Indications
Tolperisone is indicated in a fairly large number of neurological diseases:
- hypertonicity in spinal and cerebral palsy;
- spinal automatism;
- muscle spasms of various origins;
- dystonic phenomena with muscle rigidity;
- obliterating diseases of the vessels of the extremities, including Buerger's disease;
- diabetic angiopathy;
- intermittent angioedema dysbasia;
- postencephalitic parkinsonism;
- Little's disease (a form of cerebral palsy).
Mode of application
Tolperisone should be prescribed by your doctor. The dosage of the drug and the course of treatment are purely individual.
Initial dosages, as a rule, are 50 mg 2-3 times a day, the dosage can be increased gradually to 150 mg 2-3 times a day, the maximum daily dose is 600 mg. Injection is used at a dose of 100 mg twice a day, the drug is administered intravenously once a day at a dose of 100 mg.
Children under 6 years of age are recommended to take doses no higher than 5 mg per 1 kilogram of body per day, divided into three times. Children from 7 to 14 years old use a dose of 2-4 mg per 1 kilogram of body per day, also taken three times.
Tolperizon-LF
Insert leaflet - information for the consumer
TOLPERIZONE-LF,
solution for intramuscular administration (100 mg + 2.5 mg)/ml in ampoules
Active ingredients: tolperisone hydrochloride and lidocaine hydrochloride
Before using this medicine, read the leaflet in its entirety because it contains information that is important to you.
- Save the leaflet. You may need to read it again.
- If you have any additional questions, please contact your doctor.
- The medicine is prescribed specifically for you. Do not pass it on to other people. It can harm them even if their symptoms match yours.
- If you experience any unwanted reactions, contact your doctor. This recommendation applies to any possible adverse reactions, including those not listed in section 4 of the package insert.
Contents of the leaflet
- What is the drug TOLPERIZONE-LF and what is it used for?
- What you should know before using the drug TOLPERIZONE-LF
- Use of the drug TOLPERIZONE-LF
- Possible adverse reactions
- Storage of the drug TOLPERIZONE-LF
- Packaging contents and other information
- What is the drug TOLPERIZONE-LF and what is it used for?
This drug contains tolperisone and belongs to the group of centrally acting muscle relaxants.
TOLPERIZONE-LF is used for: treatment of muscle hypertonicity and muscle spasms in diseases of the musculoskeletal system (for dorsopathy, for example, spondylosis, spondyloarthrosis, reflex-myotonic syndromes, myofascial pain syndrome; arthrosis of large joints).
If you have any additional questions, please contact your doctor.
- What you should know before using the drug TOLPERIZONE-LF
Do not take TOLPERISON-LF:
- if you are hypersensitive to tolperisone or other similar chemicals (eperisone), to lidocaine, or to any of the other ingredients of the medicinal product listed in section 6 of the leaflet.
- if you have myasthenia gravis.
- for children under 18 years of age.
- during lactation.
Relative contraindication: pregnancy, mainly the first trimester.
Special instructions and precautions
Before taking the drug TOLPERIZONE-LF, you should consult your doctor.
Use in children
The drug Tolperisone-LF is not used in children.
Hypersensitivity reactions
Before starting treatment with TOLPERISON-LF, tell your doctor that you have previously had or currently have a hypersensitivity (allergy) to lidocaine, tolperisone, or other drugs or substances.
Before using Tolperisone-LF, the attending physician should make sure that the patient does not have hypersensitivity to lidocaine. In cases of known hypersensitivity to lidocaine, the use of Tolperisone-LF is contraindicated.
Hypersensitivity reactions have been reported when using drugs containing tolperisone. Allergic reactions ranged from mild skin reactions to severe systemic reactions, including anaphylactic shock, which requires immediate medical attention (rapid development of respiratory and circulatory disorders (low blood pressure, fainting), may be accompanied by changes in the skin and/or mucous membranes (common urticaria, itching, redness of the skin, swelling of the lips, tongue).
