TASMAR 100 mg Фильм-Coated Таблетки

Содержание инструкции

1. Tasmar 100 mg film-coated tablets
   1. What is Tasmar and what is it 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
2. Tasmar 200 mg film-coated tablets
   1. What is Tasmar and what is it 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

Tasmar 100 mg film-coated tablets

Tolcapone

Read this leaflet carefully before you start to take this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even 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 you take 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 is Tasmar and what is it used for

For the treatment of Parkinson's disease, Tasmar is used together with the medicine levodopa (such as
levodopa/benserazide or levodopa/carbidopa).
Tasmar is used when no other alternative medicine can stabilize Parkinson's disease.
You are already taking levodopa to treat your Parkinson's disease.
A natural protein (enzyme) present in the body, catechol-O-methyltransferase (COMT), degrades
levodopa-based medication. Tasmar blocks this enzyme and slows down the degradation of levodopa.
This means that by taking it together with levodopa (such 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 an increase in liver enzymes
• if you have severe involuntary movements (dyskinesia)
• if you have previously experienced severe symptoms of muscle rigidity, fever or mental confusion (symptomatic complex of malignant neuroleptic syndrome (MNS)) and/or if you have skeletal muscle tissue damage (non-traumatic rhabdomyolysis) or fever (hyperthermia).
• if you are allergic to the active ingredient tolcapone or to any of the other ingredients of Tasmar
• if you suffer from a particular type of adrenal medulla tumor (pheochromocytoma)
• if you are taking certain medications to treat depression and anxiety, called non-selective monoamine oxidase inhibitors (MAOIs)

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

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

Tell your doctor if you or your family members/carers notice a growing strong desire to
behave in a way that is unusual for you or to be unable to resist the urge or temptation to perform
actions that could harm you or others. These behaviors are called impulse control disorders and include gambling addiction, overeating, excessive spending, excessive sexual behavior, or concern about the onset of
increasing sexual thoughts or desires. Your doctor may decide to review your therapy.
You must only take Tasmar if Parkinson's disease is not adequately controlled by the use of
other therapies.
In addition, the doctor will stop treatment with Tasmar if there are no
improvements after 3 weeks to justify the risks associated with continuing treatment.

Liver injury
Tasmar can cause liver injury that is rare but potentially fatal. Liver injury has
occurred more frequently after 1 month and before 6 months. It should also be considered that
the risk of liver injury is higher in female patients.
Therefore, you should consider the following preventive measures.
Before starting treatment:
To reduce the risk of liver injury, you should not use Tasmar if

• you have a liver disease
• blood tests performed before starting treatment show any abnormalities in the liver (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 for the first 12 months of therapy,
• every 4 weeks for the next 6 months of therapy,
• subsequently every 8 weeks. Treatment will be discontinued if blood test values are abnormal.

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

Malignant Neuroleptic Syndrome (MNS)
Symptoms of malignant neuroleptic syndrome can develop during treatment with Tasmar.
MNS manifests with some or all of the following symptoms:

• severe muscle rigidity, jerking movements of muscles, arms or legs, and muscle pain. Sometimes, muscle injury can cause a dark coloration of the urine.
• other important symptoms are high fever and a state of mental confusion.

Rarely, after a sudden reduction or discontinuation of Tasmar or other anti-Parkinsonian drugs, you may
develop severe symptoms of muscle rigidity, fever, or mental confusion. If this should
happen, tell your doctor.
You should consider the following preventive measures.
Before starting treatment:
To reduce the risk of MNS, you should not use Tasmar if, according to your doctor, you suffer from severe
involuntary movement (dyskinesia) or have previously had a disease that may have been
MNS.
Tell your doctor about all prescription and non-prescription drugs you are taking, as
the risk of MNS may increase with the use of specific drugs.
During treatment:
If you develop symptoms such as those described above, and you think it is MNS, you should report them
immediately to your doctor.
Do not stop Tasmar or any other medication for the treatment of Parkinson's disease without telling your
doctor, as this may increase the risk of MNS.

Also tell your doctor:

• if you have other illnesses in addition to Parkinson's disease,
• if you are allergic to other drugs, foods or dyes,
• if you developed symptoms caused by levodopa, such as involuntary movement (dyskinesia) and nausea, shortly after starting and during treatment with Tasmar.

If you do not feel well, you should contact your doctor because it may be necessary 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 a lack of
safety or efficacy data. There are no relevant indications for use in children and adolescents.

Other medicines and Tasmar
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those available without a prescription (over-the-counter medicines and
herbal medicines).
Tell your doctor about all the 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 have blood tests done to monitor the blood's ability to clot.

If you are hospitalized or if a new medicine is prescribed for you, tell your 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 1 glass of water.

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

Driving and operating machinery
Since Parkinson's disease can affect your ability to drive a car or operate machinery, you should talk to your
doctor about it.
Tasmar affects the symptoms of Parkinson's disease.
The use of Tasmar together with other medicines you take for Parkinson's disease can cause excessive drowsiness (sleepiness) and sudden sleep attacks (you may fall asleep
suddenly). Therefore, until these recurring attacks and drowsiness resolve, you should avoid
driving or operating machinery.

Tasmar contains lactose and sodium
If you have been told by your doctor that you have an intolerance to certain sugars, contact 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 following always exactly the instructions of the doctor. If you have doubts consult the doctor or
the pharmacist.
Dosage and frequency of administration
The doctor must always start the treatment with the standard dose of 1 tablet three times a day
(100 mg (1 tablet)).
Tasmar must be discontinued if no improvements are observed within 3 weeks from the start of
treatment.
To improve efficacy, the doctor must only increase the dose to 2 tablets three times a day
(200 mg three times a day) only if the better control of the symptoms of Parkinson’s disease
outweighs the expected increase in side effects. Often with the higher dose the side effects can be serious and affect the liver. In the absence of improvement with the higher dose, after a total of 3 weeks, the doctor must discontinue treatment with Tasmar.
At the beginning and during treatment with Tasmar it may be necessary to adjust the dose of levodopa.
The doctor will advise you what to do.

How to take the medicine:
Swallow Tasmar with a quantity equal to a glass of water.
Do not break or crush the tablets.
The first tablet of Tasmar should be taken in the morning together with the 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 because you may need urgent medical
care.

If someone else accidentally takes the medicine, contact your doctor or hospital immediately
because this person may need urgent medical care. Among the symptoms of overdose may appear nausea, vomiting, dizziness and difficulty breathing.

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

If you stop taking Tasmar
Do not reduce or stop taking the medicine unless your doctor tells you to. Always
follow the 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 possible side effects, listed below, is defined using the
following convention:

Inform your doctor or pharmacist as soon as possible

• if you feel unwellwhile taking Tasmar
• if you have symptoms such as nausea, vomiting, abdominal pain, loss of appetite, weakness, fever,dark urine or jaundice,as liver function disorders, sometimes severe hepatitis, have been rarely observed.
• if you notice the appearance of dark urinebecause it could be a sign of muscle or liver damage. Any other yellow discoloration of the urine is normally harmless.
• if you experience persistent or severe diarrhea

Shortly after starting and during treatment with Tasmar, you may experience symptoms caused by
levodopa, such as involuntary movements and nausea. Therefore, if you feel unwell, 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, diarrhea
• headache, dizziness
• sleep disturbances, drowsiness
• feeling dizzy when standing up (orthostatic disturbances), confusion and hallucinations
• disordered movement with involuntary or uncoordinated muscle spasms (dystonia)
• excessive dreaming

Common:

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

Uncommon:

• liver injury, in rare cases with a fatal outcome

Rare:

• severe symptoms of muscle rigidity, fever or confusion (neuroleptic malignant syndrome), when antiparkinsonian treatments are abruptly reduced or stopped
• 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 embarrassing behaviors for you and others, such as increased sexual drive.
• Uncontrollable desire to spend or shop excessively.
• Uncontrolled eating (consuming large amounts of food in a short period of time) or compulsive (consuming an amount of food greater than that which determines satiety).

