ANNEX III LABELLING AND PACKAGE LEAFLET ANNEX

Transcription

1 ANNEX III LABELLING AND PACKAGE LEAFLET ANNEX

2 B. PACKAGE LEAFLET 2

3 NAME OF THE MEDICINAL PRODUCT OLANSEK 2.5 mg TABLETS (OLANZAPINE) GENERAL ADVICE Please read this information carefully before you start to take your medicine. This leaflet contains important information on OLANSEK. If you have any questions or if you are not sure about anything please ask your doctor or a pharmacist. Keep this leaflet until you have finished all your medicine as you may want to read it again. Remember this medicine is for the person named by the doctor. Never give it to anyone else. WHAT IS IN OLANSEK? Each OLANSEK tablet contains 2.5 mg of the active ingredient OLANZAPINE. OLANSEK tablets also contain the following inactive ingredients: lactose monohydrate, hydroxypropylcellulose, crospovidone, microcrystalline cellulose, magnesium stearate, methylhydroxypropylcellulose, titanium dioxide (E171), carnauba wax, macrogol, polysorbate 80 and indigo carmine colour (E132). DOSAGE FORM OLANSEK 2.5 mg coated tablets are white. They are available in cartons containing 28 tablets. TYPE OF MEDICINAL PRODUCT OLANSEK belongs to a group of medicines called antipsychotics. MARKETING AUTHORISATION HOLDER AND MANUFACTURER Eli Lilly UK Ltd, Kingsclere Road, Basingstoke, UK. OLANSEK is manufactured by: Eli Lilly and Company, Kingsclere Rd, Basingstoke UK WHAT IS OLANSEK USED FOR? OLANSEK is used to treat a disease with symptoms such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn. People with this disease may also feel depressed, anxious or tense. WHEN YOU SHOULD NOT TAKE OLANSEK You must not take OLANSEK if you have had an allergic reaction in the past to OLANSEK or any other ingredient listed under What is in OLANSEK. An allergic reaction may be recognised as a rash, itching, a swollen face, swollen lips or shortness of breath. If this has happened to you, tell your doctor. If you have been previously diagnosed with narrow-angle glaucoma, you should not take OLANSEK. PRECAUTIONS FOR USE Drugs of this type, may cause unusual movements mainly of the face or tongue. If this happens while you are taking OLANSEK talk to your doctor. 3

4 Very rarely, drugs of this type cause fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness. If this happens, stop taking the medicine and contact your doctor at once. If you suffer from any of the following illnesses tell your doctor before you take OLANSEK: Liver or kidney disease Parkinson s disease Epilepsy Prostate problems A blocked intestine (Paralytic ileus) Blood disorders As a routine precaution, if you are over 65 years your blood pressure may be monitored by your doctor. INTERACTIONS Always tell you doctor if you are taking any other medicine because taking some medicines together can be harmful. A combination of OLANSEK with the following medicines might make you feel drowsy: medicines taken for anxiety or to help you sleep (tranquillisers), antidepressants. Only take other medicines while you are on OLANSEK if your doctor tells you that you can. Also tell your doctor if you are taking medicines for Parkinson s disease before taking OLANSEK. Alcohol: You should not drink any alcohol when taking OLANSEK as OLANSEK and alcohol together may make you feel drowsy. WARNINGS Pregnancy and breast feeding: Tell your doctor if you are pregnant, think you may be pregnant or planning to become pregnant. You should not take this medicine when breast feeding. You should not take this medicine when pregnant unless you have discussed this with your doctor. Driving or using machinery: There is a risk of feeling drowsy when you take OLANSEK. If this happens do not drive or use machinery and tell your doctor. Patients who cannot take lactose should note that OLANSEK contains lactose. HOW TO TAKE OLANSEK Your doctor will tell you how many OLANSEK tablets to take and how long you should continue to take them. The daily dose of OLANSEK is between 5-20 mg. Always read the label on your medicine. You should take your OLANSEK tablets once a day following the advice of your doctor. Try to take your tablets at the same time each day. It does not matter whether you take them with or without food. You should swallow the OLANSEK tablets whole with a little water. Do not stop taking your tablets just because you feel better. It is important that you carry on taking OLANSEK for as long as your doctor tells you. 4

