ENTACAPONE VIATRIS 200 mg FILM-COATED TABLETS

2. What you need to know before you take Entacapone Viatris

Do not take Entacapone Viatris

• If you are allergic to entacapone or any of the other ingredients of this medicine (listed in section 6). The symptoms of an allergic reaction include shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body, skin rash, itching or hives.
• If you have a pheochromocytoma, a tumor of the adrenal gland (a gland located near the kidney), because this may increase the risk of severe hypertension.
• If you are taking certain antidepressants known as non-selective monoamine oxidase inhibitors (MAOIs), such as phenelzine or tranylcypromine (ask your doctor or pharmacist if your antidepressant can be taken with entacapone). If you are taking reversible type A monoamine oxidase inhibitors (such as moclobemide) together with type B monoamine oxidase inhibitors (such as selegiline).
• If you have liver disease.
• If you have ever had a rare reaction to antipsychotic drugs called Neuroleptic Malignant Syndrome (NMS). See section 4 of this leaflet "Possible side effects" for symptoms of NMS.
• If you have ever had a rare muscle disorder called rhabdomyolysis not caused by trauma. Rhabdomyolysis causes pain, sensitivity, and weakness of the muscles, sensitivity to pressure, and can cause kidney problems.

Warnings and precautions

Consult your doctor or pharmacist before taking Entacapone Viatris:

• If you have ever had a heart attack or any other heart disease.
• If you are taking any medicine that may cause dizziness or lightheadedness (low blood pressure) when standing up from a chair or bed.
• If you experience any unexplained muscle pain, sensitivity, or weakness, or sensitivity to pressure.
• If you experience prolonged diarrhea, consult your doctor as it may be a sign of colon inflammation (large intestine).
• If you experience diarrhea, it is recommended to monitor your weight to avoid excessive weight loss.
• If you experience increasing loss of appetite, weakness, exhaustion, and weight loss over a relatively short period. Your doctor may consider a general medical evaluation, including liver function tests.

Consult your doctor if you or someone in your family or caregiver notices that you are developing desires or cravings in your behavior in an unusual way or that you cannot resist the impulse or temptation to carry out an activity that may be harmful to you or others. These behaviors are called impulse control disorders and may include addiction to gambling, overeating or excessive spending, an abnormally increased desire for sex or an increase in sexual thoughts or feelings. Your doctor may need to review your treatments.

Since Entacapone Viatris must be taken together with other medicines that contain levodopa, also read the package leaflet of these medicines carefully.

It may be necessary to adjust the doses of other medicines for treating Parkinson's disease when you start taking Entacapone Viatris. Follow the instructions as indicated by your doctor.

Neuroleptic Malignant Syndrome (NMS) is a rare but serious reaction to certain medicines, and may occur especially when treatment with Entacapone Viatris and other medicines for treating Parkinson's disease is suddenly stopped or abruptly reduced. For symptoms of NMS, see section 4 "Possible side effects". Your doctor may advise gradual discontinuation of treatment with Entacapone Viatris and other medicines for Parkinson's disease.

Taking Entacapone Viatris together with levodopa may cause drowsiness and may cause you to fall asleep suddenly. If this happens to you, do not drive or operate tools or machines (see section "Driving and using machines").

Children and adolescents

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

Use of Entacapone Viatris with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take other medicines, including those obtained without a prescription, or herbal medicines.

In particular, tell your doctor if you are using any of the following medicines:

• 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 (used to thin the blood).
• Iron supplements. Entacapone Viatris may interfere with the absorption of iron. Therefore, do not take Entacapone Viatris and iron supplements at the same time. After taking one of them, wait at least 2 or 3 hours before taking the other.

Pregnancy, breastfeeding, and fertility

Do not take Entacapone Viatris during pregnancy or while breastfeeding your baby.

If you are pregnant or breastfeeding, 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

If you take Entacapone Viatris together with levodopa, it may lower your blood pressure, which may make you feel dizzy or lightheaded. Be careful when driving or operating tools or machinery.

Additionally, if you take Entacapone Viatris together with levodopa, it may cause you to feel very sleepy or fall asleep suddenly.

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

Entacapone Viatris contains sucrose.

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Entacapone Viatris

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.

Entacapone Viatris is taken together with medicines that contain levodopa (either levodopa/carbidopa or levodopa/benserazide preparations). You may also use other medicines for treating Parkinson's disease at the same time.

The recommended dose of Entacapone Viatris is one 200 mg tablet with each dose of levodopa. The maximum recommended dose is 10 tablets per day, i.e., 2,000 mg of Entacapone Viatris. This medicine can be taken with or without food.

Patients with kidney problems

If you are undergoing dialysis because you have kidney problems, your doctor may tell you to increase the time between doses.

If you take more Entacapone Viatris than you should

In case of overdose, consult your doctor, pharmacist, or go to the nearest hospital immediately. The symptoms include confusion, decreased activity, drowsiness, decreased muscle tone, discoloration of the skin, and urticaria (hives).

In case of overdose or accidental ingestion, consult the Toxicological Information Service (telephone 91 5620420), indicating the medicine and the amount taken.

If you forget to take Entacapone Viatris

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

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

If you stop taking Entacapone Viatris

Do not stop taking Entacapone Viatris unless your doctor tells you to. When stopping, it is possible that your doctor will need to adjust the dose of the other medicines for treating Parkinson's disease. Abruptly stopping treatment with Entacapone Viatris and other medicines for treating Parkinson's disease may cause 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. The side effects caused by Entacapone Viatris are generally mild or moderate.

Some of these side effects are frequently due to the increased effects caused by treatment with levodopa and are more frequent at the start of treatment. If you experience these effects at the beginning of treatment with Entacapone Viatris, you should contact your doctor, who may decide to adjust the dose of levodopa.

Consult your doctor if you experience any of the following side effects:

• Entacapone, when administered with levodopa, may rarely cause you to feel very sleepy during the day or fall asleep suddenly.
• Neuroleptic Malignant Syndrome (NMS) is a rare but serious reaction to medicines used in the treatment of nervous system disorders and may occur when these medicines are stopped or interrupted abruptly. It is characterized by stiffness, muscle spasms, tremors, agitation, and confusion, coma, increased body temperature, tachycardia, and unstable blood pressure.

• A rare, severe muscle disorder (rhabdomyolysis) that causes pain, abnormal sensitivity to touch and pressure, and weakness of the muscles, and may lead to kidney problems.
• Inability to resist the impulse to perform an action that could be harmful, may include:

• Strong impulse to gamble excessively despite serious personal or family consequences.
• Alteration or increase in sexual desire and behavior of great concern to you or others, such as increased libido.
• Uncontrolled shopping or excessive spending.
• Binge eating (eating large amounts of food in a short period) or compulsive eating (eating more food than normal and more than necessary to satisfy hunger).

Consult your doctor if you experience any of these behaviors; the doctor will assess how to manage or reduce these symptoms.

• Heart attack (symptoms include chest pain that may feel like it is traveling to other parts of the body, such as the left arm, jaw, and neck; shortness of breath, anxiety, feeling of dizziness, and nausea or vomiting. This is an uncommon side effect (may affect up to 1 in 100 people)
• Colon inflammation (colitis, symptoms include prolonged or persistent diarrhea) or liver inflammation (hepatitis) with yellowing of the skin and the white part of the eyes. The frequency of these side effects is unknown (cannot be estimated from the available data)

Other side effects:

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

• Uncontrolled movements with difficulty performing voluntary movements (dyskinesias).
• Feeling dizzy (nausea).
• Harmless brownish discoloration of the urine.

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

• Excessive movements (hyperkinesias), worsening of Parkinson's disease symptoms, prolonged muscle cramps (dystonia).
• Feeling dizzy (vomiting), diarrhea, abdominal pain, constipation, dry mouth.
• Dizziness, fatigue, increased sweating, falls.
• Hallucinations (seeing, hearing, feeling, smelling things that are not real), insomnia, vivid dreams, confusion.
• Events related to arterial or heart disease (e.g., chest pain, angina pectoris).

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

• Rashes characterized by redness or bumps on the skin.
• Abnormal liver function test results.

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

• Agitation.
• Decreased appetite, weight loss.
• Urticaria.

Frequency not known (cannot be estimated from the available data):

• Discoloration of the skin, hair, beard, and nails.

When Entacapone Viatris is administered at higher doses:

At doses of 1,400 to 2,000 mg per day, the following side effects are more frequent:

• Uncontrolled movements with difficulty performing voluntary movements (dyskinesias).
• Feeling dizzy (nausea).
• Abdominal pain.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Entacapone Viatris

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 blister and carton after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Only for the bottle: Once opened, it has a 100-day period for use.

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 protect the environment.

6. Package Contents and Additional Information

Composition of Entacapona Viatris

• The active ingredient is entacapone. Each film-coated tablet contains 200 mg of entacapone.
• The other ingredients are microcrystalline cellulose, mannitol (E-421), low-substituted hydroxypropylcellulose, magnesium stearate (E-470b), hydrogenated vegetable oil.
• The film coating contains hypromellose, titanium dioxide (E-171), glycerin, magnesium stearate (E-470b), yellow iron oxide (E-172), sucrose, polysorbate 80, red iron oxide (E-172).

Appearance of the Product and Package Contents

The film-coated tablets of Entacapona Viatris 200 mg are light orange in color, oval and biconvex in shape with the inscription "EE200" on one side of the tablet and "M" on the other side. They are presented in blisters, bottles, and boxes containing multiple bottles.

The blisters are formed by a clear transparent PVC/PE/PVdC film on one side and a tempered hard aluminum film coated with thermal varnish paper on the other side and are available in formats of 30, 60, 100, 200, 300, or 400, or single-dose perforated blisters of 100 film-coated tablets.

High-density polyethylene (HDPE) white bottles with a white opaque polypropylene (PP) screw cap containing 30, 50, 60, 100, 250, or 500 film-coated tablets.

Boxes of 200, 300, or 400 tablets, containing multiple bottles (4, 6, or 8) with 50 tablets each. The bottles are made of high-density polyethylene (HDPE) with a white opaque polypropylene (PP) screw cap.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturers

McDermott Laboratories Limited trading as Gerard Laboratories

35/36 Baldoyle Industrial Estate

Grange Road, Dublin 13

Ireland

Or

Mylan Hungary Kft.

H-2900, Komárom

Mylan utca 1.

Hungary

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication is authorized in the member states of the European Economic Area under the following names:

Cyprus Entacapone Mylan

Denmark Entacapone Mylan

Spain Entacapona Viatris

France Entacapone Mylan

Netherlands Entacapone Mylan

Portugal Entacapona Mylan

United Kingdom Entacapone Mylan

Romania Entacapona Mylan

Sweden Entacapone Mylan

Date of the Last Revision of this LeafletFebruary 2017

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)http://www.aemps.gob.es