Inform your doctor if you experience any of these behaviors, so as to discuss ways
to manage or reduce the symptoms.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through
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 which is stated on the pack.
This medicine does not require any special storage conditions.
Do not use Tasmar if you notice that the tablets are damaged.

6. Contents of the pack and other information

What Tasmar contains

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

Tablet core: calcium phosphate, microcrystalline cellulose, povidone K30, sodium starch
glycollate, 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 Tasmar and contents of the pack
Tasmar is a film-coated tablet, oval in shape, with a colour ranging from pale to light yellow, with
the words “TASMAR” and “100” embossed on one side. Tasmar is available in the form of 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 Authorisation 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 medicine, contact the local representative of the Marketing Authorisation
Holder:

Lietuva
Viatris UAB
Tel: + 370 52051288

България
Майлан ЕООД
Тел.: +359 2 44 55400

België/Belgique/Belgien
Viatris
Tél/Tel: +32 (0) 26586100

Luxembourg/Luxemburg
Viatris
Tél/Tel: +32 (0) 26586100
Belgique/Belgien

Česká republika
Viatris CZ s.r.o.
Tel: +420 222 004 400

Magyarország
Viatris Healthcare Kft.
H-1138 Budapest,
Váci út 150.
Tel.: +36 1 465 2100

Danmark
Viatris ApS
Tlf: +45 28 11 69 32

Malta
V.J. Salomone Pharma Limited
Tel: +356 21220174

Deutschland
Viatris Healthcare GmbH
Tel: + 49 8000700800

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

Norge
Viatris AS
Hagaløkkveien 26
N-1383 Asker
Tlf: +47 66 75 33 00

Ελλάδα
Viatris Hellas Ltd
Τηλ: +210 010 0002

Eesti
Viatris OÜ
Tel: +372 6363 052

Österreich
Viatris Austria GmbH Guglgasse 15
A-1110 Wien
Tel: + 43 1 86 390

España
Viatris Pharmaceuticals, S.L.
Tel: +34 900 102 712

Polska
Viatris Healthcare Sp.z.o.o.
ul. Postępu 21 B
02-676 Warszawa
Tel.: +48 22 5466400

France
Viatris Santé
1 bis place de la Défense-
Tour Trinity
92400 Courbevoie
Tél : +33 140 80 15 55

Portugal
Viatris Healthcare, Lda
Av. D. João II,
Edifício Atlantis, nº 44C – 7.3 e 7.4
1990-095 Lisboa
Tel:+351 214 127 200

Hrvatska
Viatris Hrvatska d.o.o.
Tel: +385 1 23 50 599

România
BGP PRODUCTS SRL
Tel: +40372 579 000

Ireland
Viatris Limited
Tel: +353 18711600

Slovenija
Viatris d.o.o.
Tel: +386 1 23 63 180

Ísland
Icepharma hf.
Sími: +354 540 8000

Slovenská republika
Viatris Slovakia s.r.o.
Tel: +421 2 32 199 100

Italia
Viatris Italia
Via Vittor Pisani, 20
20124 Milano
Tel: +39 0261246921

Suomi/Finland
Viatris Oy
Puh/Tel: +358 20 720 9555

Κύπρος
GPA Pharmaceuticals Ltd
Τηλ: +357 2220 7700

Sverige
Viatris AB
Tel: +46 (0) 8 630 19 00

Latvija
Viatris SIA
Tel: +371 67616137

United Kingdom (Northern Ireland)
Mylan IRE Healthcare Limited
Tel: +353 18711600
More detailed information on this medicine is available on the website of the European Medicines
Agency: http://www.ema.europa.eu .

