DIFLUCAN 50 mg Hard Capsules

Зміст інструкції

1. Diflucan 50 mg hard capsules, 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules
   1. What is Diflucan and what is it 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. Package Contents and Other Information
2. Diflucan 10 mg/ml powder for oral suspension
   1. What Diflucan is and what it is used for
   2. What you need to know before taking Diflucan
   3. How to take Diflucan
   4. Possible side effects
   5. How to store Diflucan
   6. Package Contents and Other Information
3. Diflucan 2 mg/ml solution for infusion
   1. What is Diflucan and what is it used for
   2. What you need to know before taking Diflucan
   3. How to take Diflucan
   4. Possible side effects
   5. How to store Diflucan
   6. Package contents and other information

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

fluconazole

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of 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 is Diflucan and what is it used for

Diflucan belongs to a group of medicines called “antifungals”. The active ingredient is
fluconazole.
Diflucan is used for the treatment of fungal infections and can be used to prevent
Candidainfections. The most common cause of fungal infections is a yeast called Candida.

Adults
Your doctor may prescribe this medicine for the treatment of the following fungal infections:

• Cryptococcal meningitis - a fungal infection of the brain
• Coccidioidomycosis - a disease of the bronchopulmonary system
• Infections caused by Candidaand found in the bloodstream, in organs (e.g. heart, lungs) or in the urinary tract
• Candidiasis of the mucous membranes - infection of the oral mucosa, throat infection and inflammation of the mouth from dentures
• Genital candidiasis - infection of the vagina or penis
• Skin infections - e.g. athlete's foot, ringworm, itching in the genital area, nail infections

Diflucan may be prescribed for:

• preventing the recurrence of cryptococcal meningitis
• preventing the recurrence of candidiasis of the mucous membranes
• reducing the recurrence of vaginal candidiasis
• preventing Candidainfections (if your immune system is weak or not functioning properly)

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

• Candidiasis of the mucous membranes - infection of the oral mucosa, throat infection
• Infections caused by Candidaand found in the bloodstream, in organs (e.g. heart, lungs) or in the urinary tract
• Cryptococcal meningitis - a fungal infection of the brain

Diflucan may be prescribed for:

• preventing Candidainfections (if your immune system is weak or not functioning properly).
• preventing the recurrence of cryptococcal meningitis

2. What you need to know before you take Diflucan

Do not take Diflucan

• if you are allergic to fluconazole, to other medicines that you have used for the treatment of fungal infections or to any of the other components of this medicine (listed in section 6). The symptoms may be itching, redness of the skin or difficulty in breathing
• if you are taking astemizole, terfenadine (antihistamines used for the treatment of allergies)
• if you are taking cisapride (used for the treatment of stomach disorders)
• if you are taking pimozide (used for the treatment of mental disorders)
• if you are taking quinidine (used for the treatment of heart arrhythmias)
• if you are taking erythromycin (antibiotic used for the treatment of bacterial infections).

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

• if you have problems with your liver or kidneys
• if you suffer from heart disease, including heart arrhythmia
• if you have abnormal levels of potassium, calcium or magnesium in your blood
• if severe skin reactions appear (itching, redness of the skin or difficulty in breathing).
• if signs of ‘adrenal insufficiency’ appear, whereby 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 exfoliation, blisters and/or ulcers in the mouth after taking fluconazole.

Severe skin reactions including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) related to treatment with fluconazole have been reported. Stop taking Diflucan and immediately contact your doctor if you notice any of the symptoms related to the severe skin reactions described in section 4.
Talk to your doctor or pharmacist if the fungal infection does not improve, an alternative antifungal therapy may be necessary.

Other medicines and Diflucan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
Immediatelytell your doctor if you are taking astemizole, terfenadine (antihistamine used for the treatment of allergies) or cisapride (used for the treatment of stomach disorders) or pimozide (used for the treatment of mental disorders) or quinidine (used for the treatment of heart arrhythmias) or erythromycin (antibiotic used for the treatment of bacterial infections), as they cannot be taken with Diflucan (see section: “Do not take Diflucan”).
There are some medicines that can interact with Diflucan. Tell your doctor if you are taking any of the following medicines as a dose adjustment or monitoring may be necessary to ensure that the medicines continue to have the desired effect:

• rifampicin or rifabutin (antibiotics for the treatment of bacterial infections)
• abrocitinib (used for the treatment of atopic dermatitis, also known as atopic eczema)
• alfentanil, fentanyl (anaesthetics)
• amitriptyline, nortriptyline (antidepressants)
• amphotericin B, voriconazole (antifungals)
• 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 the treatment of seizures)
• nifedipine, isradipine, amlodipine, verapamil, felodipine and losartan (used for the treatment of hypertension - high blood pressure)
• olaparib (used for the treatment of ovarian cancer)
• cyclosporine, everolimus, sirolimus or tacrolimus (used to prevent transplant rejection)
• cyclophosphamide, vinca alkaloids (vincristine, vinblastine or similar medicines) used for the treatment of cancer
• halofantrine (used for the treatment of malaria)
• statins (atorvastatin, simvastatin, fluvastatin and similar medicines) used to reduce high cholesterol levels
• methadone (used for the treatment of pain)
• celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (Non-Steroidal Anti-Inflammatory Drugs - NSAIDs)
• oral contraceptives
• prednisone (steroid)
• zidovudine, also known as AZT; saquinavir (used in patients with HIV)
• medicines for diabetes such as chlorpropamide, glibenclamide, glipizide or tolbutamide
• theophylline (used for asthma control)
• tofacitinib (used for the treatment of 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 drugs used to treat cystic fibrosis)
• amiodarone (used for the treatment of “arrhythmias”, irregular heartbeats)
• hydrochlorothiazide (a diuretic)
• ibrutinib (used for the treatment of blood cancer)
• lurasidone (used for the treatment of schizophrenia).

Diflucan with food and drink
You can take the medicine with or without food.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Diflucan if you are pregnant, suspect you are pregnant or are planning to become pregnant, unless your doctor tells you to. If you become pregnant while taking this medicine or within 1 week of the most recent dose, contact your doctor.
Fluconazole taken during the first trimester of pregnancy may increase the risk of miscarriage.
Fluconazole taken at low doses during the first trimester may slightly increase the risk that the baby is born with malformations of bones and/or muscles.
You can continue to breastfeed after taking a single dose of Diflucan 150 mg.
You should not breastfeed if you are taking repeated doses of Diflucan.

Driving and using machines
You should be aware that dizziness or convulsions may occur while driving or using machines.

Diflucan contains lactose (milk sugar) and sodium (salt)
This medicine contains a minimal amount of lactose (milk sugar). If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Diflucan capsules contains less than 1 mmol (23 mg) of sodium per capsule, that is to say essentially ‘sodium-free’.

3. How to take Diflucan

Always take this medicine exactly as your doctor has told you.If you have any doubts
ask your doctor or pharmacist.
Swallow the capsule whole with a glass of water. It is best to take the capsules every day at the
same time.
The recommended doses of this medicine to be taken depending on the infection are listed below:

Adults

Adolescents aged 12 to 17 years
Always take the dose prescribed by your doctor (either the adult dosage or the children's 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.

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

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

Patients with kidney problems
Your doctor may adjust the dosage based on kidney function.

If you take more Diflucan than you should
Taking too many capsules all at once may cause you problems. Tell your doctor immediately or go to the
nearest hospital.
In case of accidental overdose, symptoms may include seeing, hearing, perceiving and thinking
things that are not real (hallucinations and paranoid behavior). Symptomatic treatment (with adequate supportive measures and possibly gastric lavage) may be appropriate.

If you forget to take Diflucan
Do not take a double dose to make up for a missed dose. If you forget to take a
dose, take it as soon as possible. If it is time to take the next dose, do not take the dose
you forgot.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

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 immediatelyif you notice any of the
following symptoms:

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

Some people experience allergic reactions, although serious allergic reactions are rare. If you experience any side effect, including those not listed in this
leaflet, tell 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, redness of the skin or itchy red spots
• rashes
• severe skin reactions, such as rashes that cause blisters (can affect the mouth and tongue).

Diflucan can have effects on the liver. Symptoms of liver problems include:

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

If you experience any of these symptoms, stop taking Duflucan and inform your doctor
immediately.
Other side effects:
If any of the side effects gets worse, or if you notice any side effect not listed here, tell your doctor or pharmacist. The common side effects (may affect up to 1 in 10 people) are:

• headache
• stomach upset, diarrhea, nausea, vomiting
• increases in liver function values in blood tests
• rashes

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

• reduced red blood cells which can cause paleness, weakness or shortness of breath
• decreased appetite
• insomnia, drowsiness
• convulsions, dizziness, feeling of spinning, 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 feeling of discomfort, fever.

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

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

Frequency not known, but may occur (frequency cannot be estimated on the basis of available
data):

• hypersensitivity reaction with rash, fever, swollen glands, increased type of white blood cells (eosinophilia) and inflammation of internal organs (liver, lungs, heart, kidneys and colon) (drug reaction or rash with eosinophilia and systemic symptoms (DRESS))

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through 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 that is reported on the label after Exp.. The expiry date refers to the last day of that month.
• Store at a temperature below 30°C.

Do not dispose of any medicine in 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 ingredient is fluconazole.
• Each hard capsule contains fluconazole 50 mg, 100 mg, 150 mg or 200 mg.
• The excipients are: Capsule contents:lactose monohydrate, corn starch, anhydrous colloidal silicon dioxide, magnesium stearate and sodium lauryl sulfate (see paragraph 2, Diflucan contains lactose (milk sugar) and sodium (salt)) .

Contents of the capsule shells:
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 blue
Patent 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 (E 132)

Ink:lacquer, black iron oxide (E172), N-butyl alcohol, dehydrated alcohol, purified water,
propylene glycol (E1520), industrial denatured alcohol, isopropyl alcohol, strong ammonia
solution, potassium hydroxide (E525).

Description of the appearance of Diflucan and contents of the pack

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

Diflucan 50 mg, 100 mg, 150 mg and 200 mg are available in packs 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
Manufacturer:
Fareva Amboise - Zone Industrielle – 29 Route des Industries 37530 Pocé-sur-Cisse, France

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

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

Diflucan 10 mg/ml powder for oral suspension

fluconazole

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of 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 use 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 belongs to a group of medicines called “antifungals”. The active ingredient is
fluconazole.
Diflucan is used for the treatment of fungal infections and can be used to prevent
Candidainfections. The most common cause of fungal infections is a yeast called Candida.

Adults
Your doctor may prescribe this medicine for the treatment of the following fungal infections:

• Cryptococcal meningitis - a fungal infection of the brain
• Coccidioidomycosis - a disease of the bronchopulmonary system
• Infections caused by Candidaand found in the bloodstream, in organs (e.g. heart, lungs) or in the urinary tract
• Candidiasis of the mucous membranes - infection of the oral mucosa, throat infection and inflammation of the mouth from dentures
• Genital candidiasis - infection of the vagina or penis
• Skin infections - e.g. athlete's foot, ringworm, itching in the genital area, nail infections

Diflucan may be prescribed for:

• preventing the recurrence of cryptococcal meningitis
• preventing the recurrence of candidiasis of the mucous membranes
• reducing recurrences of vaginal candidiasis
• preventing Candidainfections (if your immune system is weak or not functioning properly)

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

• Candidiasis of the mucous membranes - infection of the oral mucosa, throat infection
• Infections caused by Candidaand found in the bloodstream, in organs (e.g. heart, lungs) or in the urinary tract
• Cryptococcal meningitis - a fungal infection of the brain

Diflucan may be prescribed for:

• preventing Candidainfections (if your immune system is weak or not functioning properly)
• preventing the 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 for the treatment of fungal infections or to any of the other components of this medicine (listed in section 6). The symptoms may be itching, redness of the skin 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 heart arrhythmias)
• if you are taking erythromycin (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 disease, including heart arrhythmia.
• if you have abnormal levels of potassium, calcium or magnesium in your blood.
• if you experience severe skin reactions (itching, redness of the skin or difficulty breathing).
• if you experience signs of ‘adrenal insufficiency’, 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 exfoliation, blisters and/or mouth ulcers after taking fluconazole.

Severe skin reactions including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have been reported related to treatment with fluconazole. Stop taking Diflucan and contact your doctor immediately if you notice any of the symptoms related to the severe skin reactions described in section 4.
Talk to your doctor or pharmacist if the fungal infection does not improve, an alternative antifungal therapy may be necessary.

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 immediatelyif you are taking astemizole, terfenadine (antihistamine used
to treat allergies) or cisapride (used to treat stomach disorders) or
pimozide (used to treat mental disorders) or quinidine (used to treat
heart arrhythmias) or erythromycin (antibiotic used to treat bacterial infections),
because they cannot be taken with Diflucan (see section: “Do not take Diflucan”).
There are some medicines that can interact with Diflucan. Tell your doctor if you are taking
any of the following medicines as a dose adjustment or monitoring may be necessary to ensure that the medicines continue to have the desired effect:

• rifampicin or rifabutin (antibiotics for the treatment of bacterial infections)
• abrocitinib (used for the treatment of atopic dermatitis, also known as atopic eczema)
• alfentanil, fentanyl (anaesthetics)
• amitriptyline, nortriptyline (antidepressants)
• amphotericin B, voriconazole (antifungals)
• 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 to treat seizures)
• nifedipine, isradipine, amlodipine, verapamil, felodipine and losartan (used to treat hypertension - high blood pressure) olaparib (used to treat ovarian cancer)
• cyclosporine, 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 (steroid)
• zidovudine, also known as AZT; saquinavir (used in patients with HIV)
• medicines for diabetes such as chlorpropamide, glibenclamide, glipizide or tolbutamide
• theophylline (used to control asthma)
• tofacitinib (used to treat rheumatoid arthritis)
• tolvaptan, used to treat hyponatremia (low levels of sodium in the blood) or to slow the decline in kidney function
• vitamin A (dietary supplement)
• ivacaftor (alone or in combination with other drugs 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 can take the medicine with or without food.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. If
you become pregnant while taking this medicine or within 1 week of the last dose, contact
your doctor.
Do not take Diflucan if you are pregnant, suspect you may be pregnant, unless your doctor tells you to.
Fluconazole taken during the first trimester of pregnancy may increase the risk of miscarriage.
Fluconazole taken at low doses during the first trimester may slightly increase the risk
that the baby is born with bone and/or muscle malformations.
You can continue to breastfeed after taking a single dose of Diflucan 150 mg.
You should not breastfeed if you are taking repeated doses of Diflucan.

Driving and using machines
You should be aware that dizziness or convulsions may occur while driving or
using machines.

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

• If your doctor has told you that you have an intolerance to some sugars, contact him/her before taking this medicine.
• Doses of 10 ml contain 5.5 g or more of sugar. This should be taken into account in people with diabetes mellitus.
• It may be harmful to teeth if used for periods of more 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 powder for oral suspension contains 1.13 mg of sodium per ml. This is equivalent to 4.5% of the recommended daily intake of sodium for an adult.

3. How to take Diflucan

Always take this medicine exactly as your doctor has told you.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 to be taken depending on the infection are listed below.

Adults

Adolescents from 12 to 17 years
Always take the dose prescribed by your doctor (or the dosage for adults or children).

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.

Use in infants aged 0 to 4 weeks
Use in infants from 3 to 4 weeks:
The same dosage as described above but administered once every 2 days. The maximum dose is
12 mg per kg of body weight every 48 hours.
Use in infants under 2 weeks of age:
The same dosage as 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 intended for adults should be used unless you have kidney problems.

Patients with kidney problems
Your doctor may adjust the dosage based on kidney function.

Instructions for reconstituting the suspension:
It is recommended that the reconstitution of Diflucan suspension be carried out by the pharmacist
before delivering the medicine. In any case, if the pharmacist does not reconstitute this
information is 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 use of the oral syringe:
Shake the reconstituted suspension well.

• 1. Open the bottle (safety cap);
• 2. Insert the oral syringe adapter into the neck of the bottle (Figure 1);
• 3. Turn the bottle upside down with the oral syringe and draw the amount of suspension prescribed by your doctor (Figure 2). The markings on the oral syringe are expressed in ml. In children, the maximum dose of 400 mg per day must not be exceeded (see paragraph “3. How to take Diflucan”).
• 4. Return the bottle with the oral syringe to its original position and remove the oral syringe from the bottle;
• 5. The medicine can be administered with the oral syringe, directly into the mouth. During administration, the patient must remain in an upright position. Insert the oral syringe inside the cheek and slowly release the suspension into the patient's mouth (Figure 3).
• 6. Rinse the oral syringe.
• 7. Close the bottle with the safety cap; the adapter will remain on the neck of the bottle.

For conversion of the oral suspension powder dose from mg/ml to ml/kg of body weight,
for pediatric 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 dosage.

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

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 time to take the next dose, do not take the dose
you forgot.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

Some people experience allergic reactions, although severe allergic reactions are rare. If you experience any side effect, inform your doctor or pharmacist. This
If you experience any of the following symptoms, inform your doctor immediately.

• sudden shortness of breath, difficulty breathing or a feeling of tightness in the chest
• swelling of the eyelids, face or lips
• itching all over the body, redness of the skin or itchy red spots
• rashes
• severe skin reactions, such as rashes that cause blisters (can affect the mouth and tongue). Diflucan can have effects on the liver. Symptoms of liver problems include:
• fatigue
• loss of appetite
• vomiting
• yellowing of the skin and the whites of the eyes (jaundice)

If you experience any of these symptoms, stop taking Diflucan and inform your doctor
immediately.
Other side effects:
If any of these side effects worsen, or if you notice any side effect not listed here, tell your doctor or pharmacist.
Common side effects (may affect more than 1 in 10 people) are:

• headache
• stomach discomfort, diarrhea, nausea, vomiting
• increases in liver function values in blood tests
• rashes

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

• reduction in red blood cells which can cause paleness, weakness or shortness of breath
• decreased appetite
• insomnia, drowsiness
• convulsions, dizziness, feeling of spinning, 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 feeling of being unwell, fever.

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

• lower than normal levels of white blood cells, which help to defend against infections, and platelets, which enable blood to clot
• altered skin color (red or purple) which may be caused by a reduction in platelets, other alterations of blood cells
• changes in the chemical composition of the blood (high levels of cholesterol, fats)
• low levels of potassium in the blood
• chills
• altered electrocardiogram (ECG), changes in heart rate and rhythm
• 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 may occur (frequency cannot be estimated on the basis of available data):

• hypersensitivity reaction with rash, fever, swollen glands, increased 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 get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly
through 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 Scad.. The expiry date refers to the last day of that month.
• Oral suspension powder:
• do not store at a temperature above 25°C. Keep the bottle tightly closed.
• once reconstituted, do not store the suspension at a temperature above 30°C; do not freeze.
• the validity of the suspension once reconstituted is 28 days.

Do not dispose of any medicine in wastewater or household waste. Any unused suspension must be eliminated after 28 days from reconstitution. 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 ingredient is fluconazole. 1 ml of reconstituted suspension contains 10 mg of fluconazole.
• The other ingredients 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 powder for oral suspension contains sucrose (sugar), sodium benzoate and sodium (salt)).

Description of Diflucan and Package Contents:
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 powder for oral suspension is available in bottles of two sizes:
• a 60 ml bottle containing 24.4 g of powder. After reconstitution, the volume of the suspension is 35 ml or
• a 175 ml bottle containing 67.1 g of powder. After reconstitution, the volume of the suspension is 100 ml.
• Diflucan 10 mg/ml powder for oral suspension is presented as a white to off-white powder. After the addition of water (as described in the leaflet for healthcare professionals) the powder is presented as a white to off-white suspension with an orange flavour.
• In each bottle the mixture of powder and water produces 35 ml or 100 ml of suspension.
• To correctly measure the dose for oral administration, a 5 ml graduated oral syringe with a pressure adapter for the bottle is supplied with the 35 ml suspension.
• To correctly measure the dose for oral administration, a measuring cup and a 5 ml graduated oral syringe with a pressure adapter for the bottle are supplied with the 100 ml suspension.

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

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

Other Sources of Information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency.
-----------------------------------------------------------------------------------------------------------------
This information is intended for healthcare professionals or patients (if the pharmacist does not
reconstitute the product):

Instructions for preparing the suspension:
The suspension after reconstitution appears as a white or off-white suspension with an orange flavour.
Powder for oral suspension 10 mg/ml in 60 ml bottle: 35 ml of suspension after reconstitution

• 1. Gently tap the bottle to release the powder from the walls.
• 2. Reconstitute by adding 24 ml of water. First, add a small amount of natural water and shake vigorously. Then, add water up to the marked level ( ) on the bottle (this adds the 24 ml of water needed).
• 3. Shake well for 1 or 2 minutes to obtain a homogeneous suspension.
• 4. After reconstitution, a usable volume of 35 ml will result.
• 5. Write the expiry date of the reconstituted suspension on the bottle label (the shelf life of the reconstituted suspension is 28 days). Unused suspension must not be used after this date and must be returned to the pharmacist.

Powder for oral suspension 10 mg/ml in 175 ml bottle: 100 ml of suspension after
reconstitution

• 1. Gently tap the bottle to release the powder from the walls.
• 2. Reconstitute by adding 66 ml of water. First, add a small amount of natural water and shake vigorously. Then, add water up to the marked level ( ) on the bottle (this adds the 66 ml of water needed).
• 3. Shake well for 1 or 2 minutes to obtain a homogeneous suspension.
• 4. After reconstitution, a usable volume of 100 ml will result.
• 5. Write the expiry date of the reconstituted suspension on the bottle label (the shelf life of the reconstituted suspension is 28 days). Unused suspension must not be used after this date and must be returned to the pharmacist.

Conversion of the dose of oral suspension powder from mg/ml to ml/kg of body weight
in paediatric patients:
Diflucan 10 mg/ml powder for oral suspension:
In children, Diflucan powder for oral suspension should be measured as closely as
possible according to the following equation:
child's weight (kg) X prescribed dose (mg/kg)
Dose in ml/day = ________________________________________________
product concentration (mg/ml)

The oral syringe is graduated in increments of 0.2 ml. Therefore, for intermediate weights and dosages, the dose to be administered must be calculated in ml and then rounded up or
down to the nearest graduation on the oral syringe:
For example, a child weighing 11 kg who has been prescribed Diflucan 3 mg/kg/day must
take 33 mg/day, equivalent to 3.3 ml of the 10 mg/ml oral suspension. To administer the
full dose, the latter can be rounded up to 3.4 ml, the nearest graduation
present on the oral syringe.
In the paediatric population, the maximum dose of 400 mg per day should not be exceeded (see *
in the table below).
The use of Diflucan 10 mg/ml powder for oral suspension is not recommended for doses > 15.0 ml
(consult the dosage table, highlighted in grey). If the doses exceed 15.0 ml, it is recommended to
use Diflucan 40 mg/ml powder for oral suspension.

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*

Diflucan 2 mg/ml solution for infusion

fluconazole

Read this leaflet carefully before you start to use this medicine, as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Diflucan is and what it is used for
• 2. What you need to know before you use Diflucan
• 3. How to use Diflucan
• 4. Possible side effects
• 5. How to store Diflucan
• 6. Contents of the pack and other information

1. What is Diflucan and what is it used for

Diflucan belongs to a group of medicines called “antifungals”. The active ingredient is
fluconazole.
Diflucan is used for the treatment of fungal infections and can be used to prevent
Candidainfections. The most common cause of fungal infections is a yeast called Candida

Adults
Your doctor may prescribe this medicine for the treatment of the following fungal infections:

• Cryptococcal meningitis - a fungal infection of the brain
• Coccidioidomycosis - a disease of the bronchopulmonary system
• Infections caused by Candidaand found in the bloodstream, in organs (e.g. heart, lungs) or in the urinary tract
• Candidiasis of the mucous membranes - infection of the oral mucosa, throat infection and inflammation of the mouth from dentures Diflucan may be prescribed for:
• preventing the recurrence of cryptococcal meningitis
• preventing the recurrence of candidiasis of the mucous membranes
• preventing Candidainfections (if your immune system is weak or not functioning properly)

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

• Candidiasis of the mucous membranes - infection of the oral mucosa, throat infection
• Infections caused by Candidaand found in the bloodstream, in organs (e.g. heart, lungs) or in the urinary tract
• Cryptococcal meningitis - a fungal infection of the brain

Diflucan may be prescribed for:

• preventing Candidainfections (if your immune system is weak or not functioning properly)
• preventing the 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 for the treatment of fungal infections or to any of the other components of this medicine (listed in section 6). The symptoms may be itching, redness of the skin or difficulty in 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 heart arrhythmias)
• if you are taking erythromycin (antibiotic used to treat bacterial infections).

Warnings and precautions
Consult your doctor or nurse before taking Diflucan

• if you have liver or kidney problems
• if you suffer from heart disease, including heart arrhythmia
• if you have abnormal levels of potassium, calcium or magnesium in the blood
• if severe skin reactions occur (itching, redness of the skin or difficulty in breathing)
• if signs of ‘adrenal insufficiency’ appear, whereby 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 exfoliation, blisters and/or ulcers in the mouth after taking fluconazole.

Severe skin reactions including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) related to treatment with fluconazole have been reported. Stop taking Diflucan and immediately consult your doctor if you notice any of the symptoms related to the severe skin reactions described in section 4.
Consult your doctor or pharmacist if the fungal infection does not improve, an alternative antifungal therapy may be necessary.

Other medicines and Diflucan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
Immediatelyinform your doctor if you are taking astemizole, terfenadine (antihistamine used to treat allergies) or cisapride (used to treat stomach disorders) or pimozide (used to treat mental disorders) or quinidine (used to treat heart arrhythmias) or erythromycin (antibiotic used to treat bacterial infections), because they cannot be taken with Diflucan (see section: “Do not take Diflucan”).
There are some medicines that can interact with Diflucan. Tell your doctor if you are taking any of the following medicines as a dose adjustment or monitoring may be necessary to ensure that the medicines continue to have the desired effect:

• rifampicin or rifabutin (antibiotics for the treatment of bacterial infections)
• abrocitinib (used for the treatment of atopic dermatitis, also known as atopic eczema)
• alfentanil, fentanyl (anaesthetics)
• amitriptyline, nortriptyline (antidepressants)
• amphotericin B, voriconazole (antifungals)
• 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 to treat seizures)
• nifedipine, isradipine, amlodipine, verapamil, felodipine and losartan (used to treat hypertension - high blood pressure)
• olaparib (used for the treatment of ovarian cancer)
• cyclosporine, 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 (steroid)
• zidovudine, also known as AZT; saquinavir (used in patients with HIV)
• medicines for diabetes such as chlorpropamide, glibenclamide, glipizide or tolbutamide
• theophylline (used to control asthma)
• tofacitinib (used for the treatment of rheumatoid arthritis)
• tolvaptan, used to treat hyponatremia (low sodium levels in the blood) or to slow the decline of kidney function
• vitamin A (food supplement)
• ivacaftor (alone or in combination with other drugs 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, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Diflucan if you are pregnant, suspect you may be pregnant or are planning a pregnancy, unless your doctor tells you to. If you become pregnant while taking this medicine or within 1 week of the most recent dose, consult your doctor.
Fluconazole taken during the first trimester of pregnancy may increase the risk of miscarriage.
Fluconazole taken at low doses during the first trimester may slightly increase the risk that the baby will be born with malformations of bones and/or muscles.
You can continue to breastfeed after taking a single dose of Diflucan 150 mg.
You should not breastfeed if you are taking repeated doses of Diflucan.

Driving and using machines
You should be aware that dizziness or convulsions may occur while driving or using machines.

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

3. How to take Diflucan

This medicine will be given to you by a doctor or nurse in the form of a slow injection (infusion) into a vein. Diflucan is available in solution. It will not be further diluted. The recommended doses of this medicine to be taken depending on the infection are listed below. If you have any doubts about why you have been prescribed Diflucan, consult your doctor or nurse.

Adults

Adolescents aged 12 to 17 years
Always take the dose prescribed by your doctor (either the adult or children's 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.

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

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

Patients with kidney problems
Your doctor may adjust the dosage based on kidney function.

If you take more Diflucan than you should
If you are concerned that you may have been given a dose of Diflucan higher than intended,
inform your doctor or another healthcare professional immediately. In case of accidental overdose,
symptoms may include seeing, hearing, perceiving and thinking things that are not real (hallucinations
and paranoid behavior).

If you forget to take Diflucan
Since this medicine will be given to you under close medical supervision, it is unlikely that
a dose will be forgotten. However, inform your doctor or pharmacist if you think a dose has been
forgotten.
If you have any doubts about using this medicine, ask 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 immediatelyif you notice any of the
following symptoms:

• widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity). Some people experience allergic reactionsalthough severe allergic reactions are rare. If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. If you experience any of the following symptoms inform your doctor immediately.
• sudden shortness of breath, difficulty breathing or a feeling of tightness in the chest
• swelling of the eyelids, face or lips
• itching all over the body, redness of the skin or itchy red spots
• rashes
• severe skin reactions, such as rashes that cause blisters (may affect the mouth and tongue).

