IRBESARTAN HCTZ AMNEAL 300/12.5 irbesartan hydrochlorothiazide 300/12.5 mg tablets blister pack

Main information

  • Trade name:
  • IRBESARTAN HCTZ AMNEAL 300/12.5 irbesartan hydrochlorothiazide 300/12.5 mg tablets blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • IRBESARTAN HCTZ AMNEAL 300/12.5 irbesartan hydrochlorothiazide 300/12.5 mg tablets blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 189385
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

189385

IRBESARTAN HCTZ AMNEAL 300/12.5 irbesartan hydrochlorothiazide 300/12.5 mg tablets 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

22/03/2013

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. IRBESARTAN HCTZ AMNEAL 300/12.5 irbesartan hydrochlorothiazide 300/12.5 mg tablets blister pack

Product Type

Single Medicine Product

Effective date

5/07/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Treatment of hypertension. Treatment should not be initiated with this fixed dose combination.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

24 Months

Store below 25

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

30 tablets

(S4) Prescription Only Medicine

Components

1. IRBESARTAN HCTZ AMNEAL 300/12.5 irbesartan hydrochlorothiazide 300/12.5 mg tablets blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Pink, oval shaped, biconvex 8.2 x 16.0 mm film-coated tablet with 'H' on

one side and 'I' on the other side

Active Ingredients

Hydrochlorothiazide

12.5 mg

Irbesartan

300 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 12:25:58 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 HCTZ AMNEAL CMI v4.0

Irbesartan HCTZ AMNEAL

contains the active ingredients irbesartan and hydrochlorothiazide

CONSUMER MEDICINE INFORMATION

What is in this leaflet

This leaflet answers some common

questions about IRBESARTAN HCTZ

AMNEAL.

It does not contain all of 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 IRBESARTAN

HCTZ AMNEAL against the benefits

they expect it will have 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 is IRBESARTAN HCTZ

AMNEAL

IRBESARTAN HCTZ AMNEAL tablets

contain two medicines, irbesartan

and hydrochlorothiazide.

Both these medicines are in the

tablets your doctor has prescribed

for you.

What IRBESARTAN HCTZ AMNEAL

is used for

IRBESARTAN HCTZ AMNEAL lowers

high blood pressure, which doctors

call 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 IRBESARTAN HCTZ AMNEAL. 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.

What IRBESARTAN HCTZ AMNEAL

does and how it works

IRBESARTAN HCTZ AMNEAL contains

Irbesartan and

hydrochlorothiazide. Both

medicines reduce blood pressure in

different ways. Irbesartan belongs

to a group of medicines known as

angiotensin-II receptor antagonists.

Angiotensin II is a substance

produced in the body which causes

blood vessels to tighten. Irbesartan

blocks angiotensin-II and therefore

relaxes your blood vessels. This

helps to lower your blood pressure.

Hydrochlorothiazide belongs to the

class of medicines known as

diuretics. Diuretics cause an

increase in the volume of urine.

They also help with lowering blood

pressure particularly when

combined with other blood

pressure reducing medicines.

Your doctor may have prescribed

IRBESARTAN HCTZ AMNEAL for

another use. If you want more

information, ask your doctor.

When you must not take

IRBESARTAN HCTZ AMNEAL

Do not take IRBESARTAN HCTZ

AMNEAL if:

you are pregnant (or think you

may be 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.

you are breast-feeding.

you are allergic to irbesartan or

hydrochlorothiazide or to

sulfonamide derived medicines,

or to any of the ingredients listed

under Product Description at the

end of this leaflet.

you are taking a medicine

containing aliskiren and either

have diabetes or moderate to

severe kidney impairment

you are not producing urine.

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 HCTZ

AMNEAL, talk to your doctor.

IRBESARTAN HCTZ AMNEAL should

not be given to children.

Before you start to take it

Tell your doctor if:

you are or intend to become

pregnant or plan to breast-feed

IRBESARTAN HCTZ AMNEAL should

not be used during pregnancy or

while breast-feeding

IRBESARTAN HCTZ AMNEAL CMI v4.0

you have recently had excessive

vomiting or diarrhoea or think

you are dehydrated

you suffer from any medical

conditions especially:

- kidney problems, or have had a

kidney transplant or dialysis

- heart problems

- liver problems, or have had liver

problems in the past

- diabetes

- gout or have had gout in the past

- lupus erythematosus

- high or low levels of potassium or

sodium or other electrolytes in

your blood

- primary aldosteronism

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.

have had a sympathectomy

you have been taking diuretics

you have a history of allergy or

asthma.

Be sure you tell your doctor about

any of these things before you take

any IRBESARTAN HCTZ AMNEAL.

Taking IRBESARTAN HCTZ

AMNEAL with other medicines

Tell your doctor if you are taking

any other medicines, including

any that you buy without a

prescription from a pharmacy,

supermarket or health food shop.

