Mukes

Package leaflet: Information for the user

MUKES 50 mg hard capsules, 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules

Fluconazole
Generic Medicine
Please read all of this leaflet carefully before you take 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT MUKES IS AND WHAT IT IS USED FOR

MUKES belongs to a group of medicines called "antifungals". The active substance is
fluconazole.
MUKES 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 – e.g. athlete's foot, ringworm, genital itching, nail infections

MUKES may be prescribed to you 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
• Infections caused by Candida found in the bloodstream, organs (e.g. heart, lungs) or urinary tract
• Cryptococcal meningitis – a fungal infection of the brain

MUKES may be prescribed to you to:

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

2. WHAT YOU SHOULD KNOW BEFORE TAKING MUKES

Do not take MUKES

• 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.
• If you are taking astemizole or terfenadine (antihistamines used to treat allergies)
• If you are taking cisapride (used to treat stomach disorders)
• If you are taking pimozide (used to treat mental disorders)
• If you are taking quinidine (used to treat cardiac arrhythmias)
• If you are taking erythromycin (an antibiotic used to treat bacterial infections)

Warnings and precautions
Talk to your doctor or pharmacist before taking MUKES

• if you have liver or kidney problems
• if you suffer from heart diseases, including cardiac arrhythmia
• if you have abnormal levels of potassium, calcium, or magnesium in your blood
• if severe skin reactions occur (such as itching, skin redness, or difficulty breathing)
• if 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)
• if the fungal infection does not improve, alternative antifungal therapy may be required
• if you have ever developed a severe rash, skin peeling, blisters, and/or mouth ulcers after taking fluconazole

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

Other medicines and MUKES
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.

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 MUKES (see section: “Do not take MUKES”).

There are some medicines that may interact with MUKES. Inform your doctor if you are taking any of the following medicines:

• abrocitinib (used to treat atopic dermatitis, also known as atopic eczema)
• rifampicin or rifabutin (antibiotics used to treat bacterial infections)
• alfentanil, fentanyl (anesthetics)
• amitriptyline, nortriptyline (antidepressants)
• amphotericin B, voriconazole (antifungals)
• medicines that thin the blood to prevent clot formation (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, verapamil, felodipine, and losartan (used to treat hypertension - high blood pressure)
• olaparib (used to treat ovarian cancer)
• 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 lower 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, glyburide, glipizide, or tolbutamide
• theophylline (used to control asthma)
• tofacitinib (used to treat rheumatoid arthritis)
• tolvaptan, used to treat hyponatremia (low sodium levels in the blood) or to slow the decline in kidney function
• vitamin A (dietary supplement)
• ivacaftor (used to treat cystic fibrosis)
• amiodarone (used to treat "arrhythmias", irregular heartbeats)
• hydrochlorothiazide (a diuretic)
• ibrutinib (used to treat blood cancer)
• lurasidone (used to treat schizophrenia)

MUKES with food and drink
You may take this medicine with or without food.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might 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 attempting to conceive.

For longer treatment cycles with fluconazole, consult your doctor to evaluate the need for adequate contraception during treatment, which should continue for one week after the last dose.

Do not take MUKES if you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, unless your doctor specifically tells you to.

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 infants 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 causal relationship between fluconazole and these cases is not clear.

You must not take MUKES during pregnancy unless prescribed by your doctor.

You may continue breastfeeding after taking a single dose of MUKES up to 150 mg.

You must not breastfeed if you are taking repeated doses of MUKES.

Driving and using machines
Be aware that dizziness or seizures may occur while driving or operating machinery.

MUKES contains lactose (milk sugar) and sodium (salt). This medicine contains a minimal amount of lactose (milk sugar). If your doctor has diagnosed you with an intolerance to lactose, contact your doctor before taking this medicine.

MUKES capsules contain less than 1 mmol (23 mg) of sodium per capsule, i.e., essentially 'sodium-free'.

