Tolperison Neuropharma

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE USER

Tolperison NeuroPharma, 50 mg, coated tablets

Tolperison NeuroPharma, 150 mg, coated tablets

Tolperisone hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on 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.

Table of contents of the leaflet:

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

1. What is Tolperison NeuroPharma and what is it used for

Tolperison NeuroPharma is a medicine that acts on the central nervous system, intended for the treatment of post-stroke increased muscle tone in adults.

2. Important information before taking Tolperison NeuroPharma

When not to take Tolperison NeuroPharma

• if the patient is allergic to the active substance (tolperisone) or to medicines containing eperisone or to any of the other ingredients of this medicine (listed in section 6).
• if the patient has myasthenia (an immune system disease associated with muscle weakness).
• if the patient is breastfeeding.

Warnings and precautions

Hypersensitivity reactions:
After the introduction of tolperisone-containing medicinal products (the active substance of Tolperison NeuroPharma) to the market, the most frequently 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). Additionally, it seems 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 to the medicine are: hot flashes, rash, severe skin itching (with hives), wheezing, difficulty breathing with or without facial, lip, tongue, and (or) throat swelling, difficulty swallowing, rapid heartbeat, low blood pressure, rapid decrease 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 emergency department.
If the patient has ever had an allergic reaction to tolperisone, they should not take this medicine.
If the patient has an allergy to lidocaine, they are at greater risk of an allergy to tolperisone. In such a case, they should discuss this with their doctor before starting treatment.
If a hypersensitivity reaction occurs, the patient should stop taking the medicine.

Children and adolescents

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

Tolperison NeuroPharma 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.
There is no data on the restriction of using Tolperison NeuroPharma due to interactions with other medicines.
Although Tolperison NeuroPharma is a centrally acting medicine, it does not cause sedation (does not reduce concentration). Therefore, it can be taken with sleeping pills and tranquilizers. When taken with other centrally acting muscle relaxants, the doctor will consider adjusting the dose of Tolperison NeuroPharma.
The medicine enhances the effect of niflumic acid, so when taken together, the dose of niflumic acid or another non-steroidal anti-inflammatory drug (NSAID) should be considered for reduction.

Taking Tolperison NeuroPharma with food and drink

Taking food and fluids does not affect the absorption of the medicine.
It is essential to take the medicine after consuming a sufficient amount of food.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
If the patient is pregnant or plans to have a child, they should inform their doctor.
Although there is no evidence that Tolperison NeuroPharma tablets may harm the fetus, the decision to use the medicine during pregnancy, especially during the first trimester, will be made by the doctor based on a careful assessment of the benefit-to-risk ratio.
Tolperison NeuroPharma is contraindicated during breastfeeding.

Driving and using machines

The medicine does not affect the ability to drive or operate machines. However, patients who experience dizziness, drowsiness, concentration disorders, have epilepsy, vision disorders, or muscle weakness while taking Tolperison NeuroPharma should consult their doctor.

Tolperison NeuroPharma contains lactose monohydrate

The Tolperison NeuroPharma 50 mg coated tablet, as an excipient, contains lactose monohydrate (1.44 mg in each tablet) and titanium dioxide (E 171).
The Tolperison NeuroPharma 150 mg coated tablet, as an excipient, contains lactose monohydrate (5.4 mg in each tablet) and titanium dioxide (E 171).
If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Tolperison NeuroPharma

This medicine should always be taken according to the doctor's or pharmacist's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.
The recommended dose is:

• Tolperison NeuroPharma 50 mg: 1 to 3 coated tablets 3 times a day
• Tolperison NeuroPharma 150 mg: 1 coated tablet 3 times a day.

The medicine should be taken after a meal, 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 Tolperison NeuroPharma coated tablets, 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 not take this medicine.
Patients with hepatic impairment
During treatment with Tolperison NeuroPharma coated tablets, 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 not take this medicine.

Overdose of Tolperison NeuroPharma coated tablets

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 contact their doctor, pharmacist, or emergency department.

Missed dose of Tolperison NeuroPharma coated tablets

A double dose should not be taken to make up for a missed tablet.

