Entacapone Teva 200 mg film-coated tablets

Do NOT take Entacapone Teva

• if you are allergic (hypersensitive) to entacapone or any of the other ingredients of Entacapone Teva;
• if you have a tumour of the adrenal gland (known as pheochromocytoma; this may increase the risk of severe high blood pressure);
• if you are taking certain antidepressants (ask your doctor or pharmacist whether your antidepressive medicine can be taken together with Entacapone Teva);
• if you have liver disease;
• if you have ever suffered from 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 suffered from a rare muscle disorder called rhabdomyolysis which was not caused by injury.

Take special care with Entacapone Teva
Talk to your doctor if any of the following applies to you:

• if you have ever had a heart attack or any other diseases of the heart;
• if you are taking a medicine which may cause dizziness or light-headedness (low blood pressure) when rising from a chair or bed;
• if you experience prolonged diarrhoea consult your doctor as it may be a sign of inflammation of the colon;
• if you experience diarrhoea, monitoring of your weight is recommended in order to avoid potentially excessive weight loss;
• if you experience excessive gambling or excessive sexual activity;
• if you experience increasing loss of appetite, weakness, exhaustion and weight loss within a relatively short period of time, a general medical evaluation including liver function should be considered.

As Entacapone Teva tablets will be taken together with other levodopa medicines, please also read the package leaflets of these medicines carefully.

The dose of other medicines to treat Parkinson?s disease may need to be adjusted when you start taking Entacapone Teva. Follow the instructions that your doctor has given you.

Neuroleptic Malignant Syndrome (NMS) is a serious but rare reaction to certain medicines, and may occur especially when Entacapone Teva and other medicines to treat Parkinson?s disease are suddenly stopped or the dose is suddenly reduced. For the characteristics of NMS see Section 4 Possible side effects. Your doctor may advise you to slowly discontinue the treatment with Entacapone Teva and other medicines to treat Parkinson?s disease.

Entacapone Teva taken with levodopa may cause drowsiness and may cause you to sometimes suddenly fall asleep. If this happens, you should not drive or use any tools or machines (see Driving and using machines).

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken other medicines, including medicines obtained without a prescription or herbal medicines. In particular please tell your doctor if you are taking any of the following:

• rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha-methyldopa, apomorphine;
• antidepressants including desipramine, maprotiline, venlafaxine, paroxetine;
• warfarin used to thin the blood;
• iron supplements. Entacapone Teva may make it harder for you to digest iron. Therefore, do not take Entacapone Teva and iron supplements at the same time. After taking one of them, wait at least 2 to 3 hours before taking the other.

Pregnancy and breast-feeding
Do not use Entacapone Teva during pregnancy or if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Entacapone Teva taken together with levodopa may lower your blood pressure, which may make you feel light-headed or dizzy. Be particularly careful when you drive or when you use tools or machinery.

In addition, Entacapone Teva taken with levodopa may make you feel very drowsy, or cause you to sometimes find yourself suddenly fall asleep.
Do not drive or operate machinery if you experience these side effects.

Always take Entacapone Teva exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

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

The usual 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 receiving dialysis for renal insufficiency, your doctor may tell you to increase the time between doses.

Use in children

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

If you take more Entacapone Teva than you should
In the event of an overdose, consult your doctor, pharmacist or the nearest hospital immediately.

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

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

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

When stopping your doctor may need to re-adjust the dosage of your other medicines to treat Parkinson´s disease. Suddenly stopping Entacapone Teva and other medicines to treat Parkinson´s disease may result in unwanted side effects. See Section 2 Take special care.

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

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

Some of the side effects are often caused by the increased effects of levodopa therapy and are most common at the start of treatment. If you experience such effects at the start of treatment with Entacapone Teva you should contact your doctor who may decide to adjust your dosage of levodopa.

The frequencies are defined as:

Very common affects more than 1 user in 10 Common affects 1 to 10 users in 100 Uncommon affects 1 to 10 users in 1,000 Rare affects 1 to 10 users in 10,000 Very Rare affects less than 1 user in 10,000 Not known frequency cannot be estimated from the available data

Very common:

• Uncontrollable movements with difficulty in performing voluntary movements (dyskinesias);
• feeling sick (nausea);
• harmless reddish-brown discoloration of urine.

Common:

• Excessive movements (hyperkinesias), worsening of symptoms of Parkinson´s disease, prolonged muscle cramps (dystonia);
• being sick (vomiting), diarrhoea, abdominal pain, constipation, dry mouth;
• dizziness, tiredness, increased sweating, fall;
• hallucinations (seeing/hearing/feeling/smelling things that are not really there), sleeplessness, vivid dreams, and confusion;
• heart or artery disease events (e.g. chest pain).

Uncommon:

• Heart attack.

