Fluconazole Sandoz

PACKAGE LEAFLET: INFORMATION FOR THE USER

Fluconazole Sandoz 50 mg hard capsules, 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules

Generic Medicine
Please read this leaflet carefully before taking this medicine.

• 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. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

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

1. WHAT FLUCONAZOLE SANDOZ IS AND WHAT IT IS USED FOR

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

Fluconazole Sandoz 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

Fluconazole Sandoz 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 SANDOZ

Do not take Fluconazole Sandoz if you

• are allergic (hypersensitive) to fluconazole, to other medicines used to treat fungal infections, or to any of the excipients of Fluconazole Sandoz. 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
Tell your doctor 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 (such as itching, skin redness, or difficulty breathing)

Other medicines and Fluconazole Sandoz
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 Sandoz (see section: “Do not take Fluconazole Sandoz if you”).
Some medicines may interact with Fluconazole Sandoz. Inform your doctor if you are taking any of the following medicines:

• rifampicin or rifabutin (antibiotics used to treat bacterial infections)
• alfentanil, fentanyl (anesthetics)
• 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)
• 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)
• vitamin A (dietary supplement)

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Taking Fluconazole Sandoz with food and drink
You may take this medicine with or without food.
Pregnancy and breastfeeding
Inform your doctor if you are pregnant, trying to become pregnant, or breastfeeding. You must not take Fluconazole Sandoz during pregnancy or while breastfeeding unless your doctor has specifically prescribed it.
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 operating machinery.
Fluconazole Sandoz contains lactose
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. HOW TO TAKE FLUCONAZOLE SANDOZ

Always take this medicine exactly as prescribed by your doctor. If you have any doubts, 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 usual 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. Doses may sometimes be 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. Doses may sometimes be increased up to 800 mg | | Endemic fungal infections due to Candida | 800 mg on the first day, then 400 mg once daily | | Treatment of oral mucosal infections, throat infections, and inflammation of the mouth due to dental prosthesis | 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 and throat infections | 100–200 mg once daily, or 200 mg three times weekly, for as long as you are at risk of developing an infection | | Genital candidiasis | 150 mg as a single dose | | Reduction of recurrent vaginal candidiasis | 150 mg every three days for a total of 3 doses (day 1, 4, and 7), then once monthly when you are at risk of infection | | Skin mycoses and nail infections | Depending on the site of infection: 50 mg once daily, 150 mg once weekly, or 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 has been completely replaced) | | Prevention of Candida infections (if your immune system is weakened or not functioning properly) | 200–400 mg once daily when you are at risk of infection |

Adolescents aged 12 to 17 years
Always take the dose prescribed by your doctor (either the adult or pediatric dosage regimen).

Children up to 11 years of age
The maximum daily dose in children is 400 mg. The dose will be based on the child’s body weight in kilograms.

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

Use in children aged 0 to 4 weeks
Children aged 3 to 4 weeks:
Same dosage as described above, but administered every 2 days. Maximum dose: 12 mg per kg body weight every 48 hours.

Children under 2 weeks of age:
Same dosage as described above, but administered every 3 days. Maximum dose: 12 mg per kg body weight every 72 hours.

Your doctor may sometimes prescribe doses different from those listed here. Always take the medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Use in elderly patients
The same dose as for adults should be used unless you have renal problems.

Use in patients with renal impairment
Your doctor may adjust the dosage based on kidney function.

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

If you forget to take Fluconazole Sandoz
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 almost time for your next dose, skip the missed dose and take the next dose at the regular time.

