Entacapone Viatris 200 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Entacapone Viatris 200 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Entacapone Viatris is and what it is used for
2. What you need to know before taking Entacapone Viatris
3. How to take Entacapone Viatris
4. Possible side effects
5. How to store Entacapone Viatris
6. Contents of the pack and other information

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

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

2. What you need to know before taking Entacapona Viatris

Do not take Entacapona Viatris

• If you are allergic to entacapone or any of the other ingredients of this medicine (listed in section 6). Allergic symptoms 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 phaeochromocytoma, 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 whether 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 a liver disease.
• If you have ever had a rare reaction to antipsychotic medicines called Neuroleptic Malignant Syndrome (NMS). See section 4 “Possible side effects” for symptoms of NMS.
• If you have ever experienced a rare muscle disorder called rhabdomyolysis not caused by trauma. Rhabdomyolysis causes muscle pain, tenderness and weakness, sensitivity to pressure, and may lead to kidney problems.

Warnings and precautions

Talk to your doctor or pharmacist before taking Entacapona Viatris:

• If you have ever had a heart attack or any other heart condition.
• 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 unexplained muscle pain, tenderness 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, weight monitoring is recommended to prevent 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 tests of your liver function.

Talk to your doctor if you or someone in your family or caregiver notices that you are developing unusual or irresistible urges or cravings in your behavior, or that you cannot resist the impulse or temptation to carry out an activity that could be harmful to yourself or others. These behaviors are called impulse control disorders and may include gambling addiction, excessive eating or spending, abnormally increased sex drive, or increased sexual thoughts or feelings. Your doctor may need to review your treatment.

Since Entacapona Viatris must be taken together with other medicines containing levodopa, please also read the package leaflet of these medicines carefully.

Dosages of other Parkinson’s disease medicines may need to be adjusted when you start taking Entacapona Viatris. Follow your doctor’s instructions exactly.

Neuroleptic Malignant Syndrome (NMS) is a serious but rare reaction to certain medicines, and may occur especially when treatment with Entacapona Viatris and other Parkinson’s disease medicines is suddenly stopped or rapidly reduced. For symptoms of NMS, see section 4 “Possible side effects”. Your doctor may advise gradually stopping treatment with Entacapona Viatris and other Parkinson’s disease medicines.

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 use of machines”).

Children and adolescents

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

Taking Entacapona Viatris with other medicines

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

In particular, inform your doctor if you are taking any of the following medicines:

• Rimiterol, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha-methyldopa, apomorphine.
• Antidepressants: tricyclic antidepressants (such as amitriptiline, desipramine), maprotiline, venlafaxine, paroxetine, reversible type A monoamine oxidase inhibitors (such as moclobemide).
• Warfarin (used to thin the blood).
• Iron supplements. Entacapona Viatris may interfere with iron digestion. Therefore, do not take Entacapona Viatris and iron supplements at the same time. After taking one, wait at least 2 to 3 hours before taking the other.

Pregnancy, breastfeeding and fertility

Do not take Entacapona Viatris during pregnancy or while breastfeeding.

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

Driving and use of machines

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

In addition, taking Entacapona Viatris with levodopa may make you very sleepy or cause you to fall asleep suddenly.

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

Entacapona Viatris contains sucrose.

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Entacapone Viatris

Always follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Entacapone Viatris is taken together with medications containing levodopa (either levodopa/carbidopa or levodopa/benserazide preparations). You may also be using other medicines to treat 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 due to kidney problems, your doctor may instruct you to increase the interval 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. Symptoms may include confusion, reduced activity, drowsiness, decreased muscle tone, skin discoloration, and urticaria (hives).

In case of overdose or accidental ingestion, contact the Toxicology Information Service (telephone 91 5620420), indicating the medicine and the amount ingested.

If you forget to take Entacapone Viatris

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

Do not take a double dose to make up for a missed dose.

If you stop taking Entacapone Viatris

Do not stop treatment with Entacapone Viatris unless instructed by your doctor. If treatment is stopped, your doctor may need to adjust the dose of your other Parkinson's disease medications. Abruptly stopping treatment with Entacapone Viatris and other Parkinson's disease medications may cause unwanted adverse effects. See section 2 of this leaflet, “Warnings and precautions”.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. The adverse effects caused by Entacapone Viatris are generally mild or moderate.

Some of these adverse effects are frequently due to an increase in the effects caused by treatment with levodopa and are more common at the beginning of treatment. If you experience these effects at the start 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 adverse effects:

• Entacapone, when administered with levodopa, may rarely cause excessive daytime sleepiness or sudden episodes of falling asleep.

• Neuroleptic Malignant Syndrome (NMS) is a rare but serious reaction to medicines used in the treatment of disorders of the nervous system and may occur when these medicines are abruptly discontinued or interrupted. It is characterized by muscle rigidity, muscle spasms, tremors, agitation and confusion, coma, increased body temperature, tachycardia, and unstable blood pressure.

• A rare but serious muscle disorder (rhabdomyolysis) causing muscle pain, abnormal sensitivity to touch and pressure, and muscle weakness, which may lead to kidney problems.

• Inability to resist the impulse to carry out an action that could be harmful, which may include:

• A strong urge to gamble excessively despite serious personal or family consequences.

• Altered or increased sexual desire and behavior that is concerning for you or others, such as increased libido.

• Uncontrollable shopping or excessive spending.

• 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 radiate to other parts of the body such as the left arm, jaw, and neck; shortness of breath, anxiety, dizziness, and nausea or vomiting). This is an uncommon adverse effect (may affect up to 1 in 100 people).
• Inflammation of the colon (colitis, symptoms include prolonged or persistent diarrhea) or inflammation of the liver (hepatitis) with yellowing of the skin and whites of the eyes. The frequency of these adverse effects is unknown (cannot be estimated from available data).

Other adverse effects:

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

• Involuntary movements with difficulty performing voluntary movements (dyskinesias).
• Feeling dizzy (nausea).
• Harmless reddish-brown discoloration of the urine.

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

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

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

• Skin rashes characterized by redness or bumps on the skin.
• Abnormal results in liver function tests.

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

• Agitation.
• Decreased appetite, weight loss.
• Urticaria (hives).

Frequency unknown (cannot be estimated from 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 adverse effects are more frequent:

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

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage 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 on the outer packaging, following EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

For the bottle only: Once opened, it may be used for up to 100 days.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Entacapone Viatris

• The active substance 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, polysorbate 80, red iron oxide (E-172).

Appearance of the product and contents of the pack

Entacapone Viatris 200 mg film-coated tablets are light orange in colour, oval-shaped, biconvex tablets, with the imprint "EE200" on one side and "M" on the other. They are supplied in blisters, bottles, and cartons containing multiple bottles.

The blisters consist of a clear transparent PVC/PE/PVdC film on one side and hard tempered aluminum laminated with thermally varnished paper on the other side, and are available in pack sizes of 30, 60, 100, 200, 300 or 400 tablets, or in single-dose perforated blisters containing 100 film-coated tablets.

Bottles made of white high-density polyethylene (HDPE) with white opaque polypropylene (PP) screw caps containing 30, 50, 60, 100, 250 or 500 film-coated tablets.

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

Only certain pack sizes may be commercially available.

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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorized in the European Economic Area member states 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 most recent review of this leaflet: February 2017

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es