Fluores

Patient Information Leaflet: Information for the User

Fluores 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, speak to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Fluores is and what it is used for

Fluores belongs to a group of medicines called "antifungals". The active substance is
fluconazole.
Fluores is used to treat fungal infections and can 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 – for example athlete’s foot, ringworm, genital itching, nail infections.

Fluores may be prescribed to you for:

• preventing recurrence of cryptococcal meningitis;
• preventing recurrence of mucosal candidiasis;
• reducing recurrences of vaginal candidiasis;
• preventing Candida infections (if your immune system is weakened or not functioning properly).

Children and adolescents (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.

Fluores may be prescribed to you for:

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

2. What you need to know before taking Fluores

Do not take Fluores 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.
• are taking astemizole or terfenadine (antihistamine medicines 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 Fluores.

• If you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers after taking Fluores. Serious skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with Fluores treatment. Stop taking Fluores and contact your doctor immediately if you notice any of the symptoms related to serious skin reactions described in section 4.
• If the fungal infection does not improve, alternative antifungal therapy may be required.

Tell your doctor especially 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).

Other medicines and Fluores
Inform your doctor immediately if you are taking astemizole, terfenadine (antihistamine 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 Fluores (see section: "Do not take Fluores if you").
Some medicines may interact with Fluores. 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);
• blood-thinning medicines 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, glyburide, glipizide, or tolbutamide;
• theophylline (used to control asthma);
• vitamin A (dietary supplement).

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Fluores with food and drink
You may take this medicine with or without food.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Fluores if you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, unless instructed by your doctor.
Fluconazole taken during the first trimester of pregnancy may increase the risk of miscarriage. Low-dose fluconazole taken during the first trimester may slightly increase the risk of congenital malformations affecting bones and/or muscles.
Driving and using machines
Be aware that dizziness or seizures may occur while driving or operating machinery.
Fluores contains lactose
This medicine contains a small amount of lactose (milk sugar). If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Fluores

Take this medicine exactly as directed 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 recommended doses of this medicine, depending on the infection, are listed below:
Adults

Use in adolescents from 12 to 17 years of age
Always take the dose prescribed by your doctor (either the adult dose or the pediatric dose).
Use in children up to 11 years of age
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 from 3 to 4 weeks of age:
The same dosage described above, 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, 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 these. Always take the medicine as
instructed 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 kidney problems.

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

If you take more Fluores 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 hearing, seeing, sensing, and thinking 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 Fluores
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 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 everybody gets them.
Stop taking Fluores and contact your doctor immediately if you experience any of the
following symptoms:

• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

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 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 rash;
• Skin rashes;
• Severe skin reactions, for example rashes causing blisters (which may affect the mouth and tongue).

Fluores 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 Fluores and contact your doctor immediately.

Other side effects:
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 of platelets, which are necessary for blood clotting;
• Abnormal skin colouration (red or purplish), which may be caused by a reduction in platelets or other changes in blood cells;
• Changes in blood chemistry (elevated cholesterol or 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 skin rashes with widespread blistering and peeling of the skin, severe skin reactions, swelling of the lips and face;
• Hair loss.

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 http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fluores

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 store above 30°C.
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. Package Contents and Other Information

What Fluores Contains

• The active substance is fluconazole. Each hard capsule contains 100 mg, 150 mg or 200 mg of fluconazole.
• The other components are: Capsule contents: monohydrate lactose, pregelatinized starch, magnesium stearate, anhydrous colloidal silica, sodium lauryl sulfate. Capsule shell contents: gelatin, titanium dioxide (E 171), iron oxide yellow (E 172) (only in 100 mg capsules).

Description of the Appearance of Fluores and Contents of the Package
Fluores 100 mg hard capsules are yellow. Pack containing 10 capsules of 100 mg.
Fluores 150 mg hard capsules are white. Pack containing 2 capsules of 150 mg.
Fluores 200 mg hard capsules are white. Pack containing 7 capsules of 200 mg.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Laboratorio Farmaceutico C.T. S.r.l. – Via Dante Alighieri, 71 – 18038 Sanremo (Imperia)
Manufacturer
Laboratorio Farmaceutico C.T. S.r.l. - Via Dante Alighieri, 71 - 18038 Sanremo (Imperia)