TASMAR 200 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tasmar 200 mg film-coated tablets

tolcapone

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What Tasmar is and what it is used for.
2. What you need to know before you take Tasmar.
3. How to take Tasmar.
4. Possible side effects.
5. Storing Tasmar.
6. Contents of the pack and other information.

1. What Tasmar is and what it is used for

For the treatment of Parkinson's disease, Tasmar is taken together with the medicine levodopa (such as levodopa/benserazide or levodopa/carbidopa).

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

For the treatment of your Parkinson's disease, you are already taking levodopa.

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

2. What you need to know before you take Tasmar

Do not take Tasmar

• if you have liver disease or elevated liver enzymes
• if you have severe involuntary movements (dyskinesia)
• if you have previously had severe symptoms of muscle stiffness, fever, or mental confusion (Neuroleptic Malignant Syndrome) and/or have muscle tissue injury (non-traumatic rhabdomyolysis) or fever (hyperthermia)
• if you are allergic (hypersensitive) to the active substance tolcapone or any of the other ingredients of Tasmar
• if you have a special type of tumor in the adrenal gland (pheochromocytoma)
• if you are taking certain medicines for depression and anxiety, called 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 treatment with Tasmar to you
• has explained the necessary measures to minimize these risks
• has answered any questions you may have
• if you are pregnant or plan to become pregnant. Your doctor will explain the risks and benefits of taking Tasmar during pregnancy. The effects of Tasmar in children have not been studied. While being treated with Tasmar, you should interrupt breastfeeding.

Tell your doctor if you or your family/caregiver notice that you are developing impulses or desires to behave in an unusual way, or if you cannot resist the impulse or temptation to carry out certain activities that may be harmful to you or others. These behaviors are called impulse control disorders and may include addiction to gambling, excessive eating or spending money, abnormally high sexual desire, 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 stop treatment with Tasmar if, after 3 weeks, you do not improve enough to justify the risks of continuing treatment.

Liver damage

Tasmar may cause liver damage, although rarely, but potentially fatal. Most often, liver damage occurs after 1 month and before 6 months. It should be noted that women may have a higher risk of liver damage. Therefore, the following preventive measures should be taken into account.

Before starting treatment:

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

• you have liver disease
• your liver function tests are elevated in the blood test performed before starting treatment (alanine aminotransferase (ALT) and aspartate aminotransferase (AST) tests).

While receiving treatment:

During treatment, blood tests will be performed at the following time 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 stopped if the results of the blood tests are not normal.

Treatment with Tasmar may sometimes cause liver problems. Therefore, tell your doctor immediately if you experience symptoms such as nausea, vomiting, stomach pain, loss of appetite, weakness, fever, dark-colored urine, jaundice (yellow color in skin or eyes), or if you get tired easily.

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

Neuroleptic Malignant Syndrome (NMS):

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

NMS consists of some or all of the following symptoms:

• severe muscle stiffness, muscle spasms, arms or legs, and painful muscles. Muscle injuries can sometimes cause dark-colored urine.
• other important symptoms are high fever and mental confusion.

Rarely, when stopping or suddenly reducing Tasmar or other antiparkinsonian medicines, you may experience severe symptoms of muscle stiffness, fever, or mental confusion. If this happens, tell your doctor.

The following preventive measures should be taken into account.

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 had a disease that may have been NMS.

Tell your doctor about all medicines, with or without a prescription, as you may be at increased risk of developing NMS if you are taking certain medicines.

While receiving treatment:

If you develop any symptoms similar to those described above, which make you suspect NMS, tell 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, tell your doctor:

• if you have any other disease besides Parkinson's
• if you are allergic to other medicines, foods, or dyes
• if, after starting treatment with Tasmar and during treatment, symptoms appear that may be caused by levodopa, such as involuntary movements (dyskinesia) and nausea.

If you do not feel well, you should tell your doctor because you may need a reduction in 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 medicines and Tasmar

Tell your doctor or pharmacist if you are taking, have recently taken, or might take other medicines, including those obtained without a prescription (over-the-counter medicines and herbal products).

Tell your doctor about all medicines 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 check how fluid it is.

If you go to the hospital or are prescribed a new medicine, 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 a glass of water.

Pregnancy, breastfeeding, and fertility

Tell your doctor if you are pregnant or plan to become pregnant. Your doctor will explain the risks and benefits of treatment with Tasmar during pregnancy.

The effects of Tasmar in children have not been studied. While being treated with Tasmar, you should interrupt breastfeeding.

Driving and using machines

Since the ability to drive vehicles or operate machinery may be impaired by Parkinson's disease, you should consult your doctor about this.

Tasmar affects the symptoms of Parkinson's disease.

When combining Tasmar with other Parkinson's medicines, it may cause excessive drowsiness (somnolence) and sudden episodes of sleep attacks (you may fall asleep suddenly). Therefore, you should avoid driving or operating machinery until such periodic episodes and excessive drowsiness disappear.

Tasmar contains lactose and sodium

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

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

3. How to take Tasmar

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

Dosage and frequency of administration

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, treatment with Tasmar should be stopped.

To improve efficacy, your doctor should only increase the dose to a higher dose (200 mg three times a day) if the improvement in controlling the symptoms of Parkinson's disease outweighs the increase in side effects. At the highest dose, side effects may be severe and affect the liver. If you do not improve at the highest dose after a total of 3 weeks, your doctor will stop 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 medicine

Swallow Tasmar with a glass of water.

Do not break or crush the tablets.

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

The following 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 someone else takes your medicine accidentally, contact your doctor or hospital immediately as they 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 then continue at the usual times. However, if the next dose is near, do not take the missed dose and take the next dose directly. Do not take a double dose to make up for the missed dose. If you have forgotten to take several doses, tell your doctor and follow their advice.

If you stop taking Tasmar

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

4. Possible side effects

Like all medicines, Tasmar can cause side effects, although not everybody gets them.

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

Tell your doctor or pharmacist as soon as possible:

• If you do not feel wellwhile taking Tasmar.
• If you experience symptoms such as nausea, vomiting, abdominal pain, loss of appetite, weakness, fever, dark-colored urine, or jaundiceas liver problems, sometimes severe hepatitis, have been rarely observed.
• If you notice dark-colored urineas it could be a sign of muscle or liver damage. Any other yellow discoloration of the urine is usually harmless.
• If you develop persistent or severe diarrhea.

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

Other possible side effects:

Very common:

• involuntary movements (dyskinesia),
• nausea, decreased appetite, diarrhea,
• headache, dizziness
• difficulty sleeping, somnolence,
• feeling dizzy while standing (orthostatic problems),
• mental confusion and hallucinations,
• movement disorders with muscle spasms or poor posture (dystonia),
• excessive sleepiness.

Common:

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

Uncommon:

• liver damage, in rare cases with a fatal outcome.

Rare:

• severe symptoms of muscle stiffness, fever, or mental confusion (Neuroleptic Malignant Syndrome) when antiparkinsonian treatments are suddenly reduced or stopped.
• Impulse control disorders (inability to resist the impulse to perform an action that may be harmful). This may include:
• • Intense impulse to gamble excessively, despite severe personal or family consequences;
  • Altered or increased sexual interest and behavior, which significantly affects you or others, for example, increased sexual impulse;
  • Uncontrollable compulsive shopping or spending;
  • Binge eating (eating large amounts of food in a short time) or compulsive eating (eating more food than usual and more than needed to satisfy hunger).

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Tasmar

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

Do not use Tasmar after the expiry date stated on the packaging.

This medicine does not require special storage conditions.

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

6. Package Contents and Additional Information

Tasmar Composition

• The active ingredient is tolcapone (200 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.

Coating: hydroxypropyl methylcellulose, talc, yellow iron oxide, ethylcellulose, titanium dioxide (E171), triacetin, sodium lauryl sulfate.

Product Appearance and Package Contents

Tasmar is a film-coated tablet, orange-yellow to yellow-brown in color, with an oval shape. One side has the inscriptions "TASMAR" and "200". Tasmar is supplied as film-coated tablets with 200 mg of tolcapone. It is available in blister packs of 30 or 60 tablets and in glass bottles of 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart

Dublin 15

DUBLIN

Ireland

Manufacturer:

ICN Polfa Rzeszów S.A.

ul. Przemyslowa 2

35-959 Rzeszów

Poland

For further information on this medicinal product, please contact the local representative of the marketing authorization holder.

Date of Last Revision of this Leaflet:

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