Tasmar
tolcapone
Tasmar 100 mg film-coated tablets tolcapone
Keep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor or your pharmacist.
This medicine has been prescribed for you. 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.
What is in this leaflet:
What Tasmar is and what it is used for
What do you need to know before you take Tasmar
How to take Tasmar
Possible side effects
How to store Tasmar
Contents of the pack and other information
For the treatment of Parkinson’s disease, Tasmar is used together with the medicinal product levodopa (as levodopa/benserazide or levodopa/carbidopa).
Tasmar is used when all other alternative medicines cannot stabilise your Parkinson’s disease.
For the treatment of your Parkinson’s disease you already take levodopa.
A natural protein (enzyme) in your body, the (COMT) Catechol-O-methyltransferase breaks down the levodopa. Tasmar blocks this enzyme and thus slows the breakdown of levodopa. This means when it is taken together with levodopa (as levodopa/benserazide or levodopa/carbidopa) you should have an improvement in the symptoms of your Parkinson’s disease.
if you have liver disease or increased liver enzymes
if you have severe involuntary movement (dyskinesia)
if you have a previous history of severe symptoms of muscle stiffening, fever or mental confusion (Neuroleptic Malignant Syndrome (NMS) Symptom Complex) and/or if you have damage of skeletal muscle tissue (non-traumatic rhabdomyolysis) or fever (hyperthermia)
if you are hypersensitive (allergic) to the active substance tolcapone or to any of the other ingredients of Tasmar
if you have a special type of tumour in the adrenal medulla (Phaeochromocytoma)
if you take a certain medication to treat depression and anxiety, called non-selective mono amino oxidase (MAO) inhibitors
Talk to your doctor or pharmacist before taking Tasmar. You should not start taking Tasmar until your doctor
has described the risks of treatment with Tasmar
has explained the measures necessary to minimise those risks
has answered any questions you may have
if you are pregnant or intend to become pregnant. Your doctor will discuss the risks and benefits of taking Tasmar during pregnancy. The effects of Tasmar have not been studied in infants. You should not breast-feed your infant during treatment with Tasmar.
Tell your doctor if you or your family/carer notices you are developing urges or cravings to behave in ways that are unusual for you or you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others. These behaviours are called impulse control disorders and can include addictive gambling, excessive eating or spending, an abnormally high sex drive or a preoccupation with an increase in sexual thoughts or feelings. Your doctor may need to review your treatments.
You should only receive Tasmar if your Parkinson’s disease is not adequately controlled by the use of other therapies.
In addition, your doctor will stop Tasmar treatment if after 3 weeks you do not improve enough to justify the risks of continuing treatment.
Tasmar may cause rare but potentially fatal liver injury. Liver injury has occurred most often after 1 month and before 6 months. It should also be noted that female patients may have a higher risk of liver injury. Therefore, the following preventive measures have to be considered.
Before beginning treatment:
To reduce the risk of liver injury you should not use Tasmar if
you have a liver disease
- in case of elevated liver function tests in the blood test done before starting treatment (tests of alanine amino transferase (ALT) and aspartate amino transferase (AST)).
While receiving treatment:
During treatment, blood tests will be done in the following time intervals:
every 2 weeks during the first 12 months of therapy,
every 4 weeks during the following 6 months of therapy,
every 8 weeks during further treatment.
The treatment will be stopped, if these blood tests become abnormal.
The treatment with Tasmar may sometimes lead to disturbances in the way the liver works. Therefore, you should contact your doctor immediately if you experience symptoms such as nausea, vomiting, pain in your stomach (particularly over the liver in the right upper area), loss of appetite, weakness, fever, darkening of urine, jaundice (yellow skin or eyes) or if you tire more easily.
If you have been already treated with Tasmar and developed acute liver injury during treatment, Tasmar should not be re-introduced again.
Symptoms of Neuroleptic Malignant Syndrome (NMS) may occur during Tasmar treatment. The NMS consists of some or all of the following:
severe muscle stiffness, jerking movements of muscles, arms or legs, and soreness of muscles.
