MALEAN enalapril maleate 20mg tablet blister pack

Main information

  • Trade name:
  • MALEAN enalapril maleate 20mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • MALEAN enalapril maleate 20mg tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 196489
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

196489

MALEAN enalapril maleate 20mg 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

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. MALEAN enalapril maleate 20mg tablet blister pack

Product Type

Single Medicine Product

Effective date

21/12/2015

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

Blister Pack

PVC/PVDC/Al

36 Months

Store below 25

degrees Celsius

Not recorded

Protect from Light

Protect from Moisture

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. Malean enalapril maleate 20mg 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 "20" debossed on the other side.

Active Ingredients

enalapril maleate

20 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 01:54:59 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

MALEAN CMI V0.1 Page 1 of 5

MALEAN

Enalapril maleate

Consumer Medicine Information

What is in this leaflet

This leaflet answers some

common questions about

MALEAN. 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

MALEAN 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 MALEANis used

for

MALEAN lowers high blood

pressure, which doctors call

hypertension. It is also used to

treat heart failure.

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. MALEAN

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.

MALEAN helps to treat heart

failure, whether you have

symptoms or not. In many

patients with heart failure who

have symptoms, MALEAN may

slow the progression of heart

failure and reduce the need to

go to hospital as a result of

heart failure. MALEAN may

help some of these patients live

longer.

In many patients with heart

failure who have no symptoms,

MALEAN may help to stop the

heart muscle from getting

weaker. MALEAN 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 MALEAN, heart

failure patients may have less

chance of having a heart

attack.

When used to treat heart

failure, MALEAN 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.

How MALEAN works

One of the ways MALEAN

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 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

ofmedicines called Angiotensin

Converting Enzyme (ACE)

inhibitors.

Your doctor may prescribe

MALEAN for another reason.

Ask your doctor if you have any

questions about why MALEAN

has been prescribed for you.

MALEAN is not addictive

Before you take

MALEAN

When you must not take it

Do not take MALEAN if:

MALEAN CMI V1.1

Page 2 of 5

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

MALEAN.

you have an allergy to

MALEAN, Amprace

®

or other

brands of enalapril maleate,

or any of the ingredients

listed at the end of this leaflet

Symptoms of an allergic

reaction to MALEAN or other

brands of enalapril maleate

may include skin rash,

itchiness, shortness of breath,

swelling of the face, lips or

tongue, muscle pain or

tenderness or joint pain.

you have a history of

swelling of the face, lips,

tongue, throat, hands or feet,

for no apparent reason.

You have diabetes and are

taking a medicine called

aliskiren to reduce blood

pressure.

You are taking a medicine

containing a neprilysin

inhibitor (e.g., sacubitril). Do

not take MALEAN for at least

36 hours before or after you

take sacubitril/valsartan, a

medicine containing a

neprilysin inhibitor.

Do not take MALEAN if you

are pregnant or breast-

feeding.

Your baby may absorb this

medicine in the womb or from

breast milk and therefore there

is a possibility of harm to the

baby.

Do not take MALEAN if:

the packaging is torn or

shows signs of tampering

the expiry date on the pack

has passed.

If you take this medicine after

the expiry date has passed, it

may not work.

If you are not sure whether

you should start taking

MALEAN, talk to your doctor.

Before you start to take it

Tell your doctor if:

1. you are or intend to

become pregnant or intend to

breastfeed

MALEAN should not be used

during pregnancy or while

breastfeeding.

2. you have any medical

conditions, especially the

following:

kidney disease, or are

undergoing dialysis

diabetes

heart problems

3. you have recently suffered

from excessive vomiting or

diarrhoea

4. you are following a very

low salt diet

5. You are taking potassium

supplements, potassium-

sparing agents, potassium

containing salt substitutes or

other drugs that may

increase serum potassium

(e.g., trimethoprim-

containing products).

6. you have had an allergy to

any other medicines or any

other substances, such as

foods, preservatives or dyes.

7. if you suffer from low

blood pressure (you may

notice this as faintness or

dizziness, especially when

standing).

8. surgery and anaesthesia

(even at the dentist office)

are scheduled, as there may

be a sudden fall in blood

pressure associated with

anaesthesia.

9. You are taking a medicine

containing a neprilysin

inhibitor (e.g., sacubitril).

If you have not told your

doctor about any of the

above, tell them before you

take any MALEAN.

Taking other medicines

Tell your doctor if you are

taking any other medicines,

including medicines that you

buy without a prescription

from your pharmacy,

supermarket or health food

shop. Some medicines and

MALEAN may interfere with

each other.

These include:

other blood pressure

medicines

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)

Other drugs that may increase

serum potassium (e.g.,

trimethoprim-containing

products)

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 antidiabetic

medicines. You should be

closely monitored for low blood

glucose levels, especially

during the first month of

treatment with MALEAN.

mammalian target of

rapamycin inhibitors

MALEAN CMI V1.1

Page 3 of 5

(e.g.temsirolimus, sirolimus,

everolimus) or a medicine

containing a neprilysin inhibitor

(e.g., sacubitril).

These medicines may be

affected by MALEAN, or may

affect how well it works. You

may need to take different

amounts of your medicine, or

you may need to take different

medicines.

Your doctor or pharmacist has

more information on medicines

to avoid while taking MALEAN.

How to take MALEAN

How much to take

Your doctor will tell you how

many tablets you need to

take each day. This depends

on your condition and

whether you are taking other

medicines. Take MALEAN

only when prescribed by

your doctor.

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 2.5

mg 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.

Follow all directions given to

you by your doctor 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 to take it

Take your MALEAN at about

the same time each day.

Taking your tablet(s) at the

same time each day will have

the best effect. It will also help

you remember when to take the

tablets.

It does not matter if you take

MALEAN before or after food.

Swallow MALEAN with a

glass of water.

How long to take it

MALEAN helps control your

high blood pressure and helps

improve your heart failure, but

does not cure it. Therefore

MALEAN must be taken every

day. Continue taking MALEAN

for as long as your doctor

prescribes.

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 tablet(s)

as you would normally.

If you are not sure whether to

skip the dose, talk to your

doctor or pharmacist.

Do not take a double dose to

make up for the dose that

you missed.

If you have trouble

remembering to take your

tablets, ask your pharmacist

for some hints.

If you take too much

(overdose)

Immediately telephone your

doctor or Poisons

Information Centre

(telephone 13 11 26), or go to

accident and emergency at

your nearest hospital, if you

think that you or anyone else

may have taken too much

MALEAN. Do this even if

there are no signs of

discomfort or poisoning.

If you take too many tablets,

you will probably feel light-

headed or dizzy, or you may

faint.

While you are using

MALEAN

Things you must do

Have your blood pressure

checked when your doctor

says, to make sure MALEAN

is working.

If you feel any light

headedness or dizziness

after you take your first dose

of MALEAN or if your dose is

increased, tell your doctor

immediately. This is

especially important if you

are taking MALEAN for heart

failure.

If you feel light-headed, dizzy

or faint, get up slowly when

getting out of bed or

standing up.

You may feel light-headed or

dizzy, especially if you are also

taking a diuretic (fluid tablet).

This may be because your

blood pressure is falling

suddenly. 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 gets

worse or continues, talk to your

doctor.

If you become pregnant while

taking MALEAN, tell your

doctor immediately.

If you are about to be started

on any new medicine, tell

your doctor and pharmacist

that you are taking MALEAN.

MALEAN CMI V1.1

Page 4 of 5

If you plan to have surgery

(even at the dentist) that

needs a general anaesthetic,

tell your doctor or dentist

that you are taking MALEAN.

Your blood pressure may drop

suddenly.

Make sure you drink enough

water during exercise and

hot weather when you are

taking MALEAN, especially if

you sweat a lot.

If you do not drink enough

water while taking MALEAN,

you may faint or feel 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 excessive

vomiting and/ or diarrhoea

while taking MALEAN, tell

your doctor.

This can also mean that you

are losing too much water and

salt, and may drop your blood

pressure too much.

Go to your doctor regularly

for a check-up.

Your doctor may occasionally

do a blood test to check your

potassium level in the blood

and to see how your kidneys

are working.

Things you must not do

Do not give MALEAN to

anyone else, even if they

have the same condition as

you.

Things to be careful of

Be careful driving or

Operating machinery until

you know how MALEAN

affects you.

MALEAN 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 MALEAN 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.

Side Effects

Tell your doctor or

pharmacist as soon as

possible if you do not feel

well while you are taking

MALEAN.

MALEAN 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.

Ask your doctor or

pharmacist to answer any

questions you may have.

Tell your doctor if you notice

any of the following and they

worry you:

light-headedness or dizziness

because blood pressure is too

headache

fatigue

dry cough

mild stomach upsets such as

feeling sick, diarrhoea, or

stomach pains

muscle cramps

These are usually mild side

effects of MALEAN, but may be

serious.

Tell your doctor immediately

if you notice any of the

following:

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,

MALEAN CMI V1.1

Page 5 of 5

mental confusion and fits may

develop.

Your doctor may need to

monitor your blood sodium

levels.

These may be serious side

effects. You may need urgent

medical attention.

Serious side effects are rare.

If any of the following

happen, stop taking MALEAN

and tell your doctor

immediately or go to accident

and emergency at your

nearest hospital:

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

chest pain, angina

wheeziness due to tightness

in the chest

collapse, numbness or

weakness of arms or legs

These are serious side effects.

You may need urgent medical

attention or hospitalisation.

All of these side effects are

rare.

Other side effects not listed

above may also 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.

After using MALEAN

Storage

Keep your tablets in the

blister pack until it is time to

take them.

If you take the tablets out of the

blister pack and store them in

another container they will not

keep well and they may

become soft and crumbly.

MALEAN Tablets should be

kept in a cool dry place

where the temperature stays

below 25°C.

Do not store it or any other

medicine in the bathroom or

near a sink.

Do not leave it in the car or

on window sills.

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 tells you to

stop taking MALEAN 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

MALEAN comes in three types

of tablets:

Enalapril Maleate tablets are

white to off white, round, flat-

face beveled edge tablets

with breakline on one side

and “5”, “10” and “20”

debossed on the other side.

A box of MALEAN contains 30

tablets.

Ingredients

Active ingredient:

MALEAN - 5 mg enalapril

maleate per tablet

MALEAN - 10 mg enalapril

maleate per tablet

MALEAN - 20 mg enalapril

maleate per tablet

Inactive ingredients:

-Maleic acid

-Lactose

-Hypromellose

-Croscarmellose sodium

-Sodium stearylfumarate

-Water-purified

MALEAN does not contain

gluten, sucrose, tartrazine or

any other azo dyes.

Name & Address of

Sponsor

Arrow Pharma Pty Ltd

15 – 17 Chapel Street,

Cremorne, VIC 3121

www.arrowpharma.com.au

This

leaflet

prepared

November 2018

Australian Register Numbers:

MALEAN 5 mg tablets –

AUST R 196512

MALEAN 10 mg tablets –

AUST R 196485

MALEAN 20 mg tablets –

AUST R 196489