Comtan 200 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Comtan 200mg film-coated tablets

entacapone

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Comtan is and what it is used for

Comtan tablets contain entacapone and are used in combination with levodopa to treat Parkinson's disease. Comtan helps levodopa in relieving the symptoms of Parkinson's disease. Comtan has no effect in relieving the symptoms of Parkinson's disease unless administered together with levodopa.

2. What you need to know before taking Comtan

Do not take Comtan

• if you are allergic to entacapone or to any of the other ingredients of this medicine (listed in section 6);
• if you have a tumour of the adrenal gland (known as a phaeochromocytoma, which may increase the risk of severe hypertension);
• if you are taking certain antidepressants (ask your doctor or pharmacist whether your antidepressant medicine can be taken together with Comtan);
• if you have a liver disease;
• if you have ever experienced 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 experienced a rare muscle disorder called rhabdomyolysis not caused by trauma.

Warnings and precautions

Talk to your doctor or pharmacist before taking 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 lightheadedness (low blood pressure) when standing up from a chair or bed;
• if you experience prolonged diarrhoea. Consult your doctor, as this may be a sign of inflammation of the colon;
• if you experience diarrhoea, monitoring body weight is recommended to avoid excessive weight loss;
• if you experience increasing loss of appetite, weakness, fatigue, and weight loss over a relatively short period of time, a general medical evaluation including liver function should be considered.

Inform your doctor if you or your family/carer notice that you are developing urges or a tendency to behave in ways that are unusual for you or that you cannot resist the impulse, drive, or temptation to carry out certain activities that could be harmful to yourself or others. These behaviours are known as impulse control disorders and may include gambling addiction, compulsive eating, excessive spending, or abnormally increased sexual urges or preoccupation with sexual thoughts or feelings. Your doctor may need to review your treatment.

Since Comtan must be taken together with other medicines containing levodopa, please also read the package leaflet of these medicines carefully.

It may be necessary to adjust the dose of other medicines used to treat Parkinson’s disease when you start taking Comtan. Follow your doctor’s instructions exactly.

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

The use of Comtan together with levodopa may cause drowsiness and may lead you to fall asleep suddenly. If this happens, you must not drive or operate tools or machinery (see section “Driving and use of machines”).

Other medicines and Comtan

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. In particular, inform your doctor if you are taking 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, wait at least 2 to 3 hours before taking the other.

Pregnancy, breast-feeding and fertility

Do not take Comtan during pregnancy or while breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and use of machines

Taking Comtan together with levodopa may lower your blood pressure, which may make you feel dizzy or lightheaded. Be cautious when driving or operating tools or machinery.

In addition, taking Comtan together with levodopa may make you very sleepy or cause you to fall asleep suddenly.

Do not drive or operate machinery if you experience these side effects.

Comtan contains sucrose and sodium

Comtan tablets contain a sugar called sucrose. Therefore, if your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

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

3. How to take Comtan

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Comtan is taken together with medications containing levodopa (either levodopa/carbidopa preparations or levodopa/benserazida preparations). You may also use other medications to treat Parkinson's disease at the same time.

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

If you are undergoing dialysis due to renal failure, your doctor may instruct you to increase the interval between doses.

Use in children and adolescents

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

If you take more Comtan than you should

In case of overdose, consult your doctor, pharmacist, or go to the nearest hospital immediately.

If you forget to take Comtan

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

Do not take a double dose to make up for missed doses.

If you stop taking Comtan

Do not stop treatment with Comtan unless your doctor tells you to do so.

When treatment is discontinued, your doctor may need to readjust the dose of your other medications for Parkinson's disease. Abruptly stopping treatment with Comtan and other medications for Parkinson's disease may cause unwanted adverse effects. See section 2, "Warnings and precautions".

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. The adverse effects caused by Comtan are generally mild or moderate.

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

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

• Involuntary movements with difficulty performing voluntary movements (dyskinesias);
• feeling dizzy (nausea);
• harmless reddish-brown discoloration of the urine.

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

• Excessive movements (hyperkinesia), worsening of Parkinson's disease symptoms, prolonged muscle cramps (dystonia);
• dizziness, fatigue, increased sweating, falls;
• hallucinations (seeing, hearing, feeling, or 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):

• Skin rashes;
• abnormal liver function test results.

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

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

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

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

When Comtan is administered at higher doses:

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

• Involuntary movements;
• nausea;
• abdominal pain.

Other important adverse effects that may occur:

• Comtan, when given with levodopa, may rarely cause excessive daytime sleepiness or sudden episodes of falling asleep;

• Neuroleptic Malignant Syndrome (NMS) is a rare but serious reaction to medicines used in the treatment of disorders of the nervous system. It is characterized by muscle rigidity, twitching, tremors, agitation, confusion, coma, increased body temperature, tachycardia, and unstable blood pressure;

• a rare, serious muscle disorder (rhabdomyolysis) causing muscle pain, abnormal sensitivity to touch or pressure, and muscle weakness, which may lead to kidney problems.

You may experience the following adverse effects:

• Inability to resist the impulse to carry out an action that could be harmful, which may include:

• a strong urge to gamble excessively despite serious personal or family consequences.

• increased or altered interest in sex and behavior that is concerning to you or others, such as increased sexual tendencies.

• excessive and uncontrolled shopping or spending.

• eating excessively (consuming large amounts of food in short periods of time) or compulsive eating (eating more food than usual and more than necessary to satisfy hunger).

Inform your doctor if you experience any of these behaviors; they will discuss how to manage or reduce these symptoms.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines (www.notificaRAM.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Comtan

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and on the label of the bottle. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Comtan

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

Appearance of the product and contents of the pack

Comtan 200 mg tablets are orange-brown colored, oval-shaped, with "Comtan" engraved on one side of the tablet. They are packaged in bottles.

There are three different pack sizes available (bottles containing 30, 60 or 100 tablets). Some pack sizes may not be marketed.

Marketing Authorization Holder

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Manufacturer

Orion Corporation Orion Pharma

Joensuunkatu 7

FI-24100 Salo

Finland

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.euopa.eu