Fungocap 150 mg. 3 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 a candida infection.

Yeast 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 fungi called Candida that are localized in the bloodstream, internal organs (eg heart, lungs) or urinary system.

Candidiasis of the mucous membranes - an infection affecting the mucous membrane of the mouth, throat and as a result of dental manipulations.

Genital candidiasis - 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 can also be administered to you in the following cases:

To stop the recurrence of cryptococcal meningitis. To stop the recurrence of a fungal infection of the mucous membranes. To limit the recurrence of vaginal candidiasis.

To avoid getting 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 membrane of the mouth and throat.

Infections caused by fungi called 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 administered to you:

To avoid developing an infection caused by Candida (if your immune system is weak or not working properly).

To prevent recurrence of cryptococcal meningitis

2. What you need to know 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 (listed in section 6). Symptoms may include itching, reddening of the skin, or difficulty breathing

if you are taking astemizole, terfenadine (antihistamine medicines for allergies)

if you are taking cisapride (used for stomach disorders)

if you are taking pimozide (used for mental illness)

if you are taking quinidine (used for heart arrhythmia)

if you are taking erythromycin (an antibiotic to treat infections)

Warnings and precautions

Please inform your doctor if:

you have liver or kidney problems

you suffer from heart disease, including rhythm disorders you have abnormal levels of potassium, calcium or magnesium in your blood

get severe skin reactions (itching, reddening of the skin or difficulty breathing) develop signs of adrenal insufficiency, where the adrenal glands do not produce enough of certain steroid hormones, such as cortisol (chronic or prolonged fatigue, muscle weakness, loss of appetite, decrease in body weight, abdominal pain)

have ever had a severe skin rash or skin peeling, blistering and/or mouth ulcers after taking Fungocap. Serious skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with Fungocap treatment. Stop taking Fungocap and seek medical help immediately if you notice any of the symptoms associated with these serious skin reactions described in section 4

the fungal infection does not improve, as alternative^g^^^ antifungal therapy may be needed ^^

Other medicines and Fungocap

Please tell your doctor immediately if you are taking astemizole, terfenadine (an antihistamine to treat allergies), or cisapiride (for stomach upsets), or pimozide (to treat mental illness), or quinidine (to treat heart arrhythmia), or erythromycin (an antibiotic to treat infections) as these medicines should not be taken with Fungocap (see section "Do not take Fungocap:")

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

rifampicin or rifabutin (antibiotics to treat infections)

alfentanil, fentanyl (pain relievers)

amitriptyline, nortriptyline (antidepressants)

amphotericin B, voriconazole (antifungal medicine)

medicines that prevent blood clotting (warfarin or similar medicines)

benzodiazepines (midazolam, triazolam or similar medicines) used to help you sleep or for anxiety carbamazepine, phenytoin (to treat seizures)

nifedipine, isradipine, amlodipine, felodipine and losartan (to treat hypertension - high blood pressure)

cyclospores

Fungocap with food and drink

You may take this medicine with or without food.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

You should not take Fungocap if you are pregnant, think you may be pregnant, are trying to become pregnant or are breast-feeding, unless your doctor has told you to do so.

Fluconazole taken during the first trimester of pregnancy may increase the risk of miscarriage. Fluconazole taken in low doses during the first trimester of pregnancy may slightly increase the risk of giving birth to a child with birth defects affecting the bones and/or muscles.

You can continue breastfeeding after taking a single dose of Fungocap up to 200 mg

Driving and using machines

When driving or operating machinery, it should be borne in mind that dizziness or fainting may occur,

Fungocap contains lactose (milk sugar)

This medicine contains a small amount of lactose (milk sugar)

If your doctor has told you that you have an intolerance to some sugars, consult him before taking this product.

3. How to take Fungocap

Always take Fungocap exactly as your doctor has told you. If you are not sure, ask 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

Disease Dosage

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 can be increased to 800 mg

A fungal infection of the internal organs caused by Candida

800 mg 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, as a result of 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

Fungal infections of the mucous membranes - the dosage depends on the localization of the infection

50 mg to 400 mg once daily for 7 to 30 days until you are told to stop

To 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 3 days for a total of 3 doses (day 1,4 and 7) then once weekly on

6 months while you are at risk of developing an infection

Fungal infections of the skin and nails

Depending on the site of infection 50 mg once a day, 150 mg once a week, 300 mg to 400 mg once a week for 1 to 4 weeks (for fungal infection of the foot (athlete's foot) may last up to 6 weeks, for nail infections - until the infected nail grows back)

To avoid developing an infection caused by Candida (if your immune system is weak or not working properly)

200 mg to 400 mg once a day while you are at risk of developing an infection

Adolescents from 12 to 17 years old

Follow the dosage prescribed by your doctor (children's or adult dosage).

