ANNEX II THE MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR IMPORT AND BATCH RELEASE AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Transcription

1 ANNEX I ANNEX II THE MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR IMPORT AND BATCH RELEASE AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 4

2 A. MANUFACTURING AUTHORISATION HOLDERS Manufacturers responsible for import and batch release in the European Economic Area Hoffmann-La Roche AG Emil-Barell-Str. 1 D Grenzach-Wyhlen Germany Manufacturing Authorisation issued on 26 April 1990 by the Regierungspräsidium Freiburg, Germany. Produits Roche S.A. 59 rue Pasteur Fontenay-Sous-Bois France Manufacturing Authorisation issued on 16 July 1996 by the Agence du Médicament, France. B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to renewable medical prescription. 5

3 ANNEX II ANNEX III LABELLING AND PACKAGE LEAFLET 6

4 B. PACKAGE LEAFLET 7

5 1. NAME OF THE MEDICINAL PRODUCT Tasmar 100 mg Tolcapone. 2. FULL STATEMENT OF THE ACTIVE SUBSTANCE AND EXCIPIENTS Active ingredient: Tasmar 100 mg contains 100 mg tolcapone. Inactive ingredients: In the tablet core: anhydrous calcium hydrogen phosphate, microcrystalline cellulose, polyvidone K 30, sodium starch glycollate, lactose monohydrate, talc and magnesium stearate. In the film-coat: methylhydroxypropylcellulose, talc, yellow iron oxide (E172), ethylcellulose, titanium dioxide (E171), triacetin, sodium lauryl sulfate. 3. PHARMACEUTICAL FORM AND CONTENTS Tasmar is supplied as film-coated tablets containing 100 mg of tolcapone. It is available in blisters in pack sizes of 30 and 60 film-coated tablets and in glass bottles in pack sizes of 100 film-coated tablets. 4. PHARMACO-THERAPEUTIC GROUP Catechol-O-methyltransferase (COMT, an enzyme occurring naturally in your body) breaks down levodopa. Tasmar blocks COMT and slows the breakdown of levodopa. This means when it is taken with levodopa/benserazide or levodopa/carbidopa you should have an improvement in your symptoms of Parkinson s disease and you may need to take less levodopa/benserazide or levodopa/carbidopa. 5. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, UK. NAME AND ADDRESS OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE Hoffmann-La Roche AG., Emil-Barell-Strasse 1, D Grenzach-Wyhlen, Germany Produits Roche S.A., 59 rue Pasteur, Fontenay-Sous-Bois, France 6. THERAPEUTIC INDICATIONS Tasmar is used together with levodopa/benserazide or levodopa/carbidopa when these medications can not stabilise your Parkinson s disease. 7. INFORMATION NECESSARY BEFORE TAKING THE MEDICINAL PRODUCT 8

6 Contra-indications You should not use Tasmar if you are allergic to tolcapone or to any of its inactive ingredients listed above. 9

7 Appropriate precautions for use Inform your doctor before starting treatment with Tasmar if you: - suffer from a liver condition. - have any illnesses other than Parkinson s disease. - are allergic to other medicines, foods and dyes. - are taking other medicines, including those you can obtain without a prescription. Soon after beginning and during your treatment with Tasmar, you may have symptoms caused by levodopa such as dyskinesia (involuntary movement) and nausea. Therefore, if you feel unwell, you should contact your doctor since you may need to have your levodopa dose changed. Contact your doctor if you develop persistent or severe diarrhoea. Treatment with Tasmar may sometimes lead to disturbances in the way the liver works. Your doctor may ask you to have regular blood tests to monitor your liver function. Very rarely, after abrupt reducing or stopping Tasmar or other antiparkinsonian drugs, you may experience severe symptoms of muscle stiffening, fever or mental confusion. If this happens notify your doctor. This medicine can cause a harmless yellow urine discolouration. Forms of interactions with other medicinal products and other forms of interaction which may affect the action of the medicinal product Inform your doctor about all other medicines you are taking especially antidepressants, alpha-methyldopa (antihypertensive), apomorphine (used for Parkinson s disease), dobutamine (used in the management of congestive heart failure), adrenaline (used for heart attacks) and isoprenaline (used for heart attacks ). When you are taking Tasmar with anticoagulants (that prevent blood clotting) of the warfarin type, your doctor may do regular blood tests to monitor of how easily the blood clots. If you go to hospital or if you are prescribed a new medicine, you must tell your doctor that your are taking Tasmar. Special warnings Use in Children Tasmar is not intended to be used in children. Use during pregnancy and breast-feeding You must tell your doctor if you are pregnant or intend to become pregnant. Your doctor will discuss the risks and benefits of taking Tasmar during pregnancy. The effects of Tasmar have not been studied in infants. You should not breast-feed your infant during treatment with Tasmar. 10

8 Effects on ability to drive and use machinery Tasmar has an effect on your symptoms of Parkinson s disease. Since your ability to drive a car or operate machinery may be affected by Parkinson s disease, you should discuss this with your doctor. 8. INSTRUCTIONS FOR PROPER USE Dosage and Frequency of administration The recommended dose of Tasmar is 100 mg or 200 mg three times a day. The first dose of Tasmar is taken with the first dose of the day of levodopa and the other doses of Tasmar are taken about 6 and 12 hours later. This means take one tablet in the morning, one tablet in the middle of the day and one tablet in the evening. When beginning and during treatment with Tasmar, your dose of levodopa may need to be changed. Your doctor will advise you what to do. Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed. Otherwise, your doctor may think that it was not effective or well tolerated and may change your treatment unnecessarily. Method and route of administration Your tablet should be swallowed, with water, and may be taken with or without food. Do not break or crush tablets and do not take any tablets that are damaged. Duration of treatment Long-term treatment or as instructed by your doctor. Actions to be taken in case of overdose If you take more tablets than you have been told to take, or if someone else accidentally takes your medicine, contact a doctor, pharmacist or hospital immediately as you may need urgent medical attention. Symptoms of overdose may include nausea, vomiting, dizziness and breathing difficulties. Action to be taken when one or more doses have not been taken If you forget to take your medicine at any time, take it as soon as you remember, then continue to take it at the usual times. If you have missed several doses, please inform your doctor and follow the advice given to you. Do not reduce or stop taking your medicine unless your doctor tells you to. 9. DESCRIPTION OF UNDESIRABLE EFFECTS UNDER NORMAL USE 11

9 Along with its desired effects, a medicine may cause some unwanted effects. Tell your doctor or a pharmacist as soon as possible if you do not feel well while you are taking Tasmar. The unwanted effects that are most likely to occur are: dyskinesia (involuntary movement), nausea, sleeping problems, decreased appetite and diarrhoea. Very rarely, patients develop Neuroleptic Malignant Syndrome (severe symptoms of muscle stiffening, fever or mental confusion) when antiparkinsonian treatments are abruptly reduced or withdrawn. If any other unwanted effect is noticed, you should tell your doctor or pharmacist about it. 12

10 10. EXPIRY DATE Do not take the tablets after the expiry date shown on the pack. Keep this medicine out of reach of children. 11. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST REVISED 13

11 12. OTHER INFORMATION For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder. Belgique/België/Belgien N.V. Roche S.A, Rue Dantestraat 75, B-1070 Bruxelles - Brussel Tel: (02) Danmark Roche a/s, Industriholmen 59, DK-2650 Hvidovre Tel: Deutschland Hoffmann-La Roche AG, Emil-Barell-Str.1, D Grenzach-Wyhlen Tel: (07624) 140????da Roche (Hellas) S.A., 4 Alamanas & Delfon st., GR Maroussi, Attiki Tel: (01) España Productos Roche S.A., C a. Carabanchel a la de Andalucia s/n, Madrid Tel: (91) France Produits Roche, 52 Boulevard du Parc. F Neuilly-s/Seine Cedex Tel: (01) Ireland Roche Pharmaceuticals, 3 Richview, Clonskeagh, Dublin 14 Tel: (01) Italia Roche S.p.A., Piazza Durante 11, I Milano Tel: (02) 2884 Luxembourg N.V Roche S.A, Rue Dantestraat 75, B1070 Bruxelles - Brussel Tel: (02) Nederland Roche Nederland B.V., Postbus 42, NL-3640 AA Mijdrecht Tel: (0297) Österreich Hoffmann-La Roche Wien Gesellschaft m.b.h, Jacquingasse 16-18, A-1030 Wien Tel: (0222) Portugal Roche Farmacêutica Química Lda, Estrada Nacional 249-1, 2700 Amadora 14

12 Tel: (01) Suomi/Finland Roche Oy, PL 12, FIN Espoo/Esbo Puh/Tel: (09) Sverige Roche AB, Box 47327, S Stockholm Tel: (08) United Kingdom Roche Products Ltd, 40 Broadwater Road, Welwyn Garden City, Hertfordshire, AL7 3AY Tel: (01707)

13 1. NAME OF THE MEDICINAL PRODUCT Tasmar 200 mg Tolcapone. 2. FULL STATEMENT OF THE ACTIVE SUBSTANCE AND EXCIPIENTS Active ingredient: Tasmar 200 mg contains 200 mg tolcapone. Inactive ingredients: In the tablet core: anhydrous calcium hydrogen phosphate, microcrystalline cellulose, polyvidone K 30, sodium starch glycollate, lactose monohydrate, talc and magnesium stearate. In the film-coat: methylhydroxypropylcellulose, talc, yellow iron oxide (E172), ethylcellulose, titanium dioxide (E171), triacetin, sodium lauryl sulfate. 3. PHARMACEUTICAL FORM AND CONTENTS Tasmar is supplied as film-coated tablets containing 200 mg of tolcapone. It is available in blisters in pack sizes of 30 and 60 film-coated tablets and in glass bottles in pack sizes of 100 film-coated tablets. 4. PHARMACO-THERAPEUTIC GROUP Catechol-O-methyltransferase (COMT, an enzyme occurring naturally in your body) breaks down levodopa. Tasmar blocks COMT and slows the breakdown of levodopa. This means when it is taken with levodopa/benserazide or levodopa/carbidopa you should have an improvement in your symptoms of Parkinson s disease and you may need to take less levodopa/benserazide or levodopa/carbidopa. 5. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, UK. NAME AND ADDRESS OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE Hoffmann-La Roche AG., Emil-Barell-Strasse 1, D Grenzach-Wyhlen, Germany Produits Roche S.A., 59 rue Pasteur, Fontenay-Sous-Bois, France 6. THERAPEUTIC INDICATIONS Tasmar is used together with levodopa/benserazide or levodopa/carbidopa when these medications can not stabilise your Parkinson s disease. 7. INFORMATION NECESSARY BEFORE TAKING THE MEDICINAL PRODUCT 16

14 Contra-indications You should not use Tasmar if you are allergic to tolcapone or to any of its inactive ingredients listed above. 17

15 Appropriate precautions for use Inform your doctor before starting treatment with Tasmar if you: - suffer from a liver condition. - have any illnesses other than Parkinson s disease. - are allergic to other medicines, foods and dyes. - are taking other medicines, including those you can obtain without a prescription. Soon after beginning and during your treatment with Tasmar, you may have symptoms caused by levodopa such as dyskinesia (involuntary movement) and nausea. Therefore, if you feel unwell, you should contact your doctor since you may need to have your levodopa dose changed. Contact your doctor if you develop persistent or severe diarrhoea. Treatment with Tasmar may sometimes lead to disturbances in the way the liver works. Your doctor may ask you to have regular blood tests to monitor your liver function. Very rarely, after abrupt reducing or stopping Tasmar or other antiparkinsonian drugs, you may experience severe symptoms of muscle stiffening, fever or mental confusion. If this happens notify your doctor. This medicine can cause a harmless yellow urine discolouration. Forms of interactions with other medicinal products and other forms of interaction which may affect the action of the medicinal product Inform your doctor about all other medicines you are taking especially antidepressants, alpha-methyldopa (antihypertensive), apomorphine (used for Parkinson s disease), dobutamine (used in the management of congestive heart failure), adrenaline (used for heart attacks) and isoprenaline (used for heart attacks). When you are taking Tasmar with anticoagulants (that prevent blood clotting) of the warfarin type, your doctor may do regular blood tests to monitor of how easily the blood clots. If you go to hospital or if you are prescribed a new medicine, you must tell your doctor that your are taking Tasmar. Special warnings Use in Children Tasmar is not intended to be used in children. Use during pregnancy and breast-feeding You must tell your doctor if you are pregnant or intend to become pregnant. Your doctor will discuss the risks and benefits of taking Tasmar during pregnancy. The effects of Tasmar have not been studied in infants. You should not breast-feed your infant during treatment with Tasmar. 18

