TELMISARTAN

Main information

  • Trade name:
  • TELMISARTAN AN telmisartan 40mg tablets blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • TELMISARTAN AN telmisartan 40mg tablets blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 209335
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

209335

TELMISARTAN AN telmisartan 40mg 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

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. TELMISARTAN AN telmisartan 40mg tablets blister pack

Product Type

Single Medicine Product

Effective date

8/12/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

TELMISARTAN AN 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. TELMISARTAN AN telmisartan 40mg tablet

Dosage Form

Tablet

Route of Administration

Oral

Visual Identification

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

with L203 on one side and plain on other side.

Active Ingredients

Telmisartan

40 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 20.10.2017 at 11:10:54 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

Telmisartan AN tablets – Consumer Medicine Information

Telmisartan AN CMI v2.0

Page 1

Telmisartan AN Tablets

Telmisartan

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Telmisartan AN.

It does not contain all available

information. It does not take the

place of talking to your doctor or

pharmacist.

This leaflet was last updated on the

date at the end of this leaflet. More

recent information may be

available. The latest Consumer

Medicine Information is available

from your pharmacist, doctor, or

from www.medicines.org.au and

may contain important information

about the medicine and its use of

which you should be aware.

All medicines have benefits and

risks.

Your doctor has weighed the risks

of you taking this medicine against

the benefits it is expected to have

for you.

If you have any concerns about

this medicine, ask your doctor or

pharmacist.

Keep this leaflet with the

medicine.

You may need to read it again.

What Telmisartan AN

is used for

Telmisartan AN is used to:

treat high blood pressure (also

called hypertension)

prevent cardiovascular

complications, including death

due to cardiovascular causes, in

patients older than 55 years of

with coronary artery disease,

peripheral vascular disease,

previous stroke, previous

transient ischaemic attack

(TIA) or high risk diabetes with

evidence of end organ damage

TREATMENT OF

HYPERTENSION

Telmisartan AN is used to lower

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.

How Telmisartan AN works

Telmisartan AN contains

telmisartan. Telmisartan belongs to

a group of medicines called

angiotensin II receptor antagonists.

Angiotensin II 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, your blood vessels relax

and your blood pressure goes down.

Telmisartan AN may be used either

alone or in combination with other

medicines used to treat high blood

pressure.

PREVENTION OF

CARDIOVASCULAR

COMPLICATIONS, INCLUDING

DEATH DUE TO

CARDIOVASCULAR CAUSES

Telmisartan AN is also used to

prevent cardiovascular

complications, including death due

to cardiovascular causes that may

arise in high risk patients older than

55 years of age. Examples include

heart attack, stroke, death caused by

heart diseases or hospitalisation due

to heart failure (a condition which

can cause shortness of breath or

ankle swelling).

Patients who may be considered at

high risk of developing

cardiovascular complications or at

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 high risk of developing

Telmisartan AN tablets – Consumer Medicine Information

Telmisartan AN CMI v2.0

Page 2

cardiovascular complications or if

you are at high risk of death due to

cardiovascular causes.

Your doctor may have prescribed

Telmisartan AN for another reason.

Ask your doctor if you have any

questions about why Telmisartan

AN has been prescribed for you.

Telmisartan AN is not addictive.

This medicine is available only with

a doctor’s prescription.

Use in children

The safety and effectiveness of

Telmisartan AN in children and

teenagers up to 18 years of age have

not been established.

Before you take

Telmisartan AN

When you must not take it

Do not take Telmisartan AN if

you have ever had an allergic

reaction after taking:

telmisartan (the active

ingredient in Telmisartan AN)

any other ingredients listed at

the end of this leaflet

Symptoms of an allergic reaction

may include skin rash, itchiness,

shortness of breath, swelling of the

face, lips or tongue, muscle pain or

tenderness or joint pain.

Do not take Telmisartan AN if

you are pregnant or intend to

become pregnant.

Telmisartan AN is not

recommended for use in pregnancy.

Like other similar medicines, it

could affect your unborn baby if

you take it during pregnancy.

Do not breastfeed if you are

taking Telmisartan AN.

It is not known if telmisartan, the

active ingredient in Telmisartan

AN, passes into breast milk and

there is a possibility that your baby

may be affected.

