APO-LISINOPRIL

Main information

  • Trade name:
  • APO-LISINOPRIL lisinopril 5mg (as dihydrate) tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • APO-LISINOPRIL lisinopril 5mg (as dihydrate) tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 213393
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

213393

APO-LISINOPRIL lisinopril 5mg (as dihydrate) tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

17/10/2013

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. APO-LISINOPRIL lisinopril 5mg (as dihydrate) tablet blister pack

Product Type

Single Medicine Product

Effective date

15/01/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Hypertension: For 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: For treatment of

heart failure, it is recommended that lisinopril be administered with a diuretic. Acute myocardial infarction: For 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.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

84 tablets

(S4) Prescription Only Medicine

30 tablets

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

56 tablets

(S4) Prescription Only Medicine

28 tablets

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. APO-LISINOPRIL lisinopril 5mg (as dihydrate) tablet blister pack

Dosage Form

Tablet, uncoated

Route of Administration

Oral

Visual Identification

Light pink coloured, circular, biconvex, uncoated tablets with '5' embossing

and breakline on one side, and 'BL' embossing on the other side.

Active Ingredients

Lisinopril dihydrate

QS

© 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 26.11.2017 at 11:14:33 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

APO-Lisinopril Tablets

Contains the active ingredient lisinopril (as lisinopril dihydrate)

Consumer Medicine Information

For a copy of a large print leaflet, Ph: 1800 195 055

What is in this leaflet

Read this leaflet carefully before

taking your medicine.

This leaflet answers some common

questions about lisinopril. It does not

contain all the available information.

It does not take the place of talking to

your doctor or pharmacist.

The information in this leaflet was

last updated on the date listed on the

last page. More recent information on

this medicine may be available.

Ask your doctor or pharmacist:

if there is anything you do not

understand in this leaflet,

if you are worried about taking

your medicine, or

to obtain the most up-to-date

information.

You can also download the most up

to date leaflet from

www.apotex.com.au.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you using this medicine

against the benefits they expect it

will have for you.

Pharmaceutical companies cannot

give you medical advice or an

individual diagnosis.

Keep this leaflet with your medicine.

You may want to read it again.

What this medicine is

used for

The name of your medicine is APO-

Lisinopril. It contains the active

ingredient lisinopril (as lisinopril

dihydrate).

It is used to treat the following:

People with mild or moderate

hypertension (high blood

pressure)

People with congestive heart

failure

People with acute myocardial

infarction (heart attack)

High Blood Pressure

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.

People with high blood pressure

often feel fine and have no

symptoms. You can only tell if you

have high blood pressure by having

your blood pressure regularly

checked. If high blood pressure is not

treated it can lead to serious health

problems, including stroke, heart

disease and kidney failure.

Lisinopril is used to lower high blood

pressure (hypertension).

Congestive Heart Failure

Heart failure means that the heart

muscle 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 working.

Heart failure may start off with no

symptoms, but as the condition

progresses, people may feel short of

breath or may get tired easily after

light physical activity such as

walking. Some people 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.

Lisinopril may help to improve the

symptoms of heart failure.

When used to treat heart failure,

lisinopril is almost always used with

other medicines called diuretics or

fluid tablets. These medicines help

the kidney to get rid of excess fluid

from the body.

Heart Attack

A heart attack occurs when one of

the major blood vessels supplying

blood to the heart muscle becomes

blocked. As a result of the blockage,

the heart does not receive the oxygen

it needs and the heart muscle

becomes damaged. This may lead to

further complications such as heart

failure, irregular heart rhythms and

blood clots.

In some patients, lisinopril may help

to prevent some of the further

complications of heart attack, such as

heart failure.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you. Your

APO-LISINOPRIL TABLETS

doctor may have prescribed this

medicine for another reason.

This medicine is available only with

a doctor's prescription.

How it works

Lisinopril belongs to a group of

medicines called Angiotensin

Converting Enzyme (ACE)

inhibitors.

It widens the blood vessels so that

blood can pass through them more

easily. This means that your blood

pressure will drop, and it also means

that if you have heart failure your

heart can cope with doing some

exercise and you won't run out of

breath as easily.

Lisinopril also helps prevent

complications which follow a heart

attack, such as heart failure.

There is no evidence that this

medicine is addictive.

Use in children

This medicine should not be used in

children.

Before you take this

medicine

When you must not take it

Do not take this medicine if:

You have or have had any of the

following:

renal artery stenosis (a problem

with the blood vessels to one or

both kidneys).

renal dialysis using

polyacrylonitrile high flux

membranes.

You are taking the following

medications:

aliskiren-containing medicines in

patients with diabetes

aliskiren-containing medicines in

patients with moderate to severe

kidney problems

You are pregnant.

