TRAJENTA linagliptin 5 mg film-coated tablet blister pack

Main information

  • Trade name:
  • TRAJENTA linagliptin 5 mg film-coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • TRAJENTA linagliptin 5 mg film-coated tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 175499
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

175499

TRAJENTA linagliptin 5 mg film-coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Boehringer Ingelheim Pty Ltd

Postal Address

PO Box 1969,NORTH RYDE, NSW, 2113

Australia

ARTG Start Date

1/11/2011

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. TRAJENTA linagliptin 5 mg film-coated tablet blister pack

Product Type

Single Medicine Product

Effective date

6/07/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

TRAJENTA is indicated in adult patients with type 2 diabetes mellitus to improve glycaemic control in conjunction with diet and exercise,,-as

monotherapy when metformin and sulfonylureas are not tolerated, or are contraindicated, or,-as add on to metformin, sulfonylureas or metformin plus

sulfonylureas, or to insulin (with or without metformin) or,-as add on to metformin plus SGLT2 inhibitors.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PA/Al/PVC/Al -

polyamide-aluminium

foil-polyvinylchloride/al

uminium foil

36 Months

Store below 30

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

30 tablets

(S4) Prescription Only Medicine

10 tablets

(S4) Prescription Only Medicine

Components

1. TRAJENTA linagliptin 5 mg film-coated tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Light red, round, biconvex, bevel-edged film-coated tablets, one side

debossed with the BI company symbol, the other side debossed with "D5"

Active Ingredients

Linagliptin

5 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 01:55:08 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

TRAJENTA CMI0133-09

Trajenta

®

Tablets

linagliptin

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Trajenta.

It does not contain all the available

information.

It does not take the place of talking to

your doctor, pharmacist or diabetes

educator.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking Trajenta

against the benefits they expect it

will have for you.

If you have any concerns about

taking this medicine, ask 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 (Australia)

and www.medsafe.govt.nz/

Consumers/cmi/CMIForm.asp (New

Zealand) and may contain important

information about the medicine and

its use of which you should be aware.

Keep this leaflet with the medicine.

You may need to read it again.

What Trajenta is used

for

Trajenta is used to lower blood sugar

levels in patients with type 2 diabetes

mellitus.

It may be used when diet plus

exercise do not provide adequate

blood sugar level control either:

alone as a single medicine, or

in combination with certain other

anti-diabetic medicines such as:

metformin, or

sulfonylurea medicines such

as glimepiride and

glibenclamide, or

insulin (with or without

metformin), or

metformin plus sulfonylurea

medicines, or

metformin plus sodium-

glucose transporter 2 inhibitor

medicines such as

empagliflozin.

Type 2 diabetes mellitus is also

called non-insulin-dependent

diabetes mellitus or NIDDM. Type 2

diabetes develops if the body does

not make enough insulin, or if the

insulin that your body makes does

not work as well as it should.

Insulin is a substance that helps to

lower the level of sugar in your

blood, especially after meals.

When the level of sugar builds up in

your blood, this can cause damage to

the body's cells and lead to serious

problems with your heart, brain,

eyes, circulation, nerves or kidneys.

How Trajenta works

Trajenta contains the active

ingredient linagliptin, which is a

member of a class of medicines you

take by mouth called DPP-4

(dipeptidyl peptidase-4) inhibitors

that lowers blood sugar levels in

patients with type 2 diabetes mellitus.

Trajenta helps to improve the levels

of insulin after a meal and lowers the

amount of sugar made by your body.

Lowering and controlling blood

sugar may help prevent or delay

complications of diabetes, such as

heart disease, kidney disease,

blindness and foot amputation.

Along with diet and exercise, this

medicine helps lower your blood

sugar.

Your doctor will prescribe Trajenta

alone, or in combination with another

anti-diabetic medicine if that

medicine alone is not sufficient to

control your blood sugar level. It is

important that you continue to follow

the diet and/or exercises

recommended for you while you are

on treatment with Trajenta.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

Your doctor may have prescribed it

for another reason.

This medicine is only available with

a doctor's prescription. It is not

addictive.

TRAJENTA CMI0133-09

Before you take

Trajenta

When you must not take it

Do not take Trajenta if you have

an allergy to:

any medicine containing

linagliptin (the active ingredient

in Trajenta)

any of the other ingredients listed

at the end of this leaflet.

Some of the symptoms of an allergic

reaction may include:

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.

Do not give this medicine to a child

or adolescent under the age of 18

years.

Safety and effectiveness in children

and adolescents less than 18 years

old have not been established.

Do not take this medicine 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.

If you are not sure whether you

should start taking this medicine,

talk to your doctor.

Before you start to take it

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

Tell your doctor if you are

pregnant or intend to become

pregnant.

Your doctor will discuss the possible

risks and benefits involved.

Tell your doctor if you are breast-

feeding or planning to breast-feed.

Trajenta is usually not recommended

while you are breast-feeding. It is not

known if the active ingredient of

Trajenta will pass into human breast

milk and could affect your baby.

