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308/12607501/0615

Package leaflet: Information for the user

B. Braun Melsungen AG ■ 34209 Melsungen, Germany

= 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 or pharmacist.

•    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 side effects, talk to your doctor or pharmacist. This includes any possible side effect 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 are given Fluconazole

3.    How Fluconazole is given

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 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 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)

•    stop cryptococcal meningitis from coming back

2. What you need to know before you are given Fluconazole

Do not use 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

•    are taking astemizole, terfenadine (antihistamine medicines for allergies)

•    are taking cisapride (used for stomach upsets),

•    are taking pimozide (used for treating mental illness)

•    are taking quinidine (used for treating heart arrhythmia)

•    are taking erythromycin (an antibiotic for treating infections)

Warnings and precautions

Tell to your doctor before you are given Fluconazole if you

•    have liver or kidney problems

•    suffer from heart disease, including heart rhythm problems

•    have abnormal levels of potassium, calcium or magnesium in your blood

•    develop severe skin reactions (itching, reddening of the skin or difficulty in breathing).

Other medicines and Fluconazole

Tell your doctor 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 heart arrhythmia) or erythromycin (an antibiotic for treating infections) as these should not be taken with Fluconazole (see section: 'Do not take Fluconazole').

There are some medicines that may interact with Fluconazole. 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)

•    cyclophosphamide, vinca alkaloids (vincristine, vinblastine or similar medicines) used for treating cancer

•    halofantrine (used for treating malaria)

•    statins (atorvastatin, simvastatin, 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)

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 for advice before you are given this medicine.

Your doctor will decide whether you should be given 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 sodium

Fluconazole contains 3.54 mg of sodium per ml. To be taken into consideration by patients on a controlled sodium diet.

3. How Fluconazole is given

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 dose

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

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.

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 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 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 (may affect up to 1 in 1 000 people). 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 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)

If any of these 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) are listed below:

•    headache

•    stomach discomfort, diarrhoea, feeling sick, vomiting

•    increases in blood tests of liver function

•    rash

BlBRAUN

Uncommon side effects (may affect up to 1 in 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 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 listed below:

•    lower 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 or pharmacist. 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

6. Contents of the pack and other information

What Fluconazole contains

•    The active substance is fluconazole Each ml contains 2 mg of fluconazole

•    The other ingredients are

Sodium chloride and water for injections

What Fluconazole looks like and contents of the pack

Fluconazole is a clear colourless solution of the above mentioned ingredients in water.

It comes in bottles of polyethylene, containing 50 ml, 100 ml or 200 ml Pack sizes: Packs of 10, 20 or 50 bottles Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder:

B. Braun Melsungen AG

Carl-Braun-StraBe 1    Postal address:

34212 Melsungen, Germany    34209 Melsungen, Germany

Tel.: +49-5661-71-0 Fax: +49-5661-71-45 67

Manufacturer:

B. Braun Medical S.A.

Carretera de Terrassa, 121 08191 Rubi (Barcelona)

Spain

The following information is intended for healthcare professionals only:

Intravenous infusion should be administrated at a rate not exceeding 10 ml/minute. Fluconazole 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 Cl^-. Because Fluconazole 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 2 mg/ml is compatible with the following administration fluids:

a)    Glucose 200 mg/ml solution for infusion (if available)

b)    Ringer's solution for infusion

c)    Hartmann's solution, Lactated Ringer's solution (if available)

d)    Potassium chloride solution 20 mEq/l in glucose 50 mg/ml (if available)

e)    Sodium bicarbonate 84 mg/ml (8,4%) solution for infusion (if available)

g)    Sodium Chloride 9 mg/ml (0,9%) solution for infusion

h)    Sterofundin ISO solution for infusion (if available)

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.

Shelf life after first opening:

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

Shelf life after dilution according to directions

For mixtures with the solutions listed above, chemical and physical stability has been demonstrated at 25 °C over 72 hours.

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.

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