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FLUCONAZOLE 50 MG CAPSULES

Active substance: FLUCONAZOLE

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TEVA UK Ref:

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PL 00289/0399 and 0402

PACKAGE LEAFLET: INFORMATION
FOR THE USER

IN THIS LEAFLET:

HOW TO STORE FLUCONAZOLE

Do not store above 30°C. Do not transfer the
capsules to another container.
Do not use Fluconazole after the expiry date
that is stated on the outer packaging. 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.

FURTHER INFORMATION

What Fluconazole capsules contain:
• The active ingredient is fluconazole 50 mg
or 200 mg.
• The other ingredients are lactose
monohydrate, maize starch, colloidal
anhydrous silica, sodium laurilsulfate and
magnesium stearate. The capsule shell
contains gelatin and the following colours:
• 50 mg capsules: titanium dioxide (E171)
and brilliant blue (E133)
• 200 mg capsules: titanium dioxide
(E171), azorubine (E122) and brilliant
blue (E133).
What Fluconazole capsules look like and
contents of the pack:
• Fluconazole 50 mg are hard gelatin
capsules filled with white to yellowish
white homogeneous powder, with a light
blue opaque cap and white opaque body.
• Fluconazole 200 mg are hard gelatin
capsules filled with white to yellowish
white homogeneous powder, with a purple
opaque cap and white opaque body.
• The 50 and 200 mg capsules are available
in pack sizes of 7, 10, 20, 30, 50, and 100
capsules.
Not all pack sizes may be marketed.

62020-Y
320 x 323

by Candida (if your immune system is
weak and not working properly)
• stop cryptococcal meningitis from coming
back.

2

BEFORE YOU TAKE FLUCONAZOLE

Do NOT take Fluconazole if you:
• are allergic (hypersensitive) to
Fluconazole, to other medicines you have
taken to treat fungal infections or to any of
the other ingredients of Fluconazole. The
symptoms may include itching, reddening
of the skin or difficulty in breathing.
• are taking astemizole, terfenadine
(antihistamine medicines for allergies)
• are taking cisapride (used for stomach
upsets)
• are taking pimozide (used for treating
mental illness)
• are taking quinidine (used for treating
heart arrhythmia)
• are taking erythromycin (an antibiotic for
treating infections).

Take special care with Fluconazole
Talk to your doctor if you:
• have kidney or liver problems
• suffer from heart disease, including heart
rhythm problems
1 WHAT FLUCONAZOLE IS AND WHAT • have abnormal levels of potassium,
IT IS USED FOR
calcium or magnesium in your blood
• develop severe skin reactions (itching,
Fluconazole is one of a group of medicines
reddening of the skin or difficulty in
called “antifungals”The active substance is
.
breathing).
fluconazole.
Taking other medicines
Fluconazole is used to treat infections
Tell your doctor immediately if you are
caused by fungi and may also be used to
taking astemizole, terfenadine (an
stop you from getting a candidal infection.
antihistamine for treating allergies) or
The most common cause of fungal
cisapride (used for stomach upsets) or
infections is a yeast called Candida.
pimozide (used for treating mental illness)
or quinidine (used for treating heart
Adults
arrhythmia) or erythromycin (an antibiotic
You might be given this medicine by your
for treating infections) as these should not
doctor to treat the following types of fungal be taken with Fluconazole (see section: “Do
infections:
not take Fluconazole if you”).
• Cryptococcal meningitis – a fungal
infection in the brain
There are some medicines that may interact
• Coccidioidomycosis – a disease of the
with Fluconazole. Make sure your doctor
bronchopulmonary system
knows if you are taking any of the following
• Infections caused by Candida and found in medicines:
the blood stream, body organs (e.g. heart, • rifampicin or rifabutin (antibiotics for
lungs) or urinary tract
infections)
• Mucosal thrush – infection affecting the
• alfentanil, fentanyl (used as anaesthetic)
lining of the mouth, throat and denture
• amitriptyline, nortriptyline (used as
sore mouth
anti-depressant)
• Genital thrush – infection of the vagina or • amphotericin B, voriconazole (anti-fungal)
penis
• medicines that thin the blood to prevent
• Skin infections – e.g. athlete's foot,
blood clots (warfarin or similar medicines)
ringworm, jock itch, nail infection.
• benzodiazepines (midazolam, triazolam or
similar medicines) used to help you sleep
You might also be given Fluconazole to:
or for anxiety
• stop cryptococcal meningitis from coming • carbamazepine, phenytoin (used for
back
treating fits)
• stop mucosal thrush from coming back
• nifedipine, isradipine, amlodipine,
• reduce recurrence of vaginal thrush
felodipine and losartan (for hypertension• stop you from getting an infection caused
high blood pressure)
by Candida (if your immune system is
• ciclosporin, everolimus, sirolimus or
weak and not working properly).
tacrolimus (to prevent transplant rejection)
• cyclosphosphamide, vinca alkaloids
Children and adolescents (0 to 17 years old)
(vincristine, vinblastine or similar
You might be given this medicine by your
medicines) used for treating cancer
doctor to treat the following types of fungal • halofantrine (used for treating malaria)
infections:
• statins (atorvastatin, simvastatin and
• Mucosal thrush – infection affecting the
fluvastatin or similar medicines) used for
lining of the mouth, throat
reducing high cholesterol levels
• Infections caused by Candida and found in • methadone (used for pain)
the blood stream, body organs (e.g. heart, • celecoxib, flurbiprofen, naproxen,
lungs) or urinary tract
ibuprofen, lornoxicam, meloxicam,
• Cryptococcal meningitis – a fungal
diclofenac (Non-Steroidal
infection in the brain.
Anti-inflammatory Drugs (NSAID))
• oral contraceptives
You might also be given Fluconazole to:
• stop you from getting an infection caused • prednisone (steroid)
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1. What Fluconazole is and what it is used
for
2. Before you take Fluconazole
3. How to take Fluconazole
4. Possible side effects
5. How to store Fluconazole
6. Further information

