Fluconazole ABC

Package Leaflet: Information for the User

FLUCONAZOLE ABC 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules

Fluconazole
Generic medicine
Please read all of this leaflet carefully before you take this medicine because it contains important information for you

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Fluconazole ABC is and what it is used for
2. What you need to know before taking Fluconazole ABC
3. How to take Fluconazole ABC
4. Possible side effects
5. How to store Fluconazole ABC
6. Contents of the pack and other information

1. What Fluconazolo ABC is and what it is used for

Fluconazolo ABC belongs to a group of medicines known as "antifungals". The active substance is
fluconazolo.
Fluconazolo ABC is used to treat fungal infections and can also be used to prevent Candida infections. The most common cause of fungal infections is a yeast called Candida.
Adults
Your doctor may prescribe this medicine to treat the following fungal infections:

• Cryptococcal meningitis – a fungal infection of the brain
• Coccidioidomycosis – a disease affecting the bronchopulmonary system
• Infections caused by Candida found in the bloodstream, organs (e.g. heart, lungs), or urinary tract
• Mucosal candidiasis – infection of the oral mucosa, throat infection, and denture-related stomatitis
• Genital candidiasis – infection of the vagina or penis
• Skin infections – e.g. athlete’s foot, ringworm, genital itching, nail infections

Fluconazolo ABC may be prescribed to you to:

• prevent recurrence of cryptococcal meningitis
• prevent recurrence of mucosal candidiasis
• reduce recurrences of vaginal candidiasis
• prevent Candida infections (if your immune system is weakened or not functioning properly)

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

• Mucosal candidiasis – infection of the oral mucosa, throat infection
• Infections caused by Candida found in the bloodstream, organs (e.g. heart, lungs), or urinary tract
• Cryptococcal meningitis – a fungal infection of the brain

Fluconazolo ABC may be prescribed to you to:

• prevent Candida infections (if your immune system is weakened or not functioning properly)
• prevent recurrence of cryptococcal meningitis.

2. What you need to know before taking Fluconazole ABC

Do not take Fluconazole ABC

• if you are allergic to fluconazole, to other medicines used to treat fungal infections, or to any of the other ingredients of this medicine (listed in section 6). Symptoms may include itching, skin redness, or breathing difficulties
• if you are taking astemizole or terfenadine (antihistamines used to treat allergies)
• if you are taking cisapride (used to treat stomach disorders)
• if you are taking pimozide (used to treat mental disorders)
• if you are taking quinidine (used to treat cardiac arrhythmias)
• if you are taking erythromycin (an antibiotic used to treat bacterial infections).

Warnings and precautions
Talk to your doctor or pharmacist before taking Fluconazole ABC

• if you have liver or kidney problems
• if you suffer from heart conditions, including cardiac arrhythmia
• if you have abnormal levels of potassium, calcium, or magnesium in your blood
• if severe skin reactions occur (such as itching, skin redness, or breathing difficulties)
• if signs of 'adrenal insufficiency' appear, in which the adrenal glands do not produce adequate amounts of certain steroid hormones such as cortisol (symptoms include chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain)
• if you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers after taking Fluconazole ABC. Severe skin reactions, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported with Fluconazole ABC treatment. Stop taking Fluconazole ABC and contact your doctor immediately if you notice any of the symptoms related to severe skin reactions described in section 4.

Talk to your doctor or pharmacist if your fungal infection does not improve, as alternative antifungal therapy may be needed.
Other medicines and Fluconazole ABC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Inform your doctor immediately if you are taking astemizole or terfenadine (antihistamines used to treat allergies), cisapride (used to treat stomach disorders), pimozide (used to treat mental disorders), quinidine (used to treat cardiac arrhythmias), or erythromycin (an antibiotic used to treat bacterial infections), as these must not be taken with Fluconazole ABC (see section: “Do not take Fluconazole ABC”).
Some medicines may interact with Fluconazole ABC. Inform your doctor if you are taking any of the following medicines, as dose adjustment or monitoring may be required to ensure these medicines continue to work as intended:

