Flucostenol

Package leaflet: Information for the patient

FLUCOSTENOL 50 mg hard capsules, 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules

fluconazole
Generic medicine
Please read this entire 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, 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 adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What FLUCOSTENOL is and what it is used for

FLUCOSTENOL belongs to a group of medicines called "antifungals". The active substance is
fluconazole.
FLUCOSTENOL is used to treat fungal infections and may 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

FLUCOSTENOL may be prescribed 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

FLUCOSTENOL may be prescribed to:

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

2. What you should know before taking FLUCOSTENOL

DO NOT take FLUCOSTENOL

• if you are allergic 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
• if you are taking astemizole or terfenadine (antihistamine medicines 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 FLUCOSTENOL

• if you have liver or kidney problems
• if you suffer from heart diseases, 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 difficulty breathing)
• if signs of 'adrenal insufficiency' appear, where the adrenal glands do not produce adequate amounts of certain steroid hormones such as cortisol (e.g. chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain)
• if you have previously developed a severe rash or skin peeling, blisters and/or mouth ulcers after taking Flucostenol
• if the fungal infection does not improve, an alternative antifungal therapy may be needed.

Severe skin reactions, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported with Flucostenol treatment. Stop taking Flucostenol and contact your doctor immediately if you notice any of the symptoms related to severe skin reactions described in section 4.
Other medicines and FLUCOSTENOL
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
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 FLUCOSTENOL (see section: “Do not take FLUCOSTENOL”).
Some medicines may interact with FLUCOSTENOL. 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 clotting (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 carcinoma)
• 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)
• 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)

FLUCOSTENOL with food and drinks
You may take this medicine with or without food.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take FLUCOSTENOL if you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, unless your doctor tells you to.
Fluconazole taken during the first trimester of pregnancy may increase the risk of miscarriage.
Taking fluconazole 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 FLUCOSTENOL up to 150 mg. You must not breastfeed if you are taking repeated doses of FLUCOSTENOL.
Driving and using machines
Be aware that dizziness or seizures may occur while driving or operating machinery.
FLUCOSTENOL contains lactose (milk sugar) and sodium (salt)
This medicine contains a small amount of lactose (milk sugar). If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
Flucostenol capsules contain less than 1 mmol (23 mg) of sodium per capsule, i.e., essentially 'sodium-free'.

3. How to take FLUCOSTENOL

Take this medicine exactly as your doctor has told you. If you are unsure, 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 from 12 to 17 years
Always take the dose prescribed by your doctor (either the adult dose or the children's 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 aged 0 to 4 weeks:
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.

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

Use in patients with renal impairment
The doctor may adjust the dosage according to renal function.

If you take more FLUCOSTENOL than you should
Taking too many capsules at once could cause you problems. Inform 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 behavior). Symptomatic treatment may be appropriate
(including adequate supportive measures and, if necessary, gastric lavage).

If you forget to take FLUCOSTENOL
Do not take a double dose to make up for the forgotten dose. If you forget 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
regularly 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 everyone gets them.

Some people may experience allergic reactions, although serious allergic reactions are rare. If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. Stop taking FLUCOSTENOL and contact your doctor immediately if you notice any of the following symptoms:

• sudden breathlessness, difficulty breathing, or chest tightness
• 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)
• widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

FLUCOSTENOL 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 FLUCOSTENOL 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):

• 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):

• 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)
• swellings, blisters (urticaria), itching, increased sweating
• fatigue, general malaise, fever

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

• 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 reduced platelet levels, 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 rashes with widespread blistering and peeling of the skin, severe skin reactions, swelling of the lips and face
• hair loss

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

• hypersensitivity reaction with skin 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 drug-induced hypersensitivity syndrome with eosinophilia and systemic symptoms (DRESS)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact 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 FLUCOSTENOL

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

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

6. Contents of the pack and other information

What FLUCOSTENOL contains

• The active substance is fluconazole.
• Each hard capsule contains fluconazole 50 mg, 100 mg, 150 mg or 200 mg.
• The excipients are: Capsule contents: monohydrate lactose, microcrystalline cellulose, pregelatinized corn starch, colloidal silicon dioxide, magnesium stearate, sodium lauryl sulfate. Capsule shell composition: 50 mg hard capsules: gelatin, quinoline yellow (E104), iron oxide (E172), patent blue (E131), titanium dioxide (E171). 100 mg hard capsules: gelatin, iron oxide, titanium dioxide. 150 mg hard capsules: gelatin, quinoline yellow, sunset yellow (E110), titanium dioxide. 200 mg hard capsules: gelatin, titanium dioxide.

Description of the appearance of FLUCOSTENOL and contents of the pack

• Each pack of FLUCOSTENOL 50 mg hard capsules contains 7 capsules.
• Each pack of FLUCOSTENOL 100 mg hard capsules contains 10 capsules.
• Each pack of FLUCOSTENOL 150 mg hard capsules contains 2 capsules.
• Each pack of FLUCOSTENOL 200 mg hard capsules contains 7 capsules.

Marketing Authorization Holder
Alfasigma S.p.A. - Via Ragazzi del '99, n. 5 - 40133 Bologna (BO)
Manufacturer
PHARMATHEN S.A.
Dervenakion 6 – Pallini 15351 – Attiki Greece