Keep this medicine out of the sight and
reach of children.

6

FLUCONAZOLE 50 mg AND
200 mg CAPSULES

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.
• This medicine has been prescribed for
you. Do not pass it on to others. It may
harm them, even if their symptoms are
the same as yours.
• If you get any side effects, talk to your
doctor, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet. See section 4.

Reporting of side effects
If you get any side effects, talk to your
doctor, pharmacist or nurse. 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

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Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation holder and
company responsible for manufacture:
TEVA UK Limited, Eastbourne, BN22 9AG.
This leaflet was last revised: May 2015

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Rare side effects which affect 1 to 10 users
in 10,000 are listed below:
• lower than normal white blood cells that
help defend against infections and blood
cells that help to stop bleeding
• red or purple discoloration of the skin
which may be caused by low platelet
count, other blood cell changes
• blood chemistry changes (high blood
levels of cholesterol, fats)
• low blood potassium
• shaking
• abnormal electrocardiogram (ECG),
change in heart rate or rhythm
• liver failure
• allergic reactions (sometimes severe),
including widespread blistering rash and
skin peeling, severe skin reactions,
swelling of the lips or face
• hair loss.

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• zidovudine, also known as AZT; saquinavir
(used in HIV-infected patients)
• medicines for diabetes such as
chlorpropamide, glibenclamide, glipizide
or tolbutamide
• theophylline (used to control asthma)
• vitamin A (nutritional supplement).
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without a prescription.

To treat
coccidioidomycosis

To treat internal
fungal infections
caused by Candida

Taking Fluconazole with food and drink
You can take your medicine with or without
a meal.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant, trying
to become pregnant or breast-feeding. You
should not take Fluconazole while you are
pregnant or breast-feeding unless your
doctor has told you to.
Ask your doctor or pharmacist for advice
before taking any medicines.
Driving and using machines
When driving vehicles or using machines, it
should be taken into account that
occasionally dizziness or fits may occur.
Important information about some of the
ingredients of Fluconazole
• This medicine contains a small amount of
lactose (milk sugar). If you have been told
by your doctor that you have an
intolerance to some sugars, please contact
your doctor before taking this medicine.
• The 200 mg capsules also contain E122
(Azorubine), which can cause an
allergic-type reaction, including asthma.
This reaction is more common in those
people who are allergic to aspirin.

3

To treat mucosal
thrush-dose
depends on where
the infection is
located
To stop mucosal
infections
affecting the
lining of mouth,
throat and
denture sore
mouth

150 mg every
third day for a
total of 3 doses
(day 1, 4 and 7)
and then once a
week for 6 months
while you are at
risk of getting an
infection

To treat fungal
skin and nail
infections

Adults
dose
400 mg on the
first day then
200 mg to 400 mg
once daily for 6 to
8 weeks or longer
if needed.
Sometimes doses
are increased up
to 800 mg

To stop
cryptococcal
meningitis from
coming back

200 mg once daily
until you are told
to stop

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Children to 11 years old

To stop you from
getting an
infection caused
by Candida (if
your immune
system is weak
and not working
properly)

Depending on the
site of the
infection 50 mg
once daily, 150 mg
once weekly,
300 to 400 mg
once weekly for 1
to 4 weeks
(Athlete’s foot
may be up to 6
weeks, for nail
infection
treatment until
infected nail is
replaced)
200 mg to 400 mg
once daily while
you are at risk of
getting an infection

Version 2.6

If you forget to take Fluconazole
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. If it is
almost time for your next dose, do not take
the dose that you missed.

