Fluconazole Galenica Senese

Package leaflet: Information for the patient

FLUCONAZOLE GALENICA SENESE – 100 mg/50 ml infusion solution, - 200 mg/100 ml infusion solution, - 400 mg/200 ml infusion solution

Generic medicine
Please read all of 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Fluconazolo Galenica Senese is and what it is used for

Fluconazolo Galenica Senese contains the active substance fluconazole, which belongs to a group of medicines called "antifungals", used to treat infections caused by fungi.
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 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

Fluconazolo Galenica Senese may be prescribed to you:

• to prevent recurrence of cryptococcal meningitis
• to prevent recurrence of mucosal 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 for the treatment of 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 Galenica Senese 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 need to know before taking Fluconazole Galenica Senese.

Do not take Fluconazole Galenica Senese:

• 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 difficulty breathing
• if you are taking astemizole, 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, pharmacist or nurse before taking Fluconazole Galenica Senese:

• 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 (itching, skin redness or difficulty breathing)
• if signs of 'adrenal insufficiency' appear, in which 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).

Other medicines and Fluconazole Galenica Senese.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
Tell 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 Galenica Senese (see section: “Do not take Fluconazole Galenica Senese”).
Some medicines may interact with Fluconazole Galenica Senese. 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 clot formation (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 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 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 cancers).

Pregnancy, breast-feeding and fertility.
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine.
You must not take Fluconazole Galenica Senese during pregnancy unless prescribed by your doctor.
You may continue breastfeeding after taking a single dose of Fluconazole Galenica Senese 150 mg. You must not breastfeed if you are taking repeated doses of Fluconazole Galenica Senese.
Driving and using machines.
You should be aware that dizziness or seizures may occur while driving or using machines.
Fluconazole Galenica Senese contains sodium.
This medicine contains 354 mg of sodium per 100 ml of solution (15 mmol of sodium per 100 ml). This should be taken into account in patients on a low-sodium diet.

3. How to take Fluconazole Galenica Senese.

This medicine will be administered to you by a doctor or nurse as a slow injection (infusion) into a vein. Fluconazole Galenica Senese is available as a solution. It will not be further diluted.
Instructions for healthcare professionals are included in a section at the end of this leaflet.
The recommended doses of this medicine to take, depending on the infection, are listed below. If you have any doubts about why Fluconazole Galenica Senese has been prescribed for you, consult your doctor or nurse.
Adults

Adolescents aged 12 to 17 years
Always take the dose prescribed by your doctor (either the adult or pediatric 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 children from 0 to 4 weeks of age
Use in children aged 3 to 4 weeks of life:
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.

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

If you take more Fluconazolo Galenica Senese than you should
If you are concerned that you may have received an excessive dose of Fluconazolo Galenica Senese, inform your doctor or another healthcare professional immediately. In case of accidental overdose, symptoms may include sensing, seeing, perceiving, or thinking things that are not real (hallucinations and paranoid behavior).

If you forget to take Fluconazolo Galenica Senese
Since this medicine will be administered under close medical supervision, it is unlikely that a dose will be missed. However, inform your doctor or pharmacist if you think a dose has been missed.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
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, consult your doctor or pharmacist. If you experience any of the following symptoms, contact your doctor immediately:

• sudden shortness of breath, 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)

Fluconazolo Galenica Senese 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 Fluconazolo Galenica Senese 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 patient information 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)
• swelling, 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 platelets (which enable blood clotting)
• altered skin colouration (red or purplish), possibly due to reduced platelets, other changes in blood cells
• changes in blood chemistry (elevated cholesterol, 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 (but possible; frequency cannot be estimated from the available data):

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult 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 Galenica Senese.

Keep this medicine out of the sight and reach of children. This medicine does not require
any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging and label after "Exp.".
The expiry date refers to the last day of that month. Do not dispose of medicines via wastewater or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Fluconazolo Galenica Senese contains:
Fluconazolo Galenica Senese 100 mg/50 ml solution for infusion:

• The active substance is fluconazole. Each bag contains 100 mg of fluconazole.
• The other components are: sodium chloride and water for injection.

Fluconazolo Galenica Senese 200 mg/100 ml solution for infusion:

• The active substance is fluconazole. Each bag contains 200 mg of fluconazole.
• The other components are: sodium chloride and water for injection.

Fluconazolo Galenica Senese 400 mg/200 ml solution for infusion:

• The active substance is fluconazole. Each bag contains 400 mg of fluconazole.
• The other components are: sodium chloride and water for injection.

Description of the appearance of Fluconazolo Galenica Senese and package contents
Fluconazolo Galenica Senese is available as a solution for infusion in the following pack sizes:

• Fluconazolo Galenica Senese 100 mg/50 ml solution for infusion: 1, 5, 10 and 20 polypropylene bags containing 100 mg of fluconazole.
• Fluconazolo Galenica Senese 200 mg/100 ml solution for infusion: 1, 5, 10 and 20 polypropylene bags containing 200 mg of fluconazole.
• Fluconazolo Galenica Senese 400 mg/200 ml solution for infusion: 1, 5, 10 and 20 polypropylene bags containing 400 mg of fluconazole.

Marketing Authorization Holder and Manufacturer
Industria Farmaceutica Galenica Senese S.r.l.
Via Cassia Nord 351 – 53014 Monteroni D’Arbia (SI)

Other sources of information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (Agenzia Italiana del Farmaco)

The following information is intended exclusively for physicians and healthcare professionals:
The infusion rate must not exceed 10 ml/minute. - Fluconazolo Galenica Senese solution for infusion is formulated in 0.9% sodium chloride solution; each 200 mg (100 ml bag) contains 15 mmol of Na and Cl. Since the product is supplied diluted in saline solution, the administered fluid volume should be carefully considered in patients requiring restriction of sodium or fluid intake.

Fluconazole solution for infusion is compatible with the following intravenous fluids:
a) Dextrose 20%
b) Ringer's solution
c) Hartmann's solution
d) Potassium chloride in dextrose
e) Sodium bicarbonate 4.2%
f) Aminofusin
g) Peritoneal dialysis solution
h) Normal saline solution

Fluconazole solution for infusion may be administered via an existing intravenous line together with any of the solutions listed above. Although no specific incompatibilities have been observed, concomitant mixing with other drugs prior to infusion is not recommended.

Any unused medicinal product or waste material must be disposed of in accordance with local regulations.