200 mg film-coated tablets 
entacapone

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Entacapone Teva is and what it is used for 
2. What you need to know before you take Entacapone Teva 
3. How to take Entacapone Teva 
4. Possible side effects 
5. How to store Entacapone Teva 
6. Contents of the packaging and other information 

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

Entacapone Teva tablets contain entacapone and are used with levodopa to treat Parkinson’s disease. Entacapone Teva helps levodopa reduce the symptoms of Parkinson’s disease. Entacapone Teva has no relieving effect on Parkinson’s symptoms without concomitant treatment with levodopa.

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 tumor in the adrenal gland ( pheochromocytoma ), as it 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 previously had a rare reaction to antipsychotics called neuroleptic malignant syndrome (NMS). See section 4 Possible side effects, for a description of NMS;
  • if you have previously had the rare muscle disease rhabdomyolysis that was not caused by the injury.

Warnings and cautions

Talk to your doctor or pharmacist before taking Entacapone Teva:

  • if you have had a heart attack or any other heart disease;
  • if you are taking medicines that may cause dizziness or dizziness (low blood pressure ) when you get up from a chair or bed;
  • if you experience prolonged diarrhea, consult a doctor as this may be a sign of colitis;
  • if you get diarrhea, recurrent weight control is recommended to avoid any excessive weight loss;
  • If you experience an increased appetite, weakness, fatigue, and weight loss in a relatively short time, you should undergo a general medical examination, including an examination of liver function.

Tell your doctor if you or your family/caregiver discovers that you are developing impulses or wanting to behave in ways that are unusual for you, or that you cannot resist the impulse, the urge, or the temptation to engage in a certain activity that may harm yourself or others. . This behavior is called impulse control disorder and may include compulsive spending, excessive food intake or spending, an abnormally high sex drive or a preoccupation with an increase in sexual thoughts or feelings. Your doctor may need to review your treatment.

Because Entacapone Teva tablets are taken with other levodopa medicines, also read the package leaflet for these other medicines carefully.

When you start taking Entacapone Teva, you may need to adjust the dose of one of your other medicines for Parkinson’s disease. Follow the instructions given to you by your doctor.

Neuroleptic malignant syndrome (NMS) is a severe but unusual reaction to certain medicines and can occur especially when you suddenly stop taking Entacapone Teva and other medicines for Parkinson’s disease or when you suddenly decrease the dose. For a description of NMS see section 4 Possible side effects. Your doctor may ask you to slowly stop taking Entacapone Teva and other medicines for Parkinson’s disease.

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

Other medicines and Entacapone Teva

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

  • rimiterol, isoprenaline  adrenaline, noradrenaline, dopamine, dobutamine, alpha methyldopa, apomorphine;
  • antidepressants such as desipramine, maprotiline, venlafaxine, paroxetine;
  • warfarin (blood-thinning drug);
  • iron supplements. Entacapone Teva may make it harder to absorb iron. Therefore, do not take Entacapone Teva and iron supplements at the same time. After taking one medicine, wait at least 2-3 hours before taking the other.

Pregnancy, breastfeeding, and fertility

Do not use Entacapone Teva during pregnancy or 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

Entacapone Teva with levodopa may cause low blood pressure and dizziness. Be extra careful when driving and when using machines.

Also, Entacapone Teva with levodopa may cause severe drowsiness or you may suddenly fall asleep. 
Do not drive or use machines if you experience these side effects.

How to take Entacapone Teva

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Entacapone Teva is used with medicines containing levodopa (either levodopa/carbidopa preparations or levodopa/benserazide preparations). At the same time, you can also take other medicines for Parkinson’s disease.

The recommended dose of Entacapone Teva is one 200 mg tablet with each levodopa dose. The highest recommended dose is 10 tablets per day, ie 2000 mg Entacapone Teva.

If you are undergoing dialysis treatment due to impaired kidney function, your doctor may recommend that you extend the time between doses.

Use for children and adolescents

The experience with Entacapone Teva in patients under 18 years of age is limited. Therefore, the use of Entacapone Teva in children is not recommended.

If you take more Entacapone Teva then you should

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

If you forget to take Entacapone Teva

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

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

If you stop taking Entacapone Teva

Do not stop using Entacapone Teva without consulting your doctor.

When you stop, your doctor may need to change the dose of one of your other medicines for Parkinson’s disease. Suddenly stopping Entacapone Teva and other medicines for Parkinson’s disease may result in unwanted side effects. See section 2 Warnings and Precautions.

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

4. Possible side effects

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

Some of the side effects are often caused by the increased effects of levodopa treatment and are most common when starting treatment. If you experience such effects when starting treatment with Entacapone Teva, contact your doctor who may need to adjust your dose of levodopa.

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

  • Involuntary movements with difficulty performing voluntary movements ( dyskinesias );
  • nausea;
  • reddish-brown discoloration of the urine (harmless).