Muscle injury can sometimes cause dark urine.
other important symptoms are high fever and mental confusion.
Rarely, after abruptly reducing or stopping Tasmar or other antiparkinsonian drugs, you may experience severe symptoms of muscle stiffening, fever or mental confusion. If this happens notify your doctor.
The following preventive measures have to be considered. Before beginning treatment:
To reduce the risk of NMS you should not use Tasmar if your doctor says you have severe involuntary movement (dyskinesia) or a previous illness that may have been NMS.
Inform your doctor about all prescription and non-prescription medications as the risk of NMS may be increased if you are taking some specific medications.
While receiving treatment:
If you develop any symptoms as described above, that you think may be NMS, you should report them to your doctor immediately.
Do not stop Tasmar or any other Parkinson’s medications without telling your doctor as this may increase the risk of NMS.
if you have any illnesses other than Parkinson’s disease
if you are allergic to other medicines, food and dyes
if soon after beginning and during treatment with Tasmar you have symptoms which may be caused by levodopa such as involuntary movement (dyskinesia) and nausea.
If you feel unwell, you should contact your doctor because you may need to take less levodopa.
Tasmar is not recommended for use in children below the age of 18 due to insufficient data on safety or efficacy. There is no relevant indication for use in children and adolescents.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed (non-prescription medicines and herbals).
Please inform your doctor about all other medicines you are taking especially:
antidepressants
alpha-methyldopa (used to treat increased blood pressure)
apomorphine (used for Parkinson’s disease)
dobutamine (used for the chronic heart disease)
adrenaline and isoprenaline (both used for heart attacks)
anticoagulants of the warfarin type (that prevent blood clotting). In this case your doctor may perform regular blood tests to monitor how easily your blood clots.
If you go to hospital or if you are prescribed a new medicine, you must tell your doctor that you are taking Tasmar.
You must tell your doctor if you are pregnant or intend to become pregnant. Your doctor will discuss the risks and benefits of taking Tasmar during pregnancy.
The effects of Tasmar have not been studied in infants. You should not breast-feed your infant during treatment with Tasmar.
Since your ability to drive a car or operate machinery may be affected by Parkinson’s disease, you should discuss this with your doctor.
Tasmar has an effect on the symptoms of your Parkinson’s disease.
Tasmar used with your other Parkinson medicines can cause excessive drowsiness (somnolence) and sudden sleep onset episodes (you may suddenly fall asleep). Therefore you must refrain from driving or operating machines until such recurrent episodes and excessive drowsiness have resolved.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium- free’.
Always take Tasmar exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure.
Dose and frequency of administration
Your doctor should always begin your treatment with the standard dose of 3 times daily 1 tablet (100 mg (1 tablet)).
If benefits are not seen within 3 weeks of the initiation of the treatment, Tasmar should be discontinued.
To improve efficacy your doctor should only increase the dose to 3 times daily 2 tablets (200 mg three times a day) if the increase in how your Parkinson’s disease symptoms are controlled outweighs the expected increase in side effects. The side effects at the higher dose can often be severe and affect your liver. If you do not get better at the higher dose after a total of 3 weeks, your doctor should stop your treatment with Tasmar.
When beginning and during treatment with Tasmar, your dose of levodopa may need to be changed. Your doctor will advise you what to do.
The first tablet Tasmar is to be taken in the morning together with your other parkinsonian medicine ‘levodopa’.
The following doses of Tasmar should be taken 6 and 12 hours later.
Time of day | Dose | Note |
Morning | 1 film-coated tablet Tasmar | Together with the first daily dose of levodopa |
During the day | 1 film-coated tablet Tasmar | |
Evening | 1 film-coated tablet Tasmar |
Contact your doctor, pharmacist or hospital immediately as you may need urgent medical attention. If another person accidentally takes your medicine, contact a doctor or hospital immediately as he or she may need urgent medical attention.
Symptoms of overdose may include nausea, vomiting, dizziness and breathing difficulties.
Take it as soon as you remember, then continue to take it at the usual times. However, if taking the next dose should be directly ahead, do not make up for the forgotten dose. Do not take a double dose to make up for forgotten individual doses. If you have forgotten several doses, please inform your doctor and follow the advice given to you.
Do not reduce or stop taking your medicine unless your doctor tells you to. Always follow the instructions of your doctor about the duration of the treatment with Tasmar.
Like all medicines, this medicine can have side effects, although not everybody gets them. The frequency of possible side effects listed below is defined using the following convention:
Very common | may affect more than 1 in 10 people |
Common | may affect up to 1 in 10 people |
Uncommon | may affect up to 1 in 100 people |
Rare | may affect up to 1 in 1,000 people |
Very rare | may affect up to 1 in 10,000 people |
Not known | frequency cannot be estimated from the available data |
if you do not feel well while you are taking Tasmar
if you experience symptoms such as nausea, vomiting, abdominal pain, loss of appetite, weakness, fever, darkening of urine or jaundice since uncommonly
disturbances in the way the liver works, sometimes severe hepatitis was observed,
if you notice a darkening of your urine since this could be a sign of a muscular or liver injury.
Any other yellow urine discolouring is usually harmless.
if you develop persistent or severe diarrhoea
Soon after beginning and during your treatment with Tasmar, you may have symptoms caused by levodopa such as involuntary movement and nausea. Therefore, if you feel unwell, you should contact your doctor since you may need to have your levodopa dose changed.
involuntary movement (dyskinesia)
nausea, decreased appetite, diarrhoea
headache, dizziness
sleep problems, somnolence
feeling lightheaded while you stand (orthostatic complaints)
mental confusion and hallucinations
movement disorder with involuntary muscle spasms or malpositions (dystonia)
dreaming excessive
chest pain
constipation, dyspepsia, stomach ache, vomiting, dry mouth
fainting
increased sweating
influenza-like symptoms
reduced voluntary and involuntary movement (hypokinesia)
upper respiratory tract infection
increase of specific liver enzymes
urine discoloration
liver injury, in rare cases with fatal outcome
severe symptoms of muscle stiffening, fever or mental confusion (Neuroleptic Malignant Syndrome) when antiparkinsonian treatments are abruptly reduced or withdrawn
impulse control disorders (inability to resist the impulse of an action that could be harmful) This may include:
Strong impulse to gamble excessively despite serious personal or family consequences. o Altered or increased sexual interest and behaviour of significant concern to you or to
others, for example, an increased sexual drive. o Uncontrolled excessive shopping or spending.
Binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than needed to satisfy your hunger).
If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V*.
By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children. Do not use after the expiry date which is stated on the pack.
This medicinal product does not require any special storage conditions. Do not use Tasmar if you notice that the tablets are damaged.
The active substance is tolcapone (100 mg in each film-coated tablet).
The other ingredients 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-coat: hydroxypropyl methylcellulose, talc, yellow iron oxide, ethyl cellulose, titanium dioxide (E171), triacetin, sodium lauril sulfate.
Tasmar is a pale to light yellow, oval shaped, film-coated tablet. “TASMAR” and “100” are engraved on one side. Tasmar is supplied as film-coated tablets containing 100 mg tolcapone. It is available in blisters in pack sizes of 30 or 60 tablets and in glass bottles in pack sizes of 30, 60, 100 or 200 film- coated tablets.
Not all pack sizes may be marketed.
Meda AB Pipers väg 2A S-170 09 Solna Sweden
ICN Polfa Rzeszów S.A. ul. Przemysłowa 2
35-959 Rzeszów Poland
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
B-1170 Brussels
Tél/Tel: +32 2 5 04 08 11
B-1170 Brussels
Belgique/Belgien Tél/Tel: +32 2 5 04 08 11
Майлан ЕООД
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