Symptoms of an allergic reaction: erythema (redness of the skin), rash, urticaria, itching, angioedema (rapid development of swelling of the mucous membrane, subcutaneous tissue and skin, most often on the face (tongue, cheeks, eyelids, lips), may be accompanied by rapid heartbeat, decreased blood pressure pressure, rapid breathing with a feeling of lack of air).
Female patients with hypersensitivity reactions to other drugs or previous allergic reactions are at higher risk of allergic reactions to tolperisone.
You should be alert for any symptoms of hypersensitivity (allergy). If symptoms develop, you should immediately stop using tolperisone and immediately consult a doctor at the nearest emergency department or call an ambulance. Tolperisone preparations should not be re-administered orally or by injection after an episode of hypersensitivity to tolperisone.
Other drugs and the drug TOLPERIZONE-LF
Tell your doctor if you are taking, have recently taken, or are about to take any other medications. This applies to any herbal medicines or medicines that you purchased without a prescription.
There is a risk that TOLPERISON-LF may interact with certain other medicines, causing adverse events.
Tell your doctor if you are taking drugs such as thioridazone, tolterodine, venlafaxine, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, niflumic acid, or non-steroidal anti-inflammatory drugs (drugs prescribed to reduce pain, inflammation and fever).
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, you should talk to your doctor before you start taking this drug.
According to preclinical studies, tolperisone does not have a teratogenic effect. Due to the lack of clinical studies, the use of Tolperisone-LF during pregnancy, especially in the first trimester, is possible only if the expected benefit clearly outweighs the risk of harm to the fetus.
The use of tolperisone during lactation is contraindicated due to the lack of relevant data on the penetration of tolperisone into breast milk.
Driving vehicles and working with machinery
During treatment, it is recommended to refrain from driving vehicles and working with moving machinery. Patients who experience dizziness, drowsiness, impaired attention, convulsions, blurred vision or muscle weakness while using the drug should consult a doctor!
- Use of the drug TOLPERIZONE-LF
Always take this drug as directed by your doctor. If in doubt, consult your doctor.
Your doctor will select the dose necessary for you.
TOLPERIZONE-LF is intended exclusively for intramuscular administration. Adult patients: 100 mg daily intramuscularly 2 times a day.
Special patient groups
Patients with impaired renal function
Data on use in patients with impaired renal function are limited. A higher incidence of adverse reactions was observed in this group of patients. Patients with moderate renal impairment require dose titration and careful monitoring. The use of tolperisone is not recommended in patients with severe renal impairment.
Patients with liver dysfunction
These applications in patients with impaired liver function are limited. A higher incidence of adverse reactions was observed in this group of patients. Patients with moderate hepatic impairment require dose titration and careful monitoring. The use of tolperisone is not recommended in patients with severe liver dysfunction.
Use in children and adolescents
The drug is not used in children.
If you have taken a larger dose of the drug TOLPERIZONE-LF than prescribed
Call a doctor or go to the nearest emergency room immediately. Take the package of the drug TOLPERIZONE-LF with you.
Symptoms: Symptoms of overdose mainly include drowsiness, gastrointestinal disorders (nausea, vomiting, epigastric pain), tachycardia, increased blood pressure, bradykinesia and systemic dizziness. There have been reports of severe cases of seizures and coma.
Treatment: there is no specific antidote for tolperisone; symptomatic therapy is recommended.
If you have any additional questions about the use of this medicine, contact your doctor or pharmacist.
- Possible adverse reactions
Like all medicines, TOLPERISON-LF can cause side effects, although not everyone gets them.
Conditions that require special attention (most serious adverse reactions): If you notice the development of the following reactions, you must immediately stop using the drug TOLPERIZONE-LF and immediately seek medical help, as such reactions can be life-threatening.
