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FLUCONAZOLE 2MG/ML SOLUTION FOR INFUSION

Active substance(s): FLUCONAZOLE

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Prescriber Information
Leaflet

Package leaflet: Information for the user • Mucosal thrush - infection affecting the lining of

Fluconazole 2mg/ml

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.

with Fluconazole Infusion (see section: “Do not take
Fluconazole Infusion”).

There are some medicines that may interact with
Fluconazole 2 mg/ml Intravenous Infusion. 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)
You might also be given Fluconazole Infusion to:
• amitriptyline, nortriptyline (used as
• stop you from getting an infection caused by
anti-depressant)
Candida (if your immune system is weak and not
The following
taking this medicine because it contains
• amphotericin B, voriconazole (anti-fungal)
working properly)
information is intended
important information for you.
• medicines that thin the blood to prevent blood
• stop cryptococcal meningitis from coming back.
for medical or
• Keep this leaflet. You may need to read it again.
clots (indanedione, warfarin or similar medicines)
healthcare professionals
• If you have any further questions, ask your
2 What you need to know before you
• benzodiazepines (midazolam, triazolam or similar
only:
doctor, pharmacist or nurse.
take Fluconazole infusion
medicines) used to help you sleep or for anxiety
For single use only.
• If you get any side effects, talk to your doctor,
• carbamazepine, phenytoin (used for treating fits)
Do
not
take
Fluconazole
Infusion:
Discard any remaining
pharmacist or nurse. This includes any possible
• nifedipine, isradipine, amlodipine felodipine and
solution.
side effects not listed in this leaflet. See section 4. • If you are allergic to fluconazole, to other
losartan (for hypertension - high blood pressure)
medicines you have taken to treat fungal
Although further dilution What is in this leaflet:
• ciclosporin, everolimus, sirolimus or tacrolimus
infections or any of the other ingredients of this
is unnecessary,
1. What Fluconazole Infusion is and what it is
(to prevent transplant rejection)
medicine (listed in section 6). The symptoms may
fluconazole intravenous
used for
include itching, reddening of the skin or difficulty • cyclosphosphamide, vinca alkaloids (vincristine,
infusion is compatible
2. What you need to know before you take
vinblastine or similar medicines) used for treating
in breathing
with the following
Fluconazole Infusion
cancer
• If you are taking astemizole, terfenadine
administration fluids:
3. How to take Fluconazole Infusion
• halofantrine (used for treating malaria)
(antihistamine medicines for allergies)
4. Possible side-effects

statins (atorvastatin, simvastatin and fluvastatin
a. Dextrose 20%
• If you are taking cisapride (used for stomach
5.
How
to
store
Fluconazole
Infusion
or similar medicines) used for reducing high
b. Ringer’s solution
upsets)
6. Contents of the pack and other information
cholesterol levels
c. Hartmann’s solution
• If you are taking pimozide (used for treating
• methadone (used for pain)
d. Potassium chloride in
mental illness)
What Fluconazole Infusion is and what
1
• celecoxib, flurbiprofen, naproxen, ibuprofen,
dextrose
• If you are taking quinidine (used for treating
it is used for
lornoxicam, meloxicam, diclofenac (Non-Steroidal
e. Sodium bicarbonate
heart arrhythmia)
Anti-Inflammatory Drugs (NSAID))
4.2%
Fluconazole is one of a group of medicines called
• If you are taking erythromycin (an antibiotic for
• oral contraceptives
f. Normal saline (0.9%)
"antifungals". The active substance is fluconazole.
treating infections)
• prednisone (steroid)
Fluconazole
Infusion
is
used
to
treat
infections
Recommended method
Warnings and precautions

zidovudine, also known as AZT; saquinavir (used
caused by fungi and may also be used to stop you
of administration:
Talk to your doctor or pharmacist or nurse
in HIV-infected patients)
from getting candidal infection. The most common
Fluconazole intravenous
before taking Fluconazole Infusion
• medicines for diabetes such as chlorpropamide,
infusion does not require cause of fungal infections is a yeast called Candida. • If you have a liver or kidney problem
glibenclamide, glipizide or tolbutamide
dilution prior to
Adults
• If you suffer from heart disease, including heart
• theophylline (used to control asthma)
administration. If
You might be given this medicine by your doctor to
rhythm problems
• vitamin A (nutritional supplement)
necessary, the solution
treat the following types of fungal infections:
• If you have abnormal levels of potassium, calcium • hydrochlorothiazide (a ‘water pill’)
may be infused through
• Cryptococcal meningitis – a fungal infection in
or magnesium in your blood
• amiodarone (used for treating heart problems).
an existing administration
the brain
• If you develop severe skin reactions (itching,
Pregnancy and breast-feeding
set containing one of the • Coccidioidomycosis – a disease of the
reddening of the skin or difficulty in breathing).
If you are pregnant or breast-feeding, think you may
compatible fluids listed
bronchopulmonary system
Ketoconazole is known to cause adrenal insufficiency be pregnant or are planning to have a baby, ask your
above using a suitable ‘Y’ • Infections caused by Candida and found in the
(a condition in which the adrenal glands do not
doctor or pharmacist for advice before taking this
connection. Mixing with
blood stream, body organs (e.g. heart, lungs) or
produce adequate amounts of steroid hormones),
medicine.
other drugs prior to
urinary tract
and this could also although rarely seen be
infusion is not
• Mucosal thrush - infection affecting the lining of
Driving and using machines
applicable to fluconazole.
recommended.
the mouth, throat and denture sore mouth.
When driving vehicles or using machines it should
be taken into account that occasionally dizziness or
Fluconazole intravenous
You might also be given Fluconazole Infusion to:
Other medicines and Fluconazole Infusion
infusion may be infused
• stop cryptococcal meningitis from coming back
Tell your doctor or pharmacist if you are taking, have fits may occur.
through an existing line
• stop mucosal thrush from coming back
recently taken or might take any other medicines.
Fluconazole Infusion contains Sodium chloride
with one of the above
• stop you from getting an infection caused by
Tell your doctor immediately if you are taking
Fluconazole 2 mg/ml Intravenous Infusion contains
listed fluids. No specific
Candida (if your immune system is weak and not astemizole, terfenadine (an antihistamine for
9 mg of sodium chloride per ml of solution (e.g. 25 ml
incompatibilities have
working properly).
treating allergies) or cisapride (used for stomach
vial contains 225 mg of sodium chloride and 100 ml
been noted, although
upsets)
or
pimozide
(used
for
treating
mental
vial contains 900 mg). This may make the infusion
Children and adolescents (0 to 17 years old)
mixing with any other
illness)
or
quinidine
(used
for
treating
heart
unsuitable to people on a low sodium diet. If you are
You might be given this medicine by your doctor to
drug prior to infusion is
arrhythmia) or erythromycin (an antibiotic for
unsure about whether you are on this type of diet,
treat the following types of fungal infections:
not recommended.
treating infections) as these should not be taken
please consult your nurse or doctor.

Fluconazole
Solution for Infusion
2mg/ml
The name of your medicine is Fluconazole 2 mg/ml
Solution for Solution for Infusion, which will be called
Fluconazole Infusion throughout this leaflet.
Infusion
Read all of this leaflet carefully before you start

3 How to take Fluconazole infusion
Dosage
Always take this medicine exactly as your doctor has
told you. Check with your doctor if you are not sure.
This medicine is given by your doctor or nurse as a
slow injection (infusion) into your vein.
The usual 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
fluconazole.
Adults

Condition

Dose

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
200 mg once daily until
meningitis from coming you are told to stop
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
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 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 – 50 mg to 400 mg once
dose depends on where daily for 7 to 30 days
the infection is located
until you are told to stop
To stop mucosal
infections affecting the
lining of mouth, throat

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

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

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

If a dose of Fluconazole Infusion has been
forgotten
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
Children to 11 years old
The maximum dose for children is 400 mg daily. The you think that a dose has been forgotten.
dose will be based on the child’s weight in
If you stop taking Fluconazole Infusion
kilograms.
If you have any further questions on the use of this
medicine, ask your doctor or nurse.
Daily dose
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

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.
Doctors sometimes prescribe different doses to
these. Always take your medicine exactly as your
doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
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 receive more Fluconazole Infusion than
you should
If you are concerned that you may have been given
too much Fluconazole Infusion, 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).









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.




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

of the following symptoms, tell your doctor
Rare side effects which may affect 1 in 1,000 people
immediately. Sudden wheeziness, difficulty in
are listed below:
breathing or tightness of the chest
• Lower than normal white blood cells that help
• Swelling of eyelids, face or lips
defend against infections and blood cells that
• Itching all over the body reddening of the skin or
help to stop bleeding
itchy red spots
• Red or purple discoloration of the skin which may
• Skin rash
be caused by low platelet count
• Severe skin reactions such as a rash that causes

Other blood cell changes
blistering (this can affect the mouth and tongue).
• Blood chemistry changes (high blood levels of
Fluconazole may affect your liver. The signs of liver
cholesterol, fats)
problems include:
• Low blood potassium
• Tiredness
• Shaking
• Loss of appetite
• Abnormal electrocardiogram (ECG)
• Vomiting
• Change in heart rate or rhythm
• Yellowing of your skin or the whites of your eyes • Liver failure
(jaundice).
• Allergic reactions (sometimes severe), including
If any of these happen, stop taking Fluconazole
widespread blistering rash and skin peeling,
Infusion and tell your doctor immediately.
severe skin reactions, swelling of the lips or face
• Hair loss.
Other side effects
Additionally, if any of the following side effects gets Reporting of side effects
serious, or if you notice any side effects not listed in If you get any side effects, talk to your doctor,
this leaflet, please tell your doctor or pharmacist.
pharmacist or nurse. This includes any possible side

4 Possible side effects

Common side effects which may affect up to 1 in 10
people in 100 are listed below:
• Headache
• Stomach discomfort
• Diarrhoea
• Feeling sick
• Vomiting
• Increases in blood tests of liver function
• Rash.
Uncommon side effects which may affect up to 1in
100 people are listed below:
• 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

6 Contents of the pack and other
information

What Fluconazole Infusion contains
The active substance is fluconazole.
Each ml contains 2 mg of fluconazole.
Other ingredients are sodium chloride, hydrochloric
acid, sodium hydroxide and water for injections.
What Fluconazole Infusion looks like and
contents of the pack:
Fluconazole Infusion is a clear colourless solution
Type I glass vials: 25 ml, 50 ml and 100 ml.
Marketing Authorization Holder and
Manufacturer
Teva UK Limited, Brampton Road, Hampden Park,
Eastbourne, BN22 9AG, United Kingdom.
Manufacturer
Pharmathen S.A, 6 Dervenakion str., 15351 Pallini
Attikis, Athens, Greece.
This leaflet was last revised in January 2016
PL 00289/1569

POM

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 Infusion
Your doctor or pharmacist will know how to store
Fluconazole Infusion.
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 carton after ‘EXP’. The expiry date
refers to the last day of that month.
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.
87822-E

87822-E

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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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