AQUINAFIL quinapril hydrochloride 5mg tablet blister pack

Main information

  • Trade name:
  • AQUINAFIL quinapril hydrochloride 5mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AQUINAFIL quinapril hydrochloride 5mg tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 173708
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

173708

AQUINAFIL quinapril hydrochloride 5mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Pfizer Australia Pty Ltd

Postal Address

PO Box 57,WEST RYDE, NSW, 2114

Australia

ARTG Start Date

16/02/2011

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. AQUINAFIL quinapril hydrochloride 5mg tablet blister pack

Product Type

Single Medicine Product

Effective date

16/10/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Hypertension. AQUINAFIL 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 AQUINAFIL in renovascular hypertension. Congestive Heart Failure. AQUINAFIL is indicated as an

adjunctive treatment of mild to moderate congestive heart failure when given concomitantly with a diuretic and/or cardiac glycoside.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PA/Al/PVC/Al -

polyamide-aluminium

foil-polyvinylchloride/al

uminium foil

3 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

30 tablets

(S4) Prescription Only Medicine

Components

1.

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Reddish-brown, oval, biconvex film-coated tablet with bisecting score on

both sides and debossing '5' on both sides in opposite direction.

Active Ingredients

quinapril hydrochloride

5.42 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 29.11.2017 at 03:49:03 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

AQUINAFIL

Quinapril hydrochloride

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Aquinafil.

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 Aquinafil

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 Aquinafil is used

for

What Aquinafil does

Aquinafil is used to:

lower high blood pressure

(hypertension)

treat heart failure.

Hypertension

Aquinafil is used to lower high blood

pressure (hypertension). Everyone

has blood pressure. This pressure

helps get your 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,

including stroke, heart disease and

kidney failure.

Heart Failure

Heart failure means that the heart

muscle is weak and cannot pump

blood strongly enough to supply all

the blood needed throughout the

body. Heart failure is not the same as

heart attack and does not mean that

the heart stops. Heart failure may

start off with no symptoms, but as the

condition progresses, patients may

feel short of breath or may get tired

easily after light physical activity

such as walking. Some patients may

wake up short of breath at night.

Fluid may collect in different parts of

the body, often first noticed as

swollen ankles and feet.

How Aquinafil works

This medicine works by widening

your blood vessels, which reduces

pressure in the 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.

Aquinafil belongs to a group of

medicines called angiotensin

converting enzyme (ACE) inhibitors.

Your doctor may have prescribed

Aquinafil for another reason.

Ask your doctor if you have any

questions about why Aquinafil has

been prescribed for you.

Aquinafil is not addictive.

This medicine is available only with

a doctor's prescription.

Use in Children

The safety and effectiveness of this

medicine in children have not been

established.

Before you take

Aquinafil

When you must not take it

Do not take Aquinafil if:

you have an allergy to any

medicine containing quinapril or

any of the ingredients listed at the

end of this leaflet

you have taken any other 'ACE

inhibitor' medicine before, which

caused your face, lips, tongue,

throat, hands or feet to swell up,

or made it hard for you to breathe

you or your family have a history

of swelling of the face, lips,

tongue, throat, hands or feet for

no apparent reason.

Symptoms of an allergic reaction

may include skin rash, itchiness,

shortness of breath, swelling of the

face, lips or tongue, muscle pain or

tenderness or joint pain.

If you have had an allergic reaction

to an ACE inhibitor before, you may

be allergic to Aquinafil.

Use of ACE inhibitors have been

associated with Syndrome of

Inappropriate Anti-diuretic Hormone

AQUINAFIL™

(SIADH) and subsequent low blood

sodium levels.

Your doctor may wish to do a blood

test to monitor your sodium levels to

ensure they are within normal limits.

In the elderly and other at risk

patients sodium levels may be

monitored more frequently.

Do not take Aquinafil if:

you have kidney problems or a

condition called 'renal artery

stenosis'

you have regular dialysis for

blood filtration.

You may experience an allergic

reaction.

Do not take Aquinafil if you are

currently taking a blood pressure

lowering medicine containing

aliskiren or with medicines known

as angiotensin receptor blockers

(ARB) or other ACE inhibitors

and you have the following

conditions:

diabetes

kidney problems

high levels of potassium in your

blood

congestive heart failure.

You may experience severe side

effects.

Do not take this medicine if you

are pregnant or breastfeeding.

The active ingredient quinapril

hydrochloride may enter your womb

or it may pass into the breast milk

and there is the possibility that your

baby may be affected.

Do not take this medicine after the

expiry date printed on the pack or

if the packaging is torn or shows

signs of tampering.

If you are not sure whether you

should start taking this medicine,

talk to your doctor.

Before you start to take it

Tell your doctor if you have

allergies to:

any other medicines

any other substances, such as

foods, preservatives or dyes.

Tell your doctor if you have or

have had any medical conditions,

especially the following:

kidney problems, or are having

dialysis

liver problems

heart problems

low blood pressure, which you

may notice as dizziness or light-

headedness

diabetes

high levels of potassium in your

blood.

You must also tell your doctor if

you:

are following a very low salt diet

are about to receive

desensitisation therapy for an

allergy

are about to undergo dialysis or

lipoprotein apheresis

are about to have surgery or a

general anaesthetic

plan to become pregnant or

breastfeed.

If you have not told your doctor

about any of the above, tell him or

her before you start taking

Aquinafil.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including:

all prescription medicines

all medicines, vitamins, herbal

supplements or natural therapies

you buy without a prescription

from a pharmacy, supermarket,

naturopath or health food shop.

Some medicines may be affected by

Aquinafil or may affect how well it

works. You may need different

amounts of your medicines, or you

may need to take different medicines.

Your doctor will advise you.

Tell your doctor or pharmacist if

you are taking any of the

following:

other medicines used to treat high

blood pressure

other medicines that work in a

similar fashion to ACE Inhibitors,

such as Angiotensin Receptor

Blockers (these are used to treat

high blood pressure and/or heart

failure)

other medicines that contain the

same ingredients as Aquinafil e.g.

Accupril (not all brands given)

diuretics, also known as fluid or

water tablets

non-steroidal anti-inflammatory

drugs (NSAIDs) or Cox 2

inhibiting medicines used to

relieve pain, swelling and other

symptoms of inflammation,

including arthritis

potassium supplements or

potassium-containing salt

substitutes

lithium, a medicine used to treat

mood swings and some types of

depression

tetracycline antibiotics

trimethoprim or trimethoprim/

sulfamethoxazole, medicines used

to treat bacterial infections.

Tell your doctor if you are taking

any of the following blood pressure

lowering medicines:

angiotensin II receptor blocker

(ARB)

aliskiren.

For some patients, Aquinafil should

not be taken in combination with

these medicines.

Your doctor may check your kidney

function, blood pressure and the

amount of electrolytes (e.g.

potassium) in your blood at regular

intervals.

Tell your doctor if you are taking

any of the following medicines:

mTOR inhibitors (e.g.

temsirolimus), used in the

treatment of kidney cancer

DPP-IV inhibitors (e.g.

vildagliptin), used in the

treatment of diabetes.

AQUINAFIL™

NEP inhibitors (e.g. sacubitril /

valsartan), used in the treatment

of congestive heart failure.

Taking Aquinafil in combination

with these medicines may increase

your risk of having an allergic

reaction.

If you are not sure if you are taking

any of the medicines mentioned in

this leaflet, check with your doctor or

pharmacist.

Your doctor and pharmacist may

have more information on medicines

to be careful with or avoid while

taking this medicine.

How to take Aquinafil

Follow all directions given to you

by your doctor or pharmacist

carefully.

They may differ from the

information contained in this leaflet.

If you do not understand the

instructions on the box, ask your

doctor or pharmacist for help.

How much to take

Your doctor or pharmacist will tell

you how many tablets you need to

take each day. This will depend on

your condition and whether or not

you are taking any other medicines.

For high blood pressure

For most patients not on diuretics,

the usual starting dose is 5 mg to 10

mg taken once a day. The dose may

need to be increased depending on

your blood pressure at an interval of

4 weeks. Most patients take between

10 mg and 40 mg each day.

This dose may be taken once a day or

divided into two equal doses per day

(one in the morning and one at

night).

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. Your doctor will

advise whether the dose is to be

taken as a single dose or as two

separate doses (one in the morning

and one at night).

How to take it

Swallow the tablets whole with a

full glass of water.

Do not chew the tablets.

When to take it

Take your medicine at about the

same time each day.

Taking your tablets at the same time

each day will have the best effect. It

will also help you remember when to

take the tablets.

Take this medicine before meals.

Food with a high fat content may

interfere with the absorption of this

medicine.

How long to take it

Continue taking your medicine for

as long as your doctor tells you.

This medicine helps to control your

condition, but does not cure it. It is

important to keep taking your

medicine every day even if you feel

well.

If you forget to take it

If it is almost time for your next

dose, skip the dose you missed and

take your next dose when you are

meant to.

Otherwise, take it as soon as you

remember and then go back to

taking your medicine as you would

normally.

Do not take a double dose to make

up for the dose that you missed.

This may increase the chance of you

getting an unwanted side effect.

If you are not sure what to do, ask

your doctor or pharmacist.

If you have trouble remembering

to take your medicine, ask your

pharmacist for some hints.

