Flucofast
Poland
Table of Contents
Package leaflet: Information for the patient
Flucofast, 200 mg, hard capsules
Fluconazole
Please read all of this leaflet carefully before 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 only. Do not pass it on to other people. It may harm them, even if their symptoms are the same as yours.
- If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of the leaflet
- What Flucofast is and what it is used for
- Important information before taking Flucofast
- How to take Flucofast
- Possible side effects
- How to store Flucofast
- Contents of the pack and other information
1. What Flucofast is and what it is used for
Flucofast belongs to a group of antifungal medicines. The active substance is fluconazole.
Flucofast 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 of the genus known in Latin as Candida.
Adults
Your doctor may recommend using this medicine for the following fungal infections:
- cryptococcal meningitis – a fungal infection of the brain membranes,
- coccidioidomycosis – a respiratory system disease,
- Candida infections 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 – vaginal or penile infections,
- skin mycoses – e.g. athlete's foot, body ringworm, groin ringworm, nail fungal infections.
Flucofast may also be used for:
- prevention of recurrent cryptococcal meningitis,
- prevention of recurrent mucosal Candida infections,
- prevention of recurrent vaginal yeast infections,
- prevention of yeast infections (in patients with weakened or impaired immune system).
Children and adolescents (aged 0 to 17 years)
Your doctor may recommend using this medicine to treat the following fungal infections:
- mucosal yeast infections (thrush) – infections of the mucous membranes of the mouth or throat,
- Candida infections detected in the blood, internal organs (e.g. heart, lungs), or urinary tract,
- cryptococcal meningitis – a fungal infection of the brain membranes.
Flucofast may also be used for:
- prevention of yeast infections (in patients with weakened or impaired immune system),
- prevention of recurrent cryptococcal meningitis.
2. Important information before using Flucofast
When not to use Flucofast
- if the patient is allergic to fluconazole, to other azole compounds, 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 in the treatment of allergies),
- if the patient is taking cisapride (used to treat stomach disorders),
- if the patient is taking pimozide (used to treat mental 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 treatment with Flucofast, consult a doctor or pharmacist if:
- the patient has impaired kidney or liver function,
- the patient has been diagnosed with heart disease, including heart rhythm disorders,
- the patient has abnormal blood levels of potassium, calcium, or magnesium,
- the patient experiences severe skin reactions (itching, skin redness, difficulty breathing),
- the patient has previously experienced severe skin rash, skin peeling, blisters, and/or oral ulcers after taking Flucofast,
- the patient develops symptoms of "adrenal insufficiency", where 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),
- the fungal infection does not improve, and alternative antifungal treatment may be necessary.
Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have occurred in patients treated with Flucofast. If the patient experiences any of the symptoms of severe skin reactions described in section 4, treatment with Flucofast must be discontinued immediately and medical help should be sought without delay.
Flucofast and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Immediately inform the doctor if the patient is taking astemizole, terfenadine (antihistamines used for allergies), cisapride (used for stomach disorders), pimozide (used for mental disorders), quinidine (used for heart rhythm disorders), or erythromycin (an antibiotic used to treat infections), as these should not be used together with Flucofast (see section "When not to use Flucofast").
There are also other medicines that may interact with Flucofast.
If the patient is taking any of the following medicines, ensure that the doctor is informed:
- rifampicin, rifabutin, azithromycin (antibiotics used to treat infections),
- alfentanil, fentanyl (anaesthetics),
- amitriptyline, nortriptyline (antidepressants),
- amphotericin B, voriconazole (antifungal medicines),
- anticoagulant medicines that reduce blood clotting and prevent blood clots (warfarin or similar medicines),
- benzodiazepines (midazolam, triazolam or similar medicines) used to aid sleep or for calming,
- carbamazepine, phenytoin (used to treat epilepsy),
- nifedipine, isradipine, amlodipine, felodipine, and losartan (used to treat high blood pressure),
- cyclosporine, everolimus, sirolimus, or tacrolimus (used to prevent transplant rejection),
- cyclophosphamide, vinca alkaloids (vincristine, vinblastine or similar medicines) used in the treatment of cancer,
- halofantrine (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,
- prednisone (a steroid),
- zidovudine, also known as AZT; saquinavir (used in HIV patients),
- antidiabetic medicines such as chlorpropamide, glyburide, glipizide, or tolbutamide,
- theophylline (used in asthma),
- vitamin A (dietary supplement),
- ivacaftor (used in the treatment of cystic fibrosis),
- hydrochlorothiazide (a diuretic),
- amiodarone (used to treat heart rhythm disorders).
