DIFLUCAN 2 mg /Ml Solution

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Diflucan, 2 mg/ml, Solution for Infusion
   1. Read All of This Leaflet Carefully Before You Start Using This Medicine Because It Contains Important Information for You.
   2. Contents of the Pack and Other Information
3. What Diflucan is and what it is used for
   1. Adults
   2. Children and Adolescents (from 0 to 17 years)
4. Before You Use Diflucan
   1. When Not to Use Diflucan
   2. Warnings and Precautions
   3. Diflucan and Other Medicines
   4. Pregnancy, Breast-Feeding, and Fertility
   5. Driving and Using Machines
   6. Diflucan Contains Sodium (Salt)
5. How to Use Diflucan
   1. Adults
   2. Adolescents (12-17 years)
   3. Children (up to 11 years)
   4. Children (0-4 weeks)
   5. Elderly Patients
   6. Patients with Kidney Problems
   7. Overdose of Diflucan
   8. Missed Dose of Diflucan
6. Possible Side Effects
   1. Other Side Effects
   2. Reporting Side Effects
7. How to Store Diflucan
8. Contents of the Pack and Other Information
   1. What Diflucan Contains
   2. What Diflucan Looks Like and Contents of the Pack
   3. Marketing Authorization Holder
   4. Manufacturer
   5. This Medicinal Product is Authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) Under the Following Names:
   6. Date of Last Revision of the Leaflet: 02/2024
   7. Information Intended for Healthcare Professionals Only

Package Leaflet: Information for the User

Diflucan, 2 mg/ml, Solution for Infusion

Fluconazole

Read All of This Leaflet Carefully Before You Start Using This Medicine Because It Contains Important Information for You.

• You should keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack and Other Information

• 1. What Diflucan is and what it is used for
• 2. 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 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 infections caused by fungi and can also be used to prevent fungal infections.
The most common cause of fungal infections is a type of fungus called Candida.

Adults

Your doctor may prescribe Diflucan for the following fungal infections:

• Cryptococcal meningitis - a fungal infection of the brain,
• Coccidioidomycosis - a disease of the lungs,
• Infections caused by Candida fungi and detected in the blood, internal organs (e.g., heart, lungs), or urinary tract,
• Fungal infections (thrush) of the mucous membranes - infection of the mucous membranes of the mouth, throat, and mouth sores associated with the use of dental prostheses.

Diflucan can also be used to:

• prevent relapses of cryptococcal meningitis,
• prevent relapses of fungal infections of the mucous membranes,
• prevent fungal infections (in patients with weakened and improperly functioning immune systems).

Children and Adolescents (from 0 to 17 years)

Your doctor may prescribe Diflucan to treat the following fungal infections:

• Fungal infections (thrush) of the mucous membranes - infections of the mucous membranes of the mouth or throat,
• Infections caused by Candida fungi and detected in the blood, internal organs (e.g., heart, lungs), or urinary tract,
• Cryptococcal meningitis - a fungal infection of the brain.

Diflucan can also be used to:

• prevent fungal infections (in patients with weakened and improperly functioning immune systems),
• prevent relapses of cryptococcal meningitis.

2. Before You Use Diflucan

When Not to Use Diflucan

• If you are allergic to fluconazole, other antifungal medicines, or any of the other ingredients of this medicine (listed in section 6). Symptoms may include itching, redness of the skin, or difficulty breathing.
• If you are taking astemizole, terfenadine (antihistamines used to treat allergies).
• If you are taking cisapride (for stomach disorders).
• If you are taking pimozide (for mental disorders).
• If you are taking quinidine (for heart rhythm disorders).
• If you are taking erythromycin (an antibiotic used to treat infections).

Warnings and Precautions

Before starting to use Diflucan, tell your doctor or nurse:

• if you have liver or kidney problems,
• if you have heart problems, including heart rhythm disorders,
• if you have abnormalities in blood tests (e.g., low levels of potassium, calcium, or magnesium),
• if you have severe skin reactions (itching, redness of the skin, or difficulty breathing),
• if you have symptoms of "adrenal insufficiency" (e.g., chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain),
• if you have ever had a severe skin rash or peeling after using Diflucan.

In patients treated with Diflucan, there have been cases of severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS). If you experience any symptoms of severe skin reactions, stop using Diflucan and seek medical help immediately.
If the fungal infection does not improve, other antifungal treatment may be necessary.

Diflucan and Other Medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.
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 rhythm disorders),
• erythromycin (an antibiotic used to treat infections),

because they should not be used with Diflucan (see "When Not to Use Diflucan").
There are also other medicines that may interact with Diflucan. If you are taking any of the following medicines, tell your doctor, as your dose may need to be adjusted or monitored:

• rifampicin or rifabutin (antibiotics used to treat infections),
• abrocitinib (used to treat atopic dermatitis),
• alfentanil, fentanyl (anesthetics),
• amitriptyline, nortriptyline (antidepressants),
• amphotericin B, voriconazole (antifungal medicines),
• blood thinners (e.g., warfarin),
• benzodiazepines (e.g., midazolam, triazolam),
• carbamazepine, phenytoin (used to treat epilepsy),
• nifedipine, isradipine, amlodipine, verapamil, felodipine, and losartan (used to treat high blood pressure),
• olaparib (used to treat ovarian cancer),
• cyclosporine, everolimus, sirolimus, or tacrolimus (used to prevent transplant rejection),
• cyclophosphamide, vincristine (used to treat cancer),
• halofantrine (used to treat malaria),
• statins (e.g., atorvastatin, simvastatin, fluvastatin) used to lower cholesterol,
• methadone (a pain reliever),
• celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (nonsteroidal anti-inflammatory drugs),
• oral contraceptives,
• prednisone (a steroid),
• zidovudine (also known as AZT), saquinavir (used to treat HIV),
• antidiabetic medicines (e.g., chlorpropamide, glibenclamide, glipizide, or tolbutamide),
• theophylline (used to treat asthma),
• tofacitinib (used to treat rheumatoid arthritis),
• tolvaptan (used to treat hyponatremia or to slow the worsening of kidney function),
• vitamin A (dietary supplement),
• ivacaftor (used to treat cystic fibrosis),
• amiodarone (used to treat irregular heartbeats),
• hydrochlorothiazide (a diuretic),
• ibrutinib (used to treat blood cancer),
• luraxizumab (used to treat schizophrenia).

Pregnancy, Breast-Feeding, and Fertility

If you are pregnant, breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
If you are planning to become pregnant, it is recommended that you wait for one week after taking a single dose of fluconazole before becoming pregnant.
If you are pregnant, think you may be pregnant, or are planning to have a baby, do not use Diflucan unless your doctor has told you to. If you become pregnant while using this medicine or within one week of taking the last dose, tell your doctor.
Fluconazole used during the first or second trimester of pregnancy may increase the risk of miscarriage. Fluconazole used during the first trimester of pregnancy may increase the risk of birth defects of the heart, bones, and/or muscles.
There have been cases of children born with birth defects of the skull, ears, and thigh and elbow bones to mothers treated with high doses of fluconazole (400-800 mg per day) for coccidioidomycosis for at least three months. The relationship between fluconazole and these cases is unclear.
Breast-feeding can continue after a single dose of Diflucan 150 mg. Do not breast-feed if you are taking multiple doses of Diflucan.

Driving and Using Machines

When driving or using machines, consider that dizziness or seizures may occasionally occur.

Diflucan Contains Sodium (Salt)

25 ml of Diflucan contains 88.5 mg of sodium (the main component of common salt). This corresponds to 4.4% of the recommended maximum daily intake of sodium for an adult.
If you have to take Diflucan for a long time, especially if you have been prescribed a low-salt diet, talk to your doctor or pharmacist.

3. How to Use Diflucan

Diflucan will be administered by a doctor or nurse as a slow infusion into a vein (intravenous infusion). Diflucan is supplied as a solution and will not be further diluted. Detailed information for healthcare professionals is provided at the end of the leaflet.
The recommended dose, depending on the type of infection, is shown below. If you have any doubts about using Diflucan, ask your doctor or nurse.

Adults

Adolescents (12-17 years)

The dose prescribed by your doctor (as for adults or children).

Children (up to 11 years)

The maximum dose in children is 400 mg per day.
The dose will be determined based on the child's weight in kilograms.

Children (0-4 weeks)

Dosing in children from 3-4 weeks of age:
The same dose as above, but given every other day. The maximum dose is 12 mg/kg body weight every 48 hours.
Dosing in children under 2 weeks of age:
The same dose as above, given every 3 days. The maximum dose is 12 mg/kg body weight every 72 hours.

Elderly Patients

The usual dose for adults is given, unless you have kidney problems.

Patients with Kidney Problems

Your doctor may adjust the dose depending on your kidney function.

Overdose of Diflucan

If you think you have received too much Diflucan, tell your doctor or nurse immediately. Symptoms of potential overdose include hearing, vision, or feeling disturbances (hallucinations and paranoid behavior).

Missed Dose of Diflucan

Since this medicine is used under close medical supervision, it is unlikely that a dose will be missed. However, if you think a dose has been missed, tell your doctor or pharmacist.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medicines, Diflucan can cause side effects, although not everybody gets them.
If you experience any of the following symptoms, stop using Diflucan and seek medical help immediately:

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

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

• sudden wheezing, difficulty breathing, or chest tightness,
• swelling of the eyelids, face, or lips,
• itching all over the body, redness of the skin, or hives,
• rash,
• severe skin reactions, such as blistering rash (which may also affect the mouth and tongue).

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

• feeling tired,
• loss of appetite,
• nausea and vomiting,
• yellowing of the skin or whites of the eyes (jaundice).

If you experience any of these symptoms, stop using Diflucan and seek medical help immediately.

Other Side Effects

Additionally, if any of the side effects get worse or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
Common side effects (may affect up to 1 in 10 people):

• headache,
• discomfort in the abdomen, diarrhea, nausea, vomiting,
• increased liver enzymes,
• rash.

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

• reduced red blood cell count, which can cause pale skin, weakness, and shortness of breath,
• reduced appetite,
• insomnia, drowsiness,
• seizures, dizziness, balance disturbances (feeling of spinning), sensory disturbances (tingling, prickling, or numbness), changes in taste,
• constipation, indigestion, bloating, dry mouth,
• muscle pain,
• liver damage and yellowing of the skin and eyes (jaundice),
• blisters, hives, itching, increased sweating,
• feeling tired, malaise, fever.

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

• reduced white blood cell count, which can increase the risk of infection, or reduced platelet count, which can increase the risk of bleeding,
• purple or red discoloration of the skin, which can be a sign of reduced platelet count or other blood cell abnormalities,
• changes in blood biochemistry (e.g., high cholesterol or lipid levels),
• low potassium levels in the blood,
• tremors,
• abnormal heart rhythms or ECG changes,
• liver failure,
• allergic reactions (sometimes severe), including widespread blistering rash and skin peeling, severe skin reactions, swelling of the lips or face,
• hair loss.

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• hypersensitivity reactions characterized by: skin rash, fever, swollen lymph nodes, increased eosinophils, and inflammation of internal organs (liver, lungs, heart, kidneys, and colon) [drug reaction with eosinophilia and systemic symptoms (DRESS)].

Reporting Side Effects

If you experience any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
You can also report side effects to the marketing authorization holder or its representative.
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 vial after EXP. The expiry date refers to the last day of the month.
• Storage conditions:
• Glass vials: do not freeze.
• PVC bags: store below 30°C; do not freeze.
• The medicine should be used immediately after opening. Any unused solution should be discarded. This medicine is for single use only.
• Do not use this medicine if you notice visible particles or if the solution is cloudy or has changed color.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

What Diflucan Contains

• The active substance is fluconazole. Each ml contains 2 mg of fluconazole. One vial of 25 ml solution for infusion contains 50 mg of fluconazole. One vial of 50 ml solution for infusion contains 100 mg of fluconazole. One vial of 100 ml solution for infusion contains 200 mg of fluconazole. One vial of 200 ml solution for infusion contains 400 mg of fluconazole. One PVC bag of 100 ml solution for infusion contains 200 mg of fluconazole. One PVC bag of 200 ml solution for infusion contains 400 mg of fluconazole.
• The other ingredients are sodium chloride, water for injection, and sodium hydroxide (for pH adjustment) [see section 2 "Diflucan contains sodium (salt)"].

What Diflucan Looks Like and Contents of the Pack

• Clear, colorless solution without visible particles.
• Available in glass vials or PVC bags.
• Pack sizes:
• 1 vial containing 25 ml solution for infusion
• 1, 48 vials containing 50 ml solution for infusion
• 1, 40 vials containing 100 ml solution for infusion
• 1 vial containing 200 ml solution for infusion
• 1, 5, 10, or 20 PVC bags containing 100 ml solution for infusion
• 1, 5, 10, or 20 PVC bags containing 200 ml solution for infusion

Not all pack sizes may be marketed.

Marketing Authorization Holder

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer

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

This Medicinal Product is Authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) Under the Following Names:

For more information on this medicine, contact your local representative of the marketing authorization holder:
Pfizer Polska Sp. z o.o.
Phone: 22 335 61 00

Date of Last Revision of the Leaflet: 02/2024

Detailed information on this medicine is available on the website: http://www.urpl.gov.pl/

Information Intended for Healthcare Professionals Only

Intravenous infusion should be administered at a rate not exceeding 10 ml/minute. Diflucan contains 9 mg/ml (0.9%) sodium chloride solution, each 200 mg (100 ml solution for infusion) contains 15 mmol of sodium and chloride ions. Since Diflucan is available as a sodium chloride solution, this should be taken into account for patients on a low-sodium diet.
The solution for infusion of fluconazole is compatible with the following solutions:
a)
5% and 20% glucose solution;
b)
Ringer's solution;
c)
Hartmann's solution;
d)
Potassium chloride solution in glucose solution;
e)
4.2% and 5% sodium bicarbonate solution;
f)
Aminosyn 3.5%;
g)
9 mg/ml (0.9%) sodium chloride solution;
h)
Dialaflex (peritoneal dialysis solution Soln 6.36%).
Fluconazole can be administered in infusion through an existing intravenous access line with one of the above solutions. Although there are no specific incompatibilities, it is not recommended to mix fluconazole with other medicinal products before administration.
The solution for infusion is intended for single use only.
From a microbiological point of view, the diluted solution should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless reconstitution or dilution has been carried out in controlled and validated aseptic conditions.
Dilutions should be made under aseptic conditions. Before administration, the solution should be inspected visually for particulate matter and discoloration. The solution should only be used if it is clear and free from particles.
Any unused product or waste material should be disposed of in accordance with local requirements.