APO-AMOXYCILLIN

Main information

  • Trade name:
  • APO-AMOXYCILLIN amoxicillin (as trihydrate) 250 mg capsules blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • APO-AMOXYCILLIN amoxicillin (as trihydrate) 250 mg capsules blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 208147
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

208147

APO-AMOXYCILLIN amoxicillin (as trihydrate) 250 mg capsule 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

6/08/2013

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. APO-AMOXYCILLIN amoxicillin (as trihydrate) 250 mg capsules blister pack

Product Type

Single Medicine Product

Effective date

7/07/2017

Warnings

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

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Protect from Moisture

Pack Size/Poison information

Pack Size

Poison Schedule

20 tablets

(S4) Prescription Only Medicine

Components

1. amoxycillin 250 mg capsules

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

yellow/yellow capsules with 'RX 654' in black ink 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 http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 27.11.2017 at 11:24:48 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

APO-Amoxycillin

Capsules

Contains the active ingredient amoxycillin

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 Ask your

doctor or pharmacist if you do not

understand anything or are

worried about taking your

medicine.

This leaflet answers some common

questions about amoxycillin.

It does not contain all the available

information.

It does not take the place of talking to

your doctor or pharmacist.

The information in this leaflet was

last updated on the date listed on the

last page. Some more recent

information on the medicine may be

available. Speak to your pharmacist

or doctor to obtain the most up to

date information on the medicine.

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.

Keep this leaflet with the medicine.

You may want to read it again.

What this medicine is

used for

The name of your medicine is APO-

Amoxycillin. It contains the active

ingredient, amoxycillin (as

trihydrate).

It is an antibiotic which used to treat

infections in different parts of the

body caused by bacteria.

Amoxycillin can also be used to

prevent infection.

Amoxycillin will not work against

infections caused by viruses such as

colds or the flu.

How it works

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.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

Your doctor may have prescribed

amoxycillin for another reason.

This medicine is available only with

a doctor's prescription.

There is no evidence that this

medicine is addictive.

This medicine is not expected to

affect your ability to drive a car or

operate machinery, but make sure

you know how it affects you before

driving.

Use in children

Amoxycillin Suspension is a more

suitable form of amoxycillin than

capsules, for giving to children.

Before you take this

medicine

When you must not take it

Do not take this medicine if you

have had an allergic reaction to:

amoxycillin

other penicillins or

cephalosporins

any of the ingredients listed near

the end of this leaflet.

Symptoms of an allergic reaction

may include shortness of breath,

wheezing or difficulty breathing,

swelling of the face, lips, tongue or

other parts of the body, muscle pain

or tenderness or joint pain or rash,

itching or hives on the skin.

Do not take this medicine after the

expiry date (EXP) printed on the

pack.

If you take this medicine after the

expiry date has passed, it may not

work as well.

Do not take this medicine if the

packaging is torn or shows signs of

tampering or if it does not look

quite right.

If it has expired or is damaged, return

it to your pharmacist for disposal.

If you are not sure whether you

should start taking amoxycillin,

talk to your doctor or pharmacist.

Before you start to take it

Tell your doctor if:

1.

You are allergic to:

APO-AMOXYCILLIN CAPSULES

any other medicines

any other substances, such as

foods, preservatives or dyes

2.

You have ever had an allergic

reaction (such as a rash) to any

antibiotics in the past.

3.

You have or have had any

medical conditions, especially

the following:

glandular fever (mononucleosis)

blood disorders such as

leukaemia

liver or kidney problems

4.

You are pregnant or plan to

become pregnant or breast-

feed.

Your doctor can discuss with you

the risks and benefits involved.

Amoxycillin may be used during

pregnancy. It can pass to your

baby through breast milk.

5.

Your urine has to be tested for

sugar levels while taking

amoxycillin.

Amoxycillin will produce false

positive results when some of

these tests are used. Your doctor

will help you to identify the

correct test.

If you have not told your doctor

about any of the above, tell them

before you start taking

amoxycillin.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

buy without a prescription from

your pharmacy, supermarket or

health food shop.

Some medicines and amoxycillin

may interfere with each other. These

include:

medicines used to treat gout (e.g.

probenecid or allopurinol)

other antibiotics (e.g.

tetracyclines)

the contraceptive pill. As with

other antibiotics you may need to

use extra birth control methods

(e.g. condoms).

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 and pharmacist will

advise you. They will tell you if you

are taking any of these medicines.

They may also have more

information on medicines to be

careful with or avoid while taking

amoxycillin.

How to take this

medicine

Follow all directions from your

doctor or pharmacist carefully.

They may be different to the

information in this leaflet.

If you do not understand any

written instructions, ask your

doctor or pharmacist for help.

How much to take

Your doctor or pharmacist will tell

you how many capsules you will

need to take. This depends on your

condition and whether or not you are

taking any other medicines.

