Comtan

Package leaflet: Information for the user

Comtan 200 mg film-coated tablets

entacapone
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this 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 for the treatment of Parkinson's disease. Comtan helps levodopa to relieve the symptoms of Parkinson's disease. Comtan is not effective in relieving the symptoms of Parkinson's disease if it is not taken 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 phaeochromocytoma), as this may increase the risk of severe blood pressure reactions;
• if you are taking antidepressants (please consult your doctor or pharmacist to ensure that the antidepressants being used can be taken together with Comtan);
• if you have liver disease;
• if you currently have or have previously had the rare reaction to certain antipsychotic medicines known as neuroleptic malignant syndrome (NMS). For characteristics of NMS, see section 4 Possible side effects.
• if you currently have or have previously had the rare muscle disorder called non-traumatic rhabdomyolysis.

Warnings and precautions
Talk to your doctor or pharmacist before taking Comtan:

• if you have ever had a heart attack or any other heart condition;
• if you are taking a medicine that may cause dizziness or a feeling of lightheadedness (low blood pressure) when standing up from sitting or lying down;
• if you have prolonged diarrhoea, consult your doctor, as this may be a sign of inflammation of the colon;
• if you have diarrhoea, it is recommended to monitor your weight to avoid excessive weight loss;
• if you experience progressive loss of appetite, asthenia (weakness, extreme fatigue) and weight loss over a relatively short period of time, you should consider the possibility of undergoing a general medical check-up, including liver function tests.

Inform your doctor if you, or your family members/caregivers, notice that you develop impulses or strong urges to behave in unusual ways, or are unable to resist the impulse, drive, or temptation to carry out activities that could be harmful to yourself or others. These behaviours are known as impulse control disorders and may include gambling addiction, excessive spending and eating, abnormally increased sex drive, or preoccupation with an increase in sexual thoughts or desires. Your doctor may need to reconsider your treatment.
Since Comtan tablets will be taken together with other medicines containing levodopa, please read the package leaflet of these medicines carefully as well.
When you start taking Comtan, it may be necessary to adjust the doses of other medicines used for the treatment of Parkinson's disease. Follow the instructions provided by your doctor.
Neuroleptic malignant syndrome (NMS) is a serious but rare reaction to certain medicines, and may occur particularly when Comtan and other medicines used to treat Parkinson's disease are suddenly stopped or the dose is rapidly reduced. For characteristics of NMS, see section 4 Possible side effects. Your doctor may advise you to gradually discontinue treatment with entacapone and other medicines used for the treatment of Parkinson's disease.
Comtan taken with levodopa may cause drowsiness and sudden attacks of sleep. If this occurs, you must not drive or operate machinery (see "Driving and use of machines").

Other medicines and Comtan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, please 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, paroxetine;
• warfarin, used to thin the blood;
• iron supplements. Comtan may make it more difficult to absorb iron. Therefore, it is not recommended to take Comtan at the same time as iron supplements. Comtan and iron supplements should be taken at least 2–3 hours apart.

Pregnancy, breastfeeding and fertility
Do not use Comtan during pregnancy or while breastfeeding.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and use of machines
Comtan, taken together with levodopa, may lower blood pressure, which may cause a feeling of lightheadedness or dizziness. Exercise caution when driving or operating machinery.
In addition, Comtan taken in combination with levodopa may cause drowsiness or may sometimes cause sudden episodes of falling asleep.
Do not drive or operate machinery if you experience these side effects.

Comtan contains sucrose and sodium
Comtan tablets contain a sugar called sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
This medicine contains 7.3 mg of sodium (a main component of table salt) per tablet. The maximum recommended daily dose (10 tablets) contains 73 mg of sodium. This is equivalent to 4% of the maximum daily dietary intake recommended for an adult.

3. How to take Comtan

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Comtan is administered together with levodopa-containing medicines (either levodopa/carbidopa or
levodopa/benserazide). You may also take other medicines at the same time for the
treatment of Parkinson's disease.
The recommended dose of Comtan is one 200 mg tablet taken 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 prolong
the interval between doses.
To open the bottle for the first time: open the cap and then
Figure 1
press with your thumb until the seal breaks. See

Figure 1.
Use in children and adolescents
Experience with Comtan in patients under 18 years of age is limited. Therefore, the use of Comtan is not recommended in children or adolescents.
If you take more Comtan than you should
Inform your doctor, pharmacist, or the nearest hospital if you have taken more medicine than you were told to take.
If you forget to take Comtan
If you forget to take your Comtan tablet together with your dose of levodopa, continue your treatment by taking the next Comtan tablet together with the next dose of levodopa.
Do not take a double dose to make up for the forgotten tablet.
If you stop taking Comtan
Do not stop taking Comtan unless your doctor tells you to do so.
When stopping treatment, your doctor may find it necessary to adjust the dose of other Parkinson's disease medicines you are taking. Abruptly stopping Comtan and other Parkinson's disease medicines may lead to the occurrence of unwanted adverse effects. See section 2 Warnings and precautions.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. Generally, the side effects caused by Comtan are of mild to moderate severity.
Some side effects are often due to the enhanced effects of 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 the dosage of levodopa.

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

• Involuntary movements with difficulty performing voluntary movements (dyskinesia);
• feeling unwell (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 contractions (dystonia);
• feeling unwell (vomiting), diarrhoea, abdominal pain, constipation, dry mouth;
• dizziness, fatigue, excessive sweating, falls;
• hallucinations (seeing/hearing/feeling/smelling things that are not actually present), insomnia, vivid dreams and confusion;
• heart or artery disorders (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):

• Rash;
• 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 the available data):

• Inflammation of the colon (colitis), inflammation of the liver (hepatitis) with yellowing of the skin and whites of the eyes;
• changes in the colour of 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 occur:

• Comtan taken with levodopa may rarely make you feel very sleepy during the day and cause sudden sleep attacks;
• neuroleptic malignant syndrome (NMS) is a rare and serious reaction to medicines used to treat nervous system disorders. It is characterised by muscle rigidity, muscle contraction,
  tremor/twitching, agitation, confusion, coma, high body temperature, increased heart rate and unstable blood pressure;
• a rare and serious muscle disorder (rhabdomyolysis) causing muscle pain, tenderness and weakness, which may lead to kidney problems.

You may develop the following side 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;
• altered or increased sexual interests and behaviours, causing significant concern to you or others, for example increased sexual drive;
• uncontrollable excessive shopping or spending;
• binge eating (eating large amounts of food in a short time) or compulsive eating (eating more food than usual and more than needed to satisfy hunger).

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

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Comtan Contains

• 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 tablet film coating contains hypromellose, polysorbate 80, glycerol 85%, sucrose, yellow iron oxide (E172), red iron oxide (E172), titanium dioxide (E171), and magnesium stearate.

Description of the Appearance of Comtan and Contents of the Pack
The 200 mg Comtan tablets are oval-shaped, brown-orange in colour, with the mark "Comtan" engraved on one side. They are packaged in bottles.
Three pack sizes are available (bottles containing 30, 60, or 100 tablets). Not all pack sizes may 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:

België/Belgique/Belgien Lietuva
Orion Pharma BVBA/SPRL Orion Corporation
Tél/Tel: +32 (0)15 64 10 20 Tel: +358 10 4261

България Luxembourg/Luxemburg
Orion Corporation Orion Pharma BVBA/SPRL
Тел.: +358 10 4261 Tél/Tel: +32 (0)15 64 10 20

Česká republika Magyarország
Orion Pharma s.r.o. Orion Pharma Kft.
Tel: +420 234 703 305 Tel.: +36 1 239 9095

Danmark Malta
Orion Corporation Orion Corporation
Tlf: +358 10 4261 Tel: +358 10 4261

Deutschland Nederland
Orion Corporation Orion Pharma BVBA/SPRL
Tel: +358 10 4261 Tel: +32 (0)15 64 10 20

Eesti Norge
Orion Corporation Orion Corporation
Tel: +358 10 4261 Tlf: +358 10 4261

Ελλάδα Österreich
Orion Pharma Hellas M.E.Π.E. Orion Pharma GmbH
Τηλ: +30 210 980 3355 Tel: +49 40 899 6890

España Polska
Orion Pharma S.L. Orion Corporation
Tel: +34 91 599 86 01 Tel.: +358 10 4261

France Portugal
Orion Pharma Orionfin Unipessoal Lda
Tél: +33 (0) 1 85 18 00 00 Tel: +351 21 154 68 20

Hrvatska România
Orion Pharma d.o.o. Orion Corporation
Tel. +386 (0) 1 600 8015 Tel: +358 10 4261

Ireland Slovenija
Orion Corporation Orion Corporation
Tel: +358 10 4261 Tel: +358 10 4261

Ísland Slovenská republika
Orion Corporation Orion Pharma s.r.o.
Sími: +358 10 4261 Tel: +420 234 703 305

Italia Suomi/Finland
Orion Pharma S.r.l. Orion Corporation
Tel: +39 02 67876111 Puh/Tel: +358 10 4261

Κύπρος Sverige
Orion Corporation Orion Corporation
Τηλ: +358 10 4261 Tel: +358 10 4261

Latvija United Kingdom (Northern Ireland)
Orion Corporation Orion Corporation
Tel: +358 10 4261 Tel: +358 10 4261

Other Sources of Information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.