ACCUPRIL quinapril hydrochloride 5mg tablet blister pack

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

quinapril hydrochloride, Quantity: 5.42 mg (Equivalent: quinapril, Qty 5 mg)

Disponible des:

Pfizer Australia Pty Ltd

formulario farmacéutico:

Tablet, film coated

Composición:

Excipient Ingredients: Candelilla Wax; lactose monohydrate; magnesium stearate; crospovidone; magnesium carbonate hydrate; Gelatin; titanium dioxide; hypromellose; hyprolose; iron oxide red; macrogol 400

Vía de administración:

Oral

Unidades en paquete:

30 tablets

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

Hypertension. ACCUPRIL is indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. Sufficient data have not been provided to support the use of ACCUPRIL in renovascular hypertension. Congestive Heart Failure. ACCUPRIL is indicated as an adjunctive treatment of mild to moderate congestive heart failure when given concomitantly with a diuretic and/or cardiac glycoside.

Resumen del producto:

Visual Identification: Reddish-brown, oval, biconvex film-coated tablet with bisecting score on both sides and debossing '5' on both sides in opposite direction.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Estat d'Autorització:

Registered

Data d'autorització:

1992-08-06

Informació per a l'usuari

ACCUPRIL
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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 ACCUPRIL?
Accupril contains the active ingredient quinapril hydrochloride.
Accupril is used to lower high blood pressure (hypertension). It is
also
used to treat heart failure.
For more information, see Section 1. Why am I using Accupril? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ACCUPRIL?
Do not use if you have ever had an allergic reaction to Accupril,
another ACE inhibitor, 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
Accupril? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Accupril 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 ACCUPRIL?
For high blood pressure, the usual starting dose is 5 mg to 10 mg
taken once a day. The dose may need to be increased. Most
patients take between 10 mg and 40 mg each day. For heart failure, the
usual starting dose is 5 mg taken once a day. In most
patients, effective doses are between 10 mg and 20 mg a day.
More instructions can be found in Section 4. How do I use Accupril? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ACCUPRIL?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Accupril.
•
Make sure you drink enough water during exercise and hot weather,
especially if you sweat a lot.
•
Tell your doctor if you have excess vomiting and/or diarrhoea while
taking Accupril.
•
Tell your doctor immediately if you feel light-headed or dizzy after
taking your first dose of Accupril, or
when your dose is increased.
•
Have your blood pres

Fitxa tècnica

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Page 1 of 23
AUSTRALIAN
PRODUCT
INFORMATION
–
ACCUPRIL
® (QUINAPRIL HYDROCHLORIDE)
1.
NAME OF THE MEDICINE
Quinapril hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACCUPRIL (quinapril hydrochloride) 5 mg, 10 mg and 20 mg tablets.
EXCIPIENT(S) WITH KNOWN EFFECT
Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
5 MG TABLET:
Reddish-brown, oval, biconvex, film-coated tablet, with bisecting
score on both
sides and debossing “5” on both sides in opposite direction.
10 MG TABLET:
Reddish-brown, triangular, biconvex film-coated tablet, with bisecting
score on
both sides and debossing “10” on one side.
20 MG TABLET:
Reddish-brown, round, biconvex film-coated tablet, with bisecting
score on both
sides and debossing “20” on one side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
HYPERTENSION
ACCUPRIL is indicated for the treatment of hypertension. It may be
used alone or in
combination with thiazide diuretics. Sufficient data have not been
provided to support the use
of ACCUPRIL in renovascular hypertension.
CONGESTIVE HEART FAILURE
ACCUPRIL is indicated as an adjunctive treatment of mild to moderate
congestive heart failure
when given concomitantly with a diuretic and/or cardiac glycoside.
4.2 DOSE AND METHOD OF ADMINISTRATION
ACCUPRIL should preferably be taken before meals as food with a high
fat content may
diminish the rate and extent of absorption of the drug.
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HYPERTENSION
MONOTHERAPY
The recommended initial dosage of ACCUPRIL in patients not on
diuretics is 5 to 10 mg once
daily. Dosage should be adjusted according to blood pressure response
measured at peak (2 to
6 hours after dosing) and trough (predosing). Generally, dosage
adjustments should be made
at intervals of at least 4 weeks. Most patients have required dosages
of 10 to 40 mg/day, given
as a single dose or in two equally divided dose