FLOPEN

Main information

  • Trade name:
  • FLOPEN flucloxacillin 250 mg (as sodium) capsule blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FLOPEN flucloxacillin 250 mg (as sodium) capsule blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 209367
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

209367

FLOPEN flucloxacillin 250mg (as sodium) capsule blister pack

ARTG entry for

Medicine Registered

Sponsor

Aspen Pharmacare Australia Pty Ltd

Postal Address

34-36 Chandos Street,ST LEONARDS, NSW, 2065

Australia

ARTG Start Date

14/06/2013

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. FLOPEN flucloxacillin 250 mg (as sodium) capsule blister pack

Product Type

Single Medicine Product

Effective date

15/09/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

For the treatment of confirmed or suspected staphylococcal and other Gram-positive coccal infections. Indications include pneumonia, osteomyelitis, skin

and soft tissue and wound infections, infected burns, cellulitis. Changes made as described in the letter of 30/4/1998 from Jason Borg

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Al/Al

18 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. Medicine Component

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Hard gelatin size 2 capsule - blue cap and body, both imprinted with F250

in white ink

Active Ingredients

Flucloxacillin

250 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 20.10.2017 at 11:01:24 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

FLOPEN

FLOPEN

®

Capsules

flucloxacillin

Consumer Medicine Information (CMI)

What is in this leaflet

This leaflet answers some common

questions about Flopen capsules.

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. Your doctor has weighed

the risks of you taking Flopen against

the benefits this medicine 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 medicine.

You may need to read it again.

What Flopen is used

for

Flopen contains flucloxacillin (as

flucloxacillin sodium) as the active

ingredient.

It is used to treat infections caused by

bacteria in different parts of the

body.

Flopen is an antibiotic that belongs to

a group of medicines called

penicillins. These antibiotics work

by killing the bacteria that are

causing your infection.

Flopen will not work against

infections caused by viruses, such as

colds.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

Your doctor may have prescribed

Flopen for another reason.

It is available only with a doctor's

prescription.

There is no evidence that it is

addictive.

Before you take it

When you must not be given

it

Do not take Flopen if:

your skin and/or eyes have

turned yellow (jaundice) whilst

or soon after taking this

medicine.

you have an allergy to

flucloxacillin, other penicillins

or any of the ingredients listed

at the end of this leaflet.

Some of the symptoms of an

allergic reaction may include

shortness of breath, wheezing or

difficulty in breathing; swelling

of the face, lips, tongue or any

other parts of the body; rash,

itching or hives on the skin.

you have had an allergic

reaction to cephalosporins.

You may have an increased

chance of being allergic to Flopen

if you are allergic to

cephalosporins.

Do not take Flopen after the expiry

date (EXP) printed on the pack.

Do not take it if the pack shows

signs of having been tampered

with.

Do not take this medicine to treat

any other complaints unless your

doctor has instructed you to do so.

Do not give this medicine to anyone

else.

Before you start to take it

Tell your doctor if you are allergic

to any other medicines or any

foods, dyes or preservatives.

Tell your doctor if you have or

have had any of the following

medical conditions:

jaundice, yellowing of the skin or

eyes

kidney or liver disease.

Do not take Flopen if you are

pregnant or plan to become

pregnant unless you and your

doctor have discussed the risks and

benefits involved.

Do not take it if you are breast

feeding or plan to breast feed.

If you have not told your doctor

about any of the above, tell them

before you start taking Flopen.

Taking other medicines

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.

Some medicines may interfere with

Flopen. These include probenecid

(e.g. Pro-Cid), a medicine commonly

used to treat gout. These medicines

may be affected by Flopen or may

affect how well it works. You may

need different amounts of your

medicine, or you may need to take

FLOPEN

different medicines. Your doctor or

pharmacist has more information on

medicines to be careful with or avoid

whilst taking Flopen.

Talk to your doctor about the need

for an additional method of

contraception whilst taking Flopen.

Some antibiotics may decrease the

effectiveness of some birth control

pills.

How to take it

How much to take

Your doctor will tell you how much

and how often you should take

Flopen capsules.

This will depend on the type of

infection. The dose varies from

patient to patient.

How to take it

Swallow the capsules whole with a

large glass of water.

When to take it

It is best taken a half to one hour

before meals. If you are too ill to eat,

take the medicine when it is due.

How long to take it

Continue taking Flopen for as long

as your doctor tells you.

Do not stop taking it because you

are feeling better.

It is important to complete the full

course prescribed by your doctor,

even if you begin to feel better after a

few days. If you do not, the bacteria

causing your infection may not clear

completely or your symptoms may

return.

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 Flopen as you would

normally.

Do not take a double dose to make

up for the dose that you missed.

If you are not sure what to do, talk

to your doctor or pharmacist.

If you have trouble remembering

when to take your medicine, ask

your pharmacist for some hints.

