Package Insert: Information for the User

Tasmar 100 mg Film-Coated Tablets

tolcapone

Read this package insert carefully before starting to take the medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you only, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What Tasmar is and for what it is used

2. What you need to know before starting to take Tasmar

3. How to take Tasmar

4. Possible adverse effects

5. Storage of Tasmar

6. Contents of the package and additional information

Tasmar is taken for the treatment of Parkinson's disease along with the medication levodopa (such as levodopa/benserazide or levodopa/carbidopa).

Tasmar is used when other alternative medications cannot stabilize your Parkinson's disease.

You are already taking levodopa for the treatment of your Parkinson's disease.

A protein (enzyme) in the human body, catechol-O-methyltransferase (COMT), breaks down levodopa. Tasmar inhibits this enzyme and therefore delays the breakdown of levodopa. As a result, when taken with levodopa (such as levodopa/benserazide or levodopa/carbidopa), you will notice an improvement in the symptoms of your Parkinson's disease.

Do not take Tasmar

• if you have liver disease or elevated liver enzymes
• if you have severe involuntary movements (dyskinesia)
• if you have previously experienced severe symptoms of muscle stiffness, fever, or mental confusion (Neuroleptic Malignant Syndrome Complex (NMS)) and/or muscle tissue injury (non-traumatic rhabdomyolysis) or fever (hyperthermia)
• if you are allergic (hypersensitive) to the active ingredient tolcapone or any of the other components of Tasmar
• if you have a specific type of adrenal gland tumor (pheochromocytoma)
• if you take certain medications for depression and anxiety, known as non-selective monoamine oxidase inhibitors (MAOIs)

Warnings and precautions

Consult your doctor or pharmacist before starting Tasmar.

Do not start taking Tasmar until your doctor:

• has described the risks of Tasmar treatment to you
• has explained the necessary measures to minimize those risks
• has answered any questions you may have
• if you are pregnant or intend to become pregnant. Your doctor will explain the risks and benefits of taking Tasmar during pregnancy. Tasmar has not been studied in children. While taking Tasmar, you should discontinue breastfeeding.

Inform your doctor if you or your family/caregiver notice that you are developing impulses or desires to behave in an unusual manner, or if you cannot resist the impulse or temptation to engage in certain activities that may be harmful to you or others. These behaviors are known as impulse control disorders and may include excessive gambling, excessive eating or spending, abnormal sexual impulses, or increased thoughts and feelings of sex.Your doctor may need to review your treatment.

You should only be treated with Tasmar if your Parkinson's disease is not adequately controlled with other treatments.

Additionally, your doctor will discontinue Tasmar treatment if, after 3 weeks, you do not improve sufficiently to justify continuing treatment.

Liver damage

Tasmar may cause liver damage in rare cases, but potentially fatal. Liver damage more frequently appears after 1 month and before 6 months. Be aware that women may have a higher risk of liver damage. Therefore, the following preventive measures should be taken.

Before starting treatment:

To reduce the risk of liver damage, do not take Tasmar if:

• you have liver disease.
• your blood tests show elevated liver function (alanine aminotransferase (ALT) and aspartate aminotransferase (AST)) before starting treatment.

While receiving treatment:

Blood tests will be performed at the following intervals:

• every 2 weeks during the first 12 months of treatment,
• every 4 weeks during the next 6 months of treatment,
• every 8 weeks during subsequent treatment.

Treatment will be discontinued if blood test results are not normal.

Tasmar treatment may cause occasional liver function problems. Inform your doctor immediately if you experience symptoms such as nausea, vomiting, stomach pain (particularly in the upper right side of the liver), loss of appetite, weakness, fever, dark-colored urine, jaundice (yellow skin or eyes), or if you tire easily.

If you have already taken Tasmar and developed acute liver damage during treatment, do not restart Tasmar treatment.

Neuroleptic Malignant Syndrome (NMS):

During Tasmar treatment, symptoms of Neuroleptic Malignant Syndrome (NMS) may appear.

NMS consists of one or more of the following symptoms:

• severe muscle stiffness, muscle spasms, arm or leg stiffness, and painful muscles. Muscle injuries may cause dark-colored urine.
• other important symptoms include high fever and mental confusion.

