Patient leaflet - Entacapone 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 200mg 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.
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, diarrhoea, 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 - 2,000mg 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
iiiiililliil 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 200mg 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 200mg 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 x 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
Crescent Pharma Ltd., Key House, Sarum Hill, Basingstoke, RG21 8SR, UK. This leaflet was last revised in February 2025.
P2952T
Crescent
Product: Entacapone 200mg Film-coated Tablets
Size: 148 x 436 mm
Amendment Date: 10/02/25