Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Digoxin
Aspen Pharma Trading Limited
C01AA; C01AA05
Digoxin
250 microgram(s)
Tablet
Product subject to prescription which may be renewed (B)
Digitalis glycosides; digoxin
Marketed
1980-04-01
1/8 PACKAGE LEAFLET: INFORMATION FOR THE USER LANOXIN 250 MICROGRAM TABLETS (DIGOXIN) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Lanoxin is and what it is used for 2. What you need to know before you use Lanoxin Tablets 3. How to use Lanoxin Tablets 4. Possible side effects 5. How to store Lanoxin Tablets 6. Contents of the pack and other information 1. WHAT LANOXIN IS AND WHAT IT IS USED FOR Lanoxin Tablets contains the active substance digoxin, which belongs to a group of medicines called cardiac glycosides. It is used to treat arrhythmias and heart failure. An arrhythmia is an irregularity in the heart-beat, which causes the heart to skip a beat, beat irregularly or beat at the wrong speed. This medicine works by correcting irregular heartbeats to a normal rhythm and strengthens the force of the heart-beat, which is why it is useful in heart failure. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE LANOXIN TABLETS DO NOT USE LANOXIN TABLETS IF YOU: - Are allergic to digoxin, other cardiac glycosides or any of the other ingredients of this medicine (listed in section 6). - Have serious heart problems, such as those with the conduction of the electrical impulses in the heart, especially if you have a history of Stokes-Adams attacks (abrupt, short-lived loss of consciousness caused by a sudden change in heart rate or rhythm). - Have an irregular heart-beat caused by cardiac glycoside intoxication or conditions such as Wolff-Parkinson-White syndrome. - Have obstructive cardiomyopathy (e Прочетете целия документ
Health Products Regulatory Authority 24 August 2022 CRN00CZMJ Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lanoxin 250 microgram Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 250 micrograms Digoxin. Excipients with known effect: Each tablet contains 95.525mg of Lactose Monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets. They are white, round, biconvex tablets bisected and debossed DO25 on the same side and plain on the other side. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cardiac failure Digoxin is indicated in the management of chronic cardiac failure where the dominant problem is systolic dysfunction. Its therapeutic benefit is greatest in those patients with ventricular dilatation. Digoxin is specifically indicated where cardiac failure is accompanied by atrial fibrillation. Supraventricular arrhythmias Digoxin is indicated in the management of certain supraventricular arrhythmias, particularly chronic atrial flutter and fibrillation. Health Products Regulatory Authority 24 August 2022 CRN00CZMJ Page 2 of 17 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: The dose of digoxin for each patient has to be tailored individually according to age, lean body weight and renal function. Suggested doses are intended only as an initial guide. In cases where cardiac glycosides have been taken in the preceding two weeks the recommendations for initial dosing of a patient should be reconsidered and a reduced dose is advised. The difference in bioavailability between injectable digoxin and oral formulations must be considered when changing from one dosage form to another. For example if patients are switched from oral to the I.V. formulation the dosage should be reduced by approximately 33%. Adults and paediatric populations over 10 years _Rapid oral loading:_ If medically appropriate, rapid digitalisation may Прочетете целия документ