KANDIZOL 150 mg. 1 capsule
The active substance in KANDIZOL is fluconazole, which is an antifungal for systemic use, triazole derivative.
Fluconazole is effective against superficial and systemic infection (infection of the internal organs), fungal infections caused by Candida, Cryptococcus and various dermatophytes.
KANDIZOL hard capsules is indicated for:
genital candidiasis (a fungal infection caused by fungi of the genus Candida), acute or recurrent vaginal candidiasis, and for the prophylaxis of recurrent episodes (three or more times a year), candida balanitis (inflammation of the end of the penis and / or foreskin );
prophylaxis of fungal infections in cancer patients predisposed to such infections as a consequence of cytotoxic chemotherapy and radiotherapy;
tinea (fungal infections of the skin), including tinea pedis, tinea koporis, kruris tinea, tinea verzikolor, ungium tinea (onychomycosis - fungal nail infections) and skin candidiasis;
prophylaxis of recurrent episodes of yeast infection of the oral cavity and pharynx or esophagus in patients with AIDS;
rare fungal infections in patients with weakened immune systems such as coccidioidomycosis (fungal infection of the lungs caused by breathing in spores), paracoccidioidomycosis (systemic chronic fungal infection that affects the skin, mucous membranes and internal organs), sporotrichosis (systemic fungal infection striking the skin, mucous membranes, lymphatic system, less bone and viscera) and histoplasmosis (acute or chronic pulmonary fungal infection).
2. WHAT YOU SHOULD KNOW BEFORE YOU TAKE KANDIZOL
Do not take KANDIZOL:
if you are allergic (hypersensitive) to fluconazole, to any of the other ingredients of KANDIZOL or to other azole derivatives. An allergic reaction may be recognized as a: rash, itching, redness of the skin and difficulty breathing;
if you use cisapride (for stomach disorders). Concomitant use of fluconazole with cisapride is contraindicated.
Take special care with KANDIZOL
Before treatment with KANDIZOL tell your doctor if you have:
kidney failure, to assess whether the dose should be adjusted;
severe underlying illness, as caution during treatment because of the likelihood of developing liver damage. Manifestations of liver toxicity during treatment with fluconazole are usually reversible upon discontinuation of treatment;
impaired liver function. When a significant increase in liver values doctor will decide whether to continue or discontinue;
AIDS, because such patients are more prone to developing serious skin reactions to many medications;
heart disease or concomitant therapy since taking fluconazole may lead to QT prolongation on electrocardiogram or other heart rhythm disorders;
When during treatment with fluconazole rash and / or peeling skin reactions, contact your doctor as you should be closely monitored. It is possible, though rare, can occur in any of the following severe skin reactions such as blistering of the skin, mouth, eyes and genitals, skin peeling, where therapy should be discontinued;
Tell your doctor if you are taking terfenadine, as co-administration of fluconazole with terfenadine should be carefully monitored.
Children and adolescents
Information on the use of fluconazole in children and adolescents under 16 years are limited; therefore, at this stage use in these patients is not recommended unless antifungal treatment is imperative and no suitable alternative.
There is limited information on the use of fluconazole in young children, therefore its use in children under 1 year is not recommended.
Other medicines and KANDIZOL
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines.
It is interaction with concomitant administration of fluconazole and the following medicinal products:
Anticoagulants (to prevent blood clotting);
Benzodiazepines (short acting) (hypnotics and sedatives);
Cisapride. Concomitant administration of fluconazole is contraindicated;
Cyclosporin or tacrolimus (used in transplant patients);
Hydrochlorothiazide (diuretic means - fluid retention and high blood pressure);
Oral contraceptives (birth control pills);
Phenytoin (for epilepsy);
Rifabutin or rifampicin (antibiotics);
Sulfonylurea drugs (to control diabetes);
Terfenadine (used to treat hay fever or allergy);
Theophylline (for asthma);
Zidovudine (used in AIDS patients);
Astemizole (for treatment of allergy).
KANDIZOL with food and drink
Studies have shown that the absorption of fluconazole is not affected by food intake.
Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine.
No adequate controlled studies in pregnant women. Fluconazole is used during pregnancy only if the benefit justifies the potential risk to the fetus.
Fluconazole is secreted in breast milk in concentrations similar to plasma. Therefore, the use of KANDIZOL in nursing mothers is not recommended.
Driving and using machines
Experience with fluconazole indicates that therapy it does not affect the patient's ability to drive or operate machinery.
Important information about some of the ingredients of KANDIZOL
KANDIZOL contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE KANDIZOL
Always take KANDIZOL just as you have been told by your doctor. If you're not sure, ask your doctor or pharmacist.
