TERRY

Main information

  • Trade name:
  • TERRY WHITE CHEMISTS INDAPAMIDE SR indapamide hemihydrate 1.5 mg modified release tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • TERRY WHITE CHEMISTS INDAPAMIDE SR indapamide hemihydrate 1.5 mg modified release tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 208010
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

208010

TERRY WHITE CHEMISTS INDAPAMIDE SR indapamide hemihydrate 1.5 mg modified release 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

7/05/2014

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 INDAPAMIDE SR indapamide hemihydrate 1.5 mg modified release tablet blister

pack

Product Type

Single Medicine Product

Effective date

26/08/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Treatment of hypertension. It may be tried as a sole therapeutic agent in the treatment of hypertension. Normally, indapamide is used as the initial agent

in multiple drug regimes.

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

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

30 tablets

(S4) Prescription Only Medicine

90 tablets

(S4) Prescription Only Medicine

10 tablets

(S4) Prescription Only Medicine

Components

1. TERRY WHITE CHEMISTS INDAPAMIDE SR indapamide hemihydrate 1.5 mg modified release tablet blister pack

Dosage Form

Tablet, modified release

Route of Administration

Oral

Visual Identification

White to off-white, round, biconvex, film coated tablets.

Active Ingredients

indapamide hemihydrate

1.5 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 27.11.2017 at 11:37:18 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

Terry White Chemists

Indapamide SR Tablets

Contains the active ingredient indapamide hemihydrate 1.5 mg

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 Indapamide SR. 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 Terry

White chemists Indapamide SR

Tablets. The medicine releases the

active ingredient indapamide

progressively over 24 hours

(modified release or sustained release

tablet). Indapamide belongs to a

group of medicines called

chlorosulphamoyl diuretics (a type of

"fluid" or "water" tablet).

You have been prescribed

Indapamide sustained release tablets

for high blood pressure.

This medicine is available only with

a doctor's prescription.

There is no evidence that this

medicine is addictive.

Why this medicine is used

for high blood pressure

Everyone has blood pressure. This

pressure helps to circulate blood all

around the body. Your blood

pressure may be different at different

times of the day, depending on how

busy or stressed you are.

You have high blood pressure (also

known as hypertension) when your

blood pressure stays higher than is

needed, even when you are calm and

relaxed.

If high blood pressure is not treated it

can lead to serious health problems.

You may feel fine and have no

symptoms, but eventually it can

cause stroke, heart disease and

kidney failure.

Indapamide modified (sustained)

release tablets help to lower your

blood pressure.

Ask your doctor if you have any

questions about why Indapamide

SR has been prescribed for you.

Before you take this

medicine

There are some people who should

not take Indapamide SR. Please read

the list below. If you think any of

these situations apply to you, or you

have any questions, please consult

your doctor or pharmacist.

When you must not take it

Do not take this medicine if:

You are hypersensitive to, or

have had an allergic reaction to,

Indapamide SR or any of the

ingredients listed at the end of

this leaflet.

You are allergic to

sulphonamide (sulpha)

antibiotics, or to thiazide

diuretics (a type of "fluid" or

"water" tablet).

Symptoms of an allergic reaction

may include: cough, shortness of

breath, wheezing or difficulty

breathing; swelling of the face,

lips, tongue, throat or other parts

of the body; rash, itching or hives

TERRY WHITE CHEMISTS INDAPAMIDE SR TABLETS

on the skin; fainting; or hay

fever-like symptoms.

If you think you are having an

allergic reaction, do not take

any more of the medicine and

contact your doctor

immediately or go to the

Accident and Emergency

department at the nearest

hospital.

You are pregnant or trying to

become pregnant.

You are breastfeeding or plan

to breast-feed.

You have severe kidney disease.

You have severe liver disease or

suffer from a condition called

hepatic encephalopathy (liver

problems which affect the brain

and central nervous system).

You have low potassium levels in

your blood.

The expiry date (EXP) printed

on the pack has passed.

The packaging is torn, shows

signs of tampering or it does not

look quite right.

