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FLUCONAZOLE 50 MG CAPSULES

Active substance(s): FLUCONAZOLE

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TEVA UK Ref:

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

Contents of the pack and other
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).

62020-Z
320 x 323

Fluconazole 50 mg and
200 mg capsules
Package leaflet: Information
for the user

Read all of this leaflet carefully before you
start taking this medicine because it
contains important information for you.
• 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 signs of illness
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.

You might also be given Fluconazole to:
• stop you from getting an infection caused
by Candida (if your immune system is
weak and not working properly)
• stop cryptococcal meningitis from coming
back.

2

What you need to know before
you take Fluconazole

Do not take Fluconazole:
• if you are allergic to Fluconazole or any of
the other ingredients of this medicine
(listed in section 6)..
• if you are allergic to any other medicines
you have taken to treat fungal infections.
• if you are taking astemizole, terfenadine
(antihistamine medicines for allergies)
• if you are taking cisapride (used for
stomach upsets)
• if you are taking pimozide (used for
treating mental illness)
What is in this leaflet
• if you are taking quinidine (used for
1. What Fluconazole is and what it is used for
treating heart arrhythmia)
2. What you need to know before you take
• if you are taking erythromycin (an
Fluconazole
antibiotic for treating infections)
3. How to take Fluconazole
• if you are taking amiodarone (used for
4. Possible side effects
treating uneven heartbeats ‘arrhythmias’)
5. How to store Fluconazole
6. Contents of the pack and other information Warnings and precautions
Talk to your doctor or pharmacist before
1 What Fluconazole is and what it is taking Fluconazole
used for
• if you have kidney or liver problems
• if you suffer from heart disease, including
Fluconazole is one of a group of medicines
heart rhythm problems
called “antifungals”.The active substance is
• if you have abnormal levels of potassium,
fluconazole.
calcium or magnesium in your blood
• if you develop severe skin reactions
Fluconazole is used to treat infections
(itching, reddening of the skin or difficulty
caused by fungi and may also be used to
in breathing).
stop you from getting a candidal infection.
• if you develop signs of ‘adrenal
The most common cause of fungal
insufficiency’ where the adrenal glands do
infections is a yeast called Candida.
not produce adequate amounts of certain
steroid hormones such as cortisol
Adults
(chronic, or long lasting fatigue, muscle
You might be given this medicine by your
weakness, loss of appetite, weight loss,
doctor to treat the following types of fungal
abdominal pain)
infections:
• Cryptococcal meningitis – a fungal
Other medicines and Fluconazole
infection in the brain
• Coccidioidomycosis – a disease of the
Tell your doctor or pharmacist if you are
bronchopulmonary system
taking, have recently taken or might take
• Infections caused by Candida and found in
any other medicines.
the blood stream, body organs (e.g. heart,
lungs) or urinary tract
Tell your doctor immediately if you are
• Mucosal thrush - infection affecting the
taking astemizole, terfenadine (an
lining of the mouth, throat and denture
antihistamine for treating allergies) or
sore mouth
cisapride (used for stomach upsets) or
• Genital thrush – infection of the vagina or pimozide (used for treating mental illness)
penis
or quinidine (used for treating heart
• Skin infections - e.g. athlete's foot,
arrhythmia) or erythromycin (an antibiotic
ringworm, jock itch, nail infection.
for treating infections) amiodarone (used for
treating uneven heartbeats ‘arrhythmias’) as
You might also be given Fluconazole to:
these should not be taken with Fluconazole
• stop cryptococcal meningitis from coming
(see “Do not take Fluconazole”).
back
• stop mucosal thrush from coming back
There are some medicines that may interact
• reduce recurrence of vaginal thrush
with Fluconazole. Make sure your doctor
• stop you from getting an infection caused knows if you are taking any of the following
by Candida (if your immune system is
medicines:
weak and not working properly).
• rifampicin or rifabutin (antibiotics for
infections)
Children and adolescents (0 to 17 years old)
• alfentanil, fentanyl (used as anaesthetic)
You might be given this medicine by your
• amitriptyline, nortriptyline (used as
doctor to treat the following types of fungal
anti-depressant)
infections:
• amphotericin B, voriconazole (anti-fungal)
• Mucosal thrush - infection affecting the
• medicines that thin the blood to prevent
lining of the mouth, throat
blood clots (warfarin or similar medicines)
• Infections caused by Candida and found in
• benzodiazepines (midazolam, triazolam or
the blood stream, body organs (e.g. heart,
similar medicines) used to help you sleep
lungs) or urinary tract
or for anxiety
• Cryptococcal meningitis – a fungal
• carbamazepine, phenytoin (used for
infection in the brain.
treating fits)
• nifedipine, isradipine, amlodipine,
felodipine and losartan (for hypertensionhigh blood pressure)
Peel Here To Open

Pharma code 392

How to store Fluconazole

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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.

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.

28 April 2016

PANTONE® GREEN C

323 mm
320 mm
folded to 160 mm

• tiredness, general feeling of being unwell, Marketing Authorisation Holder and
fever.
Manufacturer
Marketing Authorisation holder and
Rare: may affect up to 1 in 1,000 people
company responsible for manufacture: TEVA
• lower than normal white blood cells that
UK Limited, Eastbourne, BN22 9AG.
help defend against infections and blood
cells that help to stop bleeding
This leaflet was last revised in April 2016
• red or purple discoloration of the skin
PL 00289/0399 and 0402
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.

