Tasmar

Package leaflet: Information for the user

Tasmar 100 mg film-coated tablets

Tolcapone
Please read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Tasmar is and what it is used for
2. What you need to know before taking Tasmar
3. How to take Tasmar
4. Possible side effects
5. How to store 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 used in combination with the medicine levodopa (as
levodopa/benserazide or levodopa/carbidopa).
Tasmar is used when no other alternative medication succeeds in stabilizing Parkinson's disease.
You are already taking levodopa for your Parkinson's disease.
A natural protein (enzyme) in the body, catechol-O-methyltransferase (COMT), breaks down levodopa-containing medication. Tasmar blocks this enzyme and slows down the breakdown of levodopa.
This means that when taken together with levodopa (as levodopa/benserazide or levodopa/carbidopa), your Parkinson's disease symptoms should improve.

2. What you need to know before taking Tasmar

Do not take Tasmar:

• if you have a liver disease or elevated liver enzymes
• if you have severe involuntary movements (dyskinesia)
• if you previously experienced severe symptoms of muscle rigidity, fever, or mental confusion (neuroleptic malignant syndrome (NMS)) and/or if you had damage to skeletal muscle tissue (non-traumatic rhabdomyolysis) or fever (hyperthermia)
• if you are allergic to the active substance tolcapone or to any of the other ingredients of Tasmar
• if you have a particular type of adrenal medullary tumor (pheochromocytoma)
• if you are taking certain medicines used to treat depression and anxiety, known as non-selective monoamine oxidase inhibitors (MAO)

Warnings and precautions
Talk to your doctor or pharmacist before taking Tasmar.
You must not start taking Tasmar until your doctor:

• has explained to you the risks of treatment with Tasmar,
• has explained the necessary measures to minimize these risks,
• has answered any questions you may have.
• if you are pregnant or planning to become pregnant. Your doctor will evaluate the risks and benefits of taking Tasmar during pregnancy. The effects of Tasmar have not been studied in children. You must not breastfeed while being treated with Tasmar.

Inform your doctor if you or your family members/caregivers notice an increasing urge to behave in a way that is unusual for you or an inability to resist the impulse or temptation to carry out actions that could harm you or others. These behaviors are called impulse control disorders and include gambling addiction, excessive eating, excessive spending, excessive sexual behavior, or increasing preoccupation with sexual thoughts or desires. Your doctor may decide to review your treatment.
You should take Tasmar only if Parkinson’s disease is not adequately controlled by other therapies.
Furthermore, your doctor will discontinue treatment with Tasmar if, after 3 weeks, there are no improvements sufficient to justify the risks associated with continuing treatment.

Liver injury
Tasmar can cause rare but potentially fatal liver injury. Liver injury has occurred most frequently after 1 month and before 6 months of treatment. It should also be noted that the risk of liver injury is higher in female patients.
Therefore, consider the following preventive measures.

Before starting treatment:
To reduce the risk of liver injury, you must not use Tasmar if:

• you have liver disease
• blood tests performed before starting treatment show any abnormalities in liver function (alanine aminotransferase (ALT) and aspartate aminotransferase (AST) tests).

During treatment:
During treatment, you will need to have blood tests at the following intervals:

• every 2 weeks during the first 12 months of therapy,
• every 4 weeks during the following 6 months of therapy,
• thereafter every 8 weeks. Treatment will be discontinued if blood test results are abnormal.

Sometimes, treatment with Tasmar may cause disturbances in liver function. Therefore, if you experience symptoms such as nausea, vomiting, stomach pain (particularly in the liver area, upper right quadrant), loss of appetite, weakness, fever, dark urine, jaundice (yellowing of the skin or eyes), or if you become tired more easily, contact your doctor immediately.
If you previously took Tasmar and developed acute liver injury during treatment, you must not use Tasmar again.

Neuroleptic malignant syndrome (NMS)
During treatment with Tasmar, symptoms of neuroleptic malignant syndrome may develop.
NMS is characterized by some or all of the following symptoms:

• severe muscle rigidity, jerky muscle movements, or muscle pain. Sometimes, muscle damage may cause darkening of the urine.
• other important symptoms include high fever and mental confusion.

