Prospecto: information for the user

Entacapona Teva 200mg film-coated tablets

entacapona

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

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

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

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

3.How to take Entacapona Teva

4.Possible adverse effects

5.Storage of Entacapona Teva

6.Contents of the package and additional information

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

Do not take Entacapona Teva:

• if you are allergic to entacapone or any of the other ingredients of this medicine (listed in section 6);
• if you have a tumor of the adrenal gland (known as pheochromocytoma, this may increase the risk of severe hypertension);
• if you are taking certain antidepressants (ask your doctor or pharmacist if your antidepressant medication can be taken with Entacapona Teva);
• if you have a liver disease;
• if you have ever had a rare reaction to antipsychotic medications called Neuroleptic Malignant Syndrome (NMS). See section 4 “Possible side effects” for NMS characteristics;
• if you have ever had a rare muscle disorder called rhabdomyolysis not caused by trauma.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Entacapona Teva:

• 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 prolonged diarrhea. Consult your doctor as it may be a sign of colon inflammation;
• if you experience diarrhea, it is recommended to control your weight to avoid excessive weight loss;
• if you experienceincreasing loss of appetite,weakness, fatigue, and weight loss over a relatively short period of time, a general medical evaluation including liver function should be considered.

Inform your doctor if you or your family/caregiver notice that you are developing unusual desires or tendencies to behave in an unusual way in you or that you cannot resist the impulse, determination, or temptation to perform certain activities that may harm you or others. These behaviors are called impulse control disorders and may include excessive gambling, eating, or spending, and an abnormally elevated or excessive sexual impulse or concern about an increase in sexual thoughts or feelings.Your doctor may need to review your treatment.

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

It may be necessary to adjust the doses of other medications to treat Parkinson's disease when starting to take Entacapona Teva. Follow the instructions as indicated by your doctor.

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

The use of Entacapona Teva 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”).

Other medications and Entacapona Teva

Inform your doctor or pharmacist if you are taking or have recently taken or may need to take any other medication.In particular, inform your doctor if you are using any of the following medications:

• rimiterol, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha‑metildopa, apomorphine;
• antidepressants: desipramine, maprotiline, venlafaxine, and paroxetine;
• warfarin used to thin the blood;
• iron supplements. Entacapona Teva may make it difficult to digest iron. Therefore, do not take Entacapona Teva and iron supplements at the same time. Wait at least 2 or 3hours after taking one of them before taking the other.

Pregnancy, breastfeeding, and fertility

Do not take Entacapona Teva during pregnancy or if you are breastfeeding your baby.

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

If you take Entacapona Teva together with levodopa, it may lower your blood pressure, making you feel dizzy or lightheaded. Be careful when driving or operating tools or machinery.

Additionally, if you take Entacapona Teva 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.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Entacapona Teva is taken 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 Teva 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 Teva.

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

Use in children and adolescents

The experience with Entacapona Teva in children under 18 years is limited. Therefore, it is not possible to recommend the use of Entacapona Teva in children.

If you take more Entacapona Teva than you should

In case of overdose, consult your doctor, pharmacist, or go to the nearest hospital immediately.

If you forget to take Entacapona Teva

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

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

If you interrupt treatment with Entacapona Teva

Do not interrupt treatment with Entacapona Teva unless your doctor instructs you to do so.

When treatment is interrupted,it is possible that your doctor will need to adjust the dose of other medications to treat Parkinson's disease.Sudden interruption of treatment with Entacapona Teva andother medications to treat Parkinson's disease,may cause unwanted side effects.See section 2 “Warnings and precautions”.

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

Like all medicines, Teva Entacapone may cause side effects, although not everyone will experience them.Side effects caused by Teva Entacapone are 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 with Teva Entacapone, you should contact your doctor, who may decide to adjust the levodopa dose.

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

• Uncontrollable movements with difficulty performing voluntary movements (dyskinesias);
• Feeling dizzy (nausea);
• Brownish-red urine discoloration, harmless.

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;
• Illusions (seeing, hearing, feeling, or smelling things that are not real), insomnia, vivid dreams, confusion;
• Events related to arterial or heart disease (e.g., chest pain).

Rare (may affect up to 1 in 100 people):

• Heart attack.

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

• Rashes;
• Abnormal liver function test results.

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

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

Unknown (frequency cannot be estimated from available data):

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

When Teva Entacapone is administered at higher doses:

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

• Uncontrollable movements;
• Nausea;
• Abdominal pain.

Other important side effects that may occur:

• Teva Entacapone administered with levodopa rarely may cause excessive daytime sleepiness, or sudden sleepiness;

• The Neuroleptic Malignant Syndrome (NMS) is a rare, severe reaction to medications used in the treatment of nervous system disorders. It is characterized by rigidity, 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 or pressure, and muscle weakness, and may lead to kidney problems;

You may experience the following side effects:

• Inability to resist the urge to perform an action that could be harmful, and which may include:
• • A strong urge to gamble excessively despite severe personal or family consequences;
  • Increased or altered sexual interest and behavior that is concerning to you or others, such as increased sexual desire;
  • Excessive or uncontrolled spending;
  • Eating excessively (eating large amounts of food in short periods of time) or compulsively (eating more food than usual and more than needed to satisfy hunger).

Inform your doctor if you experience any of these behaviors; they will discuss how to manage or reduce these symptoms.

Reporting side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this leaflet.You can also report them directlythrough thenational reporting systemincluded in theAppendix V*.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 medication after the expiration date that appears on the packaging and on the blister pack label after EXP. The expiration date is the last day of the month indicated.

Norequires special storage conditions.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need.By doing so, you will help protect the environment.

Composition of Entacapone Teva

• The active ingredient is entacapone. Each film-coated tablet contains 200mg of entacapone.

- The other components aremicrocrystalline cellulose, povidone, pregelatinized starch and magnesium stearate

- The film coating containspoly(vinyl alcohol), talc, titanium dioxide (E171), macrogol, yellow iron oxide (E172), soy lecithin and red iron oxide (E172).

Appearance of the product and contents of the pack

Entacapone Teva 200mg film-coated tablets are light brown, biconvex, elliptical tablets of approximately18mmin length and10mmin width with the word “E200” engraved on one face of the tablet, and smooth on the other face.

Entacapone Teva is available in HDPE containers with polypropylene screw-top lids with desiccant containing 30, 60, 100 or 175film-coated tablets. Some pack sizes may only be marketed.

Marketing Authorization Holder and Responsible Person for Manufacturing

Marketing Authorization Holder

Teva B.V.

Swensweg 5

2031GA Haarlem

Netherlands

Responsible Person for Manufacturing

TEVAPharmaceutical Works Private Limited Company

Pallagi út 13,

4042 Debrecen,

Hungary

Pharmachemie B.V.

Swensweg 5,

2031 GA Haarlem,

Netherlands

Teva Czech Industries s.r.o.

Ostravska 29, c.p. 305,

74770 Opava-Komarov,

Czech Republic

Teva Operations Poland Sp.z.o.o

ul. Mogilska 80,

31-546, Krakow,

Poland

For any information regarding this medicinal product, please contact the local representative of the marketing authorization holder:

Last date of revision of this leaflet:MM/YYYY.

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu