COMTAN 200 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Comtan 200mg film-coated tablets

entacapone

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. 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.

Contents of the pack and other information

1. What is Comtan and what is it used for
2. What you need to know before you take Comtan
3. How to take Comtan
4. Possible side effects
5. Storing Comtan
6. Contents of the pack and other information

1. What is Comtan and what is it used for

Comtan tablets contain entacapone and are used together with levodopa to treat Parkinson's disease. Comtan helps levodopa to relieve the symptoms of Parkinson's disease. Comtan has no effect on the symptoms of Parkinson's disease unless it is taken with levodopa.

2. What you need to know before you take Comtan

Do not take Comtan

• if you are allergic to entacapone or any of the other ingredients of this medicine (listed in section 6);
• if you have a tumour of the adrenal gland (known as phaeochromocytoma, this may increase the risk of severe hypertension);
• if you are taking certain antidepressants (ask your doctor or pharmacist if your antidepressant can be taken with Comtan);
• if you have liver disease;
• if you have ever had a rare reaction to antipsychotic drugs called Neuroleptic Malignant Syndrome (NMS). See section 4 “Possible side effects” for characteristics of NMS;
• if you have ever had a rare muscular disorder called rhabdomyolysis not caused by trauma.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Comtan:

• if you have ever had a heart attack or any other heart disease;
• if you are taking any medicine that may cause dizziness or fainting (low blood pressure) when standing up from a chair or bed;
• if you experience prolonged diarrhoea. Consult your doctor as it may be a sign of colon inflammation;
• if you experience diarrhoea, it is recommended to monitor your weight to avoid excessive weight loss;
• if you experience increasing loss of appetite, weakness, exhaustion and weight loss over a relatively short period of time, a general medical evaluation including liver function should be considered.

Tell your doctor if you or your family/caregiver notice that you are developing desires or urges to behave in ways that are unusual for you or that you cannot resist the impulse, urge or temptation to perform certain activities that could harm yourself or others. These behaviours are called impulse control disorders and can include addiction to gambling, shopping or spending, and an abnormally high sex drive or preoccupation with sex. Your doctor may need to review your treatment.

As Comtan must be taken together with other medicines that contain levodopa, also read the package leaflet of these medicines carefully.

It may be necessary to adjust the dose of other medicines for treating Parkinson's disease when you start taking Comtan. Follow the instructions as told by your doctor.

Neuroleptic Malignant Syndrome (NMS) is a rare but serious reaction to certain medicines, and can appear especially when the treatment with Comtan and other medicines for Parkinson's disease is suddenly stopped or drastically reduced. For characteristics of NMS, see section 4 “Possible side effects”. Your doctor may advise gradual discontinuation of the treatment with Comtan and other medicines for Parkinson's disease.

Taking Comtan together with levodopa may cause drowsiness and can make you suddenly fall asleep. If this happens, do not drive or use tools or machinery (see section “Driving and using machines”).

Other medicines and Comtan

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor if you are using any of the following medicines:

• rimiterol, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha-methyldopa, apomorphine;
• antidepressants including desipramine, maprotiline, venlafaxine and paroxetine;
• warfarin used to thin the blood;
• iron supplements. Comtan may interfere with the absorption of iron. Therefore, do not take Comtan and iron supplements at the same time. After taking one of them, wait at least 2 or 3 hours before taking the other.

Pregnancy, breast-feeding and fertility

Do not take Comtan during pregnancy or while breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

When taking Comtan together with levodopa, it may lower your blood pressure, which may make you feel dizzy or faint. Be careful when driving or using tools or machines.

Also, when taking Comtan together with levodopa, it may cause you to be very sleepy or to fall asleep suddenly.

Do not drive or use machines if you experience these side effects.

Comtan contains sucrose and sodium

Comtan tablets contain a sugar called sucrose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

This medicine contains 7.3 mg of sodium (the main component of cooking/table salt) in each tablet. The maximum recommended daily dose (10 tablets) contains 73 mg of sodium. This is equivalent to 4% of the maximum recommended daily intake of sodium for an adult.

3. How to take Comtan

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Comtan is taken together with medicines that contain levodopa (either levodopa/carbidopa or levodopa/benserazide preparations). You may also use other medicines for treating Parkinson's disease at the same time.

