FLUCONAZOLO 100 mg Hard Capsules

Зміст інструкції

1. FLUCONAZOLO ABC 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules
   1. What is Fluconazolo ABC and what is it used for
   2. What you need to know before taking Fluconazolo ABC
   3. How to take Fluconazole ABC
   4. Possible side effects
   5. How to store Fluconazolo ABC
   6. Contents of the pack and other information

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

Fluconazole

Generic medicine

Read this leaflet carefully before you start taking 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

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

Fluconazolo ABC belongs to a group of medicines called “antifungals”. The active ingredient is
fluconazole.
Fluconazolo ABC is used for the treatment of fungal infections and can be used to prevent
Candidainfections. The most common cause of fungal infections is a yeast called Candida.

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

• Cryptococcal meningitis - a fungal infection of the brain
• Coccidioidomycosis - a disease of the bronchopulmonary system
• Infections caused by Candidaand found in the bloodstream, in organs (e.g. heart, lungs) or in the urinary tract
• Candidiasis of the mucous membranes - infection of the oral mucosa, throat infection and inflammation of the mouth from dentures
• Genital candidiasis - infection of the vagina or penis
• Skin infections - e.g. athlete's foot, ringworm, itching in the genital area, nail infections

Fluconazolo ABC may be prescribed for:

• preventing the recurrence of cryptococcal meningitis
• preventing the recurrence of candidiasis of the mucous membranes
• reducing recurrences of vaginal candidiasis
• preventing Candidainfections (if your immune system is weak or not functioning properly)

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

• Candidiasis of the mucous membranes - infection of the oral mucosa, throat infection
• Infections caused by Candidaand found in the bloodstream, in organs (e.g. heart, lungs) or in the urinary tract
• Cryptococcal meningitis - a fungal infection of the brain

Fluconazolo ABC may be prescribed for:

• preventing Candidainfections (if your immune system is weak or not functioning properly);
• preventing the recurrence of cryptococcal meningitis.

2. What you need to know before taking Fluconazolo ABC

Do not take Fluconazolo ABC

• if you are allergic to fluconazole, to other medicines that you have used for the treatment of fungal infections or to any of the other components of this medicine (listed in section 6). The symptoms may be itching, redness of the skin or difficulty in breathing
• if you are taking astemizole, 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 heart arrhythmias)
• if you are taking erythromycin (antibiotic used to treat bacterial infections).

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

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

Talk to your doctor or pharmacist if the fungal infection does not improve, an alternative antifungal therapy may be necessary.

Other medicines and Fluconazolo ABC
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
Tell your doctor immediatelyif you are taking astemizole, terfenadine (antihistamine used to treat allergies) or cisapride (used to treat stomach disorders) or pimozide (used to treat mental disorders) or quinidine (used to treat heart arrhythmias) or erythromycin (antibiotic used to treat bacterial infections), as they cannot be taken with Fluconazolo ABC (see section: “Do not take Fluconazolo ABC”).
There are some medicines that can interact with Fluconazolo ABC. Tell your doctor if you are taking any of the following medicines as a dose adjustment or monitoring may be necessary to ensure that the medicines continue to have the desired effect:

• rifampicin or rifabutin (antibiotics for the treatment of bacterial infections)
• abrocitinib (used for the treatment of atopic dermatitis, also known as atopic eczema)
• alfentanil, fentanyl (anaesthetics)
• amitriptyline, nortriptyline (antidepressants)
• amphotericin B, voriconazole (antifungals)
• medicines that thin the blood 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 seizures)
• nifedipine, isradipine, amlodipine, verapamil, felodipine and losartan (used to treat hypertension - high blood pressure)
• olaparib (used for the treatment of ovarian cancer)
• cyclosporine, everolimus, sirolimus or tacrolimus (used to prevent transplant rejection)
• cyclophosphamide, vinca alkaloids (vincristine, vinblastine or similar medicines) used for the treatment of cancer
• halofantrine (used for the treatment of malaria)
• statins (atorvastatin, simvastatin, fluvastatin and similar medicines) used to reduce high cholesterol levels
• methadone (used for the treatment of pain)
• celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (Non-Steroidal Anti-Inflammatory Drugs - NSAIDs)
• oral contraceptives
• prednisone (steroid)
• zidovudine, also known as AZT; saquinavir (used in patients with HIV)
• medicines for diabetes such as chlorpropamide, glibenclamide, glipizide or tolbutamide
• theophylline (used to control asthma)
• tofacitinib (used for the treatment of rheumatoid arthritis)
• tolvaptan, used to treat hyponatremia (low levels of sodium in the blood) or to slow the decline in kidney function
• vitamin A (food supplement)
• ivacaftor (used for the treatment of cystic fibrosis)
• amiodarone (used for the treatment of “arrhythmias”, irregular heartbeats)
• hydrochlorothiazide (a diuretic)
• ibrutinib (used for the treatment of blood cancer).
• lurasidone (used for the treatment of schizophrenia).

Fluconazolo ABC with food and drink
You can take the medicine with or without food.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Fluconazolo ABC if you are pregnant, suspect you may be pregnant or are planning a pregnancy, unless your doctor tells you to. If you become pregnant while taking this medicine or within 1 week of the most recent dose, contact your doctor.
Fluconazole taken during the first trimester of pregnancy may increase the risk of miscarriage.
Fluconazole taken at low doses during the first trimester may slightly increase the risk that the baby is born with malformations of bones and/or muscles.
You can continue to breastfeed after taking a single dose of Fluconazolo ABC up to 150 mg.
You should not breastfeed if you are taking repeated doses of Fluconazolo ABC.

Driving and using machines
You should be aware that dizziness or convulsions may occur while driving or using machines.

Fluconazolo ABC contains lactose (milk sugar) and sodium (salt)
This medicine contains a minimal amount of lactose (milk sugar). If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.
Fluconazolo ABC capsules contains less than 1 mmol (23 mg) of sodium per capsule, that is to say essentially ‘sodium-free’.

3. How to take Fluconazole ABC

Always take this medicine exactly as your doctor has told you.If you have any doubts, ask your
doctor or pharmacist.
Swallow the capsule whole with a glass of water. It is best to take the capsules every day at the same
time.
The recommended doses of this medicine to be taken depending on the infection are listed below:

Adults

Adolescents from 12 to 17 years
Always take the dose prescribed by the doctor (either the adult or the children's dosage).

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

Elderly
The same dose as provided for adults should be used unless you have kidney problems.

Patients with kidney problems
Your doctor may adjust the dosage based on kidney function.

If you take more Fluconazole ABC than you should
Taking too many capsules all at once can cause you problems. Tell your doctor immediately or go to the
nearest hospital.
In case of accidental overdose, symptoms may include feeling, seeing, perceiving and thinking things
that are not real (hallucinations and paranoid behavior). Symptomatic treatment may be appropriate (with
adequate supportive measures and possibly gastric lavage).

If you forget to take Fluconazole ABC
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
possible. If it is time to take the next dose, do not take the dose you forgot.
If you have any doubts about using 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.
Stop taking Fluconazolo ABC and contact your doctor immediatelyif you notice any of the
following symptoms:

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

Some people experience allergic reactionsalthough serious allergic reactions are rare. If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. If you experience any of the following symptoms inform your doctor immediately.

• sudden shortness of breath, difficulty breathing or feeling of tightness in the chest
• swelling of the eyelids, face or lips
• itching all over the body, redness of the skin or itchy red spots
• rashes
• severe skin reactions, such as rashes that cause blisters (may affect the mouth and tongue).

Fluconazolo ABC can have effects on the liver. Symptoms of liver problems include:

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

If you experience any of these symptoms, stop taking Fluconazolo ABC and inform your doctor immediately.

Other side effects:
If any of the side effects gets serious, or if you notice any side effect not listed here
Common side effects (may affect up to 1 in 10 people) are:

• headache
• stomach discomfort, diarrhea, nausea, vomiting
• increases in liver function values in blood tests
• rashes Uncommon side effects (may affect up to 1 in 100 people) are:
• reduction in red blood cells which can cause paleness, weakness or shortness of breath
• loss of appetite
• insomnia, drowsiness
• convulsions, dizziness, feeling of spinning, tingling, prickling or numbness, altered taste
• constipation, difficulty digesting, flatulence, dry mouth
• muscle pain
• liver damage and yellowing of the skin and eyes (jaundice)
• swellings, blisters (urticaria), itching, increased sweating
• fatigue, general feeling of being unwell, fever.

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

• lower than normal levels of white blood cells, which help you fight infection, and platelets, which help your blood clot
• altered skin colour (red or purple) which may be caused by a reduction in platelets, other changes in blood cells
• changes in the chemical composition of the blood (high levels of cholesterol, fats)
• low levels of potassium in the blood
• chills
• altered electrocardiogram (ECG), changes in heart rate and rhythm
• liver failure
• allergic reactions (sometimes severe), including skin rashes with widespread blisters and peeling skin, severe skin reactions, swelling of the lips and face
• hair loss

Frequency not known, but may occur (frequency cannot be estimated from available data):

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

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through
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 Fluconazolo ABC

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

Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack 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 content:lactose monohydrate, pregelatinized starch, magnesium stearate, anhydrous colloidal silica, sodium lauryl sulfate (see section 2, Fluconazolo ABC contains lactose (milk sugar) and sodium (salt)).

Capsule shell content:
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 contents of the pack

• Fluconazolo ABC 100 mg hard capsules pack of 10 capsules
• Fluconazolo ABC 150 mg hard capsules pack of 2 capsules
• Fluconazolo ABC 200 mg hard capsules pack of 7 capsules

Marketing Authorisation 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)