Rarely, after a sudden reduction or discontinuation of Tasmar or other anti-Parkinson drugs, you may develop severe symptoms of muscle rigidity, fever, or mental confusion. If this occurs, inform your doctor.
Consider the following preventive measures.

Before starting treatment:
To reduce the risk of NMS, you must not use Tasmar if, according to your doctor, you have severe involuntary movement (dyskinesia) or have previously had a condition that may have been NMS.
Inform your doctor about all prescription and non-prescription medicines you are taking, as the risk of NMS may increase with the use of certain medicines.

During treatment:
If you develop symptoms such as those described above and suspect NMS, inform your doctor immediately.
Do not stop taking Tasmar or any other Parkinson’s medication without consulting your doctor, as this may increase the risk of NMS.

Inform your doctor also:

• if you have other diseases besides Parkinson’s disease,
• if you are allergic to other medicines, foods, or dyes,
• if you developed symptoms caused by levodopa shortly after starting or during treatment with Tasmar, such as involuntary movements (dyskinesia) and nausea.

If you do not feel well, contact your doctor, as you may need to take a lower dose of levodopa.

Children and adolescents
Tasmar is not recommended for use in children under 18 years of age due to lack of data on safety or efficacy. There are no relevant indications for use in children and adolescents.

Other medicines and Tasmar
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not prescribed (medicines available without a prescription and herbal remedies).
Inform 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 conditions),
• adrenaline and isoprenaline (both used in heart attacks),
• anticoagulants of the warfarin type (which prevent blood clotting). In this case, your doctor may periodically perform blood tests to monitor your blood’s ability to clot.

If you are admitted to hospital or are prescribed a new medicine, inform the doctor that you are taking Tasmar.

Tasmar with food and drink and alcohol
Tasmar may be taken with or without food.
Tasmar should be taken with one glass of water.

Pregnancy, breastfeeding, and fertility
If you are pregnant or planning to become pregnant, inform your doctor. Your doctor will assess the risks and benefits of taking Tasmar during pregnancy.
The effects of Tasmar have not been studied in newborns. You must not breastfeed during treatment with Tasmar.

Driving and using machines
Since Parkinson’s disease may affect your ability to drive a car or operate machinery, discuss this with your doctor.
Tasmar affects the symptoms of Parkinson’s disease.
The use of Tasmar together with other Parkinson’s medications you are taking may cause excessive drowsiness (somnolence) and sudden sleep attacks (you may fall asleep suddenly). Therefore, until such recurring attacks and drowsiness are resolved, you must avoid driving or operating machinery.

Tasmar contains lactose and sodium
If your doctor has informed you of an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take Tasmar

Take Tasmar exactly as your doctor has told you. If you are in doubt, consult your doctor or
pharmacist.
Dose and frequency of administration
Your doctor should always start treatment with the standard dose of 1 tablet three times a day
(100 mg (1 tablet)).
Tasmar should be discontinued if no improvement occurs within 3 weeks after starting
treatment.
To improve effectiveness, your doctor should only increase the dose to 2 tablets three times a day
(200 mg three times daily) if the improved control of Parkinson's disease symptoms outweighs the expected increase in adverse effects. With the higher dose, adverse effects may often be severe and affect the liver. If there is no improvement with the higher dose after a total of 3 weeks, your doctor must stop treatment with Tasmar.
At the beginning and during treatment with Tasmar, the dose of levodopa may need to be adjusted.
Your doctor will advise you accordingly.
How to take the medicine:
Swallow Tasmar with a glass of water.
Do not break or crush the tablets.
The first Tasmar tablet should be taken in the morning together with your other anti-Parkinson medicine, “levodopa”.
The other doses of Tasmar should be taken approximately 6 and 12 hours later.

If you take more Tasmar than you should
Contact your doctor, pharmacist, or hospital immediately, as you may require urgent medical treatment.
If someone else accidentally takes this medicine, contact a doctor or hospital immediately, as that person may require urgent medical treatment.
Symptoms of overdose may include nausea, vomiting, dizziness, and breathing difficulties.

