4

ANNEX II

THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR IMPORT AND BATCH RELEASE AND CONDITIONS OR

RESTRICTIONS REGARDING SUPPLY AND USE

5

A. MANUFACTURING AUTHORISATION HOLDER Manufacturer responsible for import and batch release in the European Economic Area

Boehringer Ingelheim Pharma KG, D-55216, Ingelheim am Rhein, Germany Manufacturing authorisation issued on December 15, 1997 and confirmed on March 30, 1998 by Ministerium für Arbeit, Soziales und Gesundheit, Rheinland-Pfalz, Postfach 3180 - 55021 Mainz, Germany.

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription.

6

ANNEX III

LABELLING AND PACKAGE LEAFLET

7

B. PACKAGE LEAFLET

8

SIFROL 0.088 mg 0.088 mg pramipexole equivalent to pramipexole salt 0.125 mg Patient Information Leaflet What You Should Know About Your Medicine Please read this leaflet carefully. It contains a summary of the information available on your medicine. The information in this leaflet applies to SIFROL only. If after reading this leaflet you have any questions ask your doctor or pharmacist. The name of your medicine is SIFROL 0.088 mg. Each tablet contains 0.088 mg of pramipexole base (equivalent to 0.125 mg of pramipexole dihydrochloride monohydrate salt) as the active ingredient. The tablets also contain mannitol, maize starch, anhydrous colloidal silica, polyvidone and magnesium stearate. SIFROL tablets are available in blister packs of 30 and 100 tablets. SIFROL belongs to a group of medicines called dopamine agonists which stimulate dopamine receptors in the brain. The Marketing Authorisation for SIFROL is held by: Boehringer Ingelheim International GmbH D-55216 Ingelheim am Rhein Germany. and the tablets are manufactured by: Boehringer Ingelheim Pharma KG D-55216 Ingelheim am Rhein Germany How Your Medicine Helps You SIFROL tablets are taken by patients to treat the signs and symptoms of advanced idiopathic Parkinson's disease in combination with the drug levodopa. Before Taking Your Medicine Tell your doctor or pharmacist if: • You are allergic to the active ingredient pramipexole or any other ingredient in this

product • You are pregnant, planning to become pregnant or if you are breast feeding • Your kidney function is impaired

9

• You are taking any other medicines, in particular, drugs which affect kidney function or are excreted by the kidneys e.g. cimetidine, and other drugs to treat Parkinson's disease e.g. amantadine.

SIFROL can cause hallucinations and somnolence (drowsiness) in some patients. Before you know how SIFROL affects you do not drive or operate machinery. Special care is recommended during pregnancy. The benefits of SIFROL must be assessed against the possible effects on your unborn child. SIFROL is not recommended during breastfeeding, and is likely to stop the production of milk. Your eyes should be examined at regular intervals or if visual problems occur. If you have heart disease, consult your doctor. Your blood pressure should be measured regularly, especially at the beginning of treatment. If in doubt ask your doctor or pharmacist. How To Take Your Medicine Follow your doctors instructions about when and how to take your medicine and always read the label. The tablets should be taken orally with water as follows: At the beginning of treatment you will start by taking 0.264 mg of pramipexole base (0.375 mg of pramipexole salt) daily in 3 divided doses. The daily dose will then be increased gradually every 5-7 days until an appropriate dose for your needs is reached. You will then be maintained on this dose which will be in the range of between 0.264 mg and 3.3 mg pramipexole base (0.375 mg and 4.5 mg of pramipexole salt) per day. This daily dose will be taken in 3 equally divided doses. If you have impaired kidney function, your doctor may give you a reduced dose. If you forget to take a dose, take it as soon as you remember, then carry on as before. Do not take more than one dose at a time. If you accidentally took too many tablets, you should get medical help immediately either by calling your doctor or by going to the nearest hospital accident and emergency department (do not drive yourself). Always take the labelled medicine container with you whether or not there are any SIFROL tablets left. Undesirable effects that may be caused by SIFROL SIFROL may cause the following side-effects: • Nausea • Constipation • Somnolence (drowsiness) • Hallucinations (abnormal visual phenomena) • Dyskinesias (abnormal involuntary movements)

10

If you experience any of these side-effects and they persist or become troublesome consult your doctor. If you experience any other side-effects not mentioned above, consult your doctor or pharmacist. How To Store Your Medicine The tablets should not be used after the expiry date which is printed on the packaging. SIFROL tablets should be stored in the original blisters until needed. Once the packaging is opened the tablets should be protected from light. Keep this medicine out of the reach of children. This leaflet was written in April 1998.

11

For any further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder: Belgique/België/Belgien Luxembourg n.v. Boehringer Ingelheim s.a. n.v. Boehringer Ingelheim s.a. Avenue Ariane, Arianelaan 16 Avenue Ariane, Arianelaan 16 B-1200 Bruxelles/Brussel B - 1200 Bruxelles/Brussel tel. no. (2) 773 33 11 tel. no. (2) 773 33 11 fax. no. (2) 773 33 00 fax. no. (2) 773 33 00 Danmark Nederland Boehringer Ingelheim Danmark A/S Boehringer Ingelheim b.v. Strødamvej 52 Berenkoog 28 DK-2100 København Ø NL-1822 BJ Alkmaar tel. no. (39) 15 88 88 tel. no. (72) 5 66 24 24 fax. no. (39) 15 89 89 fax. no. (72) 5 64 19 34 Deutschland Österreich Boehringer Ingelheim Pharma KG Bender & Co Ges mbH Binger Straße 173 Dr. Boehringer-Gasse 5-11 D-55216 Ingelheim A-1121 Wien tel. no. (6132) 77-0 tel. no. (1) 80 105-0 fax no. (6132) 72-0 fax. no. (1) 804 08 23 Eλλάς Portugal Boehringer Ingelheim Ellas A.E. Boehringer Ingelheim Lda. Eλληνικού 2 Av. António A. de Aguiar 104 - 1.° GR - 167 77 Eλληνικό –Aθήνα P-1063 Lisboa Codex Tηλ. (1) 89 06 300 tel. no (1) 313 53 00 Tελεφαξ (1) 89 83 207 fax. no. (1) 313 53 03 España Suomi Boehringer Ingelheim S.A. Panfarma Oy/Boehringer Ingelheim Pablo Alcover, 33 Harmaaparrankuja 1 E-08017 – Barcelona FI-02200 Espoo / Esbo tel. no. (3) 404-51-00 tel. no. (9) 429 98 fax. no. (3) 204-28-50 fax.no. (9) 452 20 61 France Sverige Boehringer Ingelheim France S.A.R.L. Boehringer Ingelheim AB 37-39, Rue Boissière Box 44 F-75116 Paris S-127 21 Skärholmen tel. no. (1) 44 34 65 65 tel. no. (8) 721 21 00 fax. no. (1) 44 34 65 00 fax. no. (8) 710 98 84 Ireland United Kingdom Boehringer Ingelheim Ltd. Boehringer Ingelheim Ltd., 31 Sandyford Office Park Ellesfield Avenue, Blackthorn Road Bracknell, Berkshire, Sandyford UK-RG12 8YS IRL-Dublin 18 tel. no. (1344) 424 600 tel. no. (1) 295 9620 fax no. (1344) 741 444 fax. no. (1) 295 9624 Italia Boehringer Ingelheim Italia S.p.A. Via Lorenzini, 8 I-20 139 Milano tel. no. (2) 535 51 fax. no. (2) 535 52 22

12

SIFROL 0.18 mg 0.18 mg pramipexole equivalent to pramipexole salt 0.25 mg Patient Information Leaflet What You Should Know About Your Medicine Please read this leaflet carefully. It contains a summary of the information available on your medicine. The information in this leaflet applies to SIFROL only. If after reading this leaflet you have any questions ask your doctor or pharmacist. The name of your medicine is SIFROL 0.18 mg. Each tablet contains 0.18 mg of pramipexole base (equivalent to 0.25 mg of pramipexole dihydrochloride monohydrate salt) as the active ingredient. The tablets also contain mannitol, maize starch, anhydrous colloidal silica, polyvidone and magnesium stearate. SIFROL tablets are available in blister packs of 30 and 100 tablets. SIFROL belongs to a group of medicines called dopamine agonists which stimulate dopamine receptors in the brain. The Marketing Authorisation for SIFROL is held by: Boehringer Ingelheim International GmbH D-55216 Ingelheim am Rhein Germany. and the tablets are manufactured by: Boehringer Ingelheim Pharma KG D-55216 Ingelheim am Rhein Germany How Your Medicine Helps You SIFROL tablets are taken by patients to treat the signs and symptoms of advanced idiopathic Parkinson's disease in combination with the drug levodopa. Before Taking Your Medicine Tell your doctor or pharmacist if: • You are allergic to the active ingredient pramipexole or any other ingredient in this

product • You are pregnant, planning to become pregnant or if you are breast feeding • Your kidney function is impaired

13

• You are taking any other medicines, in particular, drugs which affect kidney function or are excreted by the kidneys e.g. cimetidine, and other drugs to treat Parkinson's disease e.g. amantadine.

