FUNGOLON 150mg x 6 caps
fluconazole
Read all of this leaflet carefully before you start taking this medicine,
because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you personally. Do not pass it on to other people. It may
harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This
It also includes any possible side effects not described in this leaflet. See
point 4.
What this leaflet contains
1. What Fungolon is and what it is used for
2. What you need to know before you take Fungolon
3. How to take Fungolon
4. Possible side effects
5. How to store Fungolon
6. Contents of the pack and other information
1. What Fungolon is and what it is used for
Fungolon belongs to a group of medicines called “antimycotics” (antifungals).
medicines). The active substance is fluconazole.
Fluconazole is used to treat infections caused by fungi and can be used
also to protect you from candida infection. Fungal infections are most commonly caused by
often from a yeast called Candida.
Adults
This medicine may be prescribed by your doctor to treat the following types of
fungal infections:
- cryptococcal meningitis – a fungal infection of the brain
- coccidioidomycosis – a disease of the bronchi and lungs
- infections caused by Candida that are localized in the bloodstream,
internal organs (e.g. heart, lungs) or urinary tract.
- mucosal candidiasis - an infection affecting the lining of the mouth, throat and
as a result of dental procedures.
- genital candidiasis – infections of the vagina or penis.
- skin infections – e.g. fungal infections of the foot (athlete's foot), fungal
skin infections known as ringworm, fungal infections of the groin,
nail infections.
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You may also be prescribed Fungolon in the following cases:
- to stop the recurrence of cryptococcal meningitis
- to stop the recurrence of fungal infections of the mucous membranes
- to limit the recurrence of vaginal candidiasis
- to prevent infection caused by Candida (if your immune system is
weak or not working properly).
Children and adolescents (0 to 17 years)
This medicine may be prescribed by your doctor to treat the following types of
fungal infections:
- fungal infection of the mucous membranes - an infection affecting the mucous membranes of the mouth, throat
- infections caused by Candida that are localized in the bloodstream, body tissues
organs (e.g. heart, lungs) or the urinary system.
- cryptococcal meningitis – a fungal infection of the brain.
Fungolon may be administered to you:
- to prevent developing an infection caused by Candida (if your immune system is weak
or not working properly).
- to prevent the recurrence of cryptococcal meningitis.
2. What you need to know before you take Fungolon
Do not take Fungolon:
• if you are allergic to fluconazole, to other medicines you take to treat
fungal infection or to 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 for allergies)
• if you are taking cisapride (used for stomach disorders)
• if you are taking pimozide (used for mental illness)
• if you are taking quinidine (used for heart arrhythmia)
• if you are taking erythromycin (an antibiotic to treat infections).
Warnings and precautions
Talk to your doctor or pharmacist before taking Fungolon:
- if you have liver or kidney problems
- if you suffer from heart disease, including rhythm disorders
- 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 symptoms of “adrenal insufficiency”, where the adrenal gland
gland does not produce enough of certain steroid hormones, such as
cortisol (chronic or prolonged fatigue, muscle weakness, loss of appetite,
weight loss, abdominal pain);
- if you have ever had a severe skin rash or peeling skin, blistering
and/or mouth ulcers after taking fluconazole.
Serious skin reactions, including drug reaction with eosinophilia and systemic
symptoms (DRESS) have been reported in association with fluconazole treatment. Stop taking
Fungolon and seek medical help immediately if you notice any of the symptoms,
associated with these serious skin reactions described in section 4.
Talk to your doctor or pharmacist if your fungal infection does not improve as it may
may require the prescription of alternative antifungal therapy.
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Other medicines and Fungolon
You should tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including:
you may be taking other medications.
Tell your doctor immediately if you are taking astemizole, terfenadine (antihistamines for
allergy treatment) or cisapride (used for stomach disorders) or pimozide
(used to treat mental illness) or quinidine (used to treat
heart arrhythmia) or erythromycin (an antibiotic to treat infections), as these
medicines should not be taken at the same time as fluconazole (see section “Do not take
Fungolon”).
