Lanoxin PG 50micrograms/ml elixir

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Digoxin

Tersedia dari:

Aspen Pharma Trading Ltd

Kode ATC:

C01AA05

INN (Nama Internasional):

Digoxin

Dosis:

50microgram/1ml

Bentuk farmasi:

Oral solution

Rute administrasi :

Oral

Kelas:

No Controlled Drug Status

Jenis Resep:

Valid as a prescribable product

Ringkasan produk:

BNF: 02010100; GTIN: 5010706002135

Selebaran informasi

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

Karakteristik produk

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