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a 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 the doctor the need for appropriate contraception during treatment and for one week after the last dose.
If the patient is pregnant, suspects she may be pregnant, or is trying to conceive, she should not take fluconazole unless otherwise directed by a doctor. If the patient becomes pregnant or suspects she may be 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 may increase the risk of congenital heart, bone, and/or muscle abnormalities in the baby.
Cases of babies born with craniofacial, ear, femoral, and/or elbow malformations 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.
Flucofast should not be used in breastfeeding women unless otherwise advised by a doctor. Breastfeeding may continue after a single dose of Flucofast of 200 mg or less. Breastfeeding should be avoided if the patient receives multiple doses of Flucofast.
Driving and operating machinery
When driving or operating machinery, consider that dizziness or seizures may rarely occur.
Flucofast contains monohydrate lactose, sunset yellow FCF (E 110), and sodium
This medicine may cause allergic reactions.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per capsule; therefore, the medicine is considered "sodium-free".
3. How to use Flucofast
This medicine should always be used as directed by the physician. If in doubt, consult your
doctor or pharmacist.
The capsule should be swallowed whole with a glass of water. It is best to take the capsules
at the same time each day. For children who cannot swallow the capsule and for young children
in whom precise dosing according to body weight is necessary, fluconazole is available on the
market in the form of a syrup.
The recommended dosage, depending on the type of infection, is given below.
For doses that cannot be achieved using capsules of this strength, other strengths of this
medicine are available on the market.
Adults
| Indication | Dosage |
|---|---|
| Treatment of cryptococcal meningitis | 400 mg on the first day, then 200 mg to 400 mg once daily for 6 to 8 weeks, or longer if necessary. Sometimes the dose may be increased to 800 mg. |
| Prevention of recurrence of cryptococcal meningitis | 200 mg once daily until the physician advises to discontinue treatment. |
| Treatment of coccidioidomycosis | 200 mg to 400 mg once daily for 11 to 24 months, or longer if necessary. Sometimes the dose may be increased to 800 mg. |
| Treatment of systemic Candida infections | 800 mg on the first day, then 400 mg once daily until the physician advises to discontinue treatment. |
| Treatment of oral mucosal infections, pharyngeal infections, and denture-related stomatitis | 200 mg to 400 mg on the first day, then 100 mg to 200 mg once daily until the physician advises to discontinue treatment. |
Mucosal fungal (yeast) infections
| 50 mg to 400 mg once daily for 7 to 30 days, or until the physician advises to discontinue treatment. |
| Prevention of oral and pharyngeal mucosal infections | 100 mg to 200 mg once daily, or 200 mg three times weekly, in patients at increased risk of infection recurrence. |
| Treatment of genital yeast infections | Single 150 mg dose. |
| Prevention of recurrent vaginal infections | 150 mg every third day for a total of 3 doses (days 1, 4, and 7), followed by 150 mg once weekly for 6 months (in patients at 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 require up to 6 weeks; in nail infections, treatment should continue until the infected nail is completely replaced by a new, healthy nail). |
| Prevention of yeast infections (in patients with weakened or impaired immune systems) | 200 mg to 400 mg once daily in patients at increased risk of infection recurrence. |
Adolescents aged 12 to 17 years
The dose prescribed by the doctor should be administered (as in adult patients or as in children).
Children up to 11 years of age
The maximum dose in children is 400 mg per day.
The dose will be determined based on the child's body weight in kilograms.
| Indication | Daily dose |
| Yeast infections of the oral and pharyngeal mucous membranes – dose and duration of treatment depend on the severity and location of the infection | 3 mg/kg body weight (on the first day, a dose of 6 mg/kg body weight may be administered) |
| Cryptococcal meningitis or yeast infections of internal organs | 6 to 12 mg/kg body weight |
| Prevention of yeast infections in children (when the immune system is not functioning properly) | 3 to 12 mg/kg body weight |
Dosage in children up to 4 weeks of age
Children aged 3 to 4 weeks
The same dose as above, but administered every other day. The maximum dose is 12 mg/kg body weight every 48 hours.
