ABISART

Main information

  • Trade name:
  • ABISART irbesartan 75 mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ABISART irbesartan 75 mg tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 214577
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

214577

ABISART irbesartan 75 mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Alphapharm Pty Ltd

Postal Address

PO Box R1462,ROYAL EXCHANGE, NSW, 1225

Australia

ARTG Start Date

6/11/2013

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. ABISART irbesartan 75 mg tablet blister pack

Product Type

Single Medicine Product

Effective date

16/06/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

ABISART is indicated for the treatment of hypertension.,ABISART is indicated for delaying the progression of renal disease in hypertensive type II

diabetics with persistent micro-albuminuria (> 30 mg per 24 hours) 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

24 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Blister Pack

PCTFE (Aclar)/AI

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.

Dosage Form

Tablet

Route of Administration

Oral

Visual Identification

A white to off-white film-coated, round, biconvex, bevelled edge tablet

debossed with "M" on one side of the tablet and "IN1" on the other side.

Active Ingredients

Irbesartan

75 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 26.11.2017 at 09:27:38 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

ABISART

contains the active ingredient (irbesartan)

CONSUMER MEDICINE INFORMATION

What is in this leaflet

This leaflet answers some common

questions about ABISART.

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

risks of you taking ABISART against

the benefits expected for you.

If you have any concerns about

taking this medicine, talk to your

doctor or pharmacist.

Keep this leaflet with your

medicine.

You may need to read it again.

What ABISART is

used for

ABISART is a trade name

(manufacturer's name) for the

medicine, irbesartan.

ABISART is used to lower high

blood pressure (i.e. hypertension).

Your doctor measured your blood

pressure and found it to be too high.

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)

which means your blood pressure

stays high, even when you are calm

and relaxed.

There are usually no symptoms of

high blood pressure. The only way of

knowing that you have hypertension

is to have your blood pressure

checked on a regular basis. High

blood pressure, if not treated, can

damage blood vessels in several

organs such as the heart, the kidneys,

the brain and the eyes. This may lead

to heart attacks, heart or kidney

failure, strokes, or blindness. There

are usually no symptoms of high

blood pressure before damage

occurs, so your doctor needs to

measure your blood pressure to see if

it is too high.

High blood pressure can be treated

and controlled with medicines such

as ABISART. Your doctor may also

have recommended that you adjust

your lifestyle to help to lower your

high blood pressure (losing weight,

avoiding smoking, reducing alcohol

consumption and restricting the

amount of salt in the diet). Your

doctor may also have encouraged the

practice of regular, mild (not

strenuous) exercise such as walking,

swimming, etc.

ABISART is also used in the

treatment of kidney disease in

patients with high blood pressure and

type 2 diabetes.

What ABISART does and

how it works

ABISART belongs to a group of

medicines called angiotensin-II

receptor antagonists. Angiotensin II

is a substance produced in the body

which causes blood vessels to

tighten.

ABISART works by blocking

angiotensin-II and therefore relaxes

your blood vessels. This helps to

lower your blood pressure.

ABISART slows the decrease of

kidney function in patients with high

blood pressure and type 2 diabetes.

Your doctor may also have

recommended that you adjust your

life style to help to lower your high

blood pressure (losing weight,

avoiding smoking, reducing alcohol

consumption and restricting the

amount of salt in the diet).

Your doctor may also have

encouraged the practice of regular,

mild (not strenuous) exercise such as

walking, swimming, etc.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

Your doctor may have prescribed

ABISART for another reason.

This medicine is available only with

a doctor's prescription.

Before you take

ABISART

When you must not take it

Do not take ABISART if you are:

allergic to any medicine

containing irbesartan

allergic to any of the ingredients

listed at the end of this leaflet

Some of the symptoms of an allergic

reaction may include

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue

or other parts of the body

rash, itching or hives on the skin

Do not take this medicine if you

are pregnant (or think you may be

ABISART

pregnant) or are planning to

become pregnant.

Your baby may absorb this medicine

in the womb and there is a possibility

of harm to the baby.

It may affect your developing baby if

you take it during pregnancy.

Do not breast-feed if you are

taking this medicine.

It is not known if ABISART passes

into breast milk, therefore it is not

recommended to be taken while you

are breast-feeding.

Do not give this medicine to

children.

Safety and effectiveness in children

have not been established.

Do not take ABISART if you are

taking medicine containing aliskiren

and either have diabetes or moderate

to severe kidney impairment.

