IRBESARTAN

Main information

  • Trade name:
  • IRBESARTAN HCT WINTHROP 300/25 irbesartan 300mg and hydrochlorothiazide 25mg film-coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • IRBESARTAN HCT WINTHROP 300/25 irbesartan 300mg and hydrochlorothiazide 25mg film-coated tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 196958
  • Last update:
  • 12-11-2017

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Irbesartan HCT

Winthrop

®

irbesartan & hydrochlorothiazide

Consumer Medicine Information (CMI)

What is in this leaflet

This leaflet answers some common

questions about Irbesartan HCT

Winthrop. 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 HCT

Winthrop is used for

Irbesartan HCT Winthrop 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.

How Irbesartan HCT

Winthrop works

Irbesartan HCT Winthrop 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 that

causes blood vessels to narrow.

Irbesartan 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.

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 HCT Winthrop for another

reason. Ask your doctor if you have

any questions about why Irbesartan

HCT Winthrop 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 HCT

Winthrop

When you must not take it

Do not take Irbesartan HCT

Winthrop if:

you are pregnant (or think you

may be pregnant) or are

planning to become pregnant.

Irbesartan HCT Winthrop may

affect your developing baby if

you take it during pregnancy.

you are breast-feeding or are

planning to breast-feed.

you are allergic to irbesartan or

hydrochlorothiazide or to

sulfonamide derived medicines

(commonly known as sulfur

drugs), or to any of the

ingredients listed under 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).

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 HCT

Winthrop, talk to your doctor.

IRBESARTAN HCT WINTHROP

Irbesartan HCT Winthrop should

not be given to children.

Before you start to take it

Tell your doctor if have any

allergies to:

any of the ingredients listed at the

end of this leaflet including

lactose

any other medicines, including

sulfonamide derived medicines

(commonly known as sulfur

drugs)

any other substances , such as

foods, preservatives or dyes

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 or think you are

dehydrated

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 have had a sympathectomy

you have been taking diuretics

you have a history of allergy or

asthma

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 HCT

Winthrop.

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.

It is especially important that you tell

your doctor if you are taking or plan

to take any of the following:

other medicines for high blood

pressure

other fluid tablets or diuretics

lithium or lithium-containing

medicines (for example lithium

carbonate)

potassium tablets

potassium-containing salt

substitutes

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 HCT Winthrop

and an anti-inflammatory

medicine alone or with a thiazide

diuretic (fluid tablet) may damage

your kidneys. It may also reduce

the effect Irbesartan HCT

Winthrop has on lowering blood

pressure

a medicine containing aliskiren.

Taking Irbesartan HCT Winthrop

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

tablets or capsules or insulins)

calcium supplements or

medicines containing calcium

Vitamin D

medicines for gout

powder or granules used to help

reduce cholesterol

(cholestyramine or colestipol

hydrochloride)

heart medicines such as digoxin

or antiarrhythmic medicines (for

example sotalol hydrochloride)

corticosteroid medicines such as

prednisone, cortisone or ACTH

medicines used to treat cancer

(cytotoxic medicines)

amantadine, a medicine used to

treat Parkinson's disease or to

prevent influenza

anticholinergic medicines, these

can be used to treat Parkinson's

disease, to relieve stomach

cramps or spasms or used to

prevent travel sickness

carbamazepine, an anticonvulsant

medication

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.

Your doctor and pharmacist may

have more information on medicines

to be careful with or avoid while

taking Irbesartan HCT Winthrop.

How to take Irbesartan

HCT Winthrop

How much to take:

Irbesartan HCT Winthrop will

usually be prescribed by your doctor

if previous treatment does not

produce a sufficient drop in your

blood pressure. Your doctor will tell

you how to switch from your

previous treatment to Irbesartan HCT

Winthrop.

The usual dose of Irbesartan HCT

Winthrop is one tablet 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

IRBESARTAN HCT WINTHROP

Irbesartan HCT Winthrop, your

doctor may prescribe another

medicine to be taken with Irbesartan

HCT Winthrop.

How to take it

Swallow the tablet whole with a

glass of water.

It does not matter whether you take

Irbesartan HCT Winthrop tablets

before or after food.

When to take it

Take Irbesartan HCT Winthrop 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 HCT

Winthrop until your doctor tells

you to stop.

Irbesartan HCT Winthrop helps

control your high blood pressure but

does not cure it. Therefore Irbesartan

HCT Winthrop must be taken every

day.

To help you remember to take your

tablets each day, Irbesartan HCT

Winthrop 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". 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.

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 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 HCT

Winthrop.

Do this even if there are no signs of

discomfort or poisoning.

You may need urgent medical

attention.

If you take too many Irbesartan HCT

Winthrop tablets, you will probably

feel lightheaded or dizzy.

While you are using

Irbesartan HCT

Winthrop

Things you must do

Tell any other doctors, dentists and

pharmacists who are treating you

that you are taking Irbesartan

HCT Winthrop.

