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DIFLUCAN 10MG/ML POWDER FOR ORAL SUSPENSION

Active substance(s): FLUCONAZOLE

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The following information is intended for healthcare
professionals or for patients (where the pharmacist does not
reconstitute this product):

Package leaflet: Information for the user

2. What you need to know before you take Diflucan

Diflucan® 10mg/ml Powder for Oral
Suspension

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 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)

Instructions to make up the suspension:
The reconstituted suspension will provide a white to off-white
orange-flavoured suspension after reconstitution.
10mg/ml powder for oral suspension in 60ml capacity
bottle: 35ml 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 in total to adding the required 24ml of water).
3. Shake well for 1 to 2 minutes to obtain a well mixed
suspension.
4. After reconstitution there will be a usable volume of 35ml.
5. 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 not be used after
this date and should be returned to your pharmacist.

(fluconazole)
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.
The name of your medicine is Diflucan 10mg/ml Powder for
Oral Suspension but will be referred to as Diflucan throughout
this leaflet.
What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Diflucan is and what it is used for
What you need to know before you take Diflucan
How to take Diflucan
Possible side effects
How to store Diflucan
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
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

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 or pharmacist if you are taking, have
recently taken or might take any 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 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)
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)
Diflucan with food and drink
Diflucan can be taken with or without food.

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 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 200mg.
You should not breast-feed if you are taking a repeated dose of
Diflucan.
Driving and using machines

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

-

If you have an intolerance to some sugars, please contact
your doctor before taking this medicine.
Doses of 10ml contain 5.5g 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 this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.

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

6mg to 12mg per kg of
body weight
3mg to 12mg per kg of
body weight

The recommended dose of this medicine for different infections
are below:

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 12mg per kg of body weight every 48
hours.
Use in children less than 2 weeks old:

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

Dose
400mg on the first day then
200mg to 400mg once daily
for 6 to 8 weeks or longer if
needed. Sometimes doses
are increased up to 800mg
200mg once daily until you
are told to stop
200mg to 400mg once daily
from 11 months for up to 24
months or longer if needed.
Sometimes doses are
increased up to 800mg
800mg on the first day then
400mg once daily until you
are told to stop
200mg to 400mg on the
first day then 100mg to
200mg until you are told to
stop
50mg to 400mg once daily
for 7 to 30 days until you
are told to stop
100mg to 200mg once
daily, or 200mg 3 times a
week, while you are at risk
of getting an infection
150mg as a single dose
150mg 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 50mg once
daily, 150mg once weekly,
300 to 400mg 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)

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

Children to 11 years old
The maximum dose for children is 400mg daily.
The dose will be based on the child’s weight in kilograms.

Use in children 0 to 4 weeks of age

Condition

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:

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

Adults

6. Rinse the syringe after use.
7. Close the bottle with the safety cap; the adapter will remain
on the bottle neck.

Adolescents from 12 to 17 years old
Follow the dose prescribed by your doctor (either adults or
children posology).

When driving vehicles or using machines it should be taken into
account that occasionally dizziness or fits may occur.
Diflucan powder for oral suspension contains sucrose
(sugar).

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

The same dose as above but given once every 3 days.
The maximum dose is 12mg 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.
Instructions to make up the suspension:
It is recommended that your pharmacist makes up Diflucan
powder for oral suspension before giving it to you. However
where the pharmacist does not reconstitute this product,
instructions are provided at the end of this leaflet in the section
‘The following information is intended for healthcare
professionals or for patients (where the pharmacist does not
reconstitute this product)’.

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, 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)

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.
5. How to store Diflucan
Keep out of the sight and reach of children.
Powder for oral suspension: Do not store above 25°C. Keep the
bottle tightly closed.
Reconstituted suspension: Do not store above 30°C. Do not
freeze.
The shelf life of the reconstituted suspension is 28 days. Do not
take the medicine after the expiry date which is stated on the
carton and bottle label after ‘Exp’. 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
-

The active substance is fluconazole. Each 1ml of
reconstituted suspension contains 10mg fluconazole.
The other ingredients are sucrose, colloidal anhydrous
silica, titanium dioxide (E171), xanthan gum, sodium citrate
dihydrate, citric acid anhydrous, sodium benzoate (E211)
and natural orange flavour (containing orange oil and
maltodextrin).

What Diflucan looks like and contents of the pack

If any of these happen, stop taking Diflucan and tell your
doctor immediately.

White to off-white powder for oral suspension providing a white
to off-white orange flavoured suspension after reconstitution.

Other side effects:

10mg/ml powder for oral suspension in 60ml capacity
bottle: 35ml suspension after reconstitution

Instructions to use the paediatric syringe:

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.

In each bottle the mixture of powder and water makes 35ml of
suspension.

Shake the prepared suspension well.

Common side effects (may affect up to 1 in 10 people) are:

A 5ml spoon is provided to measure the correct dose.

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

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 400mg 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.

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

Manufactured by:
Farmasierra Manufacturing S.L. Carretera de Irun, km 26.200,
San Sebastian de Los Reyes, Madrid, E-28700, Spain.
Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Diflucan® 10mg/ml Powder for Oral Suspension
PL 18799/2447
Leaflet date: 20.06.2016
Diflucan is registered trademark of Pfizer Inc.

POM

Package leaflet: Information for the user
The following information is intended for healthcare
professionals or for patients (where the pharmacist does not
reconstitute this product):

Fluconazole 10mg/ml Powder for Oral
Suspension

Instructions to make up the suspension:
The reconstituted suspension will provide a white to off-white
orange-flavoured suspension after reconstitution.

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

10mg/ml powder for oral suspension in 60ml capacity
bottle: 35ml 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 in total to adding the required 24ml of water).
3. Shake well for 1 to 2 minutes to obtain a well mixed
suspension.
4. After reconstitution there will be a usable volume of 35ml.
5. 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 not be used after
this date and should be returned to your pharmacist.

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.
The name of your medicine is Fluconazole 10mg/ml Powder for
Oral Suspension but will be referred to as Fluconazole
throughout this leaflet.
What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Fluconazole is and what it is used for
What you need to know before you take Fluconazole
How to take Fluconazole
Possible side effects
How to store Fluconazole
Contents of the pack and other information

1. What Fluconazole is and what it is used for
Fluconazole is one of a group of medicines called ‘antifungals’.
The active substance is fluconazole.

2. What you need to know 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 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 Fluconazole
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 Fluconazole
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.

Adults

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 Fluconazole (see section: ‘Do not take
Fluconazole if you’).

You might be given this medicine by your doctor to treat the
following types of fungal infections:

There are some medicines that may interact with Fluconazole.
Make sure your doctor knows if you are taking any of the
following medicines:

Fluconazole 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.

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 Fluconazole 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 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

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)
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)
Fluconazole with food and drink
Fluconazole can be taken with or without food.

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 for
advice before taking this medicine.
You should not take Fluconazole while you are pregnant unless
your doctor has told you to.
You can continue breast-feeding after taking a single dose of
Fluconazole up to 200mg.
You should not breast-feed if you are taking a repeated dose of
Fluconazole.
Driving and using machines

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

-

If you have an intolerance to some sugars, please contact
your doctor before taking this medicine.
Doses of 10ml contain 5.5g 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 Fluconazole
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
It is best to take medicine at the same time each day.
The recommended dose of this medicine for different infections
are below:
Adults

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

Dose
400mg on the first day then
200mg to 400mg once daily
for 6 to 8 weeks or longer if
needed. Sometimes doses
are increased up to 800mg
200mg once daily until you
are told to stop

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

Children to 11 years old
The maximum dose for children is 400mg 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
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)

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

6mg to 12mg per kg of
body weight

If you take more Fluconazole than you should
Taking too much Fluconazole 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

3mg to 12mg per kg of
body weight

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.

Use in children 0 to 4 weeks of age

If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

Use in children of 3 to 4 weeks of age:

4. Possible side effects

The same dose as above but given once every 2 days. The
maximum dose is 12mg per kg of body weight every 48 hours.
Condition

6. Rinse the syringe after use.
7. Close the bottle with the safety cap; the adapter will remain
on the bottle neck.

Adolescents from 12 to 17 years old
Follow the dose prescribed by your doctor (either adults or
children posology).

When driving vehicles or using machines it should be taken into
account that occasionally dizziness or fits may occur.
Fluconazole powder for oral suspension contains sucrose
(sugar).

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

Use in children less than 2 weeks old:
The same dose as above but given once every 3 days. The
maximum dose is 12mg per kg of body weight every 72 hours.
Elderly
The usual adult dose should be given unless you have kidney
problems.

200mg to 400mg once daily
from 11 months for up to 24
months or longer if needed.
Sometimes doses are
increased up to 800mg
800mg on the first day then
400mg once daily until you
are told to stop
200mg to 400mg on the
first day then 100mg to
200mg until you are told to
stop
50mg to 400mg once daily
for 7 to 30 days until you
are told to stop
100mg to 200mg once
daily, or 200mg 3 times a
week, while you are at risk
of getting an infection
150mg as a single dose

Patients with kidney problems
Your doctor may change your dose, depending on your kidney
function.

150mg 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 50mg once
daily, 150mg once weekly,
300 to 400mg 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)

Shake the prepared suspension well.

Instructions to make up the suspension:
It is recommended that your pharmacist makes up Fluconazole
powder for oral suspension before giving it to you. However
where the pharmacist does not reconstitute this product,
instructions are provided at the end of this leaflet in the section
‘The following information is intended for healthcare
professionals or for patients (where the pharmacist does not
reconstitute this product)’.
Instructions for use:
Shake the closed bottle of the suspension every time before
using.
Instructions to use the paediatric syringe:

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 400mg daily (see section ‘3.
How to take Fluconazole’).
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.

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).

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.

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.
5. How to store Fluconazole
Keep out of the sight and reach of children.
Powder for oral suspension: Do not store above 25°C. Keep the
bottle tightly closed.
Reconstituted suspension: Do not store above 30°C. Do not
freeze.
The shelf life of the reconstituted suspension is 28 days. Do not
take the medicine after the expiry date which is stated on the
carton and bottle label after ‘Exp’. 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 Fluconazole contains
-

The active substance is fluconazole. Each 1ml of
reconstituted suspension contains 10mg fluconazole.

-

The other ingredients are sucrose, colloidal anhydrous
silica, titanium dioxide (E171), xanthan gum, sodium citrate
dihydrate, citric acid anhydrous, sodium benzoate (E211)
and natural orange flavour (containing orange oil and
maltodextrin).

What Fluconazole looks like and contents of the pack
White to off-white powder for oral suspension providing a white
to off-white orange flavoured suspension after reconstitution.

Other side effects:

10mg/ml powder for oral suspension in 60ml capacity
bottle: 35ml suspension after reconstitution

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.

In each bottle the mixture of powder and water makes 35ml of
suspension.

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)

A 5ml spoon is provided to measure the correct dose.
Manufactured by:
Farmasierra Manufacturing S.L. Carretera de Irun, km 26.200,
San Sebastian de Los Reyes, Madrid, E-28700, Spain.
Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Fluconazole 10mg/ml Powder for Oral Suspension
PL 18799/2447
POM
Leaflet date: 20.06.2016

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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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