TERRY WHITE CHEMISTS METFORMIN 850

Main information

  • Trade name:
  • TERRY WHITE CHEMISTS METFORMIN 850
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • TERRY WHITE CHEMISTS METFORMIN 850
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 174820
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

174820

TERRY WHITE CHEMISTS METFORMIN 850 metformin hydrochloride 850mg tablet 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

19/08/2010

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. TERRY WHITE CHEMISTS METFORMIN 850

Product Type

Single Medicine Product

Effective date

24/07/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Treatment of type 2 diabetes mellitus in adults, particularly in over weight patients, when dietary management and exercise alone, does not result in

adequate glycaemic control. Metformin may be used as initial treatment, or in sulphonylurea failures, either alone or in combination with a sulphonylurea

and other oral agents or as adjuvant therapy in insulin dependent diabetes.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PE/PVDC/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

60 tablets

(S4) Prescription Only Medicine

Components

1.

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White, film coated, round, biconvex, plain on one side and embossed '850'

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 02:45:18 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

Terry White Chemists

Metformin 500/850/1000

Contains the active ingredient metformin (met-FOR-min) hydrochloride

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 metformin It does

not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist or diabetes educator.

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 Terry

White Chemists Metformin 500, 850

or 1000 tablets. It contains the active

ingredient metformin (as metformin

hydrochloride).

It is used to treat type 2 diabetes (also

called non-insulin dependent diabetes

mellitus or maturity onset 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, metformin can be

used alone, or in 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 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

Metformin belongs to a group of

medicines called biguanides.

Metformin lowers high blood glucose

by helping your body make better use

of the insulin produced by your

pancreas.

If your blood glucose is not properly

controlled, you may experience

hypoglycaemia (low blood glucose)

or hyperglycaemia (high blood

glucose).

People with type 2 diabetes are

unable to make enough insulin or

their body does not respond properly

to the insulin it does make. This

causes a build up of glucose in the

blood, which can lead to serious

medical problems with your heart,

eyes, circulation or kidneys.

There is no evidence that this

medicine is addictive.

Use in children

This medicine should not be used in

children under 10 years of age.

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:

-

type 1 diabetes that is 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

TERRY WHITE CHEMISTS METFORMIN 500/850/1000 TABLETS

as an unusual fruity odour on

your breath, difficulty

breathing, confusion and

frequent urination)

-

severe liver disease

-

excessive alcohol intake, binge

drinking, alcohol dependence

-

severe kidney disease or kidney

failure

-

dehydration, severe blood loss,

shock

-

a severe infection

-

certain heart or blood vessel

problems, including a recent

heart attack or severe heart

failure (when the heart fails to

pump blood effectively)

-

severe breathing difficulties

-

blood clots in the lungs

(symptoms include coughing,

shortness of breath, chest pain

and a fast heart rate)

-

gangrene

-

inflammation of the pancreas

(pancreatitis), symptoms

include severe upper stomach

pain, often with nausea and

vomiting.

You need to have major

surgery or an examination such

as an X-ray or scan requiring

an injection of iodinated

contrast (dye).

You must stop taking metformin

for a certain period of time before

and after the examination or the

surgery. Your doctor will decide

whether you need any other

treatment for this time. It is

important that you follow your

doctor's instructions precisely.

You are breast-feeding.

Metformin may pass into human

breast milk.

You are hypersensitive to, or

have had an allergic reaction to,

metformin, other biguanides 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 hay

fever-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.

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.

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

heart failure.

You drink alcohol.

Alcohol can affect the control of

your diabetes. Drinking excessive

amounts of alcohol while you are

being treated with metformin may

also lead to serious side effects.

Your doctor may suggest you

stop drinking or reduce the

amount of alcohol you drink.

You are currently pregnant or you

plan to become pregnant. Do not

take this medicine whilst

pregnant until you and your

doctor have discussed the risks

and benefits involved.

You are currently breastfeeding

or you plan to breast-feed. Do not

take this medicine whilst

breastfeeding.