Do not take this medicine after the

expiry date printed on the pack or

if the packaging is torn or shows

signs of tampering.

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.

Before you start to take it

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

Tell your doctor if you have or

have had any of the following

medical conditions:

you have recently had excessive

vomiting or diarrhoea

you suffer from any medical

conditions especially -

kidney problems, or you have had

a kidney transplant or dialysis

heart problems

liver problems, or have had liver

problems in the past

diabetes

high levels of potassium in your

blood

you are strictly restricting your

salt intake

you are lactose intolerant or have

had any allergies to any other

medicine or any other substances,

such as foods, preservatives or

dyes

Tell your doctor if you are

pregnant or plan to become

pregnant or are breastfeeding.

Your doctor can discuss with you the

risks and benefits involved.

ABISART should not be used during

pregnancy or while breastfeeding.

If you have not told your doctor

about any of the above, tell him/

her before you start taking

ABISART.

Taking other medicines

Tell your doctor or pharmacist if

you are taking or intend to take

any other medicines, including any

that you get without a prescription

from a pharmacy, supermarket or

health food shop.

Some medicines and ABISART may

interfere with each other. It is

especially important that you tell

your doctor if you are taking, or plan

to take any of the following:

other tablets for high blood

pressure

fluid tablets or diuretics

lithium or lithium containing

medicines (e.g. Lithicarb)

potassium tablets (e.g. Span-K,

Slow-K, Mag-K)

potassium containing salt

substitutes (e.g.Pressor-K)

anti-inflammatory medicines

(these are used to relieve pain,

swelling and other symptoms of

inflammation, including arthritis)

and include nonsteroidal anti-

inflammatory agents - NSAIDs

(e.g.Voltaren, Indocid, Nurofen)

and COX-2 inhibitors (e.g.

Celebrex)

Taking a combination of

ABISART with an anti-

inflammatory medicine, alone or

with a thiazide diuretic (fluid

tablet) may damage your kidneys.

It may also reduce the effect

ABISART has on reducing blood

pressure.

a medicine containing aliskiren.

Taking ABISART with aliskiren

may affect your blood pressure,

electrolyte balance and your

kidney function.

These medicines may be affected by

ABISART or may affect how well it

works. Your doctor will decide if you

need different amounts of your

medicines, if your treatment needs to

be altered or whether you should

have check-ups or blood test more

frequently.

Your doctor and pharmacist have

more information on medicines to be

careful with or avoid while taking

this medicine.

How to take ABISART

Follow all directions given to you

by your doctor and 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 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 ABISART should

be reached about 4-6 weeks after

starting treatments.

Depending on how your blood

pressure responds, your daily dose of

ABISART 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

ABISART

daily is the preferred maintenance

dose for the treatment of associated

kidney disease.

Follow all directions given to you by

your doctor 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

Swallow the tablets whole with a

full glass of water.

Do not crush or chew the tablets.

When to take it

Take your medicine at about the

same time each day.

Taking it at the same time each day

will have the best effect. It will also

help you remember when to take it.

It does not matter if you take this

medicine before or after food.

It does not matter whether you

take ABISART tablets before or

after food.

How long to take it

Continue taking your medicine for

as long as your doctor tells you to.

ABISART helps to control your high

blood pressure, but it does not cure it.

Therefore ABISART must be taken

every day. It is important to keep

taking your medicine even if you feel

well. Continue taking ABISART

until your doctor tells you to stop.

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 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

(telephone 13 11 26) for advice, or

go to Accident and Emergency at

the nearest hospital, if you think

that you or anyone else may have

taken too much ABISART. Do this

even if there are no signs of

discomfort or poisoning.

You may need urgent medical

attention.

Symptoms of an overdose may

include feeling lightheaded or dizzy.

While you are taking

ABISART

Things you must do

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are taking ABISART.

Tell any other doctors, dentists and

pharmacists who treat you that

you are taking this medicine.

If you are going to have surgery,

tell the surgeon or anaesthetist that

you are taking this medicine.

It may affect other medicines used

during surgery.

If you become pregnant while

taking this medicine, tell your

doctor immediately.

If you are about to have any blood

tests, tell your doctor that you are

taking this medicine.

It may interfere with the results of

some tests.

Keep all of your doctor's

appointments so that your progress

can be checked.

Get your blood pressure checked

when your doctor tells you to, to

make sure ABISART is working for

you.

