ACQUIN quinapril (as hydrochloride) 10 mg tablet blister pack

Main information

  • Trade name:
  • ACQUIN quinapril (as hydrochloride) 10 mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ACQUIN quinapril (as hydrochloride) 10 mg tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 192147
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

192147

ACQUIN quinapril (as hydrochloride) 10 mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Arrow Pharma Pty Ltd

Postal Address

15 - 17 Chapel Street,Cremorne, VIC, 3121

Australia

ARTG Start Date

8/12/2011

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. ACQUIN quinapril (as hydrochloride) 10 mg tablet blister pack

Product Type

Single Medicine Product

Effective date

11/02/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

HYPERTENSION: Quinapril hydrochloride tablets are 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 quinapril tablets in renovascular hypertension. CONGESTIVE HEART FAILURE:

Quinapril hydrochloride tablets are 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

Al/Al

2 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. ACQUIN quinapril 10mg (as hydrochloride) tablets

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Yellow coloured, oval shaped, film coated tablets debossed with '10' on one

side and scoreline on the other side.

Active Ingredients

quinapril hydrochloride

10.832 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 28.11.2017 at 09:27:57 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

ACQUIN- Consumer Medicine Information

Page 1 of 5

ACQUIN

quinapril (as hydrochloride)

Consumer Medicine Information (CMI)

What is in this leaflet

This leaflet answers some common

questions about ACQUIN.

It does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have benefits and

risks. Your doctor has weighed the

risks of you taking ACQUIN 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 ACQUIN is used for

ACQUIN is used to lower high blood

pressure (hypertension). It is also

used to treat heart failure. It

contains the active ingredient

quinapril hydrochloride.

Hypertension

ACQUIN 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 it works

ACQUIN 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.

ACQUIN belongs to a group of

medicines called angiotensin

converting enzyme (ACE) inhibitors.

Your doctor may have prescribed

ACQUIN for another reason. Ask

your doctor if you have any

questions about why ACQUIN has

been prescribed for you.

ACQUIN is not addictive.

This medicine is available only with

a doctor's prescription.

Before you take ACQUIN

When you must not take it

Do not take ACQUIN if you are

allergic to medicines containing

quinapril or any of the

ingredients listed at the end of

this leaflet.

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.

Do not take ACQUIN if 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

If you have had an allergic

reaction to an ACE inhibitor

before, you may be allergic to

ACQUIN.

a history of swelling of the face,

lips, tongue, throat, hands or feet

for no apparent reason

kidney problems or a condition

called renal artery stenosis

regular dialysis for blood filtration.

Do not take ACQUIN if you are

pregnant or breastfeeding.

ACQUIN 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 it if the expiry date

(Exp.) printed on the pack has

passed.

It may not work as well if you do.

Do not take it if the packaging

shows signs of tampering or the

tablets do not look quite right.

If you are not sure whether you

should start taking ACQUIN, talk

to your doctor.

Before you start to take it

Tell your doctor if you are allergic

to any other medicines, foods,

dyes or preservatives.

ACQUIN- Consumer Medicine Information

Page 2 of 5

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:

have a family history of swelling of

the face, lips, tongue, throat,

hands or feet

are following a very low salt diet

are about to receive

desensitisation therapy for an

allergy

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 them

before you start taking ACQUIN.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including

any that you buy without a

prescription from a pharmacy,

supermarket or health food shop.

Some medicines may be affected

by ACQUIN, or may affect how well

it works. These include:

other medicines used to treat high

blood pressure

diuretics, also known as fluid or

water tablets

non-steroidal anti-inflammatory

drugs (NSAIDs), 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.

Your doctor can tell you what to do

if you are taking any of these

medicines.

If you are not sure whether you

are taking any of these

medicines, check with your

doctor or pharmacist.

Your doctor and pharmacist have

more information on medicines to

be careful with or avoid while taking

ACQUIN.

Use in children

The safety and effectiveness of

ACQUIN in children have not been

established.

How to take ACQUIN

Follow all directions given to you

by your doctor or pharmacist

carefully.

They may differ from the information

contained in this leaflet.

Your doctor or pharmacist will tell

you how many tablets you will need

to take each day. This depends on

your condition and whether or not

you are taking any other medicines.

If you do not understand the

instructions on the box, ask your

doctor or pharmacist for help.

How much to take

For high blood pressure

For most patients, not on diuretics,

the usual starting dose is 5 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 and 40 mg each day.

This dose may be taken once a day

or divided into two equal doses per

day.

For heart failure

The usual starting dose is 5 mg

taken once a day. In most patients,

effective doses are between 10 and

20 mg a day. Your doctor will advise

whether the dose is to be taken a

single dose or as two separate

doses.

How to take it

Swallow ACQUIN with a full glass

of water.

Do not chew the tablets.

When to take it

Take ACQUIN 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 ACQUIN before meals. Food

with a high fat content may interfere

with the absorption of the medicine.

How long to take it

ACQUIN helps control your

condition, but does not cure it.

Therefore you must take it every

day. Continue taking your medicine

for as long as your doctor tells you.

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 the missed dose

as soon as you remember, and

then go back to taking your

tablets 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 ACQUIN

(overdose)

Immediately telephone your

doctor, or the Poisons

Information Centre (telephone 13

11 26), or go to Accident and

Emergency at the nearest

hospital, if you think you or

anyone else may have taken too

much ACQUIN. Do this even if

there are no signs of discomfort

or poisoning.