Children up to 11 years old

The maximum dose for children is 400 mg daily.

The dose is determined depending on the child's weight in kilograms.

Disease  Daily Dose

Fungal mucosal infections and throat infections caused by Candida - dosage depends on severity and site of infection

3 mg per kg of body weight (6 mg per kg of body weight can be applied on the first day)

Cryptococcal meningitis or fungal infection of 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 of body weight

Application in children aged 0 to 4 weeks

Application in children aged 3 to 4 weeks:

Same dose as above but administered every 2 days. The maximum dose is 12 mg per kg of body weight every 48 hours.

Application in children younger than 2 weeks:

Same dose as above but administered every 3 days. The maximum dose is 12 mg per kg of body weight every 72 hours.

Elderly patients

The usual adult dose is given unless you have kidney problems. Patients with kidney problems

Your doctor may change your dosage depending on your kidney function. If you have taken more than the required dose of Fungocap

Taking too many capsules at one time may make you feel unwell. Please contact your doctor immediately or go to the nearest hospital. Overdose symptoms may cause you to hear, see and think things that are not real (hallucinations and paranoid behaviour). 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 missed 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 dose you missed.

If you have any further questions related to the use of this product, please 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) an extensive rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome),

Fungocap can damage your liver. Signs of liver damage include:

fatigue

loss of appetite vomiting

yellowing of your skin or the whites of your eyes (jaundice)

If you experience any of these side effects, stop taking Fungocap and tell your doctor immediately.

Other side effects:

In addition, if any of the side effects become serious or you notice other side effects not described in this leaflet, please tell your doctor or pharmacist.

Common side effects (may affect up to 1 in 10 people):

headache

stomach discomfort, diarrhea, malaise, vomiting

increased values of liver function tests rash

Uncommon side effects (may affect up to 1 in 100 people):

decrease in the number of red blood cells, which can cause paleness, weakness or shortness of breath decreased appetite insomnia, sleepiness

fainting, dizziness, lightheadedness, numbness, tingling or numbness, changes in taste constipation, indigestion, gas, dry mouth, muscle pain

liver damage and yellowing of the skin and eyes (jaundice) rash, blisters, itching, excessive sweating tiredness, feeling unwell, fever

Rare side effects (may affect up to 1 in 1,000 people):

decreased numbers of white blood cells, which protect the body from infection, and of blood cells that help stop bleeding

red or purple discoloration of the skin, which may be caused by a decrease in the number of platelets, changes in other blood cells changes in blood tests (high levels of cholesterol in the blood, fats) low levels of potassium in the blood tremors

abnormalities in the electrocardiogram (ECG), changes in heart rate or rhythm liver failure

allergic reactions (sometimes severe), including an extensive blistering rash and peeling

on the skin, swelling of the lips or face

hair loss

5. How to store Fungocap

Keep out of the reach of children.

Do not use Fungocap after the expiry date marked on the carton. The expiration date corresponds to the last day of the specified month. At a temperature below 25 °C.

Medicines should not be disposed of down the drain or in the household waste container.

Ask your pharmacist how to dispose of your unwanted medicines. These measures will help protect the environment.

6. Contents of the package and additional information

What Fungocap contains

The active substance is fluconazole.

Each hard capsule contains 150 and 200 mg of fluconazole, respectively.

The other ingredients are: lactose monohydrate, pregelatinized starch, colloidal anhydrous silica, magnesium stearate.

Capsule shell - titanium dioxide (E 171), gelatin for the 150 mg capsules and titanium dioxide (E 171), yellow iron oxide (E 172), gelatin for the 200 mg capsules.

What Fungocap looks like and what the pack contains

Fungocap 150 mg hard capsules

Hard gelatin capsules #1

body - white; cap-white.

Contents of the capsule: white or almost white powder.

Fungocap 200 mg hard capsules

Hard gelatin capsules No. 0,

body - pale yellow; cap-pale yellow

Contents of the capsule: white or almost white powder.

Available in the following packages:

Blisters of transparent, colorless PVC/AL foil or transparent, colorless PVC/PVdC/AL foil and patient leaflet in a cardboard box.

Package size:

Fungocap 150 mg hard capsules:

Packages of 1,2, 3,4 or 10 capsules.

1 blister of 1, 2, 3, 4 or 10 capsules in a cardboard box.

4 blisters of 1 capsule in a cardboard box.

Fungocap 200 mg hard capsules:

Packages of 1, 3, 7, 10, 20 or 30 capsules.

1 blister of 1, 3, 7 or 10 capsules in a cardboard box.

2 blisters of 10 capsules in a cardboard box.

3 blisters of 10 capsules in a cardboard box.

Not all types of packaging can be put on sale.