Fungocap 150 mg. 1 capsules

WHAT FUNGOCAP IS AND WHAT IT IS USED FOR
Fungocap belongs to the group of antifungal drugs. The active substance is fluconazole.
Fungocap is used to treat infections caused by fungi and can also be used to protect you from candidiasis.
Fungal infections are most commonly caused by 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 a fungus called Candida, which are localized in the bloodstream, internal organs (eg heart, lungs) or urinary system;
Candidiasis of the mucous membranes - an infection affecting the mucous membranes of the mouth, throat and as a result of dental procedures;
Genital candidiasis - an infection of the vagina or penis;
Skin infections, e.g. fungal infections of the foot (athlete's foot), fungal infections of the skin known as ringworm, fungal infections of the groin, nail infections.
Fungocap may also be given to you in the following cases:

To stop the recurrence of cryptococcal meningitis;
To stop the recurrence of fungal infection of the mucous membranes;
To limit the recurrence of vaginal candidiasis;
To avoid contracting an 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:

Fungus on the mucous membranes - an infection affecting the mucous membranes of the mouth and throat;
Infections caused by Candida that are localized in the bloodstream, body organs (eg heart, lungs) or urinary system;
Cryptococcal meningitis - a fungal infection of the brain.
Fungocap can be applied to you:

To prevent the development of an infection caused by Candida (if your immune system is weak or not working properly);
To prevent the recurrence of cryptococcal meningitis.
2. BEFORE YOU TAKE FUNGOCAP
Do not take Fungocap:

if you are allergic (hypersensitive) to fluconazole, to other medicines you are taking to treat a fungal infection or to any of the other ingredients of Fungocap. Symptoms may include itching, reddening of the skin, or difficulty breathing;
if you are taking astemizole, terfenadine (antihistamines for allergies);
if you are taking cisapride (used for stomach upsets);
if you are taking pimozide (used for mental illness);
if you are taking quinidine (used for cardiac arrhythmia);
if you are taking erythromycin (an antibiotic used to treat infections).
Take special care with Fungocap
Please inform your doctor if:

you have liver or kidney problems;
you suffer from heart disease, including arrhythmias;
you have abnormal levels of potassium, calcium or magnesium in your blood;
get severe skin reactions (itching, reddening of the skin or difficulty breathing).
Taking other medications
Please tell your doctor immediately if you are taking astemizole, terfenadine (an antihistamine to treat allergies) or cisapyride (for stomach upsets), or pimozide (for the treatment of mental illness, or quinidine (for the treatment of cardiac arrhythmias) or erythromycin (an antibiotic for treatment of infections), as these medicines should not be taken with Fungocap (see section "Do not take Fungocap if:").

Some medicines may interact with Fungocap. Please tell your doctor if you are taking any of the following medicines:

rifampicin or rifabutin (antibiotics to treat infections);
alfentanil, fentanyl (painkillers);
amitriptyline, nortriptyline (antidepressants);
amphotericin B, voriconazole (antifungal drug);
medicines that protect the blood from clotting (warfarin or similar medicines);
benzodiazepines (midazolam, triazolam or similar medicines) used to help you fall asleep or when you are anxious;
carbamazepine, phenytoin (used to treat seizures);
nifedipine, izradipine, amlodipine, felodipine and losartan (used to treat hypertension - high blood pressure);
cyclosporine, everolimus, sirolimus or tacrolimus (to prevent organ rejection after transplantation);
cyclophosphamide, vinca alkaloids (vincristine, vinblastine or similar drugs) used in the treatment of cancer;
halofantrine (used to treat malaria);
statins (atorvastatin, simvastatin and fluvastatin or similar drugs) used to lower cholesterol;
methadone (used for pain);
celecoxib, florbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (non-steroidal anti-inflammatory drug (NSAIDs));
oral contraceptives;
prednisone (steroid);
zidovudine, known as AZT; saquinavir (used in HIV patients);
diabetes medications such as chlorpropamide, glibenclamide, glipizide or tolbutamide;
theophylline (used for asthma);
vitamin A (food supplement).
Please inform your doctor or pharmacist
Important information about some of the ingredients of Fungocap
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. HOW TO TAKE FUNGOKAP
Always take Fungocap exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.
Swallow the capsules whole with a glass of water. It is best to take the capsules at the same time each day.

The usual dosages of this medicine for different types of infections are described below:
Adults
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 longer as needed. Sometimes the dosage is increased to 800 mg.
To prevent the recurrence of cryptococcal meningitis:

200 mg once daily until you are told to stop treatment.
For the treatment of coccidioidomycosis:

200 mg to 400 mg once daily for 11 to 24 months or longer as needed. In some cases, the dosage may be increased to 800 mg.
Fungal infection of the internal organs caused by Candida:

800 mg on the first day, then 400 mg once a day until you are told to stop treatment.
For the treatment of mucosal 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 of the mucous membranes - the dosage depends on the location of the infection:

50 to 400 mg once a day for 7 to 30 days until you are told to stop treatment.
Prevent infections of the mucous membranes of the mouth and throat:

100 mg to 200 mg once a day, or 200 mg 3 times a week while you are at risk of developing an infection.
For the treatment of genital candidiasis:

150 mg as a single dose.
To limit the recurrence of vaginal candidiasis:

150 mg every three days for a total of 3 doses (days 1, 4, and 7), then once a week for 6 months until 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 weekly for 1 to 4 weeks (for fungal foot infection (athlete's foot) may last up to 6 weeks, for nail infections - until the infected nail grows back).
To prevent you from developing a Candida infection (if your immune system is weak or not working properly):

200 to 400 mg once daily while you are at risk of developing an infection.
Adolescents from 12 to 17 years
Follow the dose prescribed by your doctor (dosage for children or adults).

Children up to 11 years old
The maximum dose in children is 400 mg daily.
The dose is determined by the child's weight in kilograms.

Fungal infections of the mucous membranes and throat infections caused by Candida - the dosage depends on the severity and location of the infection:

3 mg per kg body weight (6 mg per kg body weight may be administered on the first day).
Cryptococcal meningitis or a fungal infection of the internal organs caused by Candida:

6 mg to 12 mg per kg body weight.
To prevent the child from developing an infection caused by Candida (if his immune system is weak or not working properly):

3 mg to 12 mg per kg body weight.
Use in children aged 0 to 4 weeks
Use in children aged 3 to 4 weeks:
The same dose as described above, but administered every 2 days. The maximum dose is 12 mg per kg body weight every 48 hours.

Use in children less than 2 weeks:
The same dose as described above, but administered every 3 days. The maximum dose is 12 mg per kg body weight every 72 hours.
Doctors may sometimes prescribe doses other than those listed. Always take Fungocap exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.

Elderly patients
The usual dose is used in adults unless you have kidney problems.

Patients with kidney problems
Your doctor may change your dose depending on your kidney function.

If you take more Fungocap than you should
Taking too many capsules at once can make you feel bad. Please contact your doctor immediately or go to the nearest hospital. Symptoms of overdose can make you hear, see and think things that are not real (hallucinations and paranoid behavior). Symptomatic treatment (supportive measures and gastric lavage if necessary) is appropriate.

If you forget to take Fungocap
Do not take a double dose to make up for a forgotten 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 missed dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Fungocap can cause side effects, although not everybody gets them.

Some people develop allergic reactions, although serious allergic reactions are rare. If you experience any of the following symptoms, tell your doctor immediately.

sudden shortness of breath, difficulty breathing or tightness in the chest;
swelling of the eyelids, face or lips;
itching all over the body, reddening of the skin or itchy red spots;
skin rash;
severe skin reactions such as a blistering rash (which may affect the mouth and tongue).
Fungocap can damage your liver. Signs of liver damage include:

fatigue;
loss of appetite;
vomiting;
yellowing of your skin or whites of your eyes.
If you get any of these side effects, stop taking Fungocap and tell your doctor immediately.

Other side effects:
In addition, if any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Common side effects that affect 1 to 10 patients in every 100 are described below:

headache;
stomach discomfort, diarrhea, malaise, vomiting;
elevated liver function tests;
rash.
Uncommon side effects that affect 1 to 10 patients in 1,000 are described below:

decrease in the number of red blood cells, which can cause paleness, cause weakness or shortness of breath;
decreased appetite;
insomnia, drowsiness;
fainting, drowsiness, dizziness, tingling, tingling or numbness, changes in taste;
constipation, indigestion, flatulence, dry mouth;
muscle pain;
liver damage and yellowing of the skin and eyes (jaundice);
rash, blisters, itching, excessive sweating;
fatigue, malaise, fever.
Rare side effects that affect 1 to 10 patients in 10,000 are described below:

decreased number of white blood cells that protect the body from infections and blood cells that help stop bleeding;
red or purple discoloration of the skin, which may be caused by a decrease in platelet count, changes in other blood cells;
changes in blood parameters (high levels of cholesterol in the blood, fat);
decreased levels of potassium in the blood;
trembling;
abnormalities in the electrocardiogram (ECG), changes in heart rate;
liver failure;
allergic reactions (sometimes severe), including extensive blistering and flaking of the skin, swelling of the lips or face;
hair loss.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist or healthcare provider.
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5. HOW TO STORE FUNGOKAP
Keep out of reach of children.
Do not use Fungocap after the expiry date which is stated on the carton.
The expiry date refers to the last day of that month.
At temperatures below 25 ° C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. ADDITIONAL INFORMATION
What does Fungocap capsules contain, hard
The active substance is fluconazole.
Each hard capsule contains 150 and 200 mg of fluconazole, respectively.
The other ingredients are: lactose monohydrate, pregelatinized starch, silica, colloidal, anhydrous, magnesium stearate.

Capsule shell - titanium dioxide (E171), gelatin for 150 mg capsules and titanium dioxide (E171), iron oxide, yellow (E172), gelatin for 200 mg capsules.

What Fungocap capsules look like, hard and what the package contains
Fungocap 150 mg capsules, hard:
Hard gelatin capsules № 1, body - white; lid - white.
Capsule contents: white or almost white powder.

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