SIFROL can cause hallucinations and somnolence (drowsiness) in some patients. Before you know how SIFROL affects you do not drive or operate machinery. Special care is recommended during pregnancy. The benefits of SIFROL must be assessed against the possible effects on your unborn child. SIFROL is not recommended during breastfeeding, and is likely to stop the production of milk. Your eyes should be examined at regular intervals or if visual problems occur. If you have heart disease, consult your doctor. Your blood pressure should be measured regularly, especially at the beginning of treatment. If in doubt ask your doctor or pharmacist. How To Take Your Medicine Follow your doctors instructions about when and how to take your medicine and always read the label. The tablets should be taken orally with water as follows: At the beginning of treatment you will start by taking 0.264 mg of pramipexole base (0.375 mg of pramipexole salt) daily in 3 divided doses. The daily dose will then be increased gradually every 5-7 days until an appropriate dose for your needs is reached. You will then be maintained on this dose which will be in the range of between 0.264 mg and 3.3 mg pramipexole base (0.375 mg and 4.5 mg of pramipexole salt) per day. This daily dose will be taken in 3 equally divided doses. If you have impaired kidney function, your doctor may give you a reduced dose. If you forget to take a dose, take it as soon as you remember, then carry on as before. Do not take more than one dose at a time. If you accidentally took too many tablets, you should get medical help immediately either by calling your doctor or by going to the nearest hospital accident and emergency department (do not drive yourself). Always take the labelled medicine container with you whether or not there are any SIFROL tablets left. Undesirable effects that may be caused by SIFROL SIFROL may cause the following side-effects: • Nausea • Constipation • Somnolence (drowsiness) • Hallucinations (abnormal visual phenomena) • Dyskinesias (abnormal involuntary movements)

14

If you experience any of these side-effects and they persist or become troublesome consult your doctor. If you experience any other side-effects not mentioned above, consult your doctor or pharmacist. How To Store Your Medicine The tablets should not be used after the expiry date which is printed on the packaging. SIFROL tablets should be stored in the original blisters until needed. Once the packaging is opened the tablets should be protected from light. Keep this medicine out of the reach of children. This leaflet was written in April 1998.

15

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

Belgique/België/Belgien Luxembourg n.v. Boehringer Ingelheim s.a. n.v. Boehringer Ingelheim s.a. Avenue Ariane, Arianelaan 16 Avenue Ariane, Arianelaan 16 B-1200 Bruxelles/Brussel B - 1200 Bruxelles/Brussel tel. no. (2) 773 33 11 tel. no. (2) 773 33 11 fax. no. (2) 773 33 00 fax. no. (2) 773 33 00 Danmark Nederland Boehringer Ingelheim Danmark A/S Boehringer Ingelheim b.v. Strødamvej 52 Berenkoog 28 DK-2100 København Ø NL-1822 BJ Alkmaar tel. no. (39) 15 88 88 tel. no. (72) 5 66 24 24 fax. no. (39) 15 89 89 fax. no. (72) 5 64 19 34 Deutschland Österreich Boehringer Ingelheim Pharma KG Bender & Co Ges mbH Binger Straße 173 Dr. Boehringer-Gasse 5-11 D-55216 Ingelheim A-1121 Wien tel. no. (6132) 77-0 tel. no. (1) 80 105-0 fax no. (6132) 72-0 fax. no. (1) 804 08 23 Eλλάς Portugal Boehringer Ingelheim Ellas A.E. Boehringer Ingelheim Lda. Eλληνικού 2 Av. António A. de Aguiar 104 - 1.° GR - 167 77 Eλληνικό –Aθήνα P-1063 Lisboa Codex Tηλ. (1) 89 06 300 tel. no (1) 313 53 00 Tελεφαξ (1) 89 83 207 fax. no. (1) 313 53 03 España Suomi Boehringer Ingelheim S.A. Panfarma Oy/Boehringer Ingelheim Pablo Alcover, 33 Harmaaparrankuja 1 E-08017 – Barcelona FI-02200 Espoo / Esbo tel. no. (3) 404-51-00 tel. no. (9) 429 98 fax. no. (3) 204-28-50 fax.no. (9) 452 20 61 France Sverige Boehringer Ingelheim France S.A.R.L. Boehringer Ingelheim AB 37-39, Rue Boissière Box 44 F-75116 Paris S-127 21 Skärholmen tel. no. (1) 44 34 65 65 tel. no. (8) 721 21 00 fax. no. (1) 44 34 65 00 fax. no. (8) 710 98 84 Ireland United Kingdom Boehringer Ingelheim Ltd. Boehringer Ingelheim Ltd., 31 Sandyford Office Park Ellesfield Avenue, Blackthorn Road Bracknell, Berkshire, Sandyford UK-RG12 8YS IRL-Dublin 18 tel. no. (1344) 424 600 tel. no. (1) 295 9620 fax no. (1344) 741 444 fax. no. (1) 295 9624 Italia Boehringer Ingelheim Italia S.p.A. Via Lorenzini, 8 I-20 139 Milano tel. no. (2) 535 51 fax. no. (2) 535 52 22