• rifampicin or rifabutin (antibiotics used to treat bacterial infections)
• abrocitinib (used to treat atopic dermatitis, also known as atopic eczema)
• alfentanil, fentanyl (anesthetics)
• amitriptyline, nortriptyline (antidepressants)
• amphotericin B, voriconazole (antifungals)
• blood-thinning medicines used to prevent blood clots (warfarin or similar medicines)
• benzodiazepines (midazolam, triazolam, or similar medicines) used to help you sleep or for anxiety
• carbamazepine, phenytoin (used to treat epileptic seizures)
• nifedipine, isradipine, amlodipine, verapamil, felodipine, and losartan (used to treat hypertension - high blood pressure)
• olaparib (used to treat ovarian cancer)
• ciclosporin, 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)
• statins (atorvastatin, simvastatin, fluvastatin, and similar medicines) used to lower high cholesterol levels
• methadone (used to treat pain)
• celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (Non-Steroidal Anti-Inflammatory Drugs - NSAIDs)
• oral contraceptives
• prednisone (a steroid)
• zidovudine, also known as AZT; saquinavir (used in HIV patients)
• diabetes medicines such as chlorpropamide, glibenclamide, glipizide, or tolbutamide
• theophylline (used to control asthma)
• tofacitinib (used to treat rheumatoid arthritis)
• tolvaptan, used to treat hyponatremia (low sodium levels in the blood) or to slow the decline in kidney function
• vitamin A (dietary supplement)
• ivacaftor (used to treat cystic fibrosis)
• amiodarone (used to treat "arrhythmias", irregular heartbeats)
• hydrochlorothiazide (a diuretic)
• ibrutinib (used to treat blood cancer)
• lurasidone (used to treat schizophrenia).

Fluconazole ABC with food and drink
You may take this medicine with or without food.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Fluconazole ABC if you are pregnant, think you may be pregnant, or are planning a pregnancy, unless instructed by your doctor. If you become pregnant while taking this medicine or within 1 week after the most recent dose, contact your doctor.
Fluconazole taken during the first trimester of pregnancy may increase the risk of miscarriage.
Low-dose fluconazole taken during the first trimester may slightly increase the risk of congenital bone and/or muscle malformations in the newborn.
You may continue breastfeeding after a single dose of Fluconazole ABC up to 150 mg.
You must not breastfeed if you are taking repeated doses of Fluconazole ABC.
Driving and using machines
Be aware that dizziness or seizures may occur while driving or operating machinery.
Fluconazole ABC contains lactose (milk sugar) and sodium (salt)
This medicine contains a small amount of lactose (milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Fluconazole ABC capsules contain less than 1 mmol (23 mg) of sodium per capsule, i.e., essentially 'sodium-free'.

3. How to take Fluconazole ABC

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Swallow the capsule whole with a glass of water. It is best to take the capsules at the same
time each day.
The recommended doses of this medicine, depending on the infection, are listed below:
Adults

Adolescents aged 12 to 17 years
Always take the dose prescribed by your doctor (either the adult dose or the pediatric dose).
Children up to 11 years
The maximum dose in children is 400 mg per day.
The dose will be based on the child's weight in kilograms.

Use in children from 0 to 4 weeks of age
Use in children aged 3 to 4 weeks:
The same dosage described above, administered once every 2 days. The maximum dose is 12 mg
per kg of body weight every 48 hours.
Use in children under 2 weeks of age:
The same dosage described above, administered once every 3 days. The maximum dose is 12 mg
per kg of body weight every 72 hours.

Elderly
The same dose as recommended for adults should be used, unless you have renal problems.

Patients with renal impairment
Your doctor may adjust the dosage according to your renal function.

If you take more Fluconazolo ABC than you should
Taking too many capsules at once may cause you problems. Contact your doctor immediately or go to the nearest hospital.
In case of accidental overdose, symptoms may include sensing, seeing, perceiving, and thinking things that are not real (hallucinations and paranoid behaviour). Symptomatic treatment may be advisable (with appropriate supportive measures and, if necessary, gastric lavage).