5 OLANSEK is not for patients who are under 18 years. Missed Doses (What to do if you forget to take your medicine) If you forget to take your medicine take your tablets as soon as you remember. Do not take two doses in one day. Overdosage: If you take more OLANSEK tablets than you were told to (or if someone else has taken your OLANSEK tablets) contact your doctor or hospital straight away. Show the doctor your pack of tablets. INFORMATION ON POSSIBLE ADVERSE EFFECTS Adverse effects with OLANSEK may include, sleepiness, putting on weight, dizziness, feeling more hungry, water retention, constipation, a dry mouth, restlessness, unusual movement, tremor and rigidity Some people may feel dizzy in the early stages of treatment, especially when getting up from a lying or sitting position. This will usually pass on its own but if it does not, tell your doctor. Rarely OLANSEK may cause you to become sensitive to sunlight. Some women taking drugs of this type for a long time have started to secrete milk and have missed periods or had irregular periods. If this persists tell your doctor. If OLANSEK affects you in any other way, tell your doctor or a pharmacist. EXPIRY DATE The expiry date of this medicine is printed on the label. Do not use the medicine after this date. STORAGE OLANSEK is light sensitive and should be stored in its original pack at room temperature, in a dry place and out of direct light. Please return left over medicine to your pharmacist. MEDICINES SHOULD BE KEPT OUT OF REACH OF CHILDREN DATE ON WHICH THE PACKAGE LEAFLET WAS LAST REVISED For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder. Belgique/België/Belgien: Eli Lilly Benelux S.A., Rue de l Etuve 52/1, Stoofstraat, Bruxelles 1000 Brussel. Tel: (02) Danmark: Eli Lilly Danmark A/S, Thoravej 4, 2400 København NV. Tlf: Deutschland: Lilly Deutschland GmbH, Niederlassung in Bad Homburg. Tel: Fax: Ελλάδα: ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε, 15 0 χλµ Εθνικής Οδού Αθηνών-Λαµίας, Τ.Κ Κηφισιά. Τηλ.: España: Lilly S.A., Avda. de la Industria 30, Polígono Industrial de Alcobendas, Alcobendas, Madrid. Tel: (91) France: Lilly France S.A., 203 Bureaux de la Colline, Saint-Cloud. Tel: (01)

6 Ireland: Eli Lilly & Company (Ireland) Ltd, 44 Fitzwilliam Place, Dublin 2, Republic of Ireland. Tel: Italia: Eli Lilly Italia SpA, Via Gramsci 731/733, Sesto Fiorentino (FI). Tel: (0) Luxembourg: Eli Lilly Benelux S.A., Rue de l Etuve 52/1, Stoofstraat, Bruxelles 1000 Brussel. Tel: (02) Nederland: Eli Lilly Nederland B.V., Krijtwal 17-23, 3432 ZT, Nieuwegein, Nederland. Tel: Österreich: Eli Lilly Ges. m.b.h., Barichgasse 40-42, A-1030 Wien. Tel: (1) Portugal: Lilly Farma Produtos Farmacêuticos, Lda, Rua Dr. António Loureiro Borges, 4- Piso 3, Arquiparque- Miraflores, 1495 Algés. Tel: (01) Suomi/Finland: Oy Eli Lilly Finland Ab, PL 16, Vantaa. Puh: (09) Box 16, Vanda. Tel: (09) Sverige: Eli Lilly Sweden AB, Box 30037, Stockholm. Tel: (08) United Kingdom: Eli Lilly & Company Ltd., Dextra Court, Chapel Hill, Basingstoke, Hampshire, RG21 5SY. Tel: (0)

7 NAME OF THE MEDICINAL PRODUCT OLANSEK 5 mg TABLETS (OLANZAPINE) GENERAL ADVICE Please read this information carefully before you start to take your medicine. This leaflet contains important information on OLANSEK. If you have any questions or if you are not sure about anything please ask your doctor or a pharmacist. Keep this leaflet until you have finished all your medicine as you may want to read it again. Remember this medicine is for the person named by the doctor. Never give it to anyone else. WHAT IS IN OLANSEK? Each OLANSEK tablet contains 5 mg of the active ingredient OLANZAPINE. OLANSEK tablets also contain the following inactive ingredients: lactose monohydrate, hydroxypropylcellulose, crospovidone, microcrystalline cellulose, magnesium stearate, methylhydroxypropylcellulose, titanium dioxide (E171), carnauba wax, macrogol, polysorbate 80 and indigo carmine colour (E132). DOSAGE FORM OLANSEK 5 mg coated tablets are white. They are available in cartons containing 28 tablets. TYPE OF MEDICINAL PRODUCT OLANSEK belongs to a group of medicines called antipsychotics. MARKETING AUTHORISATION HOLDER AND MANUFACTURER Eli Lilly UK Ltd, Kingsclere Road, Basingstoke, UK. OLANSEK is manufactured by: Eli Lilly and Company, Kingsclere Rd, Basingstoke UK WHAT IS OLANSEK USED FOR? OLANSEK is used to treat a disease with symptoms such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn. People with this disease may also feel depressed, anxious or tense. WHEN YOU SHOULD NOT TAKE OLANSEK You must not take OLANSEK if you have had an allergic reaction in the past to OLANSEK or any other ingredient listed under What is in OLANSEK. An allergic reaction may be recognised as a rash, itching, a swollen face, swollen lips or shortness of breath. If this has happened to you, tell your doctor. If you have been previously diagnosed with narrow-angle glaucoma, you should not take OLANSEK. PRECAUTIONS FOR USE Drugs of this type, may cause unusual movements mainly of the face or tongue. If this happens while you are taking OLANSEK talk to your doctor. 7

8 Very rarely, drugs of this type cause fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness. If this happens, stop taking the medicine and contact your doctor at once. If you suffer from any of the following illnesses tell your doctor before you take OLANSEK: Liver or kidney disease Parkinson s disease Epilepsy Prostate problems A blocked intestine (Paralytic ileus) Blood disorders As a routine precaution, if you are over 65 years your blood pressure may be monitored by your doctor. INTERACTIONS Always tell you doctor if you are taking any other medicine because taking some medicines together can be harmful. A combination of OLANSEK with the following medicines might make you feel drowsy: medicines taken for anxiety or to help you sleep (tranquillisers), antidepressants. Only take other medicines while you are on OLANSEK if your doctor tells you that you can. Also tell your doctor if you are taking medicines for Parkinson s disease before taking OLANSEK. Alcohol: You should not drink any alcohol when taking OLANSEK as OLANSEK and alcohol together may make you feel drowsy. WARNINGS Pregnancy and breast feeding: Tell your doctor if you are pregnant, think you may be pregnant or planning to become pregnant. You should not take this medicine when breast feeding. You should not take this medicine when pregnant unless you have discussed this with your doctor. Driving or using machinery: There is a risk of feeling drowsy when you take OLANSEK. If this happens do not drive or use machinery and tell your doctor. Patients who cannot take lactose should note that OLANSEK contains lactose. HOW TO TAKE OLANSEK Your doctor will tell you how many OLANSEK tablets to take and how long you should continue to take them. The daily dose of OLANSEK is between 5-20 mg. Always read the label on your medicine. You should take your OLANSEK tablets once a day following the advice of your doctor. Try to take your tablets at the same time each day. It does not matter whether you take them with or without food. You should swallow the OLANSEK tablets whole with a little water. Do not stop taking your tablets just because you feel better. It is important that you carry on taking OLANSEK for as long as your doctor tells you. 8

9 OLANSEK is not for patients who are under 18 years. Missed Doses (What to do if you forget to take your medicine) If you forget to take your medicine take your tablets as soon as you remember. Do not take two doses in one day. Overdosage: If you take more OLANSEK tablets than you were told to (or if someone else has taken your OLANSEK tablets) contact your doctor or hospital straight away. Show the doctor your pack of tablets. INFORMATION ON POSSIBLE ADVERSE EFFECTS Adverse effects with OLANSEK may include, sleepiness, putting on weight, dizziness, feeling more hungry, water retention, constipation, a dry mouth, restlessness, unusual movement, tremor and rigidity Some people may feel dizzy in the early stages of treatment, especially when getting up from a lying or sitting position. This will usually pass on its own but if it does not, tell your doctor. Rarely OLANSEK may cause you to become sensitive to sunlight. Some women taking drugs of this type for a long time have started to secrete milk and have missed periods or had irregular periods. If this persists tell your doctor. If OLANSEK affects you in any other way, tell your doctor or a pharmacist. EXPIRY DATE The expiry date of this medicine is printed on the label. Do not use the medicine after this date. STORAGE OLANSEK is light sensitive and should be stored in its original pack at room temperature, in a dry place and out of direct light. Please return left over medicine to your pharmacist. MEDICINES SHOULD BE KEPT OUT OF REACH OF CHILDREN DATE ON WHICH THE PACKAGE LEAFLET WAS LAST REVISED For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder. Belgique/België/Belgien: Eli Lilly Benelux S.A., Rue de l Etuve 52/1, Stoofstraat, Bruxelles 1000 Brussel. Tel: (02) Danmark: Eli Lilly Danmark A/S, Thoravej 4, 2400 København NV. Tlf: Deutschland: Lilly Deutschland GmbH, Niederlassung in Bad Homburg. Tel: Fax: Ελλάδα: ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε, 15 0 χλµ Εθνικής Οδού Αθηνών-Λαµίας, Τ.Κ Κηφισιά. Τηλ.: España: Lilly S.A., Avda. de la Industria 30, Polígono Industrial de Alcobendas, Alcobendas, Madrid. Tel: (91) France: Lilly France S.A., 203 Bureaux de la Colline, Saint-Cloud. Tel: (01) Ireland: Eli Lilly & Company (Ireland) Ltd, 44 Fitzwilliam Place, Dublin 2, Republic of Ireland. Tel:

10 Italia: Eli Lilly Italia SpA, Via Gramsci 731/733, Sesto Fiorentino (FI). Tel: (0) Luxembourg: Eli Lilly Benelux S.A., Rue de l Etuve 52/1, Stoofstraat, Bruxelles 1000 Brussel. Tel: (02) Nederland: Eli Lilly Nederland B.V., Krijtwal 17-23, 3432 ZT, Nieuwegein, Nederland. Tel: Österreich: Eli Lilly Ges. m.b.h., Barichgasse 40-42, A-1030 Wien. Tel: (1) Portugal: Lilly Farma Produtos Farmacêuticos, Lda, Rua Dr. António Loureiro Borges, 4- Piso 3, Arquiparque- Miraflores, 1495 Algés. Tel: (01) Suomi/Finland: Oy Eli Lilly Finland Ab, PL 16, Vantaa. Puh: (09) Box 16, Vanda. Tel: (09) Sverige: Eli Lilly Sweden AB, Box 30037, Stockholm. Tel: (08) United Kingdom: Eli Lilly & Company Ltd., Dextra Court, Chapel Hill, Basingstoke, Hampshire, RG21 5SY. Tel: (0)

11 NAME OF THE MEDICINAL PRODUCT OLANSEK 7.5 mg TABLETS (OLANZAPINE) GENERAL ADVICE Please read this information carefully before you start to take your medicine. This leaflet contains important information on OLANSEK. If you have any questions or if you are not sure about anything please ask your doctor or a pharmacist. Keep this leaflet until you have finished all your medicine as you may want to read it again. Remember this medicine is for the person named by the doctor. Never give it to anyone else. WHAT IS IN OLANSEK? Each OLANSEK tablet contains 7.5 mg of the active ingredient OLANZAPINE. OLANSEK tablets also contain the following inactive ingredients: lactose monohydrate, hydroxypropylcellulose, crospovidone, microcrystalline cellulose, magnesium stearate, methylhydroxypropylcellulose, titanium dioxide (E171), carnauba wax, macrogol, polysorbate 80 and indigo carmine colour (E132). DOSAGE FORM OLANSEK 7.5 mg coated tablets are white. They are available in cartons containing 56 tablets. TYPE OF MEDICINAL PRODUCT OLANSEK belongs to a group of medicines called antipsychotics. MARKETING AUTHORISATION HOLDER AND MANUFACTURER Eli Lilly UK Ltd, Kingsclere Road, Basingstoke, UK. OLANSEK is manufactured by: Eli Lilly and Company, Kingsclere Rd, Basingstoke UK WHAT IS OLANSEK USED FOR? OLANSEK is used to treat a disease with symptoms such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn. People with this disease may also feel depressed, anxious or tense. WHEN YOU SHOULD NOT TAKE OLANSEK You must not take OLANSEK if you have had an allergic reaction in the past to OLANSEK or any other ingredient listed under What is in OLANSEK. An allergic reaction may be recognised as a rash, itching, a swollen face, swollen lips or shortness of breath. If this has happened to you, tell your doctor. If you have been previously diagnosed with narrow-angle glaucoma, you should not take OLANSEK. PRECAUTIONS FOR USE Drugs of this type, may cause unusual movements mainly of the face or tongue. If this happens while you are taking OLANSEK talk to your doctor. 11

