APO-VALSARTAN valsartan 160 mg tablet blister pack

Main information

  • Trade name:
  • APO-VALSARTAN valsartan 160 mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • APO-VALSARTAN valsartan 160 mg tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 185821
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

185821

APO-VALSARTAN valsartan 160 mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

4/04/2012 11:00:00 PM

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. APO-VALSARTAN valsartan 160 mg tablet blister pack

Product Type

Single Medicine Product

Effective date

11/11/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Treatment of Hypertension.

Treatment of Heart failure (NYHA class II-IV) in patients receiving usual therapy (e.g. diuretics, digitalis) who are intolerant to ACE inhibitors.

To improve survival following myocardial infarction in clinically stable patients with clinical or radiological evidence of left ventricular failure and/or with left

ventricular systolic dysfunction (see Clinical Trials).

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PE/PVDC/Al

24 Months

Store below 25

degrees Celsius

Not recorded

Protect from Moisture

Protect from Heat

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

Components

1. APO-VALSARTAN valsartan 160 mg tablet blister pack

Dosage Form

Tablet

Route of Administration

Oral

Visual Identification

Yellow, modified, capsule shaped, film-coated tablets, engraved 'APO' on

one side and 'VA160' on the other side.

Active Ingredients

Valsartan

160 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 03:40:50 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

APO-Valsartan

Contains the active ingredient valsartan

Consumer Medicine Information

For a copy of a large print leaflet, Ph: 1800 195 055

What is in this leaflet

Read this leaflet carefully before

taking your medicine.

This leaflet answers some common

questions about valsartan. It does not

contain all the available information.

It does not take the place of talking to

your doctor or pharmacist.

The information in this leaflet was

last updated on the date listed on the

last page. More recent information on

this medicine may be available.

Ask your doctor or pharmacist:

if there is anything you do not

understand in this leaflet,

if you are worried about taking

your medicine, or

to obtain the most up-to-date

information.

You can also download the most up

to date leaflet from

www.apotex.com.au.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you using this medicine

against the benefits they expect it

will have for you.

Pharmaceutical companies cannot

give you medical advice or an

individual diagnosis.

Keep this leaflet with your medicine.

You may want to read it again.

What this medicine is

used for

The name of your medicine is APO-

Valsartan. It contains the active

ingredient valsartan.

This medicine belongs to a group of

medicines called angiotensin II

receptor antagonists (AIIRAs).

It is used to treat:

Hypertension

This medicine is used to control high

blood pressure, also called

hypertension. Everyone has blood

pressure. This pressure helps get your

blood 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 when your blood

pressure stays higher than is needed,

even when you are calm and relaxed.

There are usually no symptoms of

hypertension. The only way of

knowing that you have it is to have

your blood pressure checked

regularly.

High blood pressure increases the

workload of the heart and blood

vessels. If it continues for a long

time, it can damage the blood vessels

in the brain, heart and kidneys. This

can lead to stroke, heart failure or

kidney failure. High blood pressure

increases the risk of heart attacks.

Lowering your blood pressure

reduces the chance of these disorders

happening.

Heart Failure

This medicine is used to treat heart

failure. Heart failure means that the

heart muscle cannot pump blood

strongly enough to supply all the

blood needed throughout the body.

Heart failure is not the same as heart

attack and does not mean that the

heart stops. This medicine helps the

heart to function better and relieves

some of the symptoms of heart

failure.

Heart Attack

This medicine is also used to treat

people after they have had a heart

attack (myocardial infarction), to

reduce the risk of further heart

damage and reduce further heart

problems.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you. Your

doctor may have prescribed this

medicine for another reason.

This medicine is available only with

a doctor's prescription.

There is no medicine that this

medicine is addictive.

Use in children

There is not enough information to

recommend the use of this medicine

in children (below 18 years of age).

This medicine should not be used in

children.

Before you take this

medicine

When you must not take it

Do not take this medicine if:

APO-VALSARTAN TABLETS

You are also taking other blood

pressure lowering medicines

containing aliskiren and have

type 2 diabetes.

You have or have had liver

disease caused by blockage in

the bile duct or any other

severe liver disease.

You are pregnant or intend to

become pregnant.

Valsartan may affect your

developing baby if you take it

during pregnancy.

The expiry date (EXP) printed on

the pack has passed.

The packaging is torn, shows

signs of tampering or it does not

look quite right.

You are hypersensitive to or

have had an allergic reaction to

valsartan or any of the

ingredients listed at the end of

this leaflet.

Symptoms of an allergic reaction

may include cough, shortness of

breath, wheezing or difficulty

breathing; swelling of the face,

lips, tongue, throat or other parts

of the body, rash, itching or hives

on the skin; fainting or hayfever-

like symptoms

If you think you are having an

allergic reaction, do not take

any more of the medicine and

contact your doctor

immediately or go to the

Accident and Emergency

department at the nearest

hospital.

Before you start to take it

Before you start taking this

medicine, tell your doctor if:

You have allergies to:

any other medicines

any other substances, such as

foods, preservatives or dyes.

You have or have had any

medical conditions, especially the

following:

heart disease, heart failure or high

blood pressure that is being

treated with large doses of

diuretics (also called water or

fluid tablets), or are being treated

with beta-blockers, aliskiren and/

or ACE-inhibitors

high blood pressure due to

narrowing of the arteries in the

kidney

any other kidney problems or are

having dialysis

milder forms of liver disease

a hormonal disorder called

primary hyperaldosteronism,

which can increase blood

pressure

swelling, mainly of the face and

throat, while taking other

medicines (including an ACE

inhibitor or aliskiren)

you have recently had severe

vomiting or diarrhoea

you are severely limiting your salt

intake.

You are currently pregnant or you

plan to become pregnant.

Do not take this medicine whilst

pregnant.

You are currently breast-feeding

or you plan to breast-feed.

It is not known if valsartan, the

active ingredient can pass into the

breast milk. Do not take this

medicine whilst breast-feeding.

You are planning to have surgery

or an anaesthetic.

You are currently receiving or are

planning to receive dental

treatment.

You are taking or are planning to

take any other medicines.

This includes vitamins and

supplements that are available

from your pharmacy, supermarket

or health food shop.

Some medicines may interact with

valsartan. These include:

ACE-inhibitors or aliskiren,

which are also medicines used to

treat hypertension or other heart

conditions

some diuretics (water or fluid

pills) e.g. spironolactone,

triamterene, amiloride

a class of anti-inflammatory

medicines called NSAIDs and

COX-2 inhibitors

potassium supplements

salt substitutes containing

potassium

some antibiotics (rifampicin),

anti-rejection drugs (cyclosporin),

antiretrovirals (ritonavir)

lithium salts used to treat

conditions such as bipolar or

schizophrenia.

If you are taking any of these you

may need a different dose or you

may need to take different medicines.

Other medicines not listed above

may also interact with valsartan.

How to take this

medicine

Follow carefully all directions given

to you by your doctor. Their

instructions may be different to the

information in this leaflet.

How much to take

Your doctor or pharmacist will tell

you how much of this medicine you

should take. This will depend on

your condition and whether you are

taking any other medicines.

For hypertension, the usual dose is

one 80 mg tablet once a day. If your

blood pressure is still too high after 4

weeks, your doctor may increase the

dose to 160 mg once a day, or from

160 mg to 320 mg once a day. If your

blood pressure is still too high, your

doctor may add a different type of

blood pressure lowering medicine.

For heart failure, the usual starting

dose is 40 mg twice daily. Your

doctor may increase the dose

gradually up to one 160 mg tablet

twice daily.

Following a heart attack, treatment is

generally started at a dose of 20 mg

APO-VALSARTAN TABLETS

(half a 40 mg tablet) twice daily.

Your doctor may increase the dose

gradually up to 160 mg twice daily.

Do not stop taking your medicine or

change your dosage without first

checking with your doctor.

How to take it

Swallow the tablet with a full glass

of water.

Always take it in the same way in

relation to food. It does not matter if

you take it after food or on an empty

stomach, as long as you take it the

same way each day.

If your stomach is upset after taking

this medicine, always take it after a

meal (e.g. breakfast).

When to take it

This medicine comes in a calendar

pack with the days of the week

marked on it to help you remember

to take your tablet each day.

When you take the first tablet from

the pack of this medicine, take the

one marked with the correct day of

the week (e.g. if it is Wednesday,

take the tablet marked 'Wednesday').

Take this medicine at the same time

each day. Taking it at the same time

each day will have the best effect and

will also help you remember when to

take it.

How long to take it for

Continue taking your medicine for as

long as your doctor tells you.

It will take at least 4 weeks for this

medicine to have its full effect. After

that, it will be continued for as long

as your doctor thinks is needed.

Do not stop taking your medicine or

change your dosage without first

checking with your doctor.

Make sure you have enough to last

over weekends and holidays.

If you forget to take it

If it is almost time to take your next

dose, skip the missed dose and take

your next dose at the usual time.

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 missed doses.

This may increase the chance of you

experiencing side effects.

If you have trouble remembering to

take your medicine, ask your

pharmacist for some hints to help you

remember.

If you take too much

(overdose)

If you think that you or anyone

else may have taken too much of

this medicine, immediately

telephone your doctor or the

Poisons Information Centre (Tel:

13 11 26 in Australia) for advice.

Alternatively go to the Accident

and Emergency Department at

your nearest hospital.

Do this even if there are no signs of

discomfort or poisoning. You may

need urgent medical attention.

Too much of this medicine may

make you feel dizzy, lightheaded or

faint. You may experience rapid,

shallow breathing or cold, clammy

skin. Your heartbeat may be faster

than usual. This is because your

blood pressure is too low.

While you are taking

this medicine

Things you must do

Tell your doctor that you are taking

this medicine if:

for any reason, you have not

taken your medicine exactly as

prescribed, otherwise your doctor

may think that it was not effective

and change your treatment

unnecessarily

you are about to be started on any

new medicine

you are pregnant or are planning

to become pregnant. You should

not take this medicine while you

are pregnant.

you are breast-feeding or are

planning to breast-feed

you are about to have any blood

tests

you are going to have surgery or

an anaesthetic or are going into

hospital.

Be sure to keep all of your doctor's

appointments so that your progress

can be checked. Do this even if you

feel well.

It is important to keep track of your

progress. Your doctor will want to

check your blood pressure and your

kidney and liver function from time

to time.

Tell any other doctors, dentists and

pharmacists who are treating you that

you take this medicine.

Things you must not do

Do not:

Give this medicine to anyone

else, even if their symptoms seem

similar to yours

Take your medicine to treat any

other condition unless your

doctor or pharmacist tells you to

Stop taking your medicine, or

change the dosage, without first

checking with your doctor.

Things to be careful of

Be careful when driving or

operating machinery or doing jobs

that require you to be alert white

you are taking this medicine until

you know how this medicine affects

you.

This medicine can cause tiredness,

sleepiness or dizziness in some

people. If you have these symptoms,

do not drive or do anything else that

could be dangerous.

If this medicine makes you feel

dizzy or light-headed, be careful

when getting up from a sitting or

lying position.

Dizziness can usually be prevented

by getting up slowly and flexing leg

APO-VALSARTAN TABLETS

muscles and toes to get the blood

flowing. When getting out of bed,

dangle your legs over the side for a

minute or two before standing up.

Possible side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking valsartan or

if you have any questions or

concerns.

Do not be alarmed by the following

lists of side effects. You may not

experience any of them. All

medicines can have side effects.

Sometimes they are serious but most

of the time they are not.

Tell your doctor or pharmacist if

you notice any of the following side

effects.

Mostly, these are mild:

headache

dizziness, spinning sensation

(vertigo)

tiredness or weakness

diarrhoea, constipation or wind

nausea (feeling sick), vomiting

loss of appetite, stomach pains or

indigestion

dry cough, sore throat or hoarse

voice

runny nose or congested sinuses

more infections than usual

pain in the back or joints

muscle pain or cramps

difficulty sleeping

feeling anxious

tingling or numbness in the hands

or feet

problems with sexual function.

