Label: Information for the Patient

Entacapona Viatris 200 mg Film-Coated Tablets

Read this label carefully before starting to take this medication, as it contains important information for you.

- Keep this label, as you may need to read it again.

- If you have any questions, consult your doctor or pharmacist.

- This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms, as it may harm them.

- If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What is Entacapona Viatris and what is it used for

2. What you need to know before starting to take Entacapona Viatris

3. How to take Entacapona Viatris

4. Possible adverse effects

5. Storage of Entacapona Viatris

6. Contents of the pack and additional information

Entacapona Viatris tablets contain entacapone and are used in combination with levodopa to treat Parkinson's disease. Entacapona Viatris helps levodopa in relieving symptoms of Parkinson's disease. Entacapona Viatris has no effect in relieving symptoms of Parkinson's disease unless administered with levodopa.

Do not take Entacapona Viatris

• If you are allergic to entacapone or any of the other ingredients of this medication (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, skin rash, itching, or hives on the skin.
• If you have pheochromocytoma, a tumor of the adrenal gland (a gland located near the kidney), as 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 medication can be taken with entacapone). If you are taking reversible inhibitors of monoamine oxidase A (such as moclobemide) together with inhibitors of monoamine oxidase B (such as selegiline).
• If you have liver disease.
• If you have ever experienced a rare reaction to antipsychotic medications called Neuroleptic Malignant Syndrome (NMS). See section 4 of this leaflet “Possible side effects” for NMS symptoms.
• If you have ever experienced a rare muscle disorder called rhabdomyolysis not caused by trauma. Rhabdomyolysis causes muscle pain, sensitivity, and weakness, sensitivity to pressure, and may cause kidney problems.

Warnings and precautions

Consult your doctor or pharmacist before taking Entacapona Viatris:

• If you have ever had a heart attack or any other heart disease.
• If you are taking any medication 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 inflammation of the colon (large intestine).
• If you experience diarrhea, it is recommended to control your weight to avoid excessive weight loss.
• If you experience increasing loss of appetite, weakness, fatigue, and weight loss over a relatively short period of time. 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 unusual desires or cravings in your behavior, or that you cannot resist the impulse or temptation to carry out some activity that may be harmful to you or others. These behaviors are called impulse control disorders and may include excessive gaming, overeating, or excessive spending, an abnormal increase in sexual desire or an increase in sexual thoughts or feelings.Your doctor may need to review your treatments.

As Entacapona Viatris must be taken together with other medications containing levodopa, read also carefully the leaflet of these medications.

You may need to adjust the doses of other medications to treat Parkinson's disease when you start taking Entacapona Viatris. Follow the instructions as indicated by your doctor.

Neuroleptic Malignant Syndrome (NMS) is a severe but rare reaction to certain medications, and may appear especially when the treatment with Entacapona Viatris and other medications for Parkinson's disease is suddenly stopped or reduced. For NMS symptoms, see section 4 “Possible side effects”. Your doctor may advise you to gradually discontinue the treatment with Entacapona Viatris and other medications for Parkinson's disease.

The use of Entacapona Viatris together with levodopa may cause drowsiness and may cause you to fall asleep suddenly. If this happens, do not drive or operate tools or machinery (see section “Driving and operating machinery”).

Children and adolescents

The experience of Entacapona Viatris in patients under 18 years is limited. Therefore, the use of Entacapona Viatris is not recommended in children.

Use of Entacapona Viatris with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take other medications including those purchased without a prescription, or medications based on plants.

In particular, inform your doctor if you are using any of the following medications:

• Rimiterol, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha-methyldopa, apomorphine.
• Antidepressants: tricyclic antidepressants (such as amitriptyline, desipramine), maprotiline, venlafaxine, paroxetine, reversible inhibitors of monoamine oxidase A (such as moclobemide).
• Warfarin (used to thin the blood).
• Iron supplements. Entacapona Viatris may make it difficult to digest iron. Therefore, do not take Entacapona Viatris and iron supplements at the same time. Wait at least 2 or 3 hours after taking one of them before taking the other.

Pregnancy, breastfeeding, and fertility

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

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

If you take Entacapona 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 Entacapona Viatris together with levodopa, it may cause you to feel very sleepy, or make you fall asleep suddenly.

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

Entacapona Viatris contains saccharose.

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

Entacapona Viatris is taken along with medications that contain levodopa (whether levodopa/carbidopa or levodopa/benserazide preparations). You may also use other medications to treat Parkinson's disease at the same time.

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

Patients with kidney problems

If you are undergoing dialysis due to kidney problems, your doctor may instruct you to increase the time between doses.

If you take more Entacapona Viatris than you should

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

In case of overdose or accidental ingestion, contact the Toxicological Information Service, (phone 91 5620420), indicating the medication and the amount ingested.

If you forgot to take Entacapona Viatris

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

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Entacapona Viatris

Do not discontinue treatment with Entacapona Viatris unless your doctor instructs you to do so. When discontinuing, your doctor may need to adjust the dose of other medications for Parkinson's disease. Sudden discontinuation of treatment with Entacapona Viatris and other Parkinson's disease medications may cause unwanted side effects. See section 2 of this leaflet “Warnings and precautions”.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications,this medicationcan cause side effects, although not everyone will experience them. The side effects caused byEntacaponaViatrisare generally mild or moderate.

Some of these side effects are often due to an increase in the effects caused by levodopa treatment and are more frequent at the beginning of treatment. If you experience these side effects at the start of treatment withEntacaponaViatrisyou should contact your doctor, who may decide to adjust the levodopa dose.

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

• Entacapona, administered with levodopa, rarely may cause excessive daytime sleepiness or sudden sleep.
• The Malignant Neuroleptic Syndrome (MNS) is a rare severe reaction to medications used in the treatment of nervous system disorders and may occur when these medications are suddenly stopped or interrupted. It is characterized by rigidity, muscle spasms, tremors, agitation, 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 muscle weakness, and may lead to kidney problems.
• Inability to resist the urge to perform an action that could be harmful, which may include:

• A strong urge to gamble excessively despite severe personal or family consequences.
• Alteration or increase in sexual desire and behavior of great concern to you or others, such as increased libido.
• Uncontrolled spending or excessive expenditure.
• Binge eating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than needed to satisfy hunger).

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

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

Other side effects:

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

• Uncontrollable movements with difficulty performing voluntary movements (dyskinesias).
• Feeling dizzy (nausea).
• Inoffensive brownish-red discoloration of the urine.

Common (may affect 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, or smelling things that are not real), insomnia, intense dreams, confusion.
• Events related to arterial or heart disease (e.g., chest pain, angina).

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

• Characterized by redness or protuberances on the skin.
• Abnormal results from liver function tests.

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

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

Unknown frequency (cannot be estimated from available data):

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

WhenEntacaponaViatrisis administered at higher doses:

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

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

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medicationafter the expiration date that appears on the blister pack and on the container, after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGREdrop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Entacapona Viatris

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

Appearance of the product and contents of the package

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

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

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

Only some package sizes may be marketed

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible 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 medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

CyprusEntacapone Mylan

DenmarkEntacapone Mylan

SpainEntacapona Viatris

FranceEntacapone Mylan

NetherlandsEntacapone Mylan

PortugalEntacapona Mylan

United KingdomEntacapone Mylan

RomaniaEntacapona Mylan

SwedenEntacapone Mylan

Last review date of this leafletFebruary 2017

More detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es