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

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Fluconazole Sandoz may cause adverse reactions, although not everyone experiences them.
Some people may have allergic reactions, although severe 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 rash
• skin rash
• severe skin reactions, for example rashes causing blisters (which may affect the mouth and tongue)

Fluconazole Sandoz 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 Fluconazole Sandoz and contact your doctor immediately.
Other adverse reactions:
If any of the adverse reactions worsen, or if you notice any adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
Common adverse reactions, occurring in 1 to 10 patients out of 100, are:

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

Uncommon adverse reactions, occurring in 1 to 10 patients out of 1,000, 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, difficulty digesting, flatulence, dry mouth
• muscle pain
• liver damage and yellowing of the skin and eyes (jaundice)
• swellings, blisters (urticaria), itching, increased sweating
• tiredness, general malaise, fever

Rare adverse reactions, occurring in 1 to 10 patients out of 10,000, are:

• lower than normal levels of white blood cells, which help fight infections, and of platelets, which allow 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 (high levels of cholesterol, fats)
• low levels of potassium in the blood
• chills
• abnormal electrocardiogram (ECG), changes in heart rhythm and rate
• 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

If any of the adverse reactions worsen, or if you notice any adverse reactions not listed in this leaflet, inform your doctor or pharmacist.

5. HOW TO STORE FLUCONAZOLO SANDOZ

• Keep out of the reach and sight of children.
• Do not use Fluconazolo Sandoz after the expiry date which is stated on the label (Exp.). The expiry date refers to the last day of the month.
• Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Fluconazolo Sandoz 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: lactose monohydrate, maize starch, anhydrous colloidal silica, magnesium stearate, and
sodium lauryl sulfate.
Capsule shell:
gelatin, titanium dioxide (E171)
Additionally for Fluconazolo Sandoz 50 mg, 100 mg, 200 mg:
Brilliant Blue FCF (E133)

Description of the appearance of Fluconazolo Sandoz 50 mg, 100 mg, 150 mg and 200 mg hard capsules and
pack size

Fluconazolo Sandoz 50 mg hard capsules are white/blue, opaque, hard capsules, size 4.
Pack sizes
PVC/PVDC-Aluminium blisters containing 7, 10, 14, 20, 28, 30, 50, 60 and 100 capsules.

Fluconazolo Sandoz 100 mg hard capsules are white/blue, opaque, hard capsules, size 2.
Pack sizes
PVC/PVDC-Aluminium blisters containing 7, 10, 14, 20, 28, 30, 50, 60 and 100 capsules.

Fluconazolo Sandoz 150 mg hard capsules are white, opaque, hard capsules, size 1.
Pack sizes
PVC/PVDC-Aluminium blisters containing 1, 2, 4, 6 and 12 capsules.

Fluconazolo Sandoz 200 mg hard capsules are blue/blue, opaque, hard capsules, size 0.
Pack sizes
PVC/PVDC-Aluminium blisters containing 7, 10, 14, 20, 28, 30, 40, 50, 60 and 100 capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A. – Largo Umberto Boccioni 1 – 21040 Origgio (VA), Italy

Manufacturer responsible for batch release
Salutas Pharma GmbH - Dieselstrasse 5 – 70839 Gerlingen – Germany
Salutas Pharma GmbH - Otto von Guericke Allee 1 – 39179 Barleben – Germany
Sandoz GmbH – Biochemistrasse 10 – 6250 Kundl – Austria
S.C. Sandoz S.r.l. Str. Livezeni nr. 7° 540472 Targu-Mures – Romania
LEK Pharmaceuticals d.d. Verovškova 57 1526 Ljubljana – Slovenia

This medicinal product is authorized in the Member States of the European Economic Area under the following
names:
Italy: Fluconazolo Sandoz 50 mg hard capsules
Fluconazolo Sandoz 100 mg hard capsules
Fluconazolo Sandoz 150 mg hard capsules
Fluconazolo Sandoz 200 mg hard capsules
Netherlands: Fluconazol 50 mg capsules
Fluconazol 100 mg capsules
Fluconazol 150 mg capsules
Fluconazol 200 mg capsules
Slovak Republic: Fluco Sandoz 50 mg
Fluco Sandoz 100 mg
Fluco Sandoz 150 mg
Slovenia: Flukonazol Lek 50 mg trde kapsule
Flukonazol Lek 100 mg trde kapsule
Flukonazol Lek 150 mg trde kapsule

This Patient Information Leaflet was last approved on 5 July 2012