ENTACAPONE TEVA 200 mg FILM-COATED TABLETS

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

Do not take Entacapone Teva:

• if you are allergic to entacapone or any of the other ingredients of this medicine (listed in section 6);
• if you have a tumour of the adrenal gland (called phaeochromocytoma, this may increase the risk of severe high blood pressure);
• if you are taking certain antidepressants (ask your doctor or pharmacist if your antidepressant can be taken with Entacapone Teva);
• if you have 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 characteristics of NMS;
• if you have ever had a rare muscle disorder called rhabdomyolysis not caused by trauma.

Warnings and precautions

Consult 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 a chair or bed;
• if you have prolonged diarrhoea. Consult your doctor as it may be a sign of colitis;
• if you have diarrhoea, it is recommended to monitor 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, a general medical evaluation including liver function should be considered.

Tell your doctor if you or your family/caregiver notice that you are developing desires or urges to behave in ways that are unusual for you or that you cannot resist the impulse, urge or temptation to perform certain actions that could harm yourself or others. These behaviours are called impulse control disorders and can include binge eating, compulsive shopping, or a sudden increased interest in sex. Your doctor may need to adjust your treatment.

As Entacapone Teva 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 used to treat Parkinson's disease when you start taking Entacapone Teva. Follow the instructions as indicated by your doctor.

Neuroleptic malignant syndrome (NMS) is a rare but serious reaction to certain medicines used to treat disorders of the nervous system. It can occur especially when Entacapone Teva and other medicines for Parkinson's disease are suddenly stopped or the dose is reduced abruptly. For characteristics of NMS see section 4 “Possible side effects”. Your doctor may advise gradual discontinuation of Entacapone Teva and other medicines for Parkinson's disease.

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

Other medicines and Entacapone Teva

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. In particular, tell your doctor if you are using any of the following medicines:

• 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 absorption. Therefore, do not take Entacapone Teva and iron supplements at the same time. After taking one of them, wait at least 2 or 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

When Entacapone Teva is taken with levodopa, it may lower your blood pressure, which may make you feel dizzy or lightheaded. Be careful when driving or using tools or machinery.

Additionally, when Entacapone Teva is taken with levodopa, it may cause you to be very sleepy or to fall asleep suddenly.

Do not drive or use machines if you experience these side effects.

3. How to take Entacapone Teva

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

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

The recommended dose of Entacapone Teva is one 200 mg tablet with each levodopa dose. The maximum recommended dose is 10 tablets per day, i.e. 2,000 mg of Entacapone Teva.

If you are on dialysis for kidney insufficiency, your doctor may instruct you to increase the time between doses.

Use in children and adolescents

Experience with Entacapone Teva in children under 18 years is limited. Therefore, Entacapone Teva is not recommended for use in children.

If you take more Entacapone Teva than you should

In case of overdose, contact your doctor, pharmacist or the nearest hospital immediately.

If you forget to take Entacapone Teva

If you miss a dose of Entacapone Teva with your levodopa dose, you should continue with the next dose of Entacapone Teva with the next levodopa dose.

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

If you stop taking Entacapone Teva

Do not stop taking Entacapone Teva unless your doctor tells you to.

When stopping, it is possible that your doctor will need to adjust the dose of your other medicines for Parkinson's disease. Abrupt discontinuation of Entacapone Teva and other medicines for Parkinson's disease may cause unwanted side effects. See section 2 “Warnings and precautions”.

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

4. Possible side effects

Like all medicines, Entacapone Teva can cause side effects, although not everybody gets them. The side effects caused by Entacapone Teva are usually mild or moderate.

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

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

• Uncontrollable movements with difficulty performing voluntary movements (dyskinesias);
• feeling sick (nausea);
• brownish discolouration of urine, which is harmless.

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

• Excessive movements (hyperkinesias), worsening of Parkinson's disease symptoms, prolonged muscle cramps (dystonia);
• being sick (vomiting), diarrhoea, abdominal pain, constipation, dry mouth;
• dizziness, tiredness, 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).

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

• Heart attack.

Rare (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;
• hives.

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

• Colitis (inflammation of the colon), hepatitis (inflammation of the liver) with yellowing of the skin and the whites of the eyes;
• discolouration of 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 side effects are more common:

• Uncontrollable movements;
• nausea;
• abdominal pain.

Other important side effects that may appear:

• Entacapone Teva administered with levodopa may rarely cause you to be very sleepy during the day or to fall asleep suddenly;

• Neuroleptic malignant syndrome (NMS) is a rare but serious reaction to medicines used to treat nervous system disorders. It is characterised by stiffness, muscle spasms, tremors, agitation and confusion, coma, increased body temperature, rapid heart rate and unstable blood pressure;

• a rare but serious muscle disorder (rhabdomyolysis) that causes pain, abnormal sensitivity to touch or pressure and weakness of the muscles, and that may lead to kidney problems;

You may experience the following side effects:

• Inability to resist the impulse to perform an action that could be harmful, and that may include:
• • a strong impulse to gamble excessively despite severe personal or family consequences;
  • an increased or altered interest in sex and a disturbing sexual behaviour to you or to others, such as an increased sexual desire;
  • excessive or uncontrolled shopping;
  • eating large amounts of food in short periods of time or eating more food than is normal for you and more than you need to satisfy your appetite.

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

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 via the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

5. Storing 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 carton and blister after EXP. The expiry date refers to the last day of that month.

No special storage conditions are required.

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. Contents of the pack and other information

What Entacapone Teva contains

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

-The other ingredients are microcrystalline cellulose, povidone, pregelatinised starch and magnesium stearate

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

Appearance and packaging

Entacapone Teva 200 mg film-coated tablets are light brown, biconvex, elliptical and approximately 18 mm long and 10 mm wide with the letters “E200” engraved on one side of the tablet and smooth on the other side.

Entacapone Teva is available in HDPE bottles with screw caps made of polypropylene with a desiccant that contain 30, 60, 100 or 175 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Teva B.V.

Swensweg 5

2031GA Haarlem

Netherlands

Manufacturer

TEVA Pharmaceutical 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

You can request information about this medicine from the representative of the marketing authorisation holder:

Date of last revision of this leaflet:MM/YYYY.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu