Tasmar is used together with levodopa/benserazide or levodopa/carbidopa when all other alternative medicines cannot stabilise your Parkinson?s disease.
Catechol-O-methyltransferase (COMT) is a natural enzyme in your body that breaks down the levodopa medication used to treat your Parkinson?s disease. Tasmar blocks COMT and 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 your symptoms of Parkinson?s disease.
|Table of Contents|
|What do you have to consider before using it?|
|How is it used?|
|What are possible side effects?|
|How should it be stored?|
Do not take Tasmar:
- if you have liver disease or increased liver enzymes
- if you have severe dyskinesia (involuntary movement)
- if you have a previous history of Neuroleptic Malignant Syndrome (NMS) Symptom Complex (severe symptoms of muscle stiffening, fever or mental confusion) and /or if you have non-traumatic Rhabdomyolysis (damage of skeletal muscle tissue) or Hyperthermia (fever).
- if you are hypersensitive (allergic) to tolcapone or to any of the other ingredients of Tasmar.
- if you have Phaeochromocytoma (a special type of tumor)
- if you take non-selective mono amino oxidase (MAO) inhibitors (used to treat depression and anxiety)
Take special care with Tasmar:
- youshould not start taking Tasmar until your doctor has described the risks of treatment with Tasmar and measures necessary to minimise those risks, and answered any questions you may have. 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.
- Liver Injury: Tasmar may cause rare but potentially fatal liver injury. Liver injury has occurred most often after 1 month and before 6 months. Injury occurring earlier or later is also possible. It should also be noted that female patients may have a higher risk of liver injury.
Before beginning treatment: To reduce the risk of liver injury you should not use Tasmar if 1) you have liver disease or 2) blood tests done before starting treatment show any liver abnormality (tests of ALT, alanine amino transferase and AST, aspartate amino transferase). While receiving treatment: Blood tests will be done every 2 weeks for the first year of therapy, every 4 weeks for the next 6 months and every 8 weeks thereafter and treatment will be stopped if they become abnormal.
- the treatment with Tasmar may sometimes lead to disturbances in the way the liver works. Therefore, 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 of the skin or eyes) or if you tire more easily, you should contact your doctor immediately
- if you have taken already Tasmar and developed acute liver injury while on Tasmar, it should not be re-introduced again.
- NMS (Neuroleptic Malignant Syndrome): Symptoms of Neuroleptic Malignant Syndrome may occur during Tasmar treatment. NMS (Neuroleptic Malignant Syndrome) 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. Very 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. Before beginning treatment: To reduce the risk of NMS you should not use Tasmar if your doctor says you have severe dyskinesia (involuntary movement) or a previous illness that may have been NMS. Inform your doctor of all prescription and non-prescription medications as the risk of NMS may be increased if you are taking medications that may alter the effects of the brain messenger molecules of dopamine and serotonin. While receiving treatment: If you develop 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, foods and dyes.
- soon after beginning and during your treatment with Tasmar, you may have symptoms caused by levodopa such as dyskinesia (involuntary movement) and nausea. If you feel unwell, you should contact your doctor because you may need to take less levodopa.
Taking other medicines
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).
When you are taking Tasmar with anticoagulants (that prevent blood clotting) of the warfarin type, your doctor may perform regular blood tests to monitor how easily the 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.
Taking Tasmar with food and drink
Tasmar can be taken with or without food.
Pregnancy and breast-feeding
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.
Driving and using machines
Tasmar has an effect on your symptoms of Parkinson?s disease. 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 used with your other Parkinson medicines can cause somnolence (excessive drowsiness) and sudden sleep onset episodes (you may suddenly fall asleep). Therefore you must refrain from driving or engaging in activities where impaired alertness may put yourself or others at risk of serious injury or death (e.g. operating machines) until such recurrent episodes and somnolence have resolved.
Important information about some of the ingredients of Tasmar
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Always take Tasmar exactly as your doctor has told you. You should check with your doctor if you are unsure. Do not break or crush tablets. Swallow Tasmar with water.
Dose and frequency of administration
When beginning and during treatment with Tasmar, your dose of levodopa may need to be changed. Your doctor will advise you what to do.
Your doctor should always begin your treatment with the standard dose (100 mg (1 tablet) three times a day). If benefits are not seen within 3 weeks of the initiation of the treatment, Tasmar should be discontinued. The dose should only be increased to the higher dose (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.
The first dose of Tasmar is taken with the first dose of the day of levodopa and the other doses of Tasmar are taken about 6 and 12 hours later. Take one tablet in the morning, one tablet in the middle of the day and one tablet in the evening.
If you take more Tasmar than you should
Contact a 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. If you forget to take Tasmar
Take it as soon as you remember, then continue to take it at the usual times. If you have missed several doses, please inform your doctor and follow the advice given to you. Do not take a double dose to make up for forgotten individual doses.
If you stop taking Tasmar
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, Tasmar can have side effects, although not everybody gets them. Tell your doctor or a pharmacist as soon as possible if you do not feel well while you are taking Tasmar.
Disturbances in the way the liver works, sometimes severe hepatitis, have been observed. Therefore, if you experience symptoms such as nausea, vomiting, abdominal pain, loss of appetite, weakness, fever, darkening of urine or jaundice you should contact your doctor immediately.
The frequency of possible side effects listed below is defined using the following convention: Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users in 10,000)
Very rare (affects less than 1 user in 10,000)
Not known (frequency cannot be estimated from the available data).
Side effects that may occur very commonly are: dyskinesia (involuntary movement), nausea, sleeping problems, decreased appetite, diarrhoea, fainting, feeling lightheaded when you stand, hallucination, headache, confusion and sleepiness.
Commonly, chest pain, constipation, vomiting, stomach ache, dry mouth and increased sweating may occur during treatment with Tasmar. Further common side effects that may occur are, dystonia, influenza and influenza like symptoms.
Very rarely, patients develop Neuroleptic Malignant Syndrome (severe symptoms of muscle stiffening, fever or mental confusion) when antiparkinsonian treatments are abruptly reduced or withdrawn.
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.
Contact your doctor if you develop persistent or severe diarrhoea.
This medicine can cause a harmless yellow urine discoloration. However if you notice a darkening of your urine this could be a sign of muscle injury or liver injury, please inform your doctor.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Keep out of the reach and sight of children.
Do not use after the expiry date 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.
What Tasmar contains
- The active substance is tolcapone (200 mg in each film- coated tablet)
- The other ingredients are: Tablet core : Calcium hydrogen phosphate, Microcrystalline cellulose, Povidone K30, Sodium starch glycollate, Lactose monohydrate, Talc, Magnesium stearate. Film-coat : Hydroxypropylmethylcellulose, Talc, Yellow iron oxide, Ethylcellulose, Titanium dioxide, Triacetin, Sodium lauril sulfate.
What Tasmar looks like and contents of the pack
Tasmar is an orange yellow to brown yellow, oval shaped, film-coated tablet. ?TASMAR? and ?200? are engraved on one side. Tasmar is supplied as film-coated tablets containing 200 mg tolcapone. It is available in blisters in pack sizes of 30 and 60 tablets and in glass bottles in pack sizes of 100 tablets.
Not all pack sizes may be marketed.
The marketing authorisation holder is:
Pipers väg 2A
S-170 09 Solna
The manufacturer responsible for batch release is:
ICN Polfa Rzeszów S.A.
ul. Przemys-owa 2
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
BelgiëBelgiqueBelgien MEDA Pharma S.A.N.V. Chaussée de la Hulpe 166 Terhulpsesteenweg 166 B-1170 Brussels TélTel 32 2 5 04 08 11 LuxembourgLuxemburg MEDA Pharma S.A.N.V. Chaussée de la Hulpe 166 Terhulpsesteenweg 166 B-1170 Brussels BelgiqueBelgien TélTel 32 2 5 04 08 11
. 24 1124 359 02 942 70 70 Magyarország MEDA PHARMA Hungary Kereskedelmi Kft. H-1139 Budapest Váci ut 91 Tel. 36 1 236 3410
eská republika MEDA Pharma s.r.o. Kodaská 144146 CZ 100 10 Praha 10 Tel 420 234 064 203 Malta Vivian Corporation Ltd. Sanitas Building, Tower Street Msida MSD 1824 Tel 356 21 320 338
Danmark Meda AS Solvang 8 DK-3450 Allerød Tlf 45 44 52 88 88 Nederland MEDA Pharma B.V. Krijgsman 20 NL-1186 DM Amstelveen Tel 31 20 751 65 00
Deutschland MEDA Pharma GmbH Co. KG Benzstraße 1 D-61352 Bad Homburg v.d.H. Tel 49 6172 888 01 Norge Meda AS Askerveien 61 N-1384 Asker Tlf 47 66 75 33 00
EestiMeda Pharma Narva mnt 11D EE - 10151 Tallinn, Eesti Tel. 372 6261 025 Österreich MEDA Pharma GmbH Guglgasse 15 A-1110 Wien Tel 43 1 86 390 0 Polska Meda Pharmaceuticals Sp.z.o.o. Al. Jana Pawla II15 PL-00-828 Warszawa Tel 48 22 697 7100 Vianex S.A. , 18 - , GR-14671 . 52894 30.210.8009111
Portugal MEDA Pharma Produtos Farmacêuticos, , SA Rua do Centro Cultural 13 P-1749-066 Lisboa Tel 351 21 842 0300 España MEDA Pharma S.A.U. Avenida de Castilla, 2 Parque Empresarial San Fernando Edificio Berlin E-28830 San Fernando de Henares Madrid Tel 34 91 669 93 00
France MEDA PHARMA SAS 25 Bd. de lAmiral Bruix F-75016 Paris Tél 33 156 64 10 70 România MEDA Pharma GmbH Co. KG Benzstraße 1 D-61352 Bad Homburg v.d.H. Germania Tel 49 6172 888 01
Slovenija MEDA Pharma GmbH Guglgasse 15 A-1110 Wien Avstrija Tel 43 1 86 390 0 Ireland Meda Health Sales Ireland Ltd. Office 10 Dunboyne Business Park Dunboyne IRL - Co Meath Tel 353 1 802 66 24
Slovenská republika MEDA Pharma spol. s r.o. Trnavská cesta 50 SK-821 02 Bratislava Tel 421 2 4914 0172 Ísland Meda AB Box 906 S-170 09 Solna Svíjóð. Sími 46 8 630 1900
Italia Meda Pharma S.p.A. Viale Brenta, 18 I-20139 Milano Tel 39 02 57 416 1 SuomiFinland Meda Oy Vaisalantie 4 Vaisalavägen 4 FIN-02130 Espoo Esbo PuhTel 358 20 720 9550
Sverige Meda AB Box 906 S-170 09 Solna Tel 46 8 630 1900 C.A.Papaellinas Co Ltd . . . . 179 CY-2235, , , 357 22741741
Latvija Meda Pharma SIA O. Vaciesa str. 13 LV-1004 Riga, Latvia Tel. 371 67 805140 United Kingdom Meda Pharmaceuticals Ltd. Skyway House Parsonage Road Takeley Bishops Stortford CM22 6PU - UK Tel 44 845 460 0000
Veiveri- g. 134,
LT-46352 Kaunas, Lithuania
Tel. + 370 37330509
This leaflet was last approved in:
GROUNDS FOR ONE ADDITIONAL RENEWAL
GROUNDS FOR ONE ADDITIONAL RENEWAL
Tasmar was suspended from 1998 to 2004 mainly due to increasing concerns over reports of severe hepatotoxicity, including cases with a total of outcome. As part of the conclusion for the lifting of the suspension on the 22 April 2004, the MAH has committed to specify measures including intensive monitoring of hepatic reaction and Neuroleptic Malignant Syndrome.
Based on the above and on the review of the data that have become available since the lifting of the suspension, the CHMP considers that the benefit-risk balance of Tasmar remains positive, but considers that its safety profile is to be closely monitored for the following reasons:
Since the lifting of the suspension there has been a relatively limited exposure in Europe. The CHMP also noted that this is effectively the first renewal since the lifting of the suspension. Specific measures are still in place in relation to be monitoring of particular safety issues including hepatotoxicity and NMS, also remaining submission of yearly PSURs
Therefore, the CHMP concluded that the MAH should submit one additional renewal application in 5 years time.