AMLODIPINE SANDOZ amlodipine besilate 5mg tablet blister pack

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

amlodipine besilate, Quantity: 6.94 mg (Equivalent: amlodipine, Qty 5 mg)

Disponível em:

Sandoz Pty Ltd

DCI (Denominação Comum Internacional):

amlodipine besilate

Forma farmacêutica:

Tablet, uncoated

Composição:

Excipient Ingredients: calcium hydrogen phosphate; sodium starch glycollate; magnesium stearate; microcrystalline cellulose

Via de administração:

Oral

Unidades em pacote:

30 tablets

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

Hypertension: First line treatment of hypertension. It can be used as the sole agent to control blood pressure in the majority of patients. Patients not adequately controlled on a single antihypertensive agent may benefit from the addition of amlodipine besylate, which has been used in combination with a thiazide diuretic, beta-adrenoreceptor blocking agent, or an angiotensin converting enzyme inhibitor. Angina: First line treatment of chronic stable angina. Amlodipine besylate may be used alone, as monotherapy, or in combination with other antianginal drugs.

Resumo do produto:

Visual Identification: A white or almost white, oblong, bevelled tablet, scored on one side and coded 5 on the other. Size: approx. 8.6 x 5.8mm; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status de autorização:

Registered

Data de autorização:

2007-04-24

Folheto informativo - Bula

AMLODIPINE SANDOZ
1
AMLODIPINE SANDOZ
®
_amlodipine besilate tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Amlodipine 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 Amlodipine
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 AMLODIPINE
SANDOZ IS USED FOR
_WHAT IT DOES _
The name of your medicine is
Amlodipine Sandoz. It contains the
active ingredient amlodipine besilate.
Amlodipine Sandoz is used to treat
high blood pressure. Everyone has
blood pressure. This pressure helps to
circulate the blood all around your
body. Your blood pressure may be
different at different times of the day,
depending on how busy or worried
you are. You have hypertension (high
blood pressure) when your blood
pressure stays higher than is needed,
even when you are calm and relaxed.
There are usually no symptoms of
hypertension. The only way of
knowing that you have hypertension
is to have your blood pressure
checked on a regular basis. If high
blood pressure is not treated it can
lead to serious health problems. You
may feel fine and have no symptoms,
but eventually hypertension can
cause stroke, heart disease and
kidney failure. Amlodipine Sandoz
helps to lower your blood pressure.
Amlodipine Sandoz is also used to
treat angina pectoris. Angina is
caused by a shortage of the supply of
oxygen to the heart and is
characterised by a painful and
uncomfortable feeling in the chest.
This feeling often spreads to the arms
or neck, and sometimes also to the
shoulders and back.
Amlodipine Sandoz is not for the
relief of a sudden attack of angina. If
such an attack occurs, you should
take other medication that your
doctor will have given to you.
Your d

Características técnicas

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Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION
AMLODIPINE SANDOZ
®
(AMLODIPINE BESILATE)
1
NAME OF THE MEDICINE
Amlodipine besilate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Amlodipine Sandoz
®
2.5 mg tablet contains 2.5 mg amlodipine.
Each Amlodipine Sandoz
®
5 mg tablet contains 5 mg amlodipine.
Each Amlodipine Sandoz
®
10 mg tablet contains 10 mg amlodipine.
_Not all strengths may be available in Australia. _
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Amlodipine Sandoz 2.5 mg tablet: A white or almost white, oblong,
bevelled tablet, coded
“2.5” on one side.
Amlodipine Sandoz 5 mg tablet: A white or almost white, oblong,
bevelled tablet, scored on
one side and coded “5” on the other.
Amlodipine Sandoz 10 mg tablet: A white or almost white, oblong,
bevelled tablet, scored on
one side and coded “10” on the other.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
_Hypertension _
First line treatment of hypertension. It can be used as the sole agent
to control blood pressure
in the majority of patients. Patients not adequately controlled on a
single antihypertensive agent
may benefit from the addition of amlodipine besilate, which has been
used in combination with
a thiazide diuretic, beta-adrenoreceptor blocking agent, or an
angiotensin converting enzyme
inhibitor.
_Angina _
First line treatment of chronic stable angina. Amlodipine besilate may
be used alone, as
monotherapy, or in combination with other antianginal drugs.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
For hypertension or angina, the usual initial dose is 2.5 to 5 mg once
daily, which may be
increased to a maximum dose of 10 mg depending on the individual
patient's response.
Small, fragile or elderly individuals, or patients with hepatic
insufficiency should be started on
2.5 mg once daily and this dose may be used when adding amlodipine
besilate to other
antihypertensive therapy.
180921-amlodipine-sandoz-pi
Page 2 of 14
Dosage should be adjusted accordi