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

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 ana 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 Infusion 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 are given Fluconazole Infusion

You should not be treated with Fluconazole Infusion:

if you are allergic to fluconazole orto any of the other ingredients of this medicine (jisted in section 6).

if you are allergic to other medicines you have taken to treat fungal infections.

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 fortreating mental illness).

if you are taking quinidine (used fortreating irregular heartbeats 'arrhythmias').

if you are taking erythromycin (an antibiotic for treating infections).

Warnings and precautions

Talktoyourdoctor, pharmacist or nurse before you are given Fluconazole Infusion: if you have liver or kidney problems

if you sufferfrom 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 Infusion

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 irregular heartbeats) or erythromycin (an antibiotic for treating infections) as these should not be taken with Fluconazole Infusion (see section: “You should not be treated with Fluconazole Infusion:").

There are some medicines that may interact with Fluconazole 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 an anaesthetic) amitriptyline, nortriptyline (used as an anti-depressant) amphotericin B, voriconazole (an anti-fungal)

medicines that thin the blood to prevent blood dots (warfarin or similar medidnes) benzodiazepines (midazolam, triazolam or similar medicines) used to help you sleep or for anxiety

carbamazepine, phenytoin (used fortreating fits)

nifedipine, isradipine, amlodipine, verapamil, felodipine and losartan (for

hypertension - high blood pressure)

ciclosporin, everonmus, sirolimus or tacrolimus (to prevent transplant rejection) cyclophosphamide, vinca alkaloids (vincristine, vinblastine or similar medidnes) used fortreating cancer halofantrine (used fortreating malaria)

statins (atorvastatin, simvastatin and fluvastatin or similar medicines) used for reducing high cholesterol levels methadone (used for pain)

celecoxib, flurbiprofen, naproxen, ibuprofen, lomoxicam, meloxicam, didofenac (Non-Steroidal Anti-Inflammatory Drugs (NSAID)) oral contraceptives prednisone (steroid)

zidovudine, also known as AZT; saquinavir (used in FllV-infected patients) medicines for diabetes such as chlorpropamide, glibenclamide, glipizide or tolbutamide

theophylline (used to control asthma) vitamin A(nutritional supplement)

amiodarone (used fortreating uneven heartbeats 'arrhythmias') hydrochlorothiazide (a diuretic)

Pregnancy and breast-feeding

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 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 Infusion contains sodium

This medicine contains 0.154 mmol sodium per ml. To be taken into consideration by patients on a controlled sodium diet.

3. How Fluconazole is given

Always use this medicine exactly as your doctor or pharmacist has told you. Check with yourdoctor or pharmacist if you are not sure.

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

Fluconazole Infusion 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 Infusion.

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Adults

Adolescents from 12 to 17 years old

Follow the dose prescribed by yourdoctor (either adults or children posology).

Children to 11 years old

The maximum dose for children Is 400 mg dally.

The dose will be based on the child's weight in Kilograms.

Use in infants 0 to 4 weeks of age

Infants between 15 and 28 days old:

•    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.

Infants between 0and 14cfaysold:

•    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. 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

Yourdoctor may change yourdose, 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).

If a dose of Fluconazole 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 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 of the following symptoms, tell your doctor immediately. Common side effects (may affect up to 1 in 10 people) are: skin rash.

Uncommon side effects (may affect up to 1 in 100 people) are:

itching all overthe body, reddening of the skin or itchy red spots.

Rare side effects (may affect up to 1 in 1,000 people) are:

sudden wheezing, difficulty in breathing or tightness in the chest swelling of eyelids, face or lips

severe skin reactions such as a rash that causes blistering (this can affect the mouth and tongue).

If any of these symptoms happen, stop using Fluconazole [(MAH) to be completed nationally] and tell your doctor immediately.

Fluconazole [(MAH) to be completed nationally] may affect your liver. The signs of the liver problems include:

Common side effects (may affect up to 1 in 10 people) are: vomiting

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Uncommon side effects (may affect up to 1 in 100 people) are: tiredness loss of appetite

yellowing ofyourskin orthe whites of your eyes (jaundice)

Fluconazole [(MAH) to be completed nationally] may affect other organ systems as well which can result in the following symptoms:

Uncommon side effects (may affect up to 1 in 100 people) are: fits

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, leading to any unexplained bruising or bleeding, sudden fever, sore throat, mouth ulcers.

If any of these symptoms happen, stop using Fluconazole [(MAH) to be completed nationally] 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 increases in blood tests of liverfunction rash

Uncommon side effects which (may affect up to 1 in 100 people) are:

reduction in red blood cells which can make skin pale and cause weakness

or breathlessness

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

liverdamage

wheals, blistering (hives), itching, increased sweating general feeling of being unwell, fever Rare side effects (may affect up to 1 in 1,000 people) are:

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

liverfailure

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 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 and label. The expiry date refers to the last day of that month.

Do not freeze.

Bags (freeflex®): Do not store above 25°C. Do not freeze.

Bottles (KabiPac®): Do not freeze.

The medicinal product must be used immediately after first opening the container.

Do not use this medicine if you notice that the solution is not clear or if you notice any visible particles. Do not use if the bottle or bag is damaged.

The bottles and bags are for single use only. Once having been used, bottles, bags and any remaining contents must be disposed of.

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

What Fluconazole Infusion contains

The active substance is fluconazole.

Each ml contains 2 mg of fluconazole.

The other ingredients are: sodium chloride, water for injections and sodium hydroxide or hydrochloric acid (for pH adjustment).

What Fluconazole Infusion looks like and contents of the pack

Fluconazole Infusion is a clear, colourless solution with no visible particles.

_ Pack sizes-

1.10.20.25.30.40.50.60    bottles/bags x 50 ml with 100 mg of Fluconazole

1.10.20.25.30.40.50.60    bottles/bags x 100 ml with 200 mg of Fluconazole 1,10,20,25,30,40 bottles/bags x 200 ml with 400 mg of Fluconazole

Not all pack sizes may be marketeer

Marketing Authorisation Holder

Fresenius KabiLtd,

Cestrian Court, Eastgate Way,

Manor Park, Runcorn,

Cheshire, WA71 NT United Kingdom

Manufacturer

Fresenius Kabi Polska Sp. z o.o.

ul.Sienkiewicza25

99-300 Kutno

Poland

This leaflet was last amended in June 2016

Detailed information on this medicine is available on the web site of the MHRA.

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