METFORMIN AN metformin hydrochloride 850 mg tablets blister pack

Main information

  • Trade name:
  • METFORMIN AN metformin hydrochloride 850 mg tablets blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • METFORMIN AN metformin hydrochloride 850 mg tablets blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 180436
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

180436

METFORMIN AN metformin hydrochloride 850 mg 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

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. METFORMIN AN metformin hydrochloride 850 mg tablets blister pack

Product Type

Single Medicine Product

Effective date

13/02/2015

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. METFORMIN AN 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 08:14:05 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

Metformin AN tablets– Consumer Medicine Information

Doc ID: 74.AN.CMI.1.0

Page 1

Metformin AN tablets

metformin (as hydrochloride)

Consumer Medicine Information

What is in this leaflet

This

leaflet

answers

some

common

questions

about

METFORMIN

does

contain

available

information.

does

take

place

talking

your

doctor

pharmacist or diabetes educator.

medicines

have

risks

benefits.

Your

doctor

weighed the risks of you taking

METFORMIN

against

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 METFORMIN

AN is used for

METFORMIN

used

control

blood

glucose

(the

amount of sugar in the blood) in

people with diabetes mellitus.

METFORMIN AN can be used in

type

diabetes

adults

children over 10 years of age. It is

especially useful in those who are

overweight,

when

diet

exercise are not enough to lower

high

blood

glucose

levels

(hyperglycemia).

adult

patients, METFORMIN AN 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

METFORMIN

AN

has

been

prescribed for you.

Your doctor may have prescribed

METFORMIN

another

reason.

METFORMIN

available

only with a doctor’s prescription.

There

evidence

that

METFORMIN AN is addictive.

How METFORMIN AN works

METFORMIN

belongs

group

medicines

called

biguanides.

METFORMIN

lowers

high

blood

glucose

(hyperglycaemia) by helping your

body

make

better

insulin

produced

your

pancreas.

People with type 2 diabetes are

unable to make enough insulin or

their

body

does

respond

properly

insulin

does

make. This causes a build up of

glucose in the blood, which can

lead to serious medical problems.

Long-term

hyperglycaemia

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

METFORMIN AN

When you must not take it

Do not take METFORMIN AN if

you are allergic to:

Medicines

containing

Metformin

(e.g.,

Diabex,

Diaformin)

other

biguanide.

ingredients

listed

toward the end of this leaflet.

Some of the symptoms of an

allergic

reaction

include

skin

rash,

itching

hives;

swelling

face,

lips

tongue

which

cause

difficulty

swallowing

breathing;

wheezing

shortness of breath.

Do not take METFORMIN AN if

you have any of the following

conditions:

Type 1 diabetes mellitus that is

well controlled by insulin alone.

Type 2 diabetes that is already

well controlled by diet alone.

Diabetic

ketoacidosis

symptom

uncontrolled

diabetes, in which substances

called ketone bodies build up in

the blood- you may notice this

as an unusual fruity odour on

your breath, difficulty breathing,

confusion

frequent

urination).

Severe liver disease.

Excessive alcohol intake, binge

drinking, alcohol dependence.

Kidney failure or severe kidney

disease

Dehydratiion,

severe

blood

loss, shock

A severe infection.

Certain heart or blood vessel

problems,

including

recent

heart

attack

severe

heart

failure (when the heart fails to

pump blood effectively).

Severe breathing difficulties.

Blood

clots

lungs

(symptoms

include

coughing,

shortness of breath, chest pain

and a fast heart rate).

Gangrene.

Inflammation

pancreas

(pancreatitis),

symptoms

include

sever

upper

stomach

Metformin AN tablets– Consumer Medicine Information

Doc ID: 74.AN.CMI.1.0

Page 2

pain,

often

with

nausea

vomiting.

Do not take METFORMIN AN if

you

plan

to

have

any

X-ray

procedures

requiring

an

injection of iodinated contrast

(dye).

Using this type of dye while you

are taking METFORMIN AN may

cause

severe

kidney

problems

and increase the risk of a serious

condition

called

lactic

acidosis.

Your doctor will tell you when to

temporarily

stop

taking

tablets

before

X-ray

when it is safe to restart them.

Do not take METFORMIN AN if

you

are

pregnant

or

plan

to

become pregnant.

The safety of METFORMIN AN in

pregnant woman has not been

established.

Insulin

more

suitable

controlling blood glucose during

pregnancy.

Your

doctor

will

replace

METFORMIN

with

insulin while you are pregnant.

Do not take METFORMIN AN if

you are breast feeding.

METFORMIN

recommended

while

breast feeding. Your doctor will

discuss the options available to

you.

Do not take METFORMIN AN 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 METFORMIN AN 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

METFORMIN

AN,

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 can affect the control of

your diabetes. Drinking excessive

amounts of alcohol while you are

being treated with METFORMIN

lead

serious

side

effects. Your doctor may suggest

you stop drinking or reduce the

amount of alcohol you drink.

If

you

have

not

told

your

doctor

about

any

of

these

things, tell him/her before you

start taking METFORMIN AN.

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

METFORMIN AN or may affect

how well it works. These include:

Other medicines used to treat

insulin

Medicines that contain alcohol,

such as cough and cold syrups

Danazol, a medicine used to

treat endometriosis

Repaglinide

(Novonorm),

another type of medicine used

to treat diabetes.

Some medicines used to treat

high blood pressure and some

heart

conditions,

including

beta-blockers, calcium channel

blockers and ACE inhibitors

Medicines

used

prevent

blood

clots

such

warfarin

(Coumadin, Marevan).

Diuretics,

also

called

fluid

tablets

Chlorpromazine,

medicine

used to treat schizophrenia and

other mental illnesses

NSAIDs

(non-steroidal

anti-

inflammatory drugs), medicines

used to relieve pain, swelling

other

symptoms

inflammation, such as aspirin,

diclofenac,

ibuprofen,

meloxicam,

maproxen

piroxicam

Cimetidine,

medicine

commonly used to treat reflux

and ulcers.

Corticosteroids

such

prednisone or cortisone

Some medicines used to treat

asthma such as salbutamol or

terbutaline

These

medicines

affected by Metformin AN 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 or pharmacist have

more information on medicines to

careful

with

avoid

while

taking METFORMIN AN.

How to take

METFORMIN AN

Follow all directions given to

you

by

your

doctor

and

pharmacist carefully.

They

differ

from

information

contained

leaflet.

If you do not understand the

instructions on the pack, ask

your doctor or pharmacist.

How much to take METFORMIN

AN

Metformin AN tablets– Consumer Medicine Information

Doc ID: 74.AN.CMI.1.0

Page 3

The dose varies from person to

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

increase

decrease the dose, depending on

your blood glucose levels. The

maximum recommended dose is

1000 mg three times s day.

elderly

people

with

kidney

problems

need

smaller doses.

Children and adolescents:

usual

starting

dose

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

dose,

depending

your

blood glucose levels.

maximum

recommended

dose is 2 g taken as two or three

divided doses.

If your child has diabetes that is

resistant to insulin and is being

treated

hospital,

your

child’s

doctor will decide the dose

How to take METFORMIN AN

Swallow the tablet with a glass of

water.

When to take METFORMIN AN

Take METFORMIN AN during

or immediately after food.

This will reduce the chance of a

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

remember

when to take it.

How long to take METFORMIN

AN for

Keep

taking

METFORMIN

AN

for

as

long

as

your

doctor

recommends.

METFORMIN AN will help control

diabetes but will not cure it. Most

people

will

need

take

METFORMIN AN on long term

basis.

If

you

forget

to

take

METFORMIN AN

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

METFORMIN AN (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

METFORMIN AN, even if there

are no signs of discomfort or

poisoning.

take

much

METFORMIN AN, 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

serious

condition

called

lactic

acidosis

(build

lactic

acid

blood).

also

experience

symptoms of Hypoglycemia (low

blood glucose). This usually only

happens if you take too much of

METFORMIN

together

with

other medicines for diabetes or

with alcohol.

If you experience any signs of

hypoglycemia,

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

METFORMIN AN

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

METFORMIN

does

normally

cause

hypoglycaemia,

although you may experience it if

take

other

medicines

diabetes such as sulfonylureas or

repaglinide;

also

insulin.

Hypoglycaemia

occur

suddenly.

Initial signs may include:

weakness, trembling or shaking

sweating

lightheadedness,

dizziness,

head

ache

lack

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

Metformin AN tablets– Consumer Medicine Information

Doc ID: 74.AN.CMI.1.0

Page 4

drinking half a can of non-diet

soft drink

taking

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

need

consider

additional

other

treatments for your diabetes.

risk

hyperglycaemia

increased

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 if you:

become ill

become dehydrated

are injured

have a fever

have a serious infection

having

surgery

(including

dental surgery).

Your blood glucose may become

difficult to control at these times.

You may also be more at risk of

developing

serious

condition

called

lactic

acidosis

these

times, your doctor may replace

METFORMIN AN with insulin.

Before

starting

any

new

medicine,

tell

your

doctor

or

pharmacist that

you

are

taking

METFORMIN

AN.

Tell

all

the

doctors,

dentists

and

Pharmacists

who

are

treating you that you are taking

METFORMIN AN.

If you become pregnant while

taking

METFORMIN

AN,

tell

your doctor immediately.

Tell your doctor if any of the

following happen:

You become ill

You become dehydrated (for

instance due to persistent of

severe

diarrhea

recurrent

vomiting

You are injured

You have a fever

You have a serious infection

such as influenza, respiratory

tract infection or urinary tract

infection

You are having major surgery

have

examination

such as an X-ray or a scan

requiring

injection

iodinated contract agent (dye)

You blood glucose may become

difficult to control at these times.

You may also be more at risk of

developing

serious

condition

called

lactic

acidosis.

these

times, your doctor may replace

METFROMIN AN with insulin

Visit your doctor regularly for

check ups.

Your doctor may want to perform

blood

tests

check

your

kidneys, liver, heart and vitamin

level

while

taking

METFORMIN AN.

Check

your

blood

glucose

levels regularly.

This is the best way to tell if your

diabetes

being

controlled

properly. Your doctor or diabetes

educator will show you how and

when to do this.

When

start

treatment

with

METFORMIN AN, it can take up

weeks

your

blood

glucose

levels

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

METFORMIN AN.

Do not stop taking METFORMIN

AN or change the dose without

checking with your doctor.

Do not give METFORMIN AN to

anyone else, even if they have

the same condition as you.

Do not use METFORMIN AN to

treat any 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.

blood

glucose

levels

slow your reaction time and affect

your ability to drive or operate

machinery. Drinking alcohol can

make

this

worse.

However,

METFORMIN

itself

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

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

identification

(e.g.

bracelet)

showing you have Diabetes.

carry

some form

sugar

treat hypoglycaemia if it occurs,

for example, sugar sachets or

jelly beans.

Metformin AN tablets– Consumer Medicine Information

Doc ID: 74.AN.CMI.1.0

Page 5

carry emergency food rations in

case of a delay, for example,

dried

fruit,

biscuits

muesli

bars.

bring enough METFORMIN AN

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

of

heart

disease.

Quit

smoking

avoid

second hand smoke

Limit alcohol intake

Enjoy healthy eating by:

Eating plenty of vegetables

and fruit;

Reducing your standard fat

intake (eat less fatty meats,

full fat dairy products

Side Effects

Tell your doctor or pharmacist

as soon as possible if you do

not

feel

well

while

you

are

taking METFORMIN AN.

METFORMIN

helps

most

people with diabetes but it may

have

unwanted

side

effects

some people.

medicines

have

side

effects.

Sometimes

they

serious, most of the time they are

not.

need

medical

treatment 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 affects,

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

generally

mild

side

effects which disappear after the

first

weeks.

Taking

METFORMIN AN with meals can

help

reduce

nausea

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 if you notice

anything

that

is

making

you

feel unwell.

Other

side

effects

listed

above may also occur in some

people.

Some side affects (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

METFORMIN AN

Storage

Keep

the

medication

where

children cannot reach it.

A locked cupboard at least one-

and-half

metres

above

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 and dampness can destroy

some medicines.

Disposal

If your doctor tells you to stop

taking

METFORMIN

AN,

or

your tablets have passed their

expiry

date,

ask

your

pharmacist what to do with any

that are left over.

Metformin AN tablets– Consumer Medicine Information

Doc ID: 74.AN.CMI.1.0

Page 6

Product Description

What it looks like

METFORMIN

500mg

presented in blister packs of 30 &

100 and bottles of 100.

METFORMIN

850mg

presented in blister packs of 20 &

60 and bottles of 100.

METFORMIN

1000mg

presented in blister

packs of 20 &

90 and bottles of 100.

METFORMIN AN 500mg (Blister:

AUST R 180434; Bottle: AUST R

180446)

White, biconvex, circular shaped,

film

coated

tablets

with

‘A’

debossed on one side and ‘60’

debossed on the other side.

METFORMIN AN 850mg (Blister:

AUST R 180436; Bottle: AUST R

180442)

White, biconvex, circular shaped,

film

coated

tablets

with

‘A’

debossed on one side and ‘61’

debossed on the other side.

METFORMIN

AN

1000mg

(Blister: AUST R 180431; Bottle:

AUST R 180440)

White,

biconvex,

oval

shaped,

film coated tablets with a score

line in between ‘6’ and ‘2’ on one

side

‘A’

debossed

other side.

Ingredients

Active ingredients

Metformin hydrochloride

Each tablet contain either 500,

1000

Metformin

hydrochloride.

Inactive ingredients

Povidone

Magnesium stearate

Opadry YS-1R-7006 (PI-ARTG

No. 13068).

Name

and

Address

of

the

Sponsor

Amneal Pharma Australia Pty Ltd

12 River Street

South Yarra 3141

Australia

Date of Preparation

December 2013