Fluconazole Pensà: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

FLUCONAZOLE PENSA 50 mg hard capsules, 100 mg hard capsules, 150 mg hard capsules, 200 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What FLUCONAZOLE PENSA is and what it is used for
What you need to know before taking FLUCONAZOLE PENSA
How to take FLUCONAZOLE PENSA
Possible side effects
How to store FLUCONAZOLE PENSA
Contents of the pack and other information

1. What FLUCONAZOLO PENSA is and what it is used for

FLUCONAZOLO PENSA belongs to a group of medicines known as "antifungals". The active substance is fluconazole.
FLUCONAZOLO PENSA is used to treat fungal infections and may 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 PENSA may be prescribed to you:

to prevent recurrence of cryptococcal meningitis
to prevent recurrence of mucosal candidiasis
to reduce recurrences of vaginal candidiasis
to 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 PENSA may be prescribed to you:

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

2. What you should know before taking FLUCONAZOLE PENSA

Do not take FLUCONAZOLE PENSA if you

are allergic (hypersensitive) to fluconazole, to other medicines you have 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 difficulty breathing
are taking astemizole, terfenadine (antihistamines used to treat allergies)
are taking cisapride (used to treat stomach disorders)
are taking pimozide (used to treat mental disorders)
are taking quinidine (used to treat cardiac arrhythmias)
are taking erythromycin (an antibiotic used to treat bacterial infections)

Warnings and precautions
Talk to your doctor or pharmacist before taking FLUCONAZOLE PENSA if:

you have liver or kidney problems
you suffer from heart diseases, including cardiac arrhythmia
you have abnormal levels of potassium, calcium or magnesium in your blood
severe skin reactions occur (itching, skin redness or difficulty breathing)
you have ever developed a severe skin rash or skin peeling, blisters and/or mouth ulcers after taking FLUCONAZOLE PENSA
the fungal infection does not improve; alternative antifungal therapy may be needed
you develop signs of "adrenal insufficiency", a condition in which the adrenal glands do not produce adequate amounts of certain steroid hormones such as cortisol (symptoms include chronic or long-lasting fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain)

Severe skin reactions, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported in association with treatment with FLUCONAZOLE PENSA. Discontinue taking FLUCONAZOLE PENSA and contact your doctor immediately if you experience any of the symptoms related to severe skin reactions described in section 4.

Other medicines and FLUCONAZOLE PENSA
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, 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 PENSA (see section: "Do not take FLUCONAZOLE PENSA if you").

There are some medicines that may interact with FLUCONAZOLE PENSA. Inform your doctor if you are taking any of the following medicines:

rifampicin or rifabutin (antibiotics used to treat bacterial infections)
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 epileptic seizures)
nifedipine, isradipine, amlodipine, 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 reduce 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 patients with HIV)
diabetes medicines such as chlorpropamide, glibenclamide, glipizide or tolbutamide
theophylline (used to control asthma)
tofacitinib (used to treat rheumatoid arthritis)
vitamin A (dietary supplement)
ivacaftor (used to treat cystic fibrosis)
amiodarone (used to treat "arrhythmias", irregular heartbeats)
hydrochlorothiazide (used as a diuretic)

FLUCONAZOLE PENSA with food and drink
You may take this medicine with or without food.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Do not take FLUCONAZOLE PENSA if you are pregnant, think you may be pregnant, are planning pregnancy, or are breastfeeding, unless your doctor specifically tells you to.

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 of the baby being born with bone and/or muscle malformations.

You may continue breastfeeding after a single dose of FLUCONAZOLE PENSA up to 150 mg.

You must not breastfeed if you are taking repeated doses of FLUCONAZOLE PENSA.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Be aware that dizziness or seizures may occur while driving or using machinery.

FLUCONAZOLE PENSA contains lactose and sodium
This medicine contains a small amount of lactose (milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

FLUCONAZOLE PENSA contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially 'sodium-free'.

3. How to take FLUCONAZOLE PENSA

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended doses of this medicine, depending on the infection, are listed below:
Adults

Condition	Dose
Treatment of cryptococcal meningitis	400 mg on the first day, then 200–400 mg once daily for 6–8 weeks or longer, if necessary. Sometimes doses are increased up to 800 mg
Prevention of recurrence of cryptococcal meningitis	200 mg once daily until you are told to stop
Treatment of coccidioidomycosis	200–400 mg once daily for 11 to 24 months. Sometimes doses are increased up to 800 mg
Endemic Candida fungal infections	800 mg on the first day, then 400 mg once daily
Treatment of oral mucosal infections, throat infections, and denture-related stomatitis	200–400 mg on the first day, then 100–200 mg until you are told to stop
Mucosal candidiasis – dose depends on site of infection	50–400 mg once daily for 7–30 days until you are told to stop
Prevention of oral mucosal infections, throat infections	100–200 mg once daily, or 200 mg three times weekly while at risk of infection
Genital candidiasis	150 mg as a single dose
Reducing recurrences of vaginal candidiasis	150 mg every three days for a total of 3 doses (day 1, 4, and 7), then once monthly while at risk of infection
Skin mycoses and nail infections	Depending on site of infection: 50 mg once daily; 150 mg once weekly; 300–400 mg once weekly for 1 to 4 weeks (Athlete’s foot may require up to 6 weeks; treatment of nail infections continues until the infected nail is replaced)
Prevention of Candida infections (if your immune system is weakened or not functioning properly)	200–400 mg once daily while at risk of infection

Swallow the capsule whole with a glass of water. It is best to take the capsules at the same time each day.
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.

Condition	Daily dose
Oral and throat candidiasis – dosage and duration of treatment depend on the severity and site of infection	3 mg per kg of body weight (on the first day, 6 mg per kg of body weight may be administered)
Cryptococcal meningitis or endemic Candida fungal infections	6 mg to 12 mg per kg of body weight
Prevention of Candida infection in children (if their immune system is not functioning properly)	3 mg to 12 mg per kg of body weight

Use in children from 0 to 4 weeks of age
Use in children aged 3 to 4 weeks:
The same dosage described above, but 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, but administered once every 3 days. The maximum dose is 12 mg
per kg of body weight every 72 hours.
Your doctor may sometimes prescribe doses different from those indicated. Always take the medicine exactly
as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Use in elderly patients
The same dose recommended for adults should be used unless you have renal problems.
Use in patients with renal impairment
Your doctor may adjust the dosage according to renal function.
If you take more FLUCONAZOLO PENSA than you should
Taking too many capsules at once could cause you problems. Contact your doctor immediately or
go to the nearest hospital.
In case of accidental overdose, symptoms may include experiencing sensations, visions, perceptions, and thoughts of things that are not real (hallucinations and paranoid behavior). Symptomatic treatment may be appropriate (with adequate supportive measures and, if necessary, gastric lavage).
If you forget to take FLUCONAZOLO PENSA
Do not take a double dose to make up for missed doses. 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 one at the regular time.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, FLUCONAZOLE PENSA may cause side effects, although not everybody gets them.
Some people may experience allergic reactions, although serious allergic reactions are rare. 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 PENSA may affect the liver. Symptoms of liver problems include:

tiredness
loss of appetite
vomiting
yellowing of the skin and whites of the eyes (jaundice)
If you experience any of these symptoms, stop taking FLUCONAZOLE PENSA and contact your doctor immediately.

Stop taking FLUCONAZOLE PENSA 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).

Other side effects: If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Common side effects (occurring in 1 to 10 out of 100 patients) are:

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

Uncommon side effects (occurring in 1 to 10 out of 1,000 patients) 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
fatigue, general malaise, fever

Rare side effects (occurring in 1 to 10 out of 10,000 patients) are:

lower than normal levels of white blood cells, which help protect 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, other changes in blood cells
changes in blood chemistry (elevated cholesterol and fat levels)
low potassium levels in the blood
chills
abnormal electrocardiogram (ECG), changes in heart rhythm and heart rate
liver failure
allergic reactions (sometimes severe), including rashes with widespread blistering and peeling of the 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 in a type of white blood cell (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 or pharmacist.
You can also report side effects directly via the national reporting system at 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 PENSA

Keep out of the sight and reach of children.
Do not use FLUCONAZOLE PENSA after the expiry date which is stated on the label after "Exp". The expiry
date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help protect the environment.

6. Package contents and other information

What FLUCONAZOLO PENSA contains
The active substance is fluconazole.
Each hard capsule contains 50 mg, 100 mg, 150 mg or 200 mg of fluconazole.
The other components are:
Capsule contents: Lactose, Colloidal silicon dioxide, Corn starch, Magnesium stearate, Sodium lauryl sulfate.
Capsule shell contents:
50 mg hard capsules: Titanium dioxide E171, Yellow iron oxide E172, Gelatin
100 mg hard capsules: Titanium dioxide E171, Yellow iron oxide E172, Patent Blue V E131, Orange Yellow E110, Gelatin
150 mg hard capsules: Titanium dioxide E171, Yellow iron oxide E172, Indigo Carmine E132, Quinoline Yellow E104, Gelatin
200 mg hard capsules: Titanium dioxide E171, Indigo Carmine E132, Quinoline Yellow E104, Gelatin

Description of the appearance of FLUCONAZOLO PENSA 50 mg, 100 mg, 150 mg and 200 mg hard capsules and
pack size
Hard capsules.

Pack containing 7 capsules of 50 mg fluconazole
Pack containing 10 capsules of 100 mg fluconazole
Pack containing 2 capsules of 150 mg fluconazole
Pack containing 7 capsules of 200 mg fluconazole

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pensa Pharma S.p.A. – Via Ippolito Rosellini, 12 – 20124 Milano
Manufacturer
Genetic S.p.a. – Contrada Canfora – 84084 Fisciano (SA)