Tasmar 200 mg film-coated tablets

Tolcapone

Read this leaflet carefully before you start to take this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even 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 you take 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 is Tasmar and what is it used for

For the treatment of Parkinson's disease, Tasmar is used together with the medicine levodopa (such as
levodopa/benserazide or levodopa/carbidopa).
Tasmar is used when no other alternative medicine can stabilize Parkinson's disease.
You are already taking levodopa to treat your Parkinson's disease.
A natural protein (enzyme) present in the body, catechol-O-methyltransferase (COMT), degrades
the levodopa-based medicine. Tasmar blocks this enzyme and slows down the degradation of levodopa.
This means that by taking it together with levodopa (such 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 an increase in liver enzymes
• if you have severe involuntary movements (dyskinesia)
• if you have previously experienced severe symptoms of muscle rigidity, fever or mental confusion (symptomatic complex of malignant neuroleptic syndrome (MNS)) and/or if you have skeletal muscle tissue damage (a non-traumatic rhabdomyolysis) or fever (hyperthermia).
• if you are allergic to the active ingredient tolcapone or to any of the other ingredients of Tasmar
• if you suffer from a particular type of adrenal medulla tumor (pheochromocytoma)
• if you are taking certain medications to treat depression and anxiety, called non-selective monoamine oxidase inhibitors (MAOIs)

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

• has described the risks of treatment with Tasmar to you,
• has explained the measures necessary to minimize these risks to you,
• has answered any questions you may have.
• if you are pregnant or planning to become pregnant. Your doctor will examine 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.

Tell your doctor if you or your family members/carers notice a growing strong desire to
behave in a way that is unusual for you or to be unable to resist the urge or temptation to perform
actions that could harm you or others. These behaviors are called impulse control disorders and include gambling addiction, overeating, excessive spending, excessive sexual behavior, or concern about the onset of increasing
sexual thoughts or desires. Your doctor may decide to review your therapy.
You must only take Tasmar if Parkinson's disease is not adequately controlled by the use of
other therapies.
In addition, the doctor will stop treatment with Tasmar if there are no
improvements after 3 weeks to justify the risks associated with continuing treatment.

Liver injury
Tasmar can cause rare but potentially life-threatening liver injury. Liver injury has
occurred more frequently after 1 month and before 6 months. It should also be considered that
the risk of liver injury is higher in female patients.
Therefore, you must consider the following preventive measures.
Before starting treatment:
To reduce the risk of liver injury, do not use Tasmar if

• you have a liver disease
• blood tests performed before starting treatment show any abnormalities in the liver (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 next 6 months of therapy,
• subsequently every 8 weeks. Treatment will be discontinued if abnormal blood test values are present.

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

Malignant Neuroleptic Syndrome (MNS)
Symptoms of malignant neuroleptic syndrome can develop during treatment with Tasmar.
MNS manifests with some or all of the following symptoms:

• severe muscle rigidity, jerking movements of muscles, arms or legs, and muscle pain. Sometimes, muscle injury can cause a dark discoloration of the urine.
• other important symptoms are high fever and a state of mental confusion.

Rarely, after a sudden reduction or discontinuation of Tasmar or other anti-Parkinsonian drugs, you may
develop severe symptoms of muscle rigidity, fever, or mental confusion. If this should
happen, inform your doctor.
You must consider the following preventive measures.
Before starting treatment:
To reduce the risk of MNS, do not use Tasmar if, according to your doctor, you suffer from severe
involuntary movement (dyskinesia) or have previously had a disease that may have been the
MNS.
Tell your doctor about all prescription and non-prescription medications you are taking, as
the risk of MNS may increase with the use of specific medications.
During treatment:
If you develop symptoms such as those described above, and you think it is MNS, you should report them
immediately to your doctor.
Do not stop Tasmar or any other medication for the treatment of Parkinson's disease without telling your
doctor, as this may increase the risk of MNS.

Also tell your doctor:

• if you have other illnesses in addition to Parkinson's disease,
• if you are allergic to other drugs, foods or dyes,
• if you developed symptoms caused by levodopa, such as involuntary movement (dyskinesia) and nausea, shortly after starting and during treatment with Tasmar.

If you do not feel well, you should contact your doctor because it may be necessary to take a lower
dose of levodopa.