If you have too much

(overdose)

Immediately telephone your doctor

or the Poisons Information Centre

(telephone 13 11 26) for advice, or

go to Accident and Emergency at

your nearest hospital if you think

that you or anyone else may have

taken too much Flopen. Do this

even if there are no signs of

discomfort or poisoning.

You may need urgent medical

attention.

If you take too much Flopen, you

may get diarrhoea and nausea.

While you are taking it

Things you must do

Tell your doctor if the symptoms of

your infection do not improve

within a few days or if they become

worse.

If you develop itching with swelling

or skin rash or difficulty breathing

while you are taking Flopen, do not

take any more and contact your

doctor immediately.

Tell your doctor immediately if:

you develop yellow eyes or skin

(jaundice) whilst or soon after

taking Flopen.

you get severe diarrhoea. Do

this even if it occurs several

weeks after Flopen 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 diarrhoea

medicine without first checking

with your doctor.

Tell your doctor if:

you get a sore white mouth or

tongue.

you get a vaginal itching or

discharge.

This may mean you have a fungal

infection called thrush.

Sometimes the use of Flopen

allows fungi to grow and the

above symptoms to occur.

Flopen does not work against

fungi.

you become pregnant while you

are taking this medicine.

you have to have any blood

tests.

Flopen may affect the results of

some tests.

Tell any other doctor, dentist or

pharmacist who is treating you

that you are taking Flopen,

especially if you are being started

on any new medicines.

Things you must not do

Do not give Flopen to anyone else,

even if their symptoms seem

similar to yours.

Do not take Flopen to treat any

other complaints unless your

doctor tells you to.

Things to be careful of

As with any new medicine, you

should take care when driving or

operating machinery until you know

how Flopen affects you as it may

cause dizziness, drowsiness or

tiredness in some people.

Things to be aware of

Flopen can cause jaundice (yellowing

of skin and/or eyes) and severe liver

disease which may last for a long

time. This reaction is more frequent

in older patients, particularly those

over 55 years of age, and those who

take the drug for more than 14 days.

FLOPEN

Side Effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking Flopen.

This medicine helps most people

with infection but it may have

unwanted side effects in a few

people.

All medicines have side effects.

Sometimes they are serious, most of

the time they are not. You may need

medical attention if you get some of

the side effects.

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:

oral thrush - white, furry, sore

tongue and mouth

vaginal thrush - sore and itchy

vagina and/or discharge

a mild rash

vomiting or an upset stomach

nausea

diarrhoea.

Tell your doctor immediately or go

to Accident and Emergency at

your nearest hospital, if you notice

any of the following:

a severe rash

wheezing

irregular heart beat

feeling faint

jaundice, yellowing of the skin or

eyes.

Other side effects not listed above

may also occur in some people.

These include very rare conditions

such as blood, liver, and kidney

problems or fits.

After finishing Flopen

Tell your doctor if your skin

and/or eyes have turned yellow

(jaundice) whilst or soon after

taking Flopen.

Tell your doctor immediately if

you notice any of the following side

effects, even if they occur up to

several weeks after finishing

treatment with Flopen:

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. Flopen can change bacteria

(which are normally present in the

bowel and normally harmless) to

multiply and therefore cause the

above symptoms. You may need

urgent medical attention.

Do not take any diarrhoea

medicine without first checking

with your doctor.

Do not be alarmed by this list of

possible side effects. You may not

experience any of them.

Other side effects not listed above

may also occur in some people.

After taking it

Storage

Keep Flopen in a cool dry place

where the temperature stays below

25 degrees C.

Do not store it 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 the capsules in the pack until

it is time to take them.

If you take the capsules out of the

pack they may not stay in good

condition.

Keep it where children cannot

reach it.

A locked cupboard at least one-and-

a-half metres above ground is a good

place to store medicines.

Disposal

If your doctor tells you to stop

taking Flopen or you find that the

expiry date has passed, ask your

pharmacist what to do with any

Flopen that is left over.

Product description

What it looks like

Flopen 250 mg capsules are blue and

marked "F250" in white. It is

available in blister packs of 24

capsules.

Flopen 500 mg capsules are blue and

marked "F500" in white. It is

available in blister packs of 24

capsules.

Ingredients

Active ingredient:

Flopen capsules contain 250 mg or

500 mg flucloxacillin (as

flucloxacillin sodium).

Inactive ingredients:

250 mg capsules

magnesium stearate

titanium dioxide

erythrosine

brilliant blue FCF

sodium lauryl sulfate

Tekprint SW-0012 (white ink)

gelatin.

500 mg capsules

magnesium stearate

titanium dioxide

erythrosine

brillant blue FCF

sodium lauryl sulfate

Tekprint SW-0012 (white ink)

gelatin.

Flopen capsules do not contain

gluten, lactose or sucrose.

FLOPEN

Sponsor

Aspen Pharmacare Australia Pty Ltd

34-36 Chandos St

St Leonards NSW 2065

The Australian Registration Numbers

are:

250mg capsule: AUST R 209367

500mg capsule: AUST R 209368

This leaflet was revised in September

2017.