The maximum dose for children is 400 mg
daily.

If you stop taking Fluconazole
Do not stop treatment early, even if you start
to feel better, because the original infection
The dose will be based on the child’s weight may still be present and recur if treatment is
in kilograms.
stopped. Take the full course.
Condition

Daily dose

Mucosal thrush
and throat
infections caused
by Candida-dose
and duration
depends on the
severity of the
infection and on
where the
infection is located

3 mg per kg of the
body weight (6 mg
per kg of body
weight might be
given on the first
day)

Cryptococcal
meningitis or
internal fungal
infections caused
by Candida

6 mg to 12 mg per
kg of body weight

To stop children
from getting an
infection caused
by Candida (if
their immune
system is not
working properly)

150 mg as a single
dose

To reduce
recurrence of
vaginal thrush

Follow the dose prescribed by your doctor
(either adults or children posology).

100 mg to 200 mg
once daily, or
200 mg 3 times a
week, while you
are at risk of
getting an
infection

To treat genital
thrush

01 June 2015

Adolescents from 12 to 17 years old

50 mg to 400 mg
once daily for 7 to
30 days until you
are told to stop

The usual doses of this medicine for
different infections are below:

To treat
cryptococcal
meningitis

800 mg on the
first day then
400 mg once daily
until you are told
to stop

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200 mg to 400 mg
on the first day
then 100 mg to
200 mg until you
are told to stop

Always take your medicine exactly as your
doctor has told you. You should check with
your doctor or pharmacist if you are not
sure.

Condition

200 mg to 400 mg
once daily from 11
months for up to
24 months or
longer if needed.
Sometimes doses
are increased up
to 800 mg

To treat mucosal
infections
affecting the
lining of mouth,
throat and
denture sore
mouth

HOW TO TAKE FLUCONAZOLE

Swallow the capsule whole with a glass of
water. It is best to take your capsules at the
same time each day.

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3 mg to 12 mg per
kg of body weight

Use in children 0 to 4 weeks of age
Use in children of 3 to 4 weeks of age:
The same dose as above but given once
every 2 days. The maximum dose is 12 mg
per kg of body weight every 48 hours.
Use in children less than 2 weeks old:
The same dose as above but given once
every 3 days. The maximum dose is 12 mg
per kg of body weight every 72 hours.
Doctors sometimes prescribe different
doses to these. Always take your medicine
exactly as your doctor has told you. You
should check with your doctor or pharmacist
if you are not sure.

If you have any further questions on the use
of this product, ask your doctor or
pharmacist.

4

POSSIBLE SIDE EFFECTS

Like all medicines, Fluconazole can cause
side effects, although not everybody gets
them.
A few people develop allergic reactions
although serious allergic reactions are rare.
If you get any of the following symptoms,
tell your doctor immediately.
• sudden wheezing, difficulty in breathing
or tightness in the chest
• swelling of eyelids, face or lips
• itching all over the body reddening of the
skin or itchy red spots
• skin rash
• severe skin reactions such as a rash that
causes blistering (this can affect the
mouth and tongue).
Fluconazole may affect your liver. The signs
of liver problems include:
• tiredness
• loss of appetite
• vomiting
• yellowing of your skin or the whites of
your eyes (jaundice).
If any of these happen, stop taking
Fluconazole and tell your doctor
immediately.
Other side effects:
Additionally, if any of the following side
effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell
your doctor or pharmacist.
Common side effects which affect 1 to 10
users in 100 are listed below:
• headache
• stomach discomfort, diarrhoea, feeling sick,
vomiting
• increase in blood tests of liver function
• rash.

Elderly
The usual adult dose should be given unless
you have kidney problems.
Uncommon side effects which affect 1 to 10
users in 1,000 are listed below:
Patients with kidney problems
• reduction in red blood cells which can
Your doctor may change your dose,
make skin pale and cause weakness or
depending on your kidney function.
breathlessness
• decreased appetite
If you take more Fluconazole than you
• inability to sleep, feeling drowsy
should
• fit, dizziness, sensation of spinning,
Taking too many capsules at once may
tingling, pricking or numbness, changes in
make you unwell. Contact your doctor or
sense of taste
your nearest hospital casualty department at • constipation, difficult digestion, wind, dry
once. The symptoms of a possible overdose
mouth
may include hearing, seeing, feeling and
• muscle pain
thinking things that are not real
• liver damage and yellowing of the skin
(hallucination and paranoid behaviour).
and eyes (jaundice)
Symptomatic treatment (with supportive
• wheals, blistering (hives), itching,
measures and gastric lavage if necessary)
increased sweating
may be adequate.
• tiredness, general feeling of being unwell,
fever.

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Teva Pharmaceuticals Europe B.V
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APPROVALS
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Server Date
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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.

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