Fluconazole

Package leaflet: Information for the user

Flumycon, 50 mg, hard capsules
Flumycon, 100 mg, hard capsules
Flumycon, 150 mg, hard capsules
Flumycon, 200 mg, hard capsules
Fluconazole
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Flumycon is and what it is used for

Flumycon belongs to a group of medicines called "antifungals". The active substance is fluconazole.
Fluconazole is used to treat infections caused by pathogenic fungi and may also be used to prevent Candida infections. The most common cause of fungal infections are yeasts called Candida.

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

• Cryptococcal meningitis – a fungal infection of the brain
• Coccidioidomycosis – a respiratory disease
• Infections caused by Candida detected in the blood, internal organs (e.g. heart, lungs), or urinary tract
• Mucosal yeast infections (thrush) – infection of the mucous membranes of the mouth, throat, and denture-related stomatitis
• Genital yeast infections – infections of the vagina or penis
• Skin fungal infections – e.g. athlete's foot (tinea pedis), tinea corporis, tinea cruris, fungal nail infections

Flumycon may also be used:

• To prevent recurrence of cryptococcal meningitis
• To prevent recurrence of mucosal yeast infections
• To reduce the frequency of recurrent vaginal yeast infections
• To prevent Candida infections (if the patient's immune system is weakened or not functioning properly)

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

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

Flumycon may also be used:

• To prevent yeast infections (if the patient's immune system is weakened or not functioning properly)
• To prevent recurrence of cryptococcal meningitis

2. Important information before using Flumycon

When not to take Flumycon

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

Warnings and precautions
Before starting Flumycon, discuss with your doctor or pharmacist:

• if the patient has liver or kidney problems
• if the patient has heart disease, including heart rhythm disorders
• if the patient has abnormal blood levels of potassium, calcium, or magnesium
• if the patient has severe skin reactions (itching, skin redness, difficulty breathing)
• if symptoms of "adrenal insufficiency" occur, in which the adrenal glands do not produce enough steroid hormones such as cortisol (chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain)
• if the patient has ever experienced severe skin rash, skin peeling, blisters, and/or oral ulcers after taking fluconazole.

Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have occurred in patients treated with fluconazole. If the patient experiences any of the symptoms of severe skin reactions described in section 4, treatment with Flumycon must be discontinued immediately and medical help should be sought without delay.
Talk to your doctor or pharmacist if the fungal infection does not improve, as alternative antifungal therapy may be needed.

Flumycon with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
You must immediately inform your doctor if the patient is taking astemizole, terfenadine (antihistamines used in allergy), cisapride (used for stomach disorders), pimozide (used for psychiatric disorders), quinidine (used for heart rhythm disorders), or erythromycin (an antibiotic used to treat infections), as these should not be taken together with fluconazole (see section "When not to take Flumycon").

There are also other medicines that may interact with fluconazole. Make sure your doctor knows if the patient is taking any of the following medicines, as dose adjustment or monitoring may be necessary to ensure the medicines remain effective:

• rifampicin or rifabutin (antibiotics used to treat infections)
• abrocitinib (used to treat atopic dermatitis, also known as atopic eczema)
• alfentanil, fentanyl (anaesthetics)
• amitriptyline, nortriptyline (antidepressants)
• amphotericin B, voriconazole (antifungal medicines)
• medicines that reduce blood clotting and prevent blood clots (warfarin or similar medicines)
• benzodiazepines (midazolam, triazolam or similar medicines) used to help sleep or for calming
• carbamazepine, phenytoin (used to treat epileptic seizures)
• nifedipine, isradipine, amlodipine, verapamil, felodipine, and losartan (used to treat hypertension – high blood pressure)
• olaparib (used to treat ovarian cancer)
• 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 lower cholesterol levels
• methadone (a painkiller)
• celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (non-steroidal anti-inflammatory drugs – NSAIDs)
• oral contraceptives
• prednisone (a steroid)
• zidovudine, also known as AZT; saquinavir (used in patients infected with HIV)
• antidiabetic medicines such as: chlorpropamide, glyburide, glipizide, 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 worsening of kidney function)
• vitamin A (dietary supplement)
• ivacaftor (used alone or in combination with other medicines to treat cystic fibrosis)
• amiodarone (used to treat irregular heartbeat, i.e. arrhythmia)
• hydrochlorothiazide (a diuretic)
• ibrutinib (used to treat blood cancer)
• lurasidone (used to treat schizophrenia).

Flumycon with food and drink
This medicine can be taken during or independently of meals.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before taking 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.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should not take Flumycon unless otherwise advised by her doctor. If the patient becomes pregnant while taking this medicine or within one week after the last dose, she should contact her 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 malformations in the newborn.
Cases of infants born with congenital malformations of the skull, ears, and femur and elbow bones have been reported in mothers treated for coccidioidomycosis with high doses of fluconazole (400–800 mg daily) for at least 3 months. The causal relationship between fluconazole use and these cases is not clear.
The patient may continue breastfeeding after a single 150 mg dose of Flumycon.
Breastfeeding should not be continued if the patient is taking multiple doses of Flumycon.

