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FLUCONAZOLE 40 MG/ML POWDER FOR ORAL SUSPENSION

Active substance(s): FLUCONAZOLE

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Diflucan® 40 mg/ml
powder for oral suspension
Fluconazole 40 mg/ml
powder for oral suspension

2343
02.06.17[11]

(fluconazole)
PATIENT INFORMATION LEAFLET
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.
Your medicine is available using any one of the above names but will be
referred to as Diflucan throughout the following leaflet.
What is in this leaflet:
1. What Diflucan is and what it is used for
2. What you need to know before you take Diflucan
3. How to take Diflucan
4. Possible side effects
5. How to store Diflucan
6. 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
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)
 if you develop signs of ‘adrenal insufficiency’ where the adrenal glands
do not produce adequate amounts of certain steroid hormones such as
cortisol (chronic, or long lasting fatigue, muscle weakness, loss of
appetite, weight loss, abdominal pain)
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)
 amiodarone (used for treating uneven heartbeats ‘arrhythmias’)
 hydrochlorothiazide (a diuretic)
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.

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

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

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.
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 oral syringe:
Shake the prepared suspension well.
1. Open the bottle (safety cap);
2. Insert the adapter fitted onto the oral syringe into the bottle neck (Figure
1);
3. Turn the bottle with the oral syringe upside down and withdraw the
quantity of suspension prescribed by the doctor (Figure 2). The marks
on the oral syringe are shown in ml.
A maximum dose of 400 mg daily should not be exceeded in children.
(see section “3. How to take Diflucan”).
4. Remove the oral syringe from the bottle;
5. The medicinal product may be given directly into the mouth from the
oral syringe. The patient should remain upright during administration.
Point the oral syringe at the inside of the cheek; release the suspension
slowly into the patient’s mouth (Figure 3).
6. Rinse the oral syringe after use.
7. Close the bottle with the safety cap; the adapter will remain on the
bottle neck.

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
Dose
To treat cryptococcal
meningitis

400 mg on the first day then 200 mg to 400 For dose conversion of the powder for oral suspension from mg/ml to
mg once daily for 6 to 8 weeks or longer if
ml/kg body weight (BW) for paediatric patients, see section 6.
needed. Sometimes doses are increased
up to 800 mg
For adult patients, please calculate the dose in ml to administer according
200 mg once daily until you are told to stop to the posology in mg recommended and the product strength.

To stop cryptococcal
meningitis from coming back
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 400 mg once
infections caused by Candida daily until you are told to stop
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

200 mg to 400 mg on the first day then
100 mg to 200 mg until you are told to stop
50 mg to 400 mg once daily for 7 to 30
days until you are told to stop
100 mg to 200 mg once daily, or 200 mg 3
times a week, while you are at risk of
getting an infection
150 mg as a single dose

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
Depending on the site of the infection 50
nail infections
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 daily while you
infection caused by Candida (if are at risk of getting an infection
your immune 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.

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.

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:

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 orangeflavoured suspension after reconstitution.
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 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.
Dose conversion of the powder for oral suspension from mg/ml to
ml/kg body weight (BW) for paediatric patients:
Diflucan 40 mg/ml powder for oral suspension:
In children Diflucan powder for oral suspension should be measured as
closely as possible according to the following equation:
child’s weight (kg) * prescribed dosage (mg/kg)
Dose in ml/day =
product strength (mg/ml)

 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 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.
 Do not use Diflucan after the expiry date which is stated on the pack.
The expiry date refers to the last day of that month.
 Powder for oral suspension: Do not store 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.
 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
1 ml of reconstituted suspension contains 40 mg fluconazole.
 Excipients
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.
 Diflucan is a dry white to off-white powder with an aroma of orange
flavour. Your pharmacist will add 24ml of water to the powder produce,
an orange flavoured suspension containing the equivalent of 200mg of
fluconazole per 5 ml.
 In each bottle the mixture of powder and water makes 35 ml of
suspension.
 A 60 ml high density polyethylene (HDPE) bottle with a plastic childresistant closure
 A 5 ml graduated oral syringe with a press-in bottle adaptor.
The graduations of the oral syringe are in increments of 0.2 ml.
Manufacturer and Product Licence holder
Manufactured by Fareva Amboise, Zone Industrielle, 29 route des
Industries, 37530 Pocé-sur-Cisse, France
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex, HA1
1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2343

Leaflet revision and issue date (Ref) 02.06.17[11]
Diflucan is a trademark of the Pfizer Ltd.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 020 8423 2111 to obtain the
leaflet in a format suitable for you.

The graduations of the oral syringe are in increments of 0.2 ml. Therefore
for intermediate weights and dosages, the dose to be given in ml should
be calculated then rounded up or down to the nearest graduation of the
oral syringe.
For example, a child weighing 23 kg prescribed Diflucan 6 mg/kg/day
should receive 138 mg/day, equivalent to 3.45 ml of the 40 mg/ml oral
suspension. The dose may be rounded down to 3.4 ml, the nearest
graduation on the oral syringe to provide the full dose.
A maximum dose of 400 mg daily should not be exceeded in the
paediatric population (see table *).
The use of Diflucan 40 mg/ml powder for oral suspension is not
recommended for weights under 15 kg. For weights under 15 kg, it is
recommended to use Diflucan 10 mg/ml powder for oral suspension.
Weight Kg
15 kg
20 kg
25 kg
30 kg
35 kg
40 kg
50 kg

Posology (Corresponding dose in ml/day)
3mg/kg/day
6mg/kg/day
12mg/kg/day
1.2 ml
2.2 ml
4.6 ml
1.6 ml
3.0 ml
6.0 ml
1.8 ml
3.8 ml
7.6 ml
2.2 ml
4.6 ml
9.0 ml
2.6 ml
5.2 ml
10.0 ml*
3.0 ml
6.0 ml
10.0 ml*
3.8 ml
7.6 ml
10.0 ml*

Expand Transcript

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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