FLUCONAZOLE 50 MG CAPSULES

Active substance: FLUCONAZOLE

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Ref:

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

Version:

2

Trackwise Parent:

108665

22 July 2013
Child:

213818

PL Number(s),
MA Holder & Packer:
Reason for revision:

PL 00289/0399 - 0402. TEVA UK Limited Licence. Teva Regulatory Team.
Packed at TEVA UK Limited.
Packing line: Uhlmann.
V1: Text updates onto new double folded Leaflet - Teva Regulatory Team 26/01/2012 15:00. V2: RFI - QRD Updates.

F. P. Code:

231-10-05240
231-10-05260
231-10-05242
392 (10001001)
Univers
9 Pt

Pharma Code:
Fonts:
Base Font Size:

Dimensions:
L:
W:

323 mm
320 mm folded to 160 mm

Colours:
(PANTONE® is a registered
trademark of Pantone, Inc.)

PANTONE® GREEN C
BLACK

Please refer to the latest version of
the full base material specification:
92653, 92655, 92651

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier.
We must receive a copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

FOLD
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PAGE 4: AFTER FOLDING REAR FACE (OUTSIDE OF REEL AFTER FOLDING AND TACKING)

• 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.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation holder and
company responsible for manufacture:
TEVA UK Limited, Eastbourne, BN22 9AG.
This leaflet was last revised: July 2013
PL 00289/0399 and 0402

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 any of the side effects get serious, or if
you notice any side effects not listed in
this leaflet, please tell your doctor or
pharmacist.

By reporting side effects you can help
provide more information on the safety of
this medicine.

HOW TO STORE FLUCONAZOLE

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.
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.
62020-W
320 x 323

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

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

Pharma code 392

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

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

6

PACKAGE LEAFLET: INFORMATION
FOR THE USER

IN THIS LEAFLET:

Reporting of side effects

5

FLUCONAZOLE
50 mg AND 200 mg
CAPSULES

Top of page cut-off to middle of registration mark = 44 mm

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.
If any of the side effects get serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or
pharmacist.

PAGE 1: AFTER FOLDING FRONT FACE (INSIDE OF REEL AFTER FOLDING AND TACKING)

Ref:

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

Version:

2

Trackwise Parent:

22 July 2013

108665

Child:

213818

PL Number(s),
MA Holder & Packer:
Reason for revision:

PL 00289/0399 - 0402. TEVA UK Limited Licence. Teva Regulatory Team.
Packed at TEVA UK Limited.
Packing line: Uhlmann.
V1: Text updates onto new double folded Leaflet - Teva Regulatory Team 26/01/2012 15:00. V2: RFI - QRD Updates.

F. P. Code:

231-10-05240
231-10-05260
231-10-05242
392 (10001001)
Univers
9 Pt

Pharma Code:
Fonts:
Base Font Size:

Dimensions:
L:
W:

323 mm
320 mm folded to 160 mm

Colours:
(PANTONE® is a registered
trademark of Pantone, Inc.)

PANTONE® GREEN C
BLACK

Please refer to the latest version of
the full base material specification:
92653, 92655, 92651

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier.
We must receive a copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

FOLD
LINE.

PAGE 2: LEFT HAND INSIDE FACE AFTER FOLDING AND TACKING

• 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).
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
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
coccidioidomycosis

To treat internal
fungal infections
caused by Candida

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

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

To treat fungal
skin and nail
infections

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

dose

To treat
cryptococcal
meningitis

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

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

HOW TO TAKE FLUCONAZOLE

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

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 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

PAGE 3: RIGHT HAND INSIDE FACE AFTER FOLDING AND TACKING

Adolescents from 12 to 17 years old
Follow the dose prescribed by your doctor
(either adults or children posology).
Children to 11 years old
The maximum dose for children is 400 mg
daily.

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.

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

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
Elderly
The usual adult dose should be given unless • rash.
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
once. The symptoms of a possible overdose • constipation, difficult digestion, wind, dry
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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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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