated for the treatment of pathologically increased skeletal muscle tone after stroke in adult patients.

2. Important information before taking Mydocalm
When not to use Mydocalm

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

Warnings and precautions
Before starting treatment with Mydocalm, please discuss it with your doctor or pharmacist.
Hypersensitivity reactions
Since the market introduction of medicinal products containing tolperisone (the active substance in Mydocalm), the most frequently reported adverse reactions have been hypersensitivity reactions. Hypersensitivity reactions have 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 patients taking other medicines simultaneously (mainly non-steroidal anti-inflammatory drugs - NSAIDs). Furthermore, an increased risk of hypersensitivity to this medicine may occur in patients with drug allergy or in patients with past allergic diseases or conditions (such as atopy, hay fever, asthma, atopic dermatitis with high serum IgE concentration, urticaria) or in patients with a concurrent viral infection.
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Early signs of hypersensitivity include: hot flushes, rash, intense itching of the skin (with raised bumps), wheezing, difficulty breathing with or without swelling of the face, lips, tongue and (or) throat, difficulty swallowing, rapid heartbeat, low blood pressure, rapid drop in blood pressure.
If you experience any of these symptoms, you should immediately stop taking this medicine and contact your doctor or the nearest hospital emergency department.
If you have ever had an allergic reaction to tolperisone, you must not take this medicine.
If you are allergic to lidocaine, you have an increased risk of allergy to tolperisone. In such a case, you should consult your doctor before starting treatment.
Children and adolescents
The safety and efficacy of tolperisone in children have not been established.
Mydocalm with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tolperisone may enhance the effects of certain medicines, such as thioridazine (an antipsychotic), tolterodine (used to treat urinary incontinence), venlafaxine (an antidepressant), atomoxetine (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 (chest pain)), nebivolol (a beta-blocker used to treat hypertension and heart failure) and perphenazine (an antipsychotic).
Although tolperisone is a centrally-acting substance, its potential to cause drowsiness (reduced concentration) is low. However, if used concomitantly with other centrally-acting muscle relaxants, your doctor may consider reducing the dose of tolperisone.
Mydocalm enhances the effect of niflumic acid. Therefore, when used concomitantly, your doctor may consider reducing the dose of niflumic acid or other non-steroidal anti-inflammatory drugs, if 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 are planning to have a baby, consult your doctor or pharmacist before taking this medicine.
Mydocalm should not be used during pregnancy (especially during the first trimester) unless your doctor decides that the expected benefit outweighs the potential risk to the fetus.
Mydocalm is contraindicated during breastfeeding.
Driving and using machines
Mydocalm has no influence on the ability to drive and use machines. However, if you experience dizziness, drowsiness, concentration disturbances, have epilepsy, visual disturbances or muscle weakness while taking Mydocalm, you should consult your doctor.
Mydocalm contains lactose (milk sugar)
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If you have been previously diagnosed with intolerance to certain sugars, you should consult your doctor before taking this medicinal product.

3. How to take Mydocalm

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Recommended dose:

• 1 to 3 tablets of Mydocalm three times daily, according to individual need and patient tolerance.

Take the medicine after meals with a glass of water.
Renal impairment
During treatment with Mydocalm, regular control examinations, including frequent monitoring of renal function and general condition, should be performed, 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 is not recommended for patients with severe renal impairment.
Hepatic impairment
During treatment with Mydocalm, regular control examinations, including frequent monitoring of liver function and general condition, should be performed, 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 is not recommended for patients with severe hepatic impairment.
Taking more Mydocalm than recommended
Symptoms of overdose may include drowsiness, gastrointestinal symptoms (such as malaise, vomiting, upper abdominal pain), rapid heartbeat, high blood pressure, slowed 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. Bring this leaflet with you.
Missed dose of Mydocalm
Take the next dose as usual.
Do not take a double dose to make up for a missed tablet.
Stopping Mydocalm treatment
Do not stop taking the medicine even if you feel 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, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
They usually resolve after discontinuation of the medicine.
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Uncommon adverse reactions (may occur in up to 1 in 100 people): loss of appetite,
insomnia, sleep disturbances, headache, dizziness, somnolence, low blood pressure, discomfort
in the abdominal cavity, diarrhoea, dry mouth, dyspepsia (indigestion), nausea, muscle weakness,
muscle pain, limb pain, fatigue, discomfort, asthenia.
Rare adverse reactions (may occur in up to 1 in 1000 people): allergic reactions (hypersensitivity) *, severe allergic reactions (anaphylactic reactions), reduced activity, depression,
attention disturbances, tremor, epilepsy, loss of sensation, unusual skin reactions (tingling, numbness and
pricking), lethargy, blurred vision, sensation of spinning, tinnitus, angina-like chest pain (angina pectoris),
increased heart rate, sensation of rapid and irregular heartbeat, flushing, breathing difficulties,
increased respiratory rate, nosebleeds, abdominal pain, constipation, bloating, vomiting, mild liver damage, allergic skin reactions, excessive sweating, pruritus, urticaria, rash, inability to control urination and urinary incontinence, presence of excess protein in urine (detected in laboratory tests), discomfort in limbs, sensation of being intoxicated, feeling of warmth, 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 adverse reactions (may occur in up to 1 in 10,000 people): anaemia,
unusual enlargement of lymph nodes, severe allergic reactions (anaphylactic shock), excessive
feeling of thirst, confusion, bradycardia, slight decrease in bone density, discomfort in
the chest, changes in laboratory test results (increased blood creatinine concentration).
* The following symptoms have also been reported after marketing authorization (frequency unknown): sudden swelling of hands, feet, ankles, face, lips, tongue or throat. Difficulty in swallowing or breathing may also occur.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in
this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store Mydocalm

No special storage instructions are required. The medicine should be stored in a place
inaccessible and out of sight of children.
Do not use Mydocalm after the expiry date stated on the outer carton following:
"EXP". The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

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What Mydocalm contains

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

Tablet core:
Monohydrate citric acid, anhydrous colloidal silicon dioxide, stearic acid, talc, microcrystalline cellulose, corn starch, monohydrate lactose.
Coating:
Anhydrous colloidal silicon dioxide, titanium dioxide, monohydrate lactose, macrogol 6000, hypromellose.
What Mydocalm looks like and contents of the pack
White or almost white, round, biconvex, slightly shiny coated tablets with the imprint "50" on one side. When broken, the coated tablet reveals a white surface.
Marketing Authorisation Holder and Manufacturer
Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary
For further information, please contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Tel. +48 (22)755 96 48
[email protected]
fax: +48 (22) 755 96 24
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