APO-ENALAPRIL enalapril maleate 5 mg tablet blister pack

Main information

  • Trade name:
  • APO-ENALAPRIL enalapril maleate 5 mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • APO-ENALAPRIL enalapril maleate 5 mg tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 196472
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

196472

APO-ENALAPRIL enalapril maleate 5mg 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

28/05/2013

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-ENALAPRIL enalapril maleate 5mg tablet blister pack

Product Type

Single Medicine Product

Effective date

16/09/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

HYPERTENSION ,Enalapril is indicated in the treatment of all grades of essential hypertension and renovascular hypertension. ,CONGESTIVE HEART

FAILURE ,Enalapril is indicated for the treatment of all degrees of symptomatic heart failure. In such patients, it is recommended that Enalapril be

administered together with a diuretic. ,LEFT VENTRICULAR DYSFUNCTION ,All degrees of left ventricular dysfunction where the left ventricular ejection

fraction is less than 35 percent, irrespective of the presence or severity of obvious symptoms of heart failure.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Carton

PVC/PVDC/Al

36 Months

Store below 25

degrees Celsius

Not recorded

Protect from Moisture

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. APO-ENALAPRIL enalapril maleate 5mg tablet blister pack

Dosage Form

Tablet

Route of Administration

Oral

Visual Identification

White to off white, round, flat faced, beveled edge tablets with breakline on

one side and "5" debossed on the other side.

Active Ingredients

enalapril maleate

5 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 01:59:31 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

APO-Enalapril

Contains the active ingredient enalapril (as enalapril maleate)

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 enalapril. 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-

Enalapril tablets. It contains the

active ingredient enalapril maleate.

It is used to treat heart failure.

It lowers high blood pressure, which

doctors call hypertension.

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. You

may feel fine and have no symptoms,

but eventually hypertension can

cause stroke, heart disease and

kidney failure. It helps to lower your

blood pressure.

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, 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.

Enalapril helps to treat heart failure,

whether you have symptoms or not.

In many patients with heart failure

who have symptoms, it may slow the

progression of heart failure and

reduce the need to go to hospital as a

result of heart failure. It may help

some of these patients live longer.

In many patients with heart failure

who have no symptoms, enalapril

may help to stop the heart muscle

from getting weaker. It may also

slow down the development of

symptoms, such as shortness of

breath, tiredness after light physical

activity, or swelling of the ankles and

feet. These patients may be less

likely to have hospital stays due to

heart failure.

By taking this medicine, heart failure

patients may have less chance of

having a heart attack.

When used to treat heart failure,

enalapril is almost always used with

other medicines called diuretics or

fluid tablets. These medicines help

the kidney get rid of excess fluid

from the body.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you. Your

doctor may have prescribed this

medicine for another reason.

This medicine is available only with

a doctor's prescription.

How it works

One of the ways this medicine helps

lower blood pressure and treat heart

failure is that it widens blood vessels.

This means that blood is able to pass

through them more easily and the

heart doesn't have to pump as hard to

APO-ENALAPRIL

move blood around the body. This

also means that when you place extra

demands on your heart, such as

during exercise, the heart may cope

better so you may not get short of

breath as easily.

Enalapril belongs to a group of

medicines called Angiotensin

Converting Enzyme (ACE)

inhibitors.

Your doctor may prescribe this

medicine for another reason. Ask

your doctor if you have any questions

about why this medicine has been

prescribed for you.

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 taken any other 'ACE

inhibitor' medicines for high

blood pressure or heart failure

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

enalapril.

You have an allergy to

enalapril, 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.

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 a history of swelling

of the face, lips, tongue, throat,

hands or feet, for no apparent

reason.

You have diabetes while also

taking aliskiren (Rasilez) for

blood pressure control.

You are pregnant.

Do not take enalapril if you are

pregnant or breastfeeding. Your

baby may absorb this medicine in

the womb or from breast milk and

therefore there is a possibility of

harm to the baby.

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.

If you are not sure whether you

should start taking this medicine, talk

to your doctor.

Before you start to take it

Before you start taking this

medicine, tell your doctor if:

1.

You have allergies to:

any other medicines

any other substances, such as

foods, preservatives or dyes.

2.

You have or have had any

medical conditions, especially

the following:

kidney disease, or are undergoing

dialysis

diabetes

heart problems

3.

You are or intend to become

pregnant or intend to

breastfeed.

This medicine should not be used

during pregnancy or while

breastfeeding.

4.

You have recently suffered

from excessive vomiting or

diarrhoea.

5.

You are following a very low

salt diet.

6.

You suffer from low blood

pressure

You may notice this as faintness

or dizziness, especially when

standing.

7.

You are planning to have

surgery and anaesthesia (even

at the dentist office)

You may experience a sudden fall

in blood pressure associated with

anaesthesia.

Taking other medicines

Some medicines may interact with

enalapril. These include:

other blood pressure medicines

(some medications are not

recommended while taking

enalapril - speak to your doctor to

confirm)

diuretic tablets - also called fluid

or water tablets

lithium, a medicine used to treat

mood swings and some types of

depression

potassium tablets

potassium-containing salt

substitutes

potassium-sparing agents (e.g.

spironolactone, eplerenone,

triamterene, amiloride), non-

steroidal anti-inflammatory

medicines (NSAIDs or "Coxibs"/

COX-2 inhibitors), used to relieve

pain, swelling and other

symptoms of inflammation

arthritis medicines including gold

therapy

insulin or oral ant diabetic

medicines. You should be closely

monitored for low blood glucose

levels, especially during the first

month of treatment with enalapril

mTOR inhibitors (e.g.,

temsirolimus, sirolimus,

everolimus).