16

17

SIFROL 0.7 mg 0.7 mg pramipexole equivalent to pramipexole salt 1.0 mg Patient Information Leaflet What You Should Know About Your Medicine Please read this leaflet carefully. It contains a summary of the information available on your medicine. The information in this leaflet applies to SIFROL only. If after reading this leaflet you have any questions ask your doctor or pharmacist. The name of your medicine is SIFROL 0.7 mg. Each tablet contains 0.7 mg of pramipexole base (equivalent to 1.0 mg of pramipexole dihydrochloride monohydrate salt) as the active ingredient. The tablets also contain mannitol, maize starch, anhydrous colloidal silica, polyvidone and magnesium stearate. SIFROL tablets are available in blister packs of 30 and 100 tablets. SIFROL belongs to a group of medicines called dopamine agonists which stimulate dopamine receptors in the brain. The Marketing Authorisation for SIFROL is held by: Boehringer Ingelheim International GmbH D-55216 Ingelheim am Rhein Germany and the tablets are manufactured by : Boehringer Ingelheim Pharma KG D-55216 Ingelheim am Rhein Germany How Your Medicine Helps You SIFROL tablets are taken by patients to treat the signs and symptoms of advanced idiopathic Parkinson's disease in combination with the drug levodopa. Before Taking Your Medicine Tell your doctor or pharmacist if: • You are allergic to the active ingredient pramipexole or any other ingredient in this

product • You are pregnant, planning to become pregnant or if you are breast feeding • Your kidney function is impaired

18

• You are taking any other medicines, in particular, drugs which affect kidney function or are excreted by the kidneys e.g. cimetidine, and other drugs to treat Parkinson's disease e.g. amantadine.

SIFROL can cause hallucinations and somnolence (drowsiness) in some patients. Before you know how SIFROL affects you do not drive or operate machinery. Special care is recommended during pregnancy. The benefits of SIFROL must be assessed against the possible effects on your unborn child. SIFROL is not recommended during breastfeeding, and is likely to stop the production of milk. Your eyes should be examined at regular intervals or if visual problems occur. If you have heart disease, consult your doctor. Your blood pressure should be measured regularly, especially at the beginning of treatment. If in doubt ask your doctor or pharmacist. How To Take Your Medicine Follow your doctors instructions about when and how to take your medicine and always read the label. The tablets should be taken orally with water as follows: At the beginning of treatment you will start by taking 0.264 mg of pramipexole base (0.375 mg of pramipexole salt) daily in 3 divided doses. The daily dose will then be increased gradually every 5-7 days until an appropriate dose for your needs is reached. You will then be maintained on this dose which will be in the range of between 0.264 mg and 3.3 mg pramipexole base (0.375 mg and 4.5 mg of pramipexole salt) per day. This daily dose will be taken in 3 equally divided doses. If you have impaired kidney function, your doctor may give you a reduced dose. If you forget to take a dose, take it as soon as you remember, then carry on as before. Do not take more than one dose at a time. If you accidentally took too many tablets, you should get medical help immediately either by calling your doctor or by going to the nearest hospital accident and emergency department (do not drive yourself). Always take the labelled medicine container with you whether or not there are any SIFROL tablets left. Undesirable effects that may be caused by SIFROL SIFROL may cause the following side-effects: • Nausea • Constipation • Somnolence (drowsiness) • Hallucinations (abnormal visual phenomena) • Dyskinesias (abnormal involuntary movements)

19

If you experience any of these side-effects and they persist or become troublesome consult your doctor. If you experience any other side-effects not mentioned above, consult your doctor or pharmacist. How To Store Your Medicine The tablets should not be used after the expiry date which is printed on the packaging. SIFROL tablets should be stored in the original blisters until needed. Once the packaging is opened the tablets should be protected from light. Keep this medicine out of the reach of children. This leaflet was written in April 1998.

20

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

Belgique/België/Belgien Luxembourg n.v. Boehringer Ingelheim s.a. n.v. Boehringer Ingelheim s.a. Avenue Ariane, Arianelaan 16 Avenue Ariane, Arianelaan 16 B-1200 Bruxelles/Brussel B - 1200 Bruxelles/Brussel tel. no. (2) 773 33 11 tel. no. (2) 773 33 11 fax. no. (2) 773 33 00 fax. no. (2) 773 33 00 Danmark Nederland Boehringer Ingelheim Danmark A/S Boehringer Ingelheim b.v. Strødamvej 52 Berenkoog 28 DK-2100 København Ø NL-1822 BJ Alkmaar tel. no. (39) 15 88 88 tel. no. (72) 5 66 24 24 fax. no. (39) 15 89 89 fax. no. (72) 5 64 19 34 Deutschland Österreich Boehringer Ingelheim Pharma KG Bender & Co Ges mbH Binger Straße 173 Dr. Boehringer-Gasse 5-11 D-55216 Ingelheim A-1121 Wien tel. no. (6132) 77-0 tel. no. (1) 80 105-0 fax no. (6132) 72-0 fax. no. (1) 804 08 23 Eλλάς Portugal Boehringer Ingelheim Ellas A.E. Boehringer Ingelheim Lda. Eλληνικού 2 Av. António A. de Aguiar 104 - 1.° GR - 167 77 Eλληνικό –Aθήνα P-1063 Lisboa Codex Tηλ. (1) 89 06 300 tel. no (1) 313 53 00 Tελεφαξ (1) 89 83 207 fax. no. (1) 313 53 03 España Suomi Boehringer Ingelheim S.A. Panfarma Oy/Boehringer Ingelheim Pablo Alcover, 33 Harmaaparrankuja 1 E-08017 – Barcelona FI-02200 Espoo / Esbo tel. no. (3) 404-51-00 tel. no. (9) 429 98 fax. no. (3) 204-28-50 fax.no. (9) 452 20 61 France Sverige Boehringer Ingelheim France S.A.R.L. Boehringer Ingelheim AB 37-39, Rue Boissière Box 44 F-75116 Paris S-127 21 Skärholmen tel. no. (1) 44 34 65 65 tel. no. (8) 721 21 00 fax. no. (1) 44 34 65 00 fax. no. (8) 710 98 84 Ireland United Kingdom Boehringer Ingelheim Ltd. Boehringer Ingelheim Ltd., 31 Sandyford Office Park Ellesfield Avenue, Blackthorn Road Bracknell, Berkshire, Sandyford UK-RG12 8YS IRL-Dublin 18 tel. no. (1344) 424 600 tel. no. (1) 295 9620 fax no. (1344) 741 444 fax. no. (1) 295 9624 Italia Boehringer Ingelheim Italia S.p.A. Via Lorenzini, 8 I-20 139 Milano tel. no. (2) 535 51 fax. no. (2) 535 52 22

