200 mg film-coated tablets 
Entacapone

1. What Comtess is and what it is used for

Comtess tablets contain entacapone and are used with levodopa in the treatment of Parkinson’s disease. Comtess helps levodopa reduce the symptoms of Parkinson’s disease. Comtess has no relieving effect on Parkinson’s symptoms without concomitant treatment with levodopa.

2. What you need to know before taking Comtess

Do not take Comtess

  • if you are allergic to entacapone or to peanuts or soy or any of the other ingredients of this medicine (listed in section 6);
  • if you have a tumor in the adrenal gland ( pheochromocytoma ), as it may increase the risk of severe high blood pressure;
  • if you are taking certain antidepressants (ask your doctor or pharmacist if your antidepressant can be taken with Comtess);
  • if you have liver disease;
  • if you have previously had a rare reaction to antipsychotics called neuroleptic malignant syndrome (NMS). See section 4 Possible side effects, for a description of NMS;
  • if you have previously had the rare muscle disease rhabdomyolysis that was not caused by the injury.

Warnings and cautions

Talk to your doctor or pharmacist before taking Comtess:

  • if you have had a heart attack or any other heart disease;
  • if you are taking medicines that may cause dizziness or dizziness (low blood pressure ) when you get up from a chair or bed;
  • if you experience prolonged diarrhea, consult a doctor as this may be a sign of colitis;
  • if you get diarrhea, recurrent weight control is recommended to avoid any excessive weight loss;
  • If you experience an increased appetite, weakness, fatigue, and weight loss in a relatively short time, you should undergo a general medical examination, including an examination of liver function.

Tell your doctor if you or your family/caregiver discovers that you are developing impulses or wanting to behave in ways that are unusual for you, or that you cannot resist the impulse, the drive, or the temptation to engage in a certain activity that may harm yourself or others. This behavior is called impulse control disorder and may include compulsive gambling, excessive food intake or spending, an abnormally high sex drive, or a preoccupation with an increase in sexual thoughts or feelings. Your doctor may need to review your treatment.

Because Comtess tablets are taken with other levodopa medicines, also read the package leaflet for these other medicines carefully.

When you start taking Comtess, you may need to adjust the dose of one of your other medicines for Parkinson’s disease. Follow the instructions given to you by your doctor.

Neuroleptic malignant syndrome (NMS) is a severe but unusual reaction to certain medicines and can occur especially when you suddenly stop taking Comtess and other medicines for Parkinson’s disease or when the dose is suddenly reduced. For a description of NMS see section 4 Possible side effects. Your doctor may ask you to slowly stop treatment with Comtess and other medicines for Parkinson’s disease.

Concomitant use of Comtess and levodopa may cause drowsiness and may at some point cause you to suddenly fall asleep. If this happens, do not drive or use 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. Tell your doctor especially if you are taking any of the following:

  • rimiterol, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha methyldopa, apomorphine;
  • antidepressants such as desipramine, maprotiline, venlafaxine, paroxetine;
  • warfarin (blood-thinning drug);
  • iron supplements. Comtess can make it harder to absorb iron. Therefore, do not take Comtess and iron supplements at the same time. After taking one medicine, wait at least 2-3 hours before taking the other.

Pregnancy, breastfeeding, and fertility

Do not use Comtess during pregnancy or breast-feeding. If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Comtess together with levodopa can cause low blood pressure and dizziness. Be extra careful when driving and when using machines.

In addition, Comtess with levodopa may cause severe drowsiness or you may suddenly fall asleep.

Do not drive or use machines if you experience these side effects.

Important information about some of the ingredients (s) of Comtess

Comtess contains soy lecithin. If you are allergic to peanuts or soy, do not use this medicine.

3. How to take Comtess.

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Comtess is used with medicines containing levodopa (either levodopa/carbidopa preparations or levodopa/benserazide preparations). At the same time, you can also take other medicines for Parkinson’s disease.

The recommended dose of Comtess is one 200 mg tablet with each levodopa dose. The highest recommended dose is 10 tablets per day, ie 2000 mg Comtess.