Stopping treatment with Tolperison NeuroPharma coated tablets

The patient should not stop taking Tolperison NeuroPharma coated tablets, even if they feel that the effect of the medicine is too strong or too weak. In such a case, they 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, Tolperison NeuroPharma can cause side effects, although not everybody gets them.
Side effects are usually mild and disappear after stopping the medicine.
Uncommon:
in less than 1 in 100 patients, but more than 1 in 1,000 patients.
Rare:
in less than 1 in 1,000 patients, but more than 1 in 10,000 patients.
Very rare:
in less than 1 in 10,000 patients, including single cases.
Uncommon side effects:loss of appetite, insomnia, sleep disorders, headache, dizziness, drowsiness, low blood pressure, discomfort in the abdominal cavity, diarrhea, dry mouth, nausea, muscle weakness, muscle pain, limb pain, weakness, malaise, fatigue.
Rare side effects:hypersensitivity reactions (allergic), severe allergic reactions (anaphylactic reaction), decreased activity, depression, concentration disorders, hand tremors, seizures, sensory disturbances, sensory disorders, somnolence, vision disorders, dizziness, tinnitus, chest tightness, rapid heartbeat, palpitations, low blood pressure, hot flashes, breathing difficulties, nosebleeds, shortness of breath, abdominal pain, constipation, bloating, vomiting, mild liver damage, allergic skin reactions, increased sweating, itching, urticaria, rash, urinary incontinence, proteinuria, limb discomfort, feeling of being drunk, feeling of heat, increased thirst, irritability, increased bilirubin levels, abnormal liver enzyme activity, decreased platelet count, increased white blood cell count.
Very rare side effects:anemia, lymph node enlargement, severe allergic reactions (anaphylactic shock), increased thirst, confusion, slow heartbeat, osteoporosis, chest discomfort, increased creatinine levels.
A new side effect (of unknown frequency) has been reported after the product was placed on the market - angioedema (including facial swelling and lip swelling).

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 Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Tolperison NeuroPharma

Store in a temperature below 30°C.
The medicine should be stored out of sight and reach of children.
Do not use Tolperison NeuroPharma 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. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the package and other information

What Tolperison NeuroPharma 50 mg coated tablets contain

• The active substance of the medicine is tolperisone hydrochloride. Each coated tablet contains 50 mg of tolperisone hydrochloride.
• The other ingredients of the medicine are: Core:betaine hydrochloride, microcrystalline cellulose, mannitol, crospovidone, stearic acid, talc Coating:Opadry II white (lactose monohydrate, hypromellose, titanium dioxide (E 171), macrogol 4000)
• )

What Tolperison NeuroPharma 150 mg coated tablets contain

• 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: Core:betaine hydrochloride, microcrystalline cellulose, mannitol, crospovidone, stearic acid, talc Coating:Opadry II white (lactose, hypromellose, titanium dioxide (E 171), macrogol 4000)

What Tolperison NeuroPharma looks like and contents of the package

Tolperison NeuroPharma, 50 mg, coated tablets:white, round coated tablets, with the inscription "50" on one side and a special code on the other side. The color of the fracture surface is white.
20, 30, 50, and 100 coated tablets, packaged in PVC/Aluminum blisters in cardboard boxes
Tolperison NeuroPharma, 150 mg, coated tablets:white, round coated tablets, with the inscription "150" on one side and a special code on the other side. The color of the fracture surface is white.
20, 30, 50, and 100 coated tablets, packaged in PVC/Aluminum blisters in cardboard boxes

Marketing authorization holder:

neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert-Straße 23
40764 Langenfeld
Germany

Manufacturer:

neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert-Straße 23
40764 Langenfeld Germany
Meditop Gyógyszeripari KFt.,
Ady Endre street 1, 2097
Pilisborosjenő, Hungary
To obtain more detailed information, please contact the representative of the marketing authorization holder
in Poland:
Neuraxpharm Polska sp. z o.o.
ul. Domaniewska 37
02-672 Warsaw
[email protected]
Date of last revision of the leaflet:05/2020