FLUCOSTENOL 50 mg Hard Capsule

Зміст інструкції

1. FLUCOSTENOL 50 mg hard capsules, 100 mg hard capsules
   1. What is FLUCOSTENOL and what is it 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

FLUCOSTENOL 50 mg hard capsules, 100 mg hard capsules

FLUCOSTENOL 150 mg hard capsules
FLUCOSTENOL 200 mg hard capsules
fluconazole
Generic Medicine

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, 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 FLUCOSTENOL is and what it is used for
• 2. What you need to know before you take 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 is FLUCOSTENOL and what is it used for

FLUCOSTENOL belongs to a group of medicines called “antifungals”. The active ingredient is
fluconazole.
FLUCOSTENOL 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

FLUCOSTENOL may be prescribed for:

• preventing the recurrence of cryptococcal meningitis
• preventing the recurrence of candidiasis of the mucous membranes
• reducing the recurrence 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

FLUCOSTENOL 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 FLUCOSTENOL

DO NOT take FLUCOSTENOL

• 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 for the treatment of allergies)
• if you are taking cisapride (used for the treatment of stomach disorders)
• if you are taking pimozide (used for the treatment of mental disorders)
• if you are taking quinidine (used for the treatment of heart arrhythmias)
• if you are taking erythromycin (antibiotic used for the treatment of 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 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, whereby 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 you have ever developed a severe rash or exfoliation of the skin, blisters and/or ulcers in the mouth after taking Flucostenol
• if the fungal infection does not improve, an alternative antifungal therapy may be necessary.

Serious skin reactions including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have been reported related to treatment with Flucostenol. Stop taking Flucostenol and contact your doctor immediately if you notice any of the symptoms related to the serious skin reactions described in section 4.

Other medicines and FLUCOSTENOL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor immediatelyif you are taking astemizole, terfenadine (antihistamine used for the treatment of allergies) or cisapride (used for the treatment of stomach disorders) or pimozide (used for the treatment of mental disorders) or quinidine (used for the treatment of heart arrhythmias) or erythromycin (antibiotic used for the treatment of bacterial infections), as they cannot be taken with FLUCOSTENOL (see section: “Do not take FLUCOSTENOL”).
There are some medicines that can interact with FLUCOSTENOL. Tell your doctor if you are taking any of the following medicines:

• rifampicin or rifabutin (antibiotics for the treatment of 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 for the treatment of seizures)
• nifedipine, isradipine, amlodipine, verapamil, felodipine and losartan (used for the treatment of 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 for asthma control)
• tofacitinib (used for the treatment of rheumatoid arthritis)
• tolvaptan, used to treat hyponatremia (low sodium levels in the blood) or to slow the decline of 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)

FLUCOSTENOL 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 to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take FLUCOSTENOL if you are pregnant, suspect you may be pregnant or are breastfeeding, unless your doctor 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 that the baby is born with bone and/or muscle malformations.
You can continue to breastfeed after taking a single dose of FLUCOSTENOL up to 150 mg. You should not breastfeed if you are taking repeated doses of FLUCOSTENOL.

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

FLUCOSTENOL 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 your doctor before taking this medicine.
Flucostenol capsules contains less than 1 mmol (23 mg) of sodium per capsule, that is to say essentially ‘sodium free’.

3. How to take FLUCOSTENOL

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 here
below:

Adults

Adolescents from 12 to 17 years
Always take the dose prescribed by your doctor (either the adult dosage 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 intended for adults should be used unless you have kidney problems.

Use in patients with kidney problems
The doctor may adjust the dosage based on kidney function.

If you take more FLUCOSTENOL than you should
Taking too many capsules all at once may cause you problems. Immediately inform your doctor 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 (with appropriate supportive measures and possibly gastric lavage) may be appropriate.

If you forget to take FLUCOSTENOL
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, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Some people experience allergic reactions, although severe allergic reactions are rare. If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. Stop taking FLUCOSTENOL and contact your doctor immediately if you notice any of the following symptoms.

• sudden shortness of breath, difficulty breathing or a 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
• skin rashes
• severe skin reactions, such as rashes that cause blisters (may affect the mouth and tongue)
• widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity).

FLUCOSTENOL may have effects on the liver. Symptoms of liver problems include:

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

If you experience any of these symptoms, stop taking FLUCOSTENOL and inform your doctor immediately.
Other side effects:
If any of the side effects gets worse, or if you notice any side effect not listed here
Common side effects (may affect up to 1 in 10 people) are:

• headache
• stomach upset, diarrhea, nausea, vomiting
• increases in liver function values in blood tests
• skin 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
• decreased 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 to defend against infections, and platelets, which enable blood to clot
• altered skin color (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
• shivering
• altered electrocardiogram (ECG), changes in heart rate and rhythm
• 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 which may occur (frequency cannot be estimated on the basis of the available data):

• hypersensitivity reaction with rash, fever, swollen glands, increased 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 effectsIf 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 FLUCOSTENOL

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

Do not dispose of any medicine in the 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 ingredient is fluconazole.
• Each hard capsule contains fluconazole 50 mg, 100 mg, 150 mg or 200 mg.
• The excipients are: Capsule content:lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, colloidal silicon dioxide, magnesium stearate, sodium lauryl sulfate. Capsule shell content: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 Authorisation Holder
Alfasigma S.p.A. - Via Ragazzi del ’99, n. 5 - 40133 Bologna (BO)

Manufacturer
PHARMATHEN S.A.
Dervenakion 6 – Pallini 15351 – Attiki Greece