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DIFLUCAN 2 MG/ML SOLUTION FOR INFUSION

Active substance(s): FLUCONAZOLE

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DIFLUCAN IV UK /IRL

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Diflucan® 2 mg/ml
solution for infusion
fluconazole
Read all of this leaflet carefully before you start using
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 of the 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. 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 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
You might also be given Diflucan to:
- stop cryptococcal meningitis from coming back
- stop mucosal thrush from coming back
- 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 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 nurse 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 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 AntiInflammatory 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)

Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
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 or
pharmacist 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 contains sodium
Diflucan contains 0.154 mmol sodium per ml. To be taken
into consideration by patients on a controlled sodium diet.
3. How to take Diflucan
This medicine will be given by your doctor or nurse as a
slow injection (infusion) into your vein. Diflucan is supplied
as a solution. It will not be diluted further. There is more
information for healthcare professionals in a section at the
end of the leaflet.
The recommended doses of this medicine for different
infections are below. Check with your doctor or nurse if
you are not sure why you are being given Diflucan.
Adults
Condition
To treat cryptococcal
meningitis

To stop cryptococcal
meningitis from coming
back
To treat
coccidioidomycosis

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

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
infections caused by
then 400 mg once daily
Candida
until you are told to stop
To treat mucosal infections 200 mg to 400 mg on the
affecting the lining of
first day then 100 mg to
mouth, throat and denture 200 mg until you are told
sore mouth
to stop
To treat mucosal thrush – 50 mg to 400 mg once daily
dose depends on where the for 7 to 30 days until you
infection is located
are told to stop
To stop mucosal infections 100 mg to 200 mg once
affecting the lining of
daily, or 200 mg 3 times a
mouth, throat
week, while you are at risk
of getting an infection
To stop you from getting
200 mg to 400 mg once
an infection caused by
daily while you are at risk of
Candida (if your immune
getting an infection
system is weak and not
working properly)
Adolescents from 12 to 17 years old
Follow the dose prescribed by your doctor (either adults or
children posology).
Children to 11 years old
The maximum dose for children is 400 mg daily.
The dose will be based on the child’s weight in kilograms.
Condition
Mucosal thrush and
throat infections caused
by Candida – dose and
duration depends on the
severity of the infection and
on where the infection is
located
Cryptococcal meningitis or
internal fungal infections
caused by Candida
To stop children from
getting an infection caused
by Candida (if their immune
system is not working
properly)

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

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

Use in children 0 to 4 weeks of age
Use in children of 3 to 4 weeks of age:
• The same dose as above but given once every 2 days.
The maximum dose is 12 mg per kg of body weight
every 48 hours.
Use in children less than 2 weeks old:
• The same dose as above but given once every 3 days.
The maximum dose is 12 mg per kg of body weight
every 72 hours.
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.
If you take more Diflucan than you should
If you are concerned that you may have been given too
much Diflucan, tell your doctor or nurse immediately. The
symptoms of a possible overdose may include hearing,
seeing, feeling and thinking things that are not real
(hallucination and paranoid behaviour).
If you forget to take Diflucan
As you will be given this medicine under close medical
supervision, it is unlikely that a dose would be missed.
However tell your doctor or pharmacist if you think that a
dose has been forgotten.
If you have any further questions on the use of this
medicine, ask your doctor, pharmacist or nurse.
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.



Package leaflet: Information for the user

Date: 17/07/2015

- 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)
- shaking
- low blood potassium
- 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
(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 pack after EXP. The expiry date refers to
the last day of that month.
Storage conditions:
- Glass vials: Do not freeze.
- Plasticised PVC bags: Store below 30°C. Do not freeze.
- Once opened the product should be used immediately.
Any unused infusion should be discarded. This
medicinal product is for single use only.
- Do not use this medicine if you notice visible particles or
if the solution is unclear or discoloured.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how throw away
medicines you no longer use. These measures will help
protect the environment.
6. Contents of the pack and other information

Austria
Belgium, Bulgaria,
Denmark, Finland, Iceland,
Ireland, Italy, Luxembourg,
Norway, Portugal, Poland,
Sweden, United Kingdom
Cyprus, Greece
Czech Republic
Estonia
France
Germany
Hungary
Latvia
Romania
Netherlands
Slovakia
Slovenia
Spain

Diflucan 2 mg/ml
Infusionslösung
Diflucan

Fungustatin
Diflucan IV
Diflucan 2mg/ml
Triflucan 2 mg/ml, solution
injectable pour perfusion
Diflucan i.v. 2 mg/ml,
Infusionslösung
Diflucan 2 mg/ml oldatos
infúzió
Diflucan 2 mg/ml solution
for infusion
Diflucan 2 mg/ml soluţie
perfuzabilă
Diflucan I.V. 2 mg/ml,
oplossing voor infusie
Diflucan IV 2mg/ml
Diflucan 2 mg/ml raztopina
za infundiranje
Diflucan 2mg/ml solucion
para Perfusion

This leaflet was last revised in:
UK 06/2015
IE MM/YYYY
Ref: DF 9_0
--------------------------------------------------------------------The following information is intended for medical or
healthcare professionals only:
Intravenous infusion should be administrated at a rate
not exceeding 10 ml/minute. Diflucan is formulated in
sodium chloride 9 mg/ml (0.9%) solution for infusion,
each 200 mg (100 ml bottle) containing 15 mmol each
of Na+ and C1-. Because Diflucan is available as a dilute
sodium chloride solution, in patients requiring sodium or
fluid restriction, consideration should be given to the rate
of fluid administration.
Fluconazole intravenous infusion is compatible with the
following administration fluids:
a) Dextrose 5% and 20%
b) Ringer’s solution
c) Hartmann’s solution
d) Potassium chloride in dextrose
e) Sodium bicarbonate 4.2% and 5%
f) Aminosyn 3.5%
g) Sodium chloride 9 mg/ml (0.9%)
h) Dialaflex (interperitoneal dialysis Soln 6.36%)
Fluconazole may be infused through an existing line
with one of the above listed fluids. Although no specific
incompatibilities have been noted, mixing with any other
medicinal products prior to infusion is not recommended.
The solution for infusion is for single use only.
From a microbiological point of view, the dilutions
should be used immediately. If not used immediately,
in-use storage times and conditions prior to use are the
responsibility of the user and would normally not be longer
than 24 hours at 2 to 8 ° C, unless dilution has taken place
in controlled and validated aseptic conditions.
The dilution is to be made under aseptic conditions. The
solution is to be inspected visually for particulate matter
and discoloration prior to administration. The solution
should only be used if the solution is clear and free from
particles.
Any unused medicinal product or waste material should be
disposed of in accordance with local requirements.



What Diflucan contains
- The active substance is fluconazole.
- Each ml contains 2 mg of fluconazole.
1 vial with 25 ml solution for infusion contains 50 mg
fluconazole.
1 vial with 50 ml solution for infusion contains 100 mg
fluconazole.
1 vial with 100 ml solution for infusion contains 200 mg
fluconazole.
1 vial with 200 ml solution for infusion contains 400 mg
fluconazole.
1 PVC bag with 100 ml solution for infusion contains
200 mg fluconazole.
1 PVC bag with 200 ml solution for infusion contains
400 mg fluconazole.
- The other ingredients are: sodium chloride, water for
injections and sodium hydroxide (for pH adjustment).
What Diflucan looks like and contents of the pack
- Diflucan is a clear, colourless solution with no visible
particles.
- It comes in either glass vials or plasticised PVC bags
Pack sizes:
- 1 vial containing 25 ml solution for infusion
- 1, 48 vial(s) containing 50 ml solution for infusion
- 1, 40 vial(s) containing 100 ml solution for infusion
- 1 vial containing 200 ml solution for infusion
- 1, 5, 10, 20 plasticised PVC bag(s) containing 100 ml
solution for infusion
- 1, 5, 10, 20 plasticised PVC bag(s) containing 200 ml
solution for infusion
- 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:

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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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