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FLUCONAZOLE 10 MG/ML POWDER FOR ORAL SUSPENSION

Active substance(s): FLUCONAZOLE

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Package leaflet: Information for the user

Diflucan® 10 mg/ml powder for oral suspension /
Fluconazole 10 mg/ml powder for oral suspension
(fluconazole)
This product is available as any of the above names but will be referred to as Diflucan
throughout this leaflet. Please note that this leaflet also contains information on other
strength (Diflucan® 40 mg/ml powder for oral suspension).
Read all of this leaflet carefully before you start taking this medicine because it
contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may
harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1.
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

 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 (NonSteroidal 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 200 mg.
You should not breast-feed if you are taking a repeated dose of Diflucan.
Driving and using machines
When driving vehicles or using machines it should be taken into account that occasionally
dizziness or fits may occur.
Diflucan 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 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.
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

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

To stop cryptococcal meningitis from
coming back

200 mg once daily until you are told to stop

To treat coccidioidomycosis

200 mg to 400 mg once daily from 11
months for up to 24 months or longer if
needed. Sometimes doses are increased
up to 800 mg

To treat internal fungal infections caused
by Candida

800 mg on the first day then 400 mg once
daily until you are told to stop

To treat mucosal infections affecting the
lining of the mouth, throat and denture sore
mouth

200 mg to 400 mg on the first day then 100
mg to 200 mg until you are told to stop

To treat mucosal thrush – dose depends
on where the infection is located

50 mg to 400 mg once daily for 7 to 30
days until you are told to stop

To stop mucosal infections of mouth and
throat from coming back

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

To treat genital thrush

150 mg as a single dose

To reduce recurrence of vaginal thrush

150 mg every third day for a total of 3
doses (day 1, 4 and 7) and then once a
week for 6 months while you are at risk of
getting an infection

To treat fungal skin and nail infections

Depending on the site of the infection 50
mg once daily, 150 mg once weekly, 300 to
400 mg once weekly for 1 to 4 weeks
(Athlete’s foot may be up to 6 weeks, for
nail infection treatment until infected nail is
replaced)

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

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

2. What you need to know 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 this medicine (listed in section
6). The symptoms may include itching, reddening of the skin or difficulty in breathing
 if you are taking astemizole, terfenadine (antihistamine medicines for allergies)
 if you are taking cisapride (used for stomach upsets)
 if you are taking pimozide (used for treating mental illness)
 if you are taking quinidine (used for treating heart arrhythmia)
 if you are taking erythromycin (an antibiotic for treating infections)
Warnings and precautions
Talk to your doctor or pharmacist before taking Diflucan
 if you have liver or kidney problems
 if you suffer from heart disease, including heart rhythm problems
 if you have abnormal levels of potassium, calcium or magnesium in your blood
 if you develop severe skin reactions (itching, reddening of the skin or difficulty in
breathing)
Other medicines and Diflucan
Tell your doctor 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)

Dose

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

Children to 11 years old

Other side effects:

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

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

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

Instructions to make up the suspension:

Reporting of side effects

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 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.

Condition

Daily dose

Mucosal thrush and throat infections caused
by Candida – dose and duration depends on
the severity of the infection and on where the
infection is located

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

Cryptococcal meningitis or internal fungal
infections caused by Candida

6 mg to 12 mg per kg of body weight

To stop children from getting an infection
caused by Candida (if their immune system
is not working properly)

3 mg to 12 mg per kg of body weight

Use in children 0 to 4 weeks of age
Use in children of 3 to 4 weeks of age:
The same dose as above but given once every 2 days.
The maximum dose is 12 mg per kg of body weight every 48 hours.
Use in children less than 2 weeks old:
The same dose as above but given once every 3 days.
The maximum dose is 12 mg per kg of body weight every 72 hours.
Elderly
The usual adult dose should be given unless you have kidney problems.
Patients with kidney problems

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.

5. How to store Diflucan
 Keep 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: 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 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
 If your medicine becomes discoloured or show signs of any deterioration, consult your
doctor or pharmacist who will tell you what to do.
6. Contents of the pack and other information
What Diflucan contains
 The active substance is fluconazole. Each ml of reconstituted suspension contains 10
mg fluconazole. The other ingredients are: sucrose, colloidal anhydrous silica, titanium
dioxide (E171), 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:

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

 Diflucan comes in a 60 ml capacity plastic bottle which contains 24.4 g powder. After
reconstitution, the volume of the suspension is 35 ml.
 Diflucan is a White dry powder with an orange odour. 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.
 Diflucan comes in a plastic bottle with a child resistant cap and a temper evident seal,
with a 5 ml graduated plastic syringe and a plastic press in bottle adaptor to measure the
correct dose.
PL: 15814/1180

POM

Manufactured by Pfizer PGM, Pocé-sur-Cisse, France OR Fareva Amboise, Pocé-surCisse, France.
Procured from within the EU and repackaged by the Product Licence holder: O.P.D.
Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.): 07.04.2016
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.
Diflucan is a registered trademark of Pfizer group of companies.
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 off-white orange-flavoured suspension
after reconstitution.
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 (
) or (
) on the bottle (this corresponds in total to adding the required 24
ml 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 35 ml.
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.

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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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