12 Very rarely, drugs of this type cause fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness. If this happens, stop taking the medicine and contact your doctor at once. If you suffer from any of the following illnesses tell your doctor before you take OLANSEK: Liver or kidney disease Parkinson s disease Epilepsy Prostate problems A blocked intestine (Paralytic ileus) Blood disorders As a routine precaution, if you are over 65 years your blood pressure may be monitored by your doctor. INTERACTIONS Always tell you doctor if you are taking any other medicine because taking some medicines together can be harmful. A combination of OLANSEK with the following medicines might make you feel drowsy: medicines taken for anxiety or to help you sleep (tranquillisers), antidepressants. Only take other medicines while you are on OLANSEK if your doctor tells you that you can. Also tell your doctor if you are taking medicines for Parkinson s disease before taking OLANSEK. Alcohol: You should not drink any alcohol when taking OLANSEK as OLANSEK and alcohol together may make you feel drowsy. WARNINGS Pregnancy and breast feeding: Tell your doctor if you are pregnant, think you may be pregnant or planning to become pregnant. You should not take this medicine when breast feeding. You should not take this medicine when pregnant unless you have discussed this with your doctor. Driving or using machinery: There is a risk of feeling drowsy when you take OLANSEK. If this happens do not drive or use machinery and tell your doctor. Patients who cannot take lactose should note that OLANSEK contains lactose. HOW TO TAKE OLANSEK Your doctor will tell you how many OLANSEK tablets to take and how long you should continue to take them. The daily dose of OLANSEK is between 5-20 mg. Always read the label on your medicine. You should take your OLANSEK tablets once a day following the advice of your doctor. Try to take your tablets at the same time each day. It does not matter whether you take them with or without food. You should swallow the OLANSEK tablets whole with a little water. Do not stop taking your tablets just because you feel better. It is important that you carry on taking OLANSEK for as long as your doctor tells you. 12

13 OLANSEK is not for patients who are under 18 years. Missed Doses (What to do if you forget to take your medicine) If you forget to take your medicine take your tablets as soon as you remember. Do not take two doses in one day. Overdosage: If you take more OLANSEK tablets than you were told to (or if someone else has taken your OLANSEK tablets) contact your doctor or hospital straight away. Show the doctor your pack of tablets. INFORMATION ON POSSIBLE ADVERSE EFFECTS Adverse effects with OLANSEK may include, sleepiness, putting on weight, dizziness, feeling more hungry, water retention, constipation, a dry mouth, restlessness, unusual movement, tremor and rigidity Some people may feel dizzy in the early stages of treatment, especially when getting up from a lying or sitting position. This will usually pass on its own but if it does not, tell your doctor. Rarely OLANSEK may cause you to become sensitive to sunlight. Some women taking drugs of this type for a long time have started to secrete milk and have missed periods or had irregular periods. If this persists tell your doctor. If OLANSEK affects you in any other way, tell your doctor or a pharmacist. EXPIRY DATE The expiry date of this medicine is printed on the label. Do not use the medicine after this date. STORAGE OLANSEK is light sensitive and should be stored in its original pack at room temperature, in a dry place and out of direct light. Please return left over medicine to your pharmacist. MEDICINES SHOULD BE KEPT OUT OF REACH OF CHILDREN DATE ON WHICH THE PACKAGE LEAFLET WAS LAST REVISED For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder. Belgique/België/Belgien: Eli Lilly Benelux S.A., Rue de l Etuve 52/1, Stoofstraat, Bruxelles 1000 Brussel. Tel: (02) Danmark: Eli Lilly Danmark A/S, Thoravej 4, 2400 København NV. Tlf: Deutschland: Lilly Deutschland GmbH, Niederlassung in Bad Homburg. Tel: Fax: Ελλάδα: ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε, 15 0 χλµ Εθνικής Οδού Αθηνών-Λαµίας, Τ.Κ Κηφισιά. Τηλ.: España: Lilly S.A., Avda. de la Industria 30, Polígono Industrial de Alcobendas, Alcobendas, Madrid. Tel: (91) France: Lilly France S.A., 203 Bureaux de la Colline, Saint-Cloud. Tel: (01)

