البلد: مالطا
اللغة: الإنجليزية
المصدر: Medicines Authority
Viatris Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
N05AH04
QUETIAPINE FUMARATE 25 mg
FILM-COATED TABLET
QUETIAPINE FUMARATE 25 mg
POM
PSYCHOLEPTICS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2022-04-27
Page 1 of 10 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Quetiapine/VIATRIS 25 mg film-coated tablets Quetiapine/VIATRIS 100 mg film-coated tablets Quetiapine/VIATRIS 200 mg film-coated tablets Quetiapine/VIATRIS 300 mg film-coated tablets quetiapine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Quetiapine/VIATRIS is and what it is used for 2. What you need to know before you take Quetiapine/VIATRIS 3. How to take Quetiapine/VIATRIS 4. Possible side effects 5. How to store Quetiapine/VIATRIS 6. Contents of the pack and other information. 1. WHAT QUETIAPINE/VIATRIS IS AND WHAT IT IS USED FOR Quetiapine/VIATRIS contains a substance called quetiapine. This belongs to a group of medicines called anti-psychotics. Quetiapine can be used to treat several illnesses, such as: • Bipolar depression: where you feel sad. You may find that you feel depressed, feel guilty, lack energy, lose your appetite or can’t sleep. • Mania: where you may feel very excited, elated, agitated, enthusiastic or hyperactive or have poor judgment including being aggressive or disruptive. • Schizophrenia: where you may hear or feel things that are not there, believe things that are not true or feel unusually suspicious, anxious, confused, guilty, tense or depressed. Your doctor may continue to prescribe Quetiapine/VIATRIS even when you are feeling better. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE QUETIAPINE/VIATRIS DO NOT TAKE QUETIAPINE/VIATRIS: • if you are allergic to quetiapine or any of the other ingredients of t اقرأ الوثيقة كاملة
Page 1 of 25 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 25 1. NAME OF THE MEDICINAL PRODUCT Quetiapine/VIATRIS 25 mg film-coated tablets Quetiapine/VIATRIS 100 mg film-coated tablets Quetiapine/VIATRIS 200 mg film-coated tablets Quetiapine/VIATRIS 300 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Quetiapine/VIATRIS 25 mg _ Each tablet contains 25 mg of quetiapine as quetiapine fumarate _Quetiapine/VIATRIS 100 mg _ Each tablet contains 100 mg of quetiapine as quetiapine fumarate _Quetiapine/VIATRIS 200 mg _ Each tablet contains 200 mg of quetiapine as quetiapine fumarate _Quetiapine/VIATRIS 300 mg _ Each tablet contains 300mg of quetiapine as quetiapine fumarate Excipient with known effect Quetiapine/VIATRIS 25 mg: Each tablet contains 4.50 mg of lactose (as lactose monohydrate) and approximately 0.22 mg of sodium Quetiapine/VIATRIS 100 mg: Each tablet contains 18.00 mg of lactose (as lactose monohydrate) and approximately 0.87 mg of sodium Quetiapine/VIATRIS 200 mg: Each tablet contains of lactose 36.00 mg (as lactose monohydrate) and approximately 1.74 mg of sodium Quetiapine/VIATRIS 300 mg: Each tablet contains 54.00 mg of lactose (as lactose monohydrate) and approximately 2.61 mg of sodium For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. _Quetiapine/VIATRIS 25 mg film-coated tablets _ Peach coloured, round, biconvex, film-coated tablet engraved ‘Q’ on one side. _Quetiapine/VIATRIS 100 mg film-coated tablets _ Yellow, round, biconvex, film-coated tablet engraved ‘Q’ over ‘100’ on one side. _Quetiapine/VIATRIS 200 mg film-coated tablets _ White, round, biconvex, film-coated tablet engraved ‘Q’ over ‘200’ on one side. _Quetiapine/VIATRIS 300 mg film-coated tablets _ White, capsule shaped, biconvex, film-coated tablet engraved ‘Q’ breakline ‘300’ on one side. The tablet can be divided into equal doses. Page 3 of 25 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Quetiapine/VIATRIS is indicated for: • Treatment of اقرأ الوثيقة كاملة