200 mg film-coated tablets 
entacapone

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or pharmacist.

– This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Entacapone Mylan is and what it is used for 
2. What you need to know before you take Entacapone Mylan 
3. How to take Entacapone Mylan 
4. Possible side effects 
5. How to store Entacapone Mylan 
6. Contents of the packaging and other information 

1. What Entacapone Mylan is and what it is used for

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

Entacapone contained in Entacapone Mylan may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you take Entacapone Mylan

Do not take Entacapone Mylan

  • if you are allergic to entacapone or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergy include shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue, or other parts of the body, rash, itchy skin, or hives.
  • if you have pheochromocytoma, a tumor of the adrenal gland (a gland located near the kidney), as it may increase the risk of severe high blood pressure
  • if you are taking certain antidepressants, so-called non-selective monoamine oxidase (MAO) inhibitors. Examples include phenelzine and tranylcypromine (ask your doctor or pharmacist if your antidepressant can be taken with Entacapone Mylan)
  • if you are taking reversible monoamine oxidase inhibitors type A (such as moclobemide) together with monoamine oxidase inhibitors type B (such as selegiline )
  • if you have liver disease
  • if you have previously had a rare reaction to antipsychotics, so-called neuroleptic malignant syndrome (NMS). See section 4 of this leaflet (Possible side effects ) for a description of the symptoms of NMS
  • if you have previously had the rare muscle disease rhabdomyolysis that was not caused by the injury. Rhabdomyolysis causes pain, tenderness, and weakness in the muscles increased sensitivity to stress, and can lead to kidney problems.

Warnings and cautions

Talk to your doctor or pharmacist before taking Entacapone Mylan:

  • 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 any unexplained pain, tenderness or weakness in the muscles, or increased sensitivity to stress
  • if you experience prolonged diarrhea, consult a doctor as this may be a sign of colitis
  • if you get diarrhea, recurring weight control is recommended to avoid any excessive weight loss
  • If you experience an increasing loss of appetite, weakness, fatigue, and weight loss in a relatively short time, your doctor may want you to undergo a general medical examination, including an examination of your liver function.

Tell your doctor if you or your family/carer notice that you develop a strong desire or desire to behave in ways that are unusual for you, or if you can not resist the impulse, drive, or temptation to perform certain activities. which may harm you or others. These behaviors are called impaired impulse control and may include gambling addiction, compulsive eating, compulsive buying, an abnormally high sex drive, or an increase in sexual thoughts and feelings. Your doctor may need to re-evaluate your treatment.

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

When you start taking Entacapone Mylan, 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 Entacapone Mylan and other medicines for Parkinson’s disease or when you suddenly decrease the dose. For a description of the symptoms of NMS see section 4 (Possible side effects ). Your doctor may ask you to slowly stop taking Entacapone Mylan and other medicines for Parkinson’s disease.

Concomitant use of Entacapone Mylan 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”).

Children and young people

Experience with Entacapone Mylan in patients under 18 years of age is limited. Therefore, the use of Entacapone Mylan in children is not recommended.

Other medicines and Entacapone Mylan

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription or herbal remedies. Tell your doctor especially if you are taking any of the following:

  • rimiterol, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha methyldopa, apomorphine
  • antidepressants: tricyclic antidepressants (such as amitriptyline, desipramine), maprotiline, venlafaxine, paroxetine, reversible type A monoamine oxidase inhibitors (such as moclobemide)
  • warfarin (blood thinner)
  • iron supplements. Entacapone Mylan may make it harder to absorb iron. Therefore, do not take Entacapone Mylan 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 Entacapone Mylan 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

Entacapone Mylan, together with levodopa, may cause low blood pressure and dizziness. Be extra careful when driving and when using machines. Also, Entacapone Mylan with levodopa may cause drowsiness or you may suddenly fall asleep. Do not drive or use machines if you experience these side effects.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Entacapone Mylan contains sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take Entacapone Mylan

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

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

The recommended dose of Entacapone Mylan is one 200 mg tablet with each levodopa dose. The highest recommended dose is 10 tablets per day, ie 2000 mg Entacapone Mylan. This medicine can be taken with or without food.

Patients with kidney problems

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

If you take more Entacapone Mylan then you should

If you have ingested too much medicine or if e.g. a child inadvertently ingested the medicine immediately contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. Symptoms include confusion, decreased activity, drowsiness, decreased muscle tension, discoloration of the skin, and hives ( urticaria ).