Rare:

• Rashes;
• abnormal results in liver function test.

Very rare:

• Agitation;
• decreased appetite, weight loss;
• hives.

Not known:

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

When Entacapone Teva is given at higher doses:
In 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 which may occur:

• Entacapone Teva taken with levodopa may rarely make you feel very drowsy during the day, and cause you to suddenly fall asleep;
• Neuroleptic Malignant Syndrome (NMS) is a rare severe reaction to medicines used to treat disorders of the nervous system. It is characterised by stiffness, muscle twitching, shaking, agitation and confusion, coma, high body temperature, increased heart rate and unstable blood pressure;
• a rare severe muscle disorder (rhabdomyolysis) which causes pain, tenderness and weakness of the muscles and may lead to kidney problems;
• behavioural changes may occur such as an urge to gamble (pathological gambling) or increased sexual desire and urges (increased libido and hypersexuality).

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet please tell your doctor.

Keep out of the reach and sight of children.

Do not use Entacapone Teva after the expiry date which is stated on the carton and tablet container label. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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 to protect the environment.

What Entacapone Tevacontains

• The active substance is entacapone. Each film-coated tablet contains 200 mg of entacapone.
• The other ingredients in the tablet core are cellulose microcrystalline, povidone, starch pregelatinised, magnesium stearate and in the film-coating are poly(vinyl alcohol), talc, titanium dioxide (E171), macrogol, iron oxide yellow (E172), lecithin (soya), iron oxide red (E172).

What Entacapone Tevalooks like and contents of the pack
Entacapone Teva film-coated tablets are light brown, biconvex ellipse-shaped with approximately 18 mm length and 10 mm width, embossed with ?E200? on one side and plain on the other side.

Entacapone Teva is available in HDPE tablet containers with polypropylene screw caps with desiccant insert containing 30, 60, 100 or 175 film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Teva Pharma B.V.
Computerweg 10,
3542 DR Utrecht,
The Netherlands

Manufacturer:
TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13,
4042 Debrecen,
Hungary

TEVA UK Ltd

Brampton Road,

Hampden Park,Eastbourne,
East Sussex,
BN22 9AG,

United Kingdom

Pharmachemie B.V.

Swensweg 5,

2031 GA Haarlem,

The Netherlands

TEVA Santé Sa

Rue Bellocier,

89100 Sens,

France

Teva Czech Industries s.r.o.

Ostravska 29, c.p. 305,

74770 Opava-Komarov,

Czech Republic

PLIVA Krakow Zak-ady Farmaceutyczne S.A.

ul. Mogilska 80,

31-546, Krakow,

Poland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien Teva Pharma Belgium N.V.S.A. TelTél 32 3 820 73 73 LuxembourgLuxemburg Teva Pharma Belgium S.A. TélTel 32 3 820 73 73

Te 359 2 489 95 82 Magyarország Teva Magyarország Zrt Tel. 36 1 288 64 00

eská republika Teva Pharmaceuticals CR, s.r.o. Tel 420 251 007 111 Malta Teva .. el 30 210 72 79 099

Danmark Teva Denmark ApS Tlf 45 44 98 55 11 Nederland Teva Nederland B.V. Tel 31 0 800 0228400

Deutschland Teva GmbH Tel 49 351 834 0 Norge Teva Sweden AB Tlf 46 42 12 11 00

Österreich Teva GmbH Tel 49 351 834 0 Eesti Teva Eesti esindus UAB Sicor Biotech Eesti filiaal Tel 372 611 2409

Teva .. 30 210 72 79 099 Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel. 48 22 345 93 00

España Teva Pharma, S.L.U. Tél 34 91 387 32 80 Portugal Teva Pharma - Produtos Farmacêuticos Lda Tel 351 214 235 910

France Teva Santé Tél 33 1 55 91 7800 România Teva Pharmaceuticals S.R.L Tel 4021 230 65 24

Ireland Teva Pharmaceuticals Ireland Tel 353 042 9395 892 Slovenija Pliva Ljubljana d.o.o. Tel 386 1 58 90 390

Ísland Teva UK Limited Sími 44 1323 501 111 Italia Teva Italia S.r.l. Tel 39 0289179805 Slovenská republika Teva Pharmaceuticals Slovakia s.r.o. Tel 421 2 5726 7911 SuomiFinland Teva Sweden AB PuhTel 46 42 12 11 00

Teva .. 30 210 72 79 099 Sverige Teva Sweden AB Tel 46 42 12 11 00

Latvija UAB Sicor Biotech filile Latvij Tel 371 67 784 980 United Kingdom Teva UK Limited Tel 44 1323 501 111

Lietuva

UAB ?Sicor Biotech?
Tel: +370 5 266 02 03

This leaflet was last approved in MM/YYYY.