Fluconazole infusion solution 2 mg/ml

Package leaflet: Information for the patient

Fluconazole infusion solution 2 mg/ml
(Fluconazolum)
Please read all of this leaflet carefully before using this medicine, because it contains important information for you.

• Keep this leaflet, as 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 a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. This also applies to side effects not mentioned in this leaflet. See section 4.

Contents of the leaflet:

1. What Fluconazole is and what it is used for
2. Important information before using Fluconazole
3. How to use Fluconazole
4. Possible side effects
5. How to store Fluconazole
6. Contents of the pack and other information

1. What Fluconazole is and what it is used for

Fluconazole belongs to a group of antifungal medicines. The active substance is fluconazole.
Fluconazole is indicated for the treatment of fungal infections and for the prevention of
Candida yeast infections. The most common cause of fungal infections are yeasts of the
Candida species.

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 respiratory disease (bronchi and lungs),
• infections caused by Candida fungi affecting the bloodstream, internal organs (e.g. heart, lungs) or urinary tract,
• mucosal candidiasis – infection of the mucous membranes of the mouth, throat, and denture-related stomatitis.

Fluconazole may also be used for:

• prevention of recurrent cryptococcal meningitis,
• prevention of recurrent oral mucosal candidiasis,
• prevention of Candida fungal infections (when the patient's immune system is weakened and not functioning properly).

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

• mucosal candidiasis – infection of the mucous membranes of the mouth or throat,
• infections caused by Candida fungi affecting the bloodstream, internal organs (e.g. heart, lungs) or urinary tract,
• cryptococcal meningitis – a fungal infection of the brain.

Fluconazole may also be used for:

• prevention of Candida fungal infections (when the patient's immune system is weakened and not functioning properly),
• prevention of recurrent cryptococcal meningitis.

2. Important information before using Flukonazol

When not to use Flukonazol

• if the patient is allergic to fluconazole or other drugs 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 the patient is concurrently taking astemizole or terfenadine (antihistamines used to treat allergies),
• if the patient is concurrently taking cisapride (used to treat stomach disorders),
• if the patient is concurrently taking pimozide (used to treat mental disorders),
• if the patient is concurrently taking quinidine (used to treat heart rhythm disorders),
• if the patient is concurrently taking erythromycin (an antibiotic used to treat infections).

Warnings and precautions
Before starting treatment with Flukonazol, discuss with your doctor:

• if the patient has kidney or liver function disorders,
• if the patient has heart diseases, including heart rhythm disorders,
• if the patient has disturbances in blood levels of potassium, calcium, or magnesium,
• if the patient develops severe skin reactions (itching, skin redness, and/or difficulty breathing),
• if the patient develops symptoms of "adrenal insufficiency", when the adrenal glands do not produce sufficient amounts of certain steroid hormones such as cortisol (chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain),
• if the fungal infection does not resolve, alternative antifungal treatment may be necessary,
• if the patient has ever experienced severe skin rash, skin peeling, blisters, and/or oral ulcers after taking Flukonazol.

Severe skin reactions, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported in patients treated with Flukonazol. If the patient experiences any of the symptoms of severe skin reactions described in section 4, treatment with Flukonazol must be discontinued immediately and medical help should be sought without delay.

Flukonazol and other medicines
You must immediately inform your doctor if the patient is 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), or erythromycin (an antibiotic used to treat infections), as these must not be taken together with Flukonazol (see section 2 "When not to use Flukonazol").

There are also other medicines that may interact with Flukonazol. Inform your doctor if the patient is taking any of the following medicines:

• rifampicin or rifabutin (antibiotics used to treat infections),
• alfentanil, fentanyl (anaesthetics),
• amitriptyline, nortriptyline (antidepressants),
• amphotericin B, voriconazole (antifungal medicines),
• anticoagulants (blood thinners) used to prevent blood clots (e.g. warfarin or similar medicines),
• benzodiazepines (midazolam, triazolam or similar medicines) used to help sleep or treat anxiety,
• carbamazepine, phenytoin (medicines used to treat epilepsy),
• nifedipine, isradipine, amlodipine, felodipine, losartan (medicines used to treat high blood pressure),
• cyclosporine, everolimus, sirolimus, or tacrolimus (medicines used to prevent transplant rejection),
• cyclophosphamide, vinca alkaloids (vincristine, winblastine or similar medicines) used in the treatment of cancer,
• halofantrine (a medicine used to treat malaria),
• statins (atorvastatin, simvastatin, fluvastatin or similar medicines) used to lower cholesterol levels,
• methadone (a painkiller),
• celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (non-steroidal anti-inflammatory drugs, NSAIDs),
• oral contraceptives,
• prednisolone (a steroid medicine),
• zidovudine (also known as AZT), saquinavir (medicines used in HIV-infected patients),
• diabetes medicines such as chlorpropamide, glibenclamide, glipizide, or tolbutamide,
• theophylline (used to treat asthma),
• vitamin A (dietary supplement),
• ivacaftor (used to treat cystic fibrosis),
• amiodarone (used to treat heart rhythm disorders - arrhythmias),
• hydrochlorothiazide (a diuretic).

Tell your doctor, pharmacist, or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

If the patient plans to become pregnant, it is recommended to wait one week after taking a single dose of fluconazole before attempting conception.

For longer treatment courses with fluconazole, discuss with your doctor the need for appropriate contraception during treatment and for one week after the last dose.

Pregnancy
If the patient is pregnant, suspects she may be pregnant, or is trying to conceive, she should not take fluconazole unless otherwise advised by her doctor. If pregnancy occurs while taking this medicine or within one week after the last dose, contact your doctor immediately.

Fluconazole taken during the first or second trimester of pregnancy may increase the risk of miscarriage. Fluconazole taken during the first trimester of pregnancy may increase the risk of congenital heart, bone, and/or muscle abnormalities in the newborn.

Cases of infants born with congenital malformations of the skull, ears, femur, and ulna have been reported in mothers treated for coccidioidomycosis with high doses of fluconazole (400–800 mg daily) for at least three months. The causal relationship between fluconazole use and these cases is not fully established.

Breastfeeding
After receiving a single dose of Flukonazol up to 200 mg, the patient may continue breastfeeding. However, breastfeeding should be avoided if the patient receives multiple doses of Flukonazol.

Driving and using machines
When driving or operating machinery, consider the possibility of dizziness or seizures occurring.

Flukonazol contains sodium
Flukonazol contains 0.154 mmol of sodium in each 1 ml. This sodium content should be taken into account in patients on a controlled sodium diet.

3. How to use Flukonazol

Flukonazol is intended for use only by a doctor or nurse as a slow intravenous infusion. Flukonazol is supplied as a solution and will not be further diluted. Detailed information for medical and healthcare personnel is provided at the end of the leaflet.
The following is the dosing of Flukonazol depending on the type of infection. If you are unsure why you are receiving Flukonazol, please consult your doctor or nurse.
Adults

Use in children and adolescents
Adolescents aged 12 to 17 years
Follow the doctor's instructions (dosage as for adult patients or children).
Children up to 11 years of age
The maximum dose in children is 400 mg per day.
The dose should be determined based on the child's body weight (in kilograms).

Children aged 0 to 4 weeks
Dosing in children aged 3 to 4 weeks:

• The same dose as above, administered once every 2 days. 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, administered once every 3 days. The maximum dose is 12 mg/kg body weight every 72 hours.

Sometimes a doctor may recommend a different dosing regimen. The medicine should always be used according to the instructions of the doctor, pharmacist, or nurse. If in doubt, contact the doctor, pharmacist, or nurse.

Elderly patients
In patients with normal renal function, the dosing is the same as in adult patients.

Dosing in patients with renal impairment
In patients with impaired renal function, the doctor may adjust the dosing regimen depending on the severity of impairment.

Overdose of Flukonazol infusion solution
If a patient believes they have received an excessive dose of Flukonazol, they should immediately inform their doctor or nurse. Symptoms of potential overdose may include hearing and vision disturbances, as well as experiencing and thinking about unreal things (hallucinations and paranoid behavior).

Missed dose of Flukonazol
Since this medicine is administered under strict medical supervision, it is unlikely that a dose will be missed. However, if a patient suspects that a dose has been missed, they should inform their doctor or nurse.
Do not administer a double dose to make up for a missed dose.

If there are any further doubts regarding the use of this medicine, consult a doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Allergic reactions may occur in some patients, although severe allergic reactions are rare.
If any of the following symptoms occur in a patient, treatment with Flucanazole must be discontinued and immediate medical help must be sought:

• widespread rash, high fever, swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome)
• sudden wheezing, 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 appearance of red, itchy blisters;
• skin rash, sometimes with blisters, itching;
• severe skin reactions, such as blistering rash (may also affect the mouth and tongue). If any of the above symptoms occur, treatment with Flucanazole must be discontinued and immediate medical advice must be sought.

Flucanazole may affect the liver. Liver-related symptoms include:

• feeling tired,
• loss of appetite,
• vomiting,
• yellowing of the skin or whites of the eyes (jaundice). If any of the above symptoms occur, treatment with Flucanazole must be discontinued and immediate medical advice must be sought.

Flucanazole may affect the adrenal glands and the level of steroid hormones produced by them. Symptoms related to the adrenal glands include:

• fatigue,
• muscle weakness,
• loss of appetite,
• weight loss,
• abdominal pain. If any of the above symptoms occur, treatment with Flucanazole must be discontinued and immediate medical advice must be sought.

Other adverse reactions:
Common adverse reactions (may affect up to 1 in 10 patients):

• headache;
• abdominal pain, diarrhoea, nausea, vomiting;
• increased liver function test results;
• rash.

Uncommon adverse reactions (may affect up to 1 in 100 patients):

• decreased number of red blood cells causing paleness, weakness, and shortness of breath,
• decreased appetite,
• insomnia, drowsiness,
• seizures, dizziness, spinning sensation, tingling, pricking, or numbness, taste alterations,
• constipation, indigestion, bloating, dry mouth,
• muscle pain,
• liver damage and yellowing of the skin and eyes (jaundice),
• hives, blistering (urticaria), itching, increased sweating,
• fatigue, malaise, fever.

Rare adverse reactions (may affect 1 to 10 in 10,000 patients):

• decreased number of white blood cells responsible for protection against infections and blood cells responsible for stopping bleeding,
• red or purple skin discolouration, possibly due to decreased platelet count or changes in other blood cells,
• changes in blood biochemical parameters (high cholesterol, blood lipids),
• tremor,
• low blood potassium levels,
• abnormal electrocardiogram (ECG) readings, heart rate and rhythm disturbances,
• liver damage,
• allergic reactions (sometimes severe), including widespread blistering rash, skin peeling, severe skin reactions, swelling of the lips or face,
• hair loss.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Flukonazol

Keep the medicine out of the sight and reach of children.
Do not store above 25°C.
Do not freeze.
Store the vial in its outer cardboard packaging to protect from light.
Do not use this medicine after the expiry date stated on the outer packaging after "EXP". The expiry date refers to the last day of the specified month.
This medicinal product is for single use only. After opening, any unused infusion solution must be discarded.
The solution may only be used if it is clear and free from solid particles.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Flukonazol contains

• The active substance is fluconazole. Each 1 ml contains 2 mg of fluconazole. Each 100 ml of infusion solution contains 200 mg of fluconazole.
• The other components are: sodium chloride and water for injections.

What Flukonazol infusion solution looks like and contents of the pack
Flukonazol is a clear, colourless infusion solution, available in a 100 ml glass vial.
Flukonazol is available in packs containing 1 vial with 100 ml of infusion solution.
Not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
Baxter Holding B.V.
Kobaltweg 49,
3542 CE Utrecht
The Netherlands

Manufacturer/Importer:
Bieffe Medital S.P.A
Via Nuova Provinciale
23034 Grosotto (SO),
Italy
UAB Norameda
Meistru 8a, 02189, Vilnius,
Lithuania
Tramco sp. z o.o.
Wolskie, ul. Wolska 14
05-860 Płochocin
Poland

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Detailed information about this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPLWMiPB):
http://www.urpl.gov.pl

Information intended exclusively for medical professionals:

The intravenous infusion should be administered at a rate not exceeding 10 ml/min.
For patients requiring fluid or sodium restriction, the infusion rate should be carefully considered.

Fluconazole infusion solution is compatible with the following infusion solutions:
a) 5% and 20% D-glucose solution
b) Ringer's solution
c) Ringer's lactate (sodium lactate) 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 (6.36% peritoneal dialysis solution)

Fluconazole may be administered through an existing intravenous access line together with any of the above-mentioned solutions. Despite the absence of specific incompatibilities, mixing fluconazole with other medicinal products before administration is not recommended.

The infusion solution is for single use only.
From a microbiological standpoint, the medicinal product should be used immediately. If not used immediately, the user is responsible for the duration and conditions of storage prior to use. Storage should not exceed 24 hours at a temperature of 2 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 discoloration and presence of particulate matter prior to administration. The solution should only be used if it is clear and free from visible particles.

Any unused medicinal product or waste material should be disposed of in accordance with local regulations.