6

3

Colours Used:

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5

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231-30-62020-Z LEA FLUCONAZOLE CAPS A/S TUK

TEVA UK Ref:

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Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
Fluconazole with food and drink
You can take your medicine with or without
a meal.
Pregnancy and breast-feeding and fertility
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.
You should not take Fluconazole while you
are pregnant or breast-feeding unless your
doctor has told you to.

Condition

Driving and using machines
When driving vehicles or using machines, it
should be taken into account that
occasionally dizziness or fits may occur.

• 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
coccidioidomycosis

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 internal
fungal infections
caused by Candida

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

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

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

To treat mucosal
thrush-dose
depends on where
the infection is
located

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

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

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

150 mg as a single
dose

To reduce
recurrence of
vaginal thrush

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

How to take Fluconazole

Always take this medicine exactly as your
doctor has told you. Check with your doctor
or pharmacist if you are not sure.
Swallow the capsule whole with a glass of
water. It is best to take your capsules at the
same time each day.
The recommended doses of this medicine
for different infections are below:
Adults

dose

200 mg once daily
until you are told
to stop

To treat fungal skin
and nail infections

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

BLACK
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FOLD
LINE.

To stop
cryptococcal
meningitis from
coming back

Fluconazole contains Lactose and E122
(Azorubine)

28 April 2016

PANTONE® GREEN C

323 mm
320 mm
folded to 160 mm

To treat cryptococcal 400 mg on the first
meningitis
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

Ask your doctor or pharmacist for advice
before taking any medicines.

3

Colours Used:

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• ciclosporin, everolimus, sirolimus or
tacrolimus (to prevent transplant
rejection)
• cyclosphosphamide, vinca alkaloids
(vincristine, vinblastine or similar
medicines) used for treating cancer
• halofantrine (used for treating malaria)
• statins (atorvastatin, simvastatin and
fluvastatin or similar medicines) used for
reducing high cholesterol levels
• methadone (used for pain)
• celecoxib, flurbiprofen, naproxen,
ibuprofen, lornoxicam, meloxicam,
diclofenac (Non-Steroidal
Anti-inflammatory Drugs (NSAID))
• oral contraceptives
• prednisone (steroid)
• 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)
• hydrochlorothiazide (a ‘water pill’).

Version:

231-30-62020-Z LEA FLUCONAZOLE CAPS A/S TUK

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

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Use in children and adolescents
Adolescents from 12 to 17 years old
Follow the dose prescribed by your doctor
(either adults or children dosage).
Children to 11 years old
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
may still be present and recur if treatment is
stopped. Take the full course.
If you have any further questions on the use
of this medicine, ask your doctor or
pharmacist.

4

Possible side effects

The dose will be based on the child’s weight
in kilograms.
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
Condition
Daily dose
Serious side effects
Mucosal thrush and 3 mg per kg of the
A few people develop allergic reactions
body weight (6 mg
throat infections
although serious allergic reactions are rare.
per kg of body
caused by
If you get any of the following symptoms,
weight might be
Candida-dose and
tell your doctor immediately.
given on the first
duration depends
• The symptoms may include itching,
day)
on the severity of
reddening of the skin, itchy red spots or
the infection and
difficulty in breathing.
on where the
• sudden wheezing, difficulty in breathing
infection is located
or tightness in the chest
6 mg to 12 mg per
Cryptococcal
• swelling of eyelids, face or lips
kg of body weight
meningitis or
• skin rash
internal fungal
• severe skin reactions such as a rash that
infections caused
causes blistering (this can affect the
by Candida
mouth and tongue).
To stop children
from getting an
infection caused
by Candida (if
their immune
system is not
working properly)

3 mg to 12 mg per
kg of body weight

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.
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.
Elderly
The recommended adult dose should be
taken unless you have kidney problems.
Patients with kidney problems
Your doctor may change your dose,
depending on your kidney function.
If you take more Fluconazole than you
should
Taking too many capsules at once may
make you unwell. Contact your doctor or
your nearest hospital casualty department at
once. The symptoms of a possible overdose
may include hearing, seeing, feeling and
thinking things that are not real
(hallucination and paranoid behaviour).
Symptomatic treatment (with supportive
measures and gastric lavage if necessary)
may be adequate.
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.

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).
Fluconazole may affect your adrenal glands
and the levels of steroid hormones
produced.
The signs of adrenal problems include:






tiredness
muscle weakness
loss of appetite
weight loss
abdominal pain

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: may affect up to 1 in 10 people
• headache
• stomach discomfort, diarrhoea, feeling
sick, vomiting
• increase in blood tests of liver function
• rash.
Uncommon: may affect up to 1 in 100
people
• reduction in red blood cells which can
make skin pale and cause weakness or
breathlessness
• decreased appetite
• inability to sleep, feeling drowsy
• fit, dizziness, sensation of spinning,
tingling, pricking or numbness, changes in
sense of taste
• constipation, difficult digestion, wind, dry
mouth
• muscle pain
• liver damage and yellowing of the skin
and eyes (jaundice)
• wheals, blistering (hives), itching,
increased sweating

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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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