BLOOMS AMLODIPINE amlodipine besilate 10mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amlodipine besilate, Quantity: 13.87 mg (Equivalent: amlodipine, Qty 10 mg)

Available from:

Sandoz Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

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

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic 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 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.

Product summary:

Visual Identification: A white or almost white, oblong, bevelled tablet, scored on one side and coded 10 on the other. Size: approx. 10.8 x 7.5mm; 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

Authorization status:

Registered

Authorization date:

2022-12-01

Patient Information leaflet

Blooms Amlodipine
1
BLOOMS AMLODIPINE
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING BLOOMS AMLODIPINE?
Blooms Amlodipine contains the active ingredient amlodipine besilate.
Blooms Amlodipine is used to treat high blood pressure
and angina pectoris. Bloom Amlodipine is not for the relief of a
sudden attack of angina.
For more information, see Section 1. Why am I using Blooms Amlodipine?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE BLOOMS AMLODIPINE?
Do not use if you have ever had an allergic reaction to amlodipine
besilate or any of the ingredients listed at the end of the
CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Blooms Amlodipine? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Blooms Amlodipine and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE BLOOMS AMLODIPINE?
•
The usual dose of Blooms Amlodipine is one 5 mg tablet each day. Your
doctor may increase this to one 10 mg tablet each
day. Your doctor may prescribe another dose of Blooms Amlodipine
depending on your condition and how you respond to
this medicine.
•
Swallow the tablet whole with a full glass of water.
More instructions can be found in Section 4. How do I use Blooms
Amlodipine? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING BLOOMS AMLODIPINE?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Blooms Amlodipine.
•
Avoid eating large quantities of grapefruit or drinking large
quantities of grapefruit juice.
THINGS YOU
SHOULD NOT DO
•
Do not give Blooms Amlodipine to anyone else, even if they have the
same condition as you.
•
Do not t

Summary of Product characteristics

221201-Blooms Amlodipine -pi
Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION
BLOOMS AMLODIPINE
(AMLODIPINE BESILATE)
1
NAME OF THE MEDICINE
Amlodipine besilate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Blooms Amlodipine 5 mg tablet contains 5 mg amlodipine.
Each Blooms Amlodipine 10 mg tablet contains 10 mg amlodipine.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Blooms Amlodipine 5 mg tablet: A white or almost white, oblong,
bevelled tablet, scored on
one side and coded “5” on the other.
Blooms Amlodipine 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.
Dosage should be adjusted according to each patient's need. In
general, titration should proceed
over 7 to 14 days so that the doctor can fully assess the patient's
response to each dose level.
Titration may proceed more rapidly, however, if clinically warranted,
provided the patient is
assessed frequently. (See