If you take too much

(overdose)

Immediately telephone your doctor

or Poisons Information Centre

(telephone 13 11 26) for advice, or

go to Accident and Emergency at

the nearest hospital, if you think

that you or anyone else may have

taken too much Aquinafil.

Do this even if there are no signs of

discomfort or poisoning.

You may need urgent medical

attention.

If you take too much Aquinafil, you

may feel light-headed, dizzy or you

may faint.

While you are taking

Aquinafil

Things you must do

If you are about to be started on

any new medicine, remind your

doctor, dentist or pharmacist that

you are taking Aquinafil.

Make sure you drink enough water

during exercise and hot weather

when you are taking Aquinafil,

especially if you sweat a lot.

If you do not drink enough water

while taking Aquinafil, you may feel

faint, light-headed or sick. This is

because your blood pressure is

dropping suddenly. If you continue to

feel unwell, tell your doctor.

Tell your doctor if you have excess

vomiting or diarrhoea while taking

Aquinafil.

You may lose too much water and

salt and your blood pressure may

drop too much.

Tell your doctor immediately if

you feel light-headed or dizzy after

taking your first dose of Aquinafil,

or when your dose is increased.

This is especially important if you

are taking Aquinafil for heart failure.

If you are going to have surgery

that needs a general anaesthetic,

tell the surgeon, anaesthetist or

AQUINAFIL™

dentist that you are taking this

medicine.

Your blood pressure may drop

suddenly.

If you become pregnant while

taking this medicine, tell your

doctor immediately.

If you are about to have any blood

tests, tell your doctor that you are

taking Aquinafil.

This medicine may interfere with the

results of some tests as it can result in

sodium blood levels that are lower

than the normal limits

Have your blood pressure checked

when your doctor says, to make

sure Aquinafil is working.

Go to your doctor regularly for a

check-up.

Your doctor may occasionally do a

blood test to check your potassium

levels and see how your kidneys are

working.

Things you must not do

Do not give your medicine to

anyone else, even if they have the

same condition as you.

Do not take Aquinafil to treat any

other complaints unless your

doctor or pharmacist tells you to.

Do not stop taking your medicine

or change the dosage, without

checking with your doctor.

Things to be careful of

If you feel light-headed, dizzy or

faint when getting out of bed or

standing up, get up slowly.

Standing up slowly, especially when

you get up from bed or chairs, will

help your body get used to the

change in position and blood

pressure. If this problem continues or

gets worse, talk to your doctor.

Be careful driving or operating

machinery until you know how

Aquinafil affects you.

As with other ACE inhibitor

medicines, this medicine may cause

dizziness, light-headedness or

tiredness in some people. Make sure

you know how you react to this

medicine before you drive a car,

operate machinery, or do anything

else that could be dangerous if you

are dizzy or light-headed. If this

occurs do not drive. If you drink

alcohol, dizziness or light-

headedness may be worse.

Things that would be helpful

for your blood pressure or

heart failure

Some self-help measures suggested

below may help your condition.

Talk to your doctor or pharmacist

about these measures and for more

information.

Alcohol

Your doctor may advise you to limit

your alcohol intake.

Weight

Your doctor may suggest losing

some weight to help lower your

blood pressure and help lessen the

amount of work your heart has to do.

Some people may need a dietician's

help to lose weight.

Diet

Eat a healthy diet which includes

plenty of fresh vegetables, fruit,

bread (preferably wholegrain),

cereals and fish. Also eat less sugar

and fat (especially saturated fat)

which includes sausages, fatty meats,

full cream dairy products, biscuits,

cakes, pastries, chocolates, chips and

coconut. Monounsaturated and

polyunsaturated fats from olive oil,

canola oil, avocado and nuts are

beneficial in small quantities.

Salt

Your doctor may advise you to watch

the amount of salt in your diet. To

reduce your salt intake you should

avoid using salt in cooking or at the

table and avoid cooked or processed

foods containing high sodium (salt)

levels.

Exercise

Regular exercise, maintained over

the long term, helps to reduce blood

pressure and helps get the heart fitter.

Regular exercise also improves your

blood cholesterol levels, helps reduce

your weight and stress levels, and

improves your sleep, mood and

ability to concentrate. However, it is

important not to overdo it. Before

starting any exercise, ask your doctor

about the best kind of programme for

you.

Smoking

Your doctor may advise you to stop

smoking or at least cut down. Ask

your doctor or pharmacist for further

information and advice.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

Aquinafil.

Aquinafil helps most people with

high blood pressure and heart failure,

but it may have unwanted side effects

in a few people.

All medicines can have side effects.

Sometimes they are serious, most of

the time they are not. You may need

medical treatment if you get some of

the side effects.

