Tolperis vp

Package leaflet: Information for the patient

Tolperis VP, 50 mg, coated tablets
Tolperisoni hydrochloridum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

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

1. What Tolperis VP is and what it is used for

Tolperis VP is a medicine containing tolperisone as the active substance. Tolperisone is a medicine acting on the central nervous system. It is indicated in the treatment of pathologically increased skeletal muscle tone after stroke in adult patients.

2. Important information before using Tolperis VP

When not to use Tolperis VP

• if the patient is allergic to the active substance (tolperisone hydrochloride) or to eperisone-containing drugs, or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has myasthenia (an autoimmune disorder characterized by excessive muscle fatigue);
• during breastfeeding.

Warnings and precautions
Before starting treatment with Tolperis VP, discuss it with your doctor or pharmacist.
Hypersensitivity reactions
Following the marketing of medicinal products containing tolperisone (the active substance in Tolperis VP), the most frequently reported adverse reactions have been hypersensitivity reactions. These ranged from mild skin reactions to severe systemic reactions (e.g. anaphylactic shock).
The risk of hypersensitivity reactions appears to be increased in women, elderly patients, or patients taking other medications simultaneously (especially NSAIDs). Furthermore, an increased risk of hypersensitivity to this drug may occur in patients with a history of drug allergy or allergic conditions (such as atopy: hay fever, asthma, atopic dermatitis with high serum IgE levels, urticaria), or in patients with concomitant viral infection.
Early signs of drug 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 the patient experiences any of these symptoms, they should immediately stop taking this medicine and contact their doctor or the nearest hospital emergency department.
If the patient has ever experienced an allergic reaction to tolperisone, this medicine must not be used.
If the patient is allergic to lidocaine, they may have an increased risk of allergy to tolperisone. In such cases, consult a doctor before starting treatment.

Children and adolescents
The safety and efficacy of tolperisone in children have not been established.

Tolperis VP and other medicines
Inform your doctor about all medicines currently taken or recently taken, as well as any medicines planned for future use.
Although tolperisone is a centrally acting substance, its potential to cause drowsiness is low. However, when used concomitantly with other centrally acting muscle relaxants, the doctor may consider reducing the tolperisone dose.
Tolperis VP enhances the effect of niflumic acid. Therefore, when used concomitantly, the doctor may consider reducing the dose of niflumic acid or other non-steroidal anti-inflammatory drugs (NSAIDs) if they are being used.

Taking Tolperis VP 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, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Tolperis VP should not be used during pregnancy (especially during the first trimester), unless the doctor decides, based on a benefit-risk assessment, that the potential benefit justifies the potential risk to the fetus.
Tolperis VP is contraindicated during breastfeeding.

Driving and operating machinery
Tolperis VP has no influence on the ability to drive or operate machinery.
However, if the patient experiences dizziness, drowsiness, concentration disturbances, seizures, visual disturbances, or muscle weakness while taking Tolperis VP, they should consult their doctor.

Tolperis VP contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to use Tolperis VP

This medicine should always be used as directed by the physician.
In case of doubt, consult the doctor or pharmacist.
Recommended dose
Adults
1 to 3 Tolperis VP tablets, three times daily, according to individual need and
patient tolerance.
The medicine may be administered if the calculated dose does not require tablet splitting.
The medicine should be taken after meals, with a glass of water.
Use in children and adolescents
The safety and efficacy of tolperisone in children have not been established.
Patients with renal impairment
During treatment with Tolperis VP, regular monitoring should be performed,
including frequent assessment of kidney function and general condition, as adverse reactions have been observed more frequently in this patient group. If a patient has severe kidney disease, they should consult a doctor before taking this medicine, as Tolperis VP is not recommended for patients with severe renal impairment.
Patients with hepatic impairment
During treatment with Tolperis VP, regular monitoring should be performed, including frequent assessment of liver function and general condition, as adverse reactions have been observed more frequently in this patient group. If a patient has severe liver disease, they should consult a doctor before taking this medicine, as Tolperis VP is not recommended for patients with severe hepatic impairment.
Use of a higher than recommended dose of Tolperis VP
Symptoms of overdose may include drowsiness, gastrointestinal symptoms (such as
nausea, vomiting, upper abdominal pain), rapid heartbeat, high blood pressure,
slowed movements, as well as dizziness with a sensation of spinning. In severe cases, seizures,
slowed or stopped breathing, and coma have been reported.
In case of overdose, contact a doctor, pharmacist, or emergency department immediately.
Missed dose of Tolperis VP
Take the next dose as usual.
Do not take a double dose to make up for a missed dose.
Stopping Tolperis VP treatment
Do not discontinue 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 doubts regarding 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 everyone experiences them.
They usually have a mild course and resolve after discontinuation of the medicine.

Uncommon adverse reactions (may affect up to 1 in 100 people):

• loss of appetite;
• insomnia, sleep disturbances;
• headache, dizziness, drowsiness;
• low blood pressure;
• discomfort in the abdominal cavity, diarrhoea, dry mouth, dyspepsia (indigestion), nausea;
• muscle weakness, muscle pain, limb pain;
• weakness, malaise, fatigue.

Rare adverse reactions (may affect up to 1 in 1000 people):

• allergic (hypersensitivity) reactions*, severe allergic reactions (anaphylactic reactions);
• decreased activity, depression;
• attention disorders, tremor, epilepsy, loss of sensation, unusual skin reactions (tingling, numbness, and pricking), lethargy;
• blurred vision;
• dizziness, tinnitus;
• angina-like chest pain (angina pectoris), rapid heartbeat, fast and irregular heartbeat;
• rashes;
• breathing difficulties, nosebleeds;
• abdominal pain, constipation, bloating, vomiting;
• mild liver injury;
• allergic skin reactions, excessive sweating, itching, urticaria, rash;
• inability to control urination and involuntary urination, presence of excessive amounts of protein in urine;
• discomfort in limbs, feeling of being drunk;
• feeling of warmth, restlessness, thirst;
• low blood pressure;
• changes in laboratory test results (increased bilirubin concentration in blood, changes in liver enzyme activity, decreased platelet count, increased white blood cell count).

Very rare adverse reactions (may affect up to 1 in 10,000 people):

• anaemia, unusual enlargement of lymph nodes;
• severe allergic reactions (anaphylactic shock);
• excessive thirst;
• confusion;
• slow heart rate;
• decreased bone density;
• increased blood creatinine concentration.

* Since tolperisone has been marketed, the following symptoms have also been reported (frequency unknown):
sudden swelling of hands, feet, ankles, face, lips, tongue or throat. Difficulty 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, 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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Tolperis VP

Store below 25°C. Keep in the original packaging.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton.
The expiry date refers to the last day of the specified month.
Duration of use after first opening the container: 90 days.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Tolperis VP contains

• The active substance is tolperisone hydrochloride. Each coated tablet contains 50 mg of tolperisone hydrochloride.
• Other components are: tablet core: monohydrate lactose, maltodextrin, fumaric acid, talc (E 553b), magnesium stearate; coating: eudragit E 100, fumaric acid, talc (E 553b).

What Tolperis VP looks like and contents of the pack
Tolperis VP is in the form of white, round, biconvex coated tablets.
Pack size:
30 or 90 coated tablets in an HDPE container with a capacity of 30 ml, closed with a PP cap,
with a desiccant and a tamper-evident seal, together with the package leaflet, packed in a
cardboard box.
Marketing Authorisation Holder
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Manufacturer
ICN Polfa Rzeszów S.A.
Przemysłowa 2 Street
35-959 Rzeszów