14 Ireland: Eli Lilly & Company (Ireland) Ltd, 44 Fitzwilliam Place, Dublin 2, Republic of Ireland. Tel: Italia: Eli Lilly Italia SpA, Via Gramsci 731/733, Sesto Fiorentino (FI). Tel: (0) Luxembourg: Eli Lilly Benelux S.A., Rue de l Etuve 52/1, Stoofstraat, Bruxelles 1000 Brussel. Tel: (02) Nederland: Eli Lilly Nederland B.V., Krijtwal 17-23, 3432 ZT, Nieuwegein, Nederland. Tel: Österreich: Eli Lilly Ges. m.b.h., Barichgasse 40-42, A-1030 Wien. Tel: (1) Portugal: Lilly Farma Produtos Farmacêuticos, Lda, Rua Dr. António Loureiro Borges, 4- Piso 3, Arquiparque- Miraflores, 1495 Algés. Tel: (01) Suomi/Finland: Oy Eli Lilly Finland Ab, PL 16, Vantaa. Puh: (09) Box 16, Vanda. Tel: (09) Sverige: Eli Lilly Sweden AB, Box 30037, Stockholm. Tel: (08) United Kingdom: Eli Lilly & Company Ltd., Dextra Court, Chapel Hill, Basingstoke, Hampshire, RG21 5SY. Tel: (0)

15 NAME OF THE MEDICINAL PRODUCT OLANSEK 10 mg TABLETS (OLANZAPINE) GENERAL ADVICE Please read this information carefully before you start to take your medicine. This leaflet contains important information on OLANSEK. If you have any questions or if you are not sure about anything please ask your doctor or a pharmacist. Keep this leaflet until you have finished all your medicine as you may want to read it again. Remember this medicine is for the person named by the doctor. Never give it to anyone else. WHAT IS IN OLANSEK? Each OLANSEK tablet contains 10 mg of the active ingredient OLANZAPINE. OLANSEK tablets also contain the following inactive ingredients: lactose monohydrate, hydroxypropylcellulose, crospovidone, microcrystalline cellulose, magnesium stearate, methylhydroxypropylcellulose, titanium dioxide (E171), carnauba wax, macrogol, polysorbate 80 and indigo carmine colour (E132). DOSAGE FORM OLANSEK 10 mg coated tablets are white. They are available in cartons containing 7, 28 or 56 tablets. TYPE OF MEDICINAL PRODUCT OLANSEK belongs to a group of medicines called antipsychotics. MARKETING AUTHORISATION HOLDER AND MANUFACTURER Eli Lilly UK Ltd, Kingsclere Road, Basingstoke, UK. OLANSEK is manufactured by: Eli Lilly and Company, Kingsclere Rd, Basingstoke UK WHAT IS OLANSEK USED FOR? OLANSEK is used to treat a disease with symptoms such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn. People with this disease may also feel depressed, anxious or tense. WHEN YOU SHOULD NOT TAKE OLANSEK You must not take OLANSEK if you have had an allergic reaction in the past to OLANSEK or any other ingredient listed under What is in OLANSEK. An allergic reaction may be recognised as a rash, itching, a swollen face, swollen lips or shortness of breath. If this has happened to you, tell your doctor. If you have been previously diagnosed with narrow-angle glaucoma, you should not take OLANSEK. PRECAUTIONS FOR USE Drugs of this type, may cause unusual movements mainly of the face or tongue. If this happens while you are taking OLANSEK talk to your doctor. 15

16 Very rarely, drugs of this type cause fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness. If this happens, stop taking the medicine and contact your doctor at once. If you suffer from any of the following illnesses tell your doctor before you take OLANSEK: Liver or kidney disease Parkinson s disease Epilepsy Prostate problems A blocked intestine (Paralytic ileus) Blood disorders As a routine precaution, if you are over 65 years your blood pressure may be monitored by your doctor. INTERACTIONS Always tell you doctor if you are taking any other medicine because taking some medicines together can be harmful. A combination of OLANSEK with the following medicines might make you feel drowsy: medicines taken for anxiety or to help you sleep (tranquillisers), antidepressants. Only take other medicines while you are on OLANSEK if your doctor tells you that you can. Also tell your doctor if you are taking medicines for Parkinson s disease before taking OLANSEK. Alcohol: You should not drink any alcohol when taking OLANSEK as OLANSEK and alcohol together may make you feel drowsy. WARNINGS Pregnancy and breast feeding: Tell your doctor if you are pregnant, think you may be pregnant or planning to become pregnant. You should not take this medicine when breast feeding. You should not take this medicine when pregnant unless you have discussed this with your doctor. Driving or using machinery: There is a risk of feeling drowsy when you take OLANSEK. If this happens do not drive or use machinery and tell your doctor. Patients who cannot take lactose should note that OLANSEK contains lactose. HOW TO TAKE OLANSEK Your doctor will tell you how many OLANSEK tablets to take and how long you should continue to take them. The daily dose of OLANSEK is between 5-20 mg. Always read the label on your medicine. You should take your OLANSEK tablets once a day following the advice of your doctor. Try to take your tablets at the same time each day. It does not matter whether you take them with or without food. You should swallow the OLANSEK tablets whole with a little water. Do not stop taking your tablets just because you feel better. It is important that you carry on taking OLANSEK for as long as your doctor tells you. 16

17 OLANSEK is not for patients who are under 18 years Missed Doses (What to do if you forget to take your medicine) If you forget to take your medicine take your tablets as soon as you remember. Do not take two doses in one day. Overdosage: If you take more OLANSEK tablets than you were told to (or if someone else has taken your OLANSEK tablets) contact your doctor or hospital straight away. Show the doctor your pack of tablets. INFORMATION ON POSSIBLE ADVERSE EFFECTS Adverse effects with OLANSEK may include, sleepiness, putting on weight, dizziness, feeling more hungry, water retention, constipation, a dry mouth, restlessness, unusual movement, tremor and rigidity Some people may feel dizzy in the early stages of treatment, especially when getting up from a lying or sitting position. This will usually pass on its own but if it does not, tell your doctor. Rarely OLANSEK may cause you to become sensitive to sunlight. Some women taking drugs of this type for a long time have started to secrete milk and have missed periods or had irregular periods. If this persists tell your doctor. If OLANSEK affects you in any other way, tell your doctor or a pharmacist. EXPIRY DATE The expiry date of this medicine is printed on the label. Do not use the medicine after this date. STORAGE OLANSEK is light sensitive and should be stored in its original pack at room temperature, in a dry place and out of direct light. Please return left over medicine to your pharmacist. MEDICINES SHOULD BE KEPT OUT OF REACH OF CHILDREN DATE ON WHICH THE PACKAGE LEAFLET WAS LAST REVISED For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder. Belgique/België/Belgien: Eli Lilly Benelux S.A., Rue de l Etuve 52/1, Stoofstraat, Bruxelles 1000 Brussel. Tel: (02) Danmark: Eli Lilly Danmark A/S, Thoravej 4, 2400 København NV. Tlf: Deutschland: Lilly Deutschland GmbH, Niederlassung in Bad Homburg. Tel: Fax: Ελλάδα: ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε, 15 0 χλµ Εθνικής Οδού Αθηνών-Λαµίας, Τ.Κ Κηφισιά. Τηλ.: España: Lilly S.A., Avda. de la Industria 30, Polígono Industrial de Alcobendas, Alcobendas, Madrid. Tel: (91) France: Lilly France S.A., 203 Bureaux de la Colline, Saint-Cloud. Tel: (01) Ireland: Eli Lilly & Company (Ireland) Ltd, 44 Fitzwilliam Place, Dublin 2, Republic of Ireland. Tel: (0)

18 Italia: Eli Lilly Italia SpA, Via Gramsci 731/733, Sesto Fiorentino (FI). Tel: (0) Luxembourg: Eli Lilly Benelux S.A., Rue de l Etuve 52/1, Stoofstraat, Bruxelles 1000 Brussel. Tel: (02) Nederland: Eli Lilly Nederland B.V., Krijtwal 17-23, 3432 ZT, Nieuwegein, Nederland. Tel: Österreich: Eli Lilly Ges. m.b.h., Barichgasse 40-42, A-1030 Wien. Tel: (1) Portugal: Lilly Farma Produtos Farmacêuticos, Lda, Rua Dr. António Loureiro Borges, 4- Piso 3, Arquiparque- Miraflores, 1495 Algés. Tel: (01) Suomi/Finland: Oy Eli Lilly Finland Ab, PL 16, Vantaa. Puh: (09) Box 16, Vanda. Tel: (09) Sverige: Eli Lilly Sweden AB, Box 30037, Stockholm. Tel: (08) United Kingdom: Eli Lilly & Company Ltd., Dextra Court, Chapel Hill, Basingstoke, Hampshire, RG21 5SY. Tel: (0)