Candifluc

Leaflet accompanying the packaging: patient information

Candifluc, 150 mg, hard capsules

Fluconazole

Read the 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 you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Candifluc and what is it used for

Candifluc belongs to a group of antifungal medicines. The active substance of the medicine is fluconazole.
Candifluc is used to treat infections caused by pathogenic fungi and can also be used to prevent fungal infections. The most common cause of fungal infections is a type of yeast called Candida.

Indications for use

Adults

The doctor may prescribe this medicine for the following fungal infections:

• Cryptococcal meningitis - a fungal infection of the brain;
• Coccidioidomycosis - a disease of the respiratory system;
• Infections caused by Candida yeast detected in the blood, internal organs (e.g. heart, lungs) or urinary tract;
• Fungal infections (thrush) of the mucous membranes - infection of the mucous membrane of the mouth, throat and mouth ulcers related to the use of dental prostheses;
• Fungal infections of the genital organs - infections of the vagina or penis;
• Fungal skin infections - e.g. athlete's foot, body ringworm, groin ringworm, nail fungus.

Candifluc can also be used to:

• prevent relapses of cryptococcal meningitis;
• prevent relapses of fungal infections of the mucous membranes;
• prevent relapses of vaginal yeast infections;
• prevent yeast infections (in patients with a weakened and improperly functioning immune system).

Children and adolescents (from 0 to 17 years old)

The doctor may prescribe this medicine to treat the following fungal infections:

• Fungal infections (thrush) of the mucous membranes - infections of the mucous membrane of the mouth or throat;
• Infections caused by Candida yeast detected in the blood, internal organs (e.g. heart, lungs) or urinary tract;
• Cryptococcal meningitis - a fungal infection of the brain.

Candifluc can also be used to:

• prevent yeast infections (if the patient's immune system is weak and not functioning properly);
• prevent relapses of cryptococcal meningitis.

2. Important information before taking Candifluc

When not to take Candifluc:

Warnings and precautions

Before taking Candifluc, you should discuss it with your doctor or pharmacist if:

• you have kidney or liver problems;
• you have heart disease, including heart rhythm disorders;
• you have blood potassium, calcium or magnesium disorders;
• you have severe skin reactions (itching, redness of the skin, difficulty breathing);
• you have symptoms of "adrenal insufficiency", when the adrenal glands do not produce enough of certain steroid hormones, such as cortisol (chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain);
• - if you have ever had a severe skin rash or peeling after taking Candifluc;

Candifluc and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Tell your doctor immediately if you are taking:

• astemizole, terfenadine (antihistamines used to treat allergies),
• cisapride (used to treat stomach disorders),
• pimozide (used to treat mental disorders),
• quinidine (used to treat heart rhythm disorders),
• erythromycin (an antibiotic used to treat infections), as they should not be taken with Candifluc (see "When not to take Candifluc").

You should inform your doctor if you are taking any of the following medicines:

• rifampicin or rifabutin (antibiotics used to treat infections),
• alfentanil, fentanyl (anesthetics),
• amitriptyline, nortriptyline (antidepressants),
• amphotericin B, voriconazole (antifungal medicines),
• warfarin or similar medicines (medicines that reduce blood clotting, prevent blood clots),
• benzodiazepines (midazolam, triazolam or other similar medicines) that help you fall asleep or calm down,
• carbamazepine, phenytoin (used to treat epilepsy),
• nifedipine, isradipine, amlodipine, felodipine and losartan (used to treat high blood pressure),
• cyclosporine, everolimus, sirolimus or tacrolimus (prevent transplant rejection),
• cyclophosphamide, vincristine (used to treat cancer),
• halofantrine (used to treat malaria),
• atorvastatin, simvastatin and fluvastatin or other similar medicines (statins used to lower cholesterol),
• methadone (pain reliever),
• celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (non-steroidal anti-inflammatory medicines - NSAIDs),
• oral contraceptives,
• prednisolone (steroid),
• zidovudine, also known as AZT, saquinavir (used to treat HIV infection),
• chlorpropamide, glibenclamide, glipizide or tolbutamide (antidiabetic medicines),
• theophylline (medicine used to treat asthma),
• vitamin A (dietary supplement),
• ivacaftor (used to treat cystic fibrosis),
• amiodarone (used to treat heart rhythm disorders - "arrhythmia"),
• hydrochlorothiazide (diuretic),
• citalopram, escitalopram (antidepressants), as fluconazole (antifungal medicine) and cimetidine, lansoprazole and omeprazole (medicines used to treat stomach ulcers), fluvoxamine (antidepressant) and ticlopidine (medicine used to reduce blood clotting) may increase their levels in the blood.

Taking Candifluc with food and drink

The medicine can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
If you plan to become pregnant, it is recommended that you wait one week after taking a single dose of fluconazole before becoming pregnant.
For longer treatment cycles with fluconazole, you should discuss with your doctor the need for proper contraception during treatment and for one week after the last dose.
If you are pregnant, think you may be pregnant or are trying to become pregnant, you should not take fluconazole unless your doctor has told you to do so.
If you become pregnant or think you may be pregnant while taking this medicine or within one week of taking the last dose, you should contact your doctor.

• Fluconazole taken during the first or second trimester of pregnancy may increase the risk of miscarriage.
• Fluconazole taken during the first trimester of pregnancy may increase the risk of birth defects of the heart, bones and/or muscles.

There have been reports of children with birth defects of the skull, ears and/or thigh and forearm bones, born to mothers treated for coccidioidomycosis with high doses of fluconazole (400-800 mg per day) for at least 3 months. The relationship between fluconazole use and these cases is unclear.