Get up slowly when getting out of

bed or standing up.

You may feel light-headed or dizzy

while taking ABISART, especially if

you are also taking a diuretic (fluid

tablet). This may become worse if

you stand up quickly as your blood

pressure may fall. 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. This

problem is not common. If it occurs

talk to your doctor.

Make sure you drink enough water

during exercise and hot weather

when you are taking ABISART,

especially if you sweat a lot.

If you do not drink enough water

while taking ABISART, you may

faint or feel lightheaded 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

ABISART, tell your doctor.

This can also mean that you are

losing too much water and your

blood pressure may become too low.

Things you must not do

Do not take ABISART to treat any

other complaints unless your

doctor tells you to.

Do not give your medicine to

anyone else, even if they have the

same condition as you.

Do not stop taking your medicine

or change the dosage without

checking with your doctor.

If you stop taking it suddenly, your

condition may worsen.

Things to be careful of

Be careful driving or operating

machinery until you know how

ABISART affects you.

ABISART

As with many other medicines used

to treat high blood pressure,

ABISART may cause dizziness or

light-headedness in some people.

Make sure you know how you react

to ABISART before you drive a car,

operate machinery or do anything

else that could be dangerous if you

are dizzy or lightheaded.

Be careful when drinking alcohol

while you are taking this medicine.

If you drink alcohol, dizziness or

light-headedness may be worse.

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.

Lifestyle measures that help

reduce heart disease risk

By following these simple

measures, you can further reduce

the risk from heart disease.

Quit smoking and avoid second-

hand smoke.

Limit alcohol intake.

Enjoy healthy eating by:

eating plenty of vegetables and

fruit;

reducing your saturated fat intake

(eat less fatty meats, full fat dairy

products, butter, coconut and

palm oils, most take-away foods,

commercially-baked products).

Be active. Progress, over time, to

at least 30 minutes of moderate-

intensity physical activity on 5 or

more days each week. Can be

accumulated in shorter bouts of

10 minutes duration. If you have

been prescribed anti-angina

medicine, carry it with you when

being physically active.

Maintain a healthy weight.

Discuss your lifestyle and

lifestyle plans with your doctor.

For more information and tools to

improve your heart health, call

Heartline, the Heart Foundation's

national telephone information

service, on 1300 36 27 87 (local

call cost).

Know warning signs of heart

attack and what to do:

Tightness, fullness, pressure,

squeezing, heaviness or pain in

your chest, neck, jaw, throat,

shoulders, arms or back.

You may also have difficulty

breathing, or have a cold sweat or

feel dizzy or light headed or feel

like vomiting (or actually vomit).

If you have heart attack warning

signs that are severe, get worse or

last for 10 minutes even if they

are mild, call triple zero (000).

Every minute counts.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

ABISART.

This medicine helps most people

with high blood pressure, but it may

have unwanted side effects in some

people.

All medicines can have side effects.

Sometimes they are serious, most of

the time they are not. You may need

medical attention if you get some of

the side effects.

Do not be alarmed by the following

list of side effects.

You may not experience any of them.

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

The above list includes the more

common side effects of your

medicine. They are usually mild and

do not normally require treatment to

be interrupted.

Tell your doctor as soon as possible

if you notice any of the following:

skin rash or itchiness (possible

signs of an allergic reaction)

aching muscles or aching joints,

not caused by exercise

muscle pain

buzzing, ringing or other

persistent noise in the ears

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 and change in heart

rhythm

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.

The above list includes serious side

effects that may require medical

attention. Serious side are rare.

If any of the following happen, stop

taking ABISART and tell your

doctor immediately or go to

Accident and Emergency at your

nearest hospital:

swelling to 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 nettle

rash.

The above list includes very serious

side effects to ABISART. You may

need urgent medical attention or

ABISART

hospitalisation. These side effects are

very rare.

Tell your doctor or pharmacist if

you notice anything that is making

you feel unwell.

Other side effects not listed above

may also occur in some people

After taking ABISART

Storage

Keep your tablets in the blister

pack until it is time to take them.

If you take the tablets out of the pack

they may not keep well.

Keep your tablets in a cool dry

place where the temperature stays

below 25°C.

Do not store ABISART 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 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 this medicine or the expiry

date has passed, ask your

pharmacist what to do with any

medicine that is left over.

