InfoCons Consumer Protection informs you – Comtess – Package Leaflet

Before anything else

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 questi ons, 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 o rpharmacist. This in cludes any possible side effects not listed in this leaflet . See section 4 .

What is i n this leaflet 1. What Comtess is and what it is used for 2. What you need to know b efore you take Comtess 3. How to take Comtess 4. Possible side effects 5. How to store Comtess 6. Contents of the pack and other information

ℹ️ 1. What Comtess is and what it is used for

Comtess tablets contain entacapone and are used together with levodopa to treat Parkinson’s disease.

Comtess aids levodopa in relieving the symptoms of Par kinson’s disease. Comtess has no effect on relieving the symptoms of Parkinson’s disease unless taken with levodopa.

⚠️ 2. What you need to know before you take Comtess

Do not take Comtess

 if you are allergic to entacapone or to peanut or soya or any of th e other ingredients of this medicine (listed in section 6) ;  if you have a tumour of the adrenal gland (known as pheochromocytoma; this may increase the risk of severe high blood pressure);  if you are taking certain antidepressants (ask your doctor or pharm acist whether your antidepressive medicine can be taken together with Comtess );  if you have liver disease;  if you have ever suffered from a rare reaction to antipsychotic medicines called neuroleptic malignant syndrome (NMS). See section 4 Possible side ef fects for the characteristics of NMS;  if you have ever suffered from a rare muscle disorder called rhabdomyolysis which was not caused by injury.

Warnings and precautions

Talk to your doctor or pharmacist before taking Comtess :  if you have ever had a hear t attack or any other diseases of the heart ;  if you are taking a medicine which may cause dizziness or light -headedness (low blood pressure) when rising from a chair or bed;  if you experience prolonged diarrhoea consult your doctor as it may be a sign of i nflammation of the colon ; 20 if you experience diarrhoea, monitoring of your weight is recommended in order to avoid potentially excessive weight loss;  if you experience increasing loss of appetite, weakness, exhaustion and weight loss within a relatively sho rt period of time, a general medical evaluation including liver function should be considered.

Tell your doctor if you or your family/carer notices you are developing urges or cravings to behave in ways that are unusual for you or you cannot resist the im pulse, drive or temptation to carry out certain activities that could harm yourself or others. These behaviours are called impulse control disorders and can include addictive gambling, excessive eating or spending, an abnormally high sex drive or a preoccu pation with an increase in sexual thoughts or feelings. Your doctor may need to review your treatments.

As Comtess tablets will be taken together with other levodopa medicines, please also read the package leaflets of these medicines carefully.

The dose of other medicines to treat Parkinson’s disease may need to be adjusted when you start taking Comtess . Follow the instructions that your doctor has given you.

Neuroleptic Malignant Syndrome (NMS) is a serious but rare reaction to certain medicines, and m ay occur especially when Comtess and other medicines to treat Parkinson’s disease are suddenly stopped or the dose is suddenly reduced. For the characteristics of NMS see Section 4 Possible side effects.

Your doctor may advise you to slowly discontinue the treatment with Comtess and other medicines to treat Parkinson’s disease.

Comtess taken with levodopa may cause drowsiness and may cause you to sometimes suddenly fall asleep. If this happens, you should not drive or use any tools or machines (see Driving and using machines ).

Other medicines and Comtess

Tell your doctor or pharmacist if you are taking ,have recently taken or might take any other medicines. In particular please tell your doctor if you are taking any of the following:  rimiterole, isoprenali ne, adrenaline, noradrenaline, dopamine, dobutamine, alpha -methyldopa, apomorphine;  antidepressants including desipramine, maprotiline, venlafaxine, paroxetine;  warfarin used to thin the blood;  iron supplements. Comtess may make it harder for you to dige st iron. Therefore, do not take Comtess and iron supplements at the same time. After taking one of them, wait at least 2 to 3 hours before taking the other.

Pregnancy , breast -feeding and fertility Do not use Comtess during pregnancy or if you are breast -feeding.

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

Driving and using machines

Comtess taken together with levodopa may lower your b lood pressure, which may make you feel light-headed or dizzy. Be particularly careful when you drive or when you use tools or machinery.

In addition, Comtess taken with levodopa may make you feel very drowsy, or cause you to sometimes suddenly fall asleep .

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

Comtess contains soya lecithin and sodium

Comtess contains soya lecithin. If you are allergic to peanut or soya, do not use this medicin al 21product .

This medicine contains 7.9mg s odium (main component of cooking/table salt) in each tablet . The maximum recommended daily dose (10 tablets )contains 79 mg of sodium. This is equivalent to 4% of the recommended maximum daily dietary intake of so dium for an adult.

💊 3. How to take Comtess

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Comtess is taken together with medicines containing levodopa (either levodopa/carbidopa preparations or levodopa/bense razide preparations). You may also use other medicines to treat Parkinson’s disease at the same time.

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

If you are receiving dialysis for renal insufficiency, your doctor may tell you to increase the time between doses.

To open the bottle for the first time: open the closure, and then press with your thumb on the seal until it breaks. See picture 1.Picture 1 Use in children and adolescents Experience with Comtess in patients under 18 years is limited. Therefore, the use of Comtess in children oradolescents cannot be recommended.

If you take more Comtess than you should

In the event of an overdose, consult your doctor, pharmacist or the nearest hospital immediately.

If you forget to take Comtess

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

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

If you stop taking Comtess

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

When stopping your doctor may need to re -adjust the dosage of your ot her medicines to treat Parkinson´s disease. Suddenly stopping Comtess and other medicines to treat Parkinson´s disease may result in unwanted side effects. See Section 2 Warnings and precautions .

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

❗ 4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Usually side effects caused by Comtess are mild to moderate.

