Comtan is available in bottles containing 30, 60, 100 or 500 tablets. Catechol-O-methyl transferase inhibitor, antiparkinsonian medicinal product

Transcription

1 COMTAN 200 MG FILM-COATED TABLETS Entacapone Please read this leaflet carefully before you start to take your medicine. It provides important information about your medicine. If you have any further questions or are not sure about anything, please contact your doctor or pharmacist. 1. COMPOSITION OF THE COMTAN TABLET The active substance of Comtan is entacapone. Each tablet contains 200 mg of entacapone. In addition to entacapone, the Comtan tablet consists of microcrystalline cellulose, mannitol, croscarmellose sodium, hydrogenated vegetable oil, hypromellose, polysorbate 80, glycerol 85%, sucrose, magnesium stearate, yellow iron oxide (E172), red iron oxide (E172), and titanium dioxide (E171). Comtan is available in bottles containing 30, 60, 100 or 500 tablets. PHARMACO-THERAPEUTIC GROUP Catechol-O-methyl transferase inhibitor, antiparkinsonian medicinal product 2. MARKETING AUTHORISATION HOLDER AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE Marketing Authorisation Holder Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom Manufacturing Authorisation Holder Novartis GmbH Oflinger Strasse 44 D Wehr Germany 3. WHAT COMTAN IS USED FOR AND HOW IT WORKS Comtan is an enzyme inhibitor used in the treatment of Parkinson s disease in conjunction with levodopa therapy. In Parkinson's disease the amount of dopamine is decreased in certain areas of the brain and oral levodopa is given to compensate for this decrease. Levodopa is converted to dopamine in the brain, but part of the dose is broken down by an enzyme to an inactive compound before it reaches the brain. Comtan inhibits the enzymatic degradation of levodopa, and therefore increases the amount of levodopa reaching the brain. When taken together with levodopa, Comtan improves the efficacy of levodopa therapy in alleviating the symptoms of Parkinson's disease. Comtan is used in patients in whom the effect of each levodopa dose becomes shorter (wearing-off) and who subsequently experience fluctuations in the symptoms of Parkinson s disease. Comtan has no antiparkinsonian activity without levodopa. 1

2 4. WHEN COMTAN SHOULD NOT BE USED Comtan must NOT be used if you: have a history of hypersensitivity to entacapone or any other components of the Comtan tablet (see above Composition of the Comtan tablet). have pheochromocytoma (a tumour of the adrenal gland), because it may increase the risk of severe hypertensive reactions. are taking certain antidepressants (both MAO-A and MAO-B inhibitors simultaneously, or non-selective MAO-inhibitors). If you are taking antidepressants and need further information, please ask your doctor or pharmacist whether your antidepressive medication can be taken together with Comtan. have liver disease. are pregnant or breast-feeding. have a history of Neuroleptic Malignant Syndrome and/or non-traumatic rhabdomyolysis (rare form of muscle disorder). Comtan is NOT recommended if you: are under 18 years of age. 5. PRECAUTIONS TO BE OBSERVED BEFORE STARTING COMTAN THERAPY Comtan enhances the absorption of levodopa. Within the first few days or weeks of therapy you may therefore experience more frequently levodopa-related undesirable effects, e.g. involuntary movements, nausea, vomiting and hallucinations. To reduce these undesirable effects your doctor may adjust your levodopa dosage in the first few days or weeks after starting treatment with Comtan. If you need to stop taking Comtan, please consult your doctor. Withdrawal of Comtan treatment may have to be done gradually and your other antiparkinsonian therapy may need to be adjusted to prevent the worsening of your parkinsonian symptoms or unwanted side effects (e.g., rigidity, shakiness, agitation, confusion, fever). Together with levodopa, Comtan may lower your blood pressure. This may cause dizziness. You should be careful if you are taking other medicinal products which may decrease blood pressure. Comtan is always given in conjunction with levodopa treatment. Hence, the precautions applicable to levodopa treatment should also be taken into account when taking Comtan. This product has been prescribed for you personally and you should not pass it on to other persons. 6. COMTAN AND OTHER MEDICINES Comtan may increase the effects of other medicinal products such as those containing rimiterol, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha-methyldopa, and apomorphine. Therefore, always let your doctor know of other medicines that you are taking, even those not prescribed. Comtan may impair the absorption of iron from the gastrointestinal tract. Therefore, Comtan and iron-containing medicinal products should be taken at least 2-3 hours apart. See section 5 Precautions to be observed before starting Comtan therapy. 7. DRIVING OR USING MACHINES WHEN TAKING COMTAN Comtan together with levodopa may cause dizziness and low blood pressure when standing up. 2

