Main information

  • Trade name:
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug



  • Available in:
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 207004
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


AMOXYCILLIN GENERICHEALTH 250 amoxicillin (as trihydrate) 250 mg capsule blister pack

ARTG entry for

Medicine Registered


Sun Pharma ANZ Pty Ltd

Postal Address

Suite 2 02 Level 2 12 Waterloo Road,Macquarie Park, NSW, 2113


ARTG Start Date


Product category




Approval area

Drug Safety Evaluation Branch


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.



Product Type

Single Medicine Product

Effective date



See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Treatment of the following infections due to susceptible strains of sensitive organisms. Note: Therapy should be guided by bacteriological studies,

including sensitivity tests, and by clinical response. However, in emergency cases where the causative organism has not been identified, therapy with

amoxycillin may be useful. Clinical judgement will decide whether combination with another antibiotic would provide a sufficiently broad spectrum of

activity pending sensitivity test results. Skin and skin structure: staphylococcus, non-penicillinase producing; Streptococcus; E. coli. Respiratory (acute

and chronic): H. influenzae; Streptococcus; Strep. pneumoniae; Staphylococcus, non-penicillinase producing; E. coli. Genitourinary tract (complicated

and uncomplicated, acute and chronic): E.coli, P. mirabilis and Strep. faecalis. Gonorrhoea: N.gonorrhoeae (non-penicillinase producing). Prophylaxis of

endocarditis: Amoxycillin may be used for the prophylaxis of bacterial endocarditis in individuals at particular risk, such as those with a prosthetic heart

valve or those who have previously had endocarditis.

Additional Product information

Container information



Life Time




Blister Pack


3 Years

Store below 25

degrees Celsius

Not recorded

Protect from Moisture

Pack Size/Poison information

Pack Size

Poison Schedule

20 capsules

(S4) Prescription Only Medicine



Dosage Form

Capsule, hard

Route of Administration


Visual Identification

yellow hard gelatin capsules imprinted with "RX 654" in black on both cap

and body

Active Ingredients

amoxicillin trihydrate

286.96 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

Public Summary

Page 1 of

Produced at 28.11.2017 at 12:55:15 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 for contact information

Patient Information leaflet

Amoxycillin generichealth CMI V4 Jul 2013

Amoxycillin generichealth

Amoxycillin 250mg & 500mg capsules

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Amoxycillin


It does not contain all the available


It does not take the place of talking

to 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


and may contain important

information about the medicine and

its use of which you should be


All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking Amoxycillin

generichealth against the benefits

it is expected to have for you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the


You may need to read it again.

What Amoxycillin

generichealth is used


Amoxycillin is an antibiotic used to

treat infections in different parts of

the body caused by bacteria. These

may be infections of the chest

(pneumonia), tonsils (tonsillitis),

sinuses (sinusitis), urinary and

genital tract, skin and fleshy


Amoxycillin will not work against

infections caused by viruses such

as colds or the flu.

Amoxycillin is an antibiotic that

belongs to a group of medicines

called penicillins. These antibiotics

work by killing the bacteria that are

causing your infection.

Your doctor may have prescribed

Amoxycillin generichealth for

another reason.

Ask your doctor if you have any

questions about why Amoxycillin

generichealth has been

prescribed for you.

Amoxycillin is not addictive.

This medicine is available only with

a doctor’s prescription.

Before you take



When you must not take it

Do not take Amoxycillin

generichealth if you have an

allergy to:


other penicillins or


any of the ingredients listed at

the end of this leaflet.

Some of the symptoms of an

allergic reaction may include skin

rash, itchiness, shortness of breath,

swelling of the face, lips or tongue.

Do not take Amoxycillin

generichealth if the packaging is

torn or shows signs of


Do not take Amoxycillin

generichealth if the expiry date

(EXP) printed on the pack has


If you take this medicine after the

expiry date has passed, it may not

work as well.

If you are not sure whether you

should start taking Amoxycillin

generichealth, contact your


Before you start to take it

Tell your doctor if you have had

an allergic reaction to any

antibiotics in the past.

Tell your doctor if you have any

allergies to any other medicines

or any other substances, such as

foods, preservatives or dyes.

