100 mg film-coated tablets
tolcapone
What Tasmar is and what it is used for
In the treatment of Parkinson’s disease, Tasmar is used together with the drug levodopa (such as levodopa/benserazide or levodopa/carbidopa).
Tasmar is used when all other alternative medicines cannot stabilize your Parkinson’s disease.
You are already taking levodopa to treat your Parkinson’s disease.
A natural protein ( enzyme ) that occurs in your body, Catechol- O -methyltransferase (COMT), breaks down levodopa. Tasmar blocks this enzyme and thus delays the breakdown of levodopa. This means that you may experience an improvement in your Parkinson’s disease symptoms when Tasmar is taken with levodopa (such as levodopa/benserazide or levodopa/carbidopa).
What you need to know before using Tasmar
Do not take Tasmar:
- if you have liver disease or elevated liver enzymes
- if you have difficult involuntary movements ( dyskinesia )
- if you have previously had severe symptoms of muscle stiffness, fever, or mental confusion (neuroleptic malignant syndrome, NMS) and/or if you have damage to skeletal muscle tissue (non-traumatic rhabdomyolysis ) or fever ( hyperthermia ).
- if you are hypersensitive (allergic) to the active substance tolcapone or any of the other ingredients in Tasmar
- if you have a particular type of tumor in the adrenal medulla ( pheochromocytoma )
- if you are taking special medicine to treat depression and anxiety called non-selective monoamine oxidase (MAO) inhibitors.
Warnings and precautions
Talk to your doctor or pharmacist before taking Tasmar.
You should not start your treatment with Tasmar before your doctor
- have described the risks of treatment with Tasmar
- has described the measures necessary to be taken to minimize these risks
- have answered all the questions you 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 breastfeed your child during treatment with Tasmar.
Tell your doctor if you, your family, or a healthcare professional notice that you develop urges or urges to behave in ways that are unusual for you, or that you cannot resist impulses, urges, or the temptation to do certain activities that may harm you or others. These behaviors are called impulse control disorders and can include gambling addiction, excessive eating or spending, an abnormally high sex drive, or preoccupation with increased sexual thoughts or feelings. Your doctor may need to review your treatments.
You should only be treated with Tasmar if your Parkinson’s disease cannot be properly controlled with other treatment methods.
In addition, your doctor will stop treatment with Tasmar if after three weeks you do not have an improvement sufficient to justify the risks of continuing treatment.
Liver damage
Tasmar can rarely cause potentially fatal liver damage. In most cases, liver damage has occurred after 1 month and before 6 months. It should also be noted that female patients may have a higher risk of liver damage. Therefore, the following preventive measures should be taken into account:
Before treatment begins:
To reduce the risk of liver damage, do not use Tasmar if
- you have a liver disease
- blood samples were taken before the start of treatment show liver damage (alanine aminotransferase ( ALT ) and aspartate aminotransferase ( AST ) tests).
During treatment:
Blood samples will be taken at the following intervals during treatment:
- every two weeks during the first twelve months of treatment
- every four weeks during the following six months of treatment
- then every eighth week during continued treatment. Treatment will be discontinued if the samples become abnormal.
Treatment with Tasmar can sometimes cause disturbances in liver function. Therefore, you should contact your doctor immediately if you experience symptoms such as nausea, vomiting, stomach pain (especially in the upper right area above the liver), loss of appetite, weakness, fever, dark urine, or jaundice (yellow skin or eyes) or if you get tired more easily.
If you have already been treated with Tasmar and had an acute liver injury during treatment, you should not start Tasmar again.
NMS (neuroleptic malignant syndrome)
Symptoms of the neuroleptic malignant syndrome (NMS) may occur during treatment with Tasmar. NMS consists of some or all of the following symptoms:
- severe muscle stiffness, twitching in the muscles, arms, and legs, and soreness in the muscles. Muscle damage can sometimes cause dark-colored urine
- other important symptoms are high fever and mental confusion.
If you stop or stop treatment with Tasmar or other medicines for Parkinson’s disease suddenly, in rare cases you may experience severe symptoms such as muscle stiffness, fever, or mental confusion. If this occurs, contact your doctor.
