LANOXIN ELIXIR

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

DIGOXIN

Commercializzato da:

PADAGIS ISRAEL AGENCIES LTD, ISRAEL

Codice ATC:

C01AA05

Forma farmaceutica:

ELIXIR

Composizione:

DIGOXIN 0.05 MG / 1 ML

Via di somministrazione:

PER OS

Tipo di ricetta:

Required

Prodotto da:

ASPEN BAD OLDESLOE GMBH, GERMANY

Gruppo terapeutico:

DIGOXIN

Area terapeutica:

DIGOXIN

Indicazioni terapeutiche:

Lanoxin is indicated whenever digitalis therapy is required for the treatment of congestive heart failure, atrial fibrilation and/or flutter and supra-ventricular tachycardia.

Data dell'autorizzazione:

2023-04-30

Foglio illustrativo

PATIENT PACKAGE INSERT
IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s
prescription only
Lanoxin
®
Elixir
0.05 mg/ml
Each
1
ml
of
Lanoxin
Elixir
contains
digoxin 0.05 mg.
Inactive ingredients and allergens in the
p re p a ra t i o n :
s e e
s e c t i o n
2
“ I m p o r t a n t
information about some of the ingredients
of
the
medicine”
and
section
6
“Further
information” in the leaflet.
Read the leaflet carefully in its entirety
before using the medicine. This leaflet
contains concise information about the
medicine.
If
you
have
further
questions,
ask
the doctor or pharmacist.
This medicine has been prescribed for your
treatment. Do not pass it on to others. It may
harm them even if is seems to you that their
medical condition is similar.
If you experience any side effects, including
side effects which are not mentioned in
section
4
of
this
leaflet,
inform
the
doctor
or
the pharmacist.
1. WHAT IS THE MEDICINE INTENDED
FOR?
Lanoxin Elixir is indicated whenever digitalis
therapy is required for the treatment of
congestive
heart
failure,
atrial
fibrilation
and/or
flutter and supra-ventricular tachycardia.
Therapeutic group: cardiac glycosides.
2. BEFORE USING THE MEDICINE
Do not use Lanoxin Elixir if:
• You are sensitive (allergic) to the active
ingredient
digoxin,
to
other
cardiac
glycosides or to any of the additional
ingredients this medicine contains (see
section
6
“Further
information”
in
the
leaflet).
•
You suffer from serious heart problems,
such as problems 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).
• You suffer from an irregular heartbeat
caused by cardiac glycoside intoxication or
conditions such as Wolff-Parkinson-White
syndrome.
• You suffer from obstructive cardiomyopathy
(enlargement of the heart muscle).
Special warnings regarding the use of
Lanox

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Lanoxin
®
Elixir
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Digoxin 0.05 mg/1 ml
For a full list of excipients, see section 6.1.
_ _
3.
PHARMACEUTICAL FORM
Oral solution
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Lanoxin Elixir is indicated whenever digitalis therapy is required for
the treatment of congestive
heart failure, atrial fibrillation and/or flutter and
supra-ventricular tachycardia.
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
exampleif 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 heart failure,
digitalisation may be achieved more
slowly with doses of 250 to 750 micrograms (0.25 to 0.75 mg) daily for
one week followed by an
appropriate maintenance dose. A clinical response should be seen
within one week.
The choice between slow and rapid oral loading depends on the cl