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DIFLUCAN 10 MG/ML POWDER FOR ORAL SUSPENSION

Active substance: FLUCONAZOLE

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Service Développement Pfizer Amboise
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DIFLUCAN POS UK/IRL

NOIR

8819881
Couleur:
8819880
pliee ND
Minimum font size: 8 pts
157 x 315 mm
Version: 2
157 x 40 mm (8 volets)
Préparé par : A.S.Laloux
Date: 02/12/2014
Text only is subject to market approval.
Hungary
Greece
The Netherlands
Romania
Slovakia
Slovenia
Spain

Diflucan 10 mg/ml and 40 mg/ml
por belsőleges szuszpenzióhoz
Fungustatin
Diflucan 10 mg/ml and
40 mg/ml
Diflucan 10 mg/ml pulbere
pentru suspesie orală
Diflucan P.O.S. 50 mg/5 ml and
Diflucan P.O.S. 200 mg/5 ml
Diflucan 10 mg/ml and 40 mg/ml
prašek za peroralno suspenzij
Diflucan 10 mg/ml and 40 mg/ml
polvo para suspensión oral

Package leaflet: Information for the user

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 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.

This leaflet was last revised in 11/2014
Ref: DF 10_0 UK/IE
The following information is intended for healthcare
professionals or for patients (where the pharmacist does
not reconstitute this product):
Instructions to make up the suspension:
The reconstituted suspension will provide a white to offwhite orange-flavoured suspension after reconstitution.

What is in this leaflet:

10 mg/ml or 40 mg/ml powder for oral suspension
in 60 ml capacity bottle: 35 ml 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.

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.  hat Diflucan is and what it is used for
W
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.

10 mg/ml powder for oral suspension in 175 ml capacity
bottle: 100 ml 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 66ml 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
100ml.
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.

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.  hat you need to know before you take
W
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 this medicine (listed in
section 6). The symptoms may include itching, reddening of
the skin or difficulty in breathing
8819881



- 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 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 HIVinfected 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.
Driving and using machines
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).
- If you have an intolerance to some sugars, please contact
your doctor before taking this medicine.
- Doses of 10 ml contain 5.5 g or more of sugar. This should

be taken into account if you have diabetes.
- May be harmful to teeth if used for period 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.
It is best to take medicine at the same time each day.
The recommended dose 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
To stop cryptococcal
200 mg once daily until you
meningitis from coming back 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
800 mg on the first day then
infections caused by
400 mg once daily until you
Candida
are told to stop
To treat mucosal infections
200 mg to 400 mg on the first
affecting the lining of the
day then 100 mg to 200 mg
mouth, throat and denture
until you are told to stop
sore mouth
To treat mucosal thrush –
50 mg to 400 mg once daily
dose depends on where the for 7 to 30 days until you are
infection is located
told to stop
To stop mucosal infections
100 mg to 200 mg once
of mouth and throat from
daily, or 200 mg 3 times a
coming back
week, while you are at risk of
getting an infection
To treat genital thrush
150 mg as a single dose
To reduce recurrence of
150 mg every third day for a
vaginal thrush
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 Depending on the site of the
infections
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 200 mg to 400 mg once
infection caused by Candida daily while you are at risk of
(if your immune system
getting an infection
is weak and not working
properly)

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.
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)”.
Instructions for use:
Shake the closed bottle of the suspension every time before
using.
Instructions to use the paediatric syringe:
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.

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.

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 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

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.
Ireland
HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2;
Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.
hpra.ie; E-mail: medsafety@hpra.ie.

5. How to store Diflucan
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date which is
stated on the bottle and the outer carton after EXP. The
expiry date refers to the last day of that month.
Powder for oral suspension:
- Store 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.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.
6. Contents of the pack and other information
What Diflucan contains
- The active substance is fluconazole. 1 ml of reconstituted
suspension contains 10 mg or 40mg 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).
What Diflucan looks like and contents of the pack:
10 mg/ml powder for oral suspension in 60 ml capacity
bottle: 35 ml suspension after reconstitution
10 mg/ml powder for oral suspension in 175 ml capacity
bottle: 100 ml suspension after reconstitution
- Diflucan 10 mg/ml powder for oral suspension comes in two
bottle sizes
- a 60 ml capacity bottle which contains 24.4g powder. After
reconstitution, the volume of the suspension is 35ml or
- a 175 ml capacity bottle which contains 67.1g powder. After
reconstitution, the volume of the suspension is 100ml
- 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 this leaflet below) a white to off-white orange
flavoured suspension is produced.
- In each bottle the mixture of powder and water makes 35ml
or 100 ml of suspension.
- The 35ml suspension comes with 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.
- The 100ml suspension comes with a measuring cup to
measure the correct dose.
40 mg/ml powder for oral suspension in 60 ml capacity
bottle: 35 ml suspension after reconstitution
- Diflucan 40 mg/ml powder for oral suspension comes as a
60 ml capacity bottle which contains 24.4g powder. After
reconstitution, the volume of the suspension is 35ml.
- Diflucan 40 mg/ml powder for oral suspension is a dry white
to off-white powder. After adding water to the powder (as
instructed in this leaflet below) a white to off-white orange
flavoured suspension 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.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
Manufacturer
Fareva Amboise
Zone Industrielle,
29 route des Industries
37530 Pocé-sur-Cisse
France,
This medicinal product is authorised in the Member
States of the EEA under the following names:
Austria

Diflucan 10 mg/ml and
40 mg/ml Trockensaft
Diflucan

Belgium, Denmark,
Finland, Iceland, Ireland,
Italy, Luxembourg,
Norway, Portugal,
Sweden, United
Kingdom
France
Triflucan
Germany
Diflucan Trockensaft
10 mg/ml
Diflucan 40 mg/ml Pulver zur
Herstellung einer Suspension
zum Einnehmen

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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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