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

  • Excessive movements (hyperkinesias), worsening of Parkinson’s symptoms, prolonged muscle contractions ( dystonia );
  • vomiting, diarrhea, abdominal pain, constipation, dry mouth;
  • dizziness, fatigue, increased sweating, falls;
  • hallucinations (visual, auditory, sensory, and odor sensations that are not real), insomnia, vivid dreams, and confusion;
  • heart or artery disease (eg chest pain).

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

  • Heart attack.

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

  • Rash;
  • abnormal results of liver function tests.

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

  • Indignation;
  • decreased appetite, weight loss;
  • skin rash and hives.

No known frequency (cannot be calculated from the available data):

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

When Entacapone Teva is given in higher doses: 
At doses from 1,400 to 2,000 mg per day, the following side effects are more common:

  • Involuntary movements;
  • nausea;
  • abdominal pain.

Other important side effects that may occur:

  • Entacapone Teva taken with levodopa may in rare cases make you feel very drowsy during the day and cause you to suddenly fall asleep;
  • Neuroleptic malignant syndrome (NMS) is a serious rare side effect of medicines used to treat diseases of the nervous system. It is characterized by stiffness, muscle twitching, tremors, agitation and confusion, unconsciousness, high body temperature, increased heart rate, and fluctuations in blood pressure;
  • a severe rare muscle disease ( rhabdomyolysis ) that causes pain, tenderness, and weakness in the muscles and can lead to kidney problems;

You may experience the following side effects:

  • Inability to resist the impulse to perform an action that may be harmful, which may include:
    • strong impulse to play extremely much despite serious personal or family consequences;
    • altered or increased sexual interest and behavior that significantly affects you or others, such as increased sexual desire;
    • uncontrolled excessive shopping or spending;
    • binge eating (eating large amounts of food for a short period of time) or compulsive food intake (eating more food than normal and more than is needed to satisfy your hunger).

Tell your doctor if you experience any of these symptoms; one will discuss how to manage or reduce these symptoms.

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.

5. How to store 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 the jar label after EXP. The expiration date is the last day of the specified month.

No special storage instructions.

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.

6. Contents of the packaging and other information

Content declaration

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

What the medicine looks like and the contents of the pack

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

The tablets are packaged in HDPE cans with polypropylene screw caps with desiccant, containing 30, 60, 100, or 175 film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Teva BV

Swensweg 5

2031GA Haarlem

Holland

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

Pharmachemie BV 
Swensweg 5, 
2031 GA Haarlem, The 
Netherlands

Teva Czech Industries sro 
Ostravska 29, cp 305, 
74770 Opava-Komarov, 
Czech Republic

Teva Operations Poland Sp.zoo 
ul. Mogilska 80, 
31-546, Krakow, 
Poland

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienTeva Pharma Belgium NV / SA / AGTel: +32 38207373 Luxembourg / Luxemburgratiopharm GmbHTel./Tel: +49 73140202
BulgariaTeva Arma FADTel: +359 24899585 HungaryTeva Magyarország ZrtTel: +36 12886400
Czech RepublicTeva Pharmaceuticals CR, sroTel: +420 251007111 MaltaTeva Pharmaceuticals Ireland-IrelandTel: +353 19127700
DenmarkTeva Denmark A / STel: +45 44985511 The NetherlandsTeva Nederland BVTel: +31 8000228400
GermanyTEVA GmbHTel: +49 73140208 NorwayTeva Norway ASTel: +47 66775590
EestiUAB Teva Baltics Eesti subsidiaryTel: +372 6610801 Austriaratiopharm Arzneimittel Vertriebs-GmbHTel: +43 1970070
GreeceSpecifar Α.Β.Ε.Ε.:Ηλ: +30 2118805000 PolandTeva Pharmaceuticals Polska Sp. z ooTel: +48 223459300
SpainTeva Pharma, SLUTel: +34 913873280 PortugalTeva Pharma – Pharmaceutical Products Lda.Tel: +351 214767550
FranceTeva HealthTel: +33 155917800 RomaniaTeva Pharmaceuticals SRLTel: +40 212306524
IrelandTeva Pharmaceuticals IrelandTel: +353 19127700 SloveniaPliva Ljubljana dooTel: +386 15890390
IcelandTeva Finland OyFinlandPhone: +358 201805900 Slovak RepublicTEVA Pharmaceuticals Slovakia sroTel: +421 257267911
ItalyTeva Italia SrlTel: +39 028917981 Finland / FinlandTeva Finland OyPuh / Tel: +358 201805900
ΚύπροςSpecifar Α.Β.Ε.Ε.Greece:Ηλ: +30 2118805000 SwedenTeva Sweden ABTel: +46 42121100
LatviaUAB Teva Baltics subsidiary LatvijāTel: +371 67323666 United KingdomTeva UK LimitedTel: +44 1977628500
LithuaniaUAB Teva BalticsTel: +370 52660203  

Muhammad Nadeem

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