RAMIPRIL AN 5mg ramipril 5mg tablet blister pack

Main information

  • Trade name:
  • RAMIPRIL AN 5mg ramipril 5mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • RAMIPRIL AN 5mg ramipril 5mg tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 175231
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

175231

RAMIPRIL AN 5mg ramipril 5mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Amneal Pharma Australia Pty Ltd

Postal Address

12 River Street,SOUTH YARRA, VIC, 3141

Australia

ARTG Start Date

6/10/2011

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. RAMIPRIL AN 5mg ramipril 5mg tablet blister pack

Product Type

Single Medicine Product

Effective date

17/01/2017

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 revascularization

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

pressure >90mmHg (or on antihypertensive treatment); total cholesterol >5.2mmol/L; HDL cholesterol <0.9mmol/L; current smoker; known

microalbuminuria; any evidence of previous vascular disease.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/Al

2 Years

Store below 25

degrees Celsius

Not recorded

Store in a Dry Place

Blister Pack

PA/Al/PVC/Al -

polyamide-aluminium

foil-polyvinylchloride/al

uminium foil

2 Years

Store below 25

degrees Celsius

Not recorded

Store in a Dry Place

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. RAMIPRIL TABS PFIZER 5mg

Dosage Form

Tablet, uncoated

Route of Administration

Oral

Visual Identification

Light pink coloured mottled, flat faced bevel edged round uncoated tablet

debossed with 'H' & '19' separated by score line on one side and plain on

other side

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 02:14:48 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

Ramipril AN – Consumer Medicine Information

Doc ID: 93.AN.M.2.0

Page 1

Ramipril AN Tablets

Ramipril

Consumer Medicine Information

What is in this leaflet

This leaflet answers some

common questions about

Ramipril AN.

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

Ramipril AN against the benefits

it is expected to 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 Ramipril AN is

used for

Ramipril AN belongs to a group

of medicines called angiotensin

converting enzyme (ACE)

inhibitors.

Ramipril AN 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 AN 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.

Hypertension

Ramipril AN 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

hypertension when your blood

pressure stays higher than is

needed, even when you are

calm and relaxed.

There are usually no symptoms

of hypertension. The only way of

knowing that you have

hypertension is to have your

blood pressure checked on a

regular basis. If high blood

pressure is not treated it can

lead to serious health problems,

including stroke, heart disease

and kidney failure.

Heart Failure after a Heart

Attack

Ramipril AN 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 AN may be used to

treat some kidney problems.

Some conditions such as

diabetes and hypertension 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.

Prevention of Cardiovascular

Problems and Complications

Ramipril AN may be used to

reduce the risk of some of the

problems and complications that

may arise in patients aged 55 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.

Ramipril AN 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 of

one or more additional factors

such as high blood pressure,

high cholesterol levels, kidney

problems, a current smoker, or

previous disease of the blood

vessels.

How Ramipril AN works

Ramipril AN works by widening

the blood vessels, which

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

Ramipril AN – Consumer Medicine Information

Doc ID: 93.AN.M.2.0

Page 2

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 AN also improves blood

flow through the small blood

vessels found in the kidneys,

which helps the kidneys to work

more efficiently. This in turn

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 AN. Your doctor may

have also prescribed this

medicine for another reason.

Ask your doctor or pharmacist

if you have any questions

about why Ramipril AN has

been prescribed for you.

Ramipril AN is not addictive.

Ramipril AN is available only

with a doctor's prescription.

Before you take

Ramipril AN

When you must not take

it

Do not take Ramipril AN if

you:

have had an allergy to

Ramipril AN or any other

medicine containing ramipril,

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, abdominal pain,

muscle pain or tenderness, or

joint pain.

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 AN .

or your family have a history

of swelling of the face, lips,

tongue, throat, intestines,

hands or feet, for no

apparent reason.

have kidney problems or a

condition called "renal artery

stenosis".

have problems or conditions

affecting the flow of blood in

and out of your heart (e.g.

aortic or valvular stenosis).

have low blood pressure.

undergo dialysis using

certain high-flux

membranes.

are diabetic or have kidney

problems and are being

treated with aliskiren-

containing medications or a

group of medicines known

as AIIRAs (a medication also

used to treat high blood

pressure).

are pregnant or intend to

become pregnant.

Ramipril AN may affect your

developing baby if you take it

during pregnancy.

are breastfeeding.

Ramipril AN may pass into the

breast milk and affect your

breastfed baby.

Do not use Ramipril AN 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 use Ramipril AN if the

packaging is torn or shows

signs of tampering.

