מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)
Digoxin
Accord-UK Ltd
C01AA05
Digoxin
250microgram
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02010100; GTIN: 5012617004536
Actavis BST - Packing Technical BSTCutterGuideReq@actavis.com Dimensions: Component: Date Sent: Technologist: TECHNICALLY APPROVED Pharmacode: JDE No.: Digoxin Tablets All Strengths x 28’s (UK) 148x210 (Reel Fed) 50926696 Leaflet for Blisters 7391 R.Wrey 24/02/17 148x210 Leaflet Reel Fed Profile (BST) * 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@Actavis.com Technical Approval NON PRINTING COLOURS COLOURS DATE SENT: DATE RECEIVED: Item no: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: 1. 2. 3. 4. 5. 6. 1. 2. 3. DIGOXIN 62.5MICROGRAMS 125MICROGRAMS AND 250MICROGRAMS TABLETS PIL UK Black Profile BBBA0584 C.Grant 06/03/17 148x210 7pt Actavis UK N/A 01 DIGOXIN 62.5MICROGRAMS, 125MICROGRAMS AND 250MICROGRAMS TABLETS IN THIS LEAFLET: 1. WHAT DIGOXIN TABLETS ARE AND WHAT THEY ARE USED FOR 2. BEFORE YOU TAKE DIGOXIN TABLETS 3. HOW TO TAKE DIGOXIN TABLETS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE DIGOXIN TABLETS 6. FURTHER INFORMATION 1. WHAT DIGOXIN TABLETS ARE AND WHAT THEY ARE USED FOR Digoxin belongs to a group of medicines called cardiac glycosides, these slow down the rate of the heart but increase the force with which the heart muscle contracts, making the heart work more efficiently. Digoxin tablets are used to treat: • heart failure. • irregular heart beats or heart rhythm. 2. BEFORE YOU TAKE DIGOXIN TABLETS DO NOT TAKE Digoxin tablets if you: • are ALLERGIC (hypersensitive) to Digoxin tablets, other related medicines such as digitoxin, or any of the ingredients in the tablet (see section 6). An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue. If this is the first time your doctor has prescribed this medicine for you, tell them if you have taken any cardiac glycoside (such as digoxin, di קרא את המסמך השלם
OBJECT 1 DIGOXIN TABLETS BP 250 MICROGRAMS Summary of Product Characteristics Updated 09-Jan-2013 | Accord-UK Ltd 1. Name of the medicinal product DIGOXIN TABLETS BP 250 micrograms 2. Qualitative and quantitative composition Each tablet contains 250 micrograms Digoxin PhEur. 3. Pharmaceutical form White uncoated tablets. White, circular, biconvex, uncoated tablets impressed C on one face and the identifying letters DG on the reverse. 4. Clinical particulars 4.1 Therapeutic indications • Digoxin is indicated for the treatment of congestive cardiac failure. • Digoxin may be used for certain supraventricular dysrhythmias, particularly atrial fibrillation. 4.2 Posology and method of administration The following schedules are intended as an initial guide but each patient has to be tailored individually according to age, lean body weight and renal function for his/her needs: _Adults and children over 10 years:_ Rapid oral loading: 750-1500micrograms (0.75mg-1.5mg) as a single dose. If a greater risk or less urgency eg the elderly, the oral loading dose should be given in divided doses 6 hours apart, assessing clinical response, before giving each additional dose. Slow oral loading: 250-750micrograms (0.25mg-0.75mg) should be given daily for 1 week, followed by appropriate maintenance dose. A clinical response should be seen within one week. NB The clinical state of the patient and the urgency of the condition will depend on the choice between slow or rapid oral loading The maintenance dosage should be based upon the percentage of the peak body stores lost each day through elimination. The following formula has had wide clinical use: Maintenance dose: is peak body stores x (% daily loss ÷ 100) Where: peak body stores = loading dose; % daily loss = 14 + creatinine clearance (C cr )/5. C cr is creatinine clearance corrected to 70kg body weight or 1.73m 2 body surface area. If only serum creatinine (S cr ) concentrations are available, a C cr (corrected to 70kg body weight) may be estimated in men as: NB: Seru קרא את המסמך השלם