GLUCOBETE 850 metformin hydrochloride 850 mg tablets Blister pack

Main information

  • Trade name:
  • GLUCOBETE 850 metformin hydrochloride 850 mg tablets Blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GLUCOBETE 850 metformin hydrochloride 850 mg tablets Blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 180438
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

180438

GLUCOBETE 850 metformin hydrochloride 850 mg tablets Blister pack

ARTG entry for

Medicine Registered

Sponsor

Aurobindo Pharma Australia Pty Ltd

Postal Address

5 / 148 Spit Road,Mosman, NSW, 2088

Australia

ARTG Start Date

24/11/2011

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. GLUCOBETE 850 metformin hydrochloride 850 mg tablets Blister pack

Product Type

Single Medicine Product

Effective date

6/03/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Metformin is indicated in the treatment of type 2 diabetes mellitus in adults, children from 10 years of age and adolescents, particularly in overweight

patients, when dietary management and exercise alone does not result in adequate glycaemic control.,For adult patients, metformin may be used as

initial treatment or in sulfonylurea failures either alone or in combination with a sulfonylurea and other oral agents or as adjuvant therapy in insulin

requiring type 2 diabetes.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

5 Years

Store below 25

degrees Celsius

Not recorded

Store in a Dry Place

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. GLUCOBETE 850 metformin hydrochloride 850 mg tablets Blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White, biconvex, circular shaped, film coated tablets with 'A' debossed on

one side and '61' debossed on the other side

Active Ingredients

Metformin hydrochloride

850 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 08:13:15 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

GLUCOBETE

CONSUMER MEDICINE INFORMATION

Version 1.2

Page 1 of 6

GLUCOBETE 500, 850 & 1000

Metformin hydrochloride

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions

about

GLUCOBETE.

does

contain

available

information.

It does not take the place of talking

your

doctor

pharmacist

diabetes educator.

medicines

have

risks

benefits. Your doctor has weighed

risks

taking

GLUCOBETE against the benefits it

is expected for you.

If you have any concerns about

taking

this

medicine,

ask

your

doctor or pharmacist or diabetes

educator

Keep

this

leaflet

with

your

medicine.

You may need to read it again.

What GLUCOBETE is used for

GLUCOBETE

used

control

blood glucose (the amount of sugar

in the blood) in people with diabetes

mellitus.

GLUCOBETE can be used in type 2

diabetes in adults and children over

10 years of age. It is especially useful

in those who are overweight, when

diet and exercise are not enough to

lower

high

blood

glucose

levels

(hyperglycaemia). For adult patients,

GLUCOBETE can be used alone, or

combination

with

other

oral

diabetic medicines or in combination

with insulin in insulin requiring type

2 diabetes.

Ask your doctor if you have any

questions

about

why

GLUCOBETE

has

been

prescribed for you.

Your

doctor

have

prescribed

GLUCOBETE for another reason.

GLUCOBETE is available only with

a doctor’s prescription.

There

evidence

that

GLUCOBETE is addictive.

How GLUCOBETE works

GLUCOBETE belongs to a group of

medicines

called

biguanides.

GLUCOBETE

lowers

high

blood

glucose (hyperglycaemia) by helping

your body make better use of the

insulin produced by your pancreas.

People

with

type

diabetes

unable to make enough insulin or

their body does not respond properly

insulin

does

make.

This

causes a build up of glucose in the

blood,

which

lead

serious

medical problems.

Long-term hyperglycaemia can lead

to heart disease, blindness, kidney

damage, poor blood circulation and

gangrene.

Signs

hyperglycaemia

include:

tiredness or lack of energy

headache

thirst

passing large amounts of urine

blurred vision.

Before you take GLUCOBETE

When you must not take it

Do not take GLUCOBETE if you

are allergic to:

Medicines

containing

metformin

or any other biguanide.

ingredients

listed

toward the end of this leaflet.

Some of the symptoms of an allergic

reaction

include

skin

rash,

itching or hives; swelling of the face,

lips

tongue

which

cause

difficulty

swallowing

breathing; wheezing or shortness of

breath.

