AMOXYCLAV GH 500/125 amoxicillin 500mg (as trihydrate) & clavulanic acid 125mg (as potassium) tablet blister pack

Main information

  • Trade name:
  • AMOXYCLAV GH 500/125 amoxicillin 500mg (as trihydrate) & clavulanic acid 125mg (as potassium) tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AMOXYCLAV GH 500/125 amoxicillin 500mg (as trihydrate) & clavulanic acid 125mg (as potassium) tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 198110
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

198110

AMOXYCLAV GH 500/125 amoxicillin 500mg (as trihydrate) & clavulanic acid 125mg (as potassium) tablet

blister pack

ARTG entry for

Medicine Registered

Sponsor

Sandoz Pty Ltd

Postal Address

54 Waterloo Road,Macquarie Park, NSW, 2113

Australia

ARTG Start Date

12/09/2012

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. AMOXYCLAV GH 500/125 amoxicillin 500mg (as trihydrate) & clavulanic acid 125mg (as potassium) tablet

blister pack

Product Type

Single Medicine Product

Effective date

12/04/2018

Permitted Indications

No Permitted Indications included on Record

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

Short-term treatment of bacterial infection at the following sites when caused by amoxycillin/clavulanic acid sensitive, beta-lactamase producing

organisms. Skin and skin structure infections. Urinary tract infections (uncomplicated and complicated). Upper respiratory tract infections, such as

sinusitis, otitis media and recurrent tonsillitis. Lower respiratory tract infections, including community acquired pneumonia and acute exacerbations of

chronic bronchitis. Appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their)

susceptibility to AMOXYCLAV GH / CURAM tablets. However, when there is reason to believe an infection may involve any of the beta-lactamase

producing organisms listed in the microbiological section, therapy may be instituted prior to obtaining the results from bacteriological and susceptibility

studies. Once these results are known, therapy should be adjusted if appropriate. The treatment of mixed infections caused by amoxycillin susceptible

organisms and beta-lactamase producing organisms susceptible to CURAM / AMOXYCLAV GH tablets should not require the addition of another

antibiotic due to the amoxycillin content of CURAM / AMOXYCLAV GH tablets.

Warnings

See Product Information and Consumer Medicine Information for this product

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Al/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Protect from Moisture

Pack Size/Poison information

Pack Size

Poison Schedule

10 tablets

(S4) Prescription Only Medicine

Components

1. Medicine Component

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

OFF-WHITE, OVAL BICONVEX, FILM-COATED TABLETS, SCORED ON

BOTH SIDES.

Public Summary

Page 1 of

Produced at 21.05.2019 at 06:26:46 AEST

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

Active Ingredients

amoxicillin trihydrate

574 mg

potassium clavulanate

149 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 2 of

Produced at 21.05.2019 at 06:26:46 AEST

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

1412 AmoxyClav GH 500/125 and 875/125 CMI v5

Page 1 of 5

CONSUMER MEDICINE INFORMATION

AMOXYCLAV GH 500/125

AMOXYCLAV GH 875/125

amoxycillin and potassium clavulanate tablets

What is in this leaflet

Please read this leaflet

carefully before you take

AmoxyClav GH tablets.

This leaflet answers some

common questions about

AmoxyClav GH tablets.

It does not contain all the

available information. It does

not take the place of talking to

your doctor or pharmacist.

All medicines have risks and

benefits. Sometimes new risks

are found even when a

medicine has been used for

many years. Your doctor has

weighed the expected benefits

of you taking AmoxyClav GH

tablets against the risks this

medicine could have for you.

If you have any concerns

about taking this medicine,

ask your doctor or pharmacist.

Keep this leaflet with the

medicine.

You may need to read it again.

What is AmoxyClav GH

tablets used for?

AmoxyClav GH tablets contain

two active ingredients. One of

these ingredients is a type of

penicillin called amoxycillin

and the other is potassium

clavulanate.

AmoxyClav GH tablets are used

for the short term treatment of

a wide range of infections

caused by bacteria. These

infections may affect the chest

(bronchitis or pneumonia),

bladder (cystitis), sinuses

(sinusitis), the ears (otitis

media) or the skin.

AmoxyClav GH tablets work by

killing the bacteria that cause

these infections. AmoxyClav

GH tablets will not work

against infections caused by

viruses such as colds or the flu.

Your doctor may prescribe

AmoxyClav GH tablets for

another

use. If you want more

information, ask your doctor.

There is no evidence that

AmoxyClav GH tablets are

addictive.

Before you take

AmoxyClav GH tablets

Do not take AmoxyClav GH

tablets if:

You have had an allergic

reaction to penicillin or

similar types of antibiotics

(such as cephalosporins) or

any of the ingredients

contained in AmoxyClav GH

tablets. The ingredients are

listed at the end of this

leaflet.

Some of the symptoms of an

allergic reaction may

include skin rash, itching,

difficulty breathing and

swelling of the face or

tongue.

You have previously

experienced liver problems

after taking AmoxyClav GH

tablets or any other

medicines.

The expiry date printed on

the pack has passed.

1412 AmoxyClav GH 500/125 and 875/125 CMI v5

Page 2 of 5

The packaging is torn or

shows signs of tampering.

Do not give this medicine to

anyone else; your doctor has

prescribed it specifically for

you and your condition.

If you are not sure whether

you should start to take this

medicine, talk to your doctor.

Tell your doctor if:

You have ever had an

allergic reaction (such as a

rash) to antibiotics or other

substances in the past.

You are allergic to foods,

dyes, preservatives or any

other medicines.

You have experienced liver

problems after taking

AmoxyClav GH tablets or

any other medicines.

have glandular fever

(mononucleosis) or

leukaemia.

You are pregnant or think

you may be pregnant or are

breastfeeding.

Your doctor will discuss with

you the possible risks and

benefits of taking

AmoxyClav GH tablets

during pregnancy or while

you are breastfeeding

AmoxyClav GH tablets can

pass to your baby

from

breast milk.

You have any kidney or liver

problems. The dosage of

AmoxyClav GH tablets may

need to be changed or you

may need to be given an

alternative medicine.

You have to test your urine

for sugar. Amoxyclav GH

tablets may affect the

results of these tests.

Tell your doctor or

pharmacist if you are taking

any other medicines,

including medicines that

you buy without a

prescription from your

pharmacy, supermarket or

health food shop. In

particular, tell your doctor

or pharmacist if you are

taking any of the following:

Warfarin or other

medicines used to

prevent blood clot

Mycophenolate

Medicine used to treat

gout (eg. probenecid or

allopurinol).

Other antibiotics. These

may interfere with the

actions of AmoxyClav GH

tablets.

The contraceptive pill. As

with other antibiotics,

you may need to use

extra birth control

methods (e.g. condoms)

while taking AmoxyClav

GH tablets.

Some medicines may affect

the way other medicines

work. Your doctor or

pharmacist will be able to

tell you what to do when

taking AmoxyClav GH

tablets with other

medicines.

How to take AmoxyClav

GH tablets

Follow all directions given to

you by your doctor or

pharmacist carefully.

Their directions may differ

from the information

contained in this leaflet.

Please read the directions label

carefully. If you have any

concerns about how to take

this medicine, talk to your

doctor or pharmacist.

How much to take:

Take as directed by your

doctor or pharmacist.

The usual dose of AmoxyClav

GH is one tablet twice a day.

How to take it:

Swallow the AmoxyClav GH

tablets with a full glass of

water or other liquid.

AmoxyClav GH tablets should

be taken immediately before

or with the

first mouthful of

food. AmoxyClav GH tablets

work best when taken this

way. It may also help to

prevent stomach upset.

However, Amoxyclav GH

tablets still work if they are

taken without foods.

1412 AmoxyClav GH 500/125 and 875/125 CMI v5

Page 3 of 5

Space the doses as evenly as

possible throughout the day. If

you are taking AmoxyClav GH

tablets twice a day, take a dose

about every twelve hours.

How long to take it:

Keep taking AmoxyClav GH

tablets until the course is

finished or for as long as your

doctor tells you

Do not stop taking AmoxyClav

GH tablets just because you

feel better as the infection can

return.

Do not stop taking AmoxyClav

GH tablets or change the dose,

without checking with your

doctor.

If you forget to take it:

If your next dose is due within

six hours, skip the dose you

missed and take your next

dose at normal time.

Otherwise take the missed

dose as soon as you remember

and then go back to taking

your tablets as directed by

your doctor.

Do not take a double dose to

make up for the dose you

missed.

Taking more than the

prescribed dose can increase

the chance of unwanted side

effects.

What do I do if I take too

much? (Overdose)

Immediately telephone your

doctor or the Poisons

Information Centre

(telephone 13 11 26) for

advice if you think you or

anyone else has taken too

much, even if there are no

signs of discomfort or

poisoning.

Symptoms of overdose include

mild to severe nausea,

vomiting, cramps and

diarrhoea.

If you are not sure what to do,

contact your doctor,

pharmacist or nearest hospital.

Be sure to show the doctor the

AmoxyClav GH pack.

While you are taking

AmoxyClav GH tablets

Things you must do:

Take AmoxyClav GH tablets

exactly as your doctor has

prescribed.

Tell your doctor if, for any

reason, you have not taken

your medicine exactly as

directed. Otherwise your

doctor may think that it was

not working as it should and

change your treatment

unnecessarily.

Tell your doctor, dentist or

pharmacist you are taking

AmoxyClav GH tablets before

starting any other medicines.

Some medicines may affect the

way other medicines work.

Tell your doctor if the

symptoms of your infection

become worse, or do not

improve within a few days of

starting AmoxyClav GH tablets.

Things you must not do:

Do not use this medicine to

treat any other complaint

unless your doctor says to.

Do not give this medicine to

anyone else, even if their

symptoms seem similar to

yours.

Things to be careful of:

Alcohol should be avoided

during and for several days

after treatment

with

AmoxyClav GH tablets. Some

people who drink alcohol while

taking antibiotics similar to

AmoxyClav GH tablets have

experienced adverse effects.

Be careful driving or operating

machinery until you know how

this medicine affects you.

AmoxyClav GH tablets

generally do not cause any

problems with your ability to

drive a car or operate

machinery. However, as with

many other medicines, it may

cause dizziness or tiredness in

some people.

If you develop severe

diarrhoea either when taking

AmoxyClav GH tablets or

within several weeks after

treatment, tells your doctor as

1412 AmoxyClav GH 500/125 and 875/125 CMI v5

Page 4 of 5

soon as possible. Do not take

any medication to stop the

diarrhoea (eg. Lomotil or

Imodium).

What are the side effects?

Check with your doctor as

soon as possible if you think

you are experiencing any side‐

effects or allergic reactions

due to taking AmoxyClav GH

tablets, even if the problem is

not listed below.

Like other medicines,

Amoxyckav GH tablets can

cause some side effects. If they

occur, they are most likely to

be minor and temporary.

However, some may be serious

and need medical attention.

Tell your doctor about any

effect which is troublesome or

ongoing.

MILD EFFECTS

Tell your doctor if you notice

any of the following that are

troublesome or ongoing:

Diarrhoea (several loose

bowel movements

per day),

indigestion, pain in the

stomach, feeling sick or

being sick

white, furry, sore tongue

and mouth (oral thrush)

abnormal taste

soreness or itching of the

vagina (vaginal thrush)

headache, dizziness,

tiredness, hot flushes

tooth discolouration

unusually active

(hyperactive)

MORE SERIOUS EFFECTS

Tell your

doctor immediately

if you notice any of the

following during or after

taking AmoxyClav GH tablets:

dark urine or pale stools

rash, itching

yellowing of the skin or eyes

(jaundice)

severe stomach cramps

severe watery or bloody

diarrhoea

unusual bleeding or bruising

These may be symptoms of

rare but serious side‐effects

and require urgent medical

attention.

Stop taking this AmoxyClav

GH tablets and immediately

contact your doctor or go to

the emergency department of

your nearest hospital if any of

the following happens:

Wheezing, hives, severe skin

reaction, fainting swelling of

limbs, face, lips mouth or

throat, difficult breathing, joint

discomfort or swelling, swollen

lymph glands, nausea and

vomiting or fever.

These may be signs of an

allergic reaction or other

reaction to AmoxyClav GH

tablets. Allergy to these

antibiotics is rare.

Fits/seizures.

Rare events that have been

reported with AmoxyClav GH

tablets include:

inflammation of the bowel

(colitis)

inflammation of the liver

(hepatitis)

inflammation of the kidney

(nephritis)

blood disorders

crystal in the urine

(crystalluria)

Remember, you should tell

your doctor or pharmacist as

soon as possible if any of

these, or any other unusual

events

or problems occur

during or after treatment with

AmoxyClav GH tablets.

This is not a complete list of all

possible side effects. Other

may occur in some people and

there may be some side effects

not yet known.

Tell your doctor or pharmacist

if you notice any side effects

from your medicine which are

not mentioned here.

Do not be alarmed by this list

of possible side effects. You

may not experience any of

them.

How do I store AmoxyClav

GH tablets?

Keep your medicine in the

original pack until it is time to

take them.

1412 AmoxyClav GH 500/125 and 875/125 CMI v5

Page 5 of 5

If you take the tablets out of

the pack, they may not keep

well.

Keep the pack in a cool dry

place. Do not leave it in the car

on a hot day. Do not store

medicine in the bathroom or

near a sink. Heat and

dampness can destroy

AmoxyClav GH tablets.

Store all medicines out of the

reach of children, such as in a

locked cupboard.

If your doctor tells you to stop

taking AmoxyClav GH tablets,

or if the expiry date has

passed, ask your pharmacist

what to do with any that are

left over.

Product description

What it looks like

AmoxyClav GH comes in two

strengths:

AmoxyClav GH 500/125* ‐

off‐white, oval, biconvex,

film‐coated tablets scored

on both sides.

AmoxyClav GH 875/125 ‐

white to pale yellow,

oblong, biconvex, film‐

coated tablets scored on

both sides.

Available in strip and blister

packs of 10

tablets.

Ingredients

Active Ingredients:

AmoxyClav GH 500

mg/125 mg – 500 mg

amoxycillin (as trihydrate)

and 125 mg clavulanic acid

(as potassium

clavulanate).

AmoxyClav GH 875

mg/125 mg – 875 mg

amoxycillin (as trihydrate)

and 125 mg clavulanic acid

(as potassium

clavulanate).

Inactive Ingredients:

magnesium stearate

purified talc

povidone

croscarmellose sodium

microcrystalline cellulose

triethyl citrate

ethylcellulose

sodium lauryl sulfate

cetyl alcohol

hypromellose

titanium dioxide.

AmoxyClav GH 875/125 also

contains silicon dioxide.

This medicine does not contain

gluten, sucrose, tartrazine or

any other azo dyes.

* AmoxyClav GH 500/125

tablets are not marketed.

Supplier

AmoxyClav GH is supplied in

Australia by:

Generic Health Pty Ltd

Level 1, 1102 Toorak Rd

Camberwell, VIC 3124

Tel: (03) 9809 7900

This leaflet was revised in

March 2016.

Australian Register Number(s)

AmoxyClav GH 500/125 strip

pack: AUST R 82833

AmoxyClav GH 875/125 strip

pack: AUST R 82832

AmoxyClav GH 500/125 blister

pack: AUST R 198110

AmoxyClav GH 875/125 blister

pack: AUST R 198111