If you are undergoing dialysis treatment due to impaired kidney function, your doctor may recommend that you extend the time between doses.

To open the jar for the first time: open the lid and then press with your thumb on the seal until it breaks. See the picture below.

Picture 1

Use for children and adolescents

The experience of Comtess for patients under 18 years of age is limited. The use of Comtess in children or adolescents is therefore not recommended.

If you take more Comtess than you should

In case of overdose, contact your doctor, pharmacist, or nearest hospital immediately.

If you forget to take Comtess

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

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

If you stop taking Comtess

Do not stop using Comtess without consulting your doctor.

When you stop, your doctor may need to change the dose of one of your other medicines for Parkinson’s disease. Abrupt discontinuation of Comtess and other Parkinson’s medicines may result in unwanted side effects. See section 2 Warnings and Precautions.

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

4. Possible side effects

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

Some of the side effects are often caused by the increased effects of levodopa treatment and are most common when starting treatment. If you experience such effects when starting treatment with Comtess, contact your doctor who may need to adjust your dose of levodopa.

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

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

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

  • Excessive movements (hyperkinesias), worsening of Parkinson’s symptoms, prolonged muscle contractions ( dystonia );
  • vomiting, diarrhea, abdominal pain, constipation, dry mouth;
  • dizziness, fatigue, increased sweating, falls;
  • hallucinations (visual, auditory, sensory, and olfactory sensations that are not real), insomnia, vivid dreams, and confusion;
  • heart or artery disease (eg 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 results of liver function tests.

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

  • Indignation;
  • decreased appetite, weight loss;
  • skin rash and hives.

No known frequency (cannot be calculated from the available data):

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

When Comtess is given in higher doses you :

At doses ranging from 1,400 to 2,000 mg per day, the following side effects are more common:

  • Involuntary movements;
  • nausea;
  • abdominal pain.

Other important side effects that may occur;

  • Comtess taken with levodopa may, in rare cases, make you feel very sleepy during the day and cause you to suddenly fall asleep;
  • Neuroleptic malignant syndrome (NMS) is a serious rare side effect of medicines used to treat diseases of the nervous system. It is characterized by stiffness, muscle twitching, tremors, agitation and confusion, unconsciousness, high body temperature, increased heart rate, and fluctuations in blood pressure;
  • a severe rare muscle disease ( rhabdomyolysis ) that causes pain, tenderness, and weakness in the muscles and can lead to kidney problems.

You may experience the following side effects:

  • Inability to resist the impulse to perform an act that may be harmful, which may include;
  • strong impulse to play extremely much despite serious personal or family consequences;
  • altered or increased sexual interest and behavior that significantly affects you or others, such as increased sexual desire;
  • uncontrolled excessive shopping or spending;
  • binge eating (eating large amounts of food for a short period of time) or compulsive food intake (eating more food than normal and more than is needed to satisfy your hunger).

Tell your doctor if you experience any of these symptoms; one will discuss how to manage or reduce these symptoms.

Reporting of side effects ar

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. You can also report side effects directly via

The Medical Products Agency

Box 26

751 03 Uppsala

Website: www.lakemedelsverket.se

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address

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 can label after EXP. The expiry date refers to the last day of that month.

No special storage instructions

Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is entacapone. Each tablet contains 200 mg entacapone.
  • The other ingredients in the tablet core are microcrystalline cellulose, croscarmellose sodium, povidone, and magnesium stearate.
  • Other ingredients in the tablet case: partially hydrolyzed polyvinyl alcohol, talc, macrogol, soy lecithin, yellow iron oxide (E 172), red iron oxide (E 172), and titanium dioxide (E 171).

What the medicine looks like and the contents of the pack

Comtess 200 mg film-coated tablets are brown-orange, oval tablets with “COMT” engraved on one side. The tablets are packaged in jars. There are four different pack sizes (jars containing 30, 60, 100, or 175 tablets). Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Contact the representative of the marketing authorization holder to find out more about this medicine:

Muhammad Nadeem

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