Candifluc

Package leaflet: Information for the patient

Candifluc, 150 mg, hard capsules
Fluconazole
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. 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 inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Candifluc is and what it is 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 Candifluc is and what it is used for

Candifluc belongs to a group of antifungal medicines. The active substance is fluconazole.
Candifluc is used to treat infections caused by disease-causing fungi and can also be used to prevent Candida yeast infections. The most common cause of fungal infections are yeasts of a genus called in Latin Candida.

Indications for use

Adults
Your doctor may prescribe this medicine for the following fungal infections:

• cryptococcal meningitis – a fungal infection of the brain;
• coccidioidomycosis – a respiratory disease;
• infections caused by Candida yeasts detected in the blood, internal organs (e.g. heart, lungs), or urinary tract;
• mucosal yeast infections (thrush) – infection of the mucous membranes of the mouth, throat, and denture-related stomatitis;
• genital yeast infections – infections of the vagina or penis;
• skin fungal infections – e.g. athlete’s foot, fungal infections of the trunk, groin, or nails.

Candifluc may also be used to:

• prevent recurrence of cryptococcal meningitis;
• prevent recurrence of mucosal yeast infections;
• prevent recurrence of vaginal Candida infections;
• prevent yeast infections (in patients with weakened or impaired immune systems).

Children and adolescents (aged 0 to 17 years)
Your doctor may prescribe this medicine to treat the following fungal infections:

• mucosal yeast infections (thrush) – infections of the mucous membranes of the mouth or throat;
• infections caused by Candida yeasts detected in the blood, internal organs (e.g. heart, lungs), or urinary tract;
• cryptococcal meningitis – a fungal infection of the brain.

Candifluc may also be used to:

• prevent yeast infections (in patients with a weakened or poorly functioning immune system);
• prevent recurrence of cryptococcal meningitis.

2. Important information before taking Candifluc

When not to take Candifluc:

• if the patient is allergic to fluconazole, to other antifungal medicines or to any of the other ingredients of this medicine (listed in section 6). Symptoms may include itching, skin redness or difficulty breathing;
• if the patient is taking astemizole, terfenadine (antihistamine medicines used to treat allergies);
• if the patient is taking cisapride (used to treat stomach disorders);
• if the patient is taking pimozide (used to treat mental disorders);
• if the patient is taking quinidine (used to treat heart rhythm disorders);
• if the patient is taking erythromycin (an antibiotic used to treat infections).

Warnings and precautions
Before starting to take Candifluc, discuss with your doctor or pharmacist if:

• the patient has kidney or liver function disorders;
• the patient has heart diseases, including heart rhythm disorders;
• the patient has abnormal blood levels of potassium, calcium or magnesium;
• the patient experiences severe skin reactions (itching, skin redness, difficulty breathing);
• the patient develops symptoms of "adrenal insufficiency", when the adrenal glands do not produce adequate amounts of certain steroid hormones such as cortisol (chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain);
• if the patient has ever experienced severe skin rash, skin peeling, blisters and/or oral ulcers after taking Candifluc;
• if the fungal infection does not resolve, alternative antifungal treatment may be necessary. Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in patients treated with Candifluc. If the patient experiences any of the symptoms of severe skin reactions described in section 4, treatment with Candifluc must be discontinued immediately and medical help should be sought without delay.

Candifluc and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken or plans to take.
You must immediately inform your doctor if the patient is 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 these should not be taken together with Candifluc (see section "When not to take Candifluc").

The patient should inform the doctor if taking any of the following medicines:

• rifampicin or rifabutin (antibiotics used to treat infections),
• alfentanil, fentanyl (anaesthetic medicines),
• amitriptyline, nortriptyline (antidepressants),
• amphotericin B, voriconazole (antifungal medicines),
• warfarin or similar medicines (medicines that reduce blood clotting, preventing blood clots),
• benzodiazepines (midazolam, triazolam or similar medicines) to help sleep or for calming,
• carbamazepine, phenytoin (used to treat epilepsy),
• nifedipine, isradipine, amlodipine, felodipine and losartan (used to treat high blood pressure),
• cyclosporine, everolimus, sirolimus or tacrolimus (used to prevent transplant rejection),
• cyclophosphamide, vinca alkaloids (vincristine, vinblastine or similar medicines) used to treat cancer,
• halofantrine (used to treat malaria),
• atorvastatin, simvastatin and fluvastatin or similar medicines (statins used to lower cholesterol levels),
• methadone (a painkiller),
• celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (non-steroidal anti-inflammatory drugs - NSAIDs),
• oral contraceptives,
• prednisolone (a steroid),
• zidovudine, also known as AZT, saquinavir (used to treat HIV infection),
• chlorpropamide, glibenclamide, glipizide or tolbutamide (antidiabetic medicines),
• theophylline (a medicine used in asthma),
• vitamin A (dietary supplement),
• ivacaftor (used to treat cystic fibrosis),
• amiodarone (used to treat heart rhythm disorders – "arrhythmias"),
• hydrochlorothiazide (a diuretic),
• citalopram, escitalopram (antidepressants), as fluconazole (an antifungal medicine) and cimetidine, lansoprazole and omeprazole (medicines used to treat peptic ulcer disease), fluvoxamine (an antidepressant) and ticlopidine (a medicine used to reduce the risk of heart attack) may increase their blood concentrations.