Lisinopril may affect your

developing baby if you take it during

pregnancy.

You have had an allergic reaction

to lisinopril or any of the

ingredients listed at the end of this

leaflet.

Symptoms of an allergic reaction

may include cough, shortness of

breath, wheezing or difficulty

breathing; swelling of the face, lips,

tongue, throat or other parts of the

body, rash, itching or hives on the

skin; fainting or hayfever-like

symptoms

If you think you are having an

allergic reaction, do not take any

more of the medicine and contact

your doctor immediately or go to

the Accident and Emergency

department at the nearest hospital.

You have had a reaction to other

types of ACE inhibitors which

made your face, lips, tongue,

throat, hands or feet swell up, or

you had trouble breathing.

If you have had this type of allergic

reaction to another ACE inhibitor

you may have the same reaction to

lisinopril.

You have previously had swollen

face, lips, tongue, throat, hands or

feet or breathlessness, for no

apparent reason (a rare allergic

condition known as angio-oedema).

The expiry date (EXP) printed on

the pack has passed.

The packaging is torn, shows signs

of tampering or it does not look

quite right.

Before you start to take it

You have allergies to:

any other medicines

any other substances, such as

foods, preservatives or dyes.

You have or have had any

medical conditions, especially the

following:

kidney problems, or you are

having dialysis

diabetes

liver problems

heart problems

cerebrovascular disease (which

affects blood flow to the brain)

low blood pressure (you may

notice this as faintness or

dizziness, especially when

standing)

recent diarrhoea or vomiting

low levels of sodium, or high

levels of potassium in your blood

You are currently pregnant or you

plan to become pregnant. Do not

take this medicine whilst

pregnant.

You are currently breastfeeding

or you plan to breast-feed. Do not

take this medicine whilst

breastfeeding until you and your

doctor have discussed the risks

and benefits involved.

You are planning to have surgery

or a general anaesthetic.

You are following a very low salt

diet.

You are having desensitisation

treatment or have had an allergic

reaction during previous

desensitisation treatment (e.g.

treatments using bee, wasp or ant

venom).

You are currently receiving or are

planning to receive dental

treatment.

You are taking or are planning to

take any other medicines. This

includes vitamins and

supplements that are available

from your pharmacy, supermarket

or health food shop.

Some medicines may interact with

lisinopril. These include:

other medicines used for treating

high blood pressure

diuretics (fluid, or water tablets)

potassium- sparing diuretics such

as spironolactone, eplerenone,

triamterene and amiloride

potassium tablets or potassium-

containing salt substitutes

APO-LISINOPRIL TABLETS

lithium, used for mood swings

and depression

medicines to relieve pain,

swelling and other symptoms of

inflammation, including arthritis,

such as gold therapy, Non-

Steroidal Anti-inflammatory

Drugs (NSAIDs) (e.g.

indomethacin) or COX-2

inhibitors (e.g. Celebrex). It is

especially important to tell your

doctor when taking blood

pressure, water and/or heart

tablets together with NSAIDs or

COX-2 inhibitors and lisinopril.

tablets or injections used for

treating diabetes. Your blood

glucose levels should be closely

monitored whilst taking lisinopril,

especially during the first month.

general anaesthetics

If you are taking any of these you

may need a different dose or you

may need to take different medicines.

Other medicines not listed above

may also interact with lisinopril.

How to take this

medicine

Follow carefully all directions given

to you by your doctor. Their

instructions may be different to the

information in this leaflet.

How much to take

Your doctor or pharmacist will tell

you how much of this medicine you

should take. This will depend on

your condition and whether you are

taking any other medicines. If you

need to take 2.5 mg then you must

use a different brand of lisinopril, as

the 5 mg tablets must not be broken

in half to give a 2.5 mg dose.

High blood pressure

Most people start with 5 to 10 mg per

day (although some may have less).

The doctor will monitor your blood

pressure and will gradually increase

the dose of lisinopril if necessary.

Most patients take between 10 and 20

mg once each day.

Heart Failure

The usual starting dose is 2.5 mg,

taken once a day.

Depending on your response, this

dose may need to be gradually

increased.

The usual dose is 5 to 20 mg each

day, taken once a day.

Heart Attack

You may start taking lisinopril within

24 hours of the start of a heart attack,

and continue taking it for six weeks

or more.

The usual starting dose is 5 mg,

followed by 5 mg 24 hours later.

Then 10 mg is taken 48 hours later,

and once every day after that.

Some patients may have lower doses.

Do not stop taking your medicine or

change your dosage without first

checking with your doctor.

How to take it

Swallow your tablets with a glass of

water.

When to take it

Take this medicine at the same time

each day. Taking it at the same time

each day will have the best effect and

will also help you remember when to

take it.

It does not matter if you take it

before, with or after food.

How long to take it for

Lisinopril can help control blood

pressure, improve heart failure and

prevent complications of heart attack,

but it cannot cure them. Therefore

you will need to take this medicine

every day.

Continue taking your medicine for as

long as your doctor tells you.

Make sure you have enough to last

over weekends and holidays.

If you forget to take it

If it is almost time to take your next

dose, skip the missed dose and take

your next dose at the usual time.

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 missed doses.

This may increase the chance of you

experiencing side effects.

If you have trouble remembering to

take your medicine, ask your

pharmacist for some hints to help you

remember.

If you take too much

(overdose)

If you think that you or anyone

else may have taken too much of

this medicine, immediately

telephone your doctor or the

Poisons Information Centre (Tel:

13 11 26 in Australia) for advice.

Alternatively, go to the Accident

and Emergency department at

your nearest hospital.

Do this even if there are no signs of

discomfort or poisoning. You may

need urgent medical attention.

If you take too much lisinopril, you

may feel dizzy or light-headed, or

you may faint.

While you are taking

this medicine

Things you must do

Tell your doctor that you are

taking this medicine if:

you are about to be started on any

new medicine

you are pregnant or are planning

to become pregnant

you are breast-feeding or are

planning to breast-feed

you are about to have any blood

tests

APO-LISINOPRIL TABLETS

you are going to have surgery or

an anaesthetic or are going into

hospital. Your blood pressure

may drop suddenly during a

general anaesthetic.

you have diarrhoea or vomiting.

This may lead to dehydration, and

your blood pressure may drop too

much.

Your doctor will do regular blood

tests and may occasionally do other

tests to make sure the medicine is

working and to prevent side effects.

Go to your doctor regularly for a

check-up.

Tell your doctor immediately if

you feel light-headed, dizzy or

faint, after taking your first dose of

lisinopril, or after your dose is

increased.

This is especially important if you

are taking lisinopril for heart failure.

To avoid feeling light-headed,

dizzy or faint, get up slowly when

getting out of bed or standing up.

This feeling may be because your

blood pressure is falling suddenly,

especially if you are also taking a

diuretic (water) tablet. Standing up

slowly from a lying or sitting

position will help your body get used

to the change in position and blood

pressure. If this problem gets worse

or continues, tell your doctor.

Drink plenty of water during

exercise and hot weather,

especially if you sweat a lot.

If you become dehydrated your blood

pressure may drop too much and you

may feel light-headed or sick. If you

continue to feel unwell, see your

doctor.

Things you must not do

Do not:

Give this medicine to anyone

else, even if their symptoms seem

similar to yours.

Take your medicine to treat any

other condition unless your

doctor tells you to

Stop taking your medicine, or

change the dosage, without first

checking with your doctor.

Things to be careful of

Be careful when driving or operating

machinery or doing any other

dangerous activity until you know

how this medicine affects you.

Lisinopril may cause dizziness or

light-headedness in some people,

which may affect their reaction

times. This is more likely to happen

after the first dose or after increasing

the dose.

Make sure you know how you react

to lisinopril 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, avoid the above activities.

If you drink alcohol, the 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.

Diet

Eat a healthy diet which includes

plenty of fresh vegetables, fruit,

bread, cereals and fish. Also eat less

fat and sugar.

Exercise

Regular exercise helps to reduce

blood pressure and helps the heart get

fitter, but it is important not to

overdo it. Walking is good exercise,

but try to find a route that is fairly

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.

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.

Possible side effects

Tell your doctor as soon as possible

if you do not feel well while you are

taking lisinopril or if you have any

questions or concerns.

Do not be alarmed by the following

lists of side effects. You may not

experience any of them. All

medicines can have side effects.

Sometimes they are serious but most

of the time they are not.

Tell your doctor or pharmacist if

you notice any of the following and

they worry you.

This list includes the more common

side effects. Mostly, these are mild:

headache

dizziness

fatigue, weakness

a persistent, dry cough

mild stomach upsets such as

feeling or being sick, indigestion,

diarrhoea, constipation, wind or

stomach pains

Other possible reactions include:

flushing

loss of appetite

feeling sleepy or having problems

going to sleep, strange dreams

hair loss or thinning

changes in the way things taste or

smell

blurred vision

gout

flu-like symptoms

blocked or runny nose or sinus

pain.

muscle, joint, back, neck, leg or

shoulder pain

APO-LISINOPRIL TABLETS

skin problems including itchiness,

rash, or painful areas

sunburn-type rash following short

exposure to the sun

psoriasis and other serious skin

conditions

Tell your doctor as soon as possible

if you notice any of the following.

