IRBESARTAN

Main information

  • Trade name:
  • IRBESARTAN SANOFI irbesartan 150 mg film-coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • IRBESARTAN SANOFI irbesartan 150 mg film-coated tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 196951
  • Last update:
  • 12-11-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

196951

IRBESARTAN SANOFI irbesartan 150 mg film-coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Sanofi-Aventis Australia Pty Ltd

Postal Address

Locked Bag 2227,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

13/11/2012

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. IRBESARTAN SANOFI irbesartan 150 mg film-coated tablet blister pack

Product Type

Single Medicine Product

Effective date

6/10/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

IRBESARTAN SANOFI is indicated for the treatment of hypertension. IRBESARTAN SANOFI is indicated for delaying the progression of renal disease in

hypertensive type II diabetics with persistent micro-albuminuria (more than or equal to 30 mg per 24 hour) or urinary protein in excess of 900 mg per 24

hours

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

2 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. IRBESARTAN SANOFI irbesartan 150 mg film-coated tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White, biconvex, oval-shaped film-coated tablets, with a heart shape

debossed on one side, and '2872' engraved on the other side.

Active Ingredients

Irbesartan

150 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 01:14:08 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

Irbesartan Sanofi

®

irbesartan

Consumer Medicine Information (CMI)

What is in this leaflet

This leaflet answers some common

questions about Irbesartan Sanofi.

It does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have benefits and

risks. Your doctor has weighed the

benefits of you taking this medicine

against the risks it will have for you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet with your

medicine.

You may need to read it again.

What Irbesartan

Sanofi is used for

Irbesartan Sanofi is used to lower

high blood pressure, which doctors

call 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 often 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,

such as stroke, heart disease and

kidney failure. Irbesartan Sanofi is

also used in the treatment of kidney

disease in patients with high blood

pressure and type 2 diabetes.

How Irbesartan Sanofi works

Irbesartan Sanofi belongs to a group

of medicines known as angiotensin-II

receptor antagonists. Angiotensin II

is a substance produced in the body

that causes blood vessels to narrow.

Irbesartan Sanofi blocks angiotensin-

II and therefore widens your blood

vessels, making it easier for your

heart to pump blood throughout your

body. This helps to lower your blood

pressure.

Irbesartan Sanofi also slows the

decrease of kidney function in

patients with high blood pressure and

type 2 diabetes.

Your doctor may have prescribed

Irbesartan Sanofi for another reason.

Ask your doctor if you have any

questions about why Irbesartan

Sanofi has been prescribed for you.

This medicine is only available with

a doctor's prescription.

There is no evidence that this

medicine is addictive.

Before you take

Irbesartan Sanofi

When you must not take it

Do not take Irbesartan Sanofi if:

you are pregnant (or think you

may be pregnant) or are

planning to become pregnant;

Irbesartan Sanofi may affect your

developing baby if you take it

during pregnancy.

you are breast-feeding;

It is not known if Irbesartan

Sanofi passes into breast milk,

therefore it is recommended that

you not take it while you are

breast-feeding;

you are allergic to irbesartan or

to any of the ingredients listed

at the end of this leaflet;

you are diabetic or have kidney

problems and are being treated

with an ACE inhibitor, any

aliskiren-containing medicines

or a group of medicines known

as AIIRAs (medicines also used

to treat high blood pressure);

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 if you should

start taking Irbesartan Sanofi, talk

to your doctor.

Irbesartan Sanofi should not be

given to children.

Before you start to take it

Tell your doctor if you have any

allergies to:

any of the ingredients listed at the

end of this leaflet, including

lactose

any other medicines

any other substances, such as

foods, preservatives or dyes

IRBESARTAN SANOFI

Tell your doctor if you are

pregnant or intend to become

pregnant.

Tell your doctor if you are breast

feeding or plan to breastfeed.

Tell your doctor if you have or

have had any medical conditions,

especially the following:

recent excessive vomiting or

diarrhoea;

kidney problems, or you have

had a kidney transplant or

dialysis

heart problems,

liver problems, or have had

liver problems in the past

high levels of potassium in your

blood

you are strictly restricting your

salt intake.

Tell your doctor if you plan to have

surgery (even at the dentist) that

needs a general anaesthetic.

If you have not told your doctor

about any of the above, tell them

before you take Irbesartan Sanofi.

Taking other medicines

Tell your doctor 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 may affect the way

others work. Also, some other

medicines used to treat high blood

pressure may have an additive effect

with Irbesartan Sanofi in lowering

blood pressure. This may happen

with diuretics (fluid tablets). As a

result you may need different

amounts of your medicines.