Some medicines may interact with fluconazole. Make sure your doctor knows if you:
you are taking any of the following medicines, as your dose may need to be adjusted or
follow-up to check if the medications are still having the desired effect:
- rifampicin or rifabutin (antibiotics to treat infections);
- abrocitinib (used to treat atopic dermatitis, also known as atopic dermatitis)
eczema);
- alfentanil, fentanyl (used as painkillers);
- amitriptyline, nortriptyline (used as antidepressants);
- amphotericin B, voriconazole (antifungal medicines);
- medicines that prevent blood clotting (warfarin or similar medicines);
- benzodiazepines (midazolam, triazolam or similar medicines) used to make you sleepy
help you fall asleep or with anxiety;
- carbamazepine, phenytoin (used to treat seizures);
- nifedipine, isradipine, amlodipine, verapamil, felodipine and losartan (for the treatment of
hypertension (high blood pressure);
- olaparib (used to treat ovarian cancer);
- ciclosporin, everolimus, sirolimus or tacrolimus (to prevent rejection
of organs after transplantation);
- cyclophosphamide, vinca alkaloids (vincristine, vinblastine or similar drugs),
used in cancer treatment;
- halofantrine (used to treat malaria);
- statins (atorvastatin, simvastatin and fluvastatin or similar medicines) used for
lowering cholesterol;
- methadone (used for 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 infected with
HIV);
- medicines used to treat diabetes such as chlorpropamide, glibenclamide, glipizide,
chlorpropamide or tolbutamide;
- theophylline (used to treat asthma);
- tofacitinib (used to treat rheumatoid arthritis);
- tolvaptan, used to treat hyponatremia (low blood sodium levels) or
to slow the decline in kidney function;
- vitamin A (food supplement)
- ivacaftor (used to treat cystic fibrosis alone or in combination with
other medicines);
- amiodarone (used to treat abnormal heart rhythm (arrhythmia));
- hydrochlorothiazide (diuretic);
- ibrutinib (used to treat blood cancer);
- lurasidone (used to treat schizophrenia).
Fungol with food and drink
You can take this medicine with or without food.
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Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant,
ask your doctor or pharmacist before using this medicine.
If you are planning a pregnancy, it is recommended to wait one week after taking a single dose.
dose of fluconazole before you get pregnant.
For longer courses of fluconazole treatment, talk to your doctor about the need for
adequate contraception during treatment, which should continue for one week after
the last dose.
You should not take Fungolon if you are pregnant, think you may be pregnant, are trying to conceive, or are
become pregnant or breast-feed unless your doctor has told you to do so.
Contact your doctor if you become pregnant while taking this medicine or within
1 week after you took the last dose.
Fluconazole taken during the first or second trimester of pregnancy may
increased the risk of miscarriage.
Fluconazole taken during the first trimester of pregnancy may increase the risk
the baby to be born with birth defects affecting the heart, bones and/or muscles.
There have been reports of babies born with birth defects affecting the skull, ears and bones of the
the thigh and elbow, in women treated for three months or more with high doses
(400–800 mg daily) fluconazole for coccidioidomycosis. The relationship between fluconazole and these
cases is not clarified.
You can continue to breastfeed after taking a single dose of 150 mg Fungolon. No
you should breastfeed if you are taking a repeat dose of Fungolon.
Driving and using machines
When driving or operating machinery, it should be taken into account that dizziness may occur.
or fainting.
Fungolon contains lactose and sodium
Lactose: If your doctor has told you that you have an intolerance to some sugars, please advise
Talk to your doctor before taking this medicine.
Sodium: This medicine contains less than 1 mmol sodium (23 mg) per capsule, i.e. essentially ‘sodium-free’.
says it is "virtually sodium-free."
Fungolon 200 mg capsules also contain azorubine (E122)
Azorubine may cause allergic reactions.
3. How to take Fungolon
Always take this medicine exactly as your doctor has told you. If you are not sure
anything, ask your doctor or pharmacist.
Swallow the capsules whole with a glass of water. It is best to take the capsules at the same time.
every day.
The capsules can be taken with or without food.
The usual dosages of this medicine for different types of infections are described below:
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Adults
Disease Dosage
For the treatment of cryptococcal
meningitis
400 mg on the first day, then 200 mg to 400 mg
once daily for 6 to 8 weeks or more
long as necessary. Sometimes the dosage is
increases to 800 mg.
To prevent recurrence
occurrence of cryptococcal meningitis
200 mg once a day until you are told to
discontinue treatment
For the treatment of
coccidioidomycosis
200 mg to 400 mg once daily for 11 to 24 months or
longer if necessary. In some cases the dosage
may be increased to 800 mg.
