ENTACAPONE 200 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

2. what you need to know before you take entacapone tablets

Do not take Entacapone Tablets

• 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 Tablets);
• 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, pharmacist or nurse before taking Entacapone Tablets 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 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 that you are developing urges or cravings to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others. These are called impulse control disorders and can include behaviours such as addictive gambling, excessive eating or spending, an abnormally high sex drive or an increase in sexual thoughts or feelings. Your doctor may need to adjust or stop your dose.

As Entacapone Tablets 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 Tablets. 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 Tablets 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 Tablets and other medicines to treat Parkinson’s di­sease.

Entacapone Tablets 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 Tablets

Tell your doctor or pharmacist if you are taking or 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 Tablets may make it harder for you to digest iron.

Therefore, do not take Entacapone Tablets 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 Tablets during pregnancy or if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Entacapone Tablets 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 Tablets 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.

3. how to take entacapone tablets

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

Entacapone Tablets are 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 Tablets 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 Tablets.

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 Tablets in patients under 18 years is limited. Therefore, the use of Entacapone Tablets in children and adolescents cannot be recommended.

If you take more Entacapone Tablets than you should

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

If you forget to take Entacapone Tablets

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

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

If you stop taking Entacapone Tablets

Do not stop taking Entacapone Tablets 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 Tablets 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.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Usually side effects caused by Entacapone Tablets 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 Tablets 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 patient in 10) Common (affects 1 to 10 patients in 100) Uncommon (affects 1 to 10 patients in 1,000) Rare (affects 1 to 10 patients in 10,000)

Very rare (affects less than 1 patient 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.
• 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).
• Heart attack.
• Rashes;
• abnormal results in liver function test.

Very rare:

• Agitation;
• decreased appetite, weight loss;
• hives.
• 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 Tablets 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 Tablets 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;
• inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting systems listed below.

United Kingdom

Yellow Card Scheme

Malta

ADR Reporting

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store entacapone tablets

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 blister, carton and bottle label. The expiry date refers to the last day of that month.

Do not use this medicine if you notice any signs of discolouration.

This medicinal product does not require any special storage conditions.

For tablets packed in plastic bottles: Entacapone Tablets can be used for six months after first opening of the container.

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 Tablets contains

• – The active substance is entacapone. Each tablet contains 200 mg of entacapone.

• – The other ingredients (excipients) in the tablet core are mannitol, povidone K-30, crospovidone, colloidal anhydrous silica, talc and magnesium stearate.

• – The film-coating contains partly hydrolysed polyvinyl alcohol, talc, titanium dioxide (E171), macrogol, lecithin (soya), iron oxide yellow (E172) and iron oxide red (E172).

What Entacapone Tablets looks like and contents of the pack

• Entacapone Tablets 200 mg film-coated tablets are brownish-orange, oval tablets with „W477“ engraved on one side. They are packed in blister packs or bottles in the following pack sizes: Blister packs containing 30, 60, 100, or 200 tablets.
• HDPE container with screw cap, 30, 60, 100, 175, or 200 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder: Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK.

Manufacturer: CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, UK.

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

UK: Entacapone 200 mg Film-Coated Tablets

Germany: Entacapon-neuraxpharm 200 mg Filmtabletten

Malta: Entacapone 200mg Film-Coated Tablets

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only).

Please be ready to give the following information:

Product name Reference number

Entacapone 200mg Film-Coated Tablets 29831/0471

This is a service provided by the Royal National Institute of Blind People

This leaflet was last revised in 09/2015

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