If you forget to take Tasmar
Take it as soon as you remember, then continue taking it at your usual times. However, if your dosing schedule remains regular when taking the next dose, do not make up for the missed dose. Do not take a double dose to make up for a forgotten dose. If you have missed several doses, inform your doctor and follow the advice given.

If you stop taking Tasmar
Do not reduce or stop taking this medicine unless instructed by your doctor. Always follow your doctor's instructions regarding the duration of treatment with Tasmar.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The frequency of the possible side effects listed below is defined using the following convention:

Inform your doctor or pharmacist as soon as possible

• if you do not feel well while taking Tasmar
• if you experience symptoms such as nausea, vomiting, abdominal pain, loss of appetite, weakness, fever, darkening of the urine or jaundice, since liver function disorders, sometimes severe hepatitis, have been observed not uncommonly.
• if you notice dark urine, as this could be a sign of muscle or liver damage. Any other yellowish discoloration of the urine is normally harmless.
• if you experience persistent or severe diarrhoea

Shortly after starting and during treatment with Tasmar, you may experience symptoms caused by levodopa, such as involuntary movements and nausea. Therefore, if you do not feel well, contact your doctor, as it may be necessary to adjust the dose of levodopa.

Other possible side effects:

Very common:

• involuntary movements (dyskinesia)
• nausea, reduced appetite, diarrhoea
• headache, dizziness
• sleep disorders, somnolence
• dizziness upon standing (orthostatic disturbances), confusion and hallucinations
• disordered movement with involuntary or uncoordinated muscle spasms (dystonia)
• excessive dreaming

Common:

• chest pain
• constipation, dyspepsia, stomach ache, vomiting, dry mouth
• fainting
• increased sweating
• influenza-like symptoms
• reduced voluntary and involuntary movement (hypokinesia)
• upper respiratory tract infections
• increase in specific liver enzymes
• discoloration of urine

Uncommon:

• liver damage, in rare cases with fatal outcome

Rare:

• severe symptoms of muscle rigidity, fever or mental confusion (neuroleptic malignant syndrome), when anti-Parkinson treatments are abruptly reduced or discontinued
• impulse control disorders (inability to resist the impulse to perform an action that may be harmful). This may include:
• Strong urge to gamble despite serious personal and family consequences.
• Altered or increased sexual interest and related behaviours embarrassing to you and others, such as increased sexual drive.
• Uncontrollable desire to spend or make excessive purchases.
• Uncontrolled (eating large amounts of food in a short period of time) or compulsive eating (eating an amount of food larger than what leads to satiety).

Inform your doctor if you experience any of these behaviours, so that ways to manage or reduce the symptoms can be discussed.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tasmar

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton.
This medicine does not require any special storage conditions.
Do not use Tasmar if you notice that the tablets are damaged.

6. Package contents and other information

What Tasmar contains

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

Tablet core: calcium phosphate, microcrystalline cellulose, povidone K30, sodium starch glycolate, lactose monohydrate (see section 2 “Tasmar contains lactose”), talc, magnesium stearate.
Film coating: hypromellose, talc, yellow iron oxide, ethylcellulose, titanium dioxide (E171), triacetin, sodium lauryl sulfate.

Description of the appearance of Tasmar and package contents
Tasmar is a film-coated oval tablet, pale to light yellow in colour, with the inscriptions “TASMAR” and “100” engraved on one side. Tasmar is supplied as film-coated tablets containing 100 mg of tolcapone. It is available in blisters in packs of 30 or 60 tablets and in glass bottles in packs of 30, 60, 100 or 200 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. Przemysłowa 2
35-959 Rzeszów
Poland

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Viatris Viatris UAB
Tél/Tel: +32 (0) 26586100 Tel: + 370 52051288

България Luxembourg/Luxemburg
Майлан ЕООД Viatris
Тел.: +359 2 44 55400 Tél/Tel: +32 (0) 26586100
Belgique/Belgien

Česká republika Magyarország
Viatris CZ s.r.o. Viatris Healthcare Kft.
Tel: +420 222 004 400 H-1138 Budapest,
Váci út 150.
Tel.: +36 1 465 2100

