Ketokonazol

Package Leaflet: Information for the User

KETOKONAZOL POLFARMEX, 200 mg, tablets

Ketoconazole

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Table of Contents of the Leaflet:

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

1. What is Ketokonazol Polfarmex and what is it used for

Ketokonazol Polfarmex is an antifungal medicine belonging to the imidazole derivative group, intended for systemic use.

Ketokonazol Polfarmex is indicated:

for the treatment of:

• systemic fungal infections caused by Candida(single-celled fungi similar to yeast), as well as blastomycosis, coccidioidomycosis, paracoccidioidomycosis, histoplasmosis (other systemic diseases caused by pathogenic fungi);
• chronic recurrent vaginal thrush, especially in cases where local treatment is insufficient;
• severe yeast infections of the gastrointestinal tract that do not respond to other medicines;
• skin, hair, and nail infections caused by dermatophytes or yeast (skin fungus, nail fungus, pityriasis versicolor, scalp ringworm, folliculitis caused by Pityrosporum, chronic yeast infection of mucous membranes and skin), if local treatment is difficult due to the location of the infection or if local treatment is insufficient;

for the prevention of:

• fungal infections in patients with reduced immunity (congenital or caused by disease or medication).

2. Important information before taking Ketokonazol Polfarmex

When not to take Ketokonazol Polfarmex:

• if you are allergic to the active substance, other imidazole derivative medicines, or any of the other ingredients of this medicine (listed in section 6);
• if you have acute or chronic liver failure;
• at the same time as astemizole, terfenadine, mizolastine, quinidine, pimozide, cisapride, midazolam, triazolam, HMG-CoA reductase inhibitors metabolized by CYP3A4, such as simvastatin or lovastatin (cholesterol-lowering medicines);
• in children under 2 years of age.

Warnings and precautions

Before starting treatment with Ketokonazol Polfarmex, consult your doctor or pharmacist.
Particular caution is advised when using Ketokonazol Polfarmex:

• in patients with liver function disorders or alcoholic liver disease;
• in patients with adrenal insufficiency or periodically exposed to stress (e.g., major surgery, intensive therapy);
• in patients taking the medicine for more than 14 days; periodic liver function monitoring is then recommended (before treatment, after 2 weeks of treatment, and then once a month), due to the risk of liver damage, which may manifest as: malaise, elevated body temperature, dark urine, light-colored stools, or jaundice;
• when taking HMG-CoA reductase inhibitors at the same time.

There have been reports of anaphylactic reactions (severe allergic reaction) after taking the first dose of the medicine.
Do not drink alcohol during treatment with ketoconazole. There have been reports of disulfiram-like reactions (flushing, pulsating headache, nausea, and vomiting, difficulty breathing). The symptoms resolve on their own within a few hours.
Consult your doctor, even if the above warnings refer to past situations.

Other medicines and Ketokonazol Polfarmex

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Ketoconazole inhibits the metabolism and increases the plasma concentration of astemizole, terfenadine, cisapride, cyclosporine, HMG-CoA reductase inhibitors (simvastatin and lovastatin), enhances the sedative and hypnotic effects of benzodiazepines (mainly midazolam and triazolam), and the anticoagulant effect of warfarin.
Imidazole derivative antifungal medicines enhance the effect of oral antidiabetic medicines.
It is not known whether this interaction occurs with ketoconazole.
Concomitant use of ketoconazole and medicines metabolized by the cytochrome P450 system (terfenadine, astemizole, mizolastine, quinidine, pimozide, midazolam, triazolam, cisapride) increases the risk of life-threatening heart rhythm disorders (ventricular arrhythmias, including torsade de pointes).
Particular caution is advised when taking ketoconazole with oral anticoagulants, HIV protease inhibitors (indinavir, saquinavir), oncology medicines (vinca alkaloids, busulfan, docetaxel), dihydropyridine calcium channel blockers, verapamil, cyclosporine, digoxin, buspirone, alfentanil, sildenafil, alprazolam, ebastine.
When taking ketoconazole with cyclosporine, it is recommended to monitor cyclosporine plasma concentrations and adjust the dose if necessary. When taking warfarin, it is recommended to monitor prothrombin time.
When taking ketoconazole with medicines that reduce stomach acid (e.g., antacids, proton pump inhibitors, H2 receptor antagonists), ketoconazole should be taken at least 2 hours before administration of these medicines. Patients with achlorhydria (e.g., some patients with AIDS) are advised to take ketoconazole with cola-type beverages.
In diabetic patients treated with oral antidiabetic medicines, it is recommended to periodically monitor blood glucose levels at the beginning of treatment.
Alcohol and medicines with potential hepatotoxic effects taken concomitantly with ketoconazole increase the risk of liver damage, especially in patients taking ketoconazole for a long time and in patients with a history of liver disease.
Ketoconazole increases the plasma concentration of phenytoin, and phenytoin decreases the plasma concentration of ketoconazole.
Antacids, anticholinergic medicines, H2 receptor antagonists, proton pump inhibitors, sucralfate may significantly reduce the absorption of ketoconazole.
Rifampicin and isoniazid decrease the plasma concentration of ketoconazole; concomitant administration of these medicines is not recommended.