Before you start to take it

Tell your doctor if you have

allergies to:

any other medicines

any other substances, such as

foods, preservatives or dyes

Tell your doctor if you have or

have had any medical

conditions, especially the

following:

kidney problems, or are having

dialysis (note that your doctor

may give you Ramipril AN

because of your kidney

problems)

liver problems

heart problems (note that your

doctor may give you Ramipril

AN because of your heart

problems)

low blood pressure, which you

may notice as dizziness or

lightheadedness

low white blood cell counts

diabetes (note that your doctor

may give you Ramipril AN

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 must also tell your doctor

if you:

are following a very low or very

high salt diet

are dehydrated, or have had a

recent bout of vomiting or

diarrhoea

are about to have surgery or a

general anaesthetic

plan to become pregnant or

breastfeed

Ramipril AN – Consumer Medicine Information

Doc ID: 93.AN.M.2.0

Page 3

If you have not told your

doctor about any of the above,

tell them before you start

taking Ramipril AN.

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

store.

Some medicines and Ramipril

AN may interfere with each

other. These include:

other medicines used to treat

high blood pressure, including

those containing the active

ingredient aliskiren.

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

temsirolimus

if you are taking Ramipril AN

for high blood pressure, do not

take any medicines (including

the ones bought without a

prescription) for appetite

control, asthma, colds, coughs,

hayfever or sinus problems

unless you have discussed it

with your doctor or pharmacist.

These medicines may be

affected by Ramipril AN, or may

affect how well it works. You

may need to use different

amounts of your medicine, or

you may need to take different

medicines. Your doctor or

pharmacist will advise you.

Your doctor or pharmacist may

have more information on

medicines to be careful with or to

avoid while taking Ramipril AN

How to take Ramipril

AN

How much to take

Your doctor or pharmacist will

tell you how many tablets you

will need to take each day.

This depends on your

condition and whether or not

you are taking any other

medicines.

Take Ramipril AN only when

prescribed by your doctor.

Your doctor will select a dose

when they prescribe Ramipril AN

for you. Some patients may

need a lower starting dose. The

usual dose of Ramipril AN 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.

Follow all directions given to

you by your doctor or

pharmacist 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

Ramipril AN should be

swallowed whole with plenty

of fluid.

When to take it

Take Ramipril AN at about the

same time each day.

Taking your tablets at the same

time each day will have the best

effect. It will also help you

remember when to take your

medicine.

It does not matter if you take

Ramipril AN before or after

food.

How long to take it

Ramipril AN helps control your

condition, but does not cure it.

Therefore you must take

Ramipril AN every day. Continue

taking your medicine for as long

as your doctor tells you.

If you forget to take it

If it is almost time for your

next dose, skip the dose you

missed and take your next

dose when you are meant to.

Otherwise, take 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.

If you are not sure what to do

or if you have trouble

remembering when to take

Ramipril AN, ask your doctor

or pharmacist.

If you take too much

(Overdose)

Immediately telephone your

doctor or the Poisons

Information Centre (in

Australia telephone 13 11 26),

Ramipril AN – Consumer Medicine Information

Doc ID: 93.AN.M.2.0

Page 4

or go to Accident and

Emergency at the nearest

hospital if you think that you

or anyone else may have

taken too much Ramipril AN.

Do this even if there are no

signs of discomfort or

poisoning.

You may need urgent medical

attention.

If you take too much Ramipril

AN, you may feel light-headed,

dizzy or you may faint. You may

also experience slow heart beat.

While you are taking

Ramipril AN

Things you must do

Tell all the doctors, dentists

and pharmacists who are

treating you that you are

taking Ramipril AN.

If you are about to be started

on any new medicine, tell your

doctor and pharmacist that

you are taking Ramipril AN.

Make sure you drink enough

water during exercise and hot

weather when you are taking

Ramipril AN, especially if you

sweat a lot.

If you do not drink enough water

while taking Ramipril AN, you

may feel faint, lightheaded 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 AN, 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 AN, 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 AN.

Your blood pressure may drop

suddenly.

If you become pregnant or

intend to become pregnant

while taking Ramipril AN, tell

your doctor immediately.

If you are about to have any

blood tests, tell your doctor

that you are taking Ramipril

AN.

Ramipril AN may interfere with

the results of some tests.

Have your blood pressure

checked when your doctor

says, to make sure Ramipril

AN is working.

Go to your doctor regularly for

a check-up.

Your doctor may occasionally do

a blood test to check your

potassium levels and see how

your kidneys are working.

Things you must not do

Do not give Ramipril AN to

anyone else, even if they have

the same condition as you.

Do not take Ramipril AN to

treat any other complaints

unless your doctor or

pharmacist tells you to.

Do not stop taking Ramipril

AN, or lower or increase the

dosage, without checking with

your doctor.