Danmark Malta
Viatris ApS V.J. Salomone Pharma Limited
Tlf: +45 28 11 69 32 Tel: +356 21220174

Deutschland Nederland
Viatris Healthcare GmbH Mylan Healthcare B.V.
Tel: + 49 8000700800 Krijgsman 20
NL-1186 DM Amstelveen
Tel: +31 20 426 33 00

Eesti Norge
Viatris OÜ Viatris AS
Tel: +372 6363 052 Hagaløkkveien 26
N-1383 Asker
Tlf: +47 66 75 33 00

Ελλάδα Österreich
Viatris Hellas Ltd Viatris Austria GmbH Guglgasse 15
Τηλ: +210 010 0002 A-1110 Wien
Tel: + 43 1 86 390

España Polska
Viatris Pharmaceuticals, S.L. Viatris Healthcare Sp.z.o.o.
Tel: +34 900 102 712 ul. Postępu 21 B
02-676 Warszawa
Tel.: +48 22 5466400

France Portugal
Viatris Santé Viatris Healthcare, Lda
1 bis place de la Défense- Av. D. João II,
Tour Trinity Edifício Atlantis, nº 44C – 7.3 e 7.4
92400 Courbevoie 1990-095 Lisboa
Tél : +33 140 80 15 55 Tel:+351 214 127 200

Hrvatska România
Viatris Hrvatska d.o.o. BGP PRODUCTS SRL
Tel: +385 1 23 50 599 Tel: +40372 579 000

Ireland Slovenija
Viatris Limited Viatris d.o.o.
Tel: +353 18711600 Tel: +386 1 23 63 180

Ísland Slovenská republika
Icepharma hf. Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: +421 2 32 199 100

Italia Suomi/Finland
Viatris Italia Viatris Oy
Via Vittor Pisani, 20 Puh/Tel: +358 20 720 9555
20124 Milano
Tel: +39 0261246921

Κύπρος Sverige
GPA Pharmaceuticals Ltd Viatris AB
Τηλ: +357 2220 7700 Tel: +46 (0) 8 630 19 00

Latvija United Kingdom (Northern Ireland)
Viatris SIA Mylan IRE Healthcare Limited
Tel: +371 67616137 Tel: +353 18711600

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

Package leaflet: Information for the user

Tasmar 200 mg film-coated tablets

Tolcapone
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Tasmar is and what it is used for
2. What you need to know before taking Tasmar
3. How to take Tasmar
4. Possible side effects
5. How to store Tasmar
6. Package contents and other information

1. What Tasmar is and what it is used for

Tasmar is used in the treatment of Parkinson's disease, in combination with the medication levodopa (as levodopa/benserazide or levodopa/carbidopa).
Tasmar is used when no other alternative medicines are able to stabilise Parkinson's disease.
You are already taking levodopa for your Parkinson's disease.
A natural protein (enzyme) in the body, catechol-O-methyltransferase (COMT), breaks down levodopa-containing medication. Tasmar blocks this enzyme and slows down the breakdown of levodopa.
This means that when taken together with levodopa (as levodopa/benserazide or levodopa/carbidopa), your Parkinson's disease symptoms should improve.

2. What you should know before taking 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 experienced severe symptoms of muscle rigidity, fever, or mental confusion (neuroleptic malignant syndrome (NMS)) and/or if you have had damage to skeletal muscle tissue (non-traumatic rhabdomyolysis) or fever (hyperthermia)
• if you are allergic to the active substance tolcapone or to any of the other components of Tasmar
• if you have a particular type of adrenal medulla tumor (pheochromocytoma)
• if you are taking certain medicines used to treat depression and anxiety called non-selective monoamine oxidase inhibitors (MAO inhibitors)

Warnings and precautions
Talk to your doctor or pharmacist before taking Tasmar.
You must not start taking Tasmar until your doctor:

• has explained to you the risks of treatment with Tasmar,
• has explained the necessary measures to minimize these risks,
• has answered any questions you may have.
• if you are pregnant or planning to become pregnant. Your doctor will evaluate the risks and benefits of taking Tasmar during pregnancy. The effects of Tasmar have not been studied in children. You must not breastfeed during treatment with Tasmar.

Inform your doctor if you or your family members/caregivers notice a growing, strong desire to behave in a way that is unusual for you or an inability to resist impulses or urges to carry out actions that could harm you or others. These behaviors are called impulse control disorders and include gambling addiction, excessive eating, excessive spending, excessive sexual behavior, or increasing thoughts or urges related to sex. Your doctor may decide to review your therapy.
You should take Tasmar only if Parkinson’s disease is not adequately controlled by other therapies.
Furthermore, your doctor will discontinue treatment with Tasmar if, after 3 weeks, there are no improvements sufficient to justify the risks associated with continuing treatment.

Liver injury
Tasmar can cause rare but potentially fatal liver injury. Liver injury has occurred most frequently after 1 month and before 6 months of treatment. It should also be noted that the risk of liver injury is higher in female patients.
Therefore, consider the following preventive measures.

Before starting treatment:
To reduce the risk of liver injury, you must not use Tasmar if:

• you have liver disease
• blood tests performed before starting treatment show any abnormalities in liver function (alanine aminotransferase (ALT) and aspartate aminotransferase (AST) tests).

During treatment:
During treatment, you will need to have blood tests at the following intervals:

• every 2 weeks during the first 12 months of therapy,
• every 4 weeks during the following 6 months of therapy,
• thereafter every 8 weeks. Treatment will be discontinued if blood test results are abnormal.

Sometimes, treatment with Tasmar may cause disturbances in liver function. Therefore, if you experience symptoms such as nausea, vomiting, stomach pain (particularly in the liver area, upper right side), loss of appetite, weakness, fever, dark urine, jaundice (yellowing of the skin or eyes), or if you become tired more easily, contact your doctor immediately.
If you have previously taken Tasmar and developed acute liver injury during treatment, you must not reuse Tasmar.

Neuroleptic Malignant Syndrome (NMS)
During treatment with Tasmar, symptoms of neuroleptic malignant syndrome may develop.
NMS is characterized by some or all of the following symptoms:

• severe muscle rigidity, jerky movements of muscles, arms or legs, and muscle pain. Occasionally, muscle injury may cause darkening of the urine.
• other important symptoms include high fever and mental confusion.

Rarely, after a sudden reduction or discontinuation of Tasmar or other anti-Parkinson’s medications, you may develop severe symptoms of muscle rigidity, fever, or mental confusion. If this occurs, inform your doctor.
Consider the following preventive measures.

Before starting treatment:
To reduce the risk of NMS, you must not use Tasmar if, according to your doctor, you have severe involuntary movements (dyskinesia) or have previously had a condition that might have been NMS.
Inform your doctor about all prescription and non-prescription medicines you are taking, as the risk of NMS may increase with the use of certain medicines.

During treatment:
If you develop symptoms such as those described above and suspect NMS, you must report them to your doctor immediately.
Do not stop taking Tasmar or any other Parkinson’s medication without consulting your doctor, as this may increase the risk of NMS.

Inform your doctor also:

• if you have other diseases besides Parkinson’s disease,
• if you are allergic to other medicines, foods, or dyes,
• if, shortly after starting treatment with Tasmar, you develop symptoms caused by levodopa, such as involuntary movements (dyskinesia) and nausea.

If you do not feel well, contact your doctor, as you may need to take a lower dose of levodopa.

Children and adolescents
Tasmar is not recommended for use in children under 18 years of age due to lack of data on safety and efficacy. There are no relevant indications for use in children and adolescents.

Other medicines and Tasmar
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not prescribed (medicines available without a prescription and herbal medicines).
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 disease),
• adrenaline and isoprenaline (both used for heart attacks),
• anticoagulants of the warfarin type (which prevent blood clotting). In this case, your doctor may periodically perform blood tests to monitor your blood’s ability to clot.

If you are admitted to hospital or prescribed a new medicine, inform the doctor that you are taking Tasmar.

Tasmar with food and drink and alcohol
Tasmar can be taken with or without food.
Tasmar should be taken with one glass of water.

