COMTAN 200 mg Tabletki Powlekane

Treść ulotki

1. Comtan 200 mg film-coated tablets
   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. How to store Comtan
   6. Contents of the pack and other information

Comtan 200 mg film-coated tablets

entacapone

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you take 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 is Comtan and what is it used for

Comtan tablets contain entacapone and are used in combination with levodopa in 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 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 tumor of the adrenal gland (known as pheochromocytoma) as it may increase the risk of serious blood pressure reactions;
• if you are taking antidepressants (please consult your doctor or pharmacist to make sure that the antidepressants used can be taken together with Comtan);
• if you have liver disease;
• if you suffer from or have suffered from the rare reaction to certain antipsychotic drugs known as neuroleptic malignant syndrome (NMS). Regarding the characteristics of NMS, see section 4 Possible side effects.
• if you suffer from or have suffered from a rare form of muscle disease 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 problems;
• if you are taking a medicine that may cause dizziness or a feeling of lightheadedness (low blood pressure) when you get up from sitting or lying down;
• if you have prolonged diarrhea, consult your doctor as it may be a sign of colon inflammation;
• if you have diarrhea, 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 having a general medical check-up, including a liver function test.

Tell your doctor if you notice, or your family members/caregivers notice that you develop impulses or
strong desires to behave in unusual ways or cannot resist the urge, drive or
temptation to perform activities that may be harmful to you or others. These behaviors
are called impulse control disorder and may include gambling addiction,
excessive spending and eating, abnormally high sexual drive, preoccupation
with an increase in sexual thoughts or desires. Your doctor may review your treatment.
Because Comtan tablets will be taken together with other medicines containing levodopa, the
When you start taking Comtan, it may be necessary to adjust the doses of other
medicines used to treat 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 stopped abruptly or the dose is reduced sharply. Regarding
the characteristics of NMS, see section 4 Possible side effects. Your doctor may
advise you to gradually discontinue treatment with entacapone and with other medicines used
to treat Parkinson's disease.
Comtan taken with levodopa can cause drowsiness and sudden sleep attacks. If this
happens, you should not drive or operate other machinery (see “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, 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 digest 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 breastfeeding.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Comtan, when taken with levodopa, can lower blood pressure, which can cause
a feeling of lightheadedness or dizziness. Be careful when driving and using machinery.
Also, Comtan taken in combination with levodopa can cause drowsiness or can sometimes cause
sudden episodes of sleep attacks.
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 intolerance to certain sugars, contact him before taking this medicine.
This medicine contains 7.3 mg of sodium (the main component of table salt) per
each tablet. The maximum recommended daily dose (10 tablets) contains 73 mg of
sodium. This is equivalent to 4% of the recommended maximum daily intake with the diet of
an adult.

3. How to take Comtan

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
Comtan is administered with medicines containing levodopa (or levodopa/carbidopa or
levodopa/benserazide). It is also possible to take other medicines for the
treatment of Parkinson's disease at the same time.
The recommended dose of Comtan is one 200 mg tablet to be taken with each dose of
levodopa. The maximum recommended dose is equal to 10 tablets per day, i.e. 2,000 mg of Comtan.
If you are undergoing dialysis for kidney failure, your doctor may ask you to extend
the interval between doses.
To open the bottle for the first time: open the cap and then
press with your thumb until the seal breaks. See
Figure 1.
Figure 1

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

If you take more Comtan than you should
Notify your doctor, pharmacist or the nearest hospital if you have taken a dose of medicine greater than
the one you were told to take.

If you forget to take Comtan
If you forget to take the Comtan tablet together with the dose of levodopa, you should continue the
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 missed tablet.

If you stop taking Comtan
Do not stop treatment with Comtan unless your doctor decides to do so.
Upon discontinuation, your doctor may deem it necessary to modify the dose of other medicines for
the treatment of Parkinson's disease that you are taking. Sudden discontinuation of Comtan
and other medicines for the treatment of Parkinson's disease can lead to the onset of
unwanted side effects. See section 2 Warnings and precautions.
If you have any doubts about 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. Generally, the side effects caused by Comtan are mild to moderate in severity.
Some side effects are often caused by the enhanced effects of levodopa and are more
common at the beginning of treatment. If these effects occur at the beginning of treatment with Comtan
you should contact your doctor who can decide to modify the dosage of levodopa.
Very common (may affect more than 1 in 10 people):

• Involuntary movements with difficulty in performing voluntary movements (dyskinesia);
• feeling unwell (nausea);
• harmless brownish-reddish discoloration of the urine.

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

• Exaggerated movements (hyperkinesia), worsening of the symptoms of Parkinson's disease, prolonged muscle contractions (dystonia);
• feeling unwell (vomiting), diarrhea, 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):

• Skin rash;
• abnormal values of liver function tests.

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

• Agitation;
• decreased appetite, weight loss;
• urticaria (hives).

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

• Inflammation of the colon (colitis), inflammation of the liver (hepatitis) with yellowing of the skin and the white of the eye;
• alteration of the color 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 can 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 characterized by rigidity, muscle contraction,

tremor/shaking, agitation, confusion, coma, high body temperature, increased
heart rate and unstable blood pressure;

• a rare and serious muscle condition (rhabdomyolysis) that causes pain, tenderness and weakness of the muscles and can cause kidney problems.

You may develop the following side effects:

• Inability to resist the urge to perform 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 behaviors, of significant concern to you or others, for example an 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 is needed to satisfy hunger).

Tell your doctor if you experience any of these behaviors; they will discuss a way 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 side effects not listed in this leaflet. You can also report side effects directly through the national reporting system indicated 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 which is stated on the box and on the label of the
bottle. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water. Ask your pharmacist how to dispose of medicines
that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Comtan contains

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

Description of Comtan and contents of the pack
Comtan 200 mg tablets are oval, brown-orange in colour with the marking “Comtan”
embossed on one side. They are packaged in bottles.
Three pack sizes (bottles containing 30, 60 or 100 tablets) are available. 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
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

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

Lietuva
Orion Corporation
Tel: +358 10 4261

България
Orion Corporation
Тел.: +358 10 4261

Luxembourg/Luxemburg
Orion Pharma BVBA/SPRL
Tél/Tel: +32 (0)15 64 10 20

Česká republika
Orion Pharma s.r.o.
Tel: +420 234 703 305

Magyarország
Orion Pharma Kft.
Tel.: +36 1 239 9095

Danmark
Orion Corporation
Tlf: +358 10 4261

Malta
Orion Corporation
Tel: +358 10 4261

Deutschland
Orion Corporation
Tel: +358 10 4261

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

Eesti
Orion Corporation
Tel: +358 10 4261

Norge
Orion Corporation
Tlf: +358 10 4261

Ελλάδα
Orion Pharma Hellas M.E.Π.E
Τηλ: +30 210 980 3355

Österreich
Orion Pharma GmbH
Tel: +49 40 899 6890

España
Orion Pharma S.L.
Tel: +34 91 599 86 01

Polska
Orion Corporation
Tel.: +358 10 4261

France
Orion Pharma
Tél: +33 (0) 1 85 18 00 00

Portugal
Orionfin Unipessoal Lda
Tel: +351 21 154 68 20

Hrvatska
Orion Pharma d.o.o.
Tel. +386 (0) 1 600 8015

România
Orion Corporation
Tel: +358 10 4261

Ireland
Orion Corporation
Tel: +358 10 4261

Slovenija
Orion Corporation
Tel: +358 10 4261

Ísland
Orion Corporation
Sími: +358 10 4261

Slovenská republika
Orion Pharma s.r.o
Tel: +420 234 703 305

Italia
Orion Pharma S.r.l.
Tel: +39 02 67876111

Suomi/Finland
Orion Corporation
Puh/Tel: +358 10 4261

Κύπρος
Orion Corporation
Τηλ: +358 10 4261

Sverige
Orion Corporation
Tel: +358 10 4261

Latvija
Orion Corporation
Tel: +358 10 4261

United Kingdom (Northern Ireland)
Orion Corporation
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.