Entacapone Teva 200 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Entacapone Teva 200 mg film-coated tablets EFG

entacapone

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, ask 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 you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

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

2. What you need to know before taking Entacapone Teva

Do NOT take Entacapone Teva:

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Entacapone Teva:

• 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 sitting or lying down;
• if you experience prolonged diarrhea. Consult your doctor, as this may be a sign of inflammation of the colon;
• if you experience diarrhea, body weight should be monitored to prevent excessive weight loss;
• if you experience increasing loss of appetite, weakness, exhaustion, 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/carer notice that you are developing urges or a tendency to behave in a way that is unusual for you or that you cannot resist the impulse, drive, or temptation to carry out certain activities that could harm you or others. These behaviors are known as impulse control disorders and may include gambling addiction, compulsive eating, excessive spending, or abnormally increased sex drive or preoccupation with sexual thoughts or feelings. Your doctor may need to review your treatment.

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

Dosages of other medicines used to treat Parkinson’s disease may need to be adjusted when you start taking Entacapone Teva. 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 Entacapone Teva and other medicines for Parkinson’s disease is suddenly stopped or rapidly reduced. For the characteristics of NMS, see section 4 “Possible side effects”. Your doctor may advise you to gradually discontinue treatment with Entacapone Teva and other Parkinson’s disease medicines.

Taking Entacapone Teva together with levodopa may cause drowsiness and may lead you to fall asleep suddenly. If this happens, you must not drive or operate tools or machinery (see section “Driving and use of machines”).

Other medicines and Entacapone Teva

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other 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: desipramine, maprotiline, venlafaxine, and paroxetine;
• warfarin, used to thin the blood;
• iron supplements. Entacapone Teva may interfere with iron digestion. Therefore, do not take Entacapone Teva and iron supplements at the same time. After taking one, wait at least 2 to 3 hours before taking the other.

Pregnancy, breast-feeding and fertility

Do not take Entacapone Teva during pregnancy or while breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and use of machines

Taking Entacapone Teva together with levodopa may lower your blood pressure, which may make you feel dizzy or lightheaded. Be cautious when driving or operating tools or machinery.

In addition, taking Entacapone Teva together with levodopa may cause excessive sleepiness or sudden sleep episodes.

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

3. How to take Entacapone Teva

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Entacapone Teva is taken together with medications containing levodopa (either levodopa/carbidopa preparations or levodopa/benserazide preparations). You may also use other medications to treat Parkinson's disease at the same time.

The recommended dose of Entacapone Teva 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 Teva.

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

Use in children and adolescents

Experience with Entacapone Teva in children under 18 years of age is limited. Therefore, the use of Entacapone Teva in children cannot be recommended.

If you take more Entacapone Teva than you should

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

If you forget to take Entacapone Teva

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

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

If you stop taking Entacapone Teva

Do not stop treatment with Entacapone Teva unless instructed by your doctor.

When treatment is stopped, your doctor may need to readjust the dose of your other medications for Parkinson's disease. Abruptly stopping treatment with Entacapone Teva and other medications for Parkinson's disease may cause unwanted adverse effects. See section 2 "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, Entacapone Teva may cause adverse effects, although not everyone experiences them. The adverse effects caused by Entacapone Teva are generally mild or moderate.

Some of these adverse effects are frequently due to an increase in the effects caused by levodopa treatment and are more common at the beginning of treatment. If you experience these effects at the start of treatment with Entacapone Teva, you should contact your doctor, who may decide to adjust your levodopa dose.

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), diarrhoea, 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 arterial or heart diseases (e.g. chest pain).

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

• Heart attack.

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

• Skin rashes;
• abnormal liver function test results.

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

• Restlessness;
• decreased appetite, weight loss;
• urticaria.

Not known (frequency cannot be estimated from available data):

• Inflammation of the colon (colitis), inflammation of the liver (hepatitis) with yellowing of the skin and the whites of the eyes;
• discoloration of the skin, hair, beard, and nails.

When Entacapone Teva 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;
• nausea;
• abdominal pain.

Other important adverse effects that may occur:

• Entacapone Teva, when given with levodopa, may rarely cause excessive daytime sleepiness or sudden onset of sleep;

• Neuroleptic Malignant Syndrome (NMS) is a rare but serious reaction to medicines used in the treatment of disorders of the nervous system. It is characterised by muscle rigidity, muscle spasms, tremors, agitation and confusion, coma, increased body temperature, tachycardia, and unstable blood pressure;

• a rare, serious muscle disorder (rhabdomyolysis) causing muscle pain, abnormal sensitivity to touch or pressure, and muscle weakness, which may lead to kidney problems;

You may experience the following adverse effects:

• 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 consequences such as family problems;
  • increased or altered interest in sex and behaviour that is concerning to you or others, such as increased sexual behaviour;
  • excessive or uncontrolled shopping or spending;
  • eating excessively (consuming large amounts of food in short periods of time) or compulsively (eating more food than usual and more than necessary to satisfy hunger).

Inform your doctor if you experience any of these behaviours: they will discuss ways to manage or reduce these symptoms.

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 can also report them directly through the national reporting system included in Appendix V*. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Entacapone Teva

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 outer packaging and on the label of the tablet container after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Entacapone Teva

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

• The other components are microcrystalline cellulose, povidone, pregelatinized starch and magnesium stearate.

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

Nature of the product and contents of the container

Entacapone Teva 200 mg film-coated tablets are light brown, biconvex, elliptical tablets approximately 18 mm in length and 10 mm in width, with the word "E200" engraved on one side of the tablet and smooth on the other side.

Entacapone Teva is available in HDPE bottles with polypropylene screw caps and desiccant, containing 30, 60, 100 or 175 film-coated tablets. Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva B.V.

Swensweg 5

2031GA Haarlem

The Netherlands

Manufacturer

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13,

4042 Debrecen,

Hungary

Pharmachemie B.V.

Swensweg 5,

2031 GA Haarlem,

The 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

You can request any information regarding this medicinal product by contacting the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet: MM/YYYY.

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency (EMA) website: http://www.ema.euopa.eu