MUKES 50 mg Hard Capsule

Содержание инструкции

1. MUKES 50 mg hard capsules, 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules
   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. PACKAGE CONTENTS AND OTHER INFORMATION

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

Fluconazole
Equivalent Medicinal Product

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 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 ingredient is
fluconazole.
MUKES 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

MUKES 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 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

MUKES 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 YOU TAKE MUKES

Do not take MUKES

• 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 ingredients of this medicine (listed in section 6). The symptoms may be itching, redness of the skin or difficulty in breathing
• If you are taking astemizole, 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 heart arrhythmias)
• If you are taking erythromycin (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 disease, including heart arrhythmia
• if you have abnormal levels of potassium, calcium or magnesium in your blood.
• If severe skin reactions appear (itching, redness of the skin or difficulty in breathing).
• if you experience signs of ‘adrenal insufficiency’, where the adrenal glands do not produce enough 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, an alternative antifungal therapy may be necessary.
• if you have ever developed a severe rash or skin exfoliation, blisters and/or ulcers in the mouth after taking fluconazole.

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

Other medicines and MUKES
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Immediatelytell your doctor if 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 MUKES (see section: “Do not take MUKES”).
There are some medicines that can interact with MUKES. Tell 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 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, 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 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)
• tofacitinib (used to treat rheumatoid arthritis)
• tolvaptan, used to treat hyponatremia (low levels of sodium in the blood) or to slow the decline of 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 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, or if you are breastfeeding with breast milk, 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, consult your doctor to assess 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, suspect you may be pregnant or are breastfeeding, unless your doctor 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 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 bones of the thigh and elbow 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.
You should not take Mukes during pregnancy unless your doctor has prescribed it.
You can continue to breastfeed after taking a single dose of Mukes up to 150 mg.
You should not breastfeed if you are taking repeated doses of Mukes.

Driving and using machines
You should be aware that dizziness or convulsions may occur while driving or using machines.
MUKES contains lactose (milk sugar) and sodium (salt). This medicine contains a minimal amount of lactose (milk sugar). If your doctor has told you that you have an intolerance to lactose, contact your doctor before taking this medicine.
MUKES capsules contains less than 1 mmol (23 mg) of sodium per capsule, that is to say essentially ‘sodium-free’.

3. HOW TO TAKE MUKES

Take this medicine exactly as your doctor has instructed.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
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 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.

Elderly
The same dose as intended for adults should be used unless you have kidney problems.

Patients with kidney problems
Your doctor may adjust the dosage based on kidney function.

If you take more MUKES than you should
Taking too many capsules all at once could 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 adequate supportive measures and possibly gastric lavage) may be appropriate.

If you forget to take MUKES
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, MUKES can cause side effects, although not everybody gets them.
Some people experience allergic reactionsalthough serious allergic reactions are rare. If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. Stop taking Mukes and contact your doctor immediatelyif you notice any of the following symptoms :

• 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, skin redness or itchy red spots
• widespread skin rashes, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity).
• severe skin reactions, such as rashes causing blisters (may affect the mouth and tongue).

MUKES 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 MUKES and inform your doctor immediately.

Other side effects:
If any side effect gets serious, or if you notice any side effect not listed here, tell your doctor or pharmacist. Common side effects (may affect up to 1 in 10 people) are:

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

Uncommon side effects (may affect up to 1 in 100 people) are:

• 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 (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 allow 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 the chemical composition of the blood (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

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

• hypersensitivity reaction with rash, fever, swollen glands, increased type of white blood cells (eosinophilia) and inflammation of internal organs (liver, lungs, heart, kidneys and large intestine) (drug reaction or rash with eosinophilia and systemic symptoms (DRESS))

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 MUKES

• Keep this medicine out of the sight and reach of children.
• Do not use MUKES 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 waste water 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 MUKES contains

MUKES 50 mg hard capsules
The active ingredient is Fluconazole 50 mg
The other ingredients are:
Lactose, Colloidal silicon dioxide, Corn starch, Magnesium stearate, Sodium lauryl sulfate.
Capsule shells: titanium dioxide E171, Yellow iron oxide E172, Gelatin

MUKES 100 mg hard capsules
The active ingredient is Fluconazole 100 mg
The other ingredients are:
Lactose, Colloidal silicon dioxide, Corn starch, Magnesium stearate, Sodium lauryl sulfate.
Capsule shells: titanium dioxide E171, Yellow iron oxide E172, Patent blue V E131, Orange Yellow E110,
Gelatin

MUKES 150 mg hard capsules
The active ingredient is Fluconazole 150 mg
The other ingredients are:
Lactose, Colloidal silicon dioxide, Corn starch, Magnesium stearate, Sodium lauryl sulfate.
Capsule shells: titanium dioxide E171, Yellow iron oxide E172, Indigo carmine E132, Quinoline Yellow E104,
Gelatin

MUKES 200 mg hard capsules
The active ingredient is Fluconazole 200 mg
The other ingredients are:
Lactose, Colloidal silicon dioxide, Corn starch, Magnesium stearate, Sodium lauryl sulfate.
Capsule shells: titanium dioxide E171, Indigo carmine E132, Quinoline Yellow E104, Gelatin

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

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

MARKETING AUTHORISATION HOLDER
Ares Farmaceutici S.r.l.- VIA G. PORZIO SNC C.D. IS. A7/B N.12- 80143 Napoli (NA)

MANUFACTURER
Genetic S.p.A. Contrada Canfora - 84084 Fisciano (SA)
Lachifarma Srl - Laboratorio Chimico Farmaceutico Salentino - S.S. 16 Adriatica - Zona Industriale -
73010 Zollino (LE)