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DIFLUCAN 50MG CAPSULES

Active substance(s): FLUCONAZOLE

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Ref: 0128/060516/1/F
TM

Diflucan 50mg Capsules
(flucanazole)
Patient Information Leaflet
Your medicine is called Diflucan 50mg Capsules and will be referred to as
Diflucan throughout this leaflet.
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, pharmacist or nurse.
- This medicine has been prescribed for you only. 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.
What is in this leaflet
1 What Diflucan is and what it is used for
2 What you need to know before you take Diflucan
3 How to take Diflucan
4 Possible side effects
5 How to store Diflucan
6 Contents of the pack and other information

1

What Diflucan is and what it is used for

Diflucan is one of a group of medicines called “antifungals”. The active
substance is fluconazole.
Diflucan is used to treat infections caused by fungi and may also be used to
stop you from getting a candidal infection. The most common cause of fungal infections is a yeast called Candida.
Adults
You might be given this medicine by your doctor to treat the following types
of fungal infections:
- Cryptococcal meningitis – a fungal infection in the brain
- Coccidioidomycosis – a disease of the bronchopulmonary system
- Infections caused by Candida and found in the blood stream, body organs
(e.g. heart, lungs) or urinary tract
- Mucosal thrush - infection affecting the lining of the mouth, throat and
denture sore mouth
- Genital thrush – infection of the vagina or penis
- Skin infections - e.g. athlete’s foot, ringworm, jock itch, nail infection
You might also be given Diflucan to:
- stop cryptococcal meningitis from coming back
- stop mucosal thrush from coming back
- reduce recurrence of vaginal thrush
- stop you from getting an infection caused by Candida (if your immune
system is weak and not working properly)
Children and adolescents (0 to 17 years old)
You might be given this medicine by your doctor to treat the following types
of fungal infections:
- Mucosal thrush - infection affecting the lining of the mouth, throat
- Infections caused by Candida and found in the blood stream, body organs
(e.g. heart, lungs) or urinary tract
- Cryptococcal meningitis – a fungal infection in the brain

- 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)
- ivacaftor (used for treating cystic fibrosis)
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Diflucan with food and drink
You can take your medicine with or without a meal.
Pregnancy, 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 Diflucan while you are pregnant unless your doctor has
told you to.
You can continue breast-feeding after taking a single dose of Diflucan up to
200 mg.
You should not breast-feed if you are taking a repeated dose of Diflucan.
Driving and using machines
When driving vehicles or using machines, it should be taken into account
that occasionally dizziness or fits may occur.
Diflucan contains lactose (milk sugar)
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.
3

How to take Diflucan

Always take your medicine exactly as your doctor has told you. You should
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
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

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

You might also be given Diflucan 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 Diflucan

Do not take Diflucan
- if you are allergic to fluconazole, to other medicines you have taken to
treat fungal infections or to any of the other ingredients of this medicine
(listed in section 6). The symptoms may include itching, reddening of the
skin or difficulty in breathing
- 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)
- if you are taking quinidine (used for treating heart arrhythmia)
- if you are taking erythromycin (an antibiotic for treating infections)
Warnings and precautions
Talk to your doctor or pharmacist before taking Diflucan
- if you have liver or kidney problems
- if you suffer from heart disease, including heart rhythm problems
- if you have abnormal levels of potassium, calcium or magnesium in your
blood
- if you develop severe skin reactions (itching, reddening of the skin or
difficulty in breathing)
Other medicines and Diflucan
Tell your doctor immediately if you are taking astemizole, terfenadine (an
antihistamine for treating allergies) or cisapride (used for stomach upsets) or
pimozide (used for treating mental illness) or quinidine (used for treating
heart arrhythmia) or erythromycin (an antibiotic for treating infections) as
these should not be taken with Diflucan (see section: “Do not take Diflucan if
you”).
There are some medicines that may interact with Diflucan. Make sure your
doctor knows if you are taking any of the following medicines:
- rifampicin or rifabutin (antibiotics for infections)
- alfentanil, fentanyl (used as anaesthetic)
- amitriptyline, nortriptyline (used as anti-depressant)
- amphotericin B, voriconazole (anti-fungal)
- medicines that thin the blood to prevent blood clots (warfarin or similar
medicines)
- benzodiazepines (midazolam, triazolam or similar medicines) used to help
you sleep or for anxiety
- carbamazepine, phenytoin (used for treating fits)
- nifedipine, isradipine, amlodipine, felodipine and losartan (for hypertension
- high blood pressure)
- 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)

To treat mucosal infections
200 mg to 400 mg on the first
affecting the lining of mouth,
day then 100 mg to 200 mg
throat and denture sore mouth 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

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

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)

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

200 mg to 400 mg once daily
while you are at risk of getting
an infection

Ref: 0128/060516/1/B
TM

Diflucan 50mg Capsules
(flucanazole)
Patient Information Leaflet (continued)
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.
The dose will be based on the child’s weight in kilograms.
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 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.
Elderly
The usual adult dose should be given unless you have kidney problems.
Patients with kidney problems
Your doctor may change your dose, depending on your kidney function.
If you take more Diflucan 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 Diflucan
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 have any further questions on the use of this medicine, ask your
doctor or pharmacist.
4

Possible side effects

Like all medicines, this medicine 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 side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. 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).
Diflucan 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 Diflucan 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 (may affect up to 1 in 10 people) are:
- headache
- stomach discomfort, diarrhoea, feeling sick, vomiting
- increases in blood tests of liver function
- rash
Uncommon side effects (may affect up to 1 in 100 people) are:
- 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
- tiredness, general feeling of being unwell, fever
Rare side effects (may affect up to 1 in 1,000 people) are:
- 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

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 (see details below). By reporting side effects you
can help provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme website: www.mhra.gov.uk/yellowcard.

5

How to store Diflucan

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Do not take your capsules out of the blister strip until it is time to take
your dose.
Do
not use Diflucan after the expiry date which is stated on the pack. 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

Contents of the pack and other information

What Diflucan contains:
Each capsule contains 50mg fluconazole as the active ingredient.
Your medicine also contains the following inactive ingredients: Lactose,
maize starch, colloidal silicon dioxide, magnesium stearate, sodium lauryl
sulphate, patent blue V (E131), titanium dioxide (E171), gelatin and black
printing ink.
What Diflucan looks like and contents of the pack
Diflucan are light turquoise blue and white capsules, coded 'FLU-50' on the
body and 'Pfizer' on the head of the capsule.
Each blister pack contains 7 capsules.
Manufacturer and Licence Holder
The capsules are manufactured by Pfizer, PGM, Zone Industrielle de
Poce-sur-Cisse, 37401 Amboise Cedex, France and are procured from
within the EU and repackaged by the Product Licence Holder: Lexon (UK)
Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.

POM

PL 15184/0128

Diflucan 50mg Capsules

Diflucan is a registered trademark of Pfizer Limited.
Revision date: 06/05/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

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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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