TERRY

Main information

  • Trade name:
  • TERRY WHITE CHEMISTS RAMIPRIL ramipril 5mg capsule blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • TERRY WHITE CHEMISTS RAMIPRIL ramipril 5mg capsule blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 179039
  • Last update:
  • 14-11-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

179039

TERRY WHITE CHEMISTS RAMIPRIL ramipril 5mg capsule 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

27/09/2011

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. TERRY WHITE CHEMISTS RAMIPRIL ramipril 5mg capsule blister pack

Product Type

Single Medicine Product

Effective date

21/04/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

=Treatment of hypertension. (Data are currently not available to support the use of ramipril in renovascular hypertension).,=Post MI heart

failure.,=Prevention of progressive renal failure in patients with persistent proteinuria in excess of 1 g/day.,=For reducing the risk of myocardial

infarction, stroke, cardiovascular death or the need for revascularisation procedures in patients 55 years of age or more who have clinical evidence of

coronary artery disease, stroke or peripheral vascular disease.,=For reducing the risk of myocardial infarction, stroke, cardiovascular death or

revascularisation procedures in diabetic patients 55 years or more with one or more of the following risk factors: systolic blood pressure > 160 mm Hg or

diastolic blood pressure > 90 mm Hg (or on antihypertensive treatment); total cholesterol > 5.2 mmol/L; HDL cholesterol < 0.9 mmol/L; current smoker;

known microalbuminuria; any evidence of previous vascular disease.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. TERRY WHITE CHEMISTS RAMIPRIL ramipril 5mg capsule blister pack

Dosage Form

Capsule

Route of Administration

Oral

Visual Identification

red cap & white body imprinted with APO 5 in black ink

Active Ingredients

Ramipril

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 29.11.2017 at 09:33:23 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

Terry White Chemists

Ramipril

contains the active ingredient, ramipril

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 Ask your

doctor or pharmacist if you do not

understand anything or are

worried about taking your

medicine.

This leaflet answers some common

questions about ramipril.

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. Some more recent

information on your medicine may

be available. Speak to your

pharmacist or doctor to obtain the

most up-to-date information.

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.

Keep this leaflet with your

medicine.

You may want to read it again.

What ramipril is used

for

The name of your medicine is Terry

White Chemists Ramipril. It contains

the active ingredient, ramipril.

Ramipril belongs to a group of

medicines called angiotensin

converting enzyme (ACE) inhibitors.

Ramipril is used to treat:

high blood pressure

(hypertension)

some heart conditions, such as

heart failure after a heart attack

kidney problems in some patients.

Ramipril is also used to reduce the

risk of cardiovascular problems and

complications in patients aged 55

years or more with heart or blood

vessel disease, or diabetes.

High Blood Pressure

(Hypertension)

Ramipril 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

and can be influenced by how busy

or worried you are. You have 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

high blood pressure. The only way of

knowing that you have high blood

pressure 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 after a Heart Attack

Ramipril may be used after a heart

attack. A heart attack occurs when

one of the major blood vessels

supplying blood to your heart

becomes blocked. This means that

your heart muscle cannot receive the

oxygen it needs and becomes

damaged. This may lead to further

problems, such as heart failure,

irregular heart rhythms and blood

clots.

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.

Kidney Problems

Ramipril may be used to treat some

kidney problems. Some conditions,

such as diabetes and high blood

pressure, can lead to kidney

problems. These problems develop

slowly over several years. Good

control of your blood sugar and

blood pressure are important in

keeping your kidneys healthy, but

may not always prevent kidney

damage from occurring.

TERRY WHITE CHEMISTS RAMIPRIL

Prevention of Cardiovascular

Problems and Complications in

Patients aged 55 years or more

Patients with Heart or Blood

Vessel Disease

Ramipril may be used to reduce the

risk of some of the problems and

complications that may arise in

patients aged 55 years or more who

have problems such as coronary

artery disease (heart disease caused

by poor blood flow in the blood

vessels of the heart), peripheral

vascular disease (poor circulation in

the hands or feet) or stroke.

Patients with Diabetes

Ramipril may also be used to reduce

the risk of cardiovascular problems

and complications in patients with

diabetes aged 55 years or more who

may be considered at risk because

they have one or more additional risk

factors (e.g. high blood pressure,

high cholesterol levels, kidney

problems, a current smoker or

previous disease of the blood

vessels).

How it works

Ramipril works by widening the

blood vessels, which then reduces the

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.

