Страна: Велика Британія
мова: англійська
Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)
Quetiapine fumarate
Fontus Health Ltd
N05AH04
Quetiapine fumarate
300mg
Modified-release tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04020100; GTIN: 5060421930060
PACKAGE LEAFLET: INFORMATION FOR THE USER ZALURON 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 Zaluron XL is and what it is used for 2. What you need to know before you take Zaluron XL 3. How to take Zaluron XL 4. Possible side effects 5. How to store Zaluron XL 6. Contents of the pack and other information 1. WHAT ZALURON XL IS AND WHAT IT IS USED FOR Zaluron XL contains a substance called quetiapine. This belongs to a group of medicines called anti-psychotics. Zaluron 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 Zaluron 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 Zaluron XL even when you are feeling better. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZALURON XL DO NOT TAKE ZALURON XL If you are allergic to Прочитайте повний документ
OBJECT 1 ZALURON XL 300MG PROLONGED-RELEASE TABLETS Summary of Product Characteristics Updated 30-Dec-2016 | Fontus Health Ltd 1. Name of the medicinal product Zaluron XL 300 mg prolonged-release tablets 2. Qualitative and quantitative composition Zaluron 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 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 Zaluron 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 suboptimal 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 Zaluron 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 Прочитайте повний документ