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

other water 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

(for example Voltaren, Indocid,

ibuprofen) and COX-2 inhibitors

(for example Celebrex). Taking a

combination of Irbesartan HCTZ

AMNEAL and an anti-

inflammatory medicine, alone or

with a thiazide diuretic (fluid

tablet) may damage your

kidneys. It may also reduce the

effect IRBESARTAN HCTZ AMNEAL

has on reducing blood pressure.

a medicine containing aliskiren.

Taking Irbesartan HCTZ AMNEAL

with aliskiren may affect your

blood pressure, electrolyte

balance and your kidney function

alcoholic drinks

sleeping tablets

strong pain killing medicines such

as codeine or morphine

medicines for diabetes (oral

tables or capsules or insulin)

calcium supplements, medicines

containing calcium or calcium

sparing drugs (e.g. Vitamin D

therapy)

medicines for gout

powder or granules used to help

reduce cholesterol (Questran Lite

or Colestid Granules)

heart medicines such as digoxin

or antiarrythmic medicines (e.g.

Sotacor®)

corticosteroid medicines such a

prednisone, cortisone or ACTH

medicines used to treat cancer

(cytoxic medicines)

amantadine (symmetrel), a

medicine used to Parkinson’s

disease or to prevent influenza

anticholinergic medicines, these

can be used to treat Parkinson’s

disease, to relive stomach

cramps or spasms or used to

prevent travel sickness

carbamazepine anticonvulsant

medication (such as Tegretol)

medicines used during surgery

medicines used in an emergency

situation such as adrenaline.

Your doctor will decide whether

your treatment needs to be altered

or whether you should have check

ups more frequently.

How to take IRPRESTAN

HCTZ

The tablets should be taken

regularly as directed by your

doctor. The tablets should be

swallowed with a drink of water.

How much to take

IRBESARTAN HCTZ AMNEAL will

usually be prescribed by your

doctor if previous treatment does

no produce a sufficient drop in

your blood pressure. Your doctor

will tell you how to switch from

your previous treatment to

IRPRESTAN HCTZ.

The usual starting dose is one

tablet once a day. The full blood

pressure lowering effect should be

reached 6-8 weeks after beginning

treatment. If your blood pressure

is not satisfactorily reduced with

IRPRESTAN HCTZ, your doctor may

prescribe another medicine to be

taken with IRPRESTAN HCTZ.

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 to take IRPRESTAN HCTZ

You should always take your daily

dose of IRBESARTAN HCTZ

AMNEAL at about the same time

each day. Taking your

IRBESARTAN HCTZ AMNEAL

tablets at the same time each day

will have the best effect.

It does not matter whether you

take IRBESARTAN HCTZ AMNEAL

tablets before or after food.

How long to take it:

IRBESARTAN HCTZ AMNEAL helps to

control your high blood pressure,

but does not cure it. Therefore

IRBESARTAN HCTZ AMNEAL must be

taken every day. Continue taking

IRBESARTAN HCTZ AMNEAL until

your doctor tells you to stop.

If you miss a dose:

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 the missed dose as

soon as you remember, and then go

back to taking your tablets as you

would normally.

If you are not sure whether to skip

the dose, talk to your doctor or

pharmacist.

IRBESARTAN HCTZ AMNEAL CMI v4.0

Do not take a double dose to

make up for the dose you missed.

If you have trouble remembering to

take your tablets, ask your

pharmacist for some hints.

If you take too much IRBESARTAN

HCTZ AMNEAL (overdose)

Immediately telephone your

doctor, or the Poisons

Information Centre (telephone 13

11 26), or go to Accident and

Emergency at the nearest

hospital, if you think you or

anyone else may have taken too

much IRPRESTAN HCTZ. Do this

even if there are no signs of

discomfort or poisoning.

You may need urgent medical

attention.

If you take too much IRPRESTAN

HCTZ, you may feel dizzy or

lightheaded.

While you are taking

IRPRESTAN HCTZ

Things you must do:

If you become pregnant while

taking IRBESARTAN HCTZ AMNEAL

tell your doctor immediately.

Have your blood pressure

checked when your doctor tells

you to, to make sure IRBESARTAN

HCTZ AMNEAL is working.

If you are about to start on any

new medicine, tell your doctor

and pharmacist that you are

taking IRBESARTAN HCTZ

AMNEAL.

Get up slowly when getting out

of bed or standing up. You may

feel light-headed or dizzy while

taking IRBESARTAN HCTZ

AMNEAL. 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. If you get dizzy or

lightheaded talk to your doctor.

If you plan to have surgery or

other treatment (even at the

dentist) that needs an

anaesthetic, make sure that you

tell your doctor or dentist that

you are taking IRBESARTAN HCTZ

AMNEAL

Make sure you drink enough

water during exercise and hot

weather when you are taking

IRBESARTAN HCTZ AMNEAL,

especially if you sweat a lot.

If you do not drink enough water

while taking IRBESARTAN HCTZ

AMNEAL, 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 HCTZ AMNEAL, 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 give IRBESARTAN HCTZ

AMNEAL tablets to anyone else,

even if they have the same

condition as you.

Things to be careful of:

Be careful driving or operating

machinery until you know how

IRBESARTAN HCTZ AMNEAL

affects you. As with many other

medicines used to treat high

blood pressure, IRBESARTAN HCTZ

AMNEAL may cause dizziness or

light-headedness in some people.

Make sure you know how you

react to IRBESARTAN HCTZ

AMNEAL 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.

The hydrochlorothiazide

contained in this medicine could

produce a positive analytical

result in an antidoping test.

Side effects

IRBESARTAN HCTZ AMNEAL 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.

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

IRBESARTAN HCTZ AMNEAL.

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

pain in the stomach,

nausea/vomiting

sexual problems.

These 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 or aching joints,

not caused by exercise

muscle pain or weakness or

paralysis of muscles

buzzing, ringing or other

persistent noise in the ears

changes in heart rhythm

you are not urinating (passing

water) as much as normal

numbness or tingling in fingers or

toes

painful, swollen joints which may

be symptoms of gout

fainting

yellowing of the skin and/or

eyes, also called jaundice

symptoms that may occur if you

have developed diabetes, such as

excessive thirst, passing greatly

increased amounts of urine,

increased appetite with weight

loss, feeling tired, drowsy, weak,

depressed, irritable and generally

unwell

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

disturbances in your vision (such

as blurred vision and seeing

haloes around lights) and eye

pain

These are serious side effects. Skin

rash and itchiness may be

symptoms of an allergic reaction.

You may need medical attention.

If any of the following happen,

stop taking IRBESARTAN HCTZ

IRBESARTAN HCTZ AMNEAL CMI v4.0

AMNEAL and tell your doctor

immediately, or go to Accident

and Emergency at the nearest

hospital:

swelling to the face, lips, tongue

or throat which may cause

difficulty in swallowing or

breathing If you have them, you

may have a serious allergic

reaction to IRBESARTAN HCTZ

AMNEAL

severe and sudden onset of

pinkish, itchy swellings on the

skin, also called hives or nettle

rash. If you have them, you may

have a serious allergic reaction

to IRBESARTAN HCTZ AMNEAL

symptoms that may indicate liver

disease with nausea, vomiting,

loss of appetite, feeling generally

unwell, fever, itching, yellowing

of the skin and eyes and dark

coloured urine.

These are 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. If you

notice any other unwanted effects,

you should tell your doctor or

pharmacist and ask for their

advice.

After using IRPRESTAN

HCTZ

Storage

Keep IRBESARTAN HCTZ AMNEAL

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.

Keep your tablets in a cool dry

place where the temperature

stays below 25

C.

Do not store IRBESARTAN HCTZ

AMNEAL or any other medicine in

the bathroom or near a sink.

Do not leave IRBESARTAN HCTZ

AMNEAL in the car or on window

sills.

Heat and dampness can destroy

some medicines.

Disposal

If your doctor tells you to stop

taking IRBESARTAN HCTZ

AMNEAL, or your tablets have

passed their expiry date, ask your

pharmacist what to do with any

that are left over.

Product description

What it looks like

IRBESARTAN HCTZ AMNEAL comes

in 3 strengths of tablets:

IRBESARTAN HCTZ AMNEAL

150/12.5 - Pink, oval tablet with

‘H’ on one side and ‘I’ on the

other side

IRBESARTAN HCTZ AMNEAL

300/12.5 - Pink, oval tablet with

‘H’ on one side and ‘I’ on the

other side

IRBESARTAN HCTZ AMNEAL

300/25 –

Dark pink, oval tablet

with H on one side and ‘I’ on the

other side.

Each pack contains 30 tablets.

Ingredients

The active ingredients in

IRBESARTAN HCTZ AMNEAL are

irbesartan and

hydrochlorothiazide.

each IRBESARTAN HCTZ AMNEAL

150/12.5 tablet contains 150 mg

of irbesartan and 12.5 mg of

hydrochlorothiazide

each IRBESARTAN HCTZ AMNEAL

300/12.5 tablet contains 300 mg

of irbesartan and 12.5 mg of

hydrochlorothiazide

each IRBESARTAN HCTZ AMNEAL

300/25 tablet contains 300 mg of

irbesartan and 25 mg of

hydrochlorothiazide.

The tablets also contain:

mannitol

povidone

microcrystalline cellulose

croscarmellose sodium

colloidal anhydrous silica

magnesium stearate

Opadry II 85F34353 Pink

(ARTG 107713, 150/12.5 mg tablet

only)

Opadry II 85F34229 Pink

(ARTG 107715, 300/12.5 mg tablet

only)

Opadry II 85F34230 Pink

(ARTG 107714, 300/25 mg tablet

only).

The tablets do not contain lactose,

gluten, sucrose, tartrazine or any

other azo dyes.

Supplier

Amneal Pharma Australia

Pty Ltd

12 River Street

South Yarra VIC 3141

Australia

Australian registration numbers:

IRBESARTAN HCTZ AMNEAL

150/12.5 - AUST R 189375

IRBESARTAN HCTZ AMNEAL

300/12.5 - AUST R 189385

IRBESARTAN HCTZ AMNEAL 300/25

- AUST R 189388

Date of preparation:

July 2016