3 Therefore, caution should be exercised when driving or operating machines. 8. INSTRUCTIONS ON HOW TO USE COMTAN Comtan is used in combination with levodopa preparations, either levodopa/carbidopa or levodopa/benserazide. You may also use other antiparkinsonian medicinal products simultaneously. From the beginning of Comtan treatment you should take one 200 mg tablet with each levodopa dose. If you are receiving dialysis for renal insufficiency, your doctor may tell you to extend the interval between doses. The maximum recommended dose is 200 mg ten times a day, i.e. 2,000 mg of Comtan. What if you miss a dose? 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. To obtain the maximum benefit from your antiparkinsonian therapy always take all medicines, including Comtan, exactly as prescribed by your doctor. In case of overdose In the event of accidental overdose, consult your doctor or the nearest hospital immediately. 9. POSSIBLE UNDESIRABLE EFFECTS DURING THE USE OF COMTAN The most frequent undesirable effects reported with Comtan are involuntary movements (dyskinesias), nausea, aggravated symptoms of Parkinson s disease, urine discoloration, dizziness, diarrhoea, abdominal pain, constipation, dryness of the mouth, hallucinations (seeing/hearing/feeling/smelling things that are not really there) and confusion. Rashes and urticaria have been reported with Comtan infrequently. Usually undesirable effects caused by Comtan are mild to moderate. The most frequent undesirable effects caused by Comtan relate to the increased effects of levodopa therapy. This occurs most commonly at the beginning of the treatment. Some of the undesirable effects, such as dyskinesia, nausea and abdominal pains, may also be more common with higher doses (1,400 to 2,000 mg per day) than with lower doses. Hence, if for example you notice a disturbing increase in involuntary movements (dyskinesias) after starting treatment with Comtan, you should contact your doctor for possible adjustment of your levodopa dosage to decrease the severity and frequency of these effects. The colour of your urine may be turned reddish-brown by Comtan. However, this phenomenon is harmless and no action is required. Sometimes abnormal results have been found in blood and urine tests and for heart rate and blood pressure in people taking Comtan for prolonged periods. If any of the undesirable effects you notice are severe, disturbing or prolonged, please inform your doctor. 10. STORAGE CONDITIONS Please note the expiry date on the pack. Do not use Comtan after this date. Keep out of the reach and sight of children. 3

4 11. WHERE TO GO FOR FURTHER INFORMATION For further information about Comtan, please contact the local representative of the Marketing Authorisation Holder: Belgique/België/Belgien Novartis Pharma N.V. Medialaan 40 B-1800 Vilvoorde Tél/Tel: Danmark Novartis Healthcare A/S Lyngbyvej 172 DK-2100 København Ø Tlf: Deutschland Roonstrasse 25 D Nürnberg Tel: Ελλάδα Novartis (Hellas) Α.Ε.Β.Ε. 12 χλµ Εθνικής Οδού Νο 1 GR Μεταµόρφωση Τηλ: + 30 (0) España Novartis Farmacéutica, S.A. Gran Via de les Corts Catalanes, 764 E Barcelona Tel: France Novartis Pharma S.A. 2 et 4, rue Lionel Terray F Rueil-Malmaison Tél: Ireland Novartis Ireland Limited Beech House Beech Hill Office Campus Clonskeagh IRL - Dublin 4 Tel: Luxembourg/Luxemburg Roonstrasse 25 D Nürnberg Tél/Tel: Nederland Novartis Pharma B.V. Raapopseweg 1 NL-6824 DP Arnhem Tel: Österreich Brunner Strasse 59 Postfach 169 A-1235 Wien Tel: Portugal Novartis Farma - Produtos Farmacêuticos, S.A. Rua do Centro Empresarial, Edifício 8 Quinta da Beloura P Sintra Tel: Suomi/Finland Novartis Finland Oy Metsänneidonkuja / Skogsjungfrugränden 10 FIN Espoo / Esbo Puh/Tlf: Sverige Novartis Sverige AB Novartis Läkemedel Kemistvägen 1B Box 1150 S Täby Tlf: United Kingdom Novartis Pharmaceuticals UK Ltd. Frimley Business Park Frimley Camberley Surrey GU16 7SR UK Tel: Italia Novartis Farma S.p.A. Strada Statale 233 (Varesina), Km 20,5 I Origgio (Varese) 4

5 Tel: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST REVISED 5