FLUMICON 100 mg Hard Capsule

Зміст інструкції

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

FLUMICON 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules

Fluconazole
Generic Medicine

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. Do not give it to other people, even if their symptoms are the same as yours, because 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 FLUMICON is and what it is used for
• 2. What you need to know before you take FLUMICON
• 3. How to take FLUMICON
• 4. Possible side effects
• 5. How to store FLUMICON
• 6. Contents of the pack and other information

1. WHAT FLUMICON IS AND WHAT IT IS USED FOR

FLUMICON belongs to a group of medicines called “antifungals”. The active ingredient is
fluconazole.
FLUMICON is used for the treatment of fungal infections and may 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

FLUMICON may be prescribed for:

• preventing the recurrence of cryptococcal meningitis
• preventing the recurrence of candidiasis of the mucous membranes
• reducing the recurrence 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:
• 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

FLUMICON 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 FLUMICON

Do not take FLUMICON

• 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 FLUMICON. The symptoms may be itching, redness of the skin or difficulty in breathing
• if you are taking astemizole, terfenadine (antihistamines used for the treatment of allergies)
• if you are taking cisapride (used for the treatment of stomach disorders)
• if you are taking pimozide (used for the treatment of mental disorders)
• if you are taking quinidine (used for the treatment of heart arrhythmias)
• if you are taking erythromycin (antibiotic used for the treatment of bacterial infections)

Warnings and precautions
Consult your doctor or pharmacist or nurse before taking FLUMICON
Tell your doctor 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.
• the fungal infection does not improve, an alternative antifungal therapy may be necessary
• severe skin reactions appear (itching, redness of the skin or difficulty in breathing).
• you have ever developed a severe rash or skin exfoliation, blisters and/or ulcers in the mouth after taking Flumicon
• If you develop signs of adrenal insufficiency, when the adrenal gland does not produce the right amount of certain steroid hormones, such as cortisol (chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain)

Serious skin reactions including drug reaction with eosinophilia and
systemic symptoms (DRESS) have been reported with treatment with FLUMICON. Stop taking
Flumicon and contact your doctor immediately if you notice any of the symptoms related to
the serious skin reactions described in paragraph 4.
Other medicines and FLUMICON
Immediatelyinform your doctor if you are taking astemizole, terfenadine (antihistamine
used for the treatment of allergies) or cisapride (used for the treatment of stomach
disorders) or pimozide (used for the treatment of mental disorders) or quinidine (used for the
treatment of heart arrhythmias) or erythromycin (antibiotic used for the treatment of
bacterial infections), as they cannot be taken with FLUMICON (see paragraph: “Do not
take FLUMICON if you”).
There are some medicines that may interact with FLUMICON. 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 the formation of clots (warfarin or similar medicines)
• benzodiazepines (midazolam, triazolam or similar medicines) used to help you sleep or for anxiety
• carbamazepine, phenytoin (used for the treatment of seizures)
• nifedipine, isradipine, amlodipine, felodipine and losartan (used for the treatment of hypertension - high blood pressure)
• cyclosporine, everolimus, sirolimus or tacrolimus (used to prevent transplant rejection)
• cyclophosphamide, vinca alkaloids (vincristine, vinblastine or similar medicines) used for the treatment of cancer
• halofantrine (used for the treatment of malaria)
• statins (atorvastatin, simvastatin, fluvastatin and similar medicines) used to reduce high cholesterol levels
• methadone (used for the treatment of 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 for asthma control)
• vitamin A (food supplement)
• amiodarone (used for the treatment of irregular heartbeats “arrhythmia”)
• hydrochlorothiazide (diuretic)

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

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

Pregnancy breastfeeding and fertility
Tell your doctor if you are pregnant, if you are trying to become pregnant or if you are breastfeeding..
Do not take Flumicon if you are pregnant, if you suspect or are planning a pregnancy
or if you 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.
Ask your doctor or pharmacist for advice before taking any medicine.

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

FLUMICON contains lactose
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.
FLUMICON capsules contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially
‘sodium-free’.

3. HOW TO TAKE FLUMICON

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

Use in the elderly
The same dose as provided 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 FLUMICON 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, hearing, feeling and
thinking things that are not real (hallucinations and paranoid behavior).
Symptomatic treatment (with appropriate supportive measures and possibly
gastric lavage) may be appropriate.

If you forget to take FLUMICON
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 stop taking FLUMICON
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, FLUMICON can cause side effects, although not everybody gets them.
Some people experience allergic reactionsalthough serious allergic reactions occur
rarely. Stop taking FLUMICON and contact your doctor immediately if you
notice any of the following symptoms:

• 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
• widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity).
• severe skin reactions, such as rashes that cause blisters (may affect the mouth and tongue).

FLUMICON can 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 FLUMICON and inform your doctor immediately.

Other side effects:
If any of the side effects gets worse, or if you notice any side effect
The 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

The 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.

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

• levels lower than normal of white blood cells, which help to fight infections, and platelets, which make blood clot
• altered skin colour (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
• shivering
• altered electrocardiogram (ECG), change 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 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.

If any of the side effects gets worse, or if you notice any effect

5. HOW TO STORE FLUMICON

Keep this medicine out of the 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 below 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. PACKAGE CONTENTS AND OTHER INFORMATION

What FLUMICON contains
The active ingredient is fluconazole.
Each hard capsule contains fluconazole 100 mg, 150 mg or 200 mg.
The excipients are: lactose, starch, anhydrous colloidal silica, magnesium stearate and sodium lauryl sulfate.

Capsule shell contents:

100 mg hard capsules: gelatin, titanium dioxide (E171);

150 mg hard capsules: gelatin, titanium dioxide (E171), indigotine (E132);

200 mg hard capsules: gelatin, titanium dioxide (E171), indigotine (E132), black iron oxide
(E172), erythrosine (E127)

Description of the appearance of FLUMICON 100 mg, 150 mg and 200 mg hard capsules and package contents

• FLUMICON 100 mg hard capsules have a white body and a white cap. Box containing 10 capsules of 100 mg
• FLUMICON 150 mg hard capsules have a blue body and a blue cap. Box containing 2 capsules of 150 mg
• FLUMICON 200 mg hard capsules have a white body and a purple cap. Box containing 7 capsules of 200 mg

Marketing Authorisation Holder and Manufacturer
Holder
S.F. GROUP Srl – Via Tiburtina, 1143 – 00156 Roma
Manufacturers

Istituto Biogìchimico Italiano G. Lorenzini S.p.A.Via Fossignano, 2 04011 Aprilia (LT)

Special Product’s Line S.p.a
Strada Paduni, 240

• 03012- Anagni (FR)

LACHIFARMA SRL – Laboratorio Chimico Farmaceutico Salentino
73010 Zollino (LE)
S.S 16 Adriatica -Zona Industriale Zollino (Lecce)