21

SIFROL 0.88 mg 0.88 mg pramipexole equivalent to pramipexole salt 1.25 mg Patient Information Leaflet What You Should Know About Your Medicine Please read this leaflet carefully. It contains a summary of the information available on your medicine. The information in this leaflet applies to SIFROL only. If after reading this leaflet you have any questions ask your doctor or pharmacist. The name of your medicine is SIFROL 0.88 mg. Each tablet contains 0.88 mg of pramipexole base (equivalent to 1.25 mg of pramipexole dihydrochloride monohydrate salt) as the active ingredient. The tablets also contain mannitol, maize starch, anhydrous colloidal silica, polyvidone and magnesium stearate. SIFROL tablets are available in blister packs of 30 and 100 tablets. SIFROL belongs to a group of medicines called dopamine agonists which stimulate dopamine receptors in the brain. The Marketing Authorisation for SIFROL is held by: Boehringer Ingelheim International GmbH D-55216 Ingelheim am Rhein Germany and the tablets are manufactured by: Boehringer Ingelheim Pharma KG D-55216 Ingelheim am Rhein Germany How Your Medicine Helps You SIFROL tablets are taken by patients to treat the signs and symptoms of advanced idiopathic Parkinson's disease in combination with the drug levodopa. Before Taking Your Medicine Tell your doctor or pharmacist if: • You are allergic to the active ingredient pramipexole or any other ingredient in this

product • You are pregnant, planning to become pregnant or if you are breast feeding • Your kidney function is impaired

22

• You are taking any other medicines, in particular, drugs which affect kidney function or are excreted by the kidneys e.g. cimetidine, and other drugs to treat Parkinson's disease e.g. amantadine.

SIFROL can cause hallucinations and somnolence (drowsiness) in some patients. Before you know how SIFROL affects you do not drive or operate machinery. Special care is recommended during pregnancy. The benefits of SIFROL must be assessed against the possible effects on your unborn child. SIFROL is not recommended during breastfeeding, and is likely to stop the production of milk. Your eyes should be examined at regular intervals or if visual problems occur. If you have heart disease, consult your doctor. Your blood pressure should be measured regularly, especially at the beginning of treatment. If in doubt ask your doctor or pharmacist. How To Take Your Medicine Follow your doctors instructions about when and how to take your medicine and always read the label. The tablets should be taken orally with water as follows: At the beginning of treatment you will start by taking 0.264 mg of pramipexole base (0.375 mg of pramipexole salt) daily in 3 divided doses. The daily dose will then be increased gradually every 5-7 days until an appropriate dose for your needs is reached. You will then be maintained on this dose which will be in the range of between 0.264 mg and 3.3 mg pramipexole base (0.375 mg and 4.5 mg of pramipexole salt) per day. This daily dose will be taken in 3 equally divided doses. If you have impaired kidney function, your doctor may give you a reduced dose. If you forget to take a dose, take it as soon as you remember, then carry on as before. Do not take more than one dose at a time. If you accidentally took too many tablets, you should get medical help immediately either by calling your doctor or by going to the nearest hospital accident and emergency department (do not drive yourself). Always take the labelled medicine container with you whether or not there are any SIFROL tablets left. Undesirable effects that may be caused by SIFROL SIFROL may cause the following side-effects: • Nausea • Constipation • Somnolence (drowsiness) • Hallucinations (abnormal visual phenomena) • Dyskinesias (abnormal involuntary movements)

23

If you experience any of these side-effects and they persist or become troublesome consult your doctor. If you experience any other side-effects not mentioned above, consult your doctor or pharmacist. How To Store Your Medicine The tablets should not be used after the expiry date which is printed on the packaging. SIFROL tablets should be stored in the original blisters until needed. Once the packaging is opened the tablets should be protected from light. Keep this medicine out of the reach of children. This leaflet was written in April 1998.