In rare cases, when stopping or suddenly reducing Tasmar or other antiparkinsonian medications, you may experience severe muscle stiffness, fever, or mental confusion. If this occurs, inform your doctor.

The following preventive measures should be taken.

Before starting treatment:

To reduce the risk of NMS, do not take Tasmar if your doctor says you have severe involuntary movements (dyskinesia) or have previously experienced a condition that may have been NMS.

Inform your doctor of all medications, with or without a prescription, as they may increase the risk of NMS if you are taking a specific medication.

While receiving treatment:

If you develop any symptoms similar to those described above that may suggest NMS, inform your doctor immediately.

Do not stop Tasmar or any other Parkinson's medication without telling your doctor, as this may increase the risk of NMS.

Also inform your doctor:

• if you have another disease in addition to Parkinson's
• if you are allergic to other medications, foods, and dyes
• if, after starting Tasmar treatment and during treatment, you experience symptoms that may be caused by levodopa, such as involuntary movements (dyskinesia) and nausea.

If you do not feel well, inform your doctor as you may need to reduce the dose of levodopa.

Children and adolescents

Tasmar is not recommended for use in children under 18 years due to insufficient data on safety and efficacy. There is no relevant information for use in children and adolescents.

Other medications and Tasmar

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take other medications, including those purchased without a prescription (over-the-counter medications and herbs).

Inform your doctor of all medications you are taking, especially:

• antidepressants
• alpha-methyldopa (used to treat high blood pressure)
• apomorphine (used for Parkinson's disease)
• dobutamine (used for chronic heart failure)
• adrenaline and isoprenaline (both used for heart attacks)
• anticoagulants such as warfarin (which prevent blood clots). In this case, your doctor will regularly perform blood tests to monitor how fluid your blood is.

If you visit the hospital or are prescribed a new medication, tell your doctor that you are taking Tasmar.

Taking Tasmar with food, drinks, and alcohol

Tasmar can be taken with or without food.

Tasmar should be taken with 1 glass of water.

Pregnancy, breastfeeding, and fertility

Inform your doctor if you are pregnant or intend to become pregnant. Your doctor will explain the risks and benefits of taking Tasmar during pregnancy.

Tasmar has not been studied in children. While taking Tasmar, you should discontinue breastfeeding.

Driving and operating machinery

Since driving and operating machinery may be affected by Parkinson's disease, you should consult your doctor about this.

Tasmar affects Parkinson's disease symptoms.

Combining Tasmar with other Parkinson's medications may cause excessive drowsiness and sudden episodes of sleep (you may fall asleep suddenly). Therefore, you should avoid driving or operating machinery until such episodes and excessive drowsiness disappear.

Tasmar contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions for Tasmar as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Dosage and administration frequency

Your doctor will always start your treatment with the standard dose of 1 tablet (100 mg) 3 times a day.

If no benefits are observed within 3 weeks of starting treatment, the treatment with Tasmar should be discontinued.

To improve efficacy, your doctor should only increase the dose to 2 tablets (200 mg) 3 times a day if the improvement in symptom control of the disease is compensated by the increase in adverse effects. At the highest dose, adverse effects can be very severe and affect the liver. If there is no improvement at the highest dose after a total of 3 weeks, your doctor will discontinue your treatment with Tasmar.

At the start and during treatment with Tasmar, it may be necessary to change your dose of levodopa. Your doctor will give you instructions.

How to take the medication:

Swallow Tasmar with a glass of water.

Do not break or crush the tablets.

The first tablet of Tasmar is taken in the morning along with the other Parkinson's medication, "levodopa".

The next two doses of Tasmar should be taken 6 and 12 hours later.

If you take more Tasmar than you should

Contact your doctor, pharmacist, or hospital immediately as you may need urgent medical attention. If another person takes your medication accidentally, contact your doctor or hospital immediately as you may need urgent medical attention.

The symptoms of overdose may be nausea, vomiting, dizziness, and difficulty breathing.

