Kraj: Wielka Brytania
Język: angielski
Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)
Quetiapine fumarate
Aristo Pharma Ltd
N05AH04
Quetiapine fumarate
200mg
Modified-release tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04020100; GTIN: 5060430040026
PACKAGE LEAFLET: INFORMATION FOR THE USER MINTRELEQ XL 50 MG, 150 MG, 200 MG, 300 MG, 400 MG PROLONGED-RELEASE 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 Mintreleq XL is and what it is used for 2. What you need to know before you take Mintreleq XL 3. How to take Mintreleq XL 4. Possible side effects 5. How to store Mintreleq XL 6. Contents of the pack and other information 1. WHAT MINTRELEQ XL IS AND WHAT IT IS USED FOR Mintreleq XL contains a substance called quetiapine. This belongs to a group of medicines called antipsychotics. Mintreleq XL can be used to treat several illnesses, such as: Bipolar depression and major depressive episodes in major depressive disorder: 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. When Mintreleq XL is being taken to treat major depressive episodes in major depressive disorder, it will be taken in addition to another medicine being used to treat this illness. Your doctor may continue to prescribe Mintreleq XL even when you feel better. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MINTRELEQ XL DO NOT TAKE MINTRELEQ XL If you are allergic to quetiapine or Przeczytaj cały dokument
OBJECT 1 MINTRELEQ XL 50 MG PROLONGED-RELEASE TABLETS Summary of Product Characteristics Updated 09-May-2017 | Aristo Pharma Limited 1. Name of the medicinal product Mintreleq XL 50 mg prolonged-release tablets Mintreleq XL 150 mg prolonged-release tablets Mintreleq XL 200 mg prolonged-release tablets Mintreleq XL 300 mg prolonged-release tablets Mintreleq XL 400 mg prolonged-release tablets 2. Qualitative and quantitative composition Mintreleq XL 50 mg contains 50 mg quetiapine (as quetiapine fumarate) Excipient with known effect: 14 mg lactose (anhydrous) per tablet Mintreleq XL 150 mg contains 150 mg quetiapine (as quetiapine fumarate) Excipient with known effect: 42 mg lactose (anhydrous) per tablet Mintreleq XL 200 mg contains 200 mg quetiapine (as quetiapine fumarate) Excipient with known effect: 56 mg lactose (anhydrous) per tablet Mintreleq XL 300 mg contains 300 mg quetiapine (as quetiapine fumarate) Excipient with known effect: 85 mg lactose (anhydrous) per tablet Mintreleq XL 400 mg contains 400 mg quetiapine (as quetiapine fumarate) Excipient with known effect: 113 mg lactose (anhydrous) per tablet For the full list of excipients, see section 6.1. 3. Pharmaceutical form Prolonged-release tablet Mintreleq XL 50 mg: a white to off white, round biconvex tablet, 7.1 mm in diameter and 3.2 mm in thickness, engraved with “50” on one side. Mintreleq XL 150 mg: a white to off white, oblong biconvex tablet, 13.6 mm in length, 6.6 mm in width and 4.2 mm in thickness, engraved with “150” on one side. Mintreleq XL 200 mg: a white to off white, oblong biconvex tablet, 15.2 mm in length, 7.7 mm in width and 4.8 mm in thickness, engraved with “200” on one side. Mintreleq XL 300 mg: a white to off white, oblong biconvex tablet, 18.2 mm in length, 8.2 mm in width and 5.4 mm in thickness, engraved with “300” on one side. Mintreleq XL 400 mg: a white to off white, oval biconvex tablet, 20.7 mm in length, 10.2 mm in width and 6.3 mm in thickness, engraved with “400” on one side. 4. Clinical particular Przeczytaj cały dokument