Do not take Telmisartan AN if

you suffer from:

severe liver disease

biliary obstructive disorders

(problem with the flow of bile

from the gall bladder)

diabetes or kidney problems

and you are taking aliskiren (a

medicine used to treat high

blood pressure).

Do not take Telmisartan AN 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.

Do not take Telmisartan AN if the

tablets are discoloured.

If you are not sure whether you

should start taking Telmisartan

AN talk to your doctor.

Before you start to take it

Tell your doctor if you have

allergies to:

any other medicines

any other substances, such as

foods, preservatives or dyes

Tell your doctor if you have or

have had any medical conditions,

especially the following:

kidney problems

liver problems

heart problems

diabetes

a condition known as primary

hyperaldosteronism (raised

aldosterone levels, also known

as Conn’s syndrome)

recent severe diarrhoea or

vomiting

Tell your doctor if you are

following a very low salt diet.

Tell your doctor if you plan to

become pregnant or breastfeed.

If you have not told your doctor

about any of the above, tell your

doctor before you take

Telmisartan AN.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

get without a prescription from

your pharmacy, supermarket or

health food shop.

Some medicines and Telmisartan

AN may interfere with each other.

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

aspirin

nonsteroidal anti-inflammatory

agents (medicines used to

relieve pain, swelling and other

symptoms of inflammation

including arthritis)

lithium, a medicine used to

treat certain mental illnesses

digoxin, a medicine used to

treat heart failure

These medicines may be affected

by Telmisartan AN, or may affect

the way it works. Also, other

medicines used to treat high blood

pressure may have an additive

effect with Telmisartan AN in

lowering your blood pressure. You

may need different amounts of your

medicines.

Telmisartan AN tablets – Consumer Medicine Information

Telmisartan AN CMI v2.0

Page 3

Your doctor and pharmacist may

have more information on

medicines to be careful with or

avoid while taking Telmisartan AN.

How to take

Telmisartan AN

Follow all directions given to you

by your doctor or pharmacist

carefully.

They may differ from the

information contained in this

leaflet.

Your doctor or pharmacist will tell

you how many tablets you will need

to take each day. This depends on

your condition and whether or not

you are taking any other medicines.

If you do not understand the

instructions on the label, ask your

doctor or pharmacist for help.

How much to take

FOR THE TREATMENT OF

HYPERTENSION

The usual dose of Telmisartan AN

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 of Telmisartan AN

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.

It is important to take

Telmisartan AN exactly as your

doctor or pharmacist has told

you.

When to take it

Take Telmisartan AN at about

the same time each day, either

morning or evening.

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

Telmisartan AN before or after

food.

How to take it

Swallow the tablet whole with a

full glass of water.

You can take Telmisartan AN with

or without food.

How long to take it

Take Telmisartan AN every day

until your doctor tells you to stop.

Telmisartan AN 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 AN 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 for your next

dose, skip the dose you missed

and take your next dose when you

are meant to. Otherwise, take the

dose as soon as you remember,

and then go back to taking it as

you would normally.

Do not take a double dose to

make up for the dose that you

missed.

This may increase the chance of

you getting unwanted side effects.

If you have trouble remembering

when to take your medicine, ask

your pharmacist for some hints.

If you take too much

(overdose)

Immediately telephone your

doctor or Poisons Information

Centre (telephone 13 11 26) for

advice or go to the Emergency

Department at your nearest

hospital, if you think that you or

anyone else may have taken too

much Telmisartan AN.

Do this even if there are no signs

of discomfort or poisoning.

You may need urgent medical

attention.

If you take too much Telmisartan

AN you may feel dizzy, light-

headed or faint. Your heartbeat may

be faster or lower than usual. You

may experience rapid, shallow

breathing or cold, clammy skin.

This is because your blood pressure

is too low.

While you are taking

Telmisartan AN

Things you must do

Tell any other doctors, dentists

and pharmacists who are treating

you that you are taking

Telmisartan AN.

If you are about to be started on

any new medicine, tell your

doctor or pharmacist that you are

taking Telmisartan AN.

Telmisartan AN tablets – Consumer Medicine Information

Telmisartan AN CMI v2.0

Page 4

If you feel that Telmisartan AN is

not helping your condition, tell

your doctor or pharmacist.

Tell your doctor if, for any

reason, you have not used

Telmisartan AN exactly as

prescribed.

Otherwise, your doctor may think

that it was not effective and change

your treatment unnecessarily.

Tell your doctor immediately if

you become pregnant while

taking Telmisartan AN.

You should not take this medicine

while you are pregnant.

If you are going to have surgery,

tell your doctor and anaesthetist

that you are taking Telmisartan

AN.

Telmisartan AN may affect some

medicines you receive during

surgery.

Things you must not do

Do not use Telmisartan AN to

treat other complaints unless

your doctor or pharmacist tells

you to.

Do not give this medicine to

anyone else, even if they have the

same symptoms as yours.

Things to be careful of

Be careful when driving or

operating machinery while you

are taking Telmisartan AN until

you know how it affects you.

Like other medicines used to treat

high blood pressure, Telmisartan

AN may cause sleepiness, dizziness

or lightheadedness 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

AN, 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.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

Telmisartan AN even if you do

not think it is connected with the

medicine.

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.

Do not be alarmed by this list of

possible 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:

dizziness or lightheadedness

when you stand up especially

when getting up from a sitting

or lying position

dizziness or spinning sensation,

fainting

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 in the

blood, such as sweating,

weakness, hunger, dizziness,

trembling, headache or

numbness (especially in

diabetic patients)

abnormal liver functions

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

Telmisartan AN tablets – Consumer Medicine Information

Telmisartan AN CMI v2.0

Page 5

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)

Tell your doctor immediately or

go to the Emergency Department

at your nearest hospital if you

notice any of the following:

swelling of the face, lips,

mouth, tongue or throat which

may cause difficulty in

swallowing or breathing

severe and sudden onset of

itchy or raised skin rash, hives

or nettle rash

These are serious side effects. You

may need urgent medical attention

or hospitalisation. These side

effects are rare.

Tell your doctor if you notice

anything else that is making you

unwell.

Other side effects not listed above

may also occur in some people.

After taking

Telmisartan AN

Storage

Leave the tablets in the blister

strip until it is time to take them.

The blister pack protects the tablets

from light and moisture.

Keep Telmisartan AN in a cool

dry place where the temperature

stays below 30C.

Do not store Telmisartan AN or

any other medicine in the

bathroom or near a sink. Do not

leave it in the car or on window

sills.

Heat and dampness can destroy

some medicines.

Keep Telmisartan AN where

young children cannot reach it.

Disposal

If your doctor tells you to stop

using Telmisartan AN or it has

passed its expiry date, ask your

pharmacist what to do with any

that is left over.

Product description

What it looks like

Telmisartan AN is the brand name

of your medicine.

Telmisartan AN tablets are

available in two strengths: 40 mg

and 80 mg tablets.

Telmisartan AN 40 mg tablets are

white to off-white color, oval shape,

biconvex, uncoated tablets

debossed with ‘L203’ on one side

and plain on other side.

Telmisartan AN 80 mg tablets are

white to off-white color, oval shape,

biconvex, uncoated tablets

debossed with ‘L204’ on one side

and plain on other side.

Telmisartan AN tablets are

available in blister packs of 28

tablets.

Ingredients

Each Telmisartan AN 40 mg tablet

contains 40 mg telmisartan.

Each Telmisartan AN 80 mg tablet

contains 80 mg telmisartan.

The other ingredients found in both

strengths are:

povidone K25

meglumine

sodium hydroxide

mannitol

sodium stearyl fumarate

magnesium stearate

Sponsor

Amneal Pharma Australia Pty Ltd

12 River Street

South Yarra VIC 3141

Australia

This leaflet was updated in May

2016

Australian Registration

Numbers

AUST R 209335 for Telmisartan

AN 40 mg tablets

AUST R 209339 for Telmisartan

AN 80 mg tablets

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

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

16-3-2018

Pending EC decision:  Semintra, telmisartan, Opinion date: 15-Mar-2018

Pending EC decision: Semintra, telmisartan, Opinion date: 15-Mar-2018

Europe - EMA - European Medicines Agency