Driving and using machines
When driving or operating machinery, bear in mind that dizziness or seizures may occur rarely.

Flumycon contains lactose and sodium
Lactose: If the patient has previously been diagnosed with intolerance to certain sugars, she should consult her doctor before taking this medicine.
Sodium: This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free."

Flumycon 200 mg also contains cochineal red A (E 122)
This may cause allergic reactions.

3. How to use Flumycon

This medicine should always be taken exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Swallow the capsule whole with a glass of water. It is best to take the capsules at the same time each day.
The capsules may be taken with or without food.
The recommended dosage, depending on the type of infection, is given below:

Adults

| Indication | Dosage | |----------------|------------| | Treatment of cryptococcal meningitis | 400 mg on the first day, then 200 mg daily; 400 mg once daily for 6 to 8 weeks, or longer if necessary. The dose may sometimes be increased to 800 mg. | | Prevention of relapse of cryptococcal meningitis | 200 mg once daily until your doctor advises stopping treatment. | | Treatment of coccidioidomycosis | 200 mg to 400 mg once daily for 11 to 24 months, or longer if necessary. The dose may sometimes be increased to 800 mg. | | Treatment of Candida-related internal organ infections | 800 mg on the first day, then 400 mg once daily until your doctor advises stopping treatment. | | Treatment of oral, throat and oral thrush infections associated with dental prostheses | 200 mg to 400 mg on the first day, then 100 mg to 200 mg once daily until your doctor advises stopping treatment. | | Mucosal fungal (yeast) infections – dosage depends on the site of infection | 50 mg to 400 mg once daily for 7 to 30 days, or until your doctor advises stopping treatment. | | Prevention of relapse of oral and throat mucosal infections | 100 mg to 200 mg once daily, or 200 mg three times per week, if the patient has an increased risk of infection recurrence. | | Treatment of fungal infections of the genital organs | Single dose of 150 mg. | | Prevention of vaginal infection relapses | 150 mg every third day, for a total of 3 doses (day 1, 4, and 7), then once weekly for 6 months, if the patient has an increased risk of recurrence. | | Treatment of fungal skin and nail infections | Depending on the site of infection: 50 mg once daily, 150 mg once weekly, or 300 mg to 400 mg once weekly for 1 to 4 weeks (in tinea pedis, treatment may need to be extended up to 6 weeks; in nail infections, treatment should continue until the infected nail is completely replaced by a healthy, uninfected one). | | Prevention of Candida-related infections (in patients with weakened or impaired immune systems) | 200 mg to 400 mg once daily, if the patient has an increased risk of infection recurrence. |

Use in children and adolescents

Adolescents aged 12 to 17 years
Administer the dose prescribed by the doctor (as for adults or as for children).

Children up to 11 years of age
The maximum daily dose in children is 400 mg.
The dose will be determined based on the child's body weight in kilograms.

| Indication | Daily Dose | |----------------|----------------| | Mucosal candidiasis of the oral cavity and throat | 3 mg per kg body weight once daily (on the first day, a dose of 6 mg per kg body weight may be administered). The dose and duration of treatment depend on the severity and location of the infection. | | Cryptococcal meningitis or internal organ infections caused by Candida | 6 mg to 12 mg per kg body weight once daily | | Prevention of relapse of cryptococcal meningitis and encephalomyelitis | 6 mg per kg body weight once daily | | Prevention of Candida-related infections in children (in patients with impaired immune function) | 3 mg to 12 mg per kg body weight once daily |

Use in children aged 0 to 4 weeks

Use in children aged 3 to 4 weeks:

• Same dose as above, but administered every other day. Maximum dose: 12 mg per kg body weight every 48 hours.

Use in children under 2 weeks of age:

• Same dose as above, administered every 3 days. Maximum dose: 12 mg per kg body weight every 72 hours.

Your doctor may sometimes recommend a different dosage. Always take this medicine exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

Elderly patients
The usual adult dose is recommended, unless the patient has impaired kidney function.

Patients with impaired kidney function
Your doctor may adjust the dosage depending on kidney function.

Taking more Flumycon than prescribed
Taking too many capsules at once may cause feeling unwell. Seek immediate medical attention from your doctor or the nearest hospital emergency department. Symptoms of overdose may include hearing, vision, and sensory disturbances, as well as false beliefs (hallucinations and paranoid behavior). Symptomatic treatment may be required (supportive care of vital functions and gastric lavage if necessary).

If you miss a dose of Flumycon
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 almost time for your next dose, do not take the missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following symptoms occur in a patient, treatment with
Flumycon should be discontinued and immediate medical help should be sought:

• Widespread rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
  Some patients may experience allergic reactions, although severe allergic reactions are rare. If any of the following symptoms occur, inform the doctor immediately:
• Sudden wheezing, 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
• Skin rash
• Severe skin reactions, such as blistering rash (may affect the mouth and tongue)

Flumycon 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 Flumycon should be stopped and the patient should immediately contact a doctor.