Things to be careful of

If you feel light-headed, dizzy

or faint when getting out of

bed or standing up, get up

slowly.

Standing up slowly, especially

when you get up from bed or

chairs, will help your body get

used to the change in position

and blood pressure. If this

problem continues or gets

worse, talk to your doctor.

Be careful driving or operating

machinery until you know how

Ramipril AN affects you.

As with other ACE inhibitor

medicines, Ramipril AN may

cause dizziness,

lightheadedness, tiredness or

drowsiness in some people.

Make sure you know how you

react to Ramipril AN before you

drive a car, operate machinery,

or do anything else that could be

dangerous if you are dizzy or

lightheaded. If this occurs do not

drive. If you drink alcohol,

dizziness or lightheadedness

may be worse.

Things that may help

your Condition

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 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

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

Ramipril AN – Consumer Medicine Information

Doc ID: 93.AN.M.2.0

Page 5

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 Ramipril AN.

Ramipril AN helps most people,

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.

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 if you notice

any of the following and they

worry you:

feeling light-headed, dizzy or

faint

dry cough

headache

feeling sick (nausea) or

vomiting

stomach pain or discomfort

diarrhoea

indigestion

loss of taste or taste

disturbances

upper respiratory tract

infections

muscle cramps or spasms

aching muscles, muscle

tenderness or weakness, not

caused by exercise

unusual tiredness or

weakness, fatigue

ringing or buzzing in the ears

forgetfulness or confusion

These side effects are usually

mild.

Tell your doctor as soon as

possible if you notice any of

the following:

disturbed vision

symptoms of sunburn (such as

redness, itching, swelling,

blistering) which may occur

more quickly than normal

itchy or raised skin rash, hives

or nettlerash

signs of anaemia such as

tiredness, being short of breath

and looking pale

yellowing of the skin and/or

eyes

fast or irregular heart beat

shortness of breath or

tightness in the chest

numbness, tingling and colour

change (white, blue then red)

in the fingers or toes when

exposed to the cold

severe upper stomach pain,

often with nausea and vomiting

frequent infections such as

fever, severe chills, sore throat

or mouth ulcers

passing little or no urine or

more urine than is normal for

bleeding or bruising more

easily than normal

These may be serious side

effects. You may need medical

attention. Serious side effects

are rare.

If any of the following happen,

stop taking Ramipril AN 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 your doctor or

pharmacist if you notice

anything that is making you

feel unwell.

After taking Ramipril

AN

Storage

Keep your Ramipril AN tablets

in the pack until it is time to

take them.

If you take them out of the pack

they may not keep well.

Keep Ramipril AN tablets in a

cool, dry place where it stays

below 25°C.

Do not store Ramipril AN or

any other medicine in the

bathroom or near a sink. Do

not leave it on window sills or

in the car.

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 Ramipril AN or the

expiry date has passed, ask

your pharmacist what to do

with any medicine that you

have left over.

Product description

What Ramipril AN looks

like

Ramipril AN is available as

tablets containing 1.25, 2.5, 5

& 10 mg of ramipril.

Ramipril AN tablets are

Ramipril AN – Consumer Medicine Information

Doc ID: 93.AN.M.2.0

Page 6

supplied in blister packs

containing 28, 30 capsules

and HDPE bottles containing

30 tablets.

Ramipril AN 1.25 mg

White to off-white colored, flat

faced bevel edged round

uncoated tablet debossed with

“H” and “17” on one side and

plain on other side.

Blister AUST R: 175228

Bottle: AUST R: 175234

Ramipril AN 2.5 mg

Light yellow to yellow colored flat

faced bevel edged, round

uncoated tablet debossed with

“H” and “18”separated by score

line on one side and plain on

other side.

Blister AUST R: 175239

Bottle: AUST R: 175219

Ramipril AN 5 mg

Light pink colored mottled, flat

faced bevel edged round

uncoated tablet debossed with

“H” and “19” separated by score

line on one side and plain on

other side.

Blister AUST R: 175231

Bottle: AUST R: 175236

Ramipril AN 10 mg

White to off-white colored, flat

faced bevel edged round

uncoated tablet debossed with

“H” and “20”separated by score

line on one side and plain on

other side.

Blister AUST R: 175233

Bottle: AUST R: 175225

Ingredients

Active ingredient

Ramipril

Inactive ingredients

Pregelatinised maize starch

Lactose

Sodium bicarbonate

Croscarmellose sodium

Sodium stearylfumarate

Iron oxide yellow (2.5mg

tablets only)

Iron oxide red (5mg tablets

only)

Name and Address of the

Sponsor

Amneal Pharma Australia Pty

12 River St, South Yarra

VIC – 3141

Australia

Date of Preparation

July 2014

Doc ID: 93.AN.M.2.0