APO-TELMISARTAN

Main information

  • Trade name:
  • APO-TELMISARTAN telmisartan 80mg tablets blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • APO-TELMISARTAN telmisartan 80mg tablets blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 209334
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

209334

APO-TELMISARTAN telmisartan 80mg tablets 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

19/05/2014

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-TELMISARTAN telmisartan 80mg tablets blister pack

Product Type

Single Medicine Product

Effective date

3/04/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

APO-TELMISARTAN is indicated for:,Treatment of hypertension,Prevention of cardiovascular morbidity and mortality in patients 55 years or older with

coronary artery disease, peripheral artery disease, previous stroke, transient ischaemic attack or high risk diabetes with evidence of end organ damage

(see CLINICAL TRIALS)

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Al/Al

36 Months

Store below 30

degrees Celsius

Not recorded

Protect from Light

Protect from Moisture

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. APO-TELMISARTAN telmisartan 80mg tablets blister pack

Dosage Form

Tablet

Route of Administration

Oral

Visual Identification

White to off-white color, oval shape, biconvex, uncoated tablets debossed

with L204 on one side and plain on other side.

Active Ingredients

Telmisartan

80 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 27.11.2017 at 10:28:37 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-TELMISARTAN

APO-Telmisartan

Contains the active ingredient telmisartan

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 telmisartan. 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-

Telmisartan. It contains the active

ingredient telmisartan.

It is used to:

treat high blood pressure (also

called hypertension).

prevent cardiovascular

complications, including death

due to cardiovascular causes, in

patients aged 55 years of age or

older with coronary artery

disease, peripheral vascular

disease, previous stroke, previous

transient ischaemic attack (TIA)

or high risk diabetes with

evidence of end organ damage.

High blood pressure

(hypertension)

Everyone has blood pressure. This

pressure helps your blood move

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 normal, even when you

are calm or relaxed.

There are usually no signs of

hypertension. The only way of

knowing that you have hypertension

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,

including stroke, heart disease and

kidney failure.

Prevention of cardiovascular

complications, including death due

to cardiovascular causes

Patients who may be considered at a

high risk of developing

cardiovascular complications, or at a

high risk of death due to

cardiovascular causes, are those aged

55 or more who have problems such

as coronary artery disease (a heart

disease caused by poor blood flow in

the blood vessels of the heart),

peripheral vascular disease (poor

circulation in the hands or feet),

previous stroke, previous transient

ischaemic attack (TIA) or diabetes

with additional high risk factors and

evidence of end organ damage (e.g.

damage occurring in the kidneys,

heart, brain or eyes).

Your doctor can tell you if you are at

a high risk of developing

cardiovascular complications or if

you are at a high risk of death due to

cardiovascular causes.

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.

How it works

Telmisartan belongs to a group of

medicines called angiotensin II

receptor antagonists. Angiotensin II

APO-TELMISARTAN

is a substance in the body which

causes blood vessels to narrow, thus

increasing blood pressure.

Telmisartan works by blocking the

effect of angiotensin II. When the

effect of angiotensin II is blocked,

the blood vessels relax and your

blood pressure goes down.

Telmisartan may be used either alone

or in combination with other

medicines used to treat high blood

pressure.

There is no evidence that this

medicine is addictive.

Use in children

This medicine should not be used in

children. The safety and

effectiveness in children below 18

years of age have not been

established.

Before you take this

medicine

When you must not take it

Do not take this medicine if:

You have or have had any of

the following:

Severe liver disease (severe

hepatic impairment)

Bilary obstructive disorders

(problems with the flow of bile

from the gall bladder).

You are pregnant or are

planning to become pregnant.

Telmisartan may affect your

developing baby if you take it

during pregnancy.

You are breast-feeding or are

planning to breast-feed.

Telmisartan may pass into human

breast milk.

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,

telmisartan 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:

kidney problems

liver problems

heart problems

a condition known as primary

hyperaldosteronism (raised

aldersterone levels, also known as

Conn’s syndrome)

recent severe diarrhoea or

vomiting

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. Do not

take this medicine whilst breast-

feeding.

5. You are following a very low salt

diet.

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

telmisartan. These include:

ramipril or any other medicines

used to treat high blood pressure

or heart problems

potassium supplements or

potassium-containing salt

substitutes

medicines or salt-substitutes

which may increase your

potassium levels

diuretics or fluid tablets,

medicines used to help the

kidneys get rid of salt and water

by increasing the amount of urine

produced

nonsteroidal anti-inflammatory

agents (NSAIDs - medicines used

to relieve pain, swelling and other

symptoms of inflammation,

including arthritis) such as aspirin

lithium, a medicine used to treat

certain mental illnesses

digoxin, a medicine used to treat

heart failure

If you are taking any of these

medicines you may need a different

dose or you may need to take

different medicines.

Other medicines not listed above

may also interact with telmisartan.

Your doctor may have more

information on medicines to be

careful with or avoid while taking

telmisartan.

APO-TELMISARTAN

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 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.

Do not stop taking your medicine or

change your dosage without first

checking with your doctor.

For the treatment of high blood

pressure (hypertension):

The usual dose for adults is one 40

mg tablet, once a day.

If your blood pressure is still too high

after 4-8 weeks of starting treatment,

your doctor may increase your dose

to 80 mg.

For the prevention of

cardiovascular complications,

including death due to

cardiovascular causes:

The usual dose is one 80 mg tablet,

once a day.

Depending on how you respond to

the treatment, your doctor may

suggest a higher or lower dose.

How to take it

Swallow the tablet whole with a full

glass of water.

When to take it

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.

It does not matter if you take it

before, with or after food.

How long to take it for

Continue taking your medicine for as

long as your doctor tells you.

Make sure you have enough to last

over weekends and holidays.

Take telmisartan every day until

your doctor tells you to stop.

Telmisartan helps to control your

high blood pressure, and/or prevents

you from developing cardiovascular

complications, but does not cure it. It

is important to keep taking

telmisartan every day, even if you

feel well.

People who have high blood pressure

often feel well and do not notice any

signs of this problem.

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.

If you take too much telmisartan you

may feel dizzy, light-headed or faint.

Your heartbeat may be faster or

lower than usual and you may

experience rapid, shallow breathing

or cold, clammy skin. 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:

you are about to be started on any

new medicine

you plan to have any vaccinations

or immunisations

you are pregnant or are planning

to become 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.

Your doctor may occasionally do

tests to make sure the medicine is

working and to prevent side effects.

Go to your doctor regularly for a

check-up.

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 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 until you know how this

medicine affects you.

APO-TELMISARTAN

Like other medicines used to treat

high blood pressure, telmisartan may

cause sleepiness, dizziness or light

headedness in some people.

If you have any of these symptoms,

do not drive, operate machinery or

do anything else that could be

dangerous.

You may feel dizzy or light-headed

when you begin to take telmisartan,

especially if you are also taking a

diuretic (or fluid tablet) or if you are

dehydrated.

If this medicine makes you feel

dizzy or light-headed, be careful

when getting up from a sitting or

lying position.

Standing up slowly, especially when

you get up from a bed or chair, 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.

If you exercise, or if you sweat, or

if the weather is hot, you should

drink plenty of water.

Possible side effects

Tell your doctor as soon as possible

if you do not feel well while you are

taking telmisartan 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 if you notice any

of the following:

headache

dizziness or spinning sensation,

fainting

dizziness or lightheadedness

when you stand up, especially

when getting up from a sitting or

lying position

tiredness or weakness

‘flu-like’ symptoms

pain in the chest

diarrhoea

indigestion

stomach pain or discomfort

wind or excessive gas in the

stomach or bowel (flatulence)

upper respiratory tract infections

shortness of breath

back pain

aching muscles not caused by

exercise (myalgia)

muscle spasms or leg cramps or

leg pain

painful joints (arthralgia)

tendon pain or tendinitis-like

symptoms

urinary tract infections (including

cystitis)

trouble sleeping (insomnia)

feeling anxious

depression

fast or slow heart beats

visual disturbance

increased sweating

dry mouth

allergic skin reactions including:

skin rash (eczema); itchiness

(pruritus); redness of the skin

(erythema)

symptoms that may indicate low

blood sugar levels, such as

sweating, weakness, hunger,

dizziness, trembling, headache or

numbness (especially in diabetic

patients)

abnormal liver function

symptoms that may indicate a

worsening of the kidney function,

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

signs of anaemia such as

tiredness, being short of breath

when exercising, dizziness and

looking pale

bleeding or bruising more easily

than normal (thrombocytopenia)

symptoms that may indicate an

infection of the blood, such as

high fever, chills, headache,

confusion and rapid breathing

changes in your red or white

blood cell levels may occur (such

changes are usually detected by a

blood test).

Other side effects not listed above

may occur in some patients.

Allergic reactions

If you think you are having an

allergic reaction to telmisartan, 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 30°C. Protect from light and

moisture.

APO-TELMISARTAN

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 tells you to stop taking

this medicine or they have passed

their expiry date, your pharmacist

can dispose of the remaining

medicine safely.

Product description

What APO-Telmisartan looks

like

40 mg Tablet

White to off-white, biconvex, oval-

shaped tablets, one face marked with

L203 and plain on the other side.

80 mg Tablet

White to off-white, biconvex, oval-

shaped tablets, one face marked with

L204 and plain on the other side.

*Not all strengths, pack types and/or

pack sizes may be available.

Ingredients

Each tablet contains (40 mg or 80

mg) of telmisartan as the active

ingredient.

It also contains the following inactive

ingredients:

Povidone K25

Mannitol

Meglumine

Magnesium stearate

Sodium hydroxide

Sodium stearyl fumarate

This medicine is gluten-free, lactose-

free, sucrose-free, tartrazine-free and

free of other azo dyes.

Australian Registration

Numbers

APO-Telmisartan 40 mg tablets

(blister pack: Alu silver/Alu HSL) of

28 tablets: AUST R 209336

APO-Telmisartan 80 mg tablets

(blister pack: Alu silver/Alu HSL) of

28 tablets: AUST R 209334

Name and Address of the

Sponsor

Alembic Pharmaceuticals Australia

Pty Ltd

2A Porter Road

Carnegie VIC 3163

Name and Address of the

Distributor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park, NSW 2113

Australia

APO and APOTEX are registered

trade marks of Apotex Inc.

This leaflet was last updated in

September 2014.

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Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 1: Compendium of Representative Processing Techniques investigated in regulatory studies for pesticides

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 1: Compendium of Representative Processing Techniques investigated in regulatory studies for pesticides

Published on: Mon, 26 Nov 2018 EFSA is conducting pan‐European dietary exposure and risk assessments related to actual levels of pesticide residues in food commodities. These assessments use the pesticide occurrence data generated under the official monitoring programs of Member States, the consumption data from EFSA's comprehensive food consumption database and pesticide‐specific information such as processing factors. Currently no harmonised list of processing factors is available within Europe and wo...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Published on: Mon, 12 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Agro BV submitted a request to the competent national authority in the United Kingdom to set import tolerances for the active substance teflubenzuron in grapefruits and mandarins imported from Brazil and for broccoli imported from Paraguay. The data submitted were found to be sufficient to derive maximum residue level (MRL) proposals for grapefruits and broccoli. The MRL derived ...

Europe - EFSA - European Food Safety Authority Publications

10-11-2018

Pest categorisation of Popillia japonica

Pest categorisation of Popillia japonica

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The Panel on Plant Health performed a pest categorisation of Popillia japonica(Coleoptera: Scarabaeidae) for the EU. P. japonica is a distinguishable species listed in Annex IAII of Council Directive 2000/29/EC. It is native to Japan but established in the USA in the early 20th century. It spreads from New Jersey to most US states east of the Mississippi, some to the west and north into Canada. P. japonica feeds on over 700 plant species. Adults attack folia...

Europe - EFSA - European Food Safety Authority Publications

7-8-2018

Voluntary Recall Notice of El Guapo Jamaica Hibiscus Flower Pouches Due to Unlabeled Peanut Allergen

Voluntary Recall Notice of El Guapo Jamaica Hibiscus Flower Pouches Due to Unlabeled Peanut Allergen

Mojave Foods Corporation is initiating a voluntary recall of four sizes of El Guapo Jamaica Hibiscus Flower packages in flexible packaging due to an unlabeled peanut allergen

FDA - U.S. Food and Drug Administration

9-6-2018

Caito Foods, LLC Voluntarily Recalls Fresh Cut Melon Products Because of Possible Health Risk

Caito Foods, LLC Voluntarily Recalls Fresh Cut Melon Products Because of Possible Health Risk

Caito Foods is voluntarily recalling fresh cut watermelon, honeydew melon, cantaloupe and fresh-cut mixed fruit containing one of these melons, produced at the Caito Foods facility in Indianapolis, because these products have the potential to be contaminated with Salmonella.

FDA - U.S. Food and Drug Administration

24-5-2018

FDA Approves Semintra, the First FDA-approved Animal Drug for the Control of Systemic Hypertension in Cats

FDA Approves Semintra, the First FDA-approved Animal Drug for the Control of Systemic Hypertension in Cats

The FDA has approved Semintra (telmisartan oral solution), the first FDA-approved animal drug to control systemic hypertension in cats. Semintra is an oral solution administered either directly into the cat’s mouth or on top of a small amount of food.

FDA - U.S. Food and Drug Administration

11-2-2019

Tolucombi (Krka d. d., Novo mesto)

Tolucombi (Krka d. d., Novo mesto)

Tolucombi (Active substance: telmisartan/hydrochlorothiazide) - Centralised - Yearly update - Commission Decision (2019)1040 of Mon, 11 Feb 2019

Europe -DG Health and Food Safety

18-12-2018

APO-Valsartan (valsartan) tablets

APO-Valsartan (valsartan) tablets

Recall - potential contamination

Therapeutic Goods Administration - Australia

25-10-2018

Micardis (Boehringer Ingelheim International GmbH)

Micardis (Boehringer Ingelheim International GmbH)

Micardis (Active substance: telmisartan) - Centralised - Yearly update - Commission Decision (2018)7136 of Thu, 25 Oct 2018

Europe -DG Health and Food Safety

4-6-2018

Twynsta (Boehringer Ingelheim International GmbH)

Twynsta (Boehringer Ingelheim International GmbH)

Twynsta (Active substance: telmisartan / amlodipine) - Centralised - Yearly update - Commission Decision (2018)3625 of Mon, 04 Jun 2018

Europe -DG Health and Food Safety

16-5-2018

Semintra (Boehringer Ingelheim Vetmedica GmbH)

Semintra (Boehringer Ingelheim Vetmedica GmbH)

Semintra (Active substance: Telmisartan) - Centralised - Variation - Commission Decision (2018)3020 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2436/X/8

Europe -DG Health and Food Safety