Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Quetiapine fumarate
Zentiva Pharma UK Ltd
N05AH04
Quetiapine fumarate
300mg
Modified-release tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04020100; GTIN: 5000283658290
PACKAGE LEAFLET: INFORMATION FOR THE USER BRANCICO XL 200 MG, 300 MG OR 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 Brancico XL is and what it is used for 2. What you need to know before you take Brancico XL 3. How to take Brancico XL 4. Possible side effects 5. How to store Brancico XL 6. Contents of the pack and other information 1. WHAT BRANCICO XL IS AND WHAT IT IS USED FOR Brancico XL contains a substance called quetiapine. This belongs to a group of medicines called antipsychotics. Brancico 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 Brancico 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 Brancico XL even when you feel better. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BRANCICO XL DO NOT TAKE BRANCICO XL • If you are allergic to quetiap Read the complete document
OBJECT 1 BRANCICO XL 300 MG PROLONGED-RELEASE TABLETS Summary of Product Characteristics Updated 28-Sep-2016 | Zentiva 1. Name of the medicinal product Brancico XL 300 mg prolonged-release tablets 2. Qualitative and quantitative composition Brancico XL 300 mg contains 300 mg quetiapine (as quetiapine fumarate) Excipient with known effect: 85 mg lactose (anhydrous) per tablet For the full list of excipients, see section 6.1. 3. Pharmaceutical form Prolonged-release tablet 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. 4. Clinical particulars 4.1 Therapeutic indications Brancico XL is indicated for: • treatment of schizophrenia. • treatment of bipolar disorder: - For the treatment of moderate to severe manic episodes in bipolar disorder - For the treatment of major depressive episodes in bipolar disorder - For the prevention of recurrence of manic or depressed episodes in patients with bipolar disorder who previously responded to quetiapine treatment. • add-on treatment of major depressive episodes in patients with major depressive disorder (MDD) who have had sub-optimal response to antidepressant monotherapy (see section 5.1). Prior to initiating treatment, clinicians should consider the safety profile of quetiapine (see section 4.4). 4.2 Posology and method of administration Posology Different dosing schedules exist for each indication. It must therefore be ensured that patients receive clear information on the appropriate dosage for their condition. Adults _For the treatment of schizophrenia and moderate to severe manic episodes in bipolar disorder_ Brancico XL should be administered at least one hour before a meal. The daily dose at the start of therapy is 300 mg on Day 1 and 600 mg on Day 2. The recommended daily dose is 600 mg, however if clinically justified the dose may be increased to 800 mg daily. The dose should be adjusted within the effective dose range of 400 mg to 800 mg per day, depending on t Read the complete document