24

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

Belgique/België/Belgien Luxembourg n.v. Boehringer Ingelheim s.a. n.v. Boehringer Ingelheim s.a. Avenue Ariane, Arianelaan 16 Avenue Ariane, Arianelaan 16 B-1200 Bruxelles/Brussel B - 1200 Bruxelles/Brussel tel. no. (2) 773 33 11 tel. no. (2) 773 33 11 fax. no. (2) 773 33 00 fax. no. (2) 773 33 00 Danmark Nederland Boehringer Ingelheim Danmark A/S Boehringer Ingelheim b.v. Strødamvej 52 Berenkoog 28 DK-2100 København Ø NL-1822 BJ Alkmaar tel. no. (39) 15 88 88 tel. no. (72) 5 66 24 24 fax. no. (39) 15 89 89 fax. no. (72) 5 64 19 34 Deutschland Österreich Boehringer Ingelheim Pharma KG Bender & Co Ges mbH Binger Straße 173 Dr. Boehringer-Gasse 5-11 D-55216 Ingelheim A-1121 Wien tel. no. (6132) 77-0 tel. no. (1) 80 105-0 fax no. (6132) 72-0 fax. no. (1) 804 08 23 Eλλάς Portugal Boehringer Ingelheim Ellas A.E. Boehringer Ingelheim Lda. Eλληνικού 2 Av. António A. de Aguiar 104 - 1.° GR - 167 77 Eλληνικό –Aθήνα P-1063 Lisboa Codex Tηλ. (1) 89 06 300 tel. no (1) 313 53 00 Tελεφαξ (1) 89 83 207 fax. no. (1) 313 53 03 España Suomi Boehringer Ingelheim S.A. Panfarma Oy/Boehringer Ingelheim Pablo Alcover, 33 Harmaaparrankuja 1 E-08017 – Barcelona FI-02200 Espoo / Esbo tel. no. (3) 404-51-00 tel. no. (9) 429 98 fax. no. (3) 204-28-50 fax.no. (9) 452 20 61 France Sverige Boehringer Ingelheim France S.A.R.L. Boehringer Ingelheim AB 37-39, Rue Boissière Box 44 F-75116 Paris S-127 21 Skärholmen tel. no. (1) 44 34 65 65 tel. no. (8) 721 21 00 fax. no. (1) 44 34 65 00 fax. no. (8) 710 98 84 Ireland United Kingdom Boehringer Ingelheim Ltd. Boehringer Ingelheim Ltd., 31 Sandyford Office Park Ellesfield Avenue, Blackthorn Road Bracknell, Berkshire, Sandyford UK-RG12 8YS IRL-Dublin 18 tel. no. (1344) 424 600 tel. no. (1) 295 9620 fax no. (1344) 741 444 fax. no. (1) 295 9624 Italia Boehringer Ingelheim Italia S.p.A. Via Lorenzini, 8 I-20 139 Milano tel. no. (2) 535 51 fax. no. (2) 535 52 22

25

SIFROL 1.1 mg 1.1 mg pramipexole equivalent to pramipexole salt 1.5 mg Patient Information Leaflet What You Should Know About Your Medicine Please read this leaflet carefully. It contains a summary of the information available on your medicine. The information in this leaflet applies to SIFROL only. If after reading this leaflet you have any questions ask your doctor or pharmacist. The name of your medicine is SIFROL 1.1 mg. Each tablet contains 1.1 mg of pramipexole base (equivalent to 1.5 mg of pramipexole dihydrochloride monohydrate salt) as the active ingredient. The tablets also contain mannitol, maize starch, anhydrous colloidal silica, polyvidone and magnesium stearate. SIFROL tablets are available in blister packs of 30 and 100 tablets. SIFROL belongs to a group of medicines called dopamine agonists which stimulate dopamine receptors in the brain. The Marketing Authorisation for SIFROL is held by: Boehringer Ingelheim International GmbH D-55216 Ingelheim am Rhein Germany and the tablets are manufactured by: Boehringer Ingelheim Pharma KG D-55216 Ingelheim am Rhein Germany How Your Medicine Helps You SIFROL tablets are taken by patients to treat the signs and symptoms of advanced idiopathic Parkinson's disease in combination with the drug levodopa. Before Taking Your Medicine Tell your doctor or pharmacist if: • You are allergic to the active ingredient pramipexole or any other ingredient in this

product • You are pregnant, planning to become pregnant or if you are breast feeding • Your kidney function is impaired

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• You are taking any other medicines, in particular, drugs which affect kidney function or are excreted by the kidneys e.g. cimetidine, and other drugs to treat Parkinson's disease e.g. amantadine.

SIFROL can cause hallucinations and somnolence (drowsiness) in some patients. Before you know how SIFROL affects you do not drive or operate machinery. Special care is recommended during pregnancy. The benefits of SIFROL must be assessed against the possible effects on your unborn child. SIFROL is not recommended during breastfeeding, and is likely to stop the production of milk. Your eyes should be examined at regular intervals or if visual problems occur. If you have heart disease, consult your doctor. Your blood pressure should be measured regularly, especially at the beginning of treatment. If in doubt ask your doctor or pharmacist. How To Take Your Medicine Follow your doctors instructions about when and how to take your medicine and always read the label. The tablets should be taken orally with water as follows: At the beginning of treatment you will start by taking 0.264 mg of pramipexole base (0.375 mg of pramipexole salt) daily in 3 divided doses. The daily dose will then be increased gradually every 5-7 days until an appropriate dose for your needs is reached. You will then be maintained on this dose which will be in the range of between 0.264 mg and 3.3 mg pramipexole base (0.375 mg and 4.5 mg of pramipexole salt) per day. This daily dose will be taken in 3 equally divided doses. If you have impaired kidney function, your doctor may give you a reduced dose. If you forget to take a dose, take it as soon as you remember, then carry on as before. Do not take more than one dose at a time. If you accidentally took too many tablets, you should get medical help immediately either by calling your doctor or by going to the nearest hospital accident and emergency department (do not drive yourself). Always take the labelled medicine container with you whether or not there are any SIFROL tablets left. Undesirable effects that may be caused by SIFROL SIFROL may cause the following side-effects: • Nausea • Constipation • Somnolence (drowsiness) • Hallucinations (abnormal visual phenomena) • Dyskinesias (abnormal involuntary movements)

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If you experience any of these side-effects and they persist or become troublesome consult your doctor. If you experience any other side-effects not mentioned above, consult your doctor or pharmacist. How To Store Your Medicine The tablets should not be used after the expiry date which is printed on the packaging. SIFROL tablets should be stored in the original blisters until needed. Once the packaging is opened the tablets should be protected from light. Keep this medicine out of the reach of children. This leaflet was written in April 1998.

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

Belgique/België/Belgien Luxembourg n.v. Boehringer Ingelheim s.a. n.v. Boehringer Ingelheim s.a. Avenue Ariane, Arianelaan 16 Avenue Ariane, Arianelaan 16 B-1200 Bruxelles/Brussel B - 1200 Bruxelles/Brussel tel. no. (2) 773 33 11 tel. no. (2) 773 33 11 fax. no. (2) 773 33 00 fax. no. (2) 773 33 00 Danmark Nederland Boehringer Ingelheim Danmark A/S Boehringer Ingelheim b.v. Strødamvej 52 Berenkoog 28 DK-2100 København Ø NL-1822 BJ Alkmaar tel. no. (39) 15 88 88 tel. no. (72) 5 66 24 24 fax. no. (39) 15 89 89 fax. no. (72) 5 64 19 34 Deutschland Österreich Boehringer Ingelheim Pharma KG Bender & Co Ges mbH Binger Straße 173 Dr. Boehringer-Gasse 5-11 D-55216 Ingelheim A-1121 Wien tel. no. (6132) 77-0 tel. no. (1) 80 105-0 fax no. (6132) 72-0 fax. no. (1) 804 08 23 Eλλάς Portugal Boehringer Ingelheim Ellas A.E. Boehringer Ingelheim Lda. Eλληνικού 2 Av. António A. de Aguiar 104 - 1.° GR - 167 77 Eλληνικό –Aθήνα P-1063 Lisboa Codex Tηλ. (1) 89 06 300 tel. no (1) 313 53 00 Tελεφαξ (1) 89 83 207 fax. no. (1) 313 53 03 España Suomi Boehringer Ingelheim S.A. Panfarma Oy/Boehringer Ingelheim Pablo Alcover, 33 Harmaaparrankuja 1 E-08017 – Barcelona FI-02200 Espoo / Esbo tel. no. (3) 404-51-00 tel. no. (9) 429 98 fax. no. (3) 204-28-50 fax.no. (9) 452 20 61 France Sverige Boehringer Ingelheim France S.A.R.L. Boehringer Ingelheim AB 37-39, Rue Boissière Box 44 F-75116 Paris S-127 21 Skärholmen tel. no. (1) 44 34 65 65 tel. no. (8) 721 21 00 fax. no. (1) 44 34 65 00 fax. no. (8) 710 98 84 Ireland United Kingdom Boehringer Ingelheim Ltd. Boehringer Ingelheim Ltd., 31 Sandyford Office Park Ellesfield Avenue, Blackthorn Road Bracknell, Berkshire, Sandyford UK-RG12 8YS IRL-Dublin 18 tel. no. (1344) 424 600 tel. no. (1) 295 9620 fax no. (1344) 741 444 fax. no. (1) 295 9624 Italia Boehringer Ingelheim Italia S.p.A. Via Lorenzini, 8 I-20 139 Milano tel. no. (2) 535 51 fax. no. (2) 535 52 22

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