22Some of the side effects are often caus ed by the increased effects of levodopa therapy and are most common at the start of treatment. If you experience such effects at the start of treatment with Comtess you should contact your doctor who may decide to adjust your dosage of levodopa.

Very comm on(may affect mor ethan 1 in 10 people) :  Uncontrollable movements with difficulty in performing voluntary movements (dyskinesias);  feeling sick (nausea);  harmless reddish -brown discolo uration of urine.

Common (may affect up to 1 in 10 people )

 Excessive movements (hyperkinesias), worsening of symptoms of Parkinson´s disease, prolonged muscle cramps (dystonia);  being sick (vomiting), diarrhoea, abdominal pain, constipation, dry mouth;  dizziness, tiredness, increased sweating, fall ;  hallucinations (seeing /hearing/feeling/smelling things that are not really there), sleeplessness, vivid dreams, and confusion ;  heart or artery disease events (e.g. chest pain).

Uncommon (may affect up to 1 in 100 people )

 Heart attack.

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

 Rashes;  abnormal results in liver function test.

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)

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

When Comtess is given at higher doses:

In doses of 1,400 to 2,000 mg per day, the following side effects are more co mmon:  Uncontrollable movements;  nausea;  abdominal pain.

Other important side effects which may occur:  Comtess taken with levodopa may rarely make you feel very drowsy during the day, and cause you to suddenly fall asleep;  Neuroleptic Malignant Syndrome ( NMS) is a rare severe reaction to medicines used to treat disorders of the nervous system. It is characterised by stiffness, muscle twitching, shaking, agitation andconfusion, coma, high body temperature, increased heart rate ,and unstable blood pressure;  a rare severe muscle disorder (rhabdomyolysis) which causes pain, tenderness and weakness of the muscles and may lead to kidney problems .

You may experience the following side effects:

23 Inability to resist the impulse to perform an action that could be harmful, which may include: strong impulse to gamble excessively despite serious personal or family consequences; altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive; uncontr ollable excessive shopping or spending; binge eating (eating large amounts of food in a short time period) 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 ways of managing or reducing the symptoms.

Reporting of side effects

If you get any side effects, talk to your doctor orpharmacist. 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 Appendix V .By reporting side effects you can help provide more information on the safety of this medicine .

🌡️ 5. How to store Comtess

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 bottle label. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

📦 6. Contents of the pack and other information

What Comtess contains

• The active substance is entacapone. Each tablet contains 200 mg of entacapone.
• The other ingredients in the tablet core are microcrystalline cellulose, croscarmellose sodium, povidone and magnesium stearate.
• The film -coating contains partly hydrolysed polyvinyl alcohol, talc, macrogol, soy alecithin , yellow iron oxide ( E 172 ), red iron oxide ( E 172 ) and titanium dioxide ( E 171 ).

What Comtess looks like and contents of the pack

Comtess 200mgfilm-coated tablets are brownish -orange, oval tablets with “COMT” engraved on one side. They are packed in bottles.

There are four different pack sizes (bottles containing 30, 60, 100 or 175 tablets). Not all pack sizes may be marketed.

Marketing Autho risation Holder Orion Corporation Orionintie 1 FI-02200 Espoo Finland

Manufacturer

Orion Corporation Orion Pharma 24Joensuunkatu 7 FI-24100 Salo Finland Orion Corporation Orion Pharma Orionintie 1 FI-02200 Espoo Finland For further information about thismedicine , please contact the local representative of the Marketing Authorisation Holder:

België/ Belgique/ Belgien Orion Corporation Tél./Tel: + 358 10 4261Lietuva UAB Orion Pharma Tel: +370 5 276 9499 България Orion Corporation Тел.:+358 10 4261Luxembourg/Luxemburg Orion Corporation Tél./Tel: + 358 10 4261 Česká republika Orion Corporation Tel: + 358 10 4261Magyarország Orion Corporation Tel.: +358 10 4261 Danmark Orion Pharma A/S Tlf: +45 8614 0 000Malta Orion Corporation Tel: + 358 10 4261 Deutschland Orion Pharma GmbH Jürgen -Töpfer -Straße 46 22763 Hamburg Tel: +49 40 899 689 -0Nederland Orion Corporation Tel: + 358 10 4261 Eesti Orion Pharma Eesti OÜ Tel: +372 66 44 550Norge Orion Pharma AS Tlf.:+47 400042 10 Ελλάδα Orion Corporation Tηλ: +358 10 4261Österreich Orion Corporation Tel: + 358 10 4261 España Orion Corporation Tel: + 358 10 4261Polska Orion Pharma Poland Sp. z o.o.

Tel.: +48 22 8333177 France Orion Corporation Tél.: +358 10 4261Portugal Orion Corporation Tel: + 358 10 4261 Hrvatska Orion Corporation Tel.: +358 10 4261România Orion Corporation Tel: + 358 10 4261 25Ireland Orion Pharma ( Ireland ) Ltd. c/o Allphar Services Ltd.

Tel: +353 1 428 7777Slovenija Orion Corporation Tel: + 358 10 426 1 Ísland Vistor hf.

Sími: +354 535 7000Slovenská republika Orion Corporation Tel: + 358 10 4261 Italia Orion Corporation Tel: + 358 10 4261Suomi/Finland Orion Corporation Puh./Tel: +358 10 4261 Κύπρος Orion Corporation Tηλ: +358 10 4261Sverige Orion Pharma AB Tel: +46 8 623 6440 Latvija Orion Corporation Orion Pharma pārstāvniecība Tel: +371 20028332United Kingdom (Northern Ireland) Orion Pharma ( Ireland ) Ltd. c/o Allphar Services Ltd.

Tel: +353 1 428 7777

This leaflet was last revised in

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

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Comtess (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/98/082).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.