DIFLUCAN 40 MG/ML POWDER FOR ORAL SUSPENSION

Active substance: FLUCONAZOLE

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Diflucan 10 mg/ml
powder for oral
suspension
Diflucan 40 mg/ml
powder for oral
suspension
fluconazole
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.
2.
3.
4.
5.
6.

What Diflucan is and what it is used for
Before you take Diflucan
How to take Diflucan
Possible side effects
How to store Diflucan
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)



PACKAGE LEAFLET:
INFORMATION FOR THE USER

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 (NonSteroidal 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 10 ml contain 5.6 g 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

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

To stop
cryptococcal
meningitis from
coming back
To treat
200 mg to 400 mg once
coccidioidomycosis daily from 11 months
for up to 24 months
or longer if needed.
Sometimes doses are
increased up to 800 mg
To treat internal
800 mg on the first day
fungal infections
then 400 mg once daily
caused by Candida until you are told to stop
To treat mucosal
200 mg to 400 mg on the
infections affecting first day then 100 mg to
the lining of the
200 mg until you are told
mouth, throat and
to stop
denture sore mouth
To treat mucosal
50 mg to 400 mg once
thrush – dose
daily for 7 to 30 days
depends on where until you are told to stop
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

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
To treat fungal skin Depending on the site
and nail infections 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
200 mg to 400 mg
getting an infection once daily while you
caused by Candida are at risk of getting an
(if your immune
infection
system is weak
and not working
properly)
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
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
Cryptococcal meningitis
or internal fungal
infections caused by
Candida
To stop children from
getting an infection
caused by Candida (if
their immune system is
not working properly)

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

6 mg to 12 mg per
kg of body weight

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.
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.

Shake the closed bottle of the suspension every
time before using.

- vomiting
- yellowing of your skin or the whites of your
eyes (jaundice)
If any of theses happen, stop taking Diflucan
and tell your doctor immediately.

Instructions to use the paediatric syringe:

Other side effects:

Shake the prepared suspension well.
1. Open the bottle (safety cap);
2. Insert the adapter fitted onto the syringe into
the bottle neck (Figure 1);
3. Turn the bottle with the syringe upside
down and withdraw the quantity of suspension
prescribed by the doctor (Figure 2). The marks
on the syringe are shown in ml.
The maximum dose for children is 400 mg daily
(see section “3. How to take Diflucan”).
4. Remove the syringe from the bottle;
5. For younger children, the medicinal product
may be given directly into the mouth from the
syringe. The child should remain upright during
administration. Point the syringe at the inside of
the cheek; release the suspension slowly into
the child’s mouth (Figure 3). For older children,
the suspension may be put in a spoon and
drunk by the child.
6. Rinse the syringe after use.
7. Close the bottle with the safety cap; the
adapter will remain on the bottle neck.

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
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.

Instructions for use:

If you take more Diflucan than you should
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.
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

5.HOW TO STORE DIFLUCAN
- Keep out of the reach and sight of children.
- Do not use Diflucan after the expiry date which
is stated on the pack after EXP. The expiry
date refers to the last day of that month.
- Powder for oral suspension (60 ml bottle):
- Keep the bottle tightly closed. Store below
25°C
- Powder for oral suspension (175 ml bottle):
- Store the powder below 25°C. Keep the bottle
tightly closed.
- Once reconstituted, store the suspension
below 30°C, do not freeze.
- The shelf life of the reconstituted suspension
is 28 days.

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
- The active substance is fluconazole.
- The other ingredients are: sucrose, silica
colloidal anhydrous, titanium dioxide (E 171),
xanthan gum, sodium citrate, citric acid
anhydrous, sodium benzoate and natural
orange flavour (containing orange oil and
maltodextrin).

For the 175 ml bottle:
1. Tap the bottle to release the powder.
2. Measure 66 ml of still water and add the
water to the bottle.
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 28 days). Any
unused suspension should be not be used
after this date and should be returned to your
pharmacist.

What Diflucan 10 mg/ml and 40 mg/ml
powder for oral suspension look like and
contents of the pack:
For the 60 ml bottle:
- Diflucan 10 mg/ml and 40mg/ml powder for
oral suspension is a dry white to off-white
powder. After adding water to the powder
(as instructed in the leaflet for healthcare
professionals) an orange flavoured
suspension containing the equivalent of 10 mg
or 40mg of fluconazole per ml is produced.
- In each bottle the mixture of powder and water
makes 35 ml of suspension.
- A 5 ml measuring spoon and/or a 5 ml
graduated syringe with a press-in bottle
adaptor might also be provided to measure
the correct dose .
For the 175 ml bottle:
- Diflucan 10 mg/ml powder for oral suspension
is a dry white to off-white powder. After
adding water to the powder (as instructed in
the leaflet for healthcare professionals) an
orange flavoured suspension containing the
equivalent of 10 mg of fluconazole per ml is
produced.
- In each bottle the mixture of powder and water
makes 100 ml of suspension.
- A measuring cup is also provided to measure
the correct dose.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Pfizer Limited, Ramsgate Road
Sandwich, Kent
CT13 9NJ. United Kingdom.
Manufacturer
Pfizer PGM, Zone Industrielle, 29 route des
Industries,
37530 Pocé sur Cisse, France.
This leaflet was last approved in: 11/2011
Ref: DF 1_ 0 UK/IE
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.
For the 60 ml bottle:
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 28 days). Any
unused suspension should be not be used
after this date and should be returned to your
pharmacist.
8816990

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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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