The following preventive measures must be taken into account.
Before treatment begins:
To reduce the risk of NMS, you should not use Tasmar if your doctor says you have severe involuntary movements ( dyskinesia ) or a previous illness that may have been NMS.
Tell your doctor about all prescription and over-the-counter medications you are taking, as the risk of NMS may increase if you take certain medications.
During treatment:
If you experience symptoms described above that you think maybe NMS, you should tell your doctor immediately about these symptoms.
Do not stop taking Tasmar or any other Parkinson’s medicine without telling your doctor, as this may increase the risk of NMS.
Also, inform your doctor:
- if you have a disease other than Parkinson’s disease
- if you are allergic to other medicines, foods, or dyes
- if soon after starting treatment and during your treatment with Tasmar you get symptoms that may be caused by levodopa, such as involuntary movements ( dyskinesia ) and nausea.
Contact your doctor if you feel unwell as you may need to take less levodopa.
Children and young people
Tasmar is not recommended for use in children under 18 years of age due to insufficient data regarding safety and efficacy. 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 over-the-counter medicines and natural remedies.
Tell your doctor about any other medicines you are taking, especially:
- medication for depression
- alpha -methyldopa (used for high blood pressure )
- apomorphine (used in Parkinson’s disease )
- dobutamine (used in the treatment of heart failure )
- adrenaline (used in heart attacks) and isoprenaline (used in heart attacks)
- anticoagulants of the warfarin type (which prevent blood clots). In this case, your doctor may take regular blood tests to check how easily your blood clots.
If you are admitted to the hospital or if you are prescribed a new medicine, you must tell your doctor that you are taking Tasmar.
Tasmar with food, drink, and alcohol
Tasmar can be taken with or without food.
Tasmar should be taken with a glass of water.
Pregnancy, breastfeeding, and fertility
You must tell your doctor if you are pregnant or intend to become pregnant. Your doctor will tell you about the benefits and risks of taking Tasmar during pregnancy.
The effectiveness of Tasmar has not been studied in infants. You should not breastfeed your child during treatment with Tasmar.
Driving ability and use of machinery
As your ability to drive or operate machinery may be affected by Parkinson’s disease, you should consult your doctor.
Tasmar affects your symptoms of Parkinson’s disease.
Tasmar used with your other medicines for Parkinson’s disease can cause excessive drowsiness (sleepiness) and episodes of sudden sleep onset (you may fall asleep suddenly). You must therefore refrain from driving or operating machinery until such recurrent episodes and excessive drowsiness have ceased.
Tasmar contains lactose and sodium
If you have an intolerance to certain sugars, you should consult a doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. it is almost ‘sodium-free’.
How to take Tasmar
Always take Tasmar as directed by your doctor. You should check with your doctor or pharmacist if you are unsure.
Dosage and frequency of administration
Your doctor should always start your treatment with the standard dose of 1 tablet (100 mg) three times daily. If no improvement is seen within 3 weeks of starting treatment, treatment with Tasmar should be discontinued.
To increase the effect, your doctor should only increase the dose by one to 2 tablets three times daily (200 mg three times daily) if the improvement in your symptoms of Parkinson’s disease outweighs the expected increase in side effects. The side effects at the higher dose can often be serious and affect your liver. If you do not get better on the higher dose after a total of 3 weeks of treatment, your doctor should stop your treatment with Tasmar.
When you start taking Tasmar and during treatment with Tasmar, your levodopa dose may need to be changed. Your doctor will advise you on this.
How to take the medicine:
Swallow Tasmar with a glass of water.
Do not split or crush the tablets.
You should take the first tablet of Tasmar in the morning with your second medicine for Parkinson’s disease ‘levodopa’.
You should take the next dose of Tasmar 6 and 12 hours later.
| Time | Dose | Note |
| Morning | 1 film-coated tablet Tasmar | Together with the first daily dose a levodopa |
| During the day | 1 film-coated tablet Tasmar | |
| Evening | 1 film-coated tablet Tasmar |
If you have taken too much Tasmar
Contact a doctor, pharmacy, or hospital immediately as you may need urgent medical attention. If someone else accidentally takes your medicine, contact a doctor or hospital immediately as that person may need urgent medical attention.
Symptoms of overdose can appear in the form of nausea, vomiting, dizziness, and difficulty breathing.
If you forget to take Tasmar
Take it as soon as you remember and then continue to take it at the usual times. If you are due to take the next dose shortly, however, you should not make up for the missed dose. Do not take a double dose to make up for a missed single dose. If you forget to take several doses in a row, inform your doctor and follow the advice given to you.
If you stop taking Tasmar
Do not reduce or stop treatment unless your doctor tells you to. Always follow your doctor’s instructions on how long your treatment with Tasmar should last.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of possible side effects is indicated with the following convention:
| Very common: | may affect more than 1 in 10 people |
| Usual: | may affect up to 1 in 10 people |
| Less common | may affect up to 1 in 100 people |
| Rare: | may affect up to 1 in 1,000 people |
| Very rare: | may occur in up to 1 in 10,000 people |
| Not known: | frequency not known (cannot be calculated from available data) |
Tell your doctor or pharmacist as soon as possible:
- if you feel unwell while taking Tasmar.
- if you experience symptoms such as nausea, vomiting, abdominal pain, decreased appetite, weakness, fever, darkening of the urine, or jaundice because disorders of liver function, sometimes severe hepatitis, have been observed in rare cases
- if you notice darkening of the urine as this may be a sign of muscle or liver damage. Any other yellow discoloration of the urine is often harmless
- if you get persistent or severe diarrhea.
Soon after you start treatment with Tasmar or during treatment with Tasmar, you may have symptoms caused by levodopa, e.g. involuntary movements or nausea. If you feel unwell, you should therefore contact a doctor as the levodopa dose may need to be changed.
Other possible side effects:
Very common:
- involuntary movements ( dyskinesia )
- nausea, decreased appetite, diarrhea
- headache, dizziness
- trouble sleeping, sleepiness
- feeling unsteady when standing, fainting (drop in blood pressure)
- mental confusion and hallucinations
- movement disorders with involuntary muscle spasms or wrong postures ( dystonia )
- greatly increased dreaming
Usual:
- chest pain
- constipation, sensitive stomach, stomachache, vomiting, dry mouth
- fainting
- increased sweating
- flu-like symptoms
- decreased voluntary and involuntary movements ( hypokinesia )
- upper respiratory tract infection
- increase in certain liver values
- discoloration of the urine
Less common :
- liver damage, in rare cases with fatal outcome
Rare :
- severe symptoms of muscle stiffness, fever, or mental confusion (neuroleptic malignant syndrome) if treatment for Parkinson’s is suddenly reduced or stopped
- impulse control disorder (inability to resist the impulse to perform activities that may be harmful).
This may include:- Strong impulse to excessive gambling despite serious consequences for you or your family.
- Changed or increased sexual interest and behavior of significant concern to you or others, such as an increased sex drive.
- Uncontrollable 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 is needed to satisfy your hunger)
Tell your doctor if you experience any of these behaviors, and the doctor will discuss ways to manage or reduce these symptoms.
How to store Tasmar
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the packaging.
No special storage instructions.
Do not use Tasmar if you see that the tablets are damaged.
Contents of the packaging and other information
Contents declaration
- The active ingredient is tolcapone (100 mg in each film-coated tablet)
- 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. The film coating: hydroxypropyl methylcellulose, talc, yellow iron oxide, ethyl cellulose, titanium dioxide (E171), triacetin, and sodium lauryl sulfate.
Appearance and package sizes of the medicine
Tasmar is a slightly light yellow, oval film-coated tablet. “TAMAR” and “100” are marked on one side. Tasmar is supplied as film-coated tablets containing 100 mg tolcapone. Tasmar is available as blister packs in pack sizes of 30 or 60 tablets and as glass jars in pack sizes of 30, 60, 100, or 200 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Meda AB
Piper’s road 2A
S-170 09 Solna
Sweden
Manufacturer
ICN Polfa Rzeszów SA
ul. Przemysłowa 2
35-959 Rzeszów
Poland