Diflucan can have effects on the liver. Symptoms of liver problems include:

• fatigue
• loss of appetite

• vomiting
• yellowing of the skin and the white of the eyes (jaundice)

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

Other side effects:
If any of the side effects gets worse, or if you notice any side effect not listed here, tell your doctor or pharmacist. The common side effects (may affect up to 1 in 10 people) are:

• headache
• stomach discomfort, diarrhea, nausea, vomiting
• increases in liver function values in blood tests
• rashes. The uncommon side effects (may affect up to 1 in 100 people) are:
• reduction in red blood cells which can cause paleness, weakness or shortness of breath
• decreased appetite
• insomnia, drowsiness
• convulsions, dizziness, feeling giddy, 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 feeling of being unwell, fever.

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

• lower than normal levels of white blood cells, which help you fight infections, and platelets, which help your blood clot
• altered skin color (red or purple) which may be caused by a reduction in platelets, other changes in blood cells
• changes in the chemical composition of the blood (high levels of cholesterol, fats)
• low levels of potassium in the blood
• chills
• altered electrocardiogram (ECG), changes in the rhythm and rate of the heartbeat
• 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 may occur (frequency cannot be estimated on the basis of available
data):

• hypersensitivity reaction with rash, fever, swollen glands, increased 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 get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through 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 that is reported on the label after Expiry. The expiry date refers to the last day of that month.

Storage conditions

• Glass vials: Do not freeze.
• PVC plastic pouches: Do not store at a temperature above 30°C. Do not freeze.
• Once opened, the medicine must be used immediately. Any unused infusion quantities 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 discolored

Do not dispose of any medicine in 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 ingredient is fluconazole.

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

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

Description of the appearance of Diflucan and contents of the pack
Diflucan is a clear, colorless solution without visible particles.
It is available in both glass vials and plastic bags in PVC.
Pack size:
1 vial containing 25 ml of solution for infusion
1 or 48 vials containing 50 ml of solution for infusion
1 or 40 vials containing 100 ml of solution for infusion
1 vial containing 200 ml of solution for infusion
1, 5, 10 or 20 plastic bags in PVC containing 100 ml of solution for infusion
1, 5, 10 or 20 plastic bags in PVC containing 200 ml of solution for infusion
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
Manufacturer:
Fareva Amboise - Zone Industrielle – 29 Route des Industries 37530 Pocé-sur-Cisse, France

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

Other sources of information
More detailed information on this medicinal product is available on the website of the Italian Medicines
Agency
---------------------------------------------------------------------------------------------------------------------------
The information below is intended exclusively for doctors and healthcare professionals:
The infusion rate should not exceed 10 ml/minute. Diflucan solution for infusion is
formulated in 0.9% sodium chloride solution; each 200 mg (100 ml vial) contains
15 mmol of Na and Cl -. As the product is available diluted in saline solution, the
percentage of fluid administered should be carefully considered for patients requiring sodium or fluid restriction.
Fluconazole solution for infusion is compatible with the administration of the following fluids:
a) 5% and 20% Dextrose
b) Ringer's solution
c) Hartmann's solution
d) Potassium chloride in dextrose
e) 4.2% and 5% Sodium bicarbonate
f) Aminofusin 3.5%
g) Sodium chloride 9 mg/ml (0.9%)
h) Dialaflex (peritoneal dialysis Soln 6.36%)
Fluconazole solution for infusion can be administered using an existing intravenous access with one of the solutions listed above. Although no specific incompatibilities have been noted, it is not recommended to mix other drugs before infusion.
The solution for infusion is for single use only.
From a microbiological point of view, dilutions should be used immediately. If not used
immediately, the storage times and conditions before use are the responsibility
of the user and generally should not exceed 24 hours at temperatures from 2°C to 8°C, unless the dilution has taken place under controlled and validated aseptic conditions.
Dilution must be carried out under aseptic conditions. The solution should be visually inspected
for any particulate matter or discoloration before
administration. The solution should only be used if it appears clear and free of particles.
Unused medicine or waste from this medicine should be disposed of in accordance with
current local regulations.