Children and adolescents
Tasmar is not recommended for use in children under the age of 18 due to a lack of
safety or efficacy data. There is no relevant indication for use in children and adolescents.

Other medicines and Tasmar
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those available without a prescription (over-the-counter medicines and
herbal medicines).
Tell your doctor about all the 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 have blood tests done to monitor your blood's ability to clot.

If you are hospitalized or if a new medicine is prescribed to you, tell your 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 1 glass of water.

Pregnancy and breastfeeding and fertility
If you are pregnant or planning to become pregnant, tell your doctor. The doctor will take
into account 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 operating machinery
Since Parkinson's disease can affect your ability to drive a car or operate machinery, you should discuss this with your doctor.
Tasmar affects the symptoms of Parkinson's disease.
The use of Tasmar together with other medicines you take for Parkinson's disease can induce excessive drowsiness (sleepiness) and sudden attacks of sleep (you may fall asleep
suddenly). Therefore, until these recurring attacks and drowsiness resolve, you should avoid
driving or operating machinery.

Tasmar contains lactose and sodium
If you have been told by your doctor that you have an intolerance to some types of sugar, contact 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 following always exactly the instructions of the doctor. If you have doubts consult the doctor or
the pharmacist.
Dosage and frequency of administration
The doctor must always start the treatment with the standard dose of 1 tablet three times a day
(100 mg (1 tablet)).
Tasmar must be discontinued if no improvements occur within 3 weeks from the start of
treatment.
To improve efficacy, the doctor must use the highest dosage (200 mg three times a day)
only if the better control of the symptoms of Parkinson's disease outweighs the expected increase
of undesirable effects. Often with the higher dose the undesirable effects can be serious and
affect the liver. In the absence of improvement with the higher dose, after a total of 3 weeks,
the doctor must interrupt the treatment with Tasmar.
At the beginning and during the treatment with Tasmar it may be necessary to modify the dose of levodopa.
The doctor will advise you what to do.

How to take the medicine:
Swallow Tasmar with an amount equal to a glass of water.
Do not break or crush the tablets.
The first tablet of Tasmar should be taken in the morning together with the 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 because you may need urgent
medical care.
If someone else accidentally takes the medicine, contact your doctor or hospital immediately
because this person may need urgent medical care.

Among the symptoms of overdose may appear nausea, vomiting, dizziness and difficulty breathing.

If you forget to take Tasmar
Take it as soon as you remember, then continue to take it at the usual times. However, if taking the
next dose the situation remains normal, do not compensate for the missed dose. Do not take a
double dose to compensate for the forgotten dose. If you have forgotten several doses, inform the
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 the 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 everyone will experience them.
The frequency of possible side effects, listed below, is defined using the
following convention:

Inform your doctor or pharmacist as soon as possible

• if you feel unwellwhile taking Tasmar
• if you have symptoms such as nausea, vomiting, abdominal pain, loss of appetite, weakness, fever,dark urine or jaundice,as liver function disorders, sometimes severe hepatitis, have been rarely observed,
• if you notice the appearance of dark urineas it could be a sign of muscle or liver damage. Any other yellow discoloration of the urine is normally harmless,
• if you experience persistent or severe diarrhea

Shortly after starting and during treatment with Tasmar you may experience symptoms caused by
levodopa, such as involuntary movements and nausea. Therefore, if you feel unwell, contact your doctor as
it may be necessary to adjust the dose of levodopa.

Other possible side effects:
Very common:

• involuntary movements (dyskinesia)
• nausea, loss of appetite, diarrhea
• headache, dizziness
• sleep disorders, drowsiness
• feeling dizzy when getting up, (orthostatic disorders)
• mental 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
• flu-like symptoms
• reduced voluntary and involuntary movement (hypokinesia)
• upper respiratory tract infections
• increased levels of specific liver enzymes
• discoloration of urine

Uncommon:

• liver injury, in rare cases with fatal outcome

Rare:

• severe symptoms of muscle rigidity, 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:
• a strong urge to gamble despite serious personal and family consequences
• altered or increased sexual interest and related embarrassing behaviors for you and others, such as increased sexual drive
• an uncontrollable desire to spend money or make excessive purchases
• uncontrolled eating (consuming large amounts of food in a short period of time) or compulsive (consuming an amount of food greater than that which determines satiety)

Inform your doctor if you experience any of these behaviors, so you can discuss ways
to manage or reduce the symptoms.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform
your doctor or pharmacist. You can also report side effects directly through
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 which is stated on the pack.
This medicine does not require any special storage conditions.
Do not use Tasmar if you notice that the tablets are damaged.

