ATENOLOL SANDOZ atenolol 50mg tablet blister pack

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

atenolol, Quantity: 50 mg

Disponível em:

Sandoz Pty Ltd

DCI (Denominação Comum Internacional):

Atenolol

Forma farmacêutica:

Tablet, film coated

Composição:

Excipient Ingredients: maize starch; magnesium carbonate hydrate; magnesium stearate; Gelatin; sodium lauryl sulfate; titanium dioxide; lactose monohydrate; hypromellose; macrogol 4000

Via de administração:

Oral

Unidades em pacote:

30 tablets

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

Atenolol Sandoz is indicated in the management of:,- All grades of hypertension, including hypertension of renal origin,- Frequent disabling angina without evidence of cardiac failure,- Cardiac arrhythmias (acute treatment of supraventricular and ventricular arrhythmias, including those associated with acute myocardial infarction),- Myocardial infarction: Late intervention (beta-blocker class effect greater than 12 hours after onset of chest pain).

Resumo do produto:

Visual Identification: White, round convex film-coated tablets, scored on one side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Status de autorização:

Registered

Data de autorização:

2004-08-27

Folheto informativo - Bula

ATENOLOL SANDOZ
®
1
ATENOLOL SANDOZ
®
_atenolol tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Atenolol 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 this medicine
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 ATENOLOL
SANDOZ IS USED
FOR
Atenolol Sandoz contains the active
ingredient atenolol. Atenolol belongs
to a group of medicines called beta-
blockers.
It works by affecting the body's
response to certain 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. It
widens the blood vessels in the body,
causing blood pressure to fall. It also
helps the heart to beat more regularly
This medicine is used to:
•
lower high blood pressure
(hypertension)
•
prevent angina (chest pain)
•
treat irregular heart rhythm or
beat (cardiac arrhythmias)
•
treat heart attacks, or reduce your
risk of heart complications
following a heart attack.
Atenolol Sandoz may be either used
alone or in combination with other
medicines to treat your condition.
_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 or
how you are feeling.
You have hypertension (high blood
pressure) when your blood pressure
stays higher than is needed, even
when you are calm and relaxed.
Regular blood pressure checks are
the only way of knowing that you
have hypertension. There are usually
no symptoms of hypertension and
you may feel fine. If hypertension is
not treated, serious health problems
such as stroke, heart disease and
k

Características técnicas

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Page 1 of 12
AUSTRALIAN PRODUCT INFORMATION
ATENOLOL SANDOZ
® (ATENOLOL)
1
NAME OF THE MEDICINE
Atenolol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Atenolol Sandoz
®
50 mg tablet contains 50 mg Atenolol.
_Excipients with known effect: _
Each tablet contains lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Atenolol Sandoz 50 mg tablets are white, round, convex film-coated
tablets, scored on one
side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Atenolol Sandoz is indicated in the management of
•
All grades of hypertension, including hypertension of renal origin
•
Frequent disabling angina without evidence of cardiac failure
•
Cardiac arrhythmias (acute treatment of supraventricular and
ventricular arrhythmias,
including those associated with acute myocardial infarction)
•
Myocardial infarction: Late intervention (beta-blocker class effect
greater than 12 hours
after onset of chest pain).
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_ADULTS _
_Hypertension_
Therapy should be initiated with Atenolol Sandoz 50 mg daily. This may
be increased each
week in daily doses of 50 mg up to a maximum of 200 mg. Where patients
are controlled on
daily doses of 50 to 100 mg this may be given once daily. Doses above
100 mg daily should
be given on a divided basis. Where necessary, a further reduction in
blood pressure may be
achieved by combining Atenolol Sandoz with other antihypertensive
agents.
Patients can be transferred to Atenolol Sandoz from other
antihypertensive treatments with the
exception of clonidine (see Section 4.4 Special warnings and
precautions for use - Clonidine).
_Angina Pectoris _
Therapy should be initiated with Atenolol Sandoz 50 mg daily. This may
be increased, if
required, to 100 mg daily given as a single or divided dose. It is
unlikely that additional benefit
will be gained by increasing the dose.
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Page 2 of 12
_Cardiac Dysrhythmias_
Having controlled the dysrhythmias