FLUCLOXACILLIN

Flucloxacillin, as the sodium salt

What is in this leaflet

This leaflet answers some common questions about FLUCLOXACILLIN. It does not
contain all the information available on this medicine. 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 using FLUCLOXACILLIN against the
benefits expected it will have for you. If you have concerns about using this
medicine ask your doctor or pharmacist.

Keep this leaflet. You may need to read it again.

What FLUCLOXACILLIN is used for and how it works

FLUCLOXACILLIN contains the active ingredient flucloxacillin. Flucloxacillin
is an antibiotic that belongs to a group of medicines called penicillins. These
medicines work by killing the bacteria that are causing infection.

FLUCLOXACILLIN is used to treat infections caused by bacteria. Examples of
some of the infections that may be caused by bacteria include respiratory tract
infections and skin or fleshy tissue skin infections.

FLUCLOXACILLIN will not work against infections caused by viruses, such as
colds or the flu.

Your doctor, however, may have prescribed FLUCLOXACILLIN for another reason.
Ask your doctor if you have any questions about why FLUCLOXACILLIN has been
prescribed for you.

There is no evidence that FLUCLOXACILLIN is addictive.

FLUCLOXACILLIN is available only with a doctor's prescription.

Before you take FLUCLOXACILLIN

WARNING: Flucloxacillin can cause severe liver damage, particularly in
older patients and those who take it for more than 14 days.

When you must not take FLUCLOXACILLIN:

Do not take FLUCLOXACILLIN if you are allergic to:

• medicines containing flucloxacillin or any other penicillin;
• cephalosporin antibiotics;
• beta-lactam antibiotics;
• any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include skin rash, itching
or hives, swelling of the face, lips, tongue or other parts of the body,
shortness of breath, wheezing or troubled breathing.

Do not take FLUCLOXACILLIN if you have had a reaction that has affected
your liver while you were taking a medicine containing flucloxacillin.

Examples of liver reactions include hepatitis and jaundice (yellowing of the
eyes or skin).

Do not take FLUCLOXACILLIN if the expiry date has passed.

Before you start to take it

Tell your doctor if you are allergic to any other medicines, foods, dyes
or preservatives.

Tell your doctor if you are pregnant or plan to become pregnant.
Your doctor will discuss the risks and benefits of taking FLUCLOXACILLIN during
pregnancy.

Tell your doctor if you are breastfeeding or wish to breastfeed. A
very small quantity of FLUCLOXACILLIN passes into breast milk. Your doctor will
discuss the risks and benefits of taking FLUCLOXACILLIN when breastfeeding.

Tell your doctor if you have any medical conditions, especially the
following:

• liver problems;
• kidney problems;
• asthma, hay fever, eczema or other allergic conditions.

If you have not told your doctor about any of the above, tell them before you
start taking FLUCLOXACILLIN.

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 by FLUCLOXACILLIN, or may affect how well it
works. Your doctor or pharmacist can tell you what to do if you are taking
FLUCLOXACILLIN with other medicines. In particular tell your doctor or
pharmacist if you are taking probenecid, a medicine commonly used to treat gout.

Some antibiotics may decrease the effectiveness of some birth control pills,
although this has not been shown with FLUCLOXACILLIN. Talk to your doctor about
the need for additional contraception while taking FLUCLOXACILLIN.

Your doctor and pharmacist have more information on medicines to be careful
with or avoid while taking FLUCLOXACILLIN.

How to take FLUCLOXACILLIN properly

How much to take

Your doctor will tell you how much you need to take each day and when to take
it. This depends on your condition and whether or not you are taking any other
medicines.

For most infections, the usual adult dose is 250 mg to 500 mg every 8 hours,
however, this will depend on the severity of the infection.

Follow all directions given to you by your doctor carefully.

How to take FLUCLOXACILLIN

Swallow the capsules whole with a glass of water.

Take FLUCLOXACILLIN on an empty stomach, for example, half to one hour
before meals or just before you go to bed. Food can interfere with the
absorption of FLUCLOXACILLIN.

If you forget to take FLUCLOXACILLIN

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, and then go back to
taking your capsules 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 for advice.

How long to take FLUCLOXACILLIN for

Keep taking FLUCLOXACILLIN until you finish the pack, or for as long as
your doctor recommends.

Do not stop taking FLUCLOXACILLIN, even if you feel better after a few
days, unless advised by your doctor. Your infection may not clear completely
if you stop taking your medicine too soon.

While you are taking FLUCLOXACILLIN

Things you must do

Before starting any new medicine, tell your doctor or pharmacist that you
are taking FLUCLOXACILLIN.

Tell all the doctors, dentists and pharmacists who are treating you that
you are taking FLUCLOXACILLIN.

If your symptoms do not improve within a few days, or if they become worse,
tell your doctor.

If you develop jaundice (yellowing of the eyes or skin), tell your doctor
immediately. Do this even if it occurs several weeks after you have stopped
taking FLUCLOXACILLIN. Jaundice may mean that you have a serious condition
affecting your liver. You may need urgent medical care.

If you get severe diarrhoea, tell your doctor or pharmacist immediately.
Do this even if it occurs several weeks after you have stopped taking
FLUCLOXACILLIN. 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.

If you get a sore, white mouth or tongue while taking or soon after
stopping FLUCLOXACILLIN, 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 FLUCLOXACILLIN allows fungi to grow and the
above symptoms to occur. FLUCLOXACILLIN does not work against fungi.

If you are taking FLUCLOXACILLIN for a long time, visit your doctor regularly
so that they can check on your progress.

You may need to have tests to check your liver.

Things you must not do

Do not use FLUCLOXACILLIN to treat any other conditions unless your doctor
tells you to.

Do not give FLUCLOXACILLIN to anyone else, even if they have the same
condition as you.

Side effects

IMPORTANT: Flucloxacillin can cause severe liver damage, which can make
the skin and whites of the eyes turn yellow in colour. This is more likely to
occur in older patients and those who take it for more than 14 days. Immediately
contact your doctor if you notice any yellowing of your eyes or skin.

Tell your doctor or pharmacist as soon as possible if you do not feel well
while you are taking FLUCLOXACILLIN.

FLUCLOXACILLIN treats infections in most people however; it may cause side
effects in some people.

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.

Ask your doctor or pharmacist to answer any questions you may have.

While you are taking FLUCLOXACILLIN

Tell your doctor if you notice any of the following and they worry you:

• feeling sick or vomiting;
• stomach upset, diarrhoea;
• oral thrush (white, furry sore tongue and mouth);
• vaginal thrush (sore and itchy vagina, vaginal discharge).

These are the more common side effects of FLUCLOXACILLIN. Mostly these are
mild and short-lived.

Tell your doctor immediately or go to Accident and Emergency at the
nearest hospital if you notice any of the following:

• watery and severe diarrhoea, which may also be bloody;
• severe stomach cramps;
• tiredness, headaches, being short of breath when exercising, dizziness and
  looking pale;
• bleeding or bruising more easily than normal;
• frequent infections such as fever, chills, sore throat or mouth ulcers;
• yellowing of the eyes or skin (jaundice);
• painful, swollen joints;
• aching muscles, muscle tenderness or weakness, not caused by exercise;
• dark or cloudy urine, blood in the urine.

These may be serious side effects of FLUCLOXACILLIN. You may need urgent
medical attention. These serious side effects are very rare.

If any of the following happen, stop taking FLUCLOXACILLIN and tell your
doctor immediately, or go to Accident and Emergency at the nearest hospital:

• skin rash, itching or hives;
• swelling of the face, lips, tongue or other parts of the body;
• shortness of breath, wheezing or troubled breathing.

If you experience any of these side effects, you may have had a serious
allergic reaction to FLUCLOXACILLIN. You may need urgent medical attention or
hospitalisation. These side effects are very rare.

After you have finished taking FLUCLOXACILLIN

Tell your doctor immediately if you notice any of the following, even if
they occur several weeks after stopping treatment with FLUCLOXACILLIN:

• watery and severe diarrhoea, which may also be bloody;
• severe stomach cramps;
• yellowing of the eyes or skin (jaundice).

Other side effects not listed above may also occur in some patients.

Tell your doctor if you notice anything that is making you feel unwell.

Do not be alarmed by this list of possible side effects. You may not
experience any of them.

In case of overdose

You should only take the number of tablets that you have been told.

Immediately contact your doctor or the National Poisons Information Centre
(0800 POISON or 0800 764 766) or go to the Emergency department at your nearest
hospital, if you think that you may have taken too much, or if anyone else has
taken any FLUCLOXACILLIN by mistake. Do this even if there are no signs of
discomfort or poisoning. You may need urgent medical attention. Take the
container of FLUCLOXACILLIN with you if you can.

Keep telephone numbers for these places handy.

Storage conditions

Keep FLUCLOXACILLIN where children cannot reach it. A locked cupboard
at least one-and-a-half metres above the ground are a good place to store
medicines.

Keep FLUCLOXACILLIN tablets in a cool, dry place where the temperature
stays below 25 °C.

Keep FLUCLOXACILLIN mixture in the refrigerator but not in the freezer.

Do not use any mixture left in the bottle after 10 days.

Do not store FLUCLOXACILLIN or any other medicine in the bathroom or near
a sink.

Do not leave FLUCLOXACILLIN in the car or on windowsills. Heat and
dampness can destroy some medicines.

If your doctor tells you to stop taking FLUCLOXACILLIN, or your medicine has
passed its expiry date, ask your pharmacist what to do with any that is left
over.

Product Description

What it looks like

FLUCLOXACILLIN is available in capsules or as syrup.

FLUCLOXACILLIN capsules come in two strengths: FLUCLOXACILLIN 250 mg and
FLUCLOXACILLIN 500 mg. Both are grey/caramel coloured.

FLUCLOXACILLIN syrup is red coloured solution.

Ingredients

The active ingredient in FLUCLOXACILLIN tablets and syrup is flucloxacillin
(as flucloxacillin sodium).

Each FLUCLOXACILLIN 250 capsule contains 250 mg of flucloxacillin as the
sodium salt.

Each FLUCLOXACILLIN 500 capsule contains 500 mg of flucloxacillin as the sodium
salt.

The capsules also contain the following inactive ingredients (excipients):

• Silicon dioxide
• Magnesium stearate.

The capsules are gluten and lactose free.

Each 5 ml of reconstituted FLUCLOXACILLIN Syrup 125 mg/5 ml solution contains
125 mg flucloxacillin as the sodium salt.

Each 5 ml of reconstituted FLUCLOXACILLIN Syrup 250 mg/5 ml solution contains
250 mg flucloxacillin as the sodium salt.

The syrup also contains the following inactive ingredients (excipients):

• Disodium edentate;
• Sodium citrate dehydrate;
• Sucrose;
• Ammonium glycyrrhizinate;
• Saccharin sodium;
• Sodium benzoate;
• Pineapple flavour;
• Menthol flavour and
• FD&C Red.