Land: Verenigd Koninkrijk
Taal: Engels
Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)
Digoxin
Aspen Pharma Trading Ltd
C01AA05
Digoxin
50microgram/1ml
Oral solution
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02010100; GTIN: 5010706002135
1/7 PACKAGE LEAFLET: INFORMATION FOR THE USER LANOXIN-PG ELIXIR 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-PG Elixir 3. How to use Lanoxin-PG Elixir 4. Possible side effects 5. How to store Lanoxin-PG Elixir 6. Contents of the pack and other information 1. WHAT LANOXIN IS AND WHAT IT IS USED FOR Lanoxin 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-PG ELIXIR Do not use Lanoxin-PG Elixir 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 (enlargement Lees het volledige document
OBJECT 1 LANOXIN PG ELIXIR Summary of Product Characteristics Updated 03-Jan-2018 | Aspen 1. Name of the medicinal product Lanoxin PG Elixir 2. Qualitative and quantitative composition Digoxin 0.005 % w/v 3. Pharmaceutical form Oral solution. 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. 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 be achieved in a number of ways, such as 750 to 1500 micrograms (0.75 to 1.5 mg) as a single dose. Where there is less urgency, or greater risk of toxicity e.g. in the elderly, the oral loading dose should be given in divided doses six hours apart, with approximately half the total dose given as the first dose. Clinical response should be assessed before giving each additional dose (see Section 4.4). _Slow oral loading:_ In some patients, for example those with mild h Lees het volledige document