Do not take GLUCOBETE if you

have

any

of

the

following

conditions:

type

diabetes

mellitus

that

well controlled by insulin alone.

type 2 diabetes that is already well

controlled by diet alone.

diabetic ketoacidosis (a symptom

of uncontrolled diabetes, in which

substances

called

ketone

bodies

build up in the blood- you may

notice

this

unusual

fruity

odour

your

breath,

difficulty

breathing, confusion and frequent

urination).

severe liver disease.

excessive

alcohol

intake,

binge

drinking, alcohol dependence.

kidney

failure

severe

kidney

disease

dehydratiion,

severe

blood

loss,

shock

a severe infection.

certain

heart

blood

vessel

problems, including a recent heart

attack

severe

heart

failure

(when

heart

fails

pump

blood effectively).

severe breathing difficulties.

blood clots in the lungs (symptoms

include

coughing,

shortness

breath, chest pain and a fast heart

rate).

gangrene.

inflammation

pancreas

(pancreatitis),

symptoms

include

severe upper stomach pain, often

with nausea and vomiting.

Do not take GLUCOBETE if you

plan to have major surgery or an

X-ray

or

a

scan

requiring

an

injection

of

iodinated

contrast

(dye).

GLUCOBETE

CONSUMER MEDICINE INFORMATION

Version 1.2

Page 2 of 6

You must stop taking GLUCOBETE

for a certain period of time before

after

examination

surgery.

Your

doctor

will

decide

whether

need

other

treatment

this

time.

important

that

follow

your

doctor's instructions precisely.

Do not take GLUCOBETE if you

are pregnant or plan to become

pregnant.

safety

GLUCOBETE

pregnant

woman

been

established.

Insulin

more

suitable

controlling

blood

glucose

during

pregnancy. Your doctor will replace

GLUCOBETE

with

insulin

while

you are pregnant.

Do not take GLUCOBETE if you

are breast feeding.

GLUCOBETE is not recommended

while you are breast feeding. Your

doctor

will

discuss

options

available to you.

Do not take GLUCOBETE if the

expiry date (EXP) printed on the

pack has passed.

If you take this medicine after the

expiry date it may not work as well.

Do not take GLUCOBETE if the

packaging

shows

signs

of

tampering

or

the

tablets

do

not

look quite right.

If you are not sure whether you

should start taking GLUCOBETE,

ask your doctor.

Before you start to take it

Tell your doctor if you are allergic

to any other medicines, food, dyes

or preservatives

Tell your doctor if you have any

medical conditions, especially the

following:

heart failure

kidney problems

Your

doctor

may

want

to

take

special

care

if

you

have

any

of

these conditions.

Tell to your doctor if you drink

alcohol.

Alcohol

affect

control

your

diabetes.

Drinking

excessive

amounts of alcohol while you are

being

treated

with

GLUCOBETE

lead

serious

side

effects.

Your doctor may suggest you stop

drinking

reduce

amount

alcohol you drink.

If you have not told your doctor

about

any

of

these

things,

tell

him/her

before

you

start

taking

GLUCOBETE.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including any

that

you

buy

without

a

prescription

from

a

pharmacy,

supermarket or health food shop.

Some medicines may be affected by

GLUCOBETE

affect

well it works. These include:

other

medicines

used

treat

diabetes

medicines

that

contain

alcohol,

such as cough and cold syrups

tetracosactrin, a medicine used in

people with multiple sclerosis, and

in young children to treat some

types of seizures (fits)

danazol, a medicine used to treat

endometriosis

Repaglinide (Novonorm), another

type

medicine

used

treat

diabetes.

some medicines used to treat high

blood

pressure

some

heart

conditions,

including

beta-

blockers, calcium channel blockers

and ACE inhibitors.

medicines used to prevent blood

clots such as warfarin.

diuretics,

also

called

fluid

tablets.

chlorpromazine, a medicine used

treat

schizophrenia

other

mental illness.

NSAIDs

(non-steroidal

anti-

inflammatory

drugs),

medicines

used to relieve pain, swelling and

other symptoms of inflammation,

such

aspirin,

diclofenac,

ibuprofen,

meloxicam,

naproxen

or piroxicam.

cimetidine, a medicine commonly

used to treat reflux and ulcers.

corticosteroids such as prednisone

or cortisone.

some

medicines

used

treat

asthma

such

salbutamol

terbutaline

These medicines may be affected by

GLUCOBETE

affect

well

works.

need

different amounts of your medicines

or you may need to take different

medicines.

Your

doctor

pharmacist

have

more information on medicines to be

careful with or avoid while taking

GLUCOBETE.

How to take GLUCOBETE

Follow all directions given to you

by

your

doctor

and

pharmacist

carefully.

They

differ

from

information contained in the leaflet.

If

you

do

not

understand

the

instructions on the pack, ask your

doctor or pharmacist.

How much to take GLUCOBETE

dose

varies

from

person

person. Your doctor will decide the

right dose for you.

