INDAPAMIDE

Main information

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

Documents

Localization

  • Available in:
  • INDAPAMIDE AN 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:
  • 208008
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

208008

INDAPAMIDE AN SR indapamide hemihydrate 1.5 mg modified release 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

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. INDAPAMIDE AN SR indapamide hemihydrate 1.5 mg modified release tablet blister pack

Product Type

Single Medicine Product

Effective date

11/03/2016

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

10 tablets

(S4) Prescription Only Medicine

30 tablets

(S4) Prescription Only Medicine

90 tablets

(S4) Prescription Only Medicine

Components

1. INDAPAMIDE AN 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 11:38:15 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

Indapamide AN SR CMI v1.0

Page 1 of 4

INDAPAMIDE AN SR

contains the active ingredient indapamide hemihydrate 1.5 mg

CONSUMER MEDICINE INFORMATION

What is in this leaflet

This leaflet answers some common

questions about INDAPAMIDE AN SR. It

does not contain all the available

information about this medicine.

Reading this leaflet 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 INDAPAMIDE AN SR against

the expected benefits 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 INDAPAMIDE AN SR is

The name of your medicine is

INDAPAMIDE AN SR. 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).

What INDAPAMIDE AN SR is

used for

You have been prescribed indapamide

modified (sustained) release tablets

for high blood pressure.

INDAPAMIDE AN SR is available only

with a doctor's prescription.

There is no evidence that INDAPAMIDE

AN SR is addictive.

Why indapamide 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) which is 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 AN

SR has been prescribed for you.

Before you take INDAPAMIDE

AN SR

There are some people who should not

take INDAPAMIDE AN SR. Please read

the lists 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

INDAPAMIDE AN SR

Do not take INDAPAMIDE AN SR if:

You are allergic to indapamide, or

any of the other ingredients of

INDAPAMIDE AN SR 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).

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 packaging is torn or shows signs

of tampering, or the tablets do not

look quite right.

The expiry date (EXP) on the pack

has passed.

Before you start to take it:

Tell your doctor straight away if:

You have an intolerance to lactose.

You have or have had any other

health problems, including:

High or low levels of potassium,

sodium, or other problems with

salt balance

Gout

Diabetes

You have 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.

Taking INDAPAMIDE AN SR may change

the effect of some medicines, and

some medicines may affect how well

INDAPAMIDE AN SR works. You may

need different amounts of your

medication or to take different

medicines.

Indapamide AN SR CMI v1.0

Page 2 of 4

You should not take INDAMPAMIDE AN

SR with lithium medications (used to

treat mood swings and some types of

depression) due to the risk of increased

levels of lithium in the blood.

The medicines that may interact with

INDAPAMIDE AN SR include the

following:

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 used to

treat gout).

Your doctor or pharmacist has more

information on medicines to be careful

with or avoid while taking INDAPAMIDE

AN SR.

For older people or children

Elderly people can generally use

INDAPAMIDE AN SR safely. However,

some older people have reduced

kidney function - in which case

additional care may be required.

INDAPAMIDE AN SR is not

recommended for use in children.

How to take INDAPAMIDE AN SR

Follow all directions given to you by

your doctor and pharmacist carefully.

If you do not understand the

instructions on the label, ask your

doctor or pharmacist for help.

Your doctor will select a dose when

they prescribe INDAPAMIDE AN SR for

you. The usual dose is one tablet once

daily.

Swallow your tablet with a glass of

water, preferably in the morning. Do

not crush or break them.

How long to take INDAPAMIDE AN

SR for

INDAPAMIDE AN SR can help to control

your blood pressure, but cannot cure it.

INDAPAMIDE AN SR treatment is

usually for life - so you should keep

taking the tablets regularly unless

advised otherwise by your doctor.

If you forget to take INDAPAMIDE

AN SR

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 try to make up for missed

doses by taking more than one dose at

a time.