Children under 2 weeks of age
The same dose as above administered every 3 days. The maximum dose is 12 mg/kg body weight every 72 hours.
Elderly patients
The usual adult dose is administered, unless the patient has renal function impairment.
Patients with impaired renal function
The physician may adjust the dosage according to renal function.
Method of administration
The medicine can be taken independently of meals.
Use of a higher than recommended dose of Flucofast
Taking too many capsules at once may cause discomfort. Seek immediate medical attention at the nearest hospital emergency department. Symptoms of overdose may include hearing, vision and sensory disturbances, thinking about unreal things (hallucinations and paranoid behavior). Symptomatic treatment may be indicated (supportive care to maintain vital functions and gastric lavage, if necessary).
Missed dose of Flucofast
Do not take a double dose to make up for a missed dose. If a dose is missed, take it as soon as remembered. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular scheduled time.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, 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, tell your 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 red, itchy blisters,
- skin rash,
- severe skin reactions, such as blistering rash (may also affect the mouth and tongue).
If any of the following symptoms occur, stop taking Flucofast and seek immediate medical help:
- widespread rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
Flucofast may affect the liver. Liver-related symptoms include:
- feeling tired,
- loss of appetite,
- vomiting,
- yellowing of the skin or whites of the eyes (jaundice).
Flucofast may affect the adrenal cortex and the levels of steroid hormones produced. Symptoms of adrenal cortex dysfunction include:
- fatigue,
- muscle weakness,
- loss of appetite,
- weight loss,
- abdominal pain.
If any of the above symptoms occur, stop taking Flucofast and contact your doctor immediately.
Other adverse effects
Common (occur in up to 1 in 10 patients)
- headache,
- abdominal pain, diarrhoea, nausea, vomiting,
- increased liver function test values,
- rash.
Uncommon (occur in up to 1 in 100 patients)
- decrease in red blood cells causing paleness, weakness and breathlessness,
- loss of appetite,
- insomnia, drowsiness,
- seizures, dizziness, balance disorders (sensation of spinning), sensory disturbances, most commonly as tingling, pricking or numbness, taste changes,
- constipation, indigestion, bloating, dryness in the mouth,
- muscle pain,
- liver damage and yellowing of the skin and eyes (jaundice),
- blisters, urticaria, itching, increased sweating,
- feeling of fatigue, malaise, fever.
Rare (occur in up to 1 in 1,000 patients)
- decrease in white blood cells involved in the body's defence against infections and in blood cells helping to stop bleeding,
- red or purple skin discolouration, possibly due to reduced platelet count or changes in other blood cells,
- changes in blood biochemical parameters (elevated cholesterol levels, blood lipids),
- low blood potassium levels,
- tremor,
- abnormalities in ECG, heart rhythm disorders,
- liver failure,
- allergic reactions (sometimes severe), including widespread blistering rash, skin peeling, severe skin reactions, swelling of lips or face,
- hair loss.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of the medicine.
5. How to store the medicine Flucofast
Store below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the stated month.
The labelling on the packaging: EXP indicates the expiry date, and Lot/LOT indicates the batch number.
Medicines must 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 pack and other information
What Flucofast contains
- The active substance is fluconazole. Each capsule contains 200 mg of fluconazole.
- Other components:
Capsule contents: lactose monohydrate, maize starch, colloidal anhydrous silica, magnesium stearate, sodium lauryl sulfate.
Capsule shell:
Body: gelatin, titanium dioxide (E 171), erythrosine (E 127), patent blue (E 131), orange yellow (E 110);
Cap: gelatin, titanium dioxide (E 171).
What Flucofast looks like and contents of the pack
Flucofast 200 mg is a hard capsule with an amethyst-colored cap and a white body, size '0'.
The pack contains 7, 10, 12 or 14 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01
Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Medana Branch in Sieradz
ul. Władysława Łokietka 10, 98-200 Sieradz
Zakłady Farmaceutyczne POLPHARMA S.A.
Production Branch in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba