Patient Information Leaflet: Information for the User

Diflucan 50 mg hard capsules, 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules

fluconazole
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Diflucan is and what it is used for
What you need to know before taking Diflucan
How to take Diflucan
Possible side effects
How to store Diflucan
Contents of the pack and other information

1. What Diflucan is and what it is used for

Diflucan belongs to a group of medicines called "antifungals". The active substance is
fluconazole.
Diflucan is used to treat fungal infections and can also be used to prevent Candida infections. The most common cause of fungal infections is a yeast called Candida.
Adults
Your doctor may prescribe this medicine to treat the following fungal infections:

Cryptococcal meningitis – a fungal infection of the brain
Coccidioidomycosis – a disease affecting the bronchopulmonary system
Infections caused by Candida found in the bloodstream, organs (e.g. heart, lungs) or urinary tract
Mucosal candidiasis – infection of the oral mucosa, throat infection, and denture stomatitis
Genital candidiasis – infection of the vagina or penis
Skin infections – e.g. athlete's foot, ringworm, genital itching, nail infections

Diflucan may be prescribed to:

prevent recurrence of cryptococcal meningitis
prevent recurrence of mucosal candidiasis
reduce recurrences of vaginal candidiasis
prevent Candida infections (if your immune system is weakened or not functioning properly)

Children and adolescents (from 0 to 17 years of age)
Your doctor may prescribe this medicine to treat the following fungal infections:

Mucosal candidiasis – infection of the oral mucosa, throat infection
Infections caused by Candida found in the bloodstream, organs (e.g. heart, lungs) or urinary tract
Cryptococcal meningitis – a fungal infection of the brain

Diflucan may be prescribed to:

prevent Candida infections (if your immune system is weakened or not functioning properly)
prevent recurrence of cryptococcal meningitis

2. What you should know before taking Diflucan

Do not take Diflucan

if you are allergic to fluconazole, to other medicines used to treat fungal infections, or to any of the other ingredients of this medicine (listed in section 6). Symptoms may include itching, skin redness, or difficulty breathing
if you are taking astemizole or terfenadine (antihistamine medicines used to treat allergies)
if you are taking cisapride (used to treat stomach disorders)
if you are taking pimozide (used to treat mental disorders)
if you are taking quinidine (used to treat cardiac arrhythmias)
if you are taking erythromycin (an antibiotic used to treat bacterial infections).

Warnings and precautions
Talk to your doctor or pharmacist before taking Diflucan

if you have liver or kidney problems
if you suffer from heart conditions, including cardiac arrhythmia
if you have abnormal levels of potassium, calcium, or magnesium in your blood
if severe skin reactions occur (itching, skin redness, or difficulty breathing)
if signs of 'adrenal insufficiency' appear, where the adrenal glands do not produce adequate amounts of certain steroid hormones such as cortisol (chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain)
if you have ever developed a severe rash or skin peeling, blisters and/or mouth ulcers after taking fluconazole.

Severe skin reactions, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported with fluconazole treatment. Stop taking Diflucan and contact your doctor immediately if you notice any of the symptoms related to severe skin reactions described in section 4.
Talk to your doctor or pharmacist if your fungal infection does not improve, as alternative antifungal therapy may be needed.
Other medicines and Diflucan
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 (antihistamines used to treat allergies), cisapride (used to treat stomach disorders), pimozide (used to treat mental disorders), quinidine (used to treat cardiac arrhythmias), or erythromycin (an antibiotic used to treat bacterial infections), as these must not be taken with Diflucan (see section: “Do not take Diflucan”).
Some medicines may interact with Diflucan. Inform your doctor if you are taking any of the following medicines, as dose adjustment or monitoring may be needed to ensure these medicines continue to work as intended:

rifampicin or rifabutin (antibiotics used to treat bacterial infections)
abrocitinib (used to treat atopic dermatitis, also known as atopic eczema)
alfentanil, fentanyl (anesthetics)
amitriptyline, nortriptyline (antidepressants)
amphotericin B, voriconazole (antifungals)
blood-thinning medicines 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 to treat epileptic seizures)
nifedipine, isradipine, amlodipine, verapamil, felodipine, and losartan (used to treat hypertension - high blood pressure)
olaparib (used to treat ovarian carcinoma)
ciclosporin, everolimus, sirolimus, or tacrolimus (used to prevent transplant rejection)
cyclophosphamide, vinca alkaloids (vincristine, vinblastine or similar medicines) used to treat cancer
halofantrine (used to treat malaria)
statins (atorvastatin, simvastatin, fluvastatin and similar medicines) used to lower high cholesterol levels
methadone (used to treat pain)
celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (Non-Steroidal Anti-Inflammatory Drugs - NSAIDs)
oral contraceptives
prednisone (a steroid)
zidovudine, also known as AZT; saquinavir (used in patients with HIV)
diabetes medicines such as chlorpropamide, glibenclamide, glipizide, or tolbutamide
theophylline (used to control asthma)
tofacitinib (used to treat rheumatoid arthritis)
tolvaptan, used to treat hyponatremia (low sodium levels in the blood) or to slow the decline in kidney function
vitamin A (dietary supplement)
ivacaftor (alone or in combination with other medicines used to treat cystic fibrosis)
amiodarone (used to treat "arrhythmias", irregular heartbeats)
hydrochlorothiazide (a diuretic)
ibrutinib (used to treat blood cancer)
lurasidone (used to treat schizophrenia).

Diflucan with food and drink
You may take this medicine with or without food.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Diflucan if you are pregnant, think you might be pregnant, or are planning to become pregnant, unless your doctor specifically tells you to. If you become pregnant while taking this medicine or within 1 week after the most recent dose, contact your doctor.
Taking fluconazole during the first trimester of pregnancy may increase the risk of miscarriage.
Taking low-dose fluconazole during the first trimester may slightly increase the risk of the baby being born with bone and/or muscle malformations.
You may continue breastfeeding after taking a single 150 mg dose of Diflucan.
You must not breastfeed if you are taking repeated doses of Diflucan.
Driving and using machines
Be aware that dizziness or seizures may occur while driving or operating machinery.
Diflucan contains lactose (milk sugar) and sodium (salt)
This medicine contains a small amount of lactose (milk sugar). If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
Diflucan capsules contain less than 1 mmol (23 mg) of sodium per capsule, i.e., essentially 'sodium-free'.

3. How to take Diflucan

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Swallow the capsule whole with a glass of water. It is best to take the capsules at the same time each day.
The recommended doses of this medicine to be taken depending on the infection are listed below:
Adults

Condition	Dose
Treatment of cryptococcal meningitis	400 mg on the first day, then 200–400 mg once daily for 6–8 weeks or longer if needed. Sometimes doses are increased up to 800 mg.
Prevention of recurrence of cryptococcal meningitis	200 mg once daily until you are told to stop.
Treatment of coccidioidomycosis	200–400 mg once daily for 11 months up to 24 months or longer if necessary. Sometimes doses are increased up to 800 mg.
Endemic Candida fungal infections	800 mg on the first day, then 400 mg once daily until you are told to stop.
Treatment of oral mucosal infections, throat infections, and denture-related stomatitis	200–400 mg on the first day, then 100–200 mg once daily until you are told to stop.
Mucosal candidiasis – dose depends on site of infection	50–400 mg once daily for 7–30 days or until you are told to stop.
Prevention of recurrence of oral mucosal infections and throat infections	100–200 mg once daily, or 200 mg three times weekly, for as long as you remain at risk of infection.
Genital candidiasis	Single 150 mg dose.
Reduction of recurrent vaginal candidiasis	150 mg every three days for a total of 3 doses (day 1, 4, and 7), then once weekly for 6 months while you are at risk
	of acquiring infection.
Skin mycoses and nail infections	Depending on the site of infection: 50 mg once daily, 150 mg once weekly, or 300–400 mg once weekly for 1 to 4 weeks (athlete’s foot may require up to 6 weeks; treatment of nail infections continues until the infected nail is fully replaced).
Prevention of Candida infections (if your immune system is weakened or not functioning properly)	200–400 mg once daily while you are at risk of infection.

Adolescents from 12 to 17 years
Always take the dose prescribed by your doctor (either the adult dosage or the pediatric dosage).
Children up to 11 years
The maximum dose in children is 400 mg per day.
The dose will be based on the child's weight in kilograms.

Condition	Daily dose
Oropharyngeal and mucosal candidiasis – dosage and duration of treatment depend on the severity and site of infection	3 mg per kg of body weight once daily (on the first day, 6 mg per kg of body weight may be administered)
Cryptococcal meningitis or endemic fungal infections due to Candida	6 mg to 12 mg per kg of body weight once daily
Prevention of recurrence of cryptococcal meningitis	6 mg per kg of body weight once daily
Prevention of Candida infection in children (if their immune system is not working properly)	3 mg to 12 mg per kg of body weight once daily

Use in children aged 0 to 4 weeks
Use in children aged 3 to 4 weeks:
The same dosage described above, administered once every 2 days. The maximum dose is
12 mg per kg of body weight every 48 hours.
Use in children under 2 weeks of age:
The same dosage described above, administered once every 3 days. The maximum dose is
12 mg per kg of body weight every 72 hours.
Elderly
The same dose as for adults should be used unless you have renal problems.
Patients with renal impairment
Your doctor may adjust the dosage according to kidney function.
If you take more Diflucan than you should
Taking too many capsules at once could cause problems. Contact your doctor immediately or go to the nearest hospital.
In case of accidental overdose, symptoms may include sensing, seeing, perceiving, and thinking things that are not real (hallucinations and paranoid behaviour). Symptomatic treatment may be appropriate (with adequate supportive measures and, if necessary, gastric lavage).
If you forget to take Diflucan
Do not take a double dose to make up for the missed dose. If you forget to take a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and take the next dose at the regular time.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Diflucan and contact your doctor immediately if you notice any of the following symptoms:

widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Some people may experience allergic reactions, although severe allergic reactions are rare. If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. If you develop any of the following symptoms, inform your doctor immediately:

sudden breathlessness, difficulty breathing, or tightness in the chest
swelling of the eyelids, face, or lips
itching all over the body, skin redness, or itchy red patches
skin rashes
severe skin reactions, for example rashes causing blisters (which may affect the mouth and tongue).

Diflucan may affect the liver. Symptoms of liver problems include:

fatigue
loss of appetite
vomiting
yellowing of the skin and whites of the eyes (jaundice)

If you experience any of these symptoms, stop taking Diflucan and contact your doctor immediately.
Other side effects:
If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.
Common side effects (may affect up to 1 in 10 people) are:

headache
stomach discomfort, diarrhoea, nausea, vomiting
increased liver function test values in blood tests
skin rashes

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

reduced red blood cells, which may cause paleness, weakness, or breathlessness
decreased appetite
insomnia, drowsiness
seizures, dizziness, vertigo, tingling, prickling, or numbness, altered taste
constipation, indigestion, flatulence, dry mouth
muscle pain
liver damage and yellowing of the skin and eyes (jaundice)
swelling, blisters (urticaria), itching, increased sweating
tiredness, general malaise, fever.

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

lower than normal levels of white blood cells, which help defend against infections, and of platelets, which are necessary for blood clotting
altered skin colouration (red or purplish), which may be caused by reduced platelet count or other changes in blood cells
changes in blood chemistry (high levels of cholesterol, fats)
low potassium levels in the blood
chills
abnormal electrocardiogram (ECG), changes in heart rhythm and rate
liver failure
allergic reactions (sometimes severe), including rashes with widespread blistering and peeling of the skin, serious skin reactions, swelling of the lips and face
hair loss

Frequency not known, but possible (frequency cannot be estimated from available data):

hypersensitivity reaction with rash, fever, swollen glands, increase in a type of white blood cell (eosinophilia), and inflammation of internal organs (liver, lungs, heart, kidneys, and large intestine) (drug reaction or rash with eosinophilia and systemic symptoms (DRESS))

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

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 stated on the label after Exp.. The expiry date refers to the last day of that month.
Store below 30°C.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Diflucan contains

The active substance is fluconazole.
Each hard capsule contains fluconazole 50 mg, 100 mg, 150 mg or 200 mg.
The excipients are: Capsule contents: monohydrate lactose, maize starch, anhydrous colloidal silica, magnesium stearate and sodium lauryl sulfate (see section 2, Diflucan contains lactose (milk sugar) and sodium (salt)).

Capsule shell composition:
50 mg hard capsules: gelatin (E441), titanium dioxide (E171) and patent blue V (E131)
100 mg hard capsules: gelatin (E441), titanium dioxide (E171), erythrosine (E127) and patent blue V (E131)
150 mg hard capsules: gelatin (E441), titanium dioxide (E171) and patent blue V (E131)
200 mg hard capsules: gelatin (E441), titanium dioxide (E171), erythrosine (E127) and indigo carmine (E132)
Printing ink: lacquer, black iron oxide (E172), n-butyl alcohol, dehydrated alcohol, purified water, propylene glycol (E1520), industrial denatured alcohol, isopropyl alcohol, concentrated ammonia solution, potassium hydroxide (E525).

Description of the appearance of Diflucan and package contents

Diflucan 50 mg hard capsules have a white body and turquoise cap. They are printed in black ink with the word “Pfizer” and the code “FLU-50”.
Diflucan 100 mg hard capsules have a white body and blue cap. They are printed in black ink with the word “Pfizer” and the code “FLU-100”.
Diflucan 150 mg hard capsules have a turquoise body and turquoise cap. They are printed in black ink with the word “Pfizer” and the code “FLU-150”.
Diflucan 200 mg hard capsules have a white body and purple cap. They are printed in black ink with the word “Pfizer” and the code “FLU-200”.

Diflucan 50 mg, 100 mg, 150 mg and 200 mg are available in packages containing 1, 2, 3, 4, 6, 7, 10, 12, 14, 20, 28, 30, 42, 50, 60, 100 or 500 hard capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Pfizer Italia S.r.l.
Via Isonzo, 71 – 04100 Latina, Italy

Manufacturer:
Fareva Amboise - Zone Industrielle – 29 Route des Industries, 37530 Pocé-sur-Cisse, France

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria	Diflucan 50 mg Capsules Diflucan 100 mg Capsules Diflucan 150 mg Capsules Diflucan 200 mg Capsules
Belgium, Bulgaria, Denmark, Finland, Ireland, Iceland, Italy, Lithuania, Luxembourg, Norway, Portugal, United Kingdom, Sweden	Diflucan
Czech Republic	Diflucan 50 mg Diflucan 100 mg Diflucan 150 mg
Cyprus, Greece	Fungustatin
Estonia	Diflucan 150mg
France	Triflucan 50 mg capsule Triflucan 100 mg capsule Triflucan 200 mg capsule Fluconazole Pfizer 150mg capsule
Germany	Diflucan 50mg Diflucan 100mg Fungata Diflucan 200mg
Hungary	Diflucan 50 mg hard capsules Diflucan 100 mg hard capsules Diflucan 150 mg hard capsules Diflucan 200 mg hard capsules
Latvia	Diflucan 150 mg hard capsules
Netherlands	Diflucan 50 mg Diflucan 100 mg Diflucan 150 mg Diflucan 200 mg
Portugal	Diflucan 150
Romania	Diflucan 50 mg capsule Diflucan 150 mg capsule
Slovakia	Diflucan 50mg Diflucan 100mg Diflucan 150mg
Slovenia	Diflucan 50 mg hard capsules Diflucan 100 mg hard capsules Diflucan 150 mg hard capsules
Spain	Diflucan 50 mg hard capsules Diflucan 100 mg hard capsules Diflucan 150 mg hard capsules Diflucan 200 mg hard capsules

Other sources of information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency.

Patient Information Leaflet: Information for the User

Diflucan 10 mg/ml powder for oral suspension

fluconazole
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What Diflucan is and what it is used for
What you need to know before taking Diflucan
How to take Diflucan
Possible side effects
How to store Diflucan
Contents of the pack and other information

1. What Diflucan is and what it is used for

Diflucan belongs to a group of medicines called "antifungals". The active substance is
fluconazole.
Diflucan is used to treat fungal infections and can also be used to prevent
Candida infections. The most common cause of fungal infections is a yeast called Candida.
Adults
Your doctor may prescribe this medicine to treat the following fungal infections:

Cryptococcal meningitis – a fungal infection of the brain
Coccidioidomycosis – a disease affecting the bronchopulmonary system
Infections caused by Candida found in the bloodstream, organs (e.g. heart, lungs), or urinary tract
Mucosal candidiasis – infection of the oral mucosa, throat infection, and denture-related stomatitis
Genital candidiasis – infection of the vagina or penis
Skin infections – e.g. athlete’s foot, ringworm, genital itching, nail infections

Diflucan may be prescribed to you for:

preventing recurrence of cryptococcal meningitis
preventing recurrence of mucosal candidiasis
reducing recurrences of vaginal candidiasis
preventing Candida infections (if your immune system is weakened or not functioning properly)

Children and adolescents (0 to 17 years of age)
Your doctor may prescribe this medicine to treat the following fungal infections:

Mucosal candidiasis – infection of the oral mucosa, throat infection
Infections caused by Candida found in the bloodstream, organs (e.g. heart, lungs), or urinary tract
Cryptococcal meningitis – a fungal infection of the brain

Diflucan may be prescribed to you for:

preventing Candida infections (if your immune system is weakened or not functioning properly)
preventing recurrence of cryptococcal meningitis

2. What you should know before taking Diflucan

Do not take Diflucan

if you are allergic (hypersensitive) to fluconazole, to other medicines you have used to treat fungal infections, or to any of the other ingredients of this medicine (listed in section 6). Symptoms may include itching, skin redness, or difficulty breathing
if you are taking astemizole or terfenadine (antihistamine medicines used to treat allergies)
if you are taking cisapride (used to treat stomach disorders)
if you are taking pimozide (used to treat mental disorders)
if you are taking quinidine (used to treat heart arrhythmias)
if you are taking erythromycin (an antibiotic used to treat bacterial infections).

Warnings and precautions
Talk to your doctor or pharmacist before taking Diflucan

if you have liver or kidney problems.
if you suffer from heart diseases, including cardiac arrhythmia.
if you have abnormal levels of potassium, calcium, or magnesium in your blood.
if severe skin reactions occur (itching, skin redness, or difficulty breathing).
if signs of 'adrenal insufficiency' appear, meaning your adrenal glands do not produce adequate amounts of certain steroid hormones such as cortisol (chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain).
if you have ever developed a severe rash or skin peeling, blisters, and/or mouth ulcers after taking fluconazole.

Other medicines and Diflucan
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 (antihistamines used to treat allergies), cisapride (used to treat stomach disorders), pimozide (used to treat mental disorders), quinidine (used to treat heart arrhythmias), or erythromycin (an antibiotic used to treat bacterial infections), as these must not be taken with Diflucan (see section: “Do not take Diflucan”).

Some medicines may interact with Diflucan. Inform your doctor if you are taking any of the following medicines, as dose adjustment or monitoring may be necessary to ensure these medicines continue to work as intended:

rifampicin or rifabutin (antibiotics used to treat bacterial infections)
abrocitinib (used to treat atopic dermatitis, also known as atopic eczema)
alfentanil, fentanyl (anaesthetics)
amitriptyline, nortriptyline (antidepressants)
amphotericin B, voriconazole (antifungals)
blood-thinning medicines 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 to treat epileptic seizures)
nifedipine, isradipine, amlodipine, verapamil, felodipine, and losartan (used to treat hypertension – high blood pressure), olaparib (used to treat ovarian cancer)
ciclosporin, everolimus, sirolimus, or tacrolimus (used to prevent transplant rejection)
cyclophosphamide, vinca alkaloids (vincristine, vinblastine, or similar medicines) used to treat cancer
halofantrine (used to treat malaria)
statins (atorvastatin, simvastatin, fluvastatin, and similar medicines) used to reduce high cholesterol levels
methadone (used to treat pain)
celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (Non-Steroidal Anti-Inflammatory Drugs - NSAIDs)
oral contraceptives
prednisone (a steroid)
zidovudine, also known as AZT; saquinavir (used in patients with HIV)
diabetes medicines such as chlorpropamide, glibenclamide, glipizide, or tolbutamide
theophylline (used to control asthma)
tofacitinib (used to treat rheumatoid arthritis)
tolvaptan, used to treat hyponatremia (low sodium levels in the blood) or to slow the decline in kidney function
vitamin A (dietary supplement)
ivacaftor (alone or in combination with other medicines used to treat cystic fibrosis)
amiodarone (used to treat "arrhythmias", irregular heartbeats)
hydrochlorothiazide (a diuretic)
ibrutinib (used to treat blood cancer)
lurasidone (used to treat schizophrenia).

Diflucan with food and drink
You may take this medicine with or without food.

Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breast-feeding, consult your doctor or pharmacist before taking this medicine. If you become pregnant while taking this medicine or within 1 week after the most recent dose, contact your doctor.
Do not take Diflucan if you are pregnant, think you may be pregnant, or are planning a pregnancy, unless specifically advised by your doctor.
Fluconazole taken during the first trimester of pregnancy may increase the risk of miscarriage.
Low-dose fluconazole taken during the first trimester may slightly increase the risk of the baby being born with bone and/or muscle malformations.
You may continue breastfeeding after a single 150 mg dose of Diflucan.
You must not breast-feed if you are taking repeated doses of Diflucan.

Driving and using machines
Be aware that dizziness or seizures may occur while driving or operating machinery.

Diflucan oral suspension powder contains sucrose (sugar), sodium benzoate, and sodium (salt).

If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
Doses of 10 ml contain 5.5 g or more of sugar. This should be considered in patients with diabetes mellitus.
May be harmful to teeth if used for periods longer than 2 weeks.
The 60 ml bottle contains 83 mg of sodium benzoate per bottle, equivalent to 2.38 mg/ml.
The 175 ml bottle contains 238 mg of sodium benzoate per bottle, equivalent to 2.38 mg/ml.
Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).
Once reconstituted, Diflucan 10 mg/ml oral suspension powder contains 1.13 mg of sodium per ml. This corresponds to 4.5% of the maximum daily recommended sodium intake for an adult.

3. How to take Diflucan

Take this medicine exactly as prescribed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
It is best to take the medicine at the same time each day.
The recommended doses of this medicine, depending on the infection, are listed below.
Adults

Condition	Dose
Treatment of cryptococcal meningitis	400 mg on the first day, then 200–400 mg once daily for 6–8 weeks or longer, if necessary. Sometimes doses are increased up to 800 mg.
Prevention of recurrence of cryptococcal meningitis	200 mg once daily until you are told to stop.
Treatment of coccidioidomycosis	200–400 mg once daily for 11 months up to 24 months or longer if necessary. Sometimes doses are increased up to 800 mg.
Endemic Candida fungal infections	800 mg on the first day, then 400 mg once daily until you are told to stop.
Treatment of oral mucosal infections, throat infections and denture-related stomatitis	200–400 mg on the first day, then 100–200 mg once daily until you are told to stop.
Mucosal candidiasis – dose depends on site of infection	50–400 mg once daily for 7–30 days until you are told to stop.
Prevention of oral mucosal infections, throat infection	100–200 mg once daily, or 200 mg three times weekly, for as long as you are at risk of developing an infection.
Genital candidiasis	150 mg as a single dose.
Reduce recurrences of vaginal candidiasis	150 mg every three days for a total of 3 doses (day 1, 4 and 7), then once weekly for 6 months while you are at risk of developing an infection.
Skin mycoses and nail infections	Depending on the site of infection: 50 mg once daily, 150 mg once weekly, or 300–400 mg once weekly for 1 to 4 weeks (athlete’s foot may require up to 6 weeks; treatment of nail infections continues until the infected nail is fully replaced).
Prevention of Candida infections (if your immune system is weakened or not functioning properly)	200–400 mg once daily while you are at risk of developing an infection.

Adolescents aged 12 to 17 years
Always take the dose prescribed by your doctor (either the adult or pediatric dosage).
Children up to 11 years
The maximum dose in children is 400 mg per day.
The dose will be based on the child's weight in kilograms.

Condition	Daily dose
Oral and throat mucosal candidiasis – dosage and duration of treatment depend on the severity and site of infection	3 mg per kg of body weight once daily (on the first day, 6 mg per kg of body weight may be administered)
Cryptococcal meningitis or endemic Candida infections	6 mg to 12 mg per kg of body weight once daily
Prevention of recurrence of cryptococcal meningitis	6 mg per kg of body weight once daily
Prevention of Candida infection in children (if their immune system is not functioning properly)	3 mg to 12 mg per kg of body weight once daily

Use in children from 0 to 4 weeks of age
Use in children from 3 to 4 weeks of age:
The same dosage described above, administered once every 2 days. The maximum dose is
12 mg per kg of body weight every 48 hours.
Use in children under 2 weeks of age:
The same dosage described above, administered once every 3 days. The maximum dose is
12 mg per kg of body weight every 72 hours.
Elderly
The same dose as recommended for adults should be used, unless you have renal problems.
Patients with renal impairment
Your doctor may adjust the dosage according to kidney function.
Instructions for reconstitution of the suspension:
It is recommended that reconstitution of Diflucan oral suspension be performed by the pharmacist prior to dispensing the medicine. However, if the pharmacist does not reconstitute this product, instructions are included at the end of this leaflet in the section “These instructions are intended for healthcare professionals or patients (if the pharmacist does not reconstitute this product)”.

Instructions for use:

Shake the closed bottle each time before use.

Instructions for using the oral dosing syringe:

Shake the reconstituted suspension well.

Open the bottle (child-resistant cap);
Insert the oral dosing syringe adapter into the neck of the bottle (Figure 1);
Invert the bottle with the oral dosing syringe and draw up the amount of suspension prescribed by the doctor (Figure 2). The markings on the oral dosing syringe are in ml. In children, the maximum daily dose of 400 mg must not be exceeded (see section “3. How to take Diflucan”).
Return the bottle with the oral dosing syringe to the upright position and remove the oral dosing syringe from the bottle;
The medicine can be administered directly into the mouth using the oral dosing syringe. During administration, the patient must remain in an upright position. Insert the oral dosing syringe inside the cheek and slowly expel the suspension into the patient's mouth (Figure 3).
Rinse the oral dosing syringe.
Close the bottle with the child-resistant cap; the adapter will remain in the neck of the bottle.

Three sequential illustrations show how to aspirate fluid from a vial using a syringe and administer it orally to a child

For conversion of the oral suspension powder dose from mg/ml to ml/kg body weight in paediatric patients, see section 6.
For adult patients, calculate the dose to be administered in ml based on the recommended dosage in mg and the product strength.

If you take more Diflucan than you should
Taking too much Diflucan may cause you problems. Contact your doctor immediately or go to the nearest hospital.
In case of accidental overdose, symptoms may include experiencing sensations, seeing, perceiving or thinking things that are not real (hallucinations and paranoid behaviour). Symptomatic treatment may be appropriate (with adequate supportive measures and, if necessary, gastric lavage).

If you forget to take Diflucan
Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and take the next dose at the regular time.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Diflucan and contact your doctor immediately if you notice any of the following symptoms:

widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Some people may experience allergic reactions, although severe allergic reactions are rare. If you experience any side effect, inform your doctor or pharmacist. This includes any possible side effect not listed in this leaflet.
If you experience any of the following symptoms, contact your doctor immediately:

sudden breathlessness, difficulty breathing, or tightness in the chest
swelling of the eyelids, face, or lips
itching all over the body, skin redness, or itchy red patches
skin rashes
severe skin reactions, for example rashes causing blisters (may affect the mouth and tongue)

Diflucan may affect the liver. Symptoms of liver problems include:

fatigue
loss of appetite
vomiting
yellowing of the skin and whites of the eyes (jaundice)

If you experience any of these symptoms, stop taking Diflucan and contact your doctor immediately.

Other side effects
If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

Common side effects (may affect more than 1 in 10 people) are:

headache
stomach discomfort, diarrhoea, nausea, vomiting
increased liver function test values in blood tests
skin rashes

Uncommon side effects (may affect more than 1 in 100 people) are:

reduction in red blood cells, which may cause paleness, weakness, or breathlessness
decreased appetite
insomnia, drowsiness
seizures, dizziness, vertigo, tingling, prickling or numbness, altered taste
constipation, difficulty digesting, flatulence, dry mouth
muscle pain
liver damage and yellowing of the skin and eyes (jaundice)
swellings, blisters (urticaria), itching, increased sweating
fatigue, general malaise, fever

Rare side effects (may affect more than 1 in 1,000 people) are:

lower than normal levels of white blood cells (which help defend against infections) and platelets (which allow blood to clot)
skin discolouration (red or purple), which may be caused by a reduction in platelets or other changes in blood cells
changes in blood chemistry (high levels of cholesterol, fats)
low levels of potassium in the blood
chills
abnormal electrocardiogram (ECG), changes in heart rhythm and rate
liver failure
allergic reactions (sometimes severe), including rashes with widespread blistering and peeling of the skin, severe skin reactions, swelling of the lips and face
hair loss

Frequency not known (cannot be estimated from the available data):

hypersensitivity reaction with rash, fever, swollen glands, increase in a type of white blood cell (eosinophilia), and inflammation of internal organs (liver, lungs, heart, kidneys, and large intestine) (drug reaction or rash with eosinophilia and systemic symptoms (DRESS))

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at: “https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse”. By reporting side effects, you can help provide more information on the safety of this medicine.

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 bottle and label after Exp.. The expiry date refers to the last day of that month.
Powder for oral suspension:
do not store above 25°C. Keep the bottle tightly closed.
once reconstituted, do not store the suspension above 30°C; do not freeze.
the shelf life of the reconstituted suspension is 28 days.

Do not dispose of any medicine via wastewater or household waste. Any unused suspension must be discarded 28 days after reconstitution. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Diflucan contains

The active substance is fluconazole. 1 ml of reconstituted suspension contains 10 mg of fluconazole.
The other components are: sucrose, anhydrous colloidal silica, titanium dioxide (E 171), xanthan gum (E415), sodium citrate, anhydrous citric acid, sodium benzoate (E211), and natural orange flavour (containing orange oil and maltodextrin) (See section 2: Diflucan oral suspension powder contains sucrose (sugar), sodium benzoate and sodium (salt)).

Description of the appearance of Diflucan and contents of the pack:
Oral suspension powder 10 mg/ml in 60 ml bottle: 35 ml of suspension after reconstitution
Oral suspension powder 10 mg/ml in 175 ml bottle: 100 ml of suspension after reconstitution

Diflucan 10 mg/ml oral suspension powder is available in bottles of two sizes:
a 60 ml bottle containing 24.4 g of powder. After reconstitution, the suspension volume is 35 ml, or
a 175 ml bottle containing 67.1 g of powder. After reconstitution, the suspension volume is 100 ml.
Diflucan 10 mg/ml oral suspension powder is a white to off-white powder. After addition of water (as described in the instructions for healthcare professionals), the powder forms a white to off-white orange-flavoured suspension.
In each bottle, the mixture of powder and water yields 35 ml or 100 ml of suspension.
To accurately measure the oral dose, the 35 ml suspension pack includes a 5 ml graduated oral dosing syringe with a press-fit bottle adapter.
To accurately measure the oral dose, the 100 ml suspension pack includes a dosing cup and a 5 ml graduated oral dosing syringe with a press-fit bottle adapter.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Pfizer Italia S.r.l.
Via Isonzo, 71 – 04100 Latina, Italy
Manufacturer:
Fareva Amboise
Zone Industrielle – 29 Route des Industries, 37530 Pocé-sur-Cisse, France
This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria	Diflucan 10 mg/ml – Oral suspension concentrate
Belgium, Denmark, Iceland, Ireland, Italy, Luxembourg, Norway, Portugal, Sweden, United Kingdom	Diflucan
France	Triflucan 10 mg/ml, powder for oral suspension
Germany	Diflucan Oral Suspension Concentrate 10 mg/ml
Hungary	Diflucan 10 mg/ml powder for oral suspension
Netherlands	Diflucan 10 mg/ml
Romania	Diflucan 10 mg/ml powder for oral suspension
Slovakia	Diflucan P.O.S. 10 mg/ml
Spain	Diflucan 10 mg/ml powder for oral suspension

Other sources of information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (Agenzia Italiana del Farmaco).

This information is intended for healthcare professionals or patients (in case the pharmacist does not reconstitute the product):
Instructions for preparing the suspension:
After reconstitution, the suspension appears as a white or almost white orange-flavoured suspension.

Oral suspension powder 10 mg/ml in 60 ml bottle: 35 ml of suspension after reconstitution

Tap the bottle gently to loosen the powder from the walls.
Reconstitute by adding 24 ml of water. First, add a small amount of purified water and shake vigorously. Then, add water up to the marked level ( ) on the bottle (this ensures that the required 24 ml of water are added).
Shake well for 1–2 minutes to obtain a homogeneous suspension.
After reconstitution, a usable volume of 35 ml will result.
Write the expiry date of the reconstituted suspension on the bottle label (the reconstituted suspension is stable for 28 days). Unused suspension must not be used after this date and should be returned to the pharmacist.

Oral suspension powder 10 mg/ml in 175 ml bottle: 100 ml of suspension after reconstitution

Tap the bottle gently to loosen the powder from the walls.
Reconstitute by adding 66 ml of water. First, add a small amount of purified water and shake vigorously. Then, add water up to the marked level ( ) on the bottle (this ensures that the required 66 ml of water are added).
Shake well for 1–2 minutes to obtain a homogeneous suspension.
After reconstitution, a usable volume of 100 ml will result.
Write the expiry date of the reconstituted suspension on the bottle label (the reconstituted suspension is stable for 28 days). Unused suspension must not be used after this date and should be returned to the pharmacist.

Conversion of the oral suspension powder dose from mg/ml to ml/kg body weight in paediatric patients:
Diflucan 10 mg/ml oral suspension powder:
In children, Diflucan oral suspension powder should be measured as closely as possible according to the following equation:

weight of child (kg) × prescribed dose (mg/kg)
Dose in ml/day = ________________________________________________
concentration of product (mg/ml)

The oral dosing syringe is graduated in 0.2 ml increments. Therefore, for intermediate weights and doses, the dose to be administered in ml must be calculated and then rounded up or down to the nearest graduation on the oral dosing syringe.
For example, a child weighing 11 kg prescribed Diflucan 3 mg/kg/day should receive 33 mg/day, equivalent to 3.3 ml of the 10 mg/ml oral suspension. To administer the full dose, this may be rounded up to 3.4 ml, the nearest graduation on the oral dosing syringe.

In the paediatric population, the maximum daily dose of 400 mg must not be exceeded (see * in the table below).
The use of Diflucan 10 mg/ml oral suspension powder is not recommended for doses > 15.0 ml (refer to the table for doses, highlighted in grey). If doses exceed 15.0 ml, use of Diflucan 40 mg/ml oral suspension powder is recommended.

Dosage examples table:
Dosage (corresponding dose in ml/day)

| Weight (kg) | 3 mg/kg/day | 6 mg/kg/day | 12 mg/kg/day |
|------------|-------------|-------------|--------------|
| 3 kg | 1.0 ml | 1.8 ml | 3.6 ml |
| 5 kg | 1.6 ml | 3.0 ml | 6.0 ml |
| 7.5 kg | 2.2 ml | 4.6 ml | 9.0 ml |
| 10 kg | 3.0 ml | 6.0 ml | 12.0 ml |
| 12.5 kg | 3.8 ml | 7.6 ml | 15.0 ml |
| 15 kg | 4.6 ml | 9.0 ml | 18.0 ml |
| 20 kg | 6.0 ml | 12.0 ml | 24.0 ml |
| 25 kg | 7.6 ml | 15.0 ml | 30.0 ml |
| 30 kg | 9.0 ml | 18.0 ml | 36.0 ml |
| 35 kg | 10.6 ml | 21.0 ml | 40.0 ml* |
| 40 kg | 12.0 ml | 24.0 ml | 40.0 ml* |
| 45 kg | 13.6 ml | 27.0 ml | 40.0 ml* |
* Maximum recommended daily dose of 400 mg (40.0 ml of 10 mg/ml suspension) not to be exceeded. Doses above 15.0 ml/day should use Diflucan 40 mg/ml oral suspension powder.

Package leaflet: Information for the user

Diflucan 2 mg/ml solution for infusion

fluconazole
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Diflucan is and what it is used for
What you need to know before taking Diflucan
How to take Diflucan
Possible side effects
How to store Diflucan
Contents of the pack and other information

1. What Diflucan is and what it is used for

Adults
Your doctor may prescribe this medicine to treat the following fungal infections:

Cryptococcal meningitis – a fungal infection of the brain
Coccidioidomycosis – a disease affecting the bronchopulmonary system
Infections caused by Candida found in the bloodstream, organs (e.g. heart, lungs) or urinary tract
Mucosal candidiasis – infection of the oral mucosa, throat infection, and denture-related stomatitis

Diflucan may be prescribed to you to:

prevent recurrence of cryptococcal meningitis
prevent recurrence of mucosal candidiasis
prevent Candida infections (if your immune system is weakened or not functioning properly)

Children and adolescents (from 0 to 17 years of age)
Your doctor may prescribe this medicine to treat the following fungal infections:

Mucosal candidiasis – infection of the oral mucosa, throat infection
Infections caused by Candida found in the bloodstream, organs (e.g. heart, lungs) or urinary tract
Cryptococcal meningitis – a fungal infection of the brain

Diflucan may be prescribed to you to:

prevent Candida infections (if your immune system is weakened or not functioning properly)
prevent recurrence of cryptococcal meningitis

2. What you need to know before taking Diflucan

Do not take Diflucan

if you are allergic (hypersensitive) to fluconazole, to other medicines you have used to treat fungal infections, or to any of the other ingredients of this medicine (listed in section 6). Symptoms may include itching, skin redness, or difficulty breathing
if you are taking astemizole, terfenadine (antihistamines used to treat allergies)
if you are taking cisapride (used to treat stomach disorders)
if you are taking pimozide (used to treat mental disorders)
if you are taking quinidine (used to treat cardiac arrhythmias)
if you are taking erythromycin (an antibiotic used to treat bacterial 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 diseases, including cardiac arrhythmia
if you have abnormal levels of potassium, calcium, or magnesium in your blood
if severe skin reactions occur (such as itching, skin redness, or difficulty breathing)
if signs of 'adrenal insufficiency' appear, where the adrenal glands do not produce adequate amounts of certain steroid hormones such as cortisol (chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain)
if you have ever developed a severe rash or skin peeling, blisters and/or mouth ulcers after taking fluconazole.

Other medicines and Diflucan
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 (antihistamines used to treat allergies), cisapride (used to treat stomach disorders), pimozide (used to treat mental disorders), quinidine (used to treat cardiac arrhythmias), or erythromycin (an antibiotic used to treat bacterial infections), as these must not be taken with Diflucan (see section: "Do not take Diflucan").

rifampicin or rifabutin (antibiotics used to treat bacterial infections)
abrocitinib (used to treat atopic dermatitis, also known as atopic eczema)
alfentanil, fentanyl (anaesthetics)
amitriptyline, nortriptyline (antidepressants)
amphotericin B, voriconazole (antifungals)
medicines that thin the blood to prevent clot formation (warfarin or similar medicines)
benzodiazepines (midazolam, triazolam or similar medicines) used to help you sleep or for anxiety
carbamazepine, phenytoin (used to treat epileptic seizures)
nifedipine, isradipine, amlodipine, verapamil, felodipine, and losartan (used to treat hypertension - high blood pressure)
olaparib (used to treat ovarian cancer)
ciclosporin, everolimus, sirolimus, or tacrolimus (used to prevent transplant rejection)
cyclophosphamide, vinca alkaloids (vincristine, vinblastine, or similar medicines) used to treat cancer
halofantrine (used to treat malaria)
statins (atorvastatin, simvastatin, fluvastatin, and similar medicines) used to reduce high cholesterol levels
methadone (used to treat pain)
celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (Non-Steroidal Anti-Inflammatory Drugs - NSAIDs)
oral contraceptives
prednisone (a steroid)
zidovudine, also known as AZT; saquinavir (used in patients with HIV)
diabetes medicines such as chlorpropamide, glibenclamide, glipizide, or tolbutamide
theophylline (used to control asthma)
tofacitinib (used to treat rheumatoid arthritis)
tolvaptan, used to treat hyponatremia (low sodium levels in the blood) or to slow the decline in kidney function
vitamin A (dietary supplement)
ivacaftor (alone or in combination with other medicines used to treat cystic fibrosis)
amiodarone (used to treat "arrhythmias", irregular heartbeats)
hydrochlorothiazide (a diuretic)
ibrutinib (used to treat blood cancer)
lurasidone (used to treat schizophrenia).

Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breast-feeding, consult your doctor or pharmacist before taking this medicine.
Do not take Diflucan if you are pregnant, think you may be pregnant, or are planning pregnancy, unless your doctor tells you to. If you become pregnant while taking this medicine or within 1 week after the most recent dose, contact your doctor.
Taking fluconazole during the first trimester of pregnancy may increase the risk of miscarriage.
Taking low-dose fluconazole during the first trimester may slightly increase the risk of the baby being born with bone and/or muscle birth defects.
You may continue breastfeeding after a single dose of Diflucan 150 mg.
You must not breast-feed if you are taking repeated doses of Diflucan.

Driving and using machines
Be aware that dizziness or seizures may occur while driving or operating machinery.

Diflucan contains sodium (salt)
Diflucan contains 88.5 mg of sodium (the main component of table salt) per 25 ml. This corresponds to 4.4% of the maximum daily recommended dietary intake of sodium for an adult.
Talk to your doctor or pharmacist if you need Diflucan every day for a prolonged period, especially if you have been advised to follow a low-salt (low-sodium) diet.

3. How to take Diflucan

This medicine will be administered to you by a doctor or nurse as a slow injection (infusion) into a vein. Diflucan is available as a solution and will not be further diluted. Instructions for healthcare professionals are included in a section at the end of this leaflet.
The recommended doses of this medicine to be taken depending on the infection are listed below. If you have any doubts as to why Diflucan has been prescribed for you, consult your doctor or nurse.
Adults

Condition	Dosage
Treatment of cryptococcal meningitis	400 mg on the first day, then 200–400 mg once daily for 6–8 weeks or longer, if necessary. Sometimes doses are increased up to 800 mg.
Prevention of recurrence of cryptococcal meningitis	200 mg once daily until you are told to stop.
Treatment of coccidioidomycosis	200–400 mg once daily for 11 months up to 24 months or longer if necessary. Sometimes doses are increased up to 800 mg.
Endemic Candida fungal infections	800 mg on the first day, then 400 mg once daily until you are told to stop.
Treatment of oral mucosal infections, throat infections, and denture-related stomatitis	200–400 mg on the first day, then 100–200 mg once daily until you are told to stop.
Mucosal candidiasis – dosage depends on site of infection	50–400 mg once daily for 7–30 days until you are told to stop.
Prevention of recurrence of oral mucosal infections, throat infection	100–200 mg once daily, or 200 mg three times weekly while at risk of developing infection.
Prevention of Candida infections (if your immune system is weakened or not functioning properly)	200–400 mg once daily when at risk of developing infection.

Condition	Daily dose
Oral and throat candidiasis – dosage and duration of treatment depend on the severity and site of infection	3 mg per kg of body weight once daily (on the first day, 6 mg per kg of body weight may be administered)
Cryptococcal meningitis or deep endemic Candida infections	6 mg to 12 mg per kg of body weight once daily
Prevention of recurrence of cryptococcal meningitis	6 mg per kg of body weight once daily
Prevention of Candida infection in children (if their	3 mg to 12 mg per kg of body weight
immune system is not functioning properly)	once daily

Use in children from 0 to 4 weeks of age
Use in children aged 3 to 4 weeks:
The same dosage described above, but administered once every 2 days. The maximum dose is
12 mg per kg of body weight every 48 hours.
Use in children under 2 weeks of age:
The same dosage described above, but administered once every 3 days. The maximum dose is
12 mg per kg of body weight every 72 hours.

Elderly
The same dose as for adults should be used unless you have kidney problems.