16 Effects on ability to drive and use machinery Tasmar has an effect on your symptoms of Parkinson s disease. Since your ability to drive a car or operate machinery may be affected by Parkinson s disease, you should discuss this with your doctor. 8. INSTRUCTIONS FOR PROPER USE Dosage and Frequency of administration The recommended dose of Tasmar is 100 mg or 200 mg three times a day. The first dose of Tasmar is taken with the first dose of the day of levodopa and the other doses of Tasmar are taken about 6 and 12 hours later. This means take one tablet in the morning, one tablet in the middle of the day and one tablet in the evening. When beginning and during treatment with Tasmar, your dose of levodopa may need to be changed. Your doctor will advise you what to do. Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed. Otherwise, your doctor may think that it was not effective or well tolerated and may change your treatment unnecessarily. Method and route of administration Your tablet should be swallowed, with water, and may be taken with or without food. Do not break or crush tablets and do not take any tablets that are damaged. Duration of treatment Long-term treatment or as instructed by your doctor. Actions to be taken in case of overdose If you take more tablets than you have been told to take, or if someone else accidentally takes your medicine, contact a doctor, pharmacist or hospital immediately as you may need urgent medical attention. Symptoms of overdose may include nausea, vomiting, dizziness and breathing difficulties. Action to be taken when one or more doses have not been taken If you forget to take your medicine at any time, take it as soon as you remember, then continue to take it at the usual times. If you have missed several doses, please inform your doctor and follow the advice given to you. Do not reduce or stop taking your medicine unless your doctor tells you to. 9. DESCRIPTION OF UNDESIRABLE EFFECTS UNDER NORMAL USE 19

17 Along with its desired effects, a medicine may cause some unwanted effects. Tell your doctor or a pharmacist as soon as possible if you do not feel well while you are taking Tasmar. The unwanted effects that are most likely to occur are: dyskinesia (involuntary movement), nausea, sleeping problems, decreased appetite and diarrhoea. Very rarely, patients develop Neuroleptic Malignant Syndrome (severe symptoms of muscle stiffening, fever or mental confusion) when antiparkinsonian treatments are abruptly reduced or withdrawn. If any other unwanted effect is noticed, you should tell your doctor or pharmacist about it. 20

18 10. EXPIRY DATE Do not take the tablets after the expiry date shown on the pack. Keep this medicine out of reach of children. 11. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST REVISED 21

19 12. OTHER INFORMATION For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder. Belgique/België/Belgien N.V. Roche S.A, Rue Dantestraat 75, B-1070 Bruxelles - Brussel Tel: (02) Danmark Roche a/s, Industriholmen 59, DK-2650 Hvidovre Tel: Deutschland Hoffmann-La Roche AG, Emil-Barell-Str.1, D Grenzach-Wyhlen Tel: (07624) 140????da Roche (Hellas) S.A., 4 Alamanas & Delfon st., GR Maroussi, Attiki Tel: (01) España Productos Roche S.A., C a. Carabanchel a la de Andalucia s/n,28025 Madrid Tel: (91) France Produits Roche, 52 Boulevard du Parc. F Neuilly-s/Seine Cedex Tel: (01) Ireland Roche Pharmaceuticals, 3 Richview, Clonskeagh, Dublin 14 Tel: (01) Italia Roche S.p.A., Piazza Durante 11, I Milano Tel: (02) 2884 Luxembourg N.V Roche S.A, Rue Dantestraat 75, B1070 Bruxelles - Brussel Tel: (02) Nederland Roche Nederland B.V., Postbus 42, NL-3640 AA Mijdrecht Tel: (0297) Österreich Hoffmann-La Roche Wien Gesellschaft m.b.h, Jacquingasse 16-18, A-1030 Wien Tel: (0222) Portugal Roche Farmacêutica Química Lda, Estrada Nacional 249-1, 2700 Amadora 22

20 Tel: (01) Suomi/Finland Roche Oy, PL 12, FIN Espoo/Esbo Puh/Tel: (09) Sverige Roche AB, Box 47327, S Stockholm Tel: (08) United Kingdom Roche Products Ltd, 40 Broadwater Road, Welwyn Garden City, Hertfordshire, AL7 3AY Tel: (01707)