The usual starting dose for adults is

500 mg one to two times a day. Your

doctor may increase or decrease the

dose,

depending

your

blood

glucose

levels.

maximum

recommended dose is 1000 mg three

times a day.

The elderly and people with kidney

problems may need smaller doses.

GLUCOBETE

CONSUMER MEDICINE INFORMATION

Version 1.2

Page 3 of 6

Children and adolescents:

The usual starting dose for children

from 10 years of age and adolescents

is one tablet of 500 mg or 850 mg

once

daily.

Your

doctor

increase

decrease

dose,

depending

your

blood

glucose

levels.

The maximum recommended dose is

2 g taken as two or three divided

doses.

your

child

diabetes

that

resistant

insulin

being

treated

hospital,

your

child’s

doctor will decide the dose

How to take GLUCOBETE

Swallow the tablet with a glass of

water.

When to take GLUCOBETE

Take GLUCOBETE during or

immediately after food.

This

will

reduce

chance

stomach upset.

Take your medicine at about the

same time each day.

Taking it at the same time each day

will have the best effects. It will also

help you remember when to take it.

How long to take GLUCOBETE for

Keep taking GLUCOBETE for as

long as your doctor recommends.

GLUCOBETE

will

help

control

diabetes but will not cure it. Most

people

will

need

take

GLUCOBETE on long term basis.

If you forget to take GLUCOBETE

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 missed dose as

soon as you remember (with food),

and then go back to taking your

tablets as you would normally.

Do not take a double dose to make

up for the dose you missed.

If you are not sure what to do, ask

your doctor or pharmacist.

If you take too much GLUCOBETE

(Overdose)

Immediately

telephone

your

doctor

or

Poisons

Information

Centre (telephone 13 11 26), or go

to

Accident

and

Emergency

at

the nearest hospital

if you think

you or anyone else may have taken

too much GLUCOBETE, even if

there are no signs of discomfort or

poisoning.

take

much

GLUCOBETE, you may feel sleepy,

very tired, sick, vomit, have trouble

breathing and have unusual muscle

pain,

stomach

pain

diarrhoea.

These may be the early signs of a

serious

condition

called

lactic

acidosis (build up of lactic acid in

the blood).

You may also experience symptoms

Hypoglycaemia

(low

blood

glucose). This usually only happens

take

much

GLUCOBETE

together

with

other

medicines

diabetes

with

alcohol.

If

you

experience

any

signs

of

hypoglycaemia,

raise

your

blood

glucose

quickly

by

eating

jelly

beans, sugar or honey, drinking a

non-diet

soft

drink

or

taking

glucose tablets.

While you are taking

GLUCOBETE

Things you must do

Make sure that you, your friends,

family

and

work

colleagues

can

recognise

the

symptoms

of

hypoglycaemia & hyperglycaemia

and know how to treat them.

HYPOGLYCAEMIA

GLUCOBETE

does

normally

cause hypoglycaemia, although you

may experience it if you take other

medicines

diabetes

such

sulfonylureas

repaglinide;

you also use insulin.

Hypoglycaemia can occur suddenly.

Initial signs may include:

weakness, trembling or shaking

sweating

lightheadedness,

dizziness,

head

ache or lack of concentration

irritability, tearfulness or crying

hunger

numbness

around

lips

tongue.

If not treated promptly, these may

progress to:

loss of co-ordination

slurred speech

confusion

fits or loss of consciousness.

If

you

experience

any

of

the

symptoms of hypoglycaemia, you

need to raise your blood glucose

immediately.

You can do this by doing one of the

following:

eating 5 to 7 jelly beans

eating

teaspoons

sugar

honey

drinking half a can of non-diet soft

drink

taking 2 to 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 of

the

signs

of

hyperglycaemia,

contact your doctor immediately.

Your doctor may need to consider

additional

other

treatments

your diabetes.

GLUCOBETE

CONSUMER MEDICINE INFORMATION

Version 1.2

Page 4 of 6

risk

hyperglycaemia

increased in the following situations:

uncontrolled diabetes

illness, infection or stress

taking

less

GLUCOBETE

than

prescribed

taking certain other medicines

too little exercise

eating

more

carbohydrates

than

normal.

Tell your doctor if you:

become ill

become dehydrated

are injured

have a fever

have a serious infection

having

surgery

(including

dental surgery).

Your

blood

glucose

become

difficult

control

these

times.