Pregnancy and breastfeeding

In pregnancy, during breastfeeding, or if you think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
The medicine may be used during pregnancy only if the benefit to the mother outweighs the potential risk to the fetus.
The medicine passes into breast milk. It should not be used during breastfeeding. If treatment with the medicine is necessary for the mother, she should stop breastfeeding.

Driving and using machines

It is unlikely that the medicine will affect your ability to drive or use machines.

Ketokonazol Polfarmex contains lactose

The medicine contains lactose. If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Ketokonazol Polfarmex

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Adults

Skin, gastrointestinal, and systemic infections:
200 mg once a day.
Depending on the response to treatment, the daily dose may be increased to a maximum of 400 mg once a day.
Vaginal thrush:
400 mg once a day.
Prophylactically in patients with reduced immunity:
200 mg per day.

Children

For treatment:
children with a body weight of 15 to 30 kg: 100 mg once a day;
children with a body weight over 30 kg: dosing as for adults.
Prophylactically:
4 to 8 mg/kg body weight per day.

Method of administration

The medicine is taken orally during a meal.

Average treatment duration

Vaginal thrush - 5 consecutive days; skin fungal infections caused by dermatophytes - about 4 weeks, pityriasis versicolor - 10 days; oral and skin fungal infections caused by Candida- 2 to 3 weeks; hair and scalp infections - 1 to 2 months; nail infections - 6 to 12 months, depending on the rate of nail growth, until the entire nail has grown out; systemic candidiasis - 1 to 2 months or longer; coccidioidomycosis, paracoccidioidomycosis, histoplasmosis - 3 to 6 months.
Treatment should be continued for at least 1 week after all symptoms have disappeared and until a negative result of the microbiological test is obtained.

Taking a higher dose of Ketokonazol Polfarmex than recommended

In case of overdose, symptomatic and supportive treatment of vital functions is recommended. Within the first few hours after overdose, gastric lavage can be performed. If necessary, activated charcoal can be administered.

Missing a dose of Ketokonazol Polfarmex

Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common are: gastrointestinal disorders (nausea, vomiting, abdominal pain, diarrhea); rash; urticaria; itching; headache.
Less common: irregular menstrual cycle; dizziness; drowsiness; fever with chills; photophobia; sensory disturbances.
Very rare: thrombocytopenia; alopecia; impotence; transient increased intracranial pressure.
There have been reports of transient gynecomastia (breast enlargement in men) and oligospermia (reduced sperm count), especially in patients taking doses higher than 400 mg per day.
In about 10% of patients, a slight increase in liver enzyme activity is observed. In 1 in 10,000 patients treated with ketoconazole, signs of toxic liver damage (yellowing of the skin, sclera, and mucous membranes, dark urine, light-colored stools, itching, loss of appetite, abdominal pain, excessive weakness) have been observed. In most cases, the symptoms resolve on their own after discontinuation of the medicine. A few cases of hepatitis have been reported.
There have been reports of anaphylactoid reactions after the first dose of the medicine, as well as hypersensitivity reactions such as urticaria or angioedema.
If you experience any side effects, including those not listed in this leaflet, please consult your doctor or pharmacist.

5. How to store Ketokonazol Polfarmex

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister or container after EXP. The expiry date refers to the last day of that month.
Store in a dry place.
Store in the original package to protect from light.
Store 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. This will help protect the environment.

6. Contents of the pack and other information

What Ketokonazol Polfarmex contains

• The active substance is ketoconazole. One tablet contains 200 mg of ketoconazole.
• The other ingredients are: lactose monohydrate, corn starch, povidone, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate.

What Ketokonazol Polfarmex looks like and contents of the pack

The pack contains 10 or 20 tablets.

Marketing authorization holder and manufacturer

Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Tel. (24) 357 44 44

Date of last revision of the leaflet: