Comtess200 mg film-coated tablets

Comtess tablets contain entacapone and are used together with levodopa to treat Parkinson?s disease. Comtess aids levodopa in relieving the symptoms of Parkinson's disease. Comtess has no effect on relieving the symptoms of Parkinson´s disease unless taken with levodopa.

Do not takeComtess

• if you are allergic (hypersensitive) to entacapone or any of the other ingredients of Comtess;
• if you have a tumour of the adrenal gland (known as pheochromocytoma; this may increase the risk of severe high blood pressure);
• if you are taking certain antidepressants (ask your doctor or pharmacist whether your antidepressive medicine can be taken together with Comtess);
• if you have liver disease;
• if you have ever suffered from a rare reaction to antipsychotic medicines called neuroleptic malignant syndrome (NMS). See section 4 Possible side effects for the characteristics of NMS;
• if you have ever suffered from a rare muscle disorder called rhabdomyolysis which was not caused by injury.

Take special care with Comtess

Talk to your doctor if any of the following applies to you:

• if you have ever had a heart attack or any other diseases of the heart
• if you are taking a medicine which may cause dizziness or light-headedness (low blood pressure) when rising from a chair or bed;
• if you experience prolonged diarrhoea consult your doctor as it may be a sign of inflammation of the colon
• if you experience diarrhoea, monitoring of your weight is recommended in order to avoid potentially excessive weight loss;
• if you experience excessive gambling or excessive sexual activity.
• if you experience increasing loss of appetite, weakness, exhaustion and weight loss within a relatively short period of time, a general medical evaluation including liver function should be considered.

As Comtess tablets will be taken together with other levodopa medicines, please also read the package leaflets of these medicines carefully.
The dose of other medicines to treat Parkinson?s disease may need to be adjusted when you start taking Comtess. Follow the instructions that your doctor has given you.

Neuroleptic Malignant Syndrome (NMS) is a serious but rare reaction to certain medicines, and may occur especially when Comtess and other medicines to treat Parkinson?s disease are suddenly stopped or the dose is suddenly reduced. For the characteristics of NMS see Section 4 Possible side effects. Your doctor may advise you to slowly discontinue the treatment with Comtess and other medicines to treat Parkinson?s disease.

Comtess taken with levodopa may cause drowsiness and may cause you to sometimes suddenly fall asleep. If this happens, you should not drive or use any tools or machines (see Driving and using machines).

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken other medicines, including medicines obtained without a prescription or herbal medicines. In particular please tell your doctor if you are taking any of the following:

• rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha-methyldopa, apomorphine;
• antidepressants including desipramine, maprotiline, venlafaxine, paroxetine;
• warfarin used to thin the blood;
• iron supplements. Comtess may make it harder for you to digest iron. Therefore, do not take Comtess and iron supplements at the same time. After taking one of them, wait at least 2 to 3 hours before taking the other.

Pregnancy and breast-feeding
Do not use Comtess during pregnancy or if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Comtess taken together with levodopa may lower your blood pressure, which may make you feel light-headed or dizzy. Be particularly careful when you drive or when you use tools or machinery.

In addition, Comtess taken with levodopa may make you feel very drowsy, or cause you to sometimes suddenly fall asleep.
Do not drive or operate machinery if you experience these side effects.

Always take Comtess exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Comtess is taken together with medicines containing levodopa (either levodopa/carbidopa preparations or levodopa/benserazide preparations). You may also use other medicines to treat Parkinson?s disease at the same time.

The usual dose of Comtess is one 200 mg tablet with each levodopa dose. The maximum recommended dose is 10 tablets per day, i.e. 2,000 mg of Comtess.

If you are receiving dialysis for renal insufficiency, your doctor may tell you to increase the time between doses.

Use in children

Experience with Comtess in patients under 18 years is limited. Therefore, the use of Comtess in children cannot be recommended.

If you take more Comtess than you should

In the event of an overdose, consult your doctor, pharmacist or the nearest hospital immediately.

If you forget to take Comtess
If you forget to take the Comtess tablet with your levodopa dose, you should continue the treatment by taking the next Comtesstablet with your next levodopa dose.

Do not take a double dose to make up for a forgotten tablet.

If you stop taking Comtess

Do not stop taking Comtess unless your doctor tells you to.

When stopping your doctor may need to re-adjust the dosage of your other medicines to treat Parkinson´s disease. Suddenly stopping Comtess and other medicines to treat Parkinson´s disease may result in unwanted side effects. See Section 2 Take special care.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, Comtess can cause side effects, although not everybody gets them. Usually side effects caused by Comtessare mild to moderate.

Some of the side effects are often caused by the increased effects of levodopa therapy and are most common at the start of treatment. If you experience such effects at the start of treatment with Comtess you should contact your doctor who may decide to adjust your dosage of levodopa. The frequencies are defined as:
Very common ( affects more than 1 patient in 10)
Common ( affects 1 to 10 patients in 100)
Uncommon ( affects 1 to 10 patients in 1,000)
Rare ( affects 1 to 10 patients in 10,000)
Very rare ( affects less than 1 patient in 10,000)
Not known ( frequency cannot be estimated from the available data).

Very common:

• Uncontrollable movements with difficulty in performing voluntary movements (dyskinesias);
• feeling sick (nausea);
• harmless reddish-brown discoloration of urine.

Common:

• Excessive movements (hyperkinesias), worsening of symptoms of Parkinson´s disease, prolonged muscle cramps (dystonia);
• being sick (vomiting), diarrhoea, abdominal pain, constipation, dry mouth;
• dizziness, tiredness, increased sweating, fall ;
• hallucinations (seeing/hearing/feeling/smelling things that are not really there), sleeplessness, vivid dreams, and confusion.
• heart or artery disease events (e.g. chest pain).

Uncommon:

• Heart attack.

Rare:

• Rashes;
• abnormal results in liver function test.

Very rare:

• Agitation;;
• decreased appetite, weight loss;;
• hives.

Not known:

• Inflammation of the colon (colitis), inflammation of the liver (hepatitis) with yellowing of the skin and whites of the eyes;
• discolouration of skin, hair, beard and nails.

When Comtess is given at higher doses:
In doses of 1,400 to 2,000 mg per day, the following side effects are more common:

• Uncontrollable movements;
• nausea;
• abdominal pain.

Other important side effects which may occur:

• Comtess taken with levodopa may rarely make you feel very drowsy during the day, and cause you to suddenly fall asleep;
• Neuroleptic Malignant Syndrome (NMS) is a rare severe reaction to medicines used to treat disorders of the nervous system. It is characterised by stiffness, muscle twitching, shaking, agitation and confusion, coma, high body temperature, increased heart rate, and unstable blood pressure;
• a rare severe muscle disorder (rhabdomyolysis) which causes pain, tenderness and weakness of the muscles and may lead to kidney problems .
• behavioural changes may occur such as an urge to gamble (pathological gambling) or increased sexual desire and urges (increased libido and hypersexuality)

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Keep out of the reach and sight of children.

Do not use Comtess after the expiry date which is stated on the carton and on the bottle label. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

What Comtess contains

• The active substance is entacapone. Each tablet contains 200 mg of entacapone.
• The other ingredients in the tablet core are microcrystalline cellulose, croscarmellose sodium, povidone and magnesium stearate.
• The film-coating contains partly hydrolysed polyvinyl alcohol, talc, macrogol, soybean lecithin, yellow iron oxide (E 172), red iron oxide (E 172) and titanium dioxide (E 171).

What Comtess looks like and contents of the pack

Comtess 200 mg film-coated tablets are brownish-orange, oval tablets with "COMT" engraved on one side. They are packed in bottles.

There are four different pack sizes (bottles containing 30, 60, 100 or 175 tablets). Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiqueBelgiëBelgien Orion Corporation Tél.Tel 358 10 4261 LuxembourgLuxemburg Orion Corporation Tél.Tel 358 10 4261

Orion Corporation . 358 10 4261 Magyarország Orion Corporation Tel. 358 10 4261

eská republika Orion Corporation Tel 358 10 4261 Malta Orion Corporation Tel 358 10 4261

Danmark Orion Pharma AS Tlf 45 49 12 66 00 Nederland Orion Corporation Tel 358 10 4261

Deutschland Orion Pharma GmbH Tel 49 40 899 689-0 Norge Orion Pharma AS Tlf. 47 40 00 42 10

Eesti Orion Pharma Eesti OÜ Tel 372 6 616 863 Österreich Orion Corporation Tel 358 10 4261

Orion Corporation T 358 10 4261 Polska Orion Oyj S.A. Przedstawicielstwo w Polsce Tel. 48 22 8333177, 8321036

España Orion Corporation Tel 358 10 4261 Portugal Orion Corporation Tel 358 10 4261

France Orion Corporation Tél. 358 10 4261 România Orion Corporation Tel 358 10 4261

Slovenija Orion Corporation Tel 358 10 4261 Ireland Orion Pharma Ireland Ltd. co Allphar Services Ltd. Tel 353 1 428 7777

Ísland Vistor hf. Sími 354 535 7000 Slovenská republika Orion Corporation Tel 358 10 4261

Italia Orion Corporation Tel 358 10 4261 SuomiFinland Orion Corporation Puh.Tel 358 10 4261

Orion Corporation T 358 10 4261 Sverige Orion Pharma AB Tel 46 8 623 6440

United Kingdom Orion Pharma UK Ltd. Tel 44 1635 520 300 Latvija Orion Corporation Orion Pharma prstvniecba Tel 371 7455563

Lietuva
UAB Orion Pharma
Tel: +370 5 276 9499

This leaflet was last approved in

Detailed information on this medicine is available on the European Medicine?s Agency (EMA) web site: http://www.ema.europa.eu