Other adverse reactions:
Additionally, if any adverse reaction worsens or if any adverse reactions not listed in this leaflet occur, the doctor or pharmacist should be informed.

Common adverse reactions (may affect up to 1 in 10 people out of 100):

• Headache
• Rash
• Stomach discomfort, nausea, vomiting, diarrhoea
• Increased liver enzyme activity (in liver function tests)

Uncommon adverse reactions (may affect up to 1 in 1,000 people):

• Decrease in the number of red blood cells, which may cause paleness, weakness and shortness of breath
• Loss of appetite
• Insomnia, drowsiness
• Seizures, dizziness, sensation of spinning, sensory disturbances, tingling or numbness, changes in taste perception
• Constipation, indigestion, flatulence, dry mouth
• Muscle pain
• Liver damage or yellowing of the skin or eyes (jaundice)
• Blisters, hives (urticaria), itching, increased sweating
• Fatigue, general malaise, fever

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

• Decrease in white blood cells involved in the body's defence against infections and in blood cells that help stop bleeding
• Red or purple skin discolouration, which may result from a decrease in the number of platelets or changes in other blood cells
• Changes in blood biochemical parameters (elevated cholesterol, elevated blood lipids)
• Decreased potassium levels in the blood
• Tremor
• Abnormalities in ECG, changes in heart rate or heart rhythm disturbances
• Liver failure
• Allergic reactions (sometimes severe), including widespread blistering rash, skin peeling, severe skin reactions, swelling of the lips or face
• Hair loss

Frequency unknown (but may occur; frequency cannot be estimated from available data):
Hypersensitivity reaction with skin rash, fever, swollen lymph nodes, increased white blood cell count (eosinophilia), and inflammation of internal organs (liver, lungs, heart, kidneys, and large intestine) (English: Drug Reaction or rash with Eosinophilia and Systemic Symptoms (DRESS))

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, the doctor or pharmacist should be informed. 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 authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Flumycon

Keep this medicine out of sight and reach of children.
Do not store above 30°C. Do not transfer the capsules to another container.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Flumycon contains

• The active substance is fluconazole. Each hard capsule contains 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole.
• The other ingredients are monohydrate lactose, corn starch, colloidal anhydrous silica, sodium lauryl sulfate, and magnesium stearate. The capsule shell contains gelatin and the following colourants:
  50 mg, 100 mg, 150 mg capsules: titanium dioxide (E171) and brilliant blue (E133)
  200 mg capsules: titanium dioxide (E171), azorubine (E122), and brilliant blue (E133)

What Flumycon looks like and contents of the pack
Flumycon 50 mg hard capsules are unmarked gelatin capsules approximately 14 mm in size, with a light blue opaque cap and a white opaque body.
They are available in blister packs containing 1, 7, 10, 14, 20, 28, 30, 50, 100, or 500 capsules.
Flumycon 100 mg hard capsules are unmarked gelatin capsules approximately 18 mm in size, with a blue opaque cap and a white opaque body.
They are available in blister packs containing 7, 10, 14, 16, 20, 28, 30, 50 (1 x 50), 60, or 100 capsules.
Flumycon 150 mg hard capsules are unmarked gelatin capsules approximately 19 mm in size, with a light blue opaque cap and a light blue opaque body.
They are available in blister packs containing 1, 2, 4, 6, 7, or 12 capsules.
Flumycon 200 mg hard capsules are unmarked gelatin capsules approximately 22 mm in size, with a violet opaque cap and a white opaque body.
They are available in blister packs containing 1, 2, 4, 7, 10, 12, 14, 20, 30, 50, or 100 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva B.V.
Swensweg 5, 2031 GA Haarlem
The Netherlands

Manufacturer
TEVA Gyógyszergyár Zrt.
Debrecen, Pallagi út 13,
H-4042, Hungary
Pharmachemie B.V.,
Swensweg 5, 2031 GA Haarlem,
The Netherlands

For further information about this medicine, contact the representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.

This medicine is authorised in the European Economic Area countries 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: Фунголон 50 mg твърди капсули
Fungolon 50 mg hard capsules
Фунголон 100 mg твърди капсули
Fungolon 100 mg hard capsules
Фунголон 150 mg твърди капсули
Fungolon 150 mg hard capsules
Фунголон 200 mg твърди капсули
Fungolon 200 mg hard capsules
Estonia: Fluconazole Teva
Finland: Fluconazol Teva 150 mg kapseli, kova
Hungary: Fluconazole-Teva 50 mg kemény kapszula
Fluconazole-Teva 100 mg kemény kapszula
Fluconazole-Teva 150 mg kemény kapszula
Fluconazole-Teva 200 mg kemény kapszula
Iceland: Candizol
Lithuania: Fluconazole Teva 150 mg kietosios kapsulės
Latvia: Fluconazole Teva 150 mg cietās kapsulas
Poland: Flumycon
Portugal: Fluconazol ratiopharm
Sweden: Fluconazole Teva