Patient leaflet - Entacapone Niche 200 mg film-coated tablets
1. What Entacapone is and what it is used for
Entacapone film-coated tablets contain entacapone and are used together with levodopa to treat Parkinson’s disease in adults. Entacapone improves the therapeutic effect of 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 or any of the other ingredients of this medicine (listed in section 6).
- 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 ).
- 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.
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, 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.
Tell your doctor if you or your family/carer notices you are developing urges or cravings to behave in ways that are unusual for you or you cannot 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.
As Entacapone 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 . 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 Possible side effects. 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 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”).
Other medicines and Entacapone
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 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 may make it harder for you to digest iron. Therefore, do not take Entacapone and iron supplements at the same time. After taking either one of them, wait at least 2 to 3 hours before taking the other.
Pregnancy, breast-feeding and fertility
Do not use Entacapone during pregnancy or if you are 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 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 find yourself suddenly falling asleep.
Do not drive or operate machinery if you experience these side effects.
Entacapone contains lactose and sodium starch glycolate
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. How to take Entacapone
Always take this medicine exactly as your doctor 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 preparations or levodopa/benserazide preparations). 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 is 10 tablets per day, i.e. 2,000 mg of Entacapone .
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 under 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.
When stopping your doctor may need to re-adjust the dosage of your other medicines 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 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, 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 side effects at the start of treatment with Entacapone you should contact your doctor who may decide to adjust your dosage of levodopa.
The following side effects have been observed during treatment with entacapone:
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 (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 (may affect up to 1 in 100 people):
- Heart attack.
Rare (may affect up to 1 in 1,000 people):
- Rashes
- Abnormal results in liver function test.
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 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 taken with levodopa may rarely make you feel 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 central 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
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 despite serious 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; they 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 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 carton and on the bottle label after ‘EXP’. The expiry date refers to the last day of that month.
This medicine 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 of entacapone.
- The other ingredients in the tablet core are maize starch, sodium starch glycolate (Type A), silica colloidal anhydrous, povidone, polysorbate, mannitol and magnesium stearate.
- The film-coating contains hypromellose, lactose monohydrate, titanium dioxide (E 171), macrogol, iron oxide yellow (E 172), talc and iron oxide red (E 172).
What Entacapone looks like and contents of the pack
Entacapone 200 mg film-coated tablets are brown, capsule shaped, biconvex film-coated tablets, with debossing “70” on obverse side and plain on reverse.
There are two different pack sizes (bottles containing 30 or 100 tablets).
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Ipca Laboratories UK Limited
Unit 97-98, Silverbriar, Sunderland Enterprise Park East,
Sunderland, SR5 2TQ
United Kingdom
Telephone: +44 (0) 1915166517
Fax: +44 (0) 1915166526
Manufacturer:
Niche Generics Limited,
Unit 5, 151 Baldoyle Industrial Estate,
Dublin 13,
Ireland.