It is important to tell your doctor if

you are taking or plan to take any of

the following:

potassium supplements,

potassium-containing salt

substitutes (you may need to

have blood tests done regularly)

diuretics (fluid tablets)

medicines containing lithium

(you may need to have blood

tests done regularly).

anti-inflammatory medicines

such as non-steroidal anti-

inflammatory agents (for

example diclofenac, ibuprofen)

and COX-2 inhibitors (for

example celecoxib) used to

relieve pain, swelling and other

symptoms of inflammation

including arthritis. Taking

Irbesartan Sanofi and an anti-

inflammatory medicine alone or

with a thiazide diuretic (fluid

tablet) may damage your

kidneys. It may also reduce the

effect Irbesartan Sanofi has on

lowering blood pressure

a medicine containing aliskiren.

Taking Irbesartan Sanofi with

aliskiren may affect your blood

pressure, electrolyte balance and

your kidney function.

Your doctor and pharmacist may

have more information on medicines

to be careful with or avoid while

taking Irbesartan Sanofi.

How to take Irbesartan

Sanofi

How much to take

Your doctor will tell you how many

tablets to take each day.

Usually patients start with one 150

mg tablet once a day. However, some

patients may need a lower starting

dose. Your doctor will tell you if this

is necessary. The full blood pressure

lowering effect of Irbesartan Sanofi

should be reached about 4-6 weeks

after starting treatment.

Depending on how your blood

pressure responds, your daily dose of

Irbesartan Sanofi may need to be

increased. Most patients take either

150 mg or 300 mg each day.

In patients with high blood pressure

and type 2 diabetes, 300 mg once

daily is the preferred maintenance

dose for slowing the progression of

associated kidney disease.

Ask your doctor or pharmacist if

you are unsure of the correct dose

for you.

They will tell you exactly how much

to take.

Follow the instructions they give

you.

How to take it

Swallow the tablet whole with a

glass of water.

It does not matter whether you take

Irbesartan Sanofi tablets before or

after food.

When to take it

Take Irbesartan Sanofi 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 the tablets.

How long to take it

Continue taking Irbesartan Sanofi

until your doctor tells you to stop.

Irbesartan Sanofi helps to control

your high blood pressure, but it does

not cure it. Therefore Irbesartan

Sanofi must be taken every day.

To help you remember to take your

tablets each day, Irbesartan Sanofi

tablets are supplied in a Calendar

pack with the foil backing marked

with the days of the week. This is

just a way to help you to remember

to take your tablets. All of the tablets

in the pack are the same.

When you start a new strip of

tablets, take the tablet marked

"START" at the end of the blister

strip. On the next day, take the

tablet marked with the relevant

day of the week.

Continue taking your tablets each

day until all of the tablets are

taken. Commence the next strip at

"START" and continue as before.

IRBESARTAN SANOFI

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 go

back to taking your tablets as you

would normally.

Do not take a double dose to make

up for the dose you missed.

This may increase the chance of you

getting any unwanted side effects.

If you are not sure what to do, ask

your doctor or pharmacist.

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 Irbesartan Sanofi. Do

this even if there are no signs of

discomfort or poisoning.

You may need urgent medical

attention.

If you take too many Irbesartan

Sanofi tablets you will probably feel

light-headed or dizzy.

While you are using

Irbesartan Sanofi

Things you must do

Tell any other doctors, dentists,

and pharmacists who are treating

you that you are taking Irbesartan

Sanofi.

If you become pregnant while

taking Irbesartan Sanofi tell your

doctor immediately.

Have your blood pressure checked

when your doctor tells you to, to

make sure Irbesartan Sanofi is

working.

If you are about to be started on

any new medicine, tell your doctor

and pharmacist that you are taking

Irbesartan Sanofi.

If you plan to have surgery that

needs a general anaesthetic, tell

your doctor or dentist that you are

taking Irbesartan Sanofi.

Your blood pressure may drop

suddenly.

Make sure you drink enough water

during exercise and hot weather

when you are taking Irbesartan

Sanofi, especially if you sweat a lot.

If you do not drink enough water

while taking Irbesartan Sanofi, you

may faint or feel light-headed or sick.

This is because your body does not

have enough fluid and your blood

pressure is low. If you continue to

feel unwell, tell your doctor.

If you have excessive vomiting

and/or diarrhoea while taking

Irbesartan Sanofi, 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

Irbesartan Sanofi, or when your

dose is increased, tell your doctor

immediately.

Things you must not do

Do not give Irbesartan Sanofi

tablets to anyone else, even if they

have the same condition as you.

Do not take Irbesartan Sanofi to

treat any other complaints unless

your doctor or pharmacist tells you

to.

Do not stop taking Irbesartan

Sanofi, or lower 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

Irbesartan Sanofi affects you.

As with many other medicines used

to treat high blood pressure,

Irbesartan Sanofi may cause

dizziness or light-headedness in some

people.

If this occurs do not drive.

Make sure you know how you react

to Irbesartan Sanofi 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 lowering your blood

pressure

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.