Patients with renal impairment
Your doctor may adjust the dosage according to your kidney function.

If you take more Diflucan than you should
If you are concerned that you may have received more Diflucan than you should have, inform your doctor or another healthcare professional immediately. In case of accidental overdose, symptoms may include sensing, seeing, feeling, or thinking things that are not real (hallucinations and paranoid behavior).

If you forget to take Diflucan
Since this medicine will be administered under close medical supervision, it is unlikely that a dose will be missed. However, inform your doctor or pharmacist if you think a dose has been missed.

If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking Diflucan and contact your doctor immediately if you notice any of the following symptoms:

widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). Some people may experience allergic reactions, although severe allergic reactions are rare. If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. If you experience any of the following symptoms, inform your doctor immediately:
sudden shortness of breath, difficulty breathing, or tightness in the chest
swelling of the eyelids, face, or lips
itching all over the body, skin redness, or itchy red patches
skin rashes
severe skin reactions, for example rashes causing blisters (which may affect the mouth and tongue).

Diflucan may affect the liver. Symptoms of liver problems include:

fatigue
loss of appetite
vomiting
yellowing of the skin and whites of the eyes (jaundice)

headache
stomach discomfort, diarrhoea, nausea, vomiting
increased liver function test values in blood tests
skin rashes.

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

reduction in red blood cells, which may cause paleness, weakness, or breathlessness
decreased appetite
insomnia, drowsiness
seizures, dizziness, vertigo, tingling, prickling or numbness, altered taste
constipation, indigestion, flatulence, dry mouth
muscle pain
liver damage and yellowing of the skin and eyes (jaundice)
swelling, blisters (urticaria), itching, increased sweating
fatigue, general malaise, fever.

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

lower than normal levels of white blood cells, which help defend against infections, and of platelets, which are necessary for blood clotting
altered skin colouration (red or purplish), which may be caused by a reduction in platelets, other changes in blood cells
changes in blood chemistry (high levels of cholesterol, fats)
low levels of potassium in the blood
chills
abnormal electrocardiogram (ECG), changes in heart rhythm and rate
liver failure
allergic reactions (sometimes severe), including rashes with widespread blistering and peeling of the skin, severe skin reactions, swelling of the lips and face
hair loss.

Frequency not known, but possible (frequency cannot be estimated from the available data):

hypersensitivity reaction with rash, fever, swollen glands, increase in a type of white blood cells (eosinophilia), and inflammation of internal organs (liver, lungs, heart, kidneys, and large intestine) (drug reaction or rash with eosinophilia and systemic symptoms (DRESS)).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at:
“https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse”. By reporting side effects, you can help provide more information on the safety of this medicine.

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 stated on the label after "Exp.". The expiry date refers to the last day of that month.

Storage conditions

Glass vials: Do not freeze.
PVC plastic bags: Do not store above 30°C. Do not freeze.
Once the medicine has been opened, it must be used immediately. Any unused infusion solution must be discarded. This medicine is for single use only.
Do not use this medicine if you notice visible particles or if the solution is not clear or discoloured.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Diflucan contains

The active substance is fluconazole.

Each ml contains 2 mg of fluconazole.
1 vial with 25 ml of infusion solution contains 50 mg of fluconazole.
1 vial with 50 ml of infusion solution contains 100 mg of fluconazole.
1 vial with 100 ml of infusion solution contains 200 mg of fluconazole.
1 vial with 200 ml of infusion solution contains 400 mg of fluconazole.
1 PVC plastic bag with 100 ml of infusion solution contains 200 mg of fluconazole.
1 PVC plastic bag with 200 ml of infusion solution contains 400 mg of fluconazole.

The other components are: sodium chloride, water for injections, and sodium hydroxide (to adjust pH) (see section 2, Diflucan contains sodium (salt)).

Description of the appearance of Diflucan and package contents
Diflucan is a clear, colourless solution free from visible particles.
It is available in both glass vials and PVC plastic bags.
Pack sizes:
1 vial containing 25 ml of infusion solution
1 or 48 vials containing 50 ml of infusion solution
1 or 40 vials containing 100 ml of infusion solution
1 vial containing 200 ml of infusion solution
1, 5, 10 or 20 PVC plastic bags containing 100 ml of infusion solution
1, 5, 10 or 20 PVC plastic bags containing 200 ml of infusion solution
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Pfizer Italia S.r.l.
Via Isonzo, 71 – 04100 Latina, Italy

Manufacturer:
Fareva Amboise - Zone Industrielle – 29 Route des Industries, 37530 Pocé-sur-Cisse, France

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria	Diflucan 2 mg/ml infusion solution
Belgium, Denmark, Ireland, Iceland, Italy, Luxembourg, Norway, Poland, United Kingdom	Diflucan
Cyprus, Greece	Fungustatin
France	Triflucan 2 mg/ml solution for injection for infusion
Germany	Diflucan i.v. 2 mg/ml, infusion solution
Netherlands	Diflucan I.V. 2 mg/ml
Romania	Diflucan 2 mg/ml perfusion solution

Other sources of information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (Agenzia Italiana del Farmaco)

The information reported below is intended exclusively for physicians and healthcare professionals:
The infusion rate must not exceed 10 ml/minute. Diflucan infusion solution is formulated in 0.9% sodium chloride solution; each 200 mg (100 ml vial) contains 15 mmol of Na and Cl-. Since the product is supplied diluted in saline solution, the amount of administered fluid should be carefully considered in patients requiring restriction of sodium or fluid intake.

Fluconazole infusion solution is compatible with the following intravenous 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) Aminofusin 3.5%
g) Saline solution 9 mg/ml (0.9%)
h) Dialaflex (peritoneal dialysis solution 6.36%)

Fluconazole infusion solution may be administered through an existing intravenous line with any of the solutions listed above. Although no specific incompatibilities have been observed, concomitant administration of other medicinal products is not recommended unless compatibility has been established.

The infusion solution is for single use only.

From a microbiological standpoint, diluted solutions should be used immediately. If not used immediately, storage times and conditions prior to use are the responsibility of the user and, in general, should not exceed 24 hours at 2°C to 8°C, unless dilution has been carried out under controlled and validated aseptic conditions.

Dilution must be performed under aseptic conditions. The solution should be inspected visually for the presence of particulate matter or discoloration before administration. The solution should only be used if it is clear and free from particles.

Any unused medicinal product and waste material derived from this medicinal product must be disposed of in accordance with local regulations.