Comtan 200 mg film-coated tablets

Comtan tablets contain entacapone and are used together with levodopa to treat Parkinson?s disease. Comtan aids levodopa in relieving the symptoms of Parkinson's disease. Comtan has no effect on relieving the symptoms of Parkinson?s disease unless taken with levodopa.

Do not take Comtan
- if you are allergic (hypersensitive) to entacapone or any of the other ingredients of Comtan; - 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 Comtan);
- 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.

Take special care with Comtan

Talk to your doctor 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 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.

As Comtan 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 Comtan. 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 Comtan 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 Comtan and other medicines to treat Parkinson?s disease.

Comtan 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?).

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken other medicines, including medicines obtained without a prescription or herbal 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: desipramine, maprotiline, venlafaxine, paroxetine;
- warfarin used to thin the blood;
- iron supplements. Comtan may make it harder for you to digest iron. Therefore, do not take Comtan 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 Comtan during pregnancy or if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Comtan 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, Comtan 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.

Important information about some of the ingredients of Comtan

Comtan tablets contain a sugar called sucrose. Therefore, if you have been told by your doctor that you have an inherited intolerance to sucrose, contact your doctor before taking Comtan.

Always take Comtan exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Comtan 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 usual dose of Comtan is one 200 mg tablet with each levodopa dose. The maximum recommended dose is 10 tablets per day, i.e. 2,000 mg of Comtan.

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

Use in children

Experience with Comtan in patients under 18 years is limited. Therefore, the use of Comtan in children cannot be recommended.

If you take more Comtan than you should
In the event of an overdose, consult your doctor, pharmacist or the nearest hospital immediately.

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

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

If you stop taking Comtan
Do not stop taking Comtan 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 Comtan 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.

Like all medicines, Comtan can cause side effects, although not everybody gets them. Usually side effects caused by Comtan 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 the treatment. If you experience such effects at the start of treatment with Comtan 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.

Common:
- 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, falling;
- 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:
- Heart attack.

Rare Rashes abnormal results in liver function test.

Very rare:
- Agitation;
- decreased appetite, weight loss;
- hives.

Not known:
- Inflammation of the colon (colitis), inflammation of the liver (hepatitis) with yellowing of the skin and whites of the eyes;
- discolouration of the skin, hair, beard and nails.

When Comtan 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:
- Comtan 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, 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 may occur such as an urge to gamble pathological gambling or increased sexual desire and urges increased libido and hypersexuality.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Keep out of the reach and sight of children.

Do not use Comtan after the expiry date which is stated on the carton and on the bottle label. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

What Comtan contains

• The active substance is entacapone. Each tablet contains 200 mg of entacapone.
• The other ingredients are microcrystalline cellulose, mannitol, croscarmellose sodium, hydrogenated vegetable oil, magnesium stearate.
• The film-coating contains hypromellose, polysorbate 80, glycerol 85%, sucrose, yellow iron oxide (E172), red iron oxide (E172) and titanium dioxide (E171).

What Comtan looks like and contents of the pack

Comtan 200 mg film-coated tablets are brownish-orange, oval tablets with ?Comtan? engraved on one side. They are packed in bottles. There are four different pack sizes (bottles containing 30, 60, 100 or 500 tablets). Not all pack sizes may be marketed.

Marketing Authorisation Holder
Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex, RH12 5AB
United Kingdom

Manufacturer
Novartis Pharmaceuticals UK Ltd
Wimblehurst Road
Horsham
West Sussex, RH12 5AB
United Kingdom

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien Novartis Pharma N.V. TélTel 32 2 246 16 11 LuxembourgLuxemburg Novartis Pharma N.V. TélTel 32 2 246 16 11

Novartis Pharma Services Inc. . 359 2 489 98 28 Magyarország Novartis Hungária Kft. Pharma Tel. 36 1 457 65 00

eská republika Novartis s.r.o. Tel 420 225 775 111 Malta Novartis Pharma Services Inc. Tel 356 2298 3217

Danmark Novartis Healthcare AS Tlf 45 39 16 84 00 Nederland Novartis Pharma B.V. Tel 31 26 37 82 111

Deutschland Novartis Pharma GmbH Tel 49 911 273 0 Norge Novartis Norge AS Tlf 47 23 05 20 00

Eesti Novartis Pharma Services Inc. Tel 372 66 30 810 Österreich Novartis Pharma GmbH Tel 43 1 86 6570

Novartis Hellas A.E.B.E. 30 210 281 17 12 Polska Novartis Poland Sp. z o.o. Tel. 48 22 550 8888

España Novartis Farmacéutica, S.A. Tel 34 93 306 42 00 Portugal Novartis Farma - Produtos Farmacêuticos, S.A. Tel 351 21 000 8600

France Novartis Pharma S.A.S. Tél 33 1 55 47 66 00 România Novartis Pharma Services Inc. Tel 40 21 31299 01

Ireland Novartis Ireland Limited Tel 353 1 260 12 55 Slovenija Novartis Pharma Services Inc. Tel 386 1 300 75 50

Ísland Vistor hf. Sími 354 535 7000 Slovenská republika Novartis Slovakia s.r.o. Tel 421 2 5542 5439

Italia Novartis Farma S.p.A. Tel 39 02 96 54 1 SuomiFinland Novartis Finland Oy PuhTel 358 010 6133 200

Novartis Pharma Services Inc. 357 22 690 690 Sverige Novartis Sverige AB Tel 46 8 732 32 00

Latvija Novartis Pharma Services Inc. Tel 371 67 887 070 United Kingdom Novartis Pharmaceuticals UK Ltd. Tel 44 1276 698370

Lietuva
Novartis Pharma Services Inc.
Tel: +370 5 269 16 50

This leaflet was last approved in