Prospect: information for the user

Comtan 200mg film-coated tablets

entacapona

Read this prospect carefully before starting to take this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect.See section4.

1.What is Comtan and for what it is used

2.What you need to know before starting to take Comtan

3.How to take Comtan

4.Possible adverse effects

5.Storage of Comtan

6.Contents of the package and additional information

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

Do not take Comtan

• if you are allergic to entacapone or any of the other components of this medication (listed in section 6);
• if you have a tumor of the adrenal gland (known as pheochromocytoma, this may increase the risk of severe hypertension);
• if you are taking certain antidepressants (ask your doctor or pharmacist if your antidepressant medication can be taken with Comtan);
• if you have a liver disease;
• if you have ever had a rare reaction to antipsychotic medications called Neuroleptic Malignant Syndrome (NMS). See section 4 “Possible side effects” for NMS characteristics;
• if you have ever had a rare muscle 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 medication that may cause dizziness or lightheadedness (low blood pressure) when standing up from a chair or bed;
• if you experience prolonged diarrhea. Consult your doctor as it may be a sign of colon inflammation;
• if you experience diarrhea, it is recommended to control your weight 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/caregiver notice that you are developing unusual desires or tendencies to behave in an unusual way in you or that you cannot resist the impulse, determination, or temptation to perform certain activities that may harm you or others. These behaviors are called impulse control disorders and may include excessive gaming, eating, or spending, and an abnormally elevated or excessive sexual impulse or concern about increased sexual thoughts or feelings.Your doctor may need to review your treatment.

As Comtan must be taken together with other medications containing levodopa, read also carefully the leaflet of these medications.

It may be necessary to adjust the dose of other medications to treat Parkinson's disease when starting to take Comtan. Follow the instructions as indicated by your doctor.

Neuroleptic Malignant Syndrome (NMS) is a rare but severe reaction to certain medications, and may appear especially when Comtan and other Parkinson's disease medications are suddenly stopped or reduced. For NMS characteristics, see section 4 “Possible side effects”. Your doctor may advise you to gradually discontinue treatment with Comtan and other Parkinson's disease medications.

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

Other medications and Comtan

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. In particular, inform your doctor if you are using any of the following medications:

• rimiterol, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha‑metildopa, apomorphine;
• antidepressants including desipramine, maprotiline, venlafaxine, and paroxetine;
• warfarin used to thin the blood;
• iron supplements. Comtan may make it difficult to digest iron. Therefore, do not take Comtan and iron supplements at the same time. Wait at least 2 or 3hours after taking one of them before taking the other.

Pregnancy, breastfeeding, and fertility

Do not take Comtan during pregnancy or if you are breastfeeding your baby.

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

Driving and operating machines

If you take Comtan together with levodopa, it may lower your blood pressure, making you feel dizzy or lightheaded. Be careful when driving or operating machinery.

Additionally, if you take Comtan together with levodopa, it may cause you to feel very sleepy or fall asleep suddenly.

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

Comtan contains saccharose and sodium

Comtan tablets contain a sugar called saccharose. Therefore, if your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Comtan is taken with medications that contain levodopa (whether levodopa/carbidopa or levodopa/benserazide 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, that is, 2,000 mg of Comtan.

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

Use in children and adolescents

The experience with Comtan in children under 18 years is limited. Therefore, Comtan cannot be recommended for use in children and adolescents.

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 levodopa dose, you should continue treatment by taking the next Comtan tablet with the next levodopa dose.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Comtan

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

When stopping, your doctor may need to adjust the dose of other medications for Parkinson's disease. Sudden discontinuation of Comtan and other Parkinson's disease medications may cause unwanted side effects. See section 2 "Warnings and precautions".

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

Like all medicines,this medicinecan cause side effects, although not everyone will experience them.The side effects caused by Comtan are generally mild or moderate.

These side effects are often due to an increase in the effects caused by levodopa treatment and are more frequent at the beginning of treatment. If you experience these side effects at the start of 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 10people):

• Uncontrollable movements with difficulty performing voluntary movements (dyskinesias);
• Feeling dizzy (nausea);
• Brownish-red urine discoloration.

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

• Excessive movements (hyperkinesias), worsening of Parkinson's disease symptoms, prolonged muscle cramps (dystonia);
• Feeling dizzy (vomiting), diarrhea, abdominal pain, constipation, dry mouth;
• Dizziness, fatigue, increased sweating, falls;
• Illusions (seeing, hearing, feeling, or smelling things that are not real), insomnia, intense dreams, and confusion;
• Events related to arterial or heart disease (e.g., chest pain).

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

• Heart attack.

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

• Rashes;
• Abnormal liver function test results.

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

• Agitation;
• Decreased appetite, weight loss;
• Urticaria.

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

• Colon inflammation (colitis), liver inflammation (hepatitis) with yellowing of the skin and the white part of the eyes;
• Skin, hair, beard, and nail discoloration.

When Comtan is administered at higher doses:

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

• Uncontrollable movements;
• Nausea;
• Abdominal pain.

Other important side effects that may occur:

• Comtan administered with levodopa rarely may cause excessive daytime sleepiness or sudden sleepiness;

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

• A rare, severe muscle disorder (rhabdomyolysis) that causes pain, abnormal sensitivity to touch or pressure, and muscle weakness, and may lead to kidney problems.

You may experience the following side effects:

• Inability to resist the impulse to perform an action that could be harmful and may include:

• A strong impulse to gamble excessively despite severe personal or family consequences;
• Increased or altered sexual interest and behavior that is concerning to you or others, such as increased sexual desire;
• Excessive or uncontrolled spending;
• Eating excessively (eating large amounts of food in short periods) or compulsively (eating more food than usual and more than needed to satisfy hunger).

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly tothrough the Spanish System for Pharmacovigilance of Medicines for Human Use (www.notificaRAM.es).By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and on the bottle label. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition of Comtan

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

Appearance of the product and contents of the package

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

There are three different presentations (bottles with 30, 60, or 100tablets). Some package sizes may not be commercially available.

Marketing Authorization Holder

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Responsible for manufacturing

Orion Corporation Orion Pharma

Joensuunkatu 7

FI-24100 Salo

Finland

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Last review date of this leaflet:

Other sources of information

Detailed information about this medication is available on the website of the European Medicines Agency:http://www.ema.europa.eu