Fungal infection of
internal organs caused by
Candida
800 mg on the first day, then 400 mg once
daily until you are told to stop treatment
For the treatment of mucous membranes
infections of the mouth, throat and
inflammation of the mouth due to
the use of a prosthesis
200 mg to 400 mg on the first day, then 100 mg to
200 mg until you are told to stop treatment
Fungal infections
mucous membranes – dosage depends
from the localization of the infection
50 mg to 400 mg once daily for 7 to 30 days until
tell you to stop treatment
To prevent infections of
the mucous membranes of the mouth and throat
100 mg to 200 mg once daily or 200 mg 3 times
weekly while you are at risk of developing an infection
For the treatment of genital
candidiasis
150 mg single dose
To limit recurrence
of vaginal candidiasis
150 mg every three days for a total of 3 doses (days 1, 4 and 7), then
which once a week for 6 months,
while you are at risk of developing an infection
Fungal infections of the skin and
nails
Depending on the site of infection 50 mg once
daily, 150 mg once weekly, 300 mg to 400 mg
once a week for 1 to 4 weeks (for fungal
Foot infection (athlete's foot) can
last up to 6 weeks, for nail infections –
until the infected nail grows back)
To avoid developing an infection,
caused by Candida (if
your immune system is weak or
not working properly)
200 mg to 400 mg once daily while at risk
to develop an infection
Use in children and adolescents
Adolescents from 12 to 17 years old
Follow the dosage prescribed by your doctor (dose for children or for adults).
Children up to 11 years old
The maximum dose in children is 400 mg.
The dose is determined depending on the child's weight in kilograms.
Disease Daily dose
Fungal infections of the mucous membranes and infections of
Throat caused by Candida – dosage
depends on the severity and location of the infection
3 mg/kg body weight once
daily (the first day can be
administered 6 mg/kg body weight)
Cryptococcal meningitis or fungal infection of the
internal organs caused by Candida
6 mg to 12 mg/kg body weight
once a day
To prevent the recurrence of cryptococcal
meningitis
6 mg/kg body weight once
daily
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To prevent the child from developing an infection caused by
Candida (if his immune system is weak or not
works correctly)
3 mg to 12 mg/kg body weight
once a day
Use in children aged 0 to 4 weeks
Use in children aged 3 to 4 weeks:
Same dose as described above, but administered once every 2 days. The maximum dose is
12 mg/kg body weight every 48 hours.
Use in children younger than 2 weeks:
Same dose as described above, but administered once every 3 days. The maximum dose is
12 mg/kg body weight every 72 hours.
Doctors may sometimes prescribe other doses than those listed. Always take
Take your medicine exactly as your doctor has told you. If you are not sure about anything, ask
Your doctor or pharmacist.
Old age
The usual dose is used, as for adults, unless you have kidney problems.
Patients with kidney problems
Your doctor may change your dosage depending on your kidney function.
If you take more Fungolon than you should
Taking too many capsules at once may make you feel sick.
Contact your doctor immediately or go to the nearest hospital. Symptoms of
overdose may make you see, hear, or think things that are not real
(hallucinations and paranoid behavior). Symptomatic treatment is appropriate.
(supportive measures and gastric lavage if necessary).
If you forget to take Fungolon
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 you remember. If it is time for
your next dose, do not take the dose you missed.
If you have any further questions on the use of 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 Fungolon and seek medical help immediately if you notice any
of the following symptoms:
• widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome)
or drug hypersensitivity syndrome).
Some people develop allergic reactions, although serious allergic reactions occur
Rare. If you experience any of the following symptoms, tell your doctor immediately:
- sudden shortness of breath, difficulty breathing or chest tightness
- swelling of the eyelids, face or lips
- itching all over the body, redness of the skin or itchy red spots
- skin rash
- severe skin reactions, such as a rash with blisters (which may affect the mouth and tongue)
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Fluconazole can damage your liver. Signs of liver damage
include:
- fatigue
- loss of appetite
- vomiting
- yellowing of your skin or the whites of your eyes (jaundice)
If you experience any of these side effects, stop taking fluconazole capsules and
tell your doctor immediately.
Other side effects:
In addition, if any of the side effects become serious or you notice others,
side effects not described in this leaflet, please inform your doctor or pharmacist.
Common side effects, which affect 1 to 10 patients in every 100, are described below:
- headache,
- rash,
- stomach discomfort, malaise, vomiting, diarrhea,
- increased blood test values reflecting liver function
Uncommon side effects, which affect 1 to 10 patients in every 1,000, are described below.
below:
- a decrease in the number of red blood cells, which can cause paleness,
cause weakness or shortness of breath
- decreased appetite
- insomnia, drowsiness
- fainting, dizziness, feeling of vertigo, tingling, prickling or numbness,
changes in taste
- constipation, indigestion, gas, dry mouth
- muscle pain
- liver damage and yellowing of the skin and eyes (jaundice)
- rash, blisters (hives), itching, excessive sweating
- fatigue, general malaise, fever
Rare side effects, which affect 1 to 10 patients in every 10,000, are described below.
below:
- decreased number of white blood cells, which protect the body from infections and blood
cells that help stop bleeding
- red or purple discoloration of the skin, which may be caused by low
platelet count, changes in other blood cells
- changes in blood parameters (high blood cholesterol and fat levels)
- low potassium levels in the blood
- chills
- electrocardiogram (ECG) abnormalities, change in heart rate
- liver failure
- allergic reactions (sometimes severe), including widespread rash with blisters and
peeling skin, severe skin reactions, swelling of the lips or face
- hair loss.
Frequency not known but may occur (cannot be estimated from the available data)
rating):
- hypersensitivity reaction with skin rash, fever, swollen glands,
increase in the number of white blood cells (eosinophilia) and inflammation of the internal organs
organs (liver, lungs, heart, kidneys and colon) (drug reaction
or rash with eosinophilia and systemic symptoms (DRESS))
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Reporting side effects
If you experience any side effects, tell your doctor, pharmacist or
nurse. This includes any possible side effects not described in this leaflet.
You can also report side effects directly via the European Medicines Agency.
medicines, 8 Damyan Gruev Street, 1303 Sofia, tel.: 02 8903417, website: www.bda.bg. As
By reporting side effects, you can contribute to getting more
information about the safety of this medicine.
5. How to store Fungolon
Keep out of the reach of children.
Store below 30º C. Do not move the capsules to another box.
Do not use this medicine after the expiry date which is stated on the carton.
after “Expiry date”. The expiry date refers to the last day of that month.
Do not throw away medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use. These
measures will help protect the environment.
6. Contents of the pack and other information
What Fungolon contains:
− The active substance is fluconazole: 50 mg, 100 mg, 150 mg or 200 mg.
− The other ingredients are: lactose monohydrate, maize starch, colloidal anhydrous
silicon dioxide, sodium lauryl sulfate and magnesium stearate. The capsule shell
contains gelatin and the following colors:
− 50 mg, 100 mg and 150 mg capsules: titanium dioxide (E171) and brilliant blue (E133)
− 200 mg capsules: titanium dioxide (E171), azorubine (E122) and brilliant blue
(E133).
What Fungolon looks like and contents of the pack
Fungolon 50 mg hard capsules - gelatin capsules without markings, approximately 14 mm,
with a light blue opaque cap and a white opaque body. The 50 mg hard capsules are
are available in blister packs containing 1, 7, 10, 14, 20, 28, 30, 50, 100 or 500 capsules.
Fungolon 100 mg hard capsules - gelatin capsules without markings, approximately 18 mm,
with a blue opaque cap and a white opaque body. The 100 mg hard capsules are
available in blister packs containing 7, 10, 14, 16, 20, 28, 30, 50 (1 x 50), 60 or 100
capsules.
Fungolon 150 mg hard capsules - gelatin capsules without markings, approximately 19 mm,
with a light blue opaque cap and a light blue opaque body. The hard capsules of
150 mg are available in blister packs containing 1, 2, 4, 6, 7 or 12 capsules.
Fungolon 200 mg hard capsules - gelatin capsules without markings, approximately 22 mm,
with a purple opaque cap and a white opaque body. The 200 mg hard capsules are
are available in blister packs containing 1, 2, 4, 7, 10, 12, 14, 20, 30, 50 or 100 capsules.
Not all types of packaging can be placed on the market.
Marketing Authorisation Holder
Teva BV
Swensweg 5, 2031 GA Haarlem
Netherlands
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Manufacturers:
TEVA Pharmaceuticals Ltd.
Pallagi út 13, Debrecen 4042
Hungary
Pharmachemie BV
Swensweg 5, 2031 GA Haarlem
NL-2003 RN
Netherlands
This medicine is authorised for use in the Member States of the European Union.
economic space under the following names:
Italy Fluconazolo Teva Italia
Austria Fluconazol ratiopharm 50 mg Kapseln
Fluconazol ratiopharm 100 mg Kapseln
Fluconazol ratiopharm 150 mg Kapseln
Fluconazol ratiopharm 200 mg Kapseln
Bulgaria Fungolon 50 mg hard capsules
Fungolon 100 mg hard capsules
Fungolon 150 mg hard capsules
Fungolon 200 mg hard capsules
Estonia Fluconazole Teva
Finland Fluconazol ratiopharm 150 mg, kapseli kova
Hungary Fluconazole-Teva 50 mg hard kapszula
Fluconazole-Teva 100 mg hard capsule
Fluconazole-Teva 150 mg hard capsule
Fluconazole-Teva 200 mg hard capsule
Iceland Candizol
Lithuania Fluconazole Teva 150 mg kietosios kapsulės
Latvia Fluconazole Teva 150 mg cietās kapsulas
Poland Flukonazol Teva
Portugal Fluconazol ratiopharm
Sweden Fluconazole Teva
Date of last revision of the leaflet – 02/2024