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

metformin. These include:

other medicines used to treat

diabetes, such as sulfonylureas or

repaglinide

some medicines used to treat high

blood pressure and some heart

conditions, including beta-

blockers, calcium channel

blockers and ACE inhibitors;

some examples include

metoprolol, nifedipine and

enalapril

medicines used to prevent blood

clots such as warfarin

diuretics, also called fluid tablets

thyroid preparations such as

thyroxine

cimetidine, a medicine commonly

used to treat reflux and ulcers

glucocorticoids such as

prednisone and cortisone

some medicines used to treat

asthma such as salbutamol or

terbutaline.

If you are taking any of these you

may need a different dose or you

may need to take different medicines.

Other medicines not listed above

may also interact with metformin.

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.

TERRY WHITE CHEMISTS METFORMIN 500/850/1000 TABLETS

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.

Adults

The usual starting dose for adults is

500mg one to two times a day. Your

doctor may increase or decrease the

dose, depending on your blood

glucose levels. The maximum

recommended dose is 1000mg three

times a day.

People over 65 years of age or those

with kidney problems may need

smaller doses.

Children & 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 may increase

or decrease the dose, depending on

your blood glucose levels.

The maximum recommended dose is

2000 mg daily, taken as two or three

divided doses.

How to take it

Swallow the tablets with a glass of

water.

When to take it

Take your medicine during or

immediately after a meal, at about

the same time each day.

This will reduce the chance of a

stomach upset.

Taking your medicine at the same

time each day will have the best

effect. It will also help you remember

when to take it.

How long to take it for

Continue taking your medicine for as

long as your doctor tells you.

Metformin will help control your

diabetes but will not cure it. Most

people will need to take metformin

on a long-term basis.

Make sure you have enough to last

over weekends and holidays.

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 (with or immediately after

a meal) 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

getting low blood sugar levels

(hypoglycaemia).

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 metformin you

may feel sleepy, very tired, sick,

vomit, have trouble breathing and

have unusual muscle pain, stomach

pain or diarrhoea. These may be

early signs of a serious condition

called lactic acidosis (build up of

lactic acid in the blood).

You may also experience symptoms

of hypoglycaemia (low blood

glucose). This usually only happens

if you take too much metformin

together with other medicines for

diabetes or with alcohol.

While you are taking

this medicine

Things you must do

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

Metformin does not normally cause

hypoglycaemia, although you may

experience it if you also take other

medicines for diabetes such as

sulfonylureas or repaglinide; or if

you also use insulin.

Hypoglycaemia can occur suddenly.

Initial signs 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 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 3 teaspoons of sugar or

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

TERRY WHITE CHEMISTS METFORMIN 500/850/1000 TABLETS

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

Hyperglycemia is often

asymptomatic (doesn't cause any

immediate symptoms) in many

people. However some people will

develop symptoms. Those people

who develop symptoms may

experience the following:

high levels of sugar in the urine

frequent urination

increased thirst.

If you develop any signs of

hyperglycaemia, contact your

doctor immediately.

Your doctor may need to consider

additional or other treatments for

your diabetes.

The risk of hyperglycaemia is

increased in the following situations:

uncontrolled diabetes

illness, infection or stress

taking less metformin than

prescribed

taking certain other medicines

too little exercise

eating more carbohydrates than

normal.

Tell your doctor that you are

taking this medicine if:

you are about to be started on any

new medicine

you are pregnant or are planning

to become pregnant

you are breastfeeding or are

planning to breastfeed

you are about to have any blood

tests

You must also tell your doctor if:

you become ill

you become dehydrated

you are injured

you have a fever

you have a serious infection

you are having surgery (including

dental surgery) or are going into

hospital

Your blood glucose may become

difficult to control at these times.

You may also be more at risk of

developing a serious condition called

lactic acidosis. At these times, your

doctor may replace metformin with

insulin.

Go to your doctor regularly for a

check-up. Your doctor may want to

perform blood tests to check your

kidneys, liver, heart and vitamin B12

level while you are taking this

medicine.

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.

When you start treatment with

metformin, 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

Do not skip meals while taking

this medicine.

Do not give this medicine to

anyone else, even if their

symptoms seem similar to yours.

Do not take your medicine to

treat any other complaints unless

your doctor or pharmacist tells

you to.

Do not stop taking your medicine,

or change the dosage, without

checking with your doctor

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 can make this

worse. However, metformin 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 taking metformin even if

you feel unable to eat your normal

meal.

Your diabetes educator or dietician

can give you a list of foods to use for

sick days.

If you are travelling, it is a good idea

wear some form of identification

(e.g. bracelet) showing you have

diabetes

carry some form of sugar to treat

hypoglycaemia if it occurs, for

example, sugar sachets or jelly

beans

carry emergency food rations in

case of a delay, for example,

dried fruit, biscuits or muesli bars

bring your medicine with you, so

you don't miss any doses.

Possible side effects

Tell your doctor as soon as possible

if you do not feel well while you are

taking metformin.

Metformin helps most people with

diabetes, but it may have unwanted

side effects in a few people.

If you are over 65 years of age,

report any side effects to your

doctor immediately.

People over his age may have an

increased chance of getting side

effects.

Ask your doctor or pharmacist to

answer any questions you may have.

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.

TERRY WHITE CHEMISTS METFORMIN 500/850/1000 TABLETS

Tell your doctor or pharmacist if

you notice any of the following and

they worry you:

stomach upset such as feeling

sick (nausea)

vomiting

taste disturbance

loss of appetite

diarrhoea

skin reactions such as redness of

the skin, itching or an itchy rash

(urticaria)

These are generally mild side effects.

Stomach upset and diarrhoea are

common but usually short-lived.

Taking your medicine with meals can

help reduce nausea and diarrhoea.

Skin rash has been reported rarely.

Tell your doctor immediately or go

to Accident or 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 light-headedness

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 and liver problems.

Other side effects not listed above

may occur in some patients.

Tell your doctor or pharmacist if you

notice anything that is making you

feel unwell.

Allergic reactions

If you think you are having an

allergic reaction to metformin, 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,

throat or other parts of the body

rash, itching or hives on the skin

fainting

hay fever-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 25°C.

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 it has passed its

expiry date, your pharmacist can

dispose of the remaining medicine

safely.

Product description

What Terry White Chemists

Metformin 500, 850 or 1000

looks like

500 mg tablets:

White coloured, film-coated

biconvex capsule shaped tablet with

central break-line on one side and

'500' embossed on the other side.

They are packaged in a blister pack

of 100 tablets.

850 mg tablets:

White coloured, film-coated, round

biconvex tablets plain on one side

and '850' embossed on the other side.

They are packaged in a blister pack

of 60 tablets.

1000 mg tablets:

White, film-coated, capsule-shaped,

biconvex tablet, plain on one side

and a breakline on the other.

They are packed in a blister pack of

10, 30, 60 and 90 tablets.

* Not all strengths and/or pack sizes

may be available.

Ingredients

Each tablet 500 mg, 850 mg or 1000

mg of metformin hydrochloride as

the active ingredient.

It also contains the following inactive

ingredients:

hypromellose

macrogol 6000

magnesium stearate

povidone

propylene glycol

silica - colloidal anhydrous

sodium starch glycollate

starch - maize

talc- purified

colloidal anhydrous silica

titanium dioxide.

This medicine is gluten-free, lactose-

free, sucrose-free, tartrazine-free and

free of other azo dyes.

TERRY WHITE CHEMISTS METFORMIN 500/850/1000 TABLETS

Australian Registration

Numbers

Terry White Chemists Metformin

500 tablets (blister pack):

AUST R 174819.

Terry White Chemists Metformin

850 tablets (blister pack):

AUST R 174820.

Terry White chemists Metformin

1000 tablets (blister pack):

AUST R 176511

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

This leaflet was last updated in:

June 2013

TERRY WHITE CHEMISTS METFORMIN 500/850/1000 TABLETS