Land: Bretland
Tungumál: enska
Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)
Lithium citrate
Rosemont Pharmaceuticals Ltd
N05AN01
Lithium citrate
101.8mg/1ml
Oral solution
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04020300; GTIN: 5016119058899
Li-Liquid™ 509mg/5ml Oral Syrup (Lithium Citrate) JOB INFORMATION COLOURS Product Name: Print Colours: 8pt (horizontally condensed to 90%) Font Size: 1 ARTWORK VERSION: Pharmacode: N/A 379 1 EAN Code: No. of Colours: THIRD PARTY APPROVAL REQUIRED Name: Signature: Date: YES TICK APPLICABLE BOX Tabbed: Keyline Ref: 210 x 300mm UKL412 150 x 30mm No Dimensions: Folded Size: H2YD1RBJ2 New Item Code: H2YD1RBJ1 Previous Item Code: N/A Supplier Code: 150ml Pack Size: 150ml Bottle Size: 509mg/5ml Strength: N/A 1 of 2 Design Icon: Page Number: Univers Roman UNIVERS BOLD Font Type: JOB SPECIFICATION MAIN BODY TEXT Non-print Colours: BLACK 7474 265 BLACK 877 PANTONE 485 PANTONE KEYLINE BRAILLE BRAILLE SUBSTRATE APPROVALS 100 90 80 70 60 50 40 30 20 10 0 18/10/17 Date: DH Operator: - PREFLIGHT VERSION: - Date: - Operator: NO AUTHORITY APPROVAL SUPPLIED YES TICK APPLICABLE BOX N/A REGULATORY SIGN-OFF Name: Signature: Date: 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 Li-Liquid is and what it is used for 4. Possible side effects 2. What you need to know before you take Li-Liquid 5. How to store Li-Liquid 3. How to take Li-Liquid 6. Contents of the pack and other information 1. WHAT LI-LIQUID IS AND WHAT IT IS USED FOR The name of your medicine is Li-Liquid 509mg/5ml Oral Syrup (referred to as Li-Liquid in this leaflet). It contains lithium citrate. This belongs to a group of medicines called ‘anti-manics’. Lithium acts on the brain to calm your moods and emotions. Lithium can be used to: ■ t Lestu allt skjalið
OBJECT 1 LI-LIQUID 509 MG/5ML ORAL SYRUP Summary of Product Characteristics Updated 23-Jan-2018 | Rosemont Pharmaceuticals Limited 1. Name of the medicinal product Li-Liquid 509mg/5ml Oral Syrup 2. Qualitative and quantitative composition Lithium Citrate Tetrahydrate 509mg/5ml equivalent to Lithium Ion 5.4mmol equivalent to Lithium Carbonate 200mg For the full list of excipients, see section 6.1 3. Pharmaceutical form Solution for oral administration 4. Clinical particulars 4.1 Therapeutic indications • Treatment of mania and hypomania • Treatment of recurrent bipolar depression, where the use of alternative anti-depressants has been ineffective • Prophylactic treatment of recurrent affective disorders • Control of aggressive or self mutilating behaviour Treatment should be directed to stabilise manic depressive illness rather than to establish early control of acute episodes. 4.2 Posology and method of administration Dosage must be individualised depending on serum lithium levels and clinical response. The dosage necessary to maintain serum lithium levels within the therapeutic range varies from patient to patient. The minimum effective dose should be sought and maintained. For oral administration only. A simple treatment schedule has been evolved which except for some minor variations should be followed whether using Li-Liquid therapeutically or prophylactically. The minor variations to this schedule depend on the elements of the illness being treated and these are described later. ADULTS: 1. In patients of average weight (70 kg) an initial total daily dose of 1018 – 3054mg Lithium citrate (equivalent to 400 - 1200mg Lithium carbonate which is 10-30ml of liquid) should be given in divided doses, in the morning and in the evening. When changing between lithium preparations, serum lithium levels should first be checked, then Li-liquid therapy commenced at a daily dose as close as possible to that of the other form of lithium. As bioavailability varies from product to product (particularly with regard to Lestu allt skjalið