You may also be more at risk of

developing a serious condition called

lactic acidosis

At these times, your

doctor

replace

GLUCOBETE

with insulin.

Before starting any new medicine,

tell your doctor or pharmacist that

you are taking GLUCOBETE.

Tell

all

the

doctors,

dentists

and

Pharmacists who are treating you

that you are taking GLUCOBETE.

If

you

become

pregnant

while

taking

GLUCOBETE,

tell

your

doctor immediately.

Tell

your

doctor

if

any

of

the

following happen:

you become ill

become

dehydrated

(for

instance due to persistent or

severe

diarrhoea or recurrent

vomiting)

you are injured

you have a fever

you have a serious infection such

influenza,

respiratory

tract

infection or urinary tract infection

you are having major surgery

having

examination

such

X-ray

scan

requiring

injection

iodinated contrast agent (dye)

Your

blood

glucose

become

difficult

control

these

times.

You may also be more at risk of

developing a serious condition called

lactic acidosis. At these times, your

doctor

replace

GLUCOBETE

with insulin

Visit

your

doctor

regularly

for

check ups.

Your doctor may want to perform

blood tests to check your kidneys,

liver,

heart

vitamin

level

while you are taking GLUCOBETE.

Check

your

blood

glucose

levels

regularly.

This is the best way to tell if your

diabetes is being controlled properly.

Your

doctor

diabetes

educator

will show you how and when to do

this.

When

start

treatment

with

GLUCOBETE, it can take up to two

weeks for your blood glucose levels

to be properly controlled.

Carefully follow the advice of your

doctor

and

dietician

on

diet,

drinking alcohol and exercise.

Things you must not do

skip

meals

while

taking

GLUCOBETE.

Do not stop taking GLUCOBETE or

change

dose

without

checking

with your doctor.

give

GLUCOBETE

anyone else, even if they have the

same condition as you.

Do not use GLUCOBETE to treat

other

conditions

unless

your

doctor tells you to.

Things to be careful of

If you have to be alert, for example

when driving be especially careful

not to let your blood glucose levels

fall too low.

Low blood glucose levels may slow

your reaction time and affect your

ability to drive or operate machinery.

Drinking

alcohol

make

this

worse. However, GLUCOBETE by

itself is unlikely to affect how you

drive or operate machinery.

If you become sick with a cold,

fever or flu, it is very important to

continue

eating

your

normal

meals.

Your diabetes educator or dietician

can give you a list of foods to eat on

sick days.

When

you

are

traveling,

it

is

a

good idea to:

wear some form of identification

(e.g. bracelet) showing you have

Diabetes.

carry some form of sugar to treat

hypoglycaemia

occurs,

example,

sugar

sachets

jelly

beans.

carry emergency food rations in

case of a delay, for example, dried

fruit, biscuits or muesli bars.

bring enough GLUCOBETE with

you, so you don't miss any doses.

Lifestyle

measures

that

help

reduce heart disease risk

By

following

these

simple

measures, you can further reduce

the risk from heart disease.

Quit

smoking

avoid

second

hand

smoke

Limit alcohol intake

Enjoy healthy eating by:

eating plenty of vegetables and

fruit;

reducing

your

saturated

intake (eat less fatty meats,

full

dairy

products,

butter,

coconut

palm

oils,

most

take-away foods,

commercially

baked products)

Be active. Progress, over time, to

at least 30 minutes of moderate

intensity physical activity on 5 or

more

days

each

week.

accumulated in shorter bouts of 10

minutes duration. If you have been

GLUCOBETE

CONSUMER MEDICINE INFORMATION

Version 1.2

Page 5 of 6

prescribed

anti-angina

medicine,

carry

with

when

being

physically active

Maintain a healthy weight

Discuss your lifestyle and lifestyle

plans with your doctor

For more information and tools to

improve

your

heart

health,

call

Heartline, the Heart Foundation's

national

telephone

information

service, on 1300 36 27 87 (local

call cost)

Know warning signs of heart

attack and what to do:

Tightness,

fullness,

pressure,

squeezing,

heaviness

pain

your

chest,

neck,

jaw,

throat,

shoulders, arms or back

also

have

difficulty

breathing, or have a cold sweat or

feel dizzy or light headed or feel

like vomiting (or actually vomit)

If you have heart attack warning

signs that are severe, get worse or

last for 10 minutes even if they are

mild, call triple zero (000). Every

minute counts.

Side Effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well

while

you

are

taking

GLUCOBETE.

GLUCOBETE

helps

most

people

with

diabetes

have

unwanted

side

effects

some

people.