If you forget to take Fluconazolo ABC
Do not take a double dose to make up for the missed dose. If you forget to take a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and take the next dose at the scheduled time.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Fluconazole ABC and contact your doctor immediately if you notice any of the following symptoms:

• widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Some people may experience allergic reactions, although severe allergic reactions are rare. If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. If you experience any of the following symptoms, contact your doctor immediately:

• sudden breathlessness, difficulty breathing, or tightness in the chest
• swelling of the eyelids, face, or lips
• itching all over the body, skin redness, or itchy red patches
• skin rashes
• severe skin reactions, for example rashes causing blisters (which may affect the mouth and tongue).

Fluconazole ABC may affect the liver. Symptoms of liver problems include:

• fatigue
• loss of appetite
• vomiting
• yellowing of the skin and whites of the eyes (jaundice)

If you experience any of these symptoms, stop taking Fluconazole ABC and contact your doctor immediately.
Other side effects:
If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.
Common side effects (may affect up to 1 in 10 people) are:

• headache
• stomach discomfort, diarrhoea, nausea, vomiting
• increased liver function test values in blood tests
• skin rashes

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

• reduction in red blood cells, which may cause paleness, weakness, or breathlessness
• decreased appetite
• insomnia, drowsiness
• seizures, dizziness, vertigo, tingling, prickling, or numbness, altered taste
• constipation, indigestion, flatulence, dry mouth
• muscle pain
• liver damage and yellowing of the skin and eyes (jaundice)
• swelling, blisters (urticaria), itching, increased sweating
• tiredness, general malaise, fever.

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

• lower than normal levels of white blood cells, which help defend against infections, and of platelets, which are necessary for blood clotting
• altered skin colouration (red or purplish), which may be caused by a reduction in platelets or other changes in blood cells
• changes in blood chemistry (high cholesterol, high fat levels)
• low potassium levels in the blood
• chills
• abnormal electrocardiogram (ECG), changes in heart rhythm and rate
• liver failure
• allergic reactions (sometimes severe), including skin rashes with widespread blistering and peeling of the skin, severe skin reactions, swelling of the lips and face
• hair loss

Frequency not known, but possible (frequency cannot be estimated from the available data):

• hypersensitivity reaction with skin rash, fever, swollen glands, increase in a type of white blood cells (eosinophilia), and inflammation of internal organs (liver, lungs, heart, kidneys, and large intestine) (drug reaction or rash with eosinophilia and systemic symptoms (DRESS)).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fluconazole ABC

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the label after Exp.. The expiry date refers to the last day of that month.
• Store below 30 °C.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Fluconazolo ABC contains

• The active substance is fluconazole.
• Each hard capsule contains fluconazole 100 mg, 150 mg or 200 mg.
• The excipients are: Capsule contents: monohydrate lactose, pregelatinized starch, magnesium stearate, anhydrous colloidal silica, sodium lauryl sulfate (see section 2, Fluconazolo ABC contains lactose (milk sugar) and sodium (salt)).

Capsule shell composition:
100 mg hard capsules: gelatin, titanium dioxide (E171), yellow iron oxide.
150 mg hard capsules: gelatin, titanium dioxide (E171).
200 mg hard capsules: gelatin, titanium dioxide (E171).

Description of the appearance of Fluconazolo ABC and pack sizes

• Fluconazolo ABC 100 mg hard capsules, pack size: 10 capsules
• Fluconazolo ABC 150 mg hard capsules, pack size: 2 capsules
• Fluconazolo ABC 200 mg hard capsules, pack size: 7 capsules

Marketing Authorization Holder
ABC Farmaceutici S.p.A. – Corso Vittorio Emanuele II, 72 – Turin
Manufacturer
Laboratorio Farmaceutico C.T. S.r.l. – Via Dante Alighieri, 71 – 18038 Sanremo (Imperia)
ABC Farmaceutici S.p.A. – Canton Moretti, 29 – 10015 San Bernardo d’Ivrea (TO)