FLOXAPEN CAPSULES 500MG

Active substance: FLUCLOXACILLIN

View full screen / Print PDF » Download PDF ⇩

Transcript
Floxapen® 250mg and 500mg capsules
(flucloxacillin)
Read all of this leaflet carefully before you start
taking this medicine.
• Keep this leaflet. You may need to read it again.
•  If you have any further questions, ask your doctor

or pharmacist.
•   his medicine has been prescribed for you. Do not
T
pass it on to others. It may harm them, even if their
symptoms are the same as yours.

Index
1  hat Floxapen capsules are and what they
W
are used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further information
1  hat Floxapen capsules are and what they
W
are 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”.
Floxapen capsules are used to treat:
• chest infections
• throat or nose infections
• ear infections
• skin and soft tissue infections
• heart infections
• bones and joints infections
• meningitis
• digestive system infections
• blood infections
•  idney, bladder or urethra (the tube which carries urine
k
from the bladder) infections.
Floxapen capsules can also be used to prevent infections
during major surgery, particularly heart or orthopaedic
surgery.

2 Before you take
Do not take Floxapen capsules and tell your
doctor if you:

• are allergic (hypersensitive) to flucloxacillin, penicillin,

any other antibiotic or any of the other ingredients (see
section 6)
•  ave ever had liver problems after taking
h
flucloxacillin.
Continued top of next column
AAAE8602

Check with your doctor or pharmacist before
taking Floxapen capsules if you:
• have liver or kidney problems
• have any serious illness, other than this infection
• are on a low sodium diet
• are 50 years old or over.

Taking other medicines

Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription. Especially:
• probenecid (to treat gout)
•  ontraceptive pill (you will need to use extra
c
contraceptive precautions such as a condom)
• other antibiotics (used to treat infections)

Pregnancy and breast feeding

If you are pregnant, planning to become pregnant or are
breast feeding ask your doctor or pharmacist for advice
before taking this medicine.

Tests

Regular monitoring of liver and kidney function should
be performed whilst taking Floxapen capsules.
Tell your doctor that you are taking Floxapen if you are
having urine tests or blood tests because Floxapen may
affect the results.

Sodium content

Each 250mg capsule contains 13mg of sodium and each
500mg capsule contain 25mg of sodium.

3 How to take
Always take Floxapen capsules exactly as your doctor has
told you. If you are not sure, check with your doctor or
pharmacist.
Swallow the capsules whole with water, do not chew
them, half to one hour before meals. Never take more
than the recommended dose each day.
Doses:
•  dults - one 250mg capsule four times a day, your
A
doctor may prescribe a different dose for severe
infections.
•  oint infections (osteomyelitis) or heart infections
J
(endocarditis) - up to 8g daily in divided doses, six to
eight hourly.
•  o prevent infection due to surgery - 1 to 2g by injection
T
into a vein, at the same time as the anaesthetic, followed
by 500mg six hourly either by mouth or injection into a
vein or muscle for up to 72 hours.
• Children aged 2-10 years - half the adult dose.
Continued over page

• Children under 2 years - quarter the adult dose.
•  remature or babies less than 4 weeks old – Not
P
recommended.
•  evere kidney disease - your doctor may reduce your
S
dose.
If you still feel unwell after finishing the treatment, speak
to your doctor.

If you take more than you should

If you (or someone else) swallow a lot of capsules at the
same time, or you think a child may have swallowed any
contact your nearest hospital casualty department or
tell your doctor immediately. Symptoms of an overdose
include feeling or being sick and diarrhoea.

If you forget to take the capsules

Do not take a double dose to make up for a forgotten
dose. If you forget to take a dose take it as soon as you
remember it and carry on as before, try to wait about four
hours before taking the next dose.

If you stop taking the capsules

Do not stop treatment early because some bacteria may
survive and cause the infection to come back.

4 Possible side effects
Like all medicines, Floxapen capsules can cause side
effects, although not everybody gets them. Please
tell your doctor or pharmacist if you notice any of the
following effects or any effects not listed.

Stop taking Floxapen capsules and contact
your doctor at once if you experience any of the
following:

•  ypersensitivity or severe allergic reaction including
h
itchy rash, itching, sore mouth or eyes, swelling of the
face, lips, throat or tongue or breathing problems.
• severe bloody diarrhoea (pseudomembranous colitis).
Tell your doctor if you notice any of the following side
effects or notice any other effects not listed:
Common (occurs in less than 1 in 10 users): minor
stomach disturbances e.g. stomach upset or diarrhoea.
Very rare (occurs in less than 1 in 10,000 users):
inflammation of the kidney or liver, jaundice (skin or the
white of your eyes turning yellow), changes in numbers
of blood cells (causing unexplained bleeding, bruising
or skin discolouration), anaemia, skin rash with circular,
red patches (Erythema multiforme), severe skin rash
with flushing, fever, blisters or ulcers (Stevens-Johnson
syndrome) or a severe rash with reddening, peeling
and swelling of the skin that resembles burns (toxic
epidermal necrolysis). Joint or muscle pain or fever, may
develop after 2 days or more from the start of treatment
with Floxapen capsules.
Some of these reactions can be delayed for up to two
months after finishing the treatment.

Continued top of next column
AAAE8602

5 How to store
Keep out of the sight and reach of children.
Store in a dry place in the original package.
Do not use Floxapen capsules after the expiry date stated
on the label/carton/bottle. The expiry date refers to the
last day of that month.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help
to protect the environment.

6 Further information
What Floxapen capsules contain

• The active substance (the ingredient that makes the
capsules work) is flucloxacillin. Each capsule contains
either 250mg or 500mg of the active ingredient.
• The capsule also contains: magnesium stearate.
• The capsule shell contains: gelatin, titanium dioxide
(E171), black iron oxide (E172), yellow iron oxide (E172),
red iron oxide (E172).
• The printing ink contains: shellac (E904), propylene
glycol (E1520), sodium hydroxide (E524), povidone,
titanium dioxide (E171)

What Floxapen capsules look like and contents
of the pack
Floxapen are caramel hard gelatin capsules (body) fitted
with black caps.
is printed on the black cap.
The 250mg capsule has ‘250’ on the body and the
500mg capsule has ‘500’ on the body.
Pack sizes of 28
Marketing Authorisation Holder
Actavis Group PTC ehf, Reykjavíkurvegi 76-78,
220 Hafnarfjordur, Iceland
Manufacturer
Actavis B.V.,Baarnse Dijk 1, 3741 LN BAARN,
The Netherlands
Actavis Group PTC ehf, Reykjavíkurvegur 76-78,
220 Hafnarfjordur, Iceland
This leaflet was last revised in July 2014
Floxapen is a registered trademark of the Actavis Group
PTC ehf of Companies

Actavis, Barnstaple, EX32 8NS, UK

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
(web1)