FLUORES 100 mg Hard Capsule

Содержание инструкции

1. Fluores 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules
   1. What is Fluores 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

Fluores 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules

Fluconazole

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Fluores and what it is used for

Fluores belongs to a group of medicines called "antifungals". The active ingredient is
fluconazole.
Fluores 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 (for example heart, lungs) or in the urinary tract;
• oral candidiasis - infection of the oral mucosa, throat infection and inflammation of the mouth from dentures;
• genital candidiasis - infection of the vagina or penis;
• skin infections - for example athlete's foot, ringworm, itching in the genital area, nail infections.

Fluores may be prescribed for:

• preventing the recurrence of cryptococcal meningitis;
• preventing the recurrence of oral candidiasis;
• reducing recurrences 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:

• oral candidiasis - infection of the oral mucosa, throat infection;
• infections caused by Candidaand found in the bloodstream, in organs (for example heart, lungs) or in the urinary tract;
• cryptococcal meningitis - a fungal infection of the brain;

Fluores 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 Fluores

Do not take Fluores 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.
• 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 heart arrhythmias);
• are taking erythromycin (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 rash or skin exfoliation, blisters and/or ulcers in the mouth after taking Fluores. Serious skin reactions including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have been reported related to treatment with Fluores. Stop taking Fluores and contact your doctor immediately if you notice any of the symptoms related to the serious skin reactions described in section 4.
• If the fungal infection does not improve, alternative antifungal therapy may be necessary.

Inform your doctor particularly if

• you have problems with the liver or kidneys;
• you suffer from heart disease, including heart arrhythmia;
• you have abnormal levels of potassium, calcium or magnesium in the blood;
• severe skin reactions appear (itching, redness of the skin or difficulty in breathing).

Other medicines and Fluores
Tell your doctor immediatelyif you are taking astemizole, terfenadine (antihistamine
used to treat allergies) or cisapride (used to treat stomach disorders) or pimozide (used to treat
mental disorders) or quinidine (used to treat heart arrhythmias) or erythromycin (antibiotic used to
treat bacterial infections), as they cannot be taken with Fluores (see section: ''Do not take
Fluores if you").
There are some medicines that can interact with Fluores. 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 to treat seizures);
• nifedipine, isradipine, amlodipine, felodipine and losartan (used to treat hypertension - high blood pressure);
• cyclosporine, 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 (steroid);
• zidovudine, also known as AZT; saquinavir (used in patients with HIV);
• medicines for diabetes such as chlorpropamide, glibenclamide, glipizide or tolbutamide;
• theophylline (used to control asthma);
• vitamin A (food supplement).

Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, even those available without a prescription.

Fluores with food and drink
You can take the medicine with or without food.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Fluores 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 malformations of bones and/or
muscles.

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

Fluores contains lactose
This medicine contains a small 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.

3. How to take Fluores

Take this medicine following the instructions of your doctor exactly. 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 every day at the
same time.
The recommended doses of this medicine to be taken depending on the infection are listed here
below:

Adults

Always take the dose prescribed by your doctor (or the adult or children's dose).

Use in 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 from 0 to 4 weeks
Use in infants from 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:
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.
The doctor may sometimes prescribe doses different from these. Always take the medicine as
indicated by your doctor. If you have any doubts, consult your doctor or pharmacist.

Use in the 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 Fluores than you should
Taking too many capsules all at once may cause you problems. Immediately warn
your doctor or go to the nearest hospital.
In case of accidental overdose, symptoms may include seeing, perceiving and
thinking things that are not real (hallucinations and paranoid behavior). Symptomatic treatment may be appropriate (with adequate supportive measures and possibly
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 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 everybody gets them.
Stop taking Fluores and contact your doctor immediately if you notice any of the following symptoms:

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

Some people experience allergic reactionsalthough severe allergic reactions occur
rarely. If you experience any of the following symptoms inform your doctor immediately.

• 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 (can affect the mouth and tongue).

Fluores can 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 Fluores and inform your doctor immediately.

Other side effects:
Side effects common(may affect up to 1 in 10 people):

• Headache;
• Stomach upset, diarrhea, nausea, vomiting;
• Increases in liver function values in blood tests;
• Skin rashes.

Side effects uncommon(may affect up to 1 in 100 people):

• 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;
• Alteration of taste;
• Constipation, difficulty digesting, flatulence, dry mouth;
• Muscle pain;
• Liver damage and yellowing of the skin and eyes (jaundice);
• Swelling, blisters (urticaria), itching, increased sweating;
• Fatigue, general feeling of being unwell, fever.

Side effects rare(may affect up to 1 in 1,000 people):

• Lower than normal levels of white blood cells, which help to fight infections, and platelets, which make blood clotting possible;
• 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;
• Chills;
• 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.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system 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 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 store at a temperature above 30°C.
Do not dispose of any medicine in 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 Fluores contains

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

Description of the appearance of Fluores and contents of the pack
Fluores 100 mg hard capsules are yellow. Box containing 10 capsules of 100 mg.
Fluores 150 mg hard capsules are white. Box containing 2 capsules of 150 mg.
Fluores 200 mg hard capsules are white. Box containing 7 capsules of 200 mg.
Not all pack sizes may be marketed.

Marketing Authorisation 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)