Tell your doctor if you have or

have had any of the following

medical conditions:

type 1 diabetes (also known as

'juvenile onset' or 'insulin-

dependent' diabetes mellitus or

'IDDM'), a condition where your

body does not produce any

insulin

diabetic ketoacidosis, a condition

where chemicals called ketones

build up in the body or urine due

to very low insulin levels, and

results in high blood sugar, rapid

weight loss, nausea or vomiting.

Trajenta is not a substitute for

insulin. Trajenta should not be used

to treat type 1 diabetes or diabetic

ketoacidosis.

If you are not sure whether any of the

above conditions apply to you, your

doctor can advise you.

Alcohol, diet, exercise, and your

general health all strongly affect the

control of your diabetes.

Discuss these things with your

doctor.

If you have not told your doctor,

pharmacist or diabetes educator

about any of the above, tell them

before you take Trajenta.

Your doctor may want to take special

precautions if you have any of the

above conditions.

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 Trajenta may

interfere with each other. These

include:

rifampicin (an antibiotic medicine

used to treat certain infections

such as tuberculosis)

carbamazepine, phenobarbital or

phenytoin (medicines used to

control fits (seizures) or chronic

pain).

These medicines may be affected by

Trajenta or may affect how well it

works. You may need different

amounts of your medicines, or you

may need to take different medicines.

Your doctor, pharmacist or diabetes

educator can tell you what to do if

you are taking any of these

medicines. They also have more

information on medicines to be

careful with or avoid while taking

this medicine.

How to take Trajenta

Follow all directions given to you

by your doctor or pharmacist

carefully.

They may differ from the

information contained in this leaflet.

If you do not understand the

instructions on the box, ask your

doctor or pharmacist for help.

How much to take

The usual dose is one 5 mg tablet

once daily.

Take Trajenta exactly as your

doctor or pharmacist has told you.

Your doctor will prescribe Trajenta

alone, or in combination with another

anti-diabetic medicine, if that

medicine alone is not sufficient to

control your blood sugar level.

How to take it

Swallow the tablet with a full glass

of water.

When to take it

Take your medicine at about the

same time each day.

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 this

medicine before or after food.

TRAJENTA CMI0133-09

How long to take it

Continue taking Trajenta for as

long as your doctor tells you to.

Make sure you keep enough

Trajenta to last over weekends and

holidays.

Trajenta will help control your

diabetes, but will not cure it.

Therefore, you may have to take it

for a long time.

If you forget to take it

If it is almost time for your next

dose, skip the dose you missed and

take your next dose when you are

meant to.

Otherwise, take it as soon as you

remember, and then go back to

taking your medicine 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 an unwanted side effect.

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 (in

Australia telephone 13 11 26; in

New Zealand telephone 0800 764

766) for advice, or go to

Emergency at the nearest hospital,

if you think that you or anyone else

may have taken too much

Trajenta. Do this even if there are

no signs of discomfort or

poisoning.

You may need urgent medical

attention.

While you are taking

Trajenta

Things you must do

If you are about to be started on

any new medicine, tell your doctor

or pharmacist that you are taking

Trajenta.

Tell all doctors, dentists and

pharmacists who are treating you

that you are taking Trajenta.

If you become pregnant while

taking this medicine, tell your

doctor immediately.

Keep all of your doctor's

appointments so that your progress

can be checked.

Your doctor may do some tests from

time to time to make sure the

medicine is working and to prevent

unwanted side effects.

Carefully follow your doctor's

and/or dietician's advice on diet,

drinking alcohol and exercise.

Diet and exercise can help your body

use its blood sugar better. It is

important to stay on the diet and

exercise program recommended by

your doctor while taking Trajenta.

Make sure you check your blood

glucose levels regularly.

This is the best way to tell if your

diabetes is being controlled properly.

Your doctor or diabetes educator will

show you how and when to do this.

Tell your doctor if you become ill

or experience stress, injury, fever,

infection or need surgery.

Your blood glucose may become

difficult to control at these times.

Make sure that you, your friends,

family and work colleagues can

recognise the symptoms of

hypoglycaemia and

hyperglycaemia and know how to

treat them.

HYPOGLYCAEMIA

Trajenta does not normally cause

hypoglycaemia, although you may

experience it if you take certain other

medicines.

Signs of hypoglycaemia may include:

weakness, trembling or shaking

sweating

light-headedness, dizziness,

headache or lack of concentration

irritability, tearfulness or crying

hunger

numbness around the lips and

tongue.

If not treated quickly, these

symptoms may progress to:

loss of co-ordination

slurred speech

confusion

fits or loss of consciousness.

At the first signs of hypoglycaemia,

you need to raise your blood

glucose quickly.

You can do this by taking one of the

following:

5 -7 jelly beans

3 teaspoons of sugar or honey

half a can of non-diet soft drink

2-3 concentrated glucose tablets.

