Maicox

Patient Information Leaflet: Information for the User

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

Fluconazole
Generic medicine
Please read all of 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 only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including 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 taking