PATIENT
INFORMATION LEAFLET
FLUCONAZOLE CAPSULES
Read
all of this leaflet carefully before you start
taking this medicine
Keep
this leaflet, you may want to read it again. If you
have further questions, please ask your doctor or
pharmacist. This medicine has been prescribed for
you personally and you should not pass it on to
others. It may harm them, even if their symptoms are
the same as yours.
The name
of this medicine is Fluconazole Capsules. The active
ingredient is fluconazole.
What is
in your medicine?
Fluconazole
Capsules come in 4 different strengths:
- Each
yellow capsule contains 50 mg fluconazole
- Each
white/yellow capsule contains 100 mg fluconazole
- Each
green capsule contains 150 mg fluconazole?
- Each
green/white capsule contains 200 mg fluconazole
The
colouring agents used in the capsule shell are:
- 50mg
and 100mg capsules: titanium dioxide (E171) and
quinoline yellow (E104)
-
150mg and 200mg capsules: titanium dioxide (E171),
quinoline yellow (E104) and indigo carmine (E132)
Other
ingredients (all capsule strengths): lactose,
pregelatinised starch, colloidal hydrated silica, sodium
lauryl sulphate and magnesium stearate, gelatin (capsule
shell only).
50mg, 100mg
and 200mg capsule strengths come in packs of 100 and 7
capsules.
150mg
capsules are provided in packs of 100 and in single
packs, containing 1 capsule.
What
type of medicine is Fluconazole?
Fluconazole
is one of a group of medicines called anti-fungal
agents.
What is
your medicine for?
Fluconazole
capsules are used to treat infections caused by
fungi/yeasts. Fluconazole may also be used to stop you
from getting a fungal infection. The most common cause
of fungal infections is a yeast called
Candida.
You may be
given this medicine by your doctor to treat fungal
infections such as:
-
thrush of the mouth or throat (mucosal infections).
Thrush is commonly caused by
Candida
- skin
infections - e.g. athlete's foot, ringworm
-
internal fungal infections caused by
Candida - e.g.
infections of the bloodstream, urinary tract or
other body organs
-
internal fungal infections caused by
Cryptococcus e.g.
cryptococcal meningitis and infections of other
sites such as the lungs and skin.
-
genital Candida
infections, e.g. vaginal thrush or candidal
balanitis (inflammation of the end of the penis
and/or foreskin)
You may also
be given fluconazole to:
- stop
you from getting a fungal infection (if your immune
system is not working properly) or after
chemotherapy/radiotherapy.
- stop
an infection caused by
Cryptococcus from coming back (in AIDS
patients).
Before
you take Fluconazole Capsules.
If the
answer is YES to any of these
questions - tell your doctor immediately.
- Are
you pregnant or trying to become pregnant?
- Are
you breast-feeding?
- Do
you have liver or kidney problems?
- Have
you ever had an allergic reaction to any of the
ingredients of Fluconazole Capsules, or other
medicines which you may have taken to treat a fungal
infection? This may have been itching, reddening of
the skin or difficulty in breathing.
- Are
you taking either terfenadine (an antihistamine) or
cisapride (used for stomach upsets)?
Inform your
doctor if you are taking any of the following medicines:
-
warfarin or coumarin drugs (to prevent blood clots)
-
benzodiazepines such as midazolam (a sedative drug
to calm you down)
- oral
sulphonylureas such as chlorpropamide, glibenclamide,
glipizide or tolbutamide (to control diabetes)
-
diuretics, such as hydrochlorothiazide, used to
treat fluid retention and high blood pressure
-
phenytoin (used to control epilepsy)
-
rifampicin or rifabutin (antibiotics)
-
cyclosporin or tacrolimus (used to affect the immune
response)
-
theophylline (used to control asthma)
-
astemizole (an antihistamine)
-
zidovudine, also known as AZT (used in HIV-infected
patients)
Tell your
doctor of any medicines you are taking including those
that were not prescribed for you that you may have
bought.
Driving and using machines
Treatment with fluconazole is unlikely to effect
your ability to drive or operate machinery.
How to
take your medicine
Fluconazole
Capsules should only be taken by mouth.
The usual
doses of this medicine for different infections are
below. Check with your doctor if you are not sure why
you have been prescribed Fluconazole Capsules.
ADULTS
-
Mucosal infections of mouth: 50-100mg once daily
for 7-14 days
-
Mucosal infections of throat or elsewhere:
50-100mg once daily for 14-30 days
-
Fungal skin infections: 50mg once daily for 2-4
weeks. Athletes foot may need up to 6 weeks
treatment
-
Internal fungal infections caused by
Candida: 400mg on
the first day then 200-400mg once daily
-
Internal fungal infections caused by
Cryptococcus: 400mg
on the first day then 200-400mg once daily for
6-8 weeks
-
To stop you from getting a fungal infection:
50-400mg once daily while you are at risk of
getting an infection
-
To prevent a cryptococcal infection from coming
back: 100-200mg once daily indefinitely
-
To treat genital Candida
infection: 150mg as a single dose.
Children
Children
should never be given more than a maximum daily dose
of 400mg.
-
4 weeks to 15 years old
-
mucosal infections: 3mg/kg once daily
-
internal fungal infections caused by
Candida or
Cryptococcus:
6-12mg/kg once daily
-
prevention of fungal infections: 3-12mg/kg once
daily while at risk of getting an infection
-
-
2-4 weeks old
-
Same dose as above but given once every 2 days.
The maximum dose is 12mg/kg every 48 hours
-
-
Less than 2 weeks old
-
Same dose as above but given once every 3 days..
The maximum dose is 12mg/kg every 72 hours
Use of
Fluconazole for treating genital
Candida infections in
children under 16 years old is not recommended.
Elderly
The
usual adult dose should be given unless you have
kidney problems.
Patients with kidney problems
Your
doctor may modify your dose, depending on your
kidney function.
Doctors
sometimes prescribe different doses to these. The
label on the pack will tell you what dose you or
your child should take. If you are still not sure,
ask your doctor or pharmacist.
How
to take your medicine
Swallow
your capsules whole with a glass of water.
It is
best to take your capsules at about the same time
each day.
You may
take your medicine with or without a meal.
What
if you take too many capsules?
Taking
too many capsules at once may make you unwell.
Contact your doctor or your nearest hospital
casualty department immediately.
What
if you miss a capsule?
Do not
worry. Take your next dose at the right time. Do not
take a double dose to make up for a forgotten dose.
Does
this medicine cause side effects?
Like all
medicines, fluconazole may cause some side-effects. The
most common side effects are:
-
nausea
-
stomach discomfort
-
diarrhoea
-
vomiting
- rash
-
headache
These side
effects are usually mild. If they cause you discomfort
or are long lasting, check with your doctor or
pharmacist.
The
following effects have occurred in patients taking
fluconazole but the relationship to treatment with
fluconazole is not clear.
-
seizure
-
abnormalities in blood/liver function/urine and
other biochemical tests
-
liver toxicity
-
severe skin reactions
- hair
loss
Rare side effects
A few people
develop allergic reactions to medicines. If any of the
following happen, tell your doctor
immediately or go to the casualty department at
your nearest hospital:
-
sudden wheeziness, difficulty in breathing or
tightness in chest
-
swelling of eyelids, face or lips
- skin
lumps or red itchy spots
- itch
all over body
AIDS
patients should be warned that they are likely to be
prone to skin reactions to many drugs, including
fluconazole.
If you
notice any side effects not mentioned in this leaflet,
please inform your doctor or pharmacist.
Storing
Fluconazole Capsules
- Keep
all medicines out of the reach and sight of children
-
There are no special storage instructions
- Do
not use Fluconazole Capsules after the expiry date
on the carton.
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