Unless you are within 10 to 15

minutes of your next meal or

snack, follow up with extra

carbohydrates such as plain

biscuits, fruit or milk.

Taking this extra carbohydrate will

prevent a second drop in your blood

glucose level.

HYPERGLYCAEMIA

If you notice the return of any

signs of hyperglycaemia, contact

your doctor immediately. The risk

of hyperglycaemia is increased in

the following situations:

uncontrolled diabetes

illness, infection or stress

taking less Trajenta than

prescribed

taking certain other medicines

too little exercise

eating more carbohydrates than

normal.

TRAJENTA CMI0133-09

Things you must not do

Do not take Trajenta to treat any

other complaints unless your

doctor tells you to.

Do not give this medicine to anyone

else, even if they have the same

condition as you.

Things to be careful of

Be careful driving or operating

machinery while you are taking

Trajenta until you know how it

affects you.

You may experience dizziness when

taking Trajenta.

If your blood sugar level becomes

too low, you may feel dizzy, weak or

tired and your reaction time may be

slower than usual. Other symptoms

of low blood sugar are listed under

Side effects.

If you have any of these symptoms,

do not drive, operate machinery or

do anything else that could be

dangerous.

Be careful when doing any of the

following things, which increase

the risk of your blood glucose

becoming too low:

drinking alcohol

not eating enough

doing unexpected or vigorous

exercise.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking Trajenta.

This medicine helps most people

with type 2 diabetes mellitus, but it

may have unwanted side effects in a

few people.

All medicines can have side effects.

Sometimes they are serious, most of

the time they are not. You may need

medical treatment if you get some of

the side effects.

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 or pharmacist if

you notice any of the following and

they worry you:

swelling of the nose or throat

(nasopharyngitis)

mouth ulceration

cough

painful, swollen joints

back pain

headache

aching muscles, muscle

tenderness or weakness not

caused by exercise

symptoms of urinary tract

infection (such as an urge to

urinate frequently and in small

amounts, painful burning when

passing urine).

Urinary tract infections may occur in

patients who already take another

medication to treat diabetes, such as

a sulfonylurea.

constipation.

Constipation may occur in patients

who already take another medication

to treat diabetes, such as insulin.

Tell your doctor as soon as possible

if you notice any of the symptoms

of low blood sugar such as:

sweating

weakness

hunger

dizziness

trembling

headache

flushing or paleness

numbness

a fast, pounding heartbeat.

Low blood sugar may occur in

patients who already take another

medication to treat diabetes, such as

a sulfonylurea or insulin. The dose of

your sulfonylurea or insulin medicine

may need to be reduced while taking

Trajenta.

Tell your doctor immediately if

you develop blisters or the

breakdown of the outer layer of

your skin (erosion).

These may be signs of a skin reaction

called bullous pemphigoid. Your

doctor may tell you to stop taking

Trajenta.

Tell your doctor immediately or go

to Emergency if you notice any of

the following:

sudden onset of hives, itching or

skin rash

swelling of the face, lips or

tongue which may lead to

difficulty swallowing or breathing

severe upper stomach pain

radiating to the back, nausea,

vomiting, or fever (which may be

symptoms of an inflamed

pancreas - pancreatitis).

Tell your doctor or pharmacist if

you notice anything else that is

making you unwell.

Other side effects not listed above

may also occur in some people.

Some of these side effects can only

be found when your doctor does tests

from time to time to check your

progress.

After taking Trajenta

Storage

Keep your tablets in the original

blister strip until it is time to take

them.

Keep your tablets in a cool dry

place where the temperature stays

below 30°C.

Do not store Trajenta or any other

medicine in the bathroom or near a

sink. Do not leave it in the car or

on a window sill.

Heat and dampness can destroy some

medicines.

TRAJENTA CMI0133-09

Keep it 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 the expiry

date has passed, ask your

pharmacist what to do with any

medicine that is left over.

Product Description

What it looks like

Trajenta is the brand name of your

medicine.

Trajenta tablets are light red, round,

biconvex, bevel-edged film-coated

tablets, marked with the BI company

logo on one side and 'D5' on the

other.

Trajenta tablets are available in

blister packs of 10 (sample) and 30

tablets.

Ingredients

Each Trajenta tablet contains 5 mg of

linagliptin as the active ingredient.

Inactive ingredients:

mannitol

pregelatinised maize starch

maize starch

copovidone

magnesium stearate

Opadry Pink 02F34337 (as

colouring agent).

Supplier

Trajenta tablets are supplied in

Australia by:

Boehringer Ingelheim Pty Limited

ABN 52 000 452 308

78 Waterloo Road

North Ryde NSW 2113

They are supplied in New Zealand

Boehringer Ingelheim (N.Z.) Limited

Auckland

This Consumer Medicine

Information was updated in July

2017.

® Trajenta is a registered trade mark

of Boehringer Ingelheim.

© Boehringer Ingelheim Pty Limited

2017.

Australian Registration

Number

AUST R 175499