It can be difficult to tell whether side

effects are the result of taking

Aquinafil, effects of your condition

or side effects of other medicines you

may be taking. For this reason it is

important to tell your doctor of any

change in your condition.

If you are over 65 years of age you

may have an increased chance of

getting side effects.

Do not be alarmed by the list of

side effects.

You may not experience any of them.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor if...

Ask your doctor or pharmacist for

advice if you notice any of the

following and they worry you:

AQUINAFIL™

feeling light-headed, dizzy or

faint

dry cough

headache

feeling sick (nausea) or vomiting

stomach pain

diarrhoea

constipation

unusual tiredness or weakness,

fatigue

feeling drowsy or sleepy during

the day

hair loss or thinning

dry mouth or throat

taste disturbances or loss of taste

confusion or nervousness

back pain

rash

difficulty in getting or

maintaining an erection.

These side effects are usually mild.

All side effects should be reported to

a health professional.

Tell your doctor as soon as

possible if...

Tell your doctor as soon as possible

if you notice any of the following:

disturbed vision

symptoms of sunburn (such as

redness, itching, swelling,

blistering) which may occur more

quickly than normal

itchy, raised or red skin rash

signs of worrying or frequent

infections such as fever, severe

chills, sore throat or mouth ulcers

aching, tender or weak joints or

muscles not caused by exercise

feelings of deep sadness and

unworthiness (depression)

severe upper stomach pain, often

with nausea and vomiting

passing little or no urine

bleeding or bruising more easily

than normal.

The above list includes serious side

effects that may require medical

attention. Serious side effects are

rare.

Go to hospital if...

Tell your doctor immediately or go

to Accident and Emergency at

your nearest hospital, if you notice

any of the following:

fainting within a few hours of

taking a dose

fast or irregular heart beat

shortness of breath or tightness in

the chest

sudden onset of stomach pains or

cramps with or without nausea or

vomiting

severe flaking or peeling of the

skin

severe blisters and bleeding in the

lips, eyes, mouth, nose and

genitals

chest pain.

These are very serious side effects.

You may need urgent medical

attention or hospitalisation. These

side effects are very rare.

Stop taking Aquinafil and tell your

doctor immediately or go to

Accident and Emergency at your

nearest hospital if you notice any of

the following:

swelling of the face, lips, mouth,

tongue or throat which may cause

difficulty in swallowing or

breathing.

Tell your doctor or pharmacist if

you notice anything that is making

you feel unwell.

Other side effects not listed above

may also occur in some people.

After taking Aquinafil

Storage

Keep your tablets in the box until

it is time to take them.

If you take the tablets out of the box

they may not keep well.

Keep your tablets in a cool dry

place where the temperature stays

below 25°C.

Do not store Aquinafil or any other

medicine in the bathroom or near a

sink.

Do not leave it on a windowsill or

in the car on hot days.

Heat and dampness can destroy some

medicines.

Keep it where children cannot

reach it.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Disposal

If your doctor or pharmacist tells

you to stop taking this medicine or

the tablets have passed their expiry

date, ask your pharmacist what to

do with any that are left over.

Product description

What it looks like

Aquinafil tablets come in three

strengths and each has a different

appearance:

Aquinafil 5 mg - Reddish-brown,

oval, biconvex, film-coated tablet

with bisecting score on both sides

and debossing "5" on both sides in

opposite direction.

Aquinafil 10 mg - Reddish-brown,

triangular, biconvex film-coated

tablet with bisecting score on both

sides and debossing "10" on one side.

Aquinafil 20 mg - Reddish-brown,

round, biconvex film-coated tablet,

with bisecting score on both sides

and debossing "20" on one side.

A box of Aquinafil contains 30

tablets.

Ingredients

Active ingredient:

Aquinafil 5 mg - 5 mg quinapril

(as the hydrochloride)

AQUINAFIL™

Aquinafil 10 mg - 10 mg

quinapril (as the hydrochloride)

Aquinafil 20 mg - 20 mg

quinapril (as the hydrochloride)

Other ingredients:

magnesium carbonate hydrate

lactose monohydrate

gelatin

crospovidone

magnesium stearate

candelilla wax

iron oxide red

titanium dioxide.

Aquinafil does not contain sucrose,

gluten, tartrazine or any other azo

dyes.

Supplier

Aquinafil is supplied in Australia by:

Pfizer Australia Pty Ltd

ABN 50 008 422 348

38-42 Wharf Road

West Ryde NSW 2114

Australia

Toll Free Number: 1800 675 229

Australian Registration

Numbers

Aquinafil 5 mg - AUST R 173708

Aquinafil 10 mg - AUST R 173709

Aquinafil 20 mg - AUST R 173710

Date of preparation

This leaflet was prepared in April

2017. © Pfizer Australia Pty Ltd

2015.

AQUINAFIL™