Before you start to take it

Before you start taking this

medicine, tell your doctor if:

You have allergies to:

any other medicines

any other substances, such as

foods, preservatives or dyes.

an intolerance to lactose

You have or have had any

medical conditions, especially the

following:

High or low levels of potassium,

sodium, or other problems with

salt balance

Gout

Diabetes

Previously experienced an

increased sensitivity to sunlight

(photosensitivity reactions).

Systemic lupus erythematosus (a

disease affecting the skin, joints

and kidneys)

Heart rhythm problems.

Problems with your kidneys.

A test to check how well your

parathyroid gland is working

Athletes should be aware that this

medicine contains an active

ingredient, which may give a positive

reaction in doping tests.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including

medicines that you buy without a

prescription from a pharmacy,

supermarket or health food shop.

Some medicines may interact with

Indapamide SR. These include:

lithium medications (used to treat

mood swings and some types of

depression) due to the risk of

increased levels of lithium in the

blood.

Some steroid medicines.

Diuretics (sometimes called

"fluid" or "water" tablets).

Some medications used to treat

high blood pressure, a fast or

irregular heartbeat and other heart

conditions.

Medicines to treat mental

illnesses such as some medicines

for epilepsy, anxiety,

schizophrenia and some other

antidepressants (e.g. imipramine).

Non-steroidal anti-inflammatory

drugs for pain relief (e.g.

ibuprofen) or high doses of

aspirin.

Calcium supplements.

Stimulant laxatives.

Baclofen (a medicine used to treat

muscle stiffness occurring in

diseases such as multiple

sclerosis).

Metformin (a medicine used to

treat diabetes).

Cyclosporine, tacrolimus

(medicines used to treat certain

problems with the immune

system).

Amphotericin B by IV,

erythromycin by IV (antibiotic

medicines used to treat

infections).

Medicines used during scans to

see the images of your body.

Diphemanil (used to treat

excessive sweating).

Moxifloxacin (an antibiotic

medicine used to treat infections).

Pentamidine (a medicine used to

treat certain types of pneumonia).

Allopurinol (a medicine to treat

gout)

If you are taking any of these you

may need a different dose or you

may need to take different medicines.

Other medicines not listed above

may also interact with Indapamide

Your doctor or pharmacist has more

information on medicines to be

careful with or avoid while taking

Indapamide SR.

For older people or children

Elderly people can generally use

Indapamide SR safely. However,

some older people have reduced

kidney function - in which case

additional care may be required.

Indapamide SR is not

recommended for use in children.

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.

If you do not understand the

instructions on the label, ask your

doctor or pharmacist for help.

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.

TERRY WHITE CHEMISTS INDAPAMIDE SR TABLETS

The usual dose is one tablet once

daily.

Do not stop taking your medicine or

change your dosage without first

checking with your doctor.

How to take it

Swallow your tablet with a glass of

water, preferably in the morning.

Do not crush or break the tablets.

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.

How long to take it for

Indapamide SR helps control your

blood pressure, but cannot cure it.

Indapamide SR treatment is usually

for life - so you should keep taking

the tablets regularly unless advised

otherwise by your doctor.

Make sure you have enough to last

over weekends and holidays.

If you forget to take it

If your next usual dose is less than 6

hours away, just leave out the dose

that you missed. Take the next dose

at the usual time and continue as

normal.

If your next dose is more than 6

hours away, take the dose you have

missed as soon as you realise. Then

take the next dose at the usual time

and continue as normal.

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)

Taking too much Indapamide SR (an

overdose) may cause low blood

pressure (also known as

hypotension). Other effects like

sickness, cramps, sleepiness,

confusion, kidney problems, salt and

water disturbances are possible. You

may require urgent medical attention.

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 or 0800 764

766 in New Zealand) for advice.

Alternatively, go to the Accident

and Emergency department at

your nearest hospital.

Do this even if there are no signs of

discomfort or poisoning. You may

need urgent medical attention.

While you are taking

this medicine

Things you must do

Take Indapamide SR exactly as your

doctor has prescribed. Otherwise you

may not get the benefits from

treatment.

Tell all doctors, dentists and

pharmacists who are involved with

your treatment that you are taking

Indapamide SR.

Make sure you drink enough water

during exercise and hot weather

especially if you sweat a lot. This

will help you avoid any dizziness or

light-headedness caused by a sudden

drop in blood pressure.

Tell your doctor straight away if you

have excessive vomiting or diarrhoea

while taking Indapamide SR as these

may affect how Indapamide SR is

processed by your body.

If you experience any of the

following symptoms, you may be

dehydrated because you are losing

too much water:

Dry mouth or thirst

Fainting

Weakness

Tiredness or drowsiness

Muscle pain or cramps

Fast heart beat

Passing less urine than normal

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.

You may feel light-headed or dizzy

when you begin to take Indapamide

SR. This is because your blood

pressure is falling. Symptoms are

likely to be made worse if you drink

alcohol or take strong pain killers.

If you have these symptoms when

standing up or getting out of bed then

getting up more slowly can help.

This allows your body to get used to

the change in position and blood

pressure.

Indapamide SR may cause your skin

to become more sensitive to the sun.

If this happens you should stop

taking Indapamide SR and contact

your doctor.

If you have these symptoms and they

don't get better in a short time then

talk to your doctor.

Possible side effects

Tell your doctor as soon as possible

if you do not feel well while you are

taking Indapamide SR 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.

TERRY WHITE CHEMISTS INDAPAMIDE SR TABLETS

All medicines can have side effects.

Sometimes they are serious but most

of the time they are not.

Indapamide SR helps most people

with high blood pressure, but it may

sometimes have unwanted side

effects.

Tell your doctor if you notice any

of the following:

Headache.

Feeling tired or as if you have

less energy.

Feeling faint, light-headed, or

dizzy.

Feeling sick or having an upset

stomach.

Muscle pain or cramp.

Skin rashes or other allergic

reactions.

An increased risk of becoming

dehydrated (in elderly patients

and in patients with heart failure).

Low potassium levels. Symptoms

of low potassium can include a

number of those listed above, and

very occasionally this may be

severe.

Kidney diseases.

Inflammation of the pancreas.

Hepatic encephalopathy (liver

problems which affect the brain

and central nervous system).

Abnormal liver function.

If you suffer from systemic lupus

erythematosus (a type of collagen

disease), this might get worse.

Changes in blood cells, such as

thrombocytopenia (a decrease in

the number of platelets which

causes easy bruising and nasal

bleeding), leucopoenia (a

decrease of white blood cells

which may cause unexplained

fever, soreness of the throat or

other flu-like symptoms) and

anaemia (a decrease in red blood

cells).

Low blood pressure, unusual

heartbeat.

Most of these side effects are mild

when they occur.

However, if you do - or if you notice

anything else that is making you feel

unwell - you should consult your

doctor or pharmacist.

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:

Swelling of your lips, face,

mouth, tongue or throat.

Purple spots with occasional

blisters on the front of your arms

and legs and/or around your neck

and ears (A rare condition known

as Stevens-Johnson Syndrome).

Toxic epidermal necrolysis.

A fast and irregular heart beat.

Severe blisters, skin rash, itching

or other allergic reactions.

Vision problems such as visual

impairment, blurred vision or

short-sightedness

These side effects are extremely rare

but can become serious.

Other side effects not listed above

may occur in some patients.

Allergic reactions

If you think you are having an

allergic reaction to Indapamide

SR, 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

Terry White chemists

Indapamide SR (sustained

release ) tablets look like

White to off-white, round, biconvex,

film coated tablets.

Blister packs of 90 tablets.

Ingredients

Each tablet contains 1.5 mg of

Indapamide hemihydrate as the

active ingredient.

It also contains the following inactive

ingredients:

Lactose monohydrate

Povidone

Hypromellose

TERRY WHITE CHEMISTS INDAPAMIDE SR TABLETS

Colloidal anhydrous silica

Magnesium stearate

The film coating on the tablet

contains:

Opadry II 85F18378 White

(polyvinyl alcohol, macrogol,

titanium dioxide and talc)

This medicine is gluten-free.

Australian Registration

Numbers

Terry White chemists Indapamide SR

1.5mg Tablets (Blister Pack):

AUST R 208010

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

This leaflet was last updated in:

September 2015

TERRY WHITE CHEMISTS INDAPAMIDE SR TABLETS

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