FLUCLOXACILLIN 125MG/5ML ORAL SOLUTION

Active substance: FLUCLOXACILLIN SODIUM

View full screen / Print PDF » Download PDF ⇩

Transcript
Package leaflet: Information for the patient

FLUCLOXACILLIN 125MG/5ML ORAL SOLUTION
Flucloxacillin
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
•  eep this leaflet. You may need to read it again.
K
• f you have any further questions, ask your
I
doctor or pharmacist.
•  his medicine has been prescribed for you only.
T
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as
yours.
• f you get any side effects, talk to your doctor
I
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.

What is in this leaflet?
1 
What your medicine is and what it is
used for
2 
What you need to know before you
take your medicine
3 
How to take your medicine
4 
Possible side effects
5 
How to store your medicine
6 
Contents of pack and other
information
1  hat your medicine is and what it is
W

used for

Flucloxacillin is an antibiotic used to treat infections
by killing the bacteria that can cause them. It
belongs to a group of antibiotics called “penicillins”.
Flucloxacillin is used to treat:
• chest infections • throat or nose infections
• ear infections
•  kin and soft tissue
s
infections
• heart infections • bone and joint infections
• meningitis
• digestive system infections
• blood infections
•  idney, bladder or urethra (the tube which carries
k
urine from the bladder) infections.
Flucloxacillin can also be used to prevent infections
during major surgery, particularly heart or
orthopaedic surgery.

2  hat you need to know before you
W

take your medicine
Do not take this medicine if:

•  ou are allergic to flucloxacillin or any other
Y
penicillin antibiotics (see symptoms in section 4).
•  ou are allergic to any of the other ingredients of
Y
this medicine (listed in section 6).
•  ou have suffered previously from liver problems
Y
(e.g. jaundice) after taking flucloxacillin.

Warnings and precautions

Talk to your doctor or pharmacist before taking this
medicine if:
•  ou suffer from kidney problems, as you may
Y
require a lower dose than normal
•  ou suffer from liver problems, as this medicine
Y
could cause them to worsen

•  ou are 50 years of age or older
Y
•  ou have other serious illnesses (apart from the
Y
infection this medicine is treating)
•  ou are taking this medicine for a long time
Y
as regular tests of liver and kidney function is
advised

Other medicines and Flucloxacillin Oral
Solution

Check with your doctor or pharmacist before taking
this medicine if you are taking any other medicines,
especially:
•  robenecid or sulfinpyrazone (used to treat gout).
P
•  ethotrexate (a chemotherapy drug)
M
•  he contraceptive pill as antibiotics can make
T
these less effective (you will need to use extra
precautions such as condoms while taking
flucloxacillin and for a full 7 days after you finish
taking it).
•  ral typhoid vaccine (antibiotics can make this
O
less effective)
•  uggamadex (used with general anaesthetics)
S
•  iperacillin (an antibiotic taken by injection)
P
•  arfarin (medicine to prevent blood clotting)
W
Some medicines may affect the way others work.
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
This means medicines you have bought yourself as
well as medicines on prescription from a doctor.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby ask your
doctor or pharmacist for advice before taking this
medicine.

Tests

Regular monitoring of liver and kidney function
should be performed whilst taking flucloxacillin for
a long period of time. Tell your doctor that you are
taking Flucloxacillin if you are having urine tests or
blood tests because it may affect the results.

Your medicine contains sucrose and
sodium

This medicine contains up to 3.09g of sucrose
(sugar) per 5ml dose. Check with your doctor before
taking this medicine if you are a diabetic. Do not use
this medicine if you have been told by your doctor
that you have an intolerance to some sugars.
This medicine contains 18.05mg sodium per 5ml
dose. To be taken into consideration by patients on
a sodium controlled diet.

3 
How to take your medicine

Always take this medicine exactly as your doctor
or pharmacist has told you. Their directions may
differ from the information contained in this leaflet.
The pharmacist’s label should tell you how much
to take and how often. Check with your doctor or
pharmacist if you are not sure.
Take your medicine on an empty stomach, at least
thirty minutes to one hour before meals/food. It is
important that you take your medicine at the right
times.
The dose will depend on the patient and will be
decided by your doctor. However, the usual doses
for each age group are:

Continued over page

Continued top of next column
AAAG9211

Flucloxacillin 125mg/5ml Oral Solution 100ml PIL - UK
item no: AAAG9211

dimensions: 148x280

print proof no: 2

pharmacode:

origination date: 05.06.14

min pt size: 7pt

1. Black
2.
3.
4.
5.
6.

originated by: DR
approved for print/date

colours/plates:

revision date: 11.06.14

Technical Approval

revised by: DR

date sent: 05.06.14

supplier: Athlone Labs

technically app. date:

Non Printing Colours
1.
2.
3.