Product description

What it looks like

ABISART 75 mg tablet contains 75

mg of irbesartan -

White to off white, film-coated,

round, biconvex, bevelled edge tablet

debossed with "M" on one side and

"IN1" on the other side.

ABISART 150 mg tablet contains

150 mg of irbesartan -

White to off white, film-coated,

round, biconvex, bevelled edge tablet

debossed with "M" on one side and

"IN2" on the other side.

ABISART 300 mg tablet contains

300 mg of irbesartan -

White to off white, film-coated, oval,

biconvex, bevelled edge tablet

debossed with "M" on one side and

"IN3" on the other side.

Available in a blister packs of 30 for

all strengths.

Ingredients

ABISART contains irbesartan as the

active ingredient.

It also contains the following inactive

ingredients:

povidone

lactose

microcrystalline cellulose

croscarmellose sodium

magnesium stearate

colloidal anhydrous silica

OPADRY II Complete Film

Coating System OY-LS-28908

White (ARTG no. 12435)

Supplier

ABISART is supplied in Australia

Alphapharm Pty Limited

(ABN 93 002 359 739)

Level 1, 30 The Bond

30-34 Hickson Road

Millers Point NSW 2000

Phone: (02) 9298 3999

www.mylan.com.au

Australian registration numbers:

ABISART 75 mg

AUST R 214577

ABISART 150 mg

AUST R 214579

ABISART 300 mg

AUST R 214581

This leaflet was prepared on

23 June 2017.

Abisart_cmi\JUN17/00

ABISART

30-10-2018

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP  75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP 75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

ScieGen Pharmaceuticals, Inc. is voluntarily recalling listed lots, within expiry, of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms to the consumer level. These products are being recalled due to the presence of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Irbesartan, USP manufactured by Aurobindo Pharma Limited. This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a...

FDA - U.S. Food and Drug Administration

29-10-2018

Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Aurobindo Pharma Limited is voluntarily recalling 22 Batches of the drug substance Irbesartan due to the presence of an impurity, N-nitrosodiethylamine (NDEA). The impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC).

FDA - U.S. Food and Drug Administration

22-10-2018

Irbesartan / Hydrochlorothiazide Teva (Teva B.V.)

Irbesartan / Hydrochlorothiazide Teva (Teva B.V.)

Irbesartan / Hydrochlorothiazide Teva (Active substance: irbesartan / hydrochlorothiazide) - Centralised - Yearly update - Commission Decision (2018) 6974 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

12-10-2018

Irbesartan Zentiva (Zentiva k.s.)

Irbesartan Zentiva (Zentiva k.s.)

Irbesartan Zentiva (Active substance: Irbesartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6772 of Fri, 12 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/785T/79

Europe -DG Health and Food Safety

2-10-2018

CoAprovel (Sanofi Clir SNC)

CoAprovel (Sanofi Clir SNC)

CoAprovel (Active substance: Irbesartan / hydrochlorothiazide) - Centralised - Yearly update - Commission Decision (2018)6465 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

24-9-2018

Karvezide (Sanofi-Aventis groupe)

Karvezide (Sanofi-Aventis groupe)

Karvezide (Active substance: Irbesartan / hydrochlorothiazide) - Centralised - Yearly update - Commission Decision (2018)6222 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

1-8-2018

Aprovel (Sanofi Clir SNC)

Aprovel (Sanofi Clir SNC)

Aprovel (Active substance: Irbesartan) - Centralised - Yearly update - Commission Decision (2018)5198 of Wed, 01 Aug 2018

Europe -DG Health and Food Safety

23-7-2018

Irbesartan Zentiva (Sanofi-Aventis groupe)

Irbesartan Zentiva (Sanofi-Aventis groupe)

Irbesartan Zentiva (Active substance: Irbesartan) - Centralised - Yearly update - Commission Decision (2018)4892 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

17-7-2018

Karvea (Sanofi-Aventis groupe)

Karvea (Sanofi-Aventis groupe)

Karvea (Active substance: Irbesartan) - Centralised - Yearly update - Commission Decision (2018)4781 of Tue, 17 Jul 2018

Europe -DG Health and Food Safety

4-7-2018

Ifirmacombi (Krka d. d., Novo mesto)

Ifirmacombi (Krka d. d., Novo mesto)

Ifirmacombi (Active substance: Irbesartan / hydrochlorothiazide) - Centralised - Yearly update - Commission Decision (2018)4340 of Wed, 04 Jul 2018

Europe -DG Health and Food Safety