These reactions are rare but can be severe:
- widespread rash in the form of urticaria, widespread redness of the skin, itching;
- angioedema (rapid development of swelling of the mucous membrane, subcutaneous tissue and skin, most often on the face (tongue, cheeks, eyelids, lips), tachycardia (rapid heartbeat), hypotension (low blood pressure), shortness of breath (frequent breathing with a feeling of lack of air) ;
- anaphylactic shock (rapid development of respiratory and circulatory disorders (low blood pressure, fainting), may be accompanied by changes in the skin and/or mucous membranes (widespread urticaria, itching, redness of the skin, swelling of the lips, tongue).
Adverse reactions:
Common: Warmth and redness at the injection site.
Uncommon: anorexia, insomnia, sleep disturbance, headache, dizziness, drowsiness, hypotension, abdominal discomfort, diarrhea, dry mouth, dyspepsia, nausea, muscle weakness, myalgia, pain in the limbs, asthenia, malaise, fatigue.
Rarely: hypersensitivity reaction*, anaphylactic reaction, decreased activity, depression, impaired attention, tremors, convulsions, decreased sensitivity, pathological numbness, lethargy, blurred vision, tinnitus, vertigo, angina pectoris, tachycardia, palpitations, pathological flushing, dyspnea, nosebleeds, tachypnea, epigastric pain, constipation, flatulence, vomiting, mild liver disorders, allergic dermatitis, increased sweating, itching, urticaria, rashes, discomfort in the limbs, enuresis, proteinuria, feeling of intoxication, feeling of heat, irritability, thirst , decreased blood pressure, increased blood bilirubin concentration, changes in the activity of liver enzymes, decreased platelet count, increased leukocyte count.
Very rare: anemia, lymphadenopathy, anaphylactic shock, polydipsia, confusion, bradycardia, osteopenia, chest discomfort, increased blood creatinine.
When using drugs containing tolperisone, the following reactions (unknown frequency) have been reported: angioedema (including facial swelling, swollen lips).
Reporting Adverse Reactions
If you experience any unwanted reactions, consult your doctor. This recommendation applies to any possible adverse reactions, including those not listed in the package insert.
You can also report adverse reactions to the information database on adverse reactions (actions) to drugs, including reports of ineffectiveness of drugs identified in the state (UE "Center for Expertise and Testing in Healthcare of the Ministry of Health of the Republic of Belarus", https://www .rceth.by). By reporting side effects, you can help provide more information about the safety of your drug.
- Storage of the drug TOLPERIZONE-LF
Store at a temperature of 2 to 8 ºС.
Keep out of the reach of children.
Shelf life: 2 years.
Do not use after the expiration date stated on the packaging.
Do not throw this medicine down the drain. Ask your pharmacist how to dispose of any leftover medication that is no longer needed. These measures will protect the environment.
- Packaging contents and other information
1 ampoule 1 ml contains:
active ingredients: tolperisone hydrochloride – 100 mg, lidocaine hydrochloride – 2.5 mg (in the form of lidocaine hydrochloride monohydrate – 2.67 mg).
excipients: diethylene glycol monoethyl ether, 1 M hydrochloric acid solution, water for injection.
Appearance of the medicinal product TOLPERIZONE-LF and contents of the package
Transparent colorless or slightly greenish liquid with a specific odor.
1 ml of solution in dark glass ampoules with a break ring. A label is placed on the ampoule. 5 or 10 ampoules in polyvinyl chloride blister packaging. 1 (5 ampoules or 10 ampoules each) or 2 (5 ampoules each) cell packaging along with instructions for medical use in a cardboard pack.
Conditions of release: by prescription.
Marketing Authorization Holder and Manufacturer
Production address: JLLC "Lekpharm", Republic of Belarus, 223141, Logoisk, st. Minskaya, 2a/4.
Legal address: JLLC "Lekpharm", Republic of Belarus, 223141, Logoisk, st. Minskaya, 2a, room 301.
Tel./fax: (01774)-53801, www.lekpharm.by
