Patient leaflet - Entacapone Hec 200 mg film-coated tablets

1. What Entacapone is and what it is used for

Entacapone contains entacapone and is used together with levodopa to treat Parkinson’s disease. Entacapone supports levodopa in relieving the symptoms of Parkinson‘s disease. Entacapone has no effect on relieving the symptoms of Parkinson´s disease unless taken with levodopa.

2. What you need to know before you take Entacapone

Do not take Entacapone:

if you are allergic to entacapone, peanut, soya or any of the
other ingredients of this medicine (listed in section 6);
if you have a tumour of the adrenal gland, known as a
pheochromocytoma, which 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;
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 for the characteristics of NMS;
if you have ever suffered from a rare muscle disorder called
rhabdomyolysis, which was not caused by injury.

Warnings and precautions

Talk to your doctor or pharmacist before taking Entacapone:

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. Monitor your weight 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 tests should be considered.

Tell your doctor if you, your family or your carer notices that you are developing urges or cravings that are unusual for you or that you are unable to resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others. These behaviours are called impulse control disorders and can include addictive gambling, excessive eating or spending, an abnormally high sex drive or an increase in sexual thoughts or feelings. Your doctor may need to review your treatments.

Because entacapone tablets are intended be taken together with other levodopa medicines, you should 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. 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 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. Your doctor may advise you to slowly discontinue the treatment with Entacapone and other medicines to treat Parkinson’s disease.

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

Other medicines and Entacapone

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

You should tell your doctor if you are taking any one of the following medicines (see section “Do not take Entacapone”)

rimiterol, isoprenalin, adrenaline, noradrenaline, dopamine, dobutamine, alphamethyldopa and apomorphine;
medicines used to treat depression including desipramine, maprotiline, venlafaxine and paroxetine;
warfarin used to thin the blood;
iron supplements. It may make it harder for you to digest iron. Therefore, do not take entacapone 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

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.

Do not take Entacapone during pregnancy or if you are breast-feeding.

Driving and using machines

Entacapone 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 taken with levodopa may make you feel very drowsy or cause you to sometimes suddenly fall asleep.

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

Entacapone contains soya

Entacapone contains soya oil. If you are allergic to peanut or soya, do not use this medicinal product.

3. How to take Entacapone

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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

The recommended dose of entacapone is one 200 mg tablet with each levodopa dose. The maximum recommended dose of entacapone is 10 tablets per day (2000 mg).

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

Use in children and adolescents

Experience with entacapone in patients younger than 18 years is limited. Therefore, the use of entacapone in children cannot be recommended.

If you take more Entacapone than you should

In the event of an overdose, consult your doctor, pharmacist or the nearest hospital immediately.

If you forget to take Entacapone

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

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

If you stop taking Entacapone

Do not stop taking entacapone unless your doctor tells you to. In such a case your doctor may need to re-adjust the dosage of the other medicines you are taking to treat Parkinson´s disease. Suddenly stopping entacapone and other medicines to treat Parkinson´s disease may result in unwanted side effects. See Section 2. Warning 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, this medicine can cause side effects, although not everybody gets them.

Usually, side effects caused by entacapone 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 you should contact your doctor who may decide to adjust your dosage of levodopa.

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

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

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

excessive movements (hyperkinesia), worsening of symptoms
of Parkinson‘s disease, prolonged muscle spasms (dystonia)
vomiting, diarrhea, abdominal pain, constipation, dry mouth
dizziness, tiredness, increased sweating, falls
hallucinations (seeing, hearing, feeling or smelling things
that are not really there), sleeplessness, vivid dreams, and confusion
heart or artery disease events (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):

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 is given at higher doses

In doses of 1,400 - 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 taken with levodopa may rarely make you feel
very drowsy during the day and cause you to fall asleep suddenly
Neuroleptic Malignant Syndrome 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 such as the urge to gamble (pathological
gambling) or increased sexual desire and urges (increased libido and hypersexuality) have been reported in patients receiving dopaminergic medicines such as entacapone with levodopa.

You may experience the following side effects:

Inability to resist the impulse to perform an action that could be harmful, which may include:

strong impulse to gamble excessively despiteserious personal
or family consequences
altered or increased sexual interest and behaviour of significant
concern to you or to others, for example, an increased sexual drive
uncontrollable excessive shopping or spending
binge eating (eating large amounts of food in a short time
period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger).

Tell your doctor if you experience any of these behaviours; he will discuss ways of managing or reducing the symptoms.

Reporting of side effects

If you get 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 Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Entacapone

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 bottle or carton. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Entacapone contains

The active substance is entacapone. Each tablet contains
200 mg entacapone.
The other ingredients are:
Tablet core: microcrystalline cellulose, mannitol, sodium starch glycolate (type A), povidone (K29/32), magnesium stearate
Film-coating: polyvinyl alcohol (partly hydrolyzed), talc, titanium dioxide (E171), macrogol 3350, iron oxide yellow (E172), lecithin (soya), iron oxide red (E172).

What Entacapone looks like and the contents of the pack

Entacapone 200 mg film-coated tablets are orange-brown capsular-shaped film-coated tablets, debossed “S52” on one side and blank on the other side. The tablet size is 14 × 6.5 mm.

Pack sizes:

Entacapone is available in packs of 30, 90, 100 or 175 film-coated tablets in a bottle with a child-resistant cap, 30, 90, 100 or 175 film-coated tablets per carton.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

HEC Pharm GmbH

Wallstrasse 9-13

10179 Berlin, Germany

E-Mail: info@hecpharm.biz

Manufacturer

Formula Pharmazeutische und chemische Entwicklungs GmbH Goerzallee 305b

D-14167 Berlin

This medicinal product is authorised in the Member States of the EEA under the following names:

Germany Entacapon HEC 200 mg

Filmtabletten

Croatia Entakapon HEC 200 mg filmom obložene tablete Italy Entacapone HEC

United Kingdom Entacapone 200 mg film-coated tablets

This leaflet was last revised in 11/2025.