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

If you are on dialysis due to kidney insufficiency, your doctor may tell you to increase the time between doses.

Use in children and adolescents

Experience with Comtan in children under 18 years is limited. Therefore, Comtan is not recommended for use in children and adolescents.

If you take more Comtan than you should

In case of overdose, contact your doctor, pharmacist or the nearest hospital immediately.

If you forget to take Comtan

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

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

If you stop taking Comtan

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

When stopping, your doctor may need to adjust the dose of your other medicines for Parkinson's disease. Stopping the treatment with Comtan and other medicines for Parkinson's disease abruptly may cause unwanted side effects. See section 2 “Warnings and precautions”.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects caused by Comtan are, in general, mild or moderate.

These side effects are often due to the increased effects caused by the treatment with levodopa and are more common at the start of the treatment. If you experience these effects at the beginning of the treatment with Comtan, you should contact your doctor, who may decide to adjust the dose of levodopa.

Very common (may affect more than 1 in 10 people):

• Uncontrolled movements with difficulty in performing voluntary movements (dyskinesias);
• feeling sick (nausea);
• brownish discolouration of urine (harmless).

Common (may affect up to 1 in 10 people):

• Excessive movements (hyperkinesias), worsening of Parkinson's disease symptoms, prolonged muscle cramps (dystonia);
• being sick (vomiting), diarrhoea, abdominal pain, constipation, dry mouth;
• dizziness, tiredness, increased sweating, falls;
• hallucinations (seeing, hearing, feeling, smelling things that are not real), insomnia, vivid dreams and confusion;
• events related to arterial or heart disease (e.g. chest pain).

Uncommon (may affect up to 1 in 100 people):

• Heart attack.

Rare (may affect up to 1 in 1,000 people):

• Rashes;
• abnormal results of liver function tests.

Very rare (may affect up to 1 in 10,000 people):

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

Not known (frequency cannot be estimated from the available data):

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

When Comtan is given at higher doses:

At doses of 1,400 to 2,000 mg per day, the following side effects are more common:

• Uncontrolled movements;
• nausea;
• abdominal pain.

Other important side effects that may appear:

• Comtan given with levodopa may rarely cause you to be very sleepy during the day or to fall asleep suddenly;

• Neuroleptic Malignant Syndrome (NMS) is a rare but serious reaction to medicines used to treat disorders of the nervous system. It is characterised by stiffness, twitching, tremors, agitation, confusion, coma, increased body temperature, rapid heart rate and unstable blood pressure;

• a rare but serious muscle disorder (rhabdomyolysis) that causes pain, abnormal sensitivity to touch or pressure and weakness of the muscles, and may lead to kidney problems.

You may experience the following side effects:

• Failure to resist an impulse, drive or temptation to perform an action that could be harmful to you or others, which may include:

• a strong impulse to gamble excessively despite serious personal or family consequences.
• an increased or altered interest in sex and a disturbing sexual behaviour to you or to others, such as an increased sex drive.
• excessive and uncontrolled shopping or spending.
• eating large amounts of food in a short time (binge eating) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger).

Tell your doctor if you experience any of these behaviours: they will discuss with you how to manage or reduce these symptoms.

Reporting of side effects

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 the website of the Spanish Agency of Medicines and Medical Devices (www.notificaRAM.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Comtan

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 carton and on the label of the bottle. The expiry date refers to the last day of the month shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Comtan contains

• The active substance is entacapone. Each tablet contains 200 mg of entacapone.
• The other ingredients are microcrystalline cellulose, mannitol, sodium carmellose, hydrogenated vegetable oil, magnesium stearate.
• The film coating contains hypromellose, polysorbate 80, glycerol 85%, sucrose, yellow iron oxide (E172), red iron oxide (E172), titanium dioxide (E171) and magnesium stearate.

Appearance and packaging

Comtan 200 mg tablets are orange-brown, oval, with “Comtan” engraved on one side of the tablet. They are available in bottles.

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

Marketing authorisation holder

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Manufacturer

Orion Corporation Orion Pharma

Joensuunkatu 7

FI-24100 Salo

Finland

You can get more information on this medicine from the representative of the marketing authorisation holder in your country:

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu