Flumos

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Fluconazole
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, because it could be harmful.
• If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform 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 taking 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 substance is
fluconazole.
Flumos 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
Candida infections found in the bloodstream, organs (e.g. heart, lungs) or urinary tract
Mucosal candidiasis – infection of the oral mucosa, throat infection, and denture-related mouth inflammation
Genital candidiasis – infection of the vagina or penis
Skin infections – e.g. athlete's foot, ringworm, genital itching, nail infections

Flumos may be prescribed to:
prevent recurrence of cryptococcal meningitis
prevent recurrence of mucosal candidiasis
reduce recurrences of vaginal candidiasis
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
• Candida infections found in the bloodstream, organs (e.g. heart, lungs) or urinary tract
• Cryptococcal meningitis – a fungal infection of the brain

Flumos may be prescribed to:

• prevent Candida infections (if the immune system is weakened or not functioning properly)
• prevent recurrence of cryptococcal meningitis

2. WHAT YOU SHOULD KNOW BEFORE TAKING FLUMOS

Do not take Flumos if you:

• are allergic (hypersensitive) to fluconazole, to other medicines you have used to treat fungal infections, or to any of the excipients in Flumos. 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 amiodarone (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 Flumos.
Be especially careful with Flumos
Inform 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 the blood
• severe skin reactions occur (such as itching, skin redness, or difficulty breathing)
• 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)
• you have ever developed a severe skin rash or skin peeling, blisters, and/or mouth ulcers after taking Flumos.

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

• the fungal infection does not improve; alternative antifungal therapy may be required.

Other medicines and Flumos
Inform 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 Flumos (see section: “Do not take Flumos if you”).
Some medicines may interact with Flumos. 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)
• 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 patients with HIV)
• diabetes medicines such as chlorpropamide, glibenclamide, glipizide, or tolbutamide
• theophylline (used to control asthma)
• vitamin A (dietary supplement)
• amiodarone (used to treat "arrhythmias", irregular heartbeats)
• hydrochlorothiazide (a diuretic).

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those without a prescription.
Taking Flumos with food and drinks
You may take this medicine with or without food.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are planning a pregnancy, you should wait one week after a single dose of fluconazole before trying to conceive.
For longer treatment cycles with fluconazole, consult your doctor to evaluate the need for appropriate contraception during treatment, which should continue for one week after the last dose.
Do not take Flumos if you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, unless instructed by your doctor. If you become pregnant while taking this medicine or within one week after 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 of congenital malformations affecting the baby’s heart, bones, and/or muscles.
Cases of babies born with birth defects involving 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 daily) of fluconazole for coccidioidomycosis. The link between fluconazole and these cases is not clear.
Consult your doctor or pharmacist before taking any medicine.
Driving and using machines
Be aware that dizziness or seizures may occur while driving or operating machinery.
Important information about some excipients of Flumos
This medicine contains a small amount of lactose (milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, consult your doctor before taking this medicine.

3. HOW TO TAKE FLUMOS

Always take the medicine exactly as instructed 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 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 dose or the pediatric dose).
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 aged 0 to 4 weeks
Use in children aged 3 to 4 weeks:
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. Your doctor may sometimes prescribe doses different from
these. Always take the medicine exactly as indicated by your doctor.
If you have any doubts, consult your doctor or pharmacist.
Use in elderly patients
The same dose as that recommended for adults should be used, unless you have renal problems.
Use in patients with renal impairment
Your doctor may adjust the dosage according to kidney function.
If you take more Flumos than you should
Taking too many capsules at the same time could cause you problems. Contact your doctor immediately or go to the nearest hospital.
In case of accidental overdose, symptoms may include experiencing sensations, seeing, hearing, or 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 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, do not take the missed dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Flumos can cause adverse reactions, although not everyone experiences them.
Some people may experience allergic reactions, although severe allergic reactions are rare.
If you experience any of the following symptoms, contact your doctor immediately.

• sudden shortness of breath, 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 rashes
• severe skin reactions, for example rashes causing blisters (may affect mouth and tongue). Flumos 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 Flumos and contact your doctor immediately.

Stop taking Flumos 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 syndrome).

Other adverse reactions:
If any of the adverse reactions worsen, or if you notice any adverse reaction not listed in this leaflet, inform your doctor or pharmacist.
The following are common adverse reactions, occurring in 1 to 10 out of 100 patients:

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

The following are uncommon adverse reactions, occurring in 1 to 10 out of 1,000 patients:

• reduction in red blood cells, which may cause paleness, weakness, or breathlessness
• decreased appetite
• insomnia, drowsiness
• seizures, dizziness, vertigo, tingling, prickling, or numbness, taste disturbances
• constipation, indigestion, flatulence, dry mouth
• muscle pain
• liver damage and yellowing of the skin and eyes (jaundice)
• swelling, blisters (urticaria), itching, increased sweating
• tiredness, general malaise, fever

The following are rare adverse reactions, occurring in 1 to 10 out of 10,000 patients:

• lower than normal levels of white blood cells, which help defend against infections, and of platelets, which are necessary for blood clotting
• abnormal skin discoloration (red or purplish), which may be caused by reduced platelet levels or 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 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 lips and face
• hair loss

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

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, 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 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 in use. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

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