If you forget to take Entacapone Mylan

Should you forget to take the Entacapone Mylan 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 Entacapone Mylan

Do not stop using Entacapone Mylan 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. Sudden discontinuation of Entacapone Mylan and other medicines for Parkinson’s disease may result in unwanted side effects. See section 2 of this leaflet (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. Generally, the side effects caused by Entacapone Mylan 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 Entacapone Mylan, contact your doctor who may need to adjust your dose of levodopa.

Tell your doctor if you get any of the following side effects:

  • Concomitant use of entacapone and levodopa may in rare cases make you very drowsy during the day and cause you to suddenly fall asleep.
  • Neuroleptic malignant syndrome (NMS) is a rare serious reaction to certain medicines used to treat diseases of the nervous system and may occur when you suddenly stop taking these medicines or when you suddenly drop the dose. Typical symptoms are stiffness, muscle cramps, tremors, the feeling of agitation, confusion, coma, high body temperature, increased heart rate, and unstable blood pressure.
  • A rare serious muscle disease ( rhabdomyolysis ) that causes pain, soreness, and weakness in the muscles, sensitivity to stress, and can lead to kidney problems.
  • Inability to resist an impulse to perform an action that can be harmful such as:
    • A strong impulse to excessive gambling despite serious consequences for you personally or your family
    • Altered or increased sexual interest or behavior that makes you or others noticeably concerned, e.g. an increased sexual drive
    • Uncontrollable and excessive need to buy things and spend money
    • Binge eating (eating large amounts of food in a short time) 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 behaviors to discuss ways to manage or reduce the symptoms. 
  • Heart attack (symptoms include chest pain that may be experienced as it spreads to other parts of the body such as left arm, neck, and jaw, respiratory distress, anxiety, dizziness, and nausea or vomiting. This is a less common side effect (may affect up to 1 in 100 users).
  • Colon inflammation (colitis; symptoms include prolonged or difficult-to-treat diarrhea), or hepatitis ( hepatitis ) with yellowing of the skin and whites of the eyes. The frequency of these side effects is unknown (cannot be calculated from the available data).

Other side effects:

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

  • 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, angina).

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

  • A skin rash characterized by redness or swelling of the skin
  • 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.

Has been reported (occurs in an unknown number of users):

  • discoloration of skin, hair, beard, and nails.

When Entacapone Mylan is given in higher doses:

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

  • Involuntary movements with difficulty performing voluntary movements ( dyskinesias )
  • nausea
  • abdominal pain.

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

5. How to store Entacapone Mylan

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 label/carton/jar after EXP. The expiration date is the last day of the specified month.

No special storage instructions.

Can only: Used within 100 days after first opening.

Medicines should not be disposed of via wastewater or household waste. 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, mannitol, low-substituted hydroxypropylcellulose, magnesium stearate, hydrogenated vegetable oil.
  • The other ingredients in the tablet case are hypromellose, titanium dioxide (E171), glycerin, magnesium stearate, yellow iron oxide (E172), sucrose, polysorbate 80, red iron oxide (E172).

What the medicine looks like and the contents of the pack

Entacapone Mylan 200 mg film-coated tablets are light orange, oval, biconvex tablets, debossed with “EE200” on one side of the tablet and “M” on the other. The tablets are packed in blisters, jars, and cartons with several jars.

Blister packs with colorless, transparent PVC / PE / PVdC film on one side and hardened aluminum foil covered with heat-sealing varnish on the other side are available in pack sizes of 30, 60, 100, 200, 300, or 400 tablets, or packs of 100×1 tablets in perforated endosblister.

Jars in white polyethylene plastic (HDPE) with white screw caps made of polypropylene (PP) are available in pack sizes of 30, 50, 60, 100, 250, or 500 tablets.

Cartons contain 200, 300, or 400 tablets (4, 6, or 8 cans of 50 tablets). The jars are made of white polyethylene plastic (HDPE) and have white polypropylene (PP) screw caps.

Not all pack sizes may be marketed.

Manufacturer:

McDermott Laboratories (trading as Gerard Laboratories), 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.

Generics (UK) Limited, Albany Gate, Darkes Lane, Potters Bar, Herts EN6 1AG, UK.

Mylan Hungary Kft., H-2900 Komarom, Mylan utca 1, Hungary.

Muhammad Nadeem

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