Tell your doctor if you have or

have ever had any other health

problems / medical conditions,


glandular fever

blood disorders such as


liver or kidney problems.

Tell your doctor or pharmacist if

your urine has to be tested for

sugar levels while taking

Amoxycillin generichealth.

Amoxycillin will produce false

positive results when some of these

tests are used. Your doctor will

help you to identify the correct test.

Tell your doctor if you are

pregnant or intend to become

pregnant, or are breast-feeding.








benefits involved.

If you have not told your doctor

about any of the above, tell them

before you take Amoxycillin


Taking other medicines

Amoxycillin generichealth CMI V4 Jul 2013

Page 2

Tell your doctor if you are taking

any other medicines, including

medicines that you buy without a

prescription from your

pharmacy, supermarket or health

food shop.

Some medicines may interfere with

amoxycillin. These include:-

medicines used to treat gout

(eg. probenecid or allopurinol)

other antibiotics (eg.


anticoagulants (used to prevent

blood clots) such as warfarin

These medicines may be affected

by amoxycillin, or may affect how

well it works. You may need

different amounts of your medicine,

or you may need to take different

medicines. Your doctor will advise


Talk to your doctor about the

need for an additional method of

contraception while taking

Amoxycillin generichealth.

Some antibiotics may decrease the

effectiveness of some birth control


Your doctor or pharmacist may

have more information on

medicines to be careful with or

avoid while taking Amoxycillin


How to take



Follow all directions given to you

by your doctor and pharmacist


These directions may differ from

the information contained in this


If you do not understand the

instructions on the box, ask your

doctor or pharmacist for help.

How much to take

The usual adult dose is one capsule

(250 mg or 500 mg) three times a


How to take it

Swallow Amoxycillin

generichealth capsules whole

with a glass of water.

Amoxycillin generichealth can be

taken with or without food. The

effects of Amoxycillin

generichealth are not changed by


Space the doses as evenly as

possible throughout the day.

For example, if you are taking

Amoxycillin generichealth three

times a day, take a dose about

every eight hours.

How long to take it

Continue taking Amoxycillin

generichealth until you finish the

pack or until your doctor


Do not stop taking your capsules

because you are feeling better.

If you do not complete the full

course prescribed by your doctor,

the infection may not clear

completely or your symptoms may


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

capsules as you would normally.

Do not take a double dose to

make up for the dose that you


If you have trouble remembering to

take your capsules, ask your

pharmacist for some hints.

If you take too much


Immediately telephone your

doctor or Poisons Information

Centre (telephone 13 11 26) or go

to the Accident and Emergency

department at your nearest

hospital, if you think that you or

anyone else may have taken too

much Amoxycillin generichealth.

Do this even if there are no signs

of discomfort or poisoning.

Keep these telephone numbers


If you take too much amoxycillin

you may get diarrhoea and nausea.

While you are using



Things you must do

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.

If the symptoms of your infection

do not improve within a few

days, or if they become worse,

tell your doctor.

If you develop itching with

swelling or skin rash or difficulty

breathing while you are taking

Amoxycillin generichealth, do

not take any more and contact

your doctor immediately.

If you get severe diarrhoea tell

your doctor, pharmacist or nurse

immediately. Do this even if it

occurs several weeks after

amoxycillin has been stopped.

Diarrhoea may mean that you have

a serious condition affecting your

bowel. You may need urgent

medical care.

Do not take any anti-diarrhoea

medicine without first checking

with your doctor.

If you get a sore white mouth or

tongue while taking or soon after

stopping Amoxycillin

generichealth, tell your doctor.

Also tell your doctor if you get

vaginal itching or discharge.

This may mean you have a fungal

infection called thrush. Sometimes

the use of amoxycillin allows fungi

to grow and the above symptoms to

occur. Amoxycillin does not work

against fungi.

Amoxycillin generichealth CMI V4 Jul 2013

Page 3

If you become pregnant while

you are taking Amoxycillin

generichealth, tell your doctor.

If you are about to start taking

any new medicine, tell your

doctor and pharmacist that you

are taking Amoxycillin


Tell all the doctors, dentists and

pharmacists who are treating

you that you are taking

Amoxycillin generichealth.

Things you must not do

Do not stop taking your capsules

because you are feeling better,

unless advised by your doctor.

