CARVEDILOL SANDOZ carvedilol 12.5 mg tablets blister pack

Страна: Австралія

мова: англійська

Джерело: Department of Health (Therapeutic Goods Administration)

Активний інгредієнт:

carvedilol, Quantity: 12.5 mg

Доступна з:

Sandoz Pty Ltd

ІПН (Міжнародна Ім'я):

Carvedilol

Фармацевтична форма:

Tablet, uncoated

Склад:

Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; crospovidone; povidone; colloidal anhydrous silica; magnesium stearate; iron oxide yellow; iron oxide red

Адміністрація маршрут:

Oral

Одиниць в упаковці:

30, 60

Тип рецепту:

(S4) Prescription Only Medicine

Терапевтичні свідчення:

Hypertension. Data have not been provided to support the use of this drug in renovascular disease. 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).

Огляд продуктів:

Visual Identification: Red/brown, round, convex, scored tablet, coded 'C3' on one side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Статус Авторизація:

Registered

Дата Авторизація:

2005-05-31

інформаційний буклет

CARVEDILOL SANDOZ
®
1
CARVEDILOL SANDOZ
®
_carvedilol tablets _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Carvedilol Sandoz.
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 risk of you taking Carvedilol
Sandoz against the benefits it is
expected to 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 want to read it again.
WHAT CARVEDILOL
SANDOZ IS USED FOR
The name of your medicine is
Carvedilol Sandoz. It contains the
active ingredient carvedilol.
Carvedilol Sandoz is used to treat
heart failure.
Your doctor may have prescribed
Carvedilol Sandoz for another
reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
WAS PRESCRIBED FOR YOU.
_HOW CARVEDILOL SANDOZ _
_WORKS _
Carvedilol Sandoz belongs to a group
of medicines called beta-blockers.
It works by slowing down the heart
rate and relaxing blood vessels if
they are too tight. Additionally, it
works as an antioxidant.
There is no evidence that Carvedilol
Sandoz is addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
CARVEDILOL SANDOZ
_WHEN YOU MUST NOT TAKE IT _
Do not take this medicine if:
•
you are allergic to the active
ingredient or any of the inactive
ingredients mentioned at the end
of this leaflet under Product
Description. Symptoms of an
allergic reaction may include an
itchy skin rash, shortness of
breath or swelling of the face or
tongue.
•
you are pregnant or breastfeeding,
unless permitted by your doctor
•
you have asthma or other
conditions that cause difficulties
in breathing
•
you have allergic disorders
including allergic asthma and/or
allergic nose running/congestion
•
you have or have had a very slow
heart rate or uneven heartbeats
•
you have certain other heart
conditions
•
you have

Характеристики продукта

190222-Carvedilol Sandoz-pi
Page 1 of 24
AUSTRALIAN PRODUCT INFORMATION
CARVEDILOL SANDOZ (CARVEDILOL) TABLETS
1
NAME OF THE MEDICINE
Carvedilol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Carvedilol Sandoz 6.25 mg tablets: yellow, round, convex, scored
tablet, coded C2 on one side.
Carvedilol Sandoz 12.5 mg tablets: red/brown, round, convex, scored
tablet, coded C3 on one
side.
Carvedilol Sandoz 25 mg tablets: white to almost white, round, convex,
scored tablet, coded
C4 on one side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Carvedilol Sandoz is indicated for the treatment of hypertension. Data
have not been provided
to support the use of this drug in renovascular disease.
Carvedilol Sandoz 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
D
OSE AND METHOD OF 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 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.
Carvedilol can be combined with other antihypertensive agents,
thiazide diuretics in particular.
_SYMPTOMATIC CONGESTIVE HEART FAILURE _
_Dosage must be individualised and closely monitored by the doctor
during up-titration_
.
For patients receiving digitalis, diuretics and ACE inhibitors, dosing
of these agents should be
st