If you take too much INDAPAMIDE

AN SR

Taking too much INDAPAMIDE AN 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

INDAPAMIDE AN SR then act

immediately:

Telephone your doctor or the Poisons

Information Centre (13 11 26) in

Australia; 0800 764 766 in New

Zealand), or go to the Accident and

Emergency department at your nearest

hospital. Do this even if there are no

signs of discomfort or poisoning.

While you are taking

INDAPAMIDE AN SR

Things you must do

Take INDAPAMIDE AN 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 AN 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 AN SR as

these may affect how INDAPAMIDE AN

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 they have the same

condition as you.

Indapamide AN SR CMI v1.0

Page 3 of 4

Do not use INDAMPAMIDE AN SR to

treat any other complaints unless your

doctor tells you to.

Do not stop taking INDAMPAMIDE AN

SR or change the dose, without

checking with your doctor.

Things to be careful of

Be careful when driving or operating

machinery until you know how

INDAMPAMIDE AN SR affects you.

You may feel light-headed or dizzy

when you begin to take INDAMPAMIDE

AN 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.

INDAMPAMIDE AN SR may cause your

skin to become more sensitive to the

sun. If this happens you should stop

taking INDAMPAMIDE AN 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.

Unwanted effects potentially due

to treatment

If you do not feel well while you are

taking INDAMPAMIDE AN SR then tell

your doctor or pharmacist as soon as

possible.

All medicines can have side effects.

Most of the time they are not serious

but sometimes they can be.

INDAMPAMIDE AN SR helps most

people with high blood pressure, but it

may sometimes have unwanted side

effects.

These can include:

Headache.

Feeling tired or as if you have less

energy, difficulty sleeping.

Feeling faint, light-headed, or dizzy.

Feeling nervous or anxious. Feeling

sick or having an upset stomach,

having an uncomfortable feeling

after eating, vomiting or

constipation.

Muscle pain, cramp, tingling or

numbness of the hands or feet.

Skin rashes or other allergic

reactions.

Gout.

Increased sensitivity to sunlight.

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 disease.

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.

Blurred or changed vision.

Dry mouth.

Cystitis.

Most of these side effects are mild

when they occur. Do not be alarmed

by this list of possible side effects. You

may not experience any of them.

However, if you do - or if you notice

anything else that is making you feel

unwell - you should consult your doctor

or pharmacist.

If any of the signs below occur then

tell your doctor immediately or go to

the Accident and Emergency

department at your nearest hospital:

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.

These side effects are extremely

rare but can become serious.

After taking INDAPAMIDE AN SR

Storage

Keep your INDAPAMIDE AN SR tablets

in the pack until it is time to take

them. Keep them in a cool, dry place

where the temperature stays below

25°C. Keep them where children

cannot reach them.

Disposal

If your doctor tells you to stop taking

INDAPAMIDE AN SR, or the tablets

have passed their expiry date, return

any leftover tablets to your pharmacist

for disposal.

Product description

INDAPAMIDE AN SR is registered on the

Australian Register of Therapeutic

Goods and has the Australian Register

Number: AUST R 208008

What INDAPAMIDE AN SR looks

like

INDAPAMIDE AN SR modified

(sustained) release tablets are white to

off-white, round, biconvex, film coated

tablets which come in blister packs of

90 tablets.

Ingredients

Each tablet of INDAPAMIDE AN SR

contains:

1.5 mg indapamide hemihydrate as the

active ingredient and a number of

inactive ingredients.

Indapamide AN SR CMI v1.0

Page 4 of 4

The inactive ingredients in

INDAPAMIDE AN SR tablets are:

Lactose monohydrate

Povidone

Hypromellose

Colloidal anhydrous silica

Magnesium stearate

The film coating on the tablet contains:

Opadry II 85F18378 White (polyvinyl

alcohol, macrogol, titanium dioxide

and talc)

The tablets are gluten free.

Sponsor

Amneal Pharma Australia Pty Ltd

12 River Street

South Yarra, 3141

VIC, AUSTRALIA

Australian Register Number:

AUST R 208008

This leaflet was prepared in

March 2016.

There are no news related to this product.