All medicines can have side effects.

Sometimes they are serious, most of

the time they are not. You may need

medical attention if you get some of

the side effects.

If you are over 65 years of age, you

may have an increased chance of

getting side effects

Do not be alarmed by the following list

of 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:

feeling sick (nausea)

vomiting

diarrhoea

stomach pain

taste disturbance

loss of appetite

skin reactions such as redness of

the skin, itching or an itchy rash

(utricaris).

These are generally mild side effects

which disappear after the first few

weeks. Taking GLUCOBETE with

meals can help reduce nausea and

diarrhoea.

Skin

rash

been

reported rarely.

TELL

YOUR

DOCTOR

IMMEDIATELY

OR

GO

TO

ACCIDENT AND EMERGENCY

AT THE NEAREST HOSPITAL

IF YOU NOTICE ANY OF THE

FOLLOWING

SYMPTOMS

OF

LACTIC ACIDOSIS (BUILD UP

OF

LACTIC

ACID

IN

THE

BLOOD):

nausea, vomiting, stomach pain.

trouble breathing

feeling weak, tired or generally

unwell

unusual muscle pain

sleepiness

dizziness or lightheadedness

shivering, feeling extremely cold

slow heart beat.

LACTIC ACIDOSIS IS A VERY

RARE

BUT

SERIOUS

SIDE

EFFECT REQUIRING URGENT

MEDICAL

ATTENTION

OR

HOSPITALISATION.

ALTHOUGH RARE, IF LACTIC

ACIDOSIS

DOES

OCCUR,

IT

CAN BE FATAL. THE RISK OF

LACTIC ACIDOSIS IS HIGHER

IN

THE

ELDERLY,

THOSE

WHOSE DIABETES IS POORLY

CONTROLLED,

THOSE

WITH

PROLONGED

FASTING,

THOSE

WITH

CERTAIN

HEART

CONDITIONS,

THOSE

WHO

DRINK

ALCOHOL

AND

THOSE

WITH

KIDNEY

OR

LIVER PROBLEMS.

Tell your doctor or pharmacist if

you notice anything that is making

you feel unwell.

Other side effects not listed above

may also occur in some people.

Some

side

effects

(e.g.

reduced

vitamin B12 level) can only be found

when your doctor does tests from

time to time to check your progress.

After taking GLUCOBETE

Storage

Keep

the

medication

where

children cannot reach it.

A locked cupboard at least one-and-

half metres above the ground is a

good place to store medicines.

Keep your tablets in the pack until

it is time to take them.

If you take the tablets out of the pack

they may not keep well.

Keep your tablets in a cool dry

place where the temperature stays

below 25°C.

Do

not

store

it

or

any

other

medicine in the bathroom or near

a sink.

Heat

dampness

destroy

some medicines.

Disposal

If

your

doctor

tells

you

to

stop

taking

GLUCOBETE,

or

your

tablets

have

passed

their

expiry

date, ask your pharmacist what to

do with any that are left over.

Product Description

What it looks like

GLUCOBETE 500 is presented in

blister packs of 30 & 100 and bottle

pack of 100.

GLUCOBETE

CONSUMER MEDICINE INFORMATION

Version 1.2

Page 6 of 6

GLUCOBETE 850 is presented in

blister packs of 20 & 60 and bottle

packs of 60 & 100.

GLUCOBETE 1000 is presented in

blister packs of 20 & 90 and bottle

pack of 100.

GLUCOBETE 500

White,

biconvex,

circular

shaped,

film

coated

tablets

with

‘A’

debossed

side

‘60’

debossed on the other side.

GLUCOBETE 850

White,

biconvex,

circular

shaped,

film

coated

tablets

with

‘A’

debossed

side

‘61’

debossed on the other side.

GLUCOBETE 1000

White, biconvex, oval shaped, film

coated tablets with a score line in

between ‘6’ and ‘2’ on one side and

‘A’ debossed on the other side.

Ingredients

Active ingredients

Metformin hydrochloride

Each tablet contain either 500, 850

1000

Metformin

hydrochloride.

Inactive ingredients

Povidone

Magnesium stearate

Opadry

complete

film

coating

system

YS-1R-7006

Clear

(PI-

ARTG No. 13068).

Name and Address of the Sponsor

Aurobindo Pharma Australia Pty Ltd

Unit 3, North Rydelink

277-283 Lane Cove Road

Macquarie Park

NSW 2113

Australia

Date of Approval

22 November 2011

Date of most recent amendment

31 May 2012