If you become pregnant while

taking Irbesartan HCT Winthrop

tell your doctor immediately.

Have your blood pressure checked

when your doctor tells you to, to

make sure Irbesartan HCT

Winthrop is working.

If you are about to be started on

any new medicine, tell your doctor

and pharmacist that you are taking

Irbesartan HCT Winthrop.

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 HCT Winthrop.

Your blood pressure may drop

suddenly.

Make sure you drink enough water

during exercise and hot weather

when you are taking Irbesartan

HCT Winthrop, especially if you

sweat a lot.

If you do not drink enough water

while taking Irbesartan HCT

Winthrop, 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 HCT Winthrop, 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 HCT Winthrop, or

when your dose is increased, tell

your doctor immediately.

Things you must not do

Do not give Irbesartan HCT

Winthrop tablets to anyone else,

even if they have the same

condition as you.

Do not take Irbesartan HCT

Winthrop to treat any other

complaints unless your doctor or

pharmacist tells you to.

Do not stop taking Irbesartan HCT

Winthrop, 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

IRBESARTAN HCT WINTHROP

pressure. If this problem continues or

gets worse, talk to your doctor.

Be careful driving or operating

machinery until you know how

Irbesartan HCT Winthrop affects

you. As with many other medicines

used to treat high blood pressure,

Irbesartan HCT Winthrop may

cause dizziness or light-headedness

in some people. If this occurs do

not drive. Make sure you know

how you react to Irbesartan HCT

Winthrop 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.

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.

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 HCT Winthrop.

Irbesartan HCT Winthrop 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

pain in the stomach or gut nausea

and/or 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 sore joints, not

caused by exercise

muscle pain or weakness

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 that may

be symptoms of gout

fainting

yellowing of the skin and/or eyes,

also known as 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 changes 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

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.

IRBESARTAN HCT WINTHROP

You may need medical attention.

These side effects are not common.

If any of the following happen, stop

taking Irbesartan HCT Winthrop

and either 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 a 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

HCT Winthrop

Storage

Keep your Irbesartan HCT

Winthrop tablets in the blister

pack until it is time to take them.

If you take the tablets out of the

blister pack they will not keep well.

Keep Irbesartan HCT Winthrop

tablets in a cool dry place where

the temperature stays below 25°C.

Do not store Irbesartan HCT

Winthrop or any other medicine in

the bathroom near a sink. Do not

leave them near a radiator, in a car

on a hot day 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 HCT Winthrop 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 HCT Winthrop 150/12.5

tablets - peach, oval shaped film-

coated tablet with a heart shape

imprinted on one side and "2875"

engraved on the other side. Blister

pack sizes include: 3*, 5*, 7*, 14*,

28*, 30, 56* and 98* tablets.

Irbesartan HCT Winthrop 300/12.5

tablets - peach, oval shaped film-

coated tablet with a heart shape

imprinted on one side and "2876"

engraved on the other side. Blister

pack sizes include: 3*, 5*, 7*, 14*,

28*, 30, 56* and 98* tablets.

Irbesartan HCT Winthrop 300/25

tablets - pink, oval shaped film-

coated tablet with a heart shape

imprinted on one side and "2788"

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 HCT Winthrop 150/12.5

tablets - 150 mg Irbesartan and 12.5

mg Hydrochlorothiazide per tablet.

Irbesartan HCT Winthrop 300/12.5

tablets - 300 mg Irbesartan and 12.5

mg Hydrochlorothiazide per tablet.

Irbesartan HCT Winthrop 300/25

tablets - 300 mg Irbesartan and 25

mg Hydrochlorothiazide per tablet.

Other Ingredients

Irbesartan HCT Winthrop 150/12.5

& 300/12.5 tablets also contain

carnauba wax, croscarmellose

sodium, hypromellose, lactose, iron

oxide red CI 77491, iron oxide

yellow CI 77492, macrogol 3000,

magnesium stearate, microcrystalline

cellulose, silicon dioxide, and

titanium dioxide.

Irbesartan HCT Winthrop 300/25

tablets also contain carnauba wax,

croscarmellose sodium,

hypromellose, lactose, iron oxide red

CI 77491, iron oxide yellow CI

77492, iron oxide black CI 77499,

macrogol 3350, magnesium stearate,

microcrystalline cellulose, silicon

dioxide, pregelatinised maize starch,

and titanium dioxide.

Manufacturer

Irbesartan HCT Winthrop is supplied

in Australia by

sanofi-aventis australia pty ltd

12-24 Talavera Road

Macquarie Park, NSW 2113.

Irbesartan HCT Winthrop is a

registered sanofi-aventis trademark.

Australian registration number(s):

Irbesartan HCT Winthrop 150/12.5

AUST R 196956

Irbesartan HCT Winthrop 300/12.5

AUST R 196957

Irbesartan HCT Winthrop 300/25

AUST R 196958

This leaflet was prepared in March

2017

irbesartan-hct-winthrop-ccdsv14-

cmiv4-27feb17

IRBESARTAN HCT WINTHROP