FLUMOS 100 mg Kapsułka Twarda

Treść ulotki

1. FLUMOS 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules
   1. WHAT FLUMOS IS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUMOS
   3. HOW TO TAKE FLUMOS
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE FLUMOS
   6. PACKAGE CONTENTS AND OTHER INFORMATION

FLUMOS 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules

Fluconazole

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

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

1. WHAT FLUMOS IS AND WHAT IT IS USED FOR

Flumos belongs to a group of medicines called “antifungals”. The active ingredient is
fluconazole.
Flumos 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
Flumos may be prescribed for:
preventing the recurrence of cryptococcal meningitis
preventing the recurrence of candidiasis of the mucous membranes
reducing recurrences of vaginal candidiasis
preventing Candidainfections (if your immune system is weak or not functioning
correctly).

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

Flumos may be prescribed for:

• preventing Candidainfections (if your immune system is weak or not functioning correctly)
• preventing the recurrence of cryptococcal meningitis

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUMOS

Do not take Flumos if you:

• are allergic (hypersensitive) to fluconazole, to other medicines you have used for the treatment of fungal infections or to any of the excipients of Flumos. 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 amiodarone (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 Flumos.

Pay particular attention with Flumos
Tell your doctor if:

• you have problems with your liver or kidneys
• you suffer from heart disease, including heart arrhythmia
• you have abnormal levels of potassium, calcium or magnesium in your blood.
• severe skin reactions appear (itching, redness of the skin or difficulty in breathing).
• signs of ‘adrenal insufficiency’ appear, where 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)
• you have ever developed a severe rash or skin exfoliation, blisters and/or mouth ulcers after taking Flumos.

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

• the fungal infection does not improve, an alternative antifungal therapy may be necessary.

Other medicines and Flumos
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 Flumos (see section: “Do not take Flumos if you”).
There are some medicines that can interact with Flumos. 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)
• amiodarone (used to treat “arrhythmias”, irregular heartbeats)
• hydrochlorothiazide (a diuretic).

Tell your doctor or pharmacist if you are taking or have taken any other medicines, including those without a prescription.

Flumos 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 a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
If you are planning a pregnancy you should wait one week after a single dose of fluconazole before trying to start pregnancy.
For longer cycles of therapy with fluconazole, ask your doctor to assess the need for adequate contraception during treatment, which should continue for one week after the last dose.
Do not take Flumos if you are pregnant, suspect you may be pregnant or are breastfeeding, unless your doctor tells you to. If you become pregnant while taking this medicine or within 1 week of the most recent dose, contact your doctor.
Fluconazole taken during the first or second trimester of pregnancy may increase the risk of miscarriage. Fluconazole taken during the first trimester may increase the risk that the baby is born with malformations of the heart, bones and/or muscles.
Cases of children with birth defects affecting the skull, ears and thigh and elbow bones have been reported in women treated for three months or more with high doses (400-800 mg per day) of fluconazole for coccidioidomycosis. The link between fluconazole and these cases is unclear.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and operating machinery
You should be aware that dizziness or convulsions may occur while driving or operating machinery.

Important information about some of the excipients of Flumos
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.

3. HOW TO TAKE FLUMOS

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 usual doses of this medicine to be taken depending on the infection are listed below:

ADULTS

Adolescents from 12 to 17 years
Always take the dose prescribed by your doctor (either the adult 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 given 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 given 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 directed by your doctor.
If you have any doubts, ask 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
Your doctor may adjust the dosage based on kidney function.

If you take more Flumos 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 seeing, hearing, feeling 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 Flumos
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, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Flumos can cause side effects, although not everybody gets them.
Some people experience allergic reactionsalthough serious allergic reactions are rare.

rarely.
If you experience any of the following symptoms tell your doctor immediately.

• sudden shortness of breath, difficulty breathing or 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). Flumos may have effects on the liver. Symptoms of liver problems include:
• fatigue
• loss of appetite
• vomiting
• yellowing of the skin and the white of the eyes (jaundice) If you experience any of these symptoms, stop taking Flumos and tell your doctor immediately.

Stop taking Flumos and see 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).

Other side effects:
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
Common side effects, which affect between 1 and 10 patients in 100, are as follows:

• headache
• stomach upset, diarrhoea, nausea, vomiting
• increases in liver function values in blood tests
• skin rashes

Uncommon side effects, which affect between 1 and 10 patients in 1,000, are as follows:

• 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, which affect between 1 and 10 patients in 10,000, are as follows:

• lower than normal levels of white blood cells, which help you fight infections and platelets, which help your blood to clot
• altered skin colour (red or purple) 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
• 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

If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet,
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 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 FLUMOS

Keep out of the reach and sight of children.
Do not use Flumos 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 at a temperature above 30°C.
Medicines should not be disposed of 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 Flumos contains
The active ingredient is fluconazole.
Each hard capsule contains fluconazole 100 mg, 150 mg or 200 mg.
The excipients are:

Capsule contents:Lactose monohydrate, pregelatinized starch, magnesium stearate, colloidal anhydrous silica, sodium lauryl sulfate.

Capsule:Gelatin, titanium dioxide (E 171), yellow iron oxide (E 172) (only in the 100
mg capsules).

MARKETING AUTHORISATION HOLDER
AGIPS FARMACEUTICI S.r.l. - Via Amendola, 4 – 16035 Rapallo (GE)

MANUFACTURER and BATCH RELEASE RESPONSIBLE
Laboratorio Farmaceutico C.T. S.r.l. - Via Dante Alighieri, 71 - 18038 Sanremo (Imperia)