If you do not complete the full

course prescribed by your doctor,

all of the bacteria causing your

infection may not be killed. These

bacteria may continue to grow and

multiply so that your infection may

not clear completely or it may return

and be more difficult to treat.

Do not give Amoxycillin

generichealth to anyone else,

even if they have the same

condition as you.

Do not use Amoxycillin

generichealth to treat any other

complaints unless your doctor

tells you to.

Things to be careful of

Be careful driving or operating

machinery until you know how

Amoxycillin generichealth affects


Amoxycillin generally does not

cause any problems with your

ability to drive a car or operate

machinery. However, as with many

other medicines, amoxycillin may

cause dizziness / drowsiness /

tiredness in some people.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not

feel well while you are taking

Amoxycillin generichealth.

Amoxycillin helps most people with

infections, but it may have

unwanted side effects in a few


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.

Tell your doctor if you notice any

of the following and they worry


soreness of the mouth or


diarrhoea (several loose bowel

movements per day),

indigestion, feeling sick or being


overgrowth of yeast infections


These side effects are usually mild.

Tell your doctor immediately if

you notice any of the following:

itching, rash

unusual bleeding or bruising

yellowing of the skin or eyes

dark urine or pale stools

difficulty or pain on passing urine

severe diarrhoea.

These are serious side effects. You

may need urgent medical attention.

Serious side effects are rare.

If any of the following happen,

stop taking Amoxycillin

generichealth and tell your

doctor immediately or go to the

Accident and Emergency

department at your nearest


wheezing, swelling of the

lips/mouth, difficulty in breathing,

hayfever, lumpy rash (hives) or

fainting. These could be

symptoms of an allergic


These are very serious side effects.

You may need urgent medical

attention or hospitalisation. These

side effects are rare.

Other side effects not listed

above may also occur in some

patients. Tell your doctor if you

notice anything else that is

making you feel unwell.

Ask your doctor or pharmacist if

you don’t understand anything in

this list.

Do not be alarmed by this list of

possible side effects.

You may not experience any of


After using Amoxycillin



Keep your capsules in the blister

pack until it is time to take them.

If you take the capsules out of the

blister pack they may not keep well.

Keep it in a cool dry place where

the temperature stays below


C. Do not store it or any other

medicine in the bathroom or near

a sink. Do not leave it in the car

or on window sills.

Heat and dampness can destroy

some medicines.

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.


If your doctor tells you to stop

taking the capsules or the

capsules have passed their

expiry date, ask your pharmacist

what to do with any capsules

that are left over.

Product description

What it looks like

Amoxycillin generichealth

capsules are available in two

strengths, each in packs of 20


250 mg: an opaque, yellow,

hard gelatin capsule imprinted

with “RX 654” in black on both

cap and body

500 mg, an opaque,

maroon/yellow, opaque, hard

gelatin capsule, imprinted with

“RX 655” in black

Amoxycillin generichealth CMI V4 Jul 2013

Page 4


Amoxycillin generichealth contains

250 mg and 500 mg of amoxicillin

as the active ingredient.

It also contains:

sodium lauryl sulfate

colloidal anhydrous silica

croscarmellose sodium

microcrystalline cellulose

magnesium stearate

iron oxide yellow

iron oxide red (500 mg

capsule only)

iron oxide black (500 mg

capsule only)

titanium dioxide


TekPrint SW-9008 Black

Ink (proprietary ingredient #


Amoxycillin generichealth does

not contain lactose, sucrose, gluten

or tartrazine.


Amoxycillin generichealth is

supplied in Australia by:

Generic Health Pty Limited

Level 1, 1102 Toorak Rd


Australian Registration Number

Amoxycillin generichealth 250

mg capsules: AUST R 207004

Amoxycillin generichealth 500

mg capsules: AUST R 207005

This leaflet was prepared in July



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Health Canada has seized four unauthorized drugs from Gigi’s Market, 23 Montreal Road, Ottawa, ON. The products (Ampicillin, Kamox, Medampi and Medomox) are labelled to contain antibiotic drugs (ampicillin or amoxicillin) that can only be dispensed by a healthcare professional to a patient with a valid prescription. The products listed below have not been evaluated by Health Canada for safety, effectiveness or quality and may pose serious health risks.

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