Teltartan

Main information

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

Documents

Localization

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

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 209341
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

209341

Teltartan telmisartan 40mg tablets blister pack

ARTG entry for

Medicine Registered

Sponsor

Arrow Pharma Pty Ltd

Postal Address

15 - 17 Chapel Street,Cremorne, VIC, 3121

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. Teltartan telmisartan 40mg tablets blister pack

Product Type

Single Medicine Product

Effective date

24/11/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

TELTARTAN 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. Teltartan 40mg

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 11:07:04 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

Teltartan Tablets

Telmisartan

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Teltartan.

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 or

doctor 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 Teltartan is used

for

Teltartan 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 age 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

Teltartan 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 Teltartan works

Teltartan 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.

Teltartan 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

Teltartan 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 cardiovascular

complications or if you are at high risk

of death due to cardiovascular causes.

Your doctor may have prescribed

Teltartan for another reason. Ask your

doctor if you have any questions about

why Teltartan has been prescribed for

you.

Teltartan is not addictive.

This medicine is available only with a

doctor’s prescription.

Use in children

The safety and effectiveness of

Teltartan in children and teenagers up to

18 years of age have not been

established.

Before you take

Teltartan

When you must not take it

Do not take Teltartan if you have ever

had an allergic reaction after taking:

telmisartan (the active ingredient in

Teltartan)

any other ingredients listed at the

end of this leaflet

Symptoms of an allergic reaction to

Teltartan 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 Teltartan if you are

pregnant or intend to become

pregnant.

Teltartan 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

Teltartan.

It is not known if telmisartan, the active

ingredient in Teltartan, passes into

breast milk and there is a possibility that

your baby may be affected.

Do not take Teltartan 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 Teltartan after the expiry

date printed on the pack.

Do not take Teltartan 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 Teltartan if the tablets

are discoloured.

If you are not sure whether you

should start taking Teltartan 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.

Your doctor can discuss with you the

risks and benefits involved.

If you have not told your doctor

about any of the above, tell your

doctor before you take Teltartan.

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 Teltartan 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

Teltartan, or may affect the way it

works. Also, other medicines used to

treat high blood pressure may have an

additive effect with Teltartan in

lowering your blood pressure. You may

need different amounts of your

medicines.

Your doctor and pharmacist may have

more information on medicines to be

careful with or avoid while taking

Teltartan.

How to take Teltartan

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 Teltartan 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 Teltartan 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 Teltartan

exactly as your doctor or pharmacist

has told you.

When to take it

Take Teltartan 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 Teltartan

before or after food.

How to take it

Swallow the tablet whole with a full

glass of water.

You can take Teltartan with or without

food.

How long to take it

Take Teltartan every day until your

doctor tells you to stop.

Teltartan 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 Teltartan 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 are not sure what to do, ask

your doctor or pharmacist.

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 Accident and Emergency at your

nearest hospital, if you think that you

or anyone else may have taken too

much Teltartan.

Do this even if there are no signs of

discomfort or poisoning.

You may need urgent medical attention.

If you take too much Teltartan 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

Teltartan

Things you must do

If you are about to be started on any

new medicine, tell your doctor or

pharmacist that you are taking

Teltartan.

Tell any other doctors, dentists and

pharmacists who are treating you

that you are taking Teltartan.

If you are going to have surgery, tell

the surgeon or anaesthetist that you

are taking Micardis.

Micardis may affect other medicines

used during surgery.

If you become pregnant while taking

Micardis, tell your doctor

immediately.

If you feel that Teltartan is not

helping your condition, tell your

doctor or pharmacist.

Tell your doctor if, for any reason,

you have not used Teltartan exactly

as prescribed.

Otherwise, your doctor may think that it

was not effective and change your

treatment unnecessarily.

Things you must not do

Do not use Teltartan 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.

Do not stop taking Micardis or lower

the dosage without checking with

your doctor.

Things to be careful of

Be careful when driving or operating

machinery while you are taking

Teltartan until you know how it

affects you.

Like other medicines used to treat high

blood pressure, Teltartan 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 Teltartan,

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 Teltartan 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

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

casualty 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 Teltartan

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 Teltartan in a cool dry place

where the temperature stays below

30C.

Do not store Teltartan 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 Teltartan where young children

cannot reach it.

Disposal

If your doctor tells you to stop using

Teltartan 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

Teltartan is the brand name of your

medicine.

Teltartan tablets are available in two

strengths: 40 mg and 80 mg tablets.

Teltartan 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.

Teltartan 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.

Teltartan tablets are available in blister

packs of 28 tablets.

Ingredients

Each Teltartan 40 mg tablet contains 40

mg telmisartan.

Each Teltartan 80 mg tablet contains 80

mg telmisartan.

The other ingredients found in both

strengths are:

povidone K25

meglumine

sodium hydroxide

mannitol

Sodium strearyl fumarate

magnesium stearate

Sponsor

Arrow Pharma Pty Ltd

15 – 17 Chapel Street

Cremorne VIC 3121

This leaflet was updated on

September 2016

Australian Registration

Numbers

AUST R 209341 for Teltartan 40 mg

tablets

AUST R 209343 for Teltartan 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