If you are taking any of these you

may need a different dose or you

may need to take different medicines.

APO-ENALAPRIL

Other medicines not listed above

may also interact with enalapril.

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 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.

For high blood pressure:

For most patients, the usual starting

dose is 5 mg taken once a day. Some

patients may need a lower starting

dose. The dose may need to be

increased depending on your blood

pressure. Most patients take between

10 to 40 mg each day.

For heart failure:

The usual starting dose is 2.5mg

taken once a day. Depending on your

response, this dose may need to be

increased up to 20 mg each day. This

dose may be taken once a day or

divided into two doses per day.

How to take it

Swallow the 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

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.

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.

If you are not sure whether to skip

the dose, talk to your doctor.

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.

If you take too many tablets, you will

probably feel light-headed or dizzy,

or you may faint.

Do this even if there are no signs of

discomfort or poisoning. You may

need urgent medical attention.

While you are taking

this medicine

Things you must do

If you become pregnant while

taking this medicine, tell your

doctor immediately.

Tell your doctor if you have

excessive vomiting or diarrhoea or

experience any of the following

symptoms:

light-headed or dizzy

dry mouth or thirst

weakness, tiredness or drowsiness

muscle pain or cramps

fast heart beat

passing less urine than normal.

If you experience these symptoms,

you may be dehydrated because you

are losing too much water. This is

more likely to occur when you begin

to take enalapril or if your dose is

increased.

Make sure you drink enough water

during exercise and hot weather

when you are taking enalapril,

especially if you sweat a lot.

If you do not drink enough water

while taking enalapril, your blood

pressure may drop suddenly and you

may dehydrate. If you experience any

of the above symptoms, tell your

doctor.

Tell your doctor that you are taking

this medicine if:

you are about to be started on any

new medicine

you are breastfeeding or are

planning to breast-feed

you are going to have surgery or

an anaesthetic or are going into

hospital.

Having a general anaesthetic

while taking this medicine may

cause your blood pressure to drop

suddenly.

you are about to have any blood

tests

Your doctor may occasionally do

tests to make sure the medicine is

working and to prevent side effects.

Go to your doctor regularly for a

check-up.

Tell any other doctors, dentists and

pharmacists who are treating you that

you take this medicine.

APO-ENALAPRIL

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 until you know how this

medicine affects you.

Enalapril may cause dizziness or

light-headedness in some people,

especially after the first dose or if the

dose is increased. Make sure you

know how you react to enalapril

before you drive a car, operate

machinery, or do anything else that

could be dangerous if you are dizzy

or light-headed. 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.

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.

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.

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 enalapril 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 if you notice any

of the following:

light-headedness or dizziness

because blood pressure is too low

headache

fatigue

dry cough

mild stomach upsets such as

feeling sick, diarrhoea, or

stomach pains

muscle cramps

Tell your doctor as soon as possible

if you notice any of the following.

These may be serious side effects and

you may need medical attention.

Mostly, these side effects are rare:

changes in the way your heart

beats, for example, if you notice

it beating faster

fainting

yellowing of the skin and eyes,

also called jaundice

itchy skin rash or other skin

problems

signs of worrying or frequent

infections such as fever, severe

chills, sore throat or mouth ulcers

passing less urine than is normal

for you

signs of dehydration such as

nausea, vomiting, muscle cramps,

headache, drowsiness and

tiredness. 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 you may need urgent medical

attention or hospitalisation. These

side effects are usually very rare:

swelling of the face, lips, mouth

or throat which may cause

difficulty in swallowing or

breathing

swelling of the hands, feet, or

ankles

pinkish, itchy swellings on the

skin, also called hives or

nettlerash

flu-like symptoms, followed by a

painful red or purplish rash on

skin and mucous membranes

(mouth/nose, eyelids, genitals,

internal organs) that spreads and

blisters

chest pain, angina

wheeziness due to tightness in the

chest

collapse, numbness or weakness

of arms or legs

Other side effects not listed above

may occur in some patients. Tell

your doctor if you notice any other

effects.

Do not be alarmed by this list of

possible side effects. You may not

experience any of them

APO-ENALAPRIL

Allergic reactions

If you think you are having an

allergic reaction to enalapril, 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-Enalapril Tablets

looks like

5 mg tablets:

White to off white, round, flat-face

beveled edge tablets breakline on one

side and "5" debossed on the other

side.

10 mg tablets:

White to off white, round, flat-face

beveled edge tablets with breakline

on one side and "10" debossed on the

other side.

20 mg tablets:

White to off white, round, flat-face

beveled edge tablets with breakline

one side and "20" debossed on the

other side.

Available in blister packs of 30.

Ingredients

Each tablet contains 5 mg, 10 mg or

20 mg of enalapril maleate as the

active ingredient.

It also contains the following inactive

ingredients:

Maleic acid

Lactose monohydrate

Hypromellose

Croscarmellose sodium

Sodium stearylfumarate

This medicine is gluten-free, sucrose-

free, tartrazine-free and free of other

azo dyes.

Australian Registration

Numbers

APO-Enalapril 5mg Tablets (PVC/

PVDC/Al): AUST R 196472.

APO-Enalapril 10mg Tablets (PVC/

PVDC/Al): AUST R 196466.

APO-Enalapril 20mg Tablets (PVC/

PVDC/Al): AUST R 196504.

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

APO and APOTEX are registered

trade marks of Apotex Inc.

This leaflet was last updated in:

March 2018.

APO-ENALAPRIL