MAICOX 100 mg Hard Capsule

Зміст інструкції

1. Maicox 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules
   1. What Maicox is and what it is used for
   2. What you need to know before you take Maicox
   3. How to take Maicox
   4. Possible side effects
   5. How to store Maicox
   6. Contents of the pack and other information

Maicox 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules

Fluconazole
Generic medicine

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

1. What Maicox is and what it is used for

Maicox belongs to a group of medicines called “antifungals”. The active ingredient is
fluconazole.
Maicox 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.
Your doctor may prescribe this medicine for the treatment of the following fungal infections:
Adults

• 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, infection of the throat 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.

Maicox 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 your child for the treatment of the following fungal
infections:

• candidiasis of the mucous membranes, infection of the oral mucosa, infection of the throat;
• 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.

Maicox 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 Maicox

Do not take Maicox

• if you are allergic (hypersensitive) to fluconazole, to other medicines that you have used for the treatment of fungal infections or to any of the other components 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 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
Talk to your doctor or pharmacist before taking Maicox

• 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 signs of “adrenal insufficiency” appear, where the adrenal glands do not produce adequate amounts of certain steroid hormones such as cortisol (chronic or long-lasting 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 exfoliation of the skin, blisters and/or ulcers in the mouth after taking Maicox.

Severe skin reactions including drug reaction with eosinophilia and systemic symptoms (DRESS) related to treatment with Maicox have been reported. Stop taking Maicox 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 Maicox
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
Tell your doctor immediately if you are taking the following medicines: 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) because they cannot be taken with Maicox (see section “Do not take Maicox”).
There are some medicines that can interact with Maicox. 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, verapamil, felodipine and losartan (used for the treatment of hypertension - high blood pressure);
• olaparib (used for the treatment of ovarian cancer);
• 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);
• tofacitinib (used for the treatment of rheumatoid arthritis);
• vitamin A (food supplement);
• ibrutinib (used for the treatment of some cancers);
• ivacaftor (used for the treatment of cystic fibrosis);
• amiodarone (used for the treatment of irregular heartbeat “arrhythmia”);
• hydrochlorothiazide (a diuretic);
• tolvaptan (used for the treatment of patients with polycystic kidney disease).

Maicox with food and drink
You can take Maicox with or without food.

Pregnancy and breastfeeding
Do not take Maicox if you are pregnant, suspect you may be pregnant, or are planning a pregnancy, 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 bone and/or muscle malformations.
You can continue to breastfeed after taking a single dose of Maicox up to 150 mg.
You should not breastfeed if you are taking repeated doses of Maicox.

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

Maicox contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Maicox

Always take this medicine exactly as your doctor has told you.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 Maicox 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 dosage 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 children aged 0 to 4 weeks:

• Use in children aged 3 to 4 weeksThe 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 children under 2 weeks of ageThe 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. The doctor may sometimes prescribe doses different from these. Always take the medicine as directed by your doctor.

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
The doctor may adjust the dosage based on kidney function.

If you take more Maicox than you should
Taking too many capsules all at once could cause you problems. Immediately inform your doctor or
go to the nearest hospital.
In case of accidental overdose, symptoms may include feeling, seeing, perceiving 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 Maicox
Do not take a double dose to make up for the missed dose. 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, this medicine can cause side effects, although not everybody gets them.
Stop taking Maicox and contact your doctor immediately if you notice any of the following
symptoms:

• Widespread rash, high temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity).

Some people experience allergic reactions, although serious allergic reactions are rare.
If you experience any of the following symptoms, inform your doctor immediately:

• 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;
• rashes;
• severe skin reactions, such as rashes that cause blisters (may affect the mouth and tongue).

Maicox 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 Maicox and inform your doctor immediately.

Other side effects:
If any of these side effects get worse, or if you notice any side effect not listed here

Common side effects (may affect up to 1 in 10 people) are:

• headache;
• stomach upset, diarrhea, nausea, vomiting;
• increased liver function values in blood tests;
• 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 giddy, 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 1000 people) are:

• lower than normal levels of white blood cells, which help to fight infections, and platelets, which help the blood to clot;
• altered skin color (red or purple) which can 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 on the basis of 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 or pharmacist. This includes any possible side effects not listed
in this leaflet. 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 Maicox

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 pack after “Exp.”. The expiry date refers to the last day of that month.
Store at a temperature below 25°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. Contents of the pack and other information

What Maicox contains
Each hard capsule contains:

• the active ingredient is: fluconazole 100 mg, 150 mg or 200 mg;
• the other ingredients are: Capsule contents: lactose,colloidal silicon dioxide, corn starch, magnesium stearate, sodium lauryl sulfate;

Capsule shell:

100 mg hard capsules:titanium dioxide (E171), yellow iron oxide (E172), Patent Blue V
(E131), yellow orange (E110), gelatin.

150 mg hard capsules:titanium dioxide (E171), yellow iron oxide (E172), Indigo Carmine (E132), yellow
quinoline (E104), gelatin.

200 mg hard capsules:titanium dioxide (E171), Indigo Carmine (E132), yellow quinoline (E104), gelatin.

Description of Maicox and contents of the pack
Maicox 100 mg hard capsules of ivory/green color, size 2, is available in blisters containing 10 capsules
Maicox 150 mg hard capsules of ivory/dark green color, size 1, is available in blisters containing 2
capsules
Maicox 200 mg hard capsules of dark green/dark green color, size 0, is available in blisters containing 7
capsules
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Genetic S.p.A. – Via G. Della Monica, 26 – Castel San Giorgio (SA)

Manufacturer
Genetic S.p.A. Contrada Canfora 84084 Fisciano (SA)

This leaflet was last updated inMM/AAAA