• Breastfeeding can continue after taking a single dose of Candifluc 200 mg or less. Breastfeeding should not be done in case of multiple doses of Candifluc.

Driving and using machines

The medicine may affect your ability to drive and use machines. If you experience dizziness or seizures, do not drive or operate machinery.

Candifluc contains lactose monohydrate and sodium

Lactose monohydrate

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.

Sodium

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially 'sodium-free'.

3. How to take Candifluc

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

For doses that cannot be obtained with these capsules, fluconazole is available in other capsule strengths.

Swallow the capsule whole with a glass of water. The capsules are best taken at the same time every day. For children who cannot swallow the capsule and for young children, for whom precise dosing based on body weight is required, fluconazole is available in syrup form.
The recommended dosage, depending on the type of infection, is shown below.

Adults

Adolescents from 12 to 17 years old

The dose prescribed by the doctor should be taken (as for adult patients or as for children).

Children up to 11 years old

The maximum dose for children is 400 mg per day.
The dose will be determined based on the child's body weight in kilograms.

Dosage for children from 0 to 4 weeks old

Children from 3 to 4 weeks old
The same dose as above, but given every other day. The maximum dose is 12 mg per kg of body weight every 48 hours.
Children under 2 weeks old
The same dose as above, given every 3 days. The maximum dose is 12 mg per kg of body weight every 72 hours.

Elderly patients

The usual dose for adults is taken, unless the patient has kidney problems.

Patients with kidney problems

The doctor may recommend a change in dosage, depending on kidney function.

Taking more Candifluc than recommended

Taking too many capsules at once can cause discomfort. You should contact the emergency department of the nearest hospital immediately. Symptoms of possible overdose may include hearing, vision or sensation disorders, thinking about untrue things (hallucinations and paranoid behavior). Symptomatic treatment (life-sustaining treatment and stomach lavage, if necessary) may be indicated.

Missing a dose of Candifluc

Do not take a double dose to make up for a missed dose. If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some patients may experience allergic reactions, but severe allergic reactions are rare.
If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist.
This includes any side effects not listed in this leaflet.

If you experience any of the following symptoms, stop taking Candifluc and seek medical attention immediately:

• sudden wheezing, difficulty breathing or chest tightness;
• swelling of the eyelids, face or lips;
• itching all over the body, redness of the skin or red, itchy blisters;
• rash on the skin (itchy, red bumps on the skin);
• severe skin reactions, such as blistering rash (may also affect the mouth and tongue);
• widespread rash, high fever and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

Candifluc may affect the liver. Liver-related symptoms include:

• feeling tired;
• loss of appetite;
• vomiting;
• yellowing of the skin or whites of the eyes (jaundice).

Other side effects may occur

Frequently(in 1 to 10 out of 100 patients):

• headache;
• abdominal pain, diarrhea, nausea, vomiting;
• increased liver test values;
• rash.

Less frequently(in 1 to 10 out of 1,000 patients):

• decrease in red blood cell count, causing paleness, weakness and shortness of breath;
• decrease in appetite;
• insomnia, drowsiness;
• seizures, dizziness, balance disorders (feeling of spinning), sensation disorders, most often in the form of tingling, pricking or numbness, taste changes;
• constipation, indigestion, bloating, dry mouth;
• muscle pain;
• liver damage and yellowing of the skin and eyes (jaundice);
• blisters, hives, itching, increased sweating;
• feeling tired, unwell, fever.

Rarely(in 1 to 10 out of 10,000 patients):

• decrease in white blood cell count and platelet count;
• red or purple discoloration of the skin, which may be a sign of a decrease in platelet count or changes in other blood cells;
• changes in blood biochemical parameters (high cholesterol, lipid levels in the blood);
• decrease in potassium levels in the blood;
• tremors;
• ECG changes, heart rhythm disorders;
• liver failure;
• allergic reactions (sometimes severe), including widespread blistering rash and skin peeling;
• severe skin reactions, swelling of the lips or face;
• hair loss.

Frequency not known(frequency cannot be estimated from available data):

• drug reaction with eosinophilia and systemic symptoms (DRESS). Characterized by skin rash, fever, lymph node enlargement, increased white blood cell count (eosinophilia), inflammation of internal organs.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Candifluc

Keep the medicine out of the sight and reach of children.
There are no special storage instructions for the medicine.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.
Lot - batch number
EXP - expiry date
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Candifluc contains

• The active substance of the medicine is fluconazole. Each hard capsule contains 150 mg of fluconazole.
• The other ingredients are: lactose monohydrate, maize starch, sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate; capsule shell and body: titanium dioxide (E 171), sodium lauryl sulfate, gelatin, water; ink: shellac, yellow iron oxide (E 172).

What Candifluc looks like and contents of the pack

Candifluc, 150 mg: hard gelatin capsule, size ‘1’, length 19.30 ± 0.40 mm, with white to almost white body and cap, marked with yellow ink: "150" on the body and "FL" on the cap.
The packaging of the medicine is a PVC/PVDC-Aluminum blister, placed in a cardboard box with a leaflet.
The pack contains: 1 or 3 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel. (42) 22-53-100

Manufacturer/Importer

APL Swift Services (Malta) Ltd,
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000,
Malta
Generis Farmacȇutica, S.A.
Rua João de Deus, n.o 19, Venda Nova,
2700-487 Amadora,
Portugal

Date of last revision of the leaflet: