Fluco-Sol is one of a group of medicines called “antifungals”. The
active substance is fluconazole.
Fluco-Sol 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 Fluco-Sol 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 Fluco-Sol 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

if you are allergic to Fluco-Sol, 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 Fluco-Sol 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).
if you have ever developed a severe skin rash or skin peeling,
blistering and/or mouth sores after taking Fluco-Sol.
if the fungal infection does not improve, as alternative antifungal
therapy may be needed.
Serious skin reactions including drug reaction with eosinophilia and
systemic symptoms (DRESS) have been reported in association with
Fluco-Soltreatment. Stop taking Fluconazole and seek medical
attention immediately if you notice any of the symptoms related to these
serious skin reactions described in section 4.Other medicines and Fluco-Sol
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 Fluco-Sol (see section:
“Do not take Fluco-Sol if you”).
There are some medicines that may interact with Fluco-Sol. 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) use d to
help you sleep or for anxiety
• amphotericin B, voriconazole (anti-fungal)
• carbamazepine, phenytoin (used for treating fits)
• nifedipine, isradipine, amlodipine felodipine and losartan (for hypertension- high
blood pressure)
ciclosporin, everolimus, sirolimus or tacrolimus (to prevent tr ansplant 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 m edicines)
used for reducing high cholesterol levels
methadone (used for pain)
celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, melox icam,
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)
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines, including medicines obtained wi thout
a prescription.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnan t or
planning to have a baby, ask your doctor or pharmacist for advi ce
before taking this medicine.
You should not take Fluco-Sol if you are pregnant, think you ma y be
pregnant, are trying to become pregnant or breast-feeding, unle ss your
doctor has told you so.
Fluco-Sol taken during the first trimester of pregnancy may inc rease
the risk of miscarriage.
Fluco-Sol taken at low doses during the first trimester may sli ghtly
increase the risk of a baby being born with birth defects affec ting the
bones and or muscles.
You can continue breast-feeding after taking a single dose of
Fluco-Sol up to 200 mg.
You should not breast-feed if you are taking a repeated dose of Fluco-Sol .
Driving and using machines
When driving vehicles or using machines it should be taken into
account that occasionally dizziness or fits may occur.
Fluco-Sol 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 so dium
restricted diet before taking Fluco-Sol .

This medicine will be given by your doctor or nurse as a slow injection
(infusion) into your vein. Fluco-Sol is supplied as a solution. It will
not be diluted further. There is more information for healthcar e
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 Fluco-Sol

Adults

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.

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 ever y 2 days. The maximum
dose is 12 mg per kg of body weight ever y 48 hours.
Use in children less than 2 weeks old:
• The same dose as above but given once ever y 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 Fluco-Sol 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 Fluco-Sol
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.

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).
Fluco-Sol 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)
Fluco-Sol 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 Fluco-Sol and tell your doctor
immediately
Stop taking Fluco-Sol and seek medical attention immediately
if you notice any of the following symptoms:
• Widespread rash, high body temperature and enlarged lymph nodes
(DRESS syndrome or drug hypersensitivity syndrome).
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
Uncommon side effects (may affect up to 1 in 100 people):
• 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):
• 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. By reporting side effects you can help provide
more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children. Do not store above 30 C0.
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.
Do not refrigerate. Protect from light. Ask your pharmacist how to throw away medicines you no
longer use