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FLUCONAZOLE 2 MG/ML SOLUTION FOR INFUSION

Active substance(s): FLUCONAZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Fluconazole 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 Fluconazole is and what it is used for
2. What you need to know before you take Fluconazole
3. How to take Fluconazole
4. Possible side effects
5. How to store Fluconazole
6. Contents of the pack and other information
1. WHAT FLUCONAZOLE IS AND WHAT IT IS USED FOR
Fluconazole is one of a group of medicines called “antifungals”. The
active substance is fluconazole.
Fluconazole is used to treat infections caused by fungi and may also be
used to stop you from getting candidalinfection. 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 Fluconazole 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 Fluconazole to:
• stop you from getting an infection caused by Candida (if your immune
system is weak and not working properly)
• s top cryptococcal meningitis from coming back

• rifampicin

or rifabutin (antibiotics for infections)
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’)
• alfentanil,

Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines, including medicines obtained without a
prescription.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine.
You should not take Fluconazole while you are pregnant unless your
doctor has told you to.
You can continue breast-feeding after taking a single dose of
Fluconazole up to 200 mg.
You should not breast-feed if you are taking a repeated dose of
Fluconazole.
Driving and using machines
When driving vehicles or using machines it should be taken into account
that occasionally dizziness or fits may occur.
Fluconazole contains 3.54 mg sodium per ml solution. To be taken into
consideration by patients on a controlled sodium diet.
Make sure you tell your doctor or pharmacist if you are on a sodium
restricted diet before taking fluconazole.

3. HOW TO TAKE FLUCONAZOLE

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUCONAZOLE
Do not take Fluconazole:
• 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).
• if you are taking amiodarone (used for treating uneven heartbeats
‘arrhythmias’).
Warnings and precautions
Talk to your doctor or nurse before taking Fluconazole 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 Fluconazole
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 Fluconazole (see section:
“Do not take Fluconazole if you”).
There are some medicines that may interact with Fluconazole. Make
sure your doctor knows if you are taking any of the following medicines:

This medicine will be given by your doctor or nurse as a slow injection
(infusion) into your vein. Fluconazole 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 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 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 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
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

&
The following information is intended for healthcare professionals only:

Fluconazole 2 mg/ml
Solution for infusion
fluconazole
1. Administration

2. Handling Instructions

For intravenous use as infusion only.
Fluconazole is dissolved in isotonic saline solution, with an electrolyte
content of Na+ 150 mmol and Cl- 150 mmol per 1000 ml, and may be
administered directly as an infusion. The infusion rate should not exceed 20
mg (10 ml)/minute for adults. For children, it is recommended that the infusion rate not exceed 10 mg (5 ml)/min. For premature infants the infusion
time should be no less than 15 minutes. In patients requiring sodium- or
fluid restriction, the rate of administration should be taken into consideration
as Fluconazole consists of a salt solution. In such cases the infusion should
be given over a longer period.

Fluconazole intravenous infusion is compatible with the following
administration fluids:
• Dextrose 20% solution
• Ringer’s solution
• Ringer’s-lactate solution
• Potassium chloride 1% in 5% dextrose solution
• Sodium bicarbonate 4.2% solution
• Sodium chloride 9 mg/ml (0,9%) solution
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.
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.

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

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
Your doctor may change your dose, depending on your kidney function.
If you take more Fluconazole than you should
If you are concerned that you may have been given too much
Fluconazole, 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 Fluconazole
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.

• inability

to sleep, feeling drowsy
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
• fit,

Rare side effects (may affect up to 1 in 10 people):
• 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 via the national reporting system listed in
Yellow Card Scheme, Website: 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
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:
Do not freeze.
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
This leaflet does not contain all the information about this medicine. If
you have any questions or are not sure about anything, ask your doctor.
What Fluconazole contains
The active substance is fluconazole.

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).
Fluconazole 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)
Fluconazole may affect your adrenal glands and the levels of steroid
hormones produced. The signs of adrenal problems include:
• tiredness
• muscle weakness
• loss of appetite
• weight loss
• abdominal pain
If any of theses happen, stop taking Fluconazole 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):
• headache
• stomach discomfort, diarrhoea, feeling sick, vomiting
• increases in blood tests of liver function
• rash

1 ml solution for infusion contains 2 mg of fluconazole.
50 ml/100 ml of infusion vial contains 100 mg/200 mg of fluconazole.
200 ml of infusion bags contains 400 mg of fluconazole.
The other ingredients are:
• water for injections
• sodium chloride
• hydrochloric acid for pH-adjustment
What Fluconazole looks like and contents of the pack
Solution for infusion.
The solution in the vial/plastic bag is clear and colourless.
This medicine is available in:
• a vial containing a total of either 100 mg or 200 mg fluconazole in
pack sizes of 1, 5 or 10.
• a bag containing a total of 400 mg fluconazole in pack size of 1 bag.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Hikma Farmacêutica (Portugal) S.A.
Estrada do Rio da Mó n. 8, 8A e 8B
Fervença
2705-906 Terrugem SNT
Portugal
Distributed by:
Consilient Health (UK) Ltd.
No.1 Church Road,
Richmond upon Thames, Surrey,
TW9 2QE
This medicinal product is authorised in the Member States of the
EEA under the following names:
Austria:
Fluconazol Hikma 2 mg/ml Infusionslösung
Germany: Fluconazol Hikma 2 mg/ml Lösung zur Infusion
Italy:
Fluconazolo Hikma 2 mg/ml Soluzione per infusione
Netherlands: Fluconazol Hikma 2 mg/ml oplossing voor intraveuze infusie
This leaflet was last approved in April 2016

Uncommon side effects (may affect up to 1 in 10 people):
• reduction in red blood cells which can make skin pale and cause
weakness or breathlessness
• decreased appetite

P0442

&
Any unused medicinal product or waste material should be disposed of in
accordance with local requirements.
Handling glass vials:
Fluconazole 2 mg/ml may be infused via a suitable cannula directly or
diluted with any of the fluids in the list above.
Handling plastic bags:
Do not remove unit from overwrap until ready for use. The overwrap is a
moisture barrier. The inner bag maintains the sterility of the product.
To open, tear overwrap down side at slit and remove solution container.
Some opacity of the plastic due to moisture absorption during the
sterilization process may be observed. This is normal and does not affect the
solution quality or safety. The opacity will diminish gradually. After removing
overwrap, check for minute leaks by squeezing inner bag firmly. If leaks are
found, discard solution as sterility may be impaired.
CAUTION: Do not use plastic containers in series connections. Such use
could result in air embolism due to residual air being drawn from the
primary container before administration of the fluid from the secondary
container is completed.

3. Storage information
After first opening
From the microbiological point of view, the product 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 reconstitution/dilution has be taken place in
controlled and validated conditions.
After dilution
Dilution is not necessary prior to administration.
For the diluted product chemical and physical stability has been
demonstrated for 24 hours at 25°C. From a microbiological point of view,
the product 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 not normally be longer than
24 hours at 2 to 8°C, unless dilution has taken place in controlled and
validated aseptic conditions.

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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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