Lanoxin PG 62.5 microgram Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Digoxin

Available from:

Aspen Pharma Trading Limited

ATC code:

C01AA; C01AA05

INN (International Name):

Digoxin

Dosage:

62.5 microgram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Digitalis glycosides; digoxin

Authorization status:

Marketed

Authorization date:

1980-04-01

Patient Information leaflet

1/7
PACKAGE LEAFLET: INFORMATION FOR THE USER
LANOXIN PG 62.5 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 PG Tablets
3.
How to use Lanoxin PG Tablets
4.
Possible side effects
5.
How to store Lanoxin PG Tablets
6.
Contents of the pack and other information
1.
WHAT LANOXIN IS AND WHAT IT IS USED FOR
Lanoxin PG 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 PG TABLETS
DO NOT USE LANOXIN PG 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 obstruc

Summary of Product characteristics

Health Products Regulatory Authority
24 August 2022
CRN00CZMJ
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lanoxin PG 62.5 microgram Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: 62.5 micrograms Digoxin.
Excipients with known effect:
Each tablet contains 58.131 mg of Lactose Monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets.
They are blue, round, biconvex tablets debossed DO6 on the one side
and plain on the other side.
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 lo