If you forget to take Tasmar

Take it as soon as you remember, and continue with your regular schedule. However, if the next dose is due, do not take the missed dose and take the next dose directly. Do not take a double dose to compensate for the missed doses. If you have forgotten to take several doses, inform your doctor and follow their advice.

If you discontinue treatment with Tasmar

Do not reduce the dose or stop taking the medication unless your doctor tells you to. Always follow your doctor's instructions on the duration of treatment with Tasmar.

Like all medicines, Tasmar can cause side effects, although not everyone will experience them.

The frequency of possible side effects listed below is defined as follows:

Inform your doctor or pharmacist as soon as possible:

• Ifyou do not feel wellwhile taking Tasmar.
• If you experience symptoms such asnausea, vomiting, abdominal pain, loss of appetite, weakness, fever, dark urine, or jaundicesince liver dysfunction has been observed in some cases, sometimes severe hepatitis.
• If you noticedark urineas it could be a sign of muscle or liver damage. Any other yellow discoloration of urine is usually harmless.
• If you developpersistent or severe diarrhea.

After starting treatment with Tasmar and during treatment, symptoms caused by levodopa may appear such as involuntary movements and nausea. Therefore, if you do not feel well, you should inform your doctor because you may need a change in the levodopa dose.

Other possible side effects:

Very common:

• involuntary movements (dyskinesia),
• nausea, decreased appetite, diarrhea,
• headache, dizziness
• difficulty sleeping, somnolence,
• sensation of dizziness while standing (orthostatic problems),
• confusion and hallucinations.
• Movement disorders with involuntary muscle spasms or poor posture (dystonia)
• excessive sleep.

Common:

• chest pain,
• constipation, indigestion, stomach pain, vomiting, dry mouth
• syncope
• increased sweating
• flu and flu-like symptoms.
• reduced voluntary and involuntary movements (hypokinesia),
• upper respiratory tract infection,
• increase in specific liver enzymes
• urine discoloration.

Uncommon:

• liver damage, in rare cases with fatal outcome.

Rare:

• severe symptoms of muscle rigidity, fever, or mental confusion (Neuroleptic Malignant Syndrome) when antiparkinsonian treatments are reduced or stopped abruptly.
• Impulse control disorders (inability to resist the impulse to perform an action that may be harmful). This may include:
• • intense urge to gamble excessively, despite the grave personal or family consequences;
  • altered or increased sexual interest or behavior, which may compromise you or others, such as increased libido;
  • uncontrollable buying or spending, even when it has no practical value or is harmful;
  • binge eating or eating compulsively (eating a large amount of food in a short time or eating more than you need to satisfy your appetite).

Inform your doctor if you experience any of these behaviors; they will help you develop ways to manage or reduce symptoms.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational reporting systemincluded in theAnnex V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use Tasmar after the expiration date that appears on the packaging.

This medication does not require special storage conditions.

Do not use Tasmar if you observe that the tablets are damaged.

Composition of Tasmar

• The active ingredient is tolcapone (100 mg in each film-coated tablet)
• The other components are:

Tablet core: calcium hydrogen phosphate, microcrystalline cellulose, povidone K30, sodium starch glycolate, lactose monohydrate (see Section 2 “Tasmar contains lactose”), talc, magnesium stearate.

Film coating: hydroxypropylmethylcellulose, talc, yellow iron oxide, ethylcellulose, titanium dioxide (E171), triacetin, sodium lauryl sulfate.

Appearance of the product and contents of the pack

Tasmar is a film-coated tablet, pale yellow to yellow, oval in shape. On one side it bears the inscriptions “TASMAR” and “100”. Tasmar is supplied as film-coated tablets containing 100 mg of tolcapone. It is available in blister packs of a pack size of 30 or 60 tablets and in glass bottles of a pack size of 30, 60, 100 or 200 film-coated tablets.

Not all pack sizes may be marketed.

Holder of the marketing authorisation:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart

Dublin 15

DUBLIN

Ireland

Responsible for manufacturing:

ICN Polfa Rzeszów S.A.

ul. Przemyslowa 2

35-959 Rzeszów

Poland

Further information about this medicinal product can be obtained by contacting the local representative of the marketing authorisation holder:

Date of the last revision of the SmPC:

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu/