Land: Bretland
Tungumál: enska
Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)
Indometacin
Kent Pharma (UK) Ltd
M01AB01
Indometacin
50mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100
296x210 Leaflet Reel Fed Bi Fold Profile (BST) Dimensions: Component: Date Sent: Technologist: TECHNICALLY APPROVED Pharmacode: JDE No.: Indometacin Hard Capsules 25, 50mg x 28’s (UK) 296x210 (Reel Fed) 50967738 Leaflet for Blisters 4453 T. Hull 01/05/19 * 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. approved for print/date PROOF ROUND UK-Eire-Artwork-Support@accord-healthcare.com Technical Approval NON PRINTING COLOURS COLOURS DATE SENT: DATE RECEIVED: Item number: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: 1. 2. 3. 4. 5. 6. 1. 2. 3. FMD info NA (not a carton) No Yes Details INDOMETACINE 25MG & 50MG 28 TABS PIL - UK Black Profile BBBA4736 RH 09-05-19 11-11-19 RH 296x210 10pt Accord Barnstaple NA NA 05 Version 2 01.11.2017 page 4 page 1 50967738 BBBA4736 page 4 page 1 INDOMETACIN 25MG AND 50MG CAPSULES 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 INDOMETACIN CAPSULES ARE AND WHAT THEY ARE USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE INDOMETACIN CAPSULES 3 HOW TO TAKE INDOMETACIN CAPSULES 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE INDOMETACIN CAPSULES 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT INDOMETACIN CAPSULES ARE AND WHAT THEY ARE USED FOR Indometacin capsules belong to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These medicines ar Lestu allt skjalið
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Indometacin capsules 50mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 50 mg Indometacin Ph. Eur. Excipient with known effect: Also contains lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Indometacin has non-steroidal analgesic and anti-inflammatory properties. It is indicated for the following conditions: • active stages of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, degenerative joint disease of the hip, acute musculoskeletal disorders, gout and lumbago. • inflammation, pain and oedema following orthopaedic procedures. • treatment of pain and associated symptoms of primary dysmenorrhoea. Since indometacin is not a simple analgesic, its use should be limited to the above conditions. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: The dosage should be carefully adjusted according to the needs of the individual patient. To reduce the possibility of gastro-intestinal disturbance, indometacin capsules should always be taken with food, milk or an antacid and in chronic conditions start the therapy with a low dosage, increasing as required. ADULTS: The recommended oral dosage range is 50-200mg daily. Acute rheumatoid arthritis: Initially 25 mg two or three times a day. Chronic rheumatic disorders: 25 mg two or three times daily.(If response is inadequate, gradually increase by 25 mg. Adequate response is usually achieved with not more than 150 mg daily, rarely more than 200mg daily). _Sudden flare up of chronic condition:_ Increase if necessary, by 25 mg daily until a satisfactory response is obtained, or a dosage of 150-200 mg daily is reached. (If this causes any adverse effects, it should be reduced to a tolerable level for two or three days, then carefully increased, as tolerated). Acute musculoskeletal disorders: Initially 50 mg two or three times daily, according to severity for 10-14 days. Normally 150mg da Lestu allt skjalið