If you experience any of the

following, stop taking your

medicine and contact your doctor

immediately or go to the Accident

and Emergency department at

your nearest hospital.

These may be serious side effects.

You may need medical attention:

feeling of fast or irregular heart

beat (pounding, racing, skipping

beats)

chest pain

shortness of breath not caused by

exercise, with swelling of legs or

feet

tiredness or lack of energy, being

short of breath when exercising,

dizziness and looking pale

constant "flu-like" symptoms

such as chills, fever, sore throat,

aching joints, sores in mouth,

swollen glands

severe dizziness or fainting

liver disease with nausea,

vomiting, loss of appetite, feeling

generally unwell, fever, itching,

yellowing of the skin and eyes,

and dark coloured urine

Other side effects not listed above

may occur in some patients.

Allergic reactions

If you think you are having an

allergic reaction to valsartan, do

not take any more of this medicine

and tell your doctor immediately

or go to the Accident and

Emergency department at your

nearest hospital.

Symptoms of an allergic reaction

may include some or all of the

following:

cough, 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

fainting

hayfever-like symptoms

Storage and disposal

Storage

Keep your medicine in its original

packaging until it is time to take it.

If you take your medicine out of its

original packaging it may not keep

well.

Keep your medicine in a cool dry

place where the temperature will

stay below 25°C.

Do not store your medicine, 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 this medicine 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 or pharmacist tells you

to stop taking this medicine or it has

passed its expiry date, your

pharmacist can dispose of the

remaining medicine safely.

Product description

What APO-Valsartan looks

like

Valsartan 40 mg tablets

Yellow, modified, capsule shaped,

film-coated tablets, engraved 'APO'

on one side and 'VA' scored '40' on

the other side.

Valsartan 80 mg tablets

Pale red, round, biconvex, film-

coated tablets, engraved 'APO' on

one side and 'VA' over '80' on the

other side.

Valsartan 160 mg tablets

Yellow, modified, capsule shaped,

film-coated tablets, engraved 'APO'

on one side and 'VA160' on the other

side.

Valsartan 320 mg tablets

Dark grey-violet, oval shaped, film-

coated tablets, engraved 'APO' on

one side and 'VA320' on the other

side.

APO-VALSARTAN TABLETS

Ingredients

Each tablet contains 40, 80, 160 or

320 mg of valsartan as the active

ingredient.

It also contains the following inactive

ingredients:

cellulose powdered

calcium hydrogen phosphate

dihydrate

croscarmellose sodium

silica colloidal anhydrous

magnesium stearate

hypromellose

hydroxypropyl cellulose

macrogol 8000

titanium dioxide

yellow iron oxide

red iron oxide

purified water

The 160 and 320 mg tablets also

contain: black iron oxide.

This medicine is gluten-free, lactose-

free, sucrose-free, tartrazine-free and

free of other azo dyes.

Australian Registration

Numbers

APO-Valsartan 40 mg tablet

(blister pack of 7, 14, 28, 30, 56):

AUST R 185806.

(bottles of 28, 100, 500): AUST R

185853.

APO-Valsartan 80 mg tablet

blister pack of 7, 14, 28, 30, 56):

AUST R 185814.

(bottles of 28, 100, 500): AUST R

185854

APO-Valsartan 160 mg tablet

blister pack of 7, 14, 28, 30, 56):

AUST R 185821.

(bottles of 28, 100, 500): AUST R

185855.

APO-Valsartan 320 mg tablet

blister pack of 7, 14, 28, 30, 56):

AUST R 185826.

(bottles of 28, 100, 500): AUST R

185856.

Not all strengths, pack types and/or

pack sizes may be available.

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park, NSW 2113

APO and APOTEX is a registered

trade mark of Apotex Inc.

This leaflet was last updated in:

July 2014.

APO-VALSARTAN TABLETS