3. HOW TO TAKE MUKES

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
every day.
The recommended 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.
Elderly
The same dose as recommended for adults should be used, unless you have renal problems.
Patients with renal impairment
Your doctor may adjust the dosage according to your kidney function.
If you take more MUKES than you should
Taking too many capsules at once could cause you problems. Inform your doctor immediately or go to the nearest hospital.
In case of accidental overdose, symptoms may include sensing, seeing, perceiving, and thinking things that are not real (hallucinations and paranoid behaviour). Symptomatic treatment may be appropriate (with adequate supportive measures and, if necessary, gastric lavage).
If you forget to take MUKES
Do not take a double dose to make up for forgotten doses. 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 doubts about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, MUKES may cause adverse reactions, although not everyone experiences them.
Some people may have allergic reactions, although serious allergic reactions are rare. If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. Stop taking MUKES and contact your doctor immediately if you notice any of the following symptoms:

• sudden breathlessness, difficulty breathing, or chest tightness
• swelling of the eyelids, face, or lips
• itching all over the body, skin redness, or itchy red rashes
• widespread skin rashes, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome)
• severe skin reactions, for example rashes causing blisters (which may affect the mouth and tongue)

MUKES 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 MUKES and contact your doctor immediately.

Other adverse reactions:
If any of the adverse reactions worsen, or if you notice any adverse reaction not listed in this patient information leaflet, inform your doctor or pharmacist.
Common adverse reactions (may affect up to 1 in 10 people) are:

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

Uncommon adverse reactions (may affect up to 1 in 100 people) are:

• 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)
• swellings, blisters (urticaria), itching, increased sweating
• fatigue, general malaise, fever

Rare adverse reactions (may affect up to 1 in 1,000 people) are:

• lower than normal levels of white blood cells, which help defend against infections, and platelets, which are necessary for blood clotting
• altered skin colouration (red or purplish), which may be caused by a reduction in platelets, 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 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

Frequency not known, but possible (frequency cannot be estimated from the available data):

• hypersensitivity reaction with skin rash, fever, swollen glands, increase in a type of white blood cell (eosinophilia), and inflammation of internal organs (liver, lungs, heart, kidneys, and colon) (drug reaction or skin rash with eosinophilia and systemic symptoms (DRESS))

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. You can 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 MUKES

• Keep this medicine out of the sight and reach of children.
• Do not use MUKES 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. PACKAGING CONTENTS AND OTHER INFORMATION

What MUKES contains
MUKES 50 mg hard capsules
The active substance is Fluconazole 50 mg.
The other components are:
Lactose, colloidal silicon dioxide, maize starch, magnesium stearate, sodium lauryl sulfate.
Capsule shell: titanium dioxide E171, yellow iron oxide E172, gelatin.

MUKES 100 mg hard capsules
The active substance is Fluconazole 100 mg.
The other components are:
Lactose, colloidal silicon dioxide, maize starch, magnesium stearate, sodium lauryl sulfate.
Capsule shell: titanium dioxide E171, yellow iron oxide E172, patent blue V E131, orange yellow E110, gelatin.

MUKES 150 mg hard capsules
The active substance is Fluconazole 150 mg.
The other components are:
Lactose, colloidal silicon dioxide, maize starch, magnesium stearate, sodium lauryl sulfate.
Capsule shell: titanium dioxide E171, yellow iron oxide E172, indigotine E132, quinoline yellow E104, gelatin.

MUKES 200 mg hard capsules
The active substance is Fluconazole 200 mg.
The other components are:
Lactose, colloidal silicon dioxide, maize starch, magnesium stearate, sodium lauryl sulfate.
Capsule shell: titanium dioxide E171, indigotine E132, quinoline yellow E104, gelatin.

Description of the appearance of MUKES and packaging contents:
PHARMACEUTICAL FORM AND CONTENT
Hard capsules.

• Pack containing 7 capsules of 50 mg fluconazole
• Pack containing 10 capsules of 100 mg fluconazole
• Pack containing 2 capsules of 150 mg fluconazole
• Pack containing 7 capsules of 200 mg fluconazole

MARKETING AUTHORISATION HOLDER
N.I. PHARMA S.r.l. - Via dei Gracchi n.29/B - 00192 Rome (RM)
MANUFACTURER
Genetic S.p.A. Contrada Canfora - 84084 Fisciano (SA)
Lachifarma Srl - Salentino Pharmaceutical Chemical Laboratory - S.S. 16 Adriatica - Industrial Zone -
73010 Zollino (LE)