DIFLUCAN 40MG/ML POWDER FOR ORAL SUSPENSION

Active substance: FLUCONAZOLE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER
®

Diflucan 40mg/ml Powder for Oral
Suspension
(fluconazole)
Your medicine is available by the above name,
but will be referred to as Diflucan throughout the
remainder of this leaflet.
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 gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Diflucan is and what it is used for
2. Before you take Diflucan
3. How to take Diflucan
4. Possible side effects
5. How to store Diflucan
6. Further 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
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. Before you take Diflucan













Do not take Diflucan 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
Diflucan. 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 Diflucan
Tell your doctor if you
 have liver or kidney problems
 suffer from heart disease, including heart rhythm
problems
 have abnormal levels of potassium, calcium or
magnesium in your blood.
 develop severe skin reactions (itching, reddening
of the skin or difficulty in breathing).

Taking other medicines
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 antidepressant)
 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)
lornoxicam, meloxicam, diclofenac (Non-Steroidal
Anti-Inflammatory Drugs (NSAID))
oral contraceptives
prednisolone (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 Diflucan with food and drink
Diflucan can be taken with or without food.

Pregnancy and breast-feeding
Tell your doctor if you are pregnant, trying to become
pregnant or breast-feeding. You should not take
Diflucan 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 Diflucan
Diflucan powder for oral suspension contains sucrose
(sugar).
 If you have an intolerance to some sugars, please
contact your doctor before taking this medicine.
 Doses of 10ml contain 5.6g or more of sugar. This
should be taken into account if you have diabetes.
 May be harmful to teeth if used for periods of
longer than 2 weeks.

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.
It is best to take medicine at the same time each day.

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

Adults
Condition
To treat cryptococcal
meningitis

To stop cryptococcal
meningitis from
coming back
To treat
coccidioidomycosis

To treat internal
fungal infections
caused by Candida
To treat mucosal
infections affecting
the lining of the
mouth, throat and
denture sore mouth
To treat mucosal
thrush – dose
depends on where
the infection is
located
To stop mucosal
infections of mouth
and throat from
coming back
To treat genital
thrush
To reduce
recurrence of
vaginal thrush

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)

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
200 mg once daily until
you are told to stop
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
800 mg on the first day
then 400 mg once daily
until you are told to stop
200 mg to 400 mg on the
first day then 100 mg to
200 mg until you are told to
stop
50 mg to 400 mg once
daily for 7 to 30 days until
you are told to stop

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

Adolescents from 12 to 17 years old

If you take more Diflucan than you should

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

Taking too much Diflucan 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.

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
3 mg per kg of body
throat infections
weight (6 mg per kg of
caused by Candida
body weight
– dose and duration
might be given on the
depends on the
first day)
severity of the
infection
and on where the
infection is located
Cryptococcal
6 mg to 12 mg per kg
meningitis or internal of body weight
fungal infections
caused by Candida
To stop children
3 mg to 12 mg per kg
from getting an
of body weight
infection caused by
Candida (if their
immune system is
not working
properly)

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.

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.

Instructions to make up the suspension:
It is recommended that your pharmacist makes up
Diflucan powder for oral suspension before giving it
to you. Instructions are provided in a section of this
leaflet for healthcare professionals.

Instructions for use:
Shake the closed bottle of the suspension every time
before using.

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, Diflucan 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).
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.

Uncommon side effects which affect 1 to 10 users in
1,000 are listed below:
 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 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 gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

5.


How to store Diflucan
Keep out of the sight and reach of children.

Powder for oral suspension:

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
 increases in blood tests of liver function
 rash



Do not store above 25°C.
Keep the bottle tightly closed.

Reconstituted suspension:







Do not store above 30°C.
Do not freeze, shake before use.
The shelf life of the reconstituted suspension is 14
days.
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.

Further information

What Diflucan contains



1ml of reconstituted suspension contains 40mg
fluconazole
The other ingredients are sucrose, colloidal silica
anhydrous, titanium dioxide (E171), xanthan gum,
sodium citrate dihydrate, citric acid anhydrous,
sodium benzoate (E211) and natural orange
flavour.

What Diflucan looks like and contents of the
pack





Diflucan is a white to off-white powder for oral
suspension providing a white to off-white orange
flavoured suspension after reconstitution.
In each bottle the mixture of powder and water
makes 35 ml of suspension.
A 5ml spoon is provided to measure the correct
dose.

Manufacturer:
Farmasierra, S.A. Ctra.N-1, km 26,200. 28700 San
Sebastián de los Reyes (Madrid), Spain.
Procured from within the EU and repackaged by:
Amimed Direct Ltd, Hendon, London, NW9 6AQ.
Product Licence Holder: Sam Pharma Ltd, Unit 20
Garrick Industrial Estate, Irving Way, Hendon,
London, NW9 6AQ.
POM

PL: 33902/0378

Leaflet revision date: 29/01/2013
Diflucan® is a registered trademark of Pfizer Limited.

The following information is intended for
medical or healthcare professionals only:
Instructions to make up the suspension:
The reconstituted suspension will provide a
white to off-white orange-flavoured suspension
after reconstitution.
1. Tap the bottle to release the powder.
2. Add a small quantity of still water and shake
it vigorously. Add water up to the level marked
on the bottle (this corresponds to adding 24 ml
of water)
3. Shake well for one to two minutes to obtain a
well mixed suspension.
4. Write the expiry date of the reconstituted
suspension on the bottle label (the shelf life of
the reconstituted suspension is 14 days). Any
unused suspension should not be used
after this date and should be returned to your
pharmacist.

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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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