The usual adult dose is one capsule

(250 mg or 500 mg) three times a

day.

For some infections 3 grams of

amoxycillin (i.e. six 500 mg

capsules) can be taken by adults at

one time.

How to take it

Swallow amoxycillin capsules

whole with a glass of fluid.

When to take it

Take it at about the same time

each day.

Taking your medicine at the same

time each day will have the best

effect. It will also help you remember

when to take it.

Space the doses as evenly as

possible throughout the day.

For example, if you are taking

amoxycillin three times a day, take a

dose about every eight hours.

Amoxycillin can be taken with or

without food. The effects of

amoxycillin are not changed by food.

How long to take it for

Continue taking amoxycillin until

you finish the pack or until your

doctor says so.

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 return.

Make sure you have enough to last

over weekends and holidays.

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 medicine as you would

normally.

Do not take a double dose to make

up for the dose that you missed.

This may increase the chance of you

getting an unwanted side effect.

If you are not sure what to do, ask

your doctor or pharmacist.

If you have trouble remembering

to take your medicine, ask your

pharmacist for some hints.

If you take too much

(overdose)

Immediately telephone your doctor

or the Poisons Information Centre

(Tel: 13 11 26 for Australia) or go

to the Accident and Emergency

Department at the nearest hospital,

if you think that you or anyone else

may have taken too much

amoxycillin.

Do this even if there are no signs of

discomfort or poisoning.

APO-AMOXYCILLIN CAPSULES

You may need urgent medical

attention.

If you take too much amoxycillin,

you may feel sick or get diarrhoea.

While you are taking

this medicine

Things you must do

Tell your doctor if:

1.

The symptoms of your infection

do not improve within a few

days, or if they become worse.

2.

You develop itching with

swelling or skin rash or

difficulty breathing. Stop

taking this medicine and

contact your doctor

immediately.

3.

You get severe diarrhoea. Tell

your doctor, pharmacist or

nurse immediately. Do this even

if it occurs several weeks after

you stopped taking amoxycillin.

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.

4.

You get a sore white mouth or

tongue while taking or soon

after stopping amoxycillin, or 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.

5.

You are about to have any

blood tests.

6.

You become pregnant.

7.

You are about to start taking

any other new medicine.

Tell any other doctors, dentists,

and pharmacists who are treating

you that you are taking

amoxycillin.

Keep any appointments with your

doctor.

Your doctor may want to do tests to

make sure the medicine is working

and to prevent side effects.

Things you must not do

Do not stop taking your medicine

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 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

Be careful while driving or

operating machinery until you

know how amoxycillin affects you.

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 or tiredness in

some people.

Possible side effects

All medicines may have some

unwanted side effects. Sometimes

they are serious, but most of the time,

they are not. Your doctor has

weighed the risks of using this

medicine against the benefits they

expect it will have for you.

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

amoxycillin.

Ask your doctor or pharmacist to

answer any questions you may

have.

Following is a list of possible side

effects. Do not be alarmed by this

list. You may not experience any of

them.

Tell your doctor or pharmacist if

you notice any of the following and

they worry you:

oral thrush - white, furry, sore

tongue and mouth

vaginal thrush - sore and itchy

vagina and/or discharge

diarrhoea

nausea (feeling sick), indigestion

or vomiting

black or brown furry patches on

the tongue (rare)

The above list includes the more

common side effects. Mostly, these

are mild.

Tell your doctor as soon as possible

if you notice any of the following:

itching or any type of skin rash

unusual bleeding or bruising

yellowing of the skin or eyes

dark urine or pale stools

difficulty or pain on passing urine

severe diarrhoea.

feeling hyperactive or having

trouble concentrating.

These may be serious side effects.

You may need medical attention.

Most of these side effects are rare

If any of the following happen, stop

taking your medicine and either

tell your doctor immediately or go

to Accident and Emergency at

your nearest hospital:

allergic reaction including

fainting, swelling of limbs, face,

lips, mouth or throat which may

cause difficulty swallowing or

breathing.

APO-AMOXYCILLIN CAPSULES

This is a very serious side effect. You

may need urgent medical attention or

hospitalisation.

Tell your doctor immediately if

you notice any of the following side

effects, even if they occur several

weeks after you have stopped

taking amoxycillin:

severe abdominal cramps or

stomach cramps

watery and severe diarrhoea,

which may also be bloody

fever, in combination with one or

both of the above.

These are rare but serious side

effects. You may have a serious

condition affecting your bowel.

Therefore, you may need urgent

medical attention. However, this side

effect is rare.

Do not take any anti-diarrhoea

medicine without first checking

with your doctor.

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.

Ask your doctor or pharmacist if

you don't understand anything in

this list.

Storage and disposal

Storage

Keep amoxycillin in its original

packaging until it is time to take it.

If you take the capsules out of their

original packaging they may not keep

well.

Keep your medicine in a cool dry

place where the temperature will

stay below 25°C. Protect it from

moisture.

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 on hot days.

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.

Disposal

If your doctor or pharmacist tells

you to stop taking this medicine or

it has passed its expiry date, ask

your pharmacist what to do with

any medicine that is left over.

Where to go for further

information

Pharmaceutical companies are not in

a position to give people an

individual diagnosis or medical

advice. Your doctor or pharmacist is

the best person to give you advice on

the treatment of your condition.

Product description

What APO-Amoxycillin looks

like

APO-Amoxycillin capsules are

available in two strengths, each in

blister packs of 20 capsules:

250 mg yellow/yellow capsules,

with "RX 654" printed in black

500 mg maroon/yellow capsules

with "RX 655" printed in black

* Not all strengths, pack types and/or

pack sizes may be available.

Ingredients

Active Ingredient:

Each capsule contains either 250 mg

or 500 mg of amoxycillin (as

trihydrate).

They also contain the following

inactive ingredients:

magnesium stearate

microcrystalline cellulose

gelatin

sodium lauryl sulphate

colloidal anhydrous silica

croscarmellose sodium

titanium dioxide

iron oxide yellow

iron oxide red (500 mg only)

iron oxide black (500 mg only)

APO-Amoxycillin capsules do not

contain lactose, sucrose, gluten or

tartrazine.

Australian Registration

Numbers

APO-Amoxycillin 250 mg capsules

blister packs:

AUST R 208147

APO-Amoxycillin 500 mg capsules

blister packs:

AUST R 208144

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

APO and APOTEX are registered

trade marks of Apotex Inc.

This leaflet was last updated in:

July 2016

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Pest categorisation of Popillia japonica

Pest categorisation of Popillia japonica

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The Panel on Plant Health performed a pest categorisation of Popillia japonica(Coleoptera: Scarabaeidae) for the EU. P. japonica is a distinguishable species listed in Annex IAII of Council Directive 2000/29/EC. It is native to Japan but established in the USA in the early 20th century. It spreads from New Jersey to most US states east of the Mississippi, some to the west and north into Canada. P. japonica feeds on over 700 plant species. Adults attack folia...

Europe - EFSA - European Food Safety Authority Publications

7-8-2018

Voluntary Recall Notice of El Guapo Jamaica Hibiscus Flower Pouches Due to Unlabeled Peanut Allergen

Voluntary Recall Notice of El Guapo Jamaica Hibiscus Flower Pouches Due to Unlabeled Peanut Allergen

Mojave Foods Corporation is initiating a voluntary recall of four sizes of El Guapo Jamaica Hibiscus Flower packages in flexible packaging due to an unlabeled peanut allergen

FDA - U.S. Food and Drug Administration

9-6-2018

Caito Foods, LLC Voluntarily Recalls Fresh Cut Melon Products Because of Possible Health Risk

Caito Foods, LLC Voluntarily Recalls Fresh Cut Melon Products Because of Possible Health Risk

Caito Foods is voluntarily recalling fresh cut watermelon, honeydew melon, cantaloupe and fresh-cut mixed fruit containing one of these melons, produced at the Caito Foods facility in Indianapolis, because these products have the potential to be contaminated with Salmonella.

FDA - U.S. Food and Drug Administration

18-5-2018

Unauthorized prescription antibiotic drugs seized from Gigi's Market in Ottawa, ON, may pose serious health risks

Unauthorized prescription antibiotic drugs seized from Gigi's Market in Ottawa, ON, may pose serious health risks

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.

Health Canada

4-2-2019

Stalevo (Orion Corporation)

Stalevo (Orion Corporation)

Stalevo (Active substance: Levodopa,carbidopa,entacapone) - Centralised - Yearly update - Commission Decision (2019)847 of Mon, 04 Feb 2019

Europe -DG Health and Food Safety

29-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): atorvastatin (calcium trihydrate),Perindopril (arginine),indapamide, decision type: , therapeutic area: , PIP number: P/0333/2018

Opinion/decision on a Paediatric investigation plan (PIP): atorvastatin (calcium trihydrate),Perindopril (arginine),indapamide, decision type: , therapeutic area: , PIP number: P/0333/2018

Opinion/decision on a Paediatric investigation plan (PIP): atorvastatin (calcium trihydrate),Perindopril (arginine),indapamide, decision type: , therapeutic area: , PIP number: P/0333/2018

Europe - EMA - European Medicines Agency

18-12-2018

APO-Valsartan (valsartan) tablets

APO-Valsartan (valsartan) tablets

Recall - potential contamination

Therapeutic Goods Administration - Australia

10-7-2018

Corbilta (Orion Corporation)

Corbilta (Orion Corporation)

Corbilta (Active substance: levodopa / carbidopa / entacapone) - Centralised - Renewal - Commission Decision (2018)4468 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2785/R/15

Europe -DG Health and Food Safety