AMLODIPINE GH amlodipine 5 mg (as besilate) tablet blister pack

Страна: Австралия

Язык: английский

Источник: Department of Health (Therapeutic Goods Administration)

Активный ингредиент:

amlodipine besilate, Quantity: 6.9335 mg (Equivalent: amlodipine, Qty 5 mg)

Доступна с:

Generic Health Pty Ltd

ИНН (Международная Имя):

amlodipine besilate

Фармацевтическая форма:

Tablet, uncoated

состав:

Excipient Ingredients: mannitol; microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; sodium starch glycollate

Администрация маршрут:

Oral

Штук в упаковке:

30 tablets

Тип рецепта:

(S4) Prescription Only Medicine

Терапевтические показания :

Hypertension: AMLODIPINE GH tablets are indicated for the first line treatment of hypertension and 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, which has been used in combination with a thiazide diuretic, beta adrenoreceptor blocking agent or an angiotensin-converting enzyme inhibitor. Angina: AMLODIPINE GH tablets are indicated for the first line treatment of chronic stable angina. AMLODIPINE GH tablets may be used alone, as monotherapy or in combination with other antianginal drugs.

Обзор продуктов:

Visual Identification: White to off-white, octagonal shaped, uncoated tablets, debossed with "AM 5" on one side and scoreline on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Статус Авторизация:

Licence status A

Дата Авторизация:

2008-04-10

тонкая брошюра

CONSUMER MEDICINE INFORMATION
AMLODIPINE GH
(AMLODIPINE BESILATE) UNCOATED TABLET
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Amlodipine GH.
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 risks of you taking
Amlodipine GH 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 AMLODIPINE GH IS
USED FOR
Amlodipine GH is used to:
•
lower high blood pressure
(hypertension).
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.
•
treat angina pectoris.
Angina is a pain or
uncomfortable feeling in the
chest, often spreading to the
arms or neck, and sometimes to
the shoulders and back. The
pain of angina is due to a
shortage of oxygen to the heart.
Amlodipine GH is not for the
relief of a sudden attack of
angina. Your doctor will give you
other medication to treat this.
_HOW IT WORKS _
Amlodipine GH belongs to a
group of medicines called
calcium channel blockers or
calcium ion antagonists. They
work by widening your blood
vessels, making it easier for
your heart to pump blood around
the body and help increase the
supply of blood and oxygen to
your heart. Calcium channel
blockers do not change the
amount of calcium in your blood
or bones.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
AMLODIPINE GH HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have
prescribed Amlodipine GH for
another reason.
This medicine is only available
with a doctor's prescription.
_USE IN CHILDREN _
There is not enough information
to recommend the use of this
medicine in children.
BEFORE YOU TAKE
AMLODIPINE GH
_WHEN YOU MUST NOT TAKE IT _
DO NO

Характеристики продукта

AUSTRALIAN PRODUCT INFORMATION – AMLODIPINE GH
(AMLODIPINE BESILATE) UNCOATED TABLET
1
NAME OF THE MEDICINE
Amlodipine besilate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg or 10 mg amlodipine (as besilate).
List of excipients with known effects: Mannitol
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Amlodipine GH 5 mg tablets:
White to off-white, octagonal shaped, uncoated tablets, debossed with
“AM 5” on one side and scoreline
on the other side.
Amlodipine GH 10 mg tablets:
White to off-white, octagonal shaped uncoated tablets, debossed with
“AM 10” on one side and plain
on the other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1.
HYPERTENSION:_ _Amlodipine GH tablets are indicated for the first line
treatment of hypertension and
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, which has been used in combination with a thiazide
diuretic, beta-adrenoceptor blocking
agent or an angiotensin-converting enzyme (ACE) inhibitor.
2.
ANGINA:_ _Amlodipine GH tablets are indicated for the first line
treatment of chronic stable angina.
Amlodipine GH tablets may be used alone, as monotherapy or in
combination with other anti-anginal
drugs.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
For hypertension or angina, the usual initial dose is 2.5 mg to 5 mg
once daily which may be increased
to a maximum dose of 10 mg depending on the individual patient’s
response.
Amlodipine GH v5.0
Page 2 of 14
(amlodipine besilate) uncoated tablet
METHOD OF ADMINISTRATION
Amlodipine tablets are for oral administration.
DOSAGE ADJUSTMENT
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 tablets to
other antihypertensive therapy.
Amlodipine GH 5 mg tablets can be divided in half along the scor