These may be serious side effects.

You may need medical attention.

Most of these side effects are rare.

light-headedness or dizziness,

especially during the first few

days of taking lisinopril

changes in the way your heart

beats, for example, if you notice

it beating faster

chest pain

difficulty breathing, wheezing

feeling confused, anxious or

depressed

signs of frequent or worrying

infections such as fever, severe

chills, sore throat or mouth ulcers

bruising more easily than normal

severe abdominal pain

high or low blood sugar levels

weakness, tingling or numbness

of the hands or feet

passing urine more or less than is

normal for you; burning feeling

when urinating, kidney pain,

blood in the urine or cloudy urine

signs of dehydration such as dry

mouth, muscle cramps, headache,

nausea, vomiting, drowsiness,

irritability and tiredness. This

may be caused by vomiting,

diarrhoea, excessive perspiration

or not enough water. If untreated,

mental confusion and fits may

develop. Your doctor may need to

monitor your blood sodium

levels.

If you experience any of the

following, stop taking your

medicine and contact your doctor

immediately or go to the Accident

and Emergency department at

your nearest hospital.

These are very serious side effects

and are usually very rare. You may

need urgent medical attention or

hospitalisation.

swelling of the hands, feet,

ankles, face, lips, mouth or throat,

difficulty in swallowing or

breathing

fainting, especially during the

first few days of taking lisinopril

pinkish, itchy swellings on the

skin, also called hives or nettle

rash

yellowing of the skin and/or eyes,

also called jaundice

severe skin reaction which starts

with painful red areas, then large

blisters and ends with peeling of

layers of skin. This may be

accompanied by fever and chills,

aching muscles and generally

feeling unwell.

Other side effects not listed above

may occur in some patients.

Allergic reactions

If you think you are having an

allergic reaction to lisinopril, do

not take any more of this medicine

and tell your doctor immediately

or go to the Accident and

Emergency department at your

nearest hospital.

Symptoms of an allergic reaction

may include some or all of the

following:

cough, shortness of breath,

wheezing or difficulty breathing

swelling of the face, lips, tongue,

throat or other parts of the body

rash, itching or hives on the skin

fainting

hay fever-like symptoms.

Storage and disposal

Storage

Keep your medicine in its original

packaging until it is time to take it.

If you take your medicine out of its

original packaging it may not keep

well.

Keep your medicine in a cool dry

place where the temperature will stay

below 25°C.

Do not store your medicine, or any

other medicine, in the bathroom or

near a sink.

Do not leave it on a window sill or in

the car.

Heat and dampness can destroy some

medicines.

Keep this medicine 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 tells you to stop taking

this medicine or it has passed its

expiry date, your pharmacist can

dispose of the remaining medicine

safely.

Product description

What APO-Lisinopril Tablets

look like

Lisinopril 5 mg tablets:

Light pink coloured, circular,

biconvex, uncoated tablets with "5"

embossed and break line on one side

and "BL" embossing on other side.

Lisinopril 10 mg tablets:

Light pink coloured, circular,

biconvex, uncoated tablets with "10"

embossed on one side and "BL"

embossing on other side.

Lisinopril 20 mg tablets:

Pink coloured, circular, biconvex,

uncoated tablets with "20" embossed

on one side and "BL" embossing on

other side.

Alternative lisinopril products should

be used if a 2.5 mg dose is required.

The 5 mg tablets must not be broken

in half to give a 2.5 mg dose.

APO-LISINOPRIL TABLETS

Ingredients

Each tablet contains 5, 10 or 20 mg

of lisinopril, present as lisinopril

dihydrate, as the active ingredient.

It also contains the following inactive

ingredients:

calcium hydrogen phosphate

Mannitol

maize starch

magnesium stearate

iron oxide red.

This medicine is gluten-free, lactose-

free, sucrose-free, tartrazine-free and

free of other azo dyes.

Australian Registration

Numbers

APO-Lisinopril 5 mg tablets:

PVC/Al blister packs of 10, 14, 28,

30, 50, 56, 84 and 100 tablets.

AUST R 213393.

APO-Lisinopril 10 mg tablets:

PVC/Al blister packs of 10, 14, 28,

30, 50, 56, 84 and 100 tablets. AUST

R 213394.

APO-Lisinopril 20 mg tablets:

PVC/Al Blister packs of 10, 14, 28,

30, 50, 56, 84 and 100 tablets.

AUST R 213395.

*Not all strengths or pack sizes may

be available

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

APO and APOTEX are registered

trade marks of Apotex Inc.

This leaflet was prepared in May

2016

APO-LISINOPRIL TABLETS

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