Package leaflet: Information for the user

Diflucan® 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 Diflucan is and what it is used for

2.    What you need to know before you take Diflucan

3.    How to take Diflucan

4.    Possible side effects

5.    How to store Diflucan

6.    Contents of the pack and other information

1.    What Diflucan is and what it is used for Diflucan is one of a group of medicines called “antifungals”. The active substance is fluconazole.

Diflucan 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 Diflucan 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 Diflucan 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 take Diflucan Do not take Diflucan

-    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)

Warnings and precautions

Talk to your doctor or nurse before taking Diflucan

-    if you 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)

Other medicines and Diflucan

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 Diflucan (see section: “Do not take Diflucan if you”).

There are some medicines that may interact with Diflucan. 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)

-    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 AntiInflammatory 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)

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Pregnancy, breast-feeding and fertility

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 Diflucan while you are pregnant unless your doctor has told you to.

You can continue breast-feeding after taking a single dose of Diflucan up to 200 mg.

You should not breast-feed if you are taking a repeated dose of Diflucan.

Driving and using machines

When driving vehicles or using machines it should be taken into account that occasionally dizziness or fits may occur.

Diflucan contains sodium

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

3. How to take Diflucan

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

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 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 Diflucan than you should

If you are concerned that you may have been given too much Diflucan, 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 Diflucan 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 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).

Diflucan 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 Diflucan 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, vomiting

-    increases in blood tests of liver function

-    rash

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

-    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:

-    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 (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.

5.    How to store Diflucan

-    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:

-    Glass vials: Do not freeze.

-    Plasticised PVC bags: Store below 30°C. Do not freeze.

-    Once opened the product should be used immediately. Any unused infusion should be discarded. This medicinal product is for single use only.

-    Do not use this medicine if you notice visible particles or if the solution is unclear or discoloured.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how throw away medicines you no longer use. These measures will help protect the environment.

6.    Contents of the pack and other information

What Diflucan contains

-    The active substance is fluconazole.

-    Each ml contains 2 mg of fluconazole.

1 vial with 25 ml solution for infusion contains 50 mg fluconazole.

1 vial with 50 ml solution for infusion contains 100 mg fluconazole.

1 vial with 100 ml solution for infusion contains 200 mg fluconazole.

1 vial with 200 ml solution for infusion contains 400 mg fluconazole.

1 PVC bag with 100 ml solution for infusion contains 200 mg fluconazole.

1 PVC bag with 200 ml solution for infusion contains 400 mg fluconazole.

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

What Diflucan looks like and contents of the pack

-    Diflucan is a clear, colourless solution with no visible particles.

-    It comes in either glass vials or plasticised PVC bags Pack sizes:

-    1 vial containing 25 ml solution for infusion

-    1,48 vial(s) containing 50 ml solution for infusion

-    1,40 vial(s) containing 100 ml solution for infusion

-    1 vial containing 200 ml solution for infusion

-    1,5, 10, 20 plasticised PVC bag(s) containing 100 ml solution for infusion

-    1,5, 10, 20 plasticised PVC bag(s) containing 200 ml solution for infusion

-    Not all pack sizes may be marketed.

Marketing Authorisation Holder Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ United kingdom

Manufacturer

Fareva Amboise Zone Industrielle 29 route des Industries 37530 Poce-sur-Cisse France

This medicinal product is authorised in the Member States of the EEA under the following names:

This leaflet was last revised in: UK 06/2015 IE MM/YYYY

Ref: DF 9_0

The following information is intended for medical or healthcare professionals only:

Intravenous infusion should be administrated at a rate not exceeding 10 ml/minute. Diflucan 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 C1 -. Because Diflucan 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 intravenous infusion is compatible with the following administration fluids:

a)    Dextrose 5% and 20%

b)    Ringer’s solution

c)    Hartmann’s solution

d)    Potassium chloride in dextrose

e)    Sodium bicarbonate 4.2% and 5%

f)    Aminosyn 3.5%

g)    Sodium chloride 9 mg/ml (0.9%)

h)    Dialaflex (interperitoneal dialysis Soln 6.36%) 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.

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.

Mock up from 8817124-2