Weight -

if you are overweight, 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.

Diet -

your doctor may advise you to eat

a healthy low-fat diet which

includes plenty of fresh

vegetables, fruit, bread, cereals

and fish.

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.

IRBESARTAN SANOFI

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.

Smoking -

your doctor may advise you to

stop smoking or at least cut down.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

Irbesartan Sanofi.

Irbesartan Sanofi helps most people

with high blood pressure, 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:

headache

dizziness or light-headedness

(vertigo)

unusual tiredness or weakness,

fatigue

nausea/vomiting.

These are common side effects. They

are generally mild and do not

normally require treatment to be

interrupted.

Tell your doctor immediately if

you notice any of the following:

skin rash or itchiness

aching muscles, not caused by

exercise

muscle pain or weakness

buzzing, ringing or other

persistent noise in the ear

yellowing of the skin and/or eyes,

also called jaundice

symptoms that may indicate

kidney disease, such as passing

little or no urine, drowsiness,

nausea, vomiting, breathlessness,

loss of appetite and weakness

symptoms that may indicate high

potassium levels in the blood,

such as nausea, diarrhoea, muscle

weakness, change in heart rhythm

symptoms that may indicate liver

disease such as nausea, vomiting,

loss of appetite, feeling generally

unwell, fever, itching, yellowing

of the skin and eyes and dark

coloured urine

symptoms that may indicate low

platelet count such as easy or

excessive bruising, bleeding from

gums or nose, prolonged bleeding

from cuts and blood in urine or

stools.

These are serious side effects. Skin

rash and itchiness may be symptoms

of an allergic reaction. You may need

medical attention.

These side effects are not common.

If any of the following happen, stop

taking Irbesartan Sanofi and either

tell your doctor immediately or go

to Accident and Emergency

Department at your nearest

hospital:

swelling of the face, lips, tongue

or throat which may cause

difficulty in swallowing or

breathing;

severe and sudden onset of

pinkish, itchy swellings on the

skin, also called hives or

nettlerash.

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 using Irbesartan

Sanofi

Storage

Keep your Irbesartan Sanofi

tablets in the blister pack until it is

time to take them.

If you take the tablets out of the

blister pack they may not keep well.

Keep Irbesartan Sanofi tablets in a

cool dry place where the

temperature stays below 25

degrees C.

Do not store Irbesartan Sanofi or

any other medicine in the

bathroom or near a sink. Do not

leave them near a radiator, in a car

on hot days or on a window sill.

Heat and dampness can destroy some

medicines.

Keep all medicines out of the reach

of children.

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 Irbesartan Sanofi or the

tablets have passed their expiry

date, ask your pharmacist what to

do with any tablets that are left

over.

Product description

What it looks like

Irbesartan Sanofi 75 mg tablets:

white, oval shaped film-coated

tablets with a heart shape imprinted

on one side and "2871" engraved on

the other side. Blister pack sizes

include: 3*, 5*, 7*, 14*, 28*, 30*,

56* and 98* tablets.

IRBESARTAN SANOFI

Irbesartan Sanofi 150 mg tablets:

white, oval shaped film-coated

tablets with a heart shape imprinted

on one side and "2872" engraved on

the other side. Blister pack sizes

include: 3*, 5*, 7*, 14*, 28*, 30*,

56* and 98* tablets.

Irbesartan Sanofi 300 mg tablets:

white, oval shaped film-coated

tablets with a heart shape imprinted

on one side and "2873" engraved on

the other side. Blister pack sizes

include: 3*, 5*, 7*, 14*, 28*, 30*,

56* and 98* tablets.

* presentations currently not-

marketed.

Active ingredients

Irbesartan Sanofi 75 mg tablets: 75

mg irbesartan per tablet.

Irbesartan Sanofi 150 mg tablets: 150

mg irbesartan per tablet.

Irbesartan Sanofi 300 mg tablets: 300

mg irbesartan per tablet.

Other Ingredients

Irbesartan Sanofi tablets also contain

carnauba wax, croscarmellose

sodium, hypromellose, lactose,

macrogol 3000, magnesium stearate,

microcrystalline cellulose, silicon

dioxide, and titanium dioxide

Supplier

Irbesartan Sanofi is supplied in

Australia by:

sanofi-aventis australia pty ltd

12-24 Talavera Road

Macquarie Park, NSW 2113.

Irbesartan Sanofi is a registered

trademark of sanofi-aventis.

Australian registration number(s):

Irbesartan Sanofi 75mg AUST R

196950

Irbesartan Sanofi 150mg AUST R

196951

Irbesartan Sanofi 300mg AUST R

196952

This leaflet was prepared in March

2017.

irbesartan-sanofi-ccdsv14-cmiv3-

27feb17

IRBESARTAN SANOFI