Pregnancy, breastfeeding, and fertility
If you are pregnant or planning to become pregnant, inform your doctor. Your doctor will evaluate the risks and benefits of taking Tasmar during pregnancy.
The effects of Tasmar have not been studied in newborns. You must not breastfeed during treatment with Tasmar.

Driving and using machines
Since Parkinson’s disease may affect your ability to drive or operate machinery, discuss this with your doctor.
Tasmar affects the symptoms of Parkinson’s disease.
The use of Tasmar together with other Parkinson’s medications you are taking may cause excessive drowsiness (somnolence) and sudden sleep attacks (you may fall asleep suddenly). Therefore, until these recurring sleep attacks and drowsiness resolve, you must avoid driving or operating machinery.

Tasmar contains lactose and sodium
If your doctor has informed you of an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take Tasmar

Take Tasmar exactly as directed by your doctor. If you have any doubts, consult your doctor or
pharmacist.
Dose and frequency of administration
Your doctor should always start treatment with the standard dose of 1 tablet three times a day
(100 mg (1 tablet)).
Tasmar should be discontinued if no improvement occurs within 3 weeks of starting treatment.
To improve effectiveness, your doctor should use the higher dose (200 mg three times daily)
only if the improved control of Parkinson’s disease symptoms outweighs the expected increase
in adverse effects. With the higher dose, adverse effects are often severe and may affect the liver.
If there is no improvement with the higher dose after a total of 3 weeks, your doctor must stop
treatment with Tasmar.
At the beginning and during treatment with Tasmar, it may be necessary to adjust the dose of levodopa.
Your doctor will advise you accordingly.
How to take the medicine:
Swallow Tasmar with a glass of water.
Do not break or crush the tablets.
The first Tasmar tablet should be taken in the morning together with your other anti-Parkinson's
medication "levodopa".
The other doses of Tasmar should be taken approximately 6 and 12 hours later.

If you take more Tasmar than you should
Contact your doctor, pharmacist, or hospital immediately, as you may require urgent medical treatment.
If someone else accidentally takes the medicine, contact a doctor or hospital immediately, as this person may require urgent medical treatment.
Symptoms of overdose may include nausea, vomiting, dizziness, and breathing difficulties.

If you forget to take Tasmar
Take it as soon as you remember, then continue taking it at your usual times. However, if taking the next dose keeps your schedule on track, do not make up for the missed dose. Do not take a double dose to compensate for a forgotten dose. If you have missed several doses, inform your doctor and follow the advice given to you.

If you stop taking Tasmar
Do not reduce 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, this medicine can cause side effects, although not everybody gets them.
The frequency of the possible side effects listed below is defined using the following convention:

Inform your doctor or pharmacist as soon as possible

• if you do not feel well while taking Tasmar
• if you experience symptoms such as nausea, vomiting, abdominal pain, loss of appetite, weakness, fever, dark urine, or jaundice, since liver function disorders have been observed, sometimes severe hepatitis
• if you notice dark urine, as this may be a sign of muscle or liver damage. Any other yellowish discoloration of urine is usually harmless
• if you experience persistent or severe diarrhoea

Shortly after starting or during treatment with Tasmar, you may experience symptoms caused by levodopa, such as involuntary movements and nausea. Therefore, if you do not feel well, contact your doctor, as it may be necessary to adjust the dose of levodopa.

Other possible side effects:

Very common:

• involuntary movements (dyskinesia)
• nausea, decreased appetite, diarrhoea
• headache, dizziness
• sleep disturbances, drowsiness
• dizziness upon standing (orthostatic disorders)
• confusion and hallucinations
• disordered, involuntary or uncoordinated muscle spasms (dystonia)
• excessive dreaming

Common:

• chest pain
• constipation, indigestion, stomach ache, vomiting, dry mouth
• fainting
• increased sweating
• flu-like symptoms
• reduced voluntary and involuntary movement (hypokinesia)
• upper respiratory tract infections
• increased levels of specific liver enzymes
• discoloration of urine

Uncommon:

• liver damage, in rare cases with fatal outcome

Rare:

