APO-CARVEDILOL carvedilol 12.5 mg tablet blister pack

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

carvedilol, Quantity: 12.5 mg

Tilgjengelig fra:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Carvedilol

Legemiddelform:

Tablet, film coated

Sammensetning:

Excipient Ingredients: lactose monohydrate; colloidal anhydrous silica; magnesium stearate; crospovidone; microcrystalline cellulose; povidone; titanium dioxide; macrogol 8000; hypromellose; polydextrose; triethyl citrate

Administreringsrute:

Oral

Enheter i pakken:

60 tablets

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

Carvedilol is indicated for the treatment of hypertension. Data have not been provided to support the use of this drug in renovascular disease. Carvedilol is indicated for the treatment of patients with symptomatic mild to severe (NYHA class II to IV) congestive heart failure (CHF) as an adjunct to conventional treatments (e.g. diuretics, digoxin, ACE inhibitors and vasodilators).

Produkt oppsummering:

Visual Identification: White, oval shaped, film-coated tablets, imprinted '12.5' on one side and 'P' logo on the other side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Autorisasjon status:

Licence status A

Autorisasjon dato:

2006-11-15

Informasjon til brukeren

APO-CARVEDILOL
_Contains the active ingredient, carvedilol_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH 1800 195 055_
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about carvedilol. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
the medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with the medicine.
You may need to read it again
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Carvedilol. It contains the active
ingredient, carvedilol.
It is used to treat high blood pressure
and, together with other medicines,
to help treat congestive heart failure.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
_HOW IT WORKS_
Carvedilol belongs to a group of
medicines called beta-blockers.
These medicines work by relaxing
tightened blood vessels and slowing
the heart rate. Carvedilol has the
additional effect of being an
antioxidant.
Heart failure occurs when the heart
can no longer pump blood strongly
enough for the body's needs. Often
the heart grows in size to try to
improve the blood flow but this can
make the heart failure worse.
Symptoms of heart failure include
shortness of breath and swelling of
the feet or legs due to fluid bu

Preparatomtale

1
AUSTRALIAN PRODUCT INFORMATION
APO- CARVEDILOL (CARVEDILOL) TABLETS
1
NAME OF THE MEDICINE
Carvedilol.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 3.125 mg, 6.25 mg, 12.5 mg or 25 mg of carvedilol
as the active
ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Sugars as lactose monohydrate
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
3.125 MG TABLETS
White oval shaped, film-coated tablets, imprinted with « P » logo on
one side and plain on the
other side.
6.25 MG TABLETS
White oval shaped, film-coated tablets, imprinted « 6.25 » on one
side and « P » logo on the
other side
12.5 MG TABLETS
White oval shaped, film-coated tablets, imprinted « 12.5 » on one
side and « P » logo on the
other side
25 MG TABLETS
White oval shaped, film-coated tablets, imprinted « 25 » on one side
and « P » logo on the
other side
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Carvedilol is indicated for the treatment of hypertension. Data have
not been provided to
support the use of this drug in renovascular disease.
Carvedilol is indicated for the treatment of patients with symptomatic
mild to severe (NYHA
class II to IV) congestive heart failure (CHF) as an adjunct to
conventional treatments (e.g.
diuretics, digoxin, ACE inhibitors and vasodilators).
2
4.2
DOSE AND METHOD OF ADMINISTRATION
APO- Carvedilol tablets are intended for oral administration.
DOSAGE
HYPERTENSION
Once daily dosing is recommended.
Adults
The recommended dose for initiation of therapy is 12.5 mg once a day
for the first two days.
Thereafter the recommended dosage is 25 mg once a day. If necessary,
the dosage may
subsequently be increased at intervals of at least two weeks up to the
recommended maximum
daily dose of 50 mg given once a day or twice daily.
Elderly
The recommended dose for initiation of therapy is 12.5 mg once daily,
which has provided
satisfactory control in some patients. If the response is inadequate,
the dose may be titrated
at intervals of at least two weeks up to the reco