EDECRIN etacrynic acid 25 mg tablet bottle

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

etacrynic acid

Disponible des:

A Menarini Australia Pty Ltd

Estat d'Autorització:

Registered

Informació per a l'usuari

EDECRIN
_etacrynic acid_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about EDECRIN. 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 EDECRIN
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 EDECRIN IS
USED FOR
EDECRIN helps to reduce the
amount of fluid in the body for
people who have:
•
swelling of the ankles, feet and
legs, which is called oedema
•
fluid accumulation in the lungs,
which is called pulmonary
oedema
•
fluid accumulation around the
eyes due to kidney disease
•
fluid accumulation in the stomach
area, which is also called ascites,
due to liver disease
•
a heart condition called
congestive heart failure.
EDECRIN is also used in children
over 2 years old to remove fluid that
occurs in some heart and kidney
conditions.
EDECRIN belongs to a group of
medicines called diuretics or fluid
tablets.
It works by making your kidneys
pass more water and salt from the
body.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
BEFORE YOU TAKE
EDECRIN
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE EDECRIN IF YOU HAVE
AN ALLERGY TO:
•
EDECRIN
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
DO NOT TAKE THIS MEDICINE IF YOU
ARE PREGNANT OR INTEND TO BECOME
PREGNANT.
Like most medicines, EDECRIN is
not recommended for use during
pregnancy.
DO NOT TAKE THIS MEDICINE IF YOU
ARE NOT PA

Fitxa tècnica

AUSTRALIAN PRODUCT INFORMATION –
EDECRIN (ETACRYNIC ACID) TABLETS
EDECRIN PI vA04-0
Page 1 of 7
1
NAME OF THE MEDICINE
Etacrynic acid
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
EDECRIN tablet contains 25 mg etacrynic acid.
Excipient with known effect: lactose monohydrate.
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
EDECRIN 25 mg tablets are white capsule-shaped tablets, scored and
engraved “VRX 205”
on one side and the other side engraved “EDECRIN”.
The splitting of EDECRIN 25 mg tablets is not advised.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
EDECRIN is indicated for the treatment of oedema when urgent diuresis
by a potent
saluretic-diuretic agent with rapid onset of action is essential.
•
Congestive heart failure
•
Pulmonary oedema
•
Renal oedema
•
Hepatic cirrhosis with ascites
•
Oedema due to other causes
Paediatric Indications
EDECRIN tablets have been found useful in patients of the paediatric
age group with the
nephrotic syndrome. This experience has generally been limited to
short term therapy in
hospitalised patients resistant to other therapy. Paediatric patients
with congenital heart
disease also have responded to EDECRIN. EDECRIN should not be given to
infants under
two years of age. (see also section 4.3 CONTRAINDICATIONS)
4.2
DOSE AND METHOD OF ADMINISTRATION
The dosage must be carefully regulated so as to adjust the diuretic
response to the rate and
extent most desirable for the individual patient. Daily weighings and,
when possible, serum
electrolyte determinations will contribute greatly to the success of
treatment.
Oral Use
The splitting of EDECRIN 25 mg tablets is not advised.
Initial Dosage
The smallest dose required to produce a gradual weight loss (about 1/2
to 1 kg per day) is
recommended.
EDECRIN PI vA04-0
Page 2 of 7
ADULTS
The recommended dose is 50 mg (2 tablets) daily immediately after
breakfast. If necessary,
increase the total daily dosage by amounts of 25 to 50 mg (1 to 2
tablets). The usual
effective daily