• severe symptoms of muscle rigidity, fever, or mental confusion (neuroleptic malignant syndrome), when anti-Parkinson’s treatments are abruptly reduced or discontinued
• impulse control disorders (inability to resist the impulse to perform an action that may be harmful). This may include:
• strong urge to gamble despite serious personal and family consequences
• altered or increased sexual interest and related behaviours embarrassing to you and others, such as increased sexual drive
• uncontrollable desire to spend money or excessive shopping
• uncontrolled (eating large amounts of food in a short period of time) or compulsive eating (eating an amount of food larger than what causes satiety)

Inform your doctor if you experience any of these behaviours, so that ways to manage or reduce the
symptoms can be discussed.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tasmar

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton.
This medicine does not require any special storage conditions.
Do not use Tasmar if you notice that the tablets are damaged.

6. Package contents and other information

What Tasmar contains

• The active substance is tolcapone (200 mg in each film-coated tablet).
• The other components are:
  Tablet core: calcium 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.

Description of the appearance of Tasmar and contents of the pack
Tasmar is a film-coated tablet, oval-shaped, yellow-orange to dark yellow in colour, with the inscriptions “TASMAR” and “200” engraved on one side. Tasmar is supplied as film-coated tablets containing 200 mg of tolcapone. It is available in blisters containing 30 or 60 tablets, and in glass bottles containing 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. Przemysłowa 2
35-959 Rzeszów
Poland

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Viatris Viatris UAB
Tél/Tel: +32 (0) 26586100 Tel: +370 52059367

България Luxembourg/Luxemburg
Майлан ЕООД Viatris
Тел.: +359 2 445 5400 Tél/Tel: +32 (0) 26586100
Belgique/Belgien

Česká republika Magyarország
Viatris CZ s.r.o. Viatris Healthcare Kft.
Tel: +420 222 004 400 H-1138 Budapest,
Váci út 150.
Tel.: +36 1 465 2100

Danmark Malta
Viatris ApS V.J. Salomone Pharma Limited
Tlf: +45 28 11 69 32 Tel: +356 21220174

Deutschland Nederland
Viatris Healthcare GmbH Mylan Healthcare B.V.
Tel: +49 8000700800 Krijgsman 20
NL-1186 DM Amstelveen
Tel: +31 20 7426 33 00

Eesti Norge
Viatris OÜ Viatris AS
Tel: +372 62 61 025 Tlf: +47 66 75 33 00

Ελλάδα Österreich
Viatris Hellas Ltd Viatris Austria GmbH
Τηλ: +30 210 010 0002 Guglgasse 15
A-1110 Wien
Tel: +43 1 86 390

España Polska
Viatris Pharmaceuticals, S.L. Viatris Healthcare Sp. z o.o.
Tel: +34 900 102 712 ul. Postępu 21 B
02-676 Warszawa
Tel.: +48 22 5466400

France Portugal
Viatris Santé Viatris Healthcare, Lda
1 bis place de la Défense- Av. D. João II,
Tour Trinity Edifício Atlantis, nº 44C – 7.3 e 7.4
92400 Courbevoie 1990-095 Lisboa
Tél: +33 1 40 80 15 55 Tel: +351 214 127 200

Hrvatska România
Viatris Hrvatska d.o.o. BGP PRODUCTS SRL
Tel: +385 1 23 50 599 Tel: +40372 579 000

Ireland Slovenija
Viatris Limited Viatris d.o.o.
Tel: +353 18711600 Tel: +386 1 23 63 180

Ísland Slovenská republika
Icepharma hf. Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: +421 2 32 199 100

Italia Suomi/Finland
Viatris Italia Viatris Oy
Via Vittor Pisani, 20 Puh/Tel: +358 20 720 9555
20124 Milano
Tel: +39 0261246921

Κύπρος Sverige
GPA Pharmaceuticals Ltd Viatris AB
Τηλ: +357 22863100 Tel: +46 (0) 8 630 19 00

Latvija United Kingdom (Northern Ireland)
Viatris SIA Mylan IRE Healthcare Limited
Tel: +371 67616137 Tel: +353 18711600

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