The capsules should be taken orally.
for the treatment of vaginal candidiasis - once accepted single dose of 150 mg (1 capsule) KANDIZOL. To reduce the recurrence rate of vaginal candidiasis is considered 150 mg (1 capsule) KANDIZOL once a month. The duration of treatment is individual, but ranges from 4 to 12 months;
when Candida balanitis is appointed once-daily dose of 150 mg (1 capsule) KANDIZOL;
The recommended prophylactic dose for the prevention of candidiasis is between 50 mg and 400 mg, according to the risk for development of fungal infection;
in skin infections including tinea pedis, tinea korporis, kruris tinea and skin candida infections the recommended dose is 150 mg once a week. The duration of treatment is usually 2-4 weeks, tinea pedis but (athlete's foot) may be necessary to extend treatment to 6 weeks;
The recommended dose for tinea verzikolor (tinea versicolor) is 300 mg in a single dose per week for 2 weeks, but some patients may require application of 300 mg and in the third week, while some patients may be sufficient single dose of 300 mg to 400 mg;
in the treatment of tinea infections ungium (onychomycosis) the recommended dose is 150 mg once a week. Treatment continued until infected nail removed and replaced by a new uninfected. The growth of nails and toes respectively lasts 3-6 months and 6-12 months. These periods vary widely depending on the patient and his age. After successful treatment of chronic persistent infection in some cases remain partly misshapen nails;
in the prevention of fungal infection recurrences of the oral cavity and pharynx or esophagus in patients with AIDS following the initial course of treatment, fluconazole may be administered at a dose of 150 mg once a week;
in treating deep mycoses endemic dose ranges from 200 mg to 400 mg daily for up to 2 years;
in patients with kidney disease - your doctor will decide what dose to prescribe, depending on your kidney function.
If you take more dose KANDIZOL
If you take more dose KANDIZOL immediately visit the nearest hospital and take your medicine or its container with you or contact your doctor.
Do not exceed the recommended dose and duration of treatment.
If you forget to take KANDIZOL
If you forget to take a dose, just take your next dose in time for the next intake. Later you follow the prescribed treatment.
Do not take a double dose to make up for a forgotten capsule.
If you stop taking KANDIZOL
Do not stop taking KANDIZOL before you have completed the full course of treatment even though you feel better. You may not have cured completely and some of the symptoms to recur.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, KANDIZOL can cause side effects, although not everybody gets them:
In this leaflet, when side effects were described as "very common" this means that they have been reported in more than 1 in 10 patients;
When side effects are described as the "common", this means that they were reported in more than 1 out of 100 patients, but less than 1 out of 10 patients;
When side effects are described as "uncommon", this means that they were reported in more than 1 in 1000 patients but less than 1 out of 100 patients;
When side effects are described as "rare", this means that they were reported in more than 1 in 10 000 patients, but less than 1 out of 1000 patients;
When side effects are described as "very rare", this means that they have been reported in less than 1 in every 10,000 patients.
Fluconazole is generally well tolerated.
In some cases, any of the following side effects:
Nervous system disorders:
Very common: headache, dizziness, seizures.
Very common: abdominal pain, diarrhea, flatulence, nausea, indigestion, vomiting, change in taste.
Rare: liver toxicity, increased liver tests, which occur rarely, most often in patients in serious condition. Toxicity usually disappears after discontinuation of the drug.
In some patients, particularly those with serious underlying diseases such as AIDS and cancer, during treatment with fluconazole and drugs similar changes were observed in blood and kidney function tests, and elevated liver function tests.
Skin and subcutaneous tissue disorders:
Very common: rash, hair loss, peeling skin, blistering of the skin, mouth, eyes and genitals.
Blood and lymphatic system:
Very common: blood dyscrasias: reducing the number of white blood cells, which increases the likelihood of infection; reduction of platelet count, which increases the risk of bleeding or bruising.
Immune system disorders:
Very common: allergic reactions causing swelling of the face or throat, itching, rash.
Metabolism and nutrition disorders:
Very common: elevated cholesterol or triglycerides in the blood, reducing the level of potassium.
Cardiac and vascular disorders:
Very common: changes in the electrocardiogram, heart rhythm disturbances.
5. HOW TO STORE KANDIZOL
Keep out of reach of children.
Store in the original container.
Do not use KANDIZOL after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACKAGE AND ADDITIONAL INFORMATION
The active substance is fluconazole. Each capsule contains 150 mg of fluconazole.
The other ingredients are lactose monohydrate, maize starch, colloidal anhydrous silica, magnesium stearate, sodium lauryl sulfate.
Capsule shell: Azorubine (E122), titanium dioxide, gelatin.
KANDIZOL looks like and contents of the pack
Capsules are opaque with a pink cap and white body containing white homogeneous powder.
One blister contains 1, 2 or 3 capsules.
One blister packed in a cardboard box.