By increasing the supply of oxygen

to your heart, your heart does not

have to work as hard and it is under

less stress, which may reduce the risk

of further damage occurring to it

following a heart attack.

Ramipril also improves blood flow

through the small blood vessels

found in the kidneys, which helps the

kidneys to work more efficiently.

This in turn can help to slow down

the progression of kidney damage

that might result from having

diabetes or high blood pressure.

Therefore, there are quite a few

reasons why your doctor might have

decided to treat you with ramipril.

However, your doctor may have

prescribed ramipril for another

reason.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

This medicine is available only with

a doctor's prescription.

There is no evidence that this

medicine is addictive.

Use in children

This medicine should not be used in

children.

Before you take

ramipril

When you must not take it

Do not take this medicine if you

have had an allergic reaction to it

or to any other medicine

containing ramipril or to any of the

ingredients listed at the end of this

leaflet.

Do not take Terry White Chemists

Ramipril if you are intolerant or

allergic to lactose - this medicine

contains lactose.

Some of the symptoms of an allergic

reaction may include: shortness of

breath, wheezing or difficulty

breathing; swelling of the face, lips,

tongue, throat or other parts of the

body; muscle pain or tenderness or

joint pain; or rash, itching or hives on

the skin.

Do not ramipril 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 ramipril.

Do not take ramipril if you are also

taking:

aliskiren-containing medications

and have kidney problems or

Type 2 diabetes

angiotensin II receptor

antagonists (e.g. candesartan,

irbesartan, olmesartan etc.), and

have kidney problems caused by

diabetes

Do not take ramipril if you or your

family have a history of swelling of

the face, lips, tongue, throat,

intestines, hands or feet, for no

apparent reason.

Do not take ramipril if you have

kidney problems or a condition

called 'renal artery stenosis'.

Do not take ramipril if you have

problems or conditions affecting

the flow of blood in and out of your

heart (e.g. aortic or valvular

stenosis).

Do not take ramipril if you have

low blood pressure.

Do not take ramipril if you

undergo dialysis using certain

high-flux membranes.

Do not take ramipril if you are

pregnant or intend to become

pregnant.

Ramipril may affect your developing

baby if you take it during pregnancy.

Do not take ramipril if you are

breastfeeding.

Ramipril may pass into breast milk

and affect your breastfed baby.

Do not take your medicine after

the expiry date (EXP) printed on

the pack.

If you take this medicine after the

expiry date has passed, it may not

work as well.

Do not take this medicine if the

packaging is torn, shows signs of

tampering or if it does not look

quite right.

If it has expired or is damaged, return

it to your pharmacist for disposal.

If you are not sure whether you

should start taking this medicine,

talk to your doctor.

TERRY WHITE CHEMISTS RAMIPRIL

Before you start to take it

Tell your doctor if:

1.

You have allergies to:

any other medicines

any other substances, such as

foods, preservatives or dyes.

lactose - Terry White Chemists

Ramipril contains lactose

2.

You have or have had any

medical conditions, especially

the following:

kidney problems, or are having

dialysis (note: your doctor may

give you ramipril because of your

kidney problems)

liver problems

heart problems (note: your doctor

may give you ramipril because of

your heart problems)

low blood pressure, which you

may notice as dizziness or

light-headedness

low white blood cell counts

diabetes (note: your doctor may

give you ramipril because of your

diabetes)

high levels of potassium in your

blood

Systemic Lupus Erythematosus

(SLE), scleroderma or other

autoimmune conditions.

Tell your doctor if you have a

family history of swelling of the

face, lips, tongue, throat, intestines,

hands or feet.

You are planning to have surgery

or an anaesthetic.

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.

You are following a very low or

very high salt diet

You are dehydrated, or have had

a recent bout of vomiting or

diarrhoea

You plan to become pregnant or

breastfeed.

If you have not told your doctor

about any of the above, tell them

before you start taking this

medicine.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

buy without a prescription from

your pharmacy, supermarket or

health food shop.

Some medicines and ramipril may

interfere with each other. These

include:

other medicines used to treat high

blood pressure

diuretics, also known as fluid or

water tablets

lithium, a medicine used to treat

mood swings and some types of

depression

potassium supplements or

potassium-containing salt

substitutes

non-steroidal anti-inflammatory

drugs (NSAIDs), medicines used

to relieve pain, swelling and

other symptoms of inflammation

insulin and tablets used to treat

diabetes

heparin

general anaesthetics

medicines which may affect the

blood cells, such as allopurinol,

procainamide, corticosteroids,

immunosuppressants or

medicines used to treat cancer

if you are taking ramipril for high

blood pressure, do not take any

medicines (including the ones

bought without a prescription)

for appetite control, asthma,

colds, coughs, hay fever or sinus

problems unless you have

discussed it with your doctor or

pharmacist.

These medicines may be affected by

ramipril, or may affect how well it

works. You may need different

amounts of your medicine, or you

may need to take different medicines.

Your doctor will advise you.

Other medicines not listed above

may also interact with ramipril.

How to take this

medicine

Follow all directions given to you

by your doctor or pharmacist

carefully.

They may differ from the

information contained in this leaflet.

How much to take

Your doctor or pharmacist will tell

you how many capsules you will

need to take. This depends on your

condition and whether or not you

are taking any other medicines.

Some patients may need a lower

starting dose. The usual dose is:

for high blood pressure, 2.5 mg to

10 mg per day

for heart failure, 5 mg to 10 mg

per day

for kidney problems, 1.25 mg to 5

mg per day

for cardiovascular risk, 2.5 mg to

10 mg per day.

Depending on your response, your

doctor may adjust the dose.

If two capsules are prescribed, your

doctor may want you to take both of

them together or at different times.

This will depend on the condition

being treated and how you respond to

ramipril.

Do not stop taking your medicine or

change your dosage without first

checking with your doctor.

How to take it

The capsules should be swallowed

whole with plenty of fluid.

When to take it

Take it at about the same time

each day.

TERRY WHITE CHEMISTS RAMIPRIL

Taking your capsules at the same

time each day will have the best

effect. It will also help you remember

when to take the capsules.

It does not matter if you it before or

after food.

How long to take it

Ramipril helps control your

condition, but does not cure it.

Therefore, you must take ramipril

every day.

Continue taking ramipril for as long

as your doctor tells you.

Make sure you have enough capsules

to last over weekends and holidays.

If you forget to take it

If it is almost time for your next

dose, skip the dose you missed and

take your next dose when you are

meant to.

Otherwise, take it as soon as you

remember, and then go back to

taking your medicine as you would

normally.

Do not take a double dose to make

up for the dose that you missed.

This may increase the chance of you

getting an unwanted side effect.

If you are not sure what to do, ask

your doctor or pharmacist.

If you have trouble remembering to

take your medicine, ask your

pharmacist for some hints.

If you take too much

(overdose)

Immediately telephone your doctor

or the Poisons Information Centre

(Tel: 13 11 26 for Australia) or go

to the Accident and Emergency

Department at the nearest hospital,

if you think that you or anyone else

may have taken too much ramipril.

Do this even if there are no signs of

discomfort or poisoning.

You may need urgent medical

attention.

If you take too much ramipril, you

may feel light-headed, dizzy or you

may faint. You may also experience

a slow heartbeat.

While you are taking

ramipril

Things you must do

Tell any other doctors, dentists and

pharmacists who are treating you

that you are taking ramipril.

If you are about to be started on

any new medicine, tell your doctor,

dentist or pharmacist that you are

taking ramipril.

Tell your doctor immediately if

you become pregnant.

Make sure you drink enough water

during exercise and hot weather

when you are taking ramipril,

especially if you sweat a lot.

If you do not drink enough water

while taking ramipril, 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 ramipril,

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

ramipril, or when your dose is

increased, tell your doctor

immediately.

If you plan to have surgery that

needs a general anaesthetic, tell

your doctor or dentist that you are

taking ramipril.

Your blood pressure may drop

suddenly.

If you are about to have any blood

tests, tell your doctor that you are

taking ramipril.

Ramipril may interfere with the

results of some tests.

Have your blood pressure checked

when your doctor says, to make

sure ramipril is working.

Go to your doctor regularly for a

check-up.

Your doctor may occasionally do

tests to make sure the medicine is

working and to prevent side effects.

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

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 while driving or

operating machinery until you

know how ramipril affects you.

As with other ACE inhibitor

medicines, ramipril may cause

dizziness, light-headedness, tiredness

or drowsiness in some people. Make

sure you know how you react to

ramipril 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 may help your

condition

Some self-help measures suggested

below may help your condition.

TERRY WHITE CHEMISTS RAMIPRIL

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 low-fat 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 get the heart fitter, but 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 exercise 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, or at least cut

down, smoking.

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

All medicines may have some

unwanted side effects. Sometimes

they are serious, but most of the time,

they are not. Your doctor has

weighed the risks of using this

medicine against the benefits they

expect it will have for you.

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking ramipril.

Ramipril helps most people, but it

may have unwanted side effects in a

few people. All medicines may have

some unwanted side effects.

Sometimes they are serious, but most

of the time they are not.

Your doctor has weighed the risks of

using this medicine against the

benefits he/she expects it will have

for you. 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.

Following is a list of possible side

effects. Do not be alarmed by this

list. You may not experience any of

them.

Tell your doctor or pharmacist if

you notice any of the following and

they worry you:

feeling light-headed, dizzy or

faint

persistent dry cough and/or

tickling cough

headache

feeling sick (nausea) or vomiting

reflux

stomach pain

diarrhoea

taste disturbance

unusual tiredness or weakness,

fatigue

skin reactions

ringing or buzzing in the ears

forgetfulness or confusion

increase in nasal congestion or

asthma symptoms.

The above list includes the more

common side effects. Mostly, these

are 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 or raised skin rash, hives or

nettle rash

yellowing of the skin and/or eyes

severe upper stomach pain, often

with nausea and vomiting

fast or irregular heart beat

shortness of breath or tightness in

the chest

signs of anaemia such as

tiredness, being short of breath

and looking pale

numbness, tingling and colour

change (white, blue then red) in

the fingers or toes when exposed

to the cold

frequent infections such as fever,

severe chills, sore throat or

mouth ulcers

passing little or no urine or more

urine than is normal for you

bleeding or bruising more easily

than normal.

mood changes.

These may be serious side effects.

You may need medical attention.

Most of these side effects are rare

If any of the following happen, stop

taking your medicine 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

severe dizziness and confusion

with visual disturbances and

speech problems

swelling of the face, lips, mouth,

tongue or throat which may cause

difficulty in swallowing or

breathing

pink or red itchy spots on the skin

which may blister and progress to

form raised, red, pale-centred

marks

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

TERRY WHITE CHEMISTS RAMIPRIL

your doctor or pharmacist if you

notice anything that is making you

feel unwell.

Allergic reactions

If you think you are having an

allergic reaction to ramipril, 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 capsules in the pack

until it is time to take them.

If you take the capsules out of the

pack they may not keep well.

Keep your capsules in a cool dry

place where the temperature is

below 25°C.

Do not store your medicine in the

bathroom or near a sink.

Do not leave it on a window sill or in

the car on hot days.

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 Terry White Chemists

Ramipril Capsules looks like

Terry White Chemists Ramipril

Capsules are available in four

different strengths:

1.25 mg capsules have a yellow

cap and white body; they are

imprinted with "APO 1.25" in

black ink.

2.5 mg capsules have an orange

cap and white body; they are

imprinted with "APO 2.5" in

black ink.

5 mg capsules have a red cap and

white body; they are imprinted

with "APO 5" in black ink.

10 mg capsules have a blue cap

and white body; they are

imprinted with "APO 10" in black

ink.

The 1.25 mg, 2.5 mg and 5 mg

capsules are supplied as 30 capsules

packed in blisters or bottles.

The 10 mg capsules are supplied as

7, 10, 14, 28 or 30 capsules packed in

blisters or bottles.

Ingredients

Active Ingredient:

Ramipril (1.25 mg, 2.5 mg, 5 mg or

10 mg ramipril in each capsule).

It also contains the following inactive

ingredients:

lactose

magnesium stearate

gelatin

titanium dioxide

black printing ink

yellow iron oxide CI 77492 (1.25

mg & 2.5 mg strengths only)

erythrosine CI 45430 (2.5 mg, 5

mg and 10 mg strengths only)

indigo carmine CI 73015 (5 mg

and 10 mg strengths only)

black iron oxide CI 77499 (10 mg

strength only).

This medicine is gluten-free, sucrose-

free, tartrazine-free and other azo

dyes-free.

Australian Registration

Numbers

Terry White Chemists Ramipril

1.25 mg capsules: AUST R 179022

Terry White Chemists Ramipril

2.5 mg capsules: AUST R 179030

Terry White Chemists Ramipril

5 mg capsules: AUST R 179039

Terry White Chemists Ramipril

10 mg capsules: AUST R 179017

Sponsor

Apotex Pty Ltd

16 Giffnock Ave

Macquarie Park, NSW 2113

This leaflet was prepared in June

2014.

TERRY WHITE CHEMISTS RAMIPRIL