6. Contents of the pack and other information

What Tasmar contains

• The active ingredient is tolcapone (200 mg in each film-coated tablet)
• Other ingredients 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 Tasmar and contents of the pack
Tasmar is a film-coated tablet, oval in shape, with a colour ranging from yellow-orange to dark yellow,
with the words “TASMAR” and “200” engraved on one side. Tasmar is available in the form of film-coated
tablets containing 200 mg of tolcapone. It is available in blisters in packs of 30 or 60
tablets and in glass bottles in packs of 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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 medicine, contact the local representative of the Marketing Authorisation
Holder:
Viatris UAB
Tel: + 370 52059367

България
Майлан ЕООД
Тел.: +359 2 44
55400

België/Belgique/Belgien
Viatris
Tél/Tel: +32 (0) 26586100

Luxembourg/Luxemburg
Viatris
Tél/Tel: +32 (0) 26586100
Belgique/Belgien

Česká republika
Viatris CZ s.r.o.
Tel: +420 222 004 400

Magyarország
Viatris Healthcare Kft.
H-1138 Budapest,
Váci út 150.
Tel.: +36 1 465 2100

Danmark
Viatris ApS
Tlf: +45 28 11 69 32

Malta
V.J. Salomone Pharma Limited
Tel: +356 21220174

Deutschland
Viatris Healthcare GmbH
Tel: + 49 8000700800

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

Eesti
Viatris OÜ
Tel: +372 62 61 025

Norge
Viatris AS
Tlf: +47 66 75 33 00

Ελλάδα
Viatris Hellas Ltd
Τηλ: +30 210 010 0002

Österreich
Viatris Austria GmbH
Guglgasse 15
A-1110 Wien
Tel: + 43 1 86 390

España
Viatris Pharmaceuticals, S.L.
Tel: +34 900 102 712

Polska
Viatris Healthcare Sp.z.o.o.
ul. Postępu 21 B
02-676 Warszawa
Tel.: +48 22 5466400

France
Viatris Santé
1 bis place de la Défense-
Tour Trinity
92400 Courbevoie
Tél: +33 1 40 80 15 55

Portugal
Viatris Healthcare, Lda
Av. D. João II,
Edifício Atlantis, nº 44C – 7.3 e 7.4
1990-095 Lisboa
Tel:+351 214 127 200

Hrvatska
Viatris Hrvatska d.o.o.
Tel: +385 1 23 50 599

România
BGP PRODUCTS SRL
Tel: +40372 579 000

Ireland
Viatris Limited
Tel: +353 18711600

Slovenija
Viatris d.o.o.
Tel: +386 1 23 63 180

Ísland
Icepharma hf.
Sími: +354 540 8000

Slovenská republika
Viatris Slovakia s.r.o.
Tel: +421 2 32 199 100

Italia
Viatris Italia
Via Vittor Pisani, 20
20124 Milano
Tel: +39 0261246921

Suomi/Finland
Viatris Oy
Puh/Tel: +358 20 720 9555

Κύπρος
GPA Pharmaceuticals Ltd
Τηλ: +357 22863100

Sverige
Viatris AB
Tel: +46 (0) 8 630 19 00

Latvija
Viatris SIA
Tel: +371 67616137

United Kingdom (Northern Ireland)
Mylan IRE Healthcare Limited
Tel: +353 18711600
More detailed information on this medicine is available on the website of the European Medicines
Agency: http://www.ema.europa.eu .