Taking Candifluc with food and drink
This medicine may be taken during meals or independently of food intake.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
If the patient plans to become pregnant, it is recommended to wait one week after taking a single dose of fluconazole before attempting conception.
For longer treatment courses with fluconazole, discuss with your doctor the need for appropriate contraception during treatment and for one week after the last dose.
If the patient is pregnant, suspects she may be pregnant, or is trying to conceive, she should not take fluconazole unless otherwise advised by a doctor.
If the patient becomes pregnant or suspects she may be pregnant while taking this medicine or within one week after the last dose, she should contact her doctor immediately.

• 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 congenital heart, bone and/or muscle malformations in the newborn.

Cases have been reported of children born with cranial, ear, femoral and/or elbow bone malformations to mothers treated for coccidioidomycosis with high doses of fluconazole (400–800 mg daily) for at least 3 months. The causal relationship between fluconazole use and these cases is not fully established.

• Breastfeeding may be continued after a single dose of Candifluc of 200 mg or less. Breastfeeding should not be continued if the patient is taking multiple doses of Candifluc.

Driving and operating machinery
This medicine may affect the ability to drive and operate machinery. If dizziness or seizures occur, the patient should not drive or operate machinery.
Candifluc contains monohydrate lactose and sodium
Monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to take Candifluc

This medicine should always be taken exactly as directed by the doctor. If in doubt, consult
the doctor or pharmacist.
For doses that cannot be achieved with capsules of this strength, other fluconazole-containing
medicines in capsules of different strengths are available.
The capsule should be swallowed whole with a glass of water. Capsules are best taken
at the same time each day. For children who cannot swallow the capsule and for young children
in whom precise dosing according to body weight is necessary, fluconazole syrup is available.
The recommended dosage, depending on the type of infection, is given below.
Adults

Adolescents aged 12 to 17 years
Administer the dose prescribed by the physician (as in adult patients or as in children).
Children up to 11 years of age
The maximum dose in children is 400 mg per day.
The dose will be determined based on the child's body weight in kilograms.

Dosage in children from 0 to 4 weeks of age
Children aged 3 to 4 weeks
The same dose as above, but administered every other day. The maximum dose is 12 mg per kg body weight every 48 hours.

Children under 2 weeks of age
The same dose as above, administered every 3 days. The maximum dose is 12 mg per kg body weight every 72 hours.

Elderly patients
The dose usually administered to adults should be given, unless the patient has impaired kidney function.

Patients with impaired kidney function
The physician may recommend adjusting the dosage depending on kidney function.

Taking more Candifluc than recommended
Taking too many capsules at once may cause feeling unwell. Seek immediate medical attention at the nearest hospital emergency department. Symptoms of overdose may include disturbances in hearing, vision, and sensation, as well as thinking about things that are not real (hallucinations and paranoid behavior). Symptomatic treatment may be indicated (supportive care to maintain vital functions and gastric lavage if necessary).

Missed dose of Candifluc
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 almost time for the next dose, skip the missed dose and take the next dose at the regular scheduled time.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Allergic reactions may occur in some patients, although severe allergic reactions are rare.
If any adverse reaction occurs, consult a doctor or pharmacist.
This also applies to any adverse reactions not listed in this leaflet.
If any of the following symptoms occur in a patient, stop taking
the medicine Candifluc and seek immediate medical help:

• sudden wheezing, difficulty breathing or tightness in the chest;
• swelling of the eyelids, face or lips;
• itching all over the body, redness of the skin or red itchy blisters;
• skin rash (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 swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

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

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

Other adverse reactions may occur
Common (in 1 to 10 out of 100 patients):

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

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

• decrease in the number of red blood cells, causing paleness, weakness and breathlessness;
• decreased appetite;
• insomnia, drowsiness;
• seizures, dizziness, balance disorders (sensation of spinning), sensory disturbances, most commonly as tingling, prickling or numbness, taste changes;
• constipation, indigestion, bloating, dryness in the mouth;
• muscle pain;
• liver damage and yellowing of the skin and eyes (jaundice);
• blisters, urticaria, itching, increased sweating;
• feeling of fatigue, malaise, fever.

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

• decrease in the number of white blood cells involved in the body's defence against infections and in blood cells helping to stop bleeding;
• red or purple skin discolouration, possibly due to a decrease in the number of platelets or changes in other blood cells;
• changes in blood biochemical parameters (elevated cholesterol, blood lipids);
• decreased potassium levels in the blood;
• tremor;
• abnormalities in ECG, 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, swollen lymph nodes, increased white blood cell count (eosinophilia), and inflammation of internal organs.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Candifluc

Keep this medicine out of sight and reach of children.
There are no special requirements for storage of this 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 stated month.
LOT - batch number
EXP - expiry date
Medicines must 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 package and other information

What Candifluc contains

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

What Candifluc looks like and contents of the pack
Candifluc, 150 mg: hard gelatin capsule size '1', 19.30 ± 0.40 mm in length,
with body and cap in white to almost white colour, marked with yellow print: “150” on the
body and “FL” on the cap.
The medicine is packed in a PVC/PVDC-Aluminium blister, placed in a cardboard box with a leaflet.
Pack contents: 1 or 3 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation 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 Farmacêutica, S.A.
Rua João de Deus, n.o 19, Venda Nova,
2700-487 Amadora,
Portugal