FIBSOL 10 lisinopril 10mg (as dihydrate) tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lisinopril dihydrate, Quantity: 10.89 mg (Equivalent: lisinopril, Qty 10 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Lisinopril dihydrate

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: calcium hydrogen phosphate dihydrate; mannitol; maize starch; pregelatinised maize starch; magnesium stearate; colloidal anhydrous silica

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Hypertension: Treatment of hypertension. Lisinopril may be used alone or concomitantly with other classes of antihypertensive agents. Sufficient data have not been provided to support the use of lisinopril in severe hypertension or renovascular hypertension. Congestive heart failure: Treatment of heart failure. In such patients, it is recommended that lisinopril be administered together with a diuretic. Acute myocardial infarction: Treatment of acute myocardial infarction in haemodynamically stable patients, defined as patients who are not in cardiogenic shock and who have a systolic blood pressure greater than 100 mmHg. Lisinopril may be initiated within 24 hours of an acute myocardial infarction.

Product summary:

Visual Identification: Off white round tablet, debossed with "L" break-line "10" on one side and plain on other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2004-05-07

Patient Information leaflet

FIBSOL- Consumer Medicine Information
Page 1 of 5
FIBSOL
lisinopril dihydrate
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about FIBSOL.
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 FIBSOL
against the benefits they expect it
will have for you.
TALK TO YOUR DOCTOR OR
PHARMACIST IF YOU HAVE ANY
CONCERNS ABOUT TAKING THIS
MEDICINE.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT FIBSOL IS USED FOR
FIBSOL is used to treat:
•
high blood pressure
(hypertension)
•
heart failure
•
patients who have had a heart
attack.
FIBSOL belongs to a group of
medicines called angiotensin
converting enzyme (ACE) inhibitors.
How FIBSOL works
FIBSOL works by widening your
blood vessels, making it easier for
your heart to pump blood around
your body.
This helps increase the supply of
oxygen to your heart, so that when
you place extra demands on your
heart, such as during exercise, your
heart may cope better and you may
not get short of breath as easily.
By increasing the supply of oxygen
to your heart, your heart does not
have to work as hard which may
reduce the risk of further damage
to your heart after you have a heart
attack.
Your doctor may have prescribed
FIBSOL for another reason. Ask
your doctor if you have any
questions about why FIBSOL has
been prescribed for you.
FIBSOL is not addictive.
This medicine is available only with
a doctor's prescription.
Use in children
The safety and effectiveness of
FIBSOL in children have not been
established.
BEFORE YOU TAKE IT
When you must not take it
DO NOT TAKE FIBSOL IF:
•
YOU ARE ALLERGIC TO FIBSOL OR
ANY OTHER MEDICINE
CONTAINING LISINOPRIL, OR ANY OF
THE INGREDIENTS LISTED AT THE
END OF THIS LEAFLET.
Symptoms of an allergic reaction
to FIBSOL may include skin rash,
itchiness, shortness of breath,
swelling of the face, lips or
tongue, muscl

Summary of Product characteristics

1
AUSTRALIAN PI – FIBSOL (LISINOPRIL DIHYDRATE)
1
NAME OF THE MEDICINE
Lisinopril dihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lisinopril dihydrate is a white to off-white crystalline powder that
is soluble in water, sparingly soluble
in methanol and practically insoluble in ethanol.
Fibsol tablets come in three strengths and contain lisinopril
dihydrate equivalent to 5 mg, 10 mg or 20
mg of lisinopril.
For full list of excipients, see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
FIBSOL 5
White, round tablet, marked L

5 on one side and
>
on the other side.
FIBSOL 10
White, round tablet, marked L

10 on one side and
>
on the other side.
FIBSOL 20
White, round tablet, marked L

20 on one side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Hypertension.
Treatment of hypertension. Lisinopril may be used alone or
concomitantly with other classes of
antihypertensive agents. Sufficient data have not been provided to
support the use of lisinopril in
severe hypertension or renovascular hypertension.
Congestive heart failure.
Treatment of heart failure. In such patients, it is recommended that
lisinopril be administered together
with a diuretic.
Acute myocardial infarction.
Treatment of acute myocardial infarction in haemodynamically stable
patients, defined as patients
who are not in cardiogenic shock and who have a systolic blood
pressure greater than 100 mmHg.
Lisinopril may be initiated within 24 hours of an acute myocardial
infarction.
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
Since there is no clinically significant effect of food on the
absorption of lisinopril, the tablets may be
administered before, during or after meals. Lisinopril should be
administered in a single daily dose.
ESSENTIAL
HYPERTENSION.
In-patients
with
uncomplicated
essential
hypertension
not
on
diuretic
therapy, the usual recommended starting dose is 5 to 10 mg. The usual
maintenance dosage is 10 to
20 mg/day administered in a single daily dose. Dosage should be
adjusted at two to four week
intervals according to