Tolperis Vp

Package Leaflet: Information for the Patient

Tolperis VP, 50 mg, Film-Coated Tablets

Tolperisone Hydrochloride

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, You May Need to Read it Again.
• If You Have Any Further Questions, Ask Your Doctor or Pharmacist.
• This Medication Has Been Prescribed for You Only. Do Not Pass it on to Others. It May Harm Them, Even if Their Symptoms are the Same as Yours.
• If You Experience Any Side Effects, Including Those Not Listed in This Package Leaflet, Tell Your Doctor or Pharmacist. See Section 4.

Package Leaflet Contents:

• 1. What is Tolperis VP and What is it 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. Package Contents and Other Information

1. What is Tolperis VP and What is it Used for

Tolperis VP is a Medication Containing Tolperisone as the Active Substance. Tolperisone is a Medication Acting on the Central Nervous System. It is Indicated for the Treatment of Pathologically Increased Muscle Tension of the Skeletal Muscles After a Stroke in Adult Patients.

2. Important Information Before Taking Tolperis VP

When Not to Take Tolperis VP

• If You are Allergic to the Active Substance (Tolperisone Hydrochloride) or to Medications Containing Eperisone or Any of the Other Ingredients of this Medication (Listed in Section 6);
• If You Have Myasthenia (an Immune System 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
After the Introduction of Tolperisone-Containing Medications 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 Appears that the Risk of Hypersensitivity Reactions is Increased in Women, Elderly Patients, or Those Taking Other Medications (Mainly Non-Steroidal Anti-Inflammatory Drugs). Additionally, it Appears that the Risk of Hypersensitivity Reactions to this Medication May be Increased in Patients with a History of Allergies or Allergic Conditions (such as Atopy: Hay Fever, Asthma, Atopic Dermatitis with High IgE Levels in the Blood, Urticaria) or Those with Concurrent Viral Infections.
Early Symptoms of Hypersensitivity to the Medication are: Hot Flushes, Rash, Severe 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 Heart Rate, Low Blood Pressure, Sudden Drop in Blood Pressure.
If You Experience These Symptoms, You Should Immediately Stop Taking this Medication and Contact Your Doctor or the Nearest Emergency Department.
If You Have Ever Had an Allergic Reaction to Tolperisone, You Should Not Take this Medication.
If You Have Been Diagnosed with an Allergy to Lidocaine, You are at a Higher Risk of Being Allergic to Tolperisone. In this Case, You Should Discuss it with Your Doctor Before Starting Treatment.

Children and Adolescents

The Safety and Efficacy of Tolperisone in Children Have Not Been Established.

Tolperis VP and Other Medications

Tell Your Doctor About All Medications You are Currently Taking or Have Recently Taken, as Well as Any Medications You Plan to Take.
Although Tolperisone is a Medication Acting on the Central Nervous System, its Potential to Cause Drowsiness is Low. In Case of Concurrent Use with Other Centrally Acting Muscle Relaxants, Your Doctor Will Consider Reducing the Dose of Tolperisone.
Tolperis VP Enhances the Effect of Niflumic Acid. Therefore, in Case of Concurrent Use, Your Doctor Will Consider Reducing the Dose of Niflumic Acid or Other Non-Steroidal Anti-Inflammatory Medications, if They are Being Used.

Taking Tolperis VP with Food and Drink

The Medication Should be Taken 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 Plan to Have a Child, Consult Your Doctor or Pharmacist Before Taking this Medication.
Tolperis VP Should Not be Used During Pregnancy (Especially in the First Trimester) Unless Your Doctor Decides to Use it Based on the Balance of Expected Benefits and Potential Risks to the Fetus.
Tolperis VP is Contraindicated During Breastfeeding.

Driving and Operating Machinery

Tolperis VP Does Not Affect the Ability to Drive and Operate Machinery.
If You Experience Dizziness, Drowsiness, Disturbances of Concentration, Seizures, Visual Disturbances, or Muscle Weakness While Taking Tolperis VP, Consult Your Doctor.

Tolperis VP Contains Lactose

If You Have Been Diagnosed with an Intolerance to Some Sugars, Consult Your Doctor Before Taking this Medication.

3. How to Take Tolperis VP

This Medication Should Always be Taken as Directed by Your Doctor.
In Case of Doubts, Consult Your Doctor or Pharmacist.
Recommended Dose
Adults
1 to 3 Tablets of Tolperis VP, Three Times a Day, According to the Individual Needs and Tolerance of the Patient.
The Medication Can be Used if the Calculated Dose Does Not Require Dividing the Tablet.
The Medication 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 Tolperis VP, Regular Check-Ups Should be Performed, Including Frequent Monitoring of Renal Function and Overall Condition, as a Higher Frequency of Adverse Reactions has Been Observed in this Group of Patients. If You Have Severe Kidney Disease, Consult Your Doctor Before Taking this Medication, as Tolperis VP is Not Recommended for Patients with Severe Renal Impairment.

Patients with Hepatic Impairment

During Treatment with Tolperis VP, 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 You Have Severe Liver Disease, Consult Your Doctor Before Taking this Medication, as Tolperis VP is Not Recommended for Patients with Severe Hepatic Impairment.

Overdose of Tolperis VP

Symptoms of Overdose May Include Drowsiness, Gastrointestinal Symptoms (such as Nausea, Vomiting, Abdominal Pain), Rapid Heart Rate, High Blood Pressure, Slowed Movements, and Dizziness with a Feeling of Spinning. In Severe Cases, Seizures, Slowed or Stopped Breathing, and Coma Have Been Reported.
In Case of Overdose, Immediately Contact Your Doctor, Pharmacist, or Emergency Department.

Missed Dose of Tolperis VP

Take the Next Dose as Usual.
Do Not Take a Double Dose to Make Up for the Missed Dose.

Stopping Treatment with Tolperis VP

Do Not Stop Taking the Medication, Even if You Feel it is Too Strong or Too Weak. In Such a Case, Consult Your Doctor or Pharmacist.
In Case of Any Further Doubts Regarding the Use of this Medication, Consult Your Doctor or Pharmacist.

4. Possible Side Effects

Like All Medications, Tolperis VP Can Cause Side Effects, Although Not Everybody Gets Them.
They Usually Have a Mild Course and Disappear After Stopping the Medication.

Uncommon Side Effects (May Affect Up to 1 in 100 People):

• Lack of Appetite;
• Insomnia, Sleep Disturbances;
• Headache, Dizziness, Drowsiness;
• Low Blood Pressure;
• Discomfort in the Abdominal Cavity, Diarrhea, Dry Mouth, Dyspepsia (Indigestion), Nausea;
• Muscle Weakness, Muscle Pain, Limb Pain;
• Weakness, Discomfort, Fatigue.

Rare Side Effects (May Affect Up to 1 in 1,000 People):

• Allergic Reactions (Hypersensitivity)*, Severe Allergic Reactions (Anaphylactic Reactions);
• Decreased Activity, Depression;
• Attention Disturbances, Tremors, Seizures, Loss of Sensation, Unusual Skin Reactions (Tingling, Numbness, and Prickling), Lethargy;
• Blurred Vision;
• Dizziness, Ringing in the Ears;
• Chest Pain (Angina Pectoris), Rapid Heart Rate, Rapid and Irregular Heartbeat;
• Rashes;
• Breathing Difficulties, Nosebleeds;
• Abdominal Pain, Constipation, Bloating, Vomiting;
• Mild Liver Damage;
• Allergic Skin Reactions, Excessive Sweating, Itching, Urticaria, Rash;
• Urinary Incontinence and Involuntary Urination, Presence of Excess Protein in the Urine;
• Discomfort in the Limbs, Feeling of Being Drunk;
• Feeling of Heat, Restlessness, Thirst;
• Low Blood Pressure;
• Changes in Laboratory Results (Increased Bilirubin Levels in the Blood, 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 Enlargement of the Lymph Nodes;
• Severe Allergic Reactions (Anaphylactic Shock);
• Excessive Thirst;
• Confusion;
• Slowed Heart Rate;
• Decreased Bone Density;
• Increased Creatinine Levels in the Blood.

* After the Introduction of Tolperisone to the Market, the Following Symptoms Have Also Been 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 Those Not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist. Side Effects Can be Reported Directly to the Department of Adverse Reaction Monitoring 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
Side Effects Can Also be Reported to the Marketing Authorization Holder.
Reporting Side Effects Will Help to Gather More Information on the Safety of the Medication.

5. How to Store Tolperis VP

Store in a Temperature Below 25°C. Store in the Original Package.
Keep the Medication Out of Sight and Reach of Children.
Do Not Use this Medication After the Expiration Date Stated on the Label and Carton.
The Expiration Date Refers to the Last Day of the Given Month.
Shelf Life After First Opening of the Container: 90 Days.
Medications Should Not be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medications No Longer Needed. This Will Help Protect the Environment.

6. Package Contents and Other Information

What Tolperis VP Contains

• The Active Substance of the Medication is Tolperisone Hydrochloride. Each Film-Coated Tablet Contains 50 mg of Tolperisone Hydrochloride.
• Other Ingredients are: Tablet Core:Lactose Monohydrate, 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 Package

Tolperis VP is a White, Round, Biconvex Film-Coated Tablet.
Package Size:
30 or 90 Film-Coated Tablets in a 30 ml HDPE Container, Closed with a PP Cap with a Desiccant and a Guarantee Ring, Together with the Package Leaflet, in a Cardboard Box.

Marketing Authorization Holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer

ICN Polfa Rzeszów S.A.
ul. Przemysłowa 2
35-959 Rzeszów

Date of Last Revision of the Package Leaflet: