SIGMAXIN PG digoxin 62.5microgram tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

digoxin, Quantity: 0.0625 microgram

Available from:

Aspen Pharma Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: lactose monohydrate; rice starch; magnesium stearate; hydrolysed maize starch; povidone; indigo carmine; oxidised maize starch

Administration route:

Oral

Units in package:

200 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Congestive heart failure - Sigmaxin is useful regardless of whether the failure is predominantly of the left or right ventricle, or involves both sides of the heart. It is particularly useful in heart failure resulting from chronic overload (hypertension, valvular lesions, atherosclerotic heart disease) in which the supply of energy is not impaired. Sigmaxin does not cause major benefit in situations in which the metabolic energy supply is compromised as in thyrotoxicosis, hypoxia, and severe thiamine deficiency. Atrial fibrillation - Because Sigmaxin depresses conduction in the atrioventricular bundle, producing a slower ventricular beat, it is valuable in atrial fibrillation. It will frequently convert atrial flutter into fibrillation and, upon withdrawal of the drug, normal sinus rhythm may be restored. Paroxysmal atrial tachycardia - Sigmaxin may relieve or prevent an attack, but its use in paroxysmal ventricular tachycardia is dangerous.

Product summary:

Visual Identification: Blue, biconvex, round tablet, coded 'U3A' on the upper face. Bottom face plain.; Container Type: Bottle; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2002-07-29

Patient Information leaflet

SIGMAXIN- Consumer Medicine Information
Page 1 of 4
SIGMAXIN
digoxin
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about
SIGMAXIN
. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking
SIGMAXIN
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT SIGMAXIN IS
USED FOR
SIGMAXIN
belongs to a group of
medicines known as
cardiac
glycosides.
They work by slowing
down the rate while increasing the
force of your heart when it beats.
It is used to treat certain heart
problems, such as:
CHRONIC HEART FAILURE
Heart failure is when your heart
can’t pump strongly enough to
supply blood needed through out
the whole body. It is not the same
as a heart attack and does not
mean that your heart stops.
CERTAIN TYPE OF IRREGULAR HEART
BEATS
Irregular heart rhythms caused by
an electrical problem in the upper
chamber of your heart. They cause
your heart to beat too fast or in an
uneven way.
Your doctor may have prescribed
this medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY
SIGMAXIN HAS BEEN PRESCRIBED
FOR YOU.
There is no evidence that
SIGMAXIN
is addictive.
BEFORE YOU TAKE IT
WHEN YOU MUST NOT TAKE IT
DO NOT TAKE
SIGMAXIN IF YOU
HAVE AN ALLERGY TO:

digoxin or other cardiac
glycosides

any of the ingredients listed at
the end of this leaflet.
Symptoms of an allergic reaction to
SIGMAXIN
may include:

shortness of breath, wheezing
or difficulty breathing

swelling of the face, lips, tongue
or other parts of the body

skin rash, itching or hives
DO NOT TAKE
SIGMAXIN
IF YOU
HAVE OR HAVE HAD ANY OF THE
FOLLOWING MEDICAL CONDITIONS:

intermittent or complete heart
block or second degree
atrioventricular block,
(conditions

Summary of Product characteristics

SIGMAXIN- Product Information
Page 1 of 19
AUSTRALIAN PRODUCT INFORMATION
SIGMAXIN (DIGOXIN)
1.
NAME OF THE MEDICINE
Digoxin
2.
QUALITATIVE AND QUANTITAIVE COMPOSITION
SIGMAXIN TABLETS contain DIGOXIN 0.250 MG, Lactose, maize starch,
hydrolyzed maize
starch, rice starch, magnesium stearate.
SIGMAXIN PG TABLETS contain DIGOXIN 0.0625 MG, Lactose, maize starch,
hydrolyzed
maize starch, rice starch, magnesium stearate, povidone, colouring
(indigo carmine -
CI73015).
Excipients with known effect: Sigmaxin and Sigmaxin PG contain sugars
(as lactose)
3.
PHARMACEUTICAL FORM
TABLETS, 250 microgram (white, biconvex, round tablet, scored and
coded “X3A” on upper
face, bottom face plain): 100s.
PG (PAEDIATRIC/GERIATRIC) TABLETS, 62.5 microgram (blue, biconvex,
round tablet, coded
”U3A” on upper face, bottom face plain): 200s.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
CONGESTIVE
HEART
FAILURE
-
Digoxin
is
useful
regardless
of
whether
the
failure
is
predominantly of the left or right ventricle, or involves both sides
of the heart. It is particularly
useful in heart failure resulting from chronic overload (hypertension,
valvular lesions,
atherosclerotic heart disease) in which the supply of energy is not
impaired. Digoxin does
not cause major benefit in situations in which the metabolic energy
supply is compromised
as in thyrotoxicosis, hypoxia, and severe thiamine deficiency.
ATRIAL FIBRILLATION - Because Digoxin depresses conduction in the
atrioventricular bundle,
producing a slower ventricular beat, it is valuable in atrial
fibrillation. It will frequently convert
atrial flutter into fibrillation and, upon withdrawal of the drug,
normal sinus rhythm may be
restored.
PAROXYSMAL ATRIAL TACHYCARDIA - Digoxin may relieve or prevent an
attack, but its use in
paroxysmal ventricular tachycardia is dangerous.
4.2 DOSE AND METHOD OF ADMINISTRATION
Dosage of Digoxin must be adjusted individually for each patient and
the suggested doses
are intended only as a guide. Use of the drug in heart failure should
be based on