Adults (including the elderly)

•  he usual dose is 250mg four times a day
T
•  one or heart infection:
B
U
 p to 8g daily, in divided doses at six to eight
hours apart.
•  urgical prophylaxis:
S
 to 2g IV at induction of anaesthesia followed by
1
500mg every six hours for up to 72 hours.

Use in children

Children (10-18 years of age):  50mg four times
2
daily
Children (2-10 years of age):  25mg four times
1
daily
Children under 2 years of age:  2.5mg four times
6
daily

Patients with kidney problems

If you suffer from severe kidney failure your doctor
will give you lower or fewer doses.

How long to take your medicine for:

Keep taking your medicine until your doctor tells
you to stop. Do not stop taking it just because you
feel better. If you stop taking the medicine, your
infection may return or get worse. If you are still
unwell after taking all the medicine, go and see your
doctor.

If you take more of your medicine than you
should
If you (or somebody else) takes too much of your
medicine, speak to your doctor or pharmacist
immediately.

If you forget to take your medicine

If you forget to take a dose, take it as soon as you
remember, then carry on as before. Do not take a
double dose to make up for a forgotten dose.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4  ossible side effects
P


Like all medicines, this medicine may cause side
effects, although not everybody gets them. If they
occur, they are likely to be temporary, and not
serious. However, some may be serious and need
medical attention.
STOP taking flucloxacillin and contact your
doctor if you experience:
•  llergy or hypersensitivity including itchy rash,
a
itching, sore mouth or eyes, swelling of the face,
lips, throat or tongue or breathing problems.
•  evere, bloody diarrhoea
s
• aundice (yellow colour in the skin and whites
j
of the eyes), hepatitis (liver inflammation) sometimes these effects on the liver can be
delayed for up to 2 months after finishing
treatment.
•  evere skin rash with flushing, fever, blisters or
s
ulcers (Stevens Johnson syndrome) or a severe
rash with reddening, peeling and swelling of
the skin that looks like a burn (toxic epidermal
necrolysis).

Tell your doctor if you notice any of the
following effects:
Common (may affect up to 1 in 10 people):
•  iarrhoea, stomach upset and feeling sick D
Should be mild and wear off after a few days. If
severe or lasting longer, tell your doctor.

•  kin rash with circular red patches (Erythema
s
Multiforme).
• oint or muscle pains or fever (may develop 2 days
j
after starting treatment).
Check with your doctor if you have any problems
while taking this medicine, even if you think the
problems are not connected with the medicine, or
are not listed in this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the yellow card scheme at
www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on
the safety of this medicine.

5 
How to store your medicine

Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
shown on the label.
Dry powder: Store in a dry place below 25°C. Protect
from light.
Do not open the foil pouch until ready to
reconstitute the product. Once opened the foil may
be discarded.
Reconstituted mixture: Store for 7 days at 2°C-8°C in
a refrigerator.
Once reconstituted (mixed) by the pharmacist, this
medicine must be used within 7 days.
Return any left-over medicine to the pharmacist.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

6  ontents of pack and other
C

information

What Flucloxacillin Oral Solution contains

The active substance is flucloxacillin as flucloxacillin
sodium
The other ingredients are sodium benzoate
(E211), disodium edetate, saccharin sodium,
monoammonium-glycyrrhizinate, sodium citrate,
flavour pineapple, flavour menthol, RED FD&C No. 3
(E127) and sucrose.
Please refer to information on sucrose in section 2.

What Flucloxacillin Oral Solution looks like
and contents of the pack

Unconstituted powder: a pink granular powder with
a characteristic odour of pineapple.
Reconstituted solution: a pink coloured solution
with a characteristic flavour and odour of pineapple.
Flucloxacillin Solution is available in a size of 100ml
on reconstitution.
Marketing Authorisation Holder
Athlone Pharmaceuticals Limited, Ballymurray,
Co. Roscommon, Ireland
Manufacturer
Athlone Laboratories Limited, Ballymurray,
Co. Roscommon, Ireland.
Distributed by:
Actavis, Barnstaple, EX32 8NS, UK
PL30464/0167
This leaflet was last revised in April 2014.

Very rare (may affect up to 1 in 10,000 people):
•  ifficulty passing water or blood in the urine (may
d
be a sign of inflammation of the kidney)
•  nusual bleeding or bruising, anaemia (may be
u
caused by changes in the numbers of blood cells)

Continued top of next column
AAAG9211

Actavis, Barnstaple, EX32 8NS, UK

Flucloxacillin 125mg/5ml Oral Solution 100ml PIL - UK
item no: AAAG9211

dimensions: 148x280

print proof no: 2

pharmacode:

origination date: 05.06.14

min pt size: 7pt

1. Black
2.
3.
4.
5.
6.

originated by: DR
approved for print/date

colours/plates:

revision date: 11.06.14

Technical Approval

revised by: DR

date sent: 05.06.14

supplier: Athlone Labs

technically app. date:

Non Printing Colours
1.
2.
3.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web4)