DIFLUCAN 2 MG/ML SOLUTION FOR INFUSION

PACKAGE LEAFLET: INFORMATION FOR THE USER

Diflucan 2 mg/ml solution for infusion fluconazole
Read all of this leaflet carefully before you start taking this medicine. - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Diflucan is and what it is used for 2. Before you are given Diflucan 3. How Diflucan is given 4. Possible side effects 5. How to store Diflucan 6. Further 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 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 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

- 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 - prednisolone (steroid) - zidovudine, also known as AZT; saquinavir (used in HIVinfected patients) - medicines for diabetes such as chlorpropamide, glibenclamide, glipizide or tolbutamide - theophylline (used to control asthma) - vitamin A (nutritional supplement) Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Pregnancy and breast-feeding Tell your doctor if you are pregnant, trying to become pregnant or breast-feeding and your doctor will decide whether you should be given Diflucan. Ask your doctor or pharmacist for advice before taking any medicines. Driving and using machines When driving vehicles or using machines it should be taken into account that occasionally dizziness or fits may occur. Important information about some of the ingredients of Diflucan Diflucan contains 0.154 mmol sodium per ml. To be taken into consideration by patients on a controlled sodium diet.

3. HOW DIFLUCAN IS GIVEN
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 usual 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 Condition To treat cryptococcal meningitis Dose 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 200 mg once daily until you are To stop cryptococcal meningitis from coming told to stop back To treat 200 mg to 400 mg once daily from coccidioidomycosis 11 months for up to 24 months or longer if needed. Sometimes doses are increased up to 800 mg To treat internal fungal 800 mg on the first day then 400 mg once daily until you are infections caused by told to stop Candida To treat mucosal 200 mg to 400 mg on the first day infections affecting the then 100 mg to 200 mg until you lining of mouth, throat are told to stop and denture sore mouth To treat mucosal thrush dose depends on where the infection is located To stop mucosal infections affecting the lining of mouth, throat To stop you from getting an infection caused by Candida (if your immune system is weak and not working properly) 50 mg to 400 mg once daily for 7 to 30 days until you are told to stop 100 mg to 200 mg once daily, or 200 mg 3 times a week, while you are at risk of getting an infection 200 mg to 400 mg once daily while you are at risk of getting an infection

2. BEFORE YOU ARE GIVEN DIFLUCAN
You should not be treated with Diflucan if you - are allergic (hypersensitive) to fluconazole, to other medicines you have taken to treat fungal infections or to any of the other ingredients of Diflucan. 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) Take special care with Diflucan Tell your doctor 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) Taking 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 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)

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 childs weight in kilograms. Condition 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 Cryptococcal meningitis or internal fungal infections caused by Candida To stop children from getting an infection caused by Candida (if their immune system is not working properly) Daily dose 3 mg per kg of body weight (6 mg per kg of body weight might be given on the first day) 6 mg to 12 mg per kg of body weight 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 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 a dose of Diflucan 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.

- wheals, blistering (hives), itching, increased sweating - tiredness, general feeling of being unwell, fever Rare side effects which affect 1 to 10 users in 10,000 are listed below: - 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 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist or nurse.

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5. HOW TO STORE DIFLUCAN
- Keep out of the reach and sight of children. - Do not use after the expiry date which is stated on the pack after EXP. The expiry date refers to the last day of that month - Glass vials: Do not freeze. - This medicinal product is for single use. Once opened, any unused infusion should be discarded. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION
What Diflucan solution for 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 (for pH adjustment). What Diflucan solution for infusion looks like and contents of the pack - Diflucan is a clear, colourless solution with no visible particles. - It comes in a glass vial containing a total of 50 mg, 100 mg, 200 mg or 400 mg fluconazole. Not all pack sizes may be marketed. Marketing Authorisation Holder Pfizer Limited, Ramsgate Road Sandwich, Kent CT13 9NJ. United Kingdom. Manufacturer Pfizer PGM, Zone Industrielle, 29 route des Industries, 37530 Poc sur Cisse, France. This leaflet was last approved in: 11/2011 Ref: DF 1_0 UK/IE 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) Ringers solution c) Hartmanns 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.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Diflucan 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. - 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 theses 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 which affect 1 to 10 users in 100 are listed below: - headache - stomach discomfort, diarrhoea, feeling sick, vomiting - increases in blood tests of liver function - rash Uncommon side effects which affect 1 to 10 users in 1,000 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)