DICARZ carvedilol 12.5 mg tablet blister pack

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Viambatanisho vya kazi:

carvedilol, Quantity: 12.5 mg

Inapatikana kutoka:

Alphapharm Pty Ltd

INN (Jina la Kimataifa):

Carvedilol

Dawa fomu:

Tablet, film coated

Tungo:

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

Njia ya uendeshaji:

Oral

Vitengo katika mfuko:

60 tablets

Dawa ya aina:

(S4) Prescription Only Medicine

Matibabu dalili:

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

Bidhaa muhtasari:

Visual Identification: White, oval shaped, film-coated tablets, with breakline on both sides, imprinted "12.5" on one side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Idhini hali ya:

Licence status A

Idhini ya tarehe:

2007-04-24

Taarifa za kipeperushi

DICARZ
_carvedilol_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Dicarz.
It does not contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Dicarz against the
benefits he/she expects it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT DICARZ IS USED
FOR
Dicarz is used to treat:
•
heart failure
•
high blood pressure
(hypertension).
•
Dicarz belongs to a group of
medicines called beta-blockers.
These medicines work by
affecting the body's response to
some nerve impulses, especially
in the heart. As a result, it
decreases the heart's need for
blood and oxygen and therefore
reduces the amount of work the
heart has to do. Dicarz also slows
your heart rate, which in turn
increases the efficiency of your
heart. Dicarz has the additional
effect of being an antioxidant.
HEART FAILURE:
Heart failure means that the heart
muscle cannot pump blood strongly
enough to supply all the blood
needed throughout the body. Heart
failure is not the same as heart attack
and does not mean that the heart
stops working. Heart failure may
start off with no symptoms, but as the
condition progresses, patients may
feel short of breath or may get tired
easily after light physical activity
such as walking. Some patients may
wake up short of breath at night.
Fluid may collect in different parts of
the body, often first noticed as
swollen ankles and feet.
Dicarz can help to reduce the number
of heart failure episodes needing
hospital admission and also the risk
of sudden death.
Dicarz is often used with other
medicines to treat heart failure.
HYPERTENSION:
All people have blood pressure. This
pressure helps to push blood all
around your body. Your blood
pressure changes during the day,
depending on how busy you are

Tabia za bidhaa

AUSTRALIAN PRODUCT INFORMATION
DICARZ
_Carvedilol film-coated tablets_
_ _
1
NAME OF THE MEDICINE
Carvedilol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each DICARZ tablet contains 3.125 mg, 6.25 mg, 12.5 mg or 25 mg of
carvedilol as the active ingredient.
DICARZ also contains sugars (as lactose).
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
DICARZ 3.125 MG TABLETS:
White, oval shaped, film-coated tablets, plain on both sides.
DICARZ 6.25 MG TABLETS:
White, oval shaped, film-coated tablets, with break line on both
sides, imprinted “6.25” on one side.
DICARZ 12.5 MG TABLETS:
White, oval shaped, film-coated tablets, with break line on both
sides, imprinted “12.5” on one side.
DICARZ 25 MG TABLETS:
White, oval shaped, film-coated tablets, with break line on both
sides, imprinted “25” on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DICARZ is indicated for the treatment of hypertension. Data have not
been provided to support the use of this
drug in renovascular disease.
DICARZ IS INDICATED FOR THE TREATMENT OF PATIENTS WITH SYMPTOMATIC
MILD TO SEVERE (NYHA CLASS II -
IV) CONGESTIVE HEART FAILURE (CHF) AS AN ADJUNCT TO CONVENTIONAL
TREATMENTS (E.G. DIURETICS, DIGOXIN,
ACE INHIBITORS AND VASODILATORS).
4.2
DOSE AND METHOD OF ADMINISTRATION
HYPERTENSION
Once daily dosing is recommended.
Adults:
The recommended dose for initiation of therapy is 12.5 mg once a day
for the first 2 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 recommended maximum daily dose.
DICARZ – PRODUCT INFORMATION
2
Carvedilol can be combined with other anti-h