You may need urgent medical

attention.

ACQUIN- Consumer Medicine Information

Page 3 of 5

If you take too much ACQUIN, you

may feel light-headed, dizzy or you

may faint.

While you are taking

ACQUIN

Things you must do

Before starting any new

medicine, tell your doctor or

pharmacist that you are taking

ACQUIN.

Make sure you drink enough

water during exercise and hot

weather when you are taking

ACQUIN, especially if you sweat

a lot.

If you do not drink enough water

while taking ACQUIN, 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.

If you have excess vomiting or

diarrhoea while taking ACQUIN,

tell your doctor.

You may lose too much water and

salt and your blood pressure may

drop too much.

If you feel light-headed or dizzy

after taking your first dose of

ACQUIN, or when your dose is

increased, tell your doctor

immediately.

This is especially important if you

are taking ACQUIN for heart failure.

If you plan to have surgery that

needs a general anaesthetic, tell

your doctor or dentist that you

are taking ACQUIN.

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 ACQUIN.

The medicine may interfere with the

results of some tests.

Have your blood pressure

checked when your doctor says,

to make sure ACQUIN 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 ACQUIN to anyone

else, even if they have the same

condition as you.

Do not take it to treat any other

complaints unless your doctor or

pharmacist tells you to.

Do not stop taking ACQUIN, or

lower 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

ACQUIN affects you.

As with other ACE inhibitor

medicines, ACQUIN may cause

dizziness, light-headedness or

tiredness in some people. Make

sure you know how you react to

ACQUIN 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. Walking

is good exercise, but try to find a

route that is reasonably flat.

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. There are enormous

benefits to be gained from giving

up smoking. There are many

professionals, organisations and

strategies to help you quit. 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

ACQUIN.

ACQUIN- Consumer Medicine Information

Page 4 of 5

Like all other medicines, ACQUIN

may have unwanted side effects in

some people. Sometimes they are

serious, most of the time they are

not. You may need medical

treatment if you get some of the

side effects.

If you are over 65 years of age you

may have an increased chance of

getting side effects.

Do not be alarmed by this list of

possible side effects.

You may not experience any of

them.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor or pharmacist if

you notice any of the following

and they worry you:

dry cough

feeling light-headed, dizzy or faint

because your blood pressure is

too low

headache

feeling sick (nausea) or vomiting

stomach pain

diarrhoea

constipation

aching, tender or weak muscles

not caused by exercise

unusual tiredness or weakness,

fatigue

feelings of deep sadness and

unworthiness (depression)

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.

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

fast or irregular heart beat

shortness of breath or tightness in

the chest

signs of worrying or frequent

infections such as fever, severe

chills, sore throat or mouth ulcers

severe upper stomach pain, often

with nausea and vomiting

passing little or no urine

bleeding or bruising more easily

than normal.

These may be serious side effects.

You may need medical attention.

Serious side effects are rare.

If any of the following happen,

stop taking ACQUIN and either

tell your doctor immediately or

go to Accident and Emergency at

your nearest hospital:

fainting within a few hours of

taking a dose

swelling of the face, lips, mouth,

tongue or throat which may cause

difficulty in swallowing or

breathing

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.

Other side effects not listed

above may occur in some

patients. Tell your doctor or

pharmacist if you notice anything

that is making you feel unwell.

After using it

Storage

Keep your tablets in the pack

until it is time to take them.

If you take the tablets out of the

pack they will not keep well.

Keep ACQUIN 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.

Keep your tablets in a cool dry

place where the temperature

stays below 25

C.

Do not store ACQUIN or any

other medicine in the bathroom

or near a sink.

Do not leave ACQUIN on a

windowsill or in the car on hot

days.

Heat and dampness can destroy

some medicines.

Disposal

If your doctor or pharmacist tells

you to stop taking ACQUIN, or

your tablets have passed their

expiry date, ask your pharmacist

what to do with any that are left

over.

Product description

What it looks like

ACQUIN comes in 3 strengths of

tablets:

ACQUIN 5 - Yellow, oval, film-

coated tablets debossed with “5”

on one side and a breakline on

the other.

ACQUIN 10 - Yellow, capsule

shaped, film-coated tablets

debossed with “10” on one side

and a breakline on the other.

ACQUIN 20 - Yellow, round, film-

coated tablets debossed with “20”

on one side and a breakline on

the other.

Each blister pack contains 30

tablets.

Ingredients

The active ingredient in ACQUIN is

quinapril (as hydrochloride):

each ACQUIN 5 tablet contains

5 mg of quinapril.

each ACQUIN 10 tablet contains

10 mg of quinapril.

each ACQUIN 20 tablet contains

20 mg of quinapril.

The tablets also contain:

magnesium carbonate – heavy

calcium sulphate dihydrate

colloidal anhydrous silica

crospovidone

povidone

magnesium stearate

polyvinyl alcohol

ACQUIN- Consumer Medicine Information

Page 5 of 5

titanium dioxide

purified talc

lecithin

iron oxide yellow

xanthan gum

The tablets are gluten free.

Supplier

Aspen Pharma Pty Ltd

34-36 Chandos St

St Leonards NSW 2065

Australia

Australian registration numbers:

ACQUIN 5 –

AUST R 192146

ACQUIN 10 –

AUST R 192147

ACQUIN 20 –

AUST R 192148

Date of preparation:

February 2016