Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Diclofenac potassium
Accord-UK Ltd
M01AB05
Diclofenac potassium
50mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100; GTIN: 5012617016201
approved for print/date PROOF ROUND Technical Approval DATE SENT: DATE RECEIVED: Item number: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: NON PRINTING COLOURS COLOURS 1. 2. 3. 4. 5. 6. 1. 2. 3. EU-Artwork-Support@accord-healthcare.com R.Paul 07.09.2022 04.10.2022 R.Paul 170 x 320 8pts Specifar S.A. 07.09.2022 DICLOFENAC POTASSIUM 25MG & 50MG 28 (4X7) TABLETS PIL FOR BLISTERS - UK Black Profile BBBB5584 2 * Please note that ONLY Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. Version 7 12.02.2020 Cartons and label leaflets only (labels only when specified) German GTIN 14 (incorporating PZN): BBBB5584 _Continued top of next column_ DICLOFENAC POTASSIUM 25MG & 50MG TABLETS PACKAGE LEAFLET: INFORMATION FOR THE PATIENT • 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. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. _Continued over page_ WHAT IS IN THIS LEAFLET: 1. WHAT DICLOFENAC POTASSIUM TABLETS ARE AND WHAT THEY ARE USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DICLOFENAC POTASSIUM TABLETS 3. HOW TO TAKE DICLOFENAC POTASSIUM TABLETS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE DICLOFENAC POTASSIUM TABLETS 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT DICLOFENAC POTASSIUM TABLETS ARE AND WHAT THEY ARE USED FOR Diclofenac potassium belongs to a group of medicines called non- steroidal anti-inflammatory drugs (NSAIDs), which are used to reduce pain and inflammation in the following conditions: Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diclofenac Potassium 50 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg of diclofenac potassium Also contains: Lecithin Soya E322. 0.150 mmol (5.85mg) potassium per 50mg tablet. 0.73mg sodium per 50mg tablet. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablets Reddish brown, circular, coated, biconvex tablets, diameter 9 mm 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rheumatoid arthritis Osteoarthrosis Low back pain Migraine attacks Acute musculo-skeletal disorders and trauma such as periarthritis (especially frozen shoulder), tendinitis, tenosynovitis, bursitis, sprains, strains and dislocations; relief of pain in fractures Ankylosing spondylitis Acute gout Control of pain and inflammation in orthopaedic, dental and other minor surgery Pyrophosphate arthropathy and associated disorders 4.2 POSOLOGY AND METHOD OF ADMINISTRATION UNDESIRABLE EFFECTS MAY BE MINIMISED BY USING THE LOWEST EFFECTIVE DOSE FOR THE SHORTEST DURATION NECESSARY TO CONTROL SYMPTOMS (SEE SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). For oral administration It is recommended that the tablets be taken with fluid, preferably with or after food. ADULTS The recommended daily dose is 100-150mg in two or three divided doses. For milder cases, 75-100mg daily in two or three divided doses is usually sufficient. In migraine an initial dose of 50mg should be taken at the first signs of an impending attack. In cases where relief 2 hours after the first dose is not sufficient, a further dose of 50mg may be taken. If needed, further doses of 50mg may be taken at intervals of 4-6 hours, not exceeding a total dose of 200mg per day. SPECIAL POPULATIONS PAEDIATRIC POPULATION For children over 14 years of age, the recommended daily dose is 75-100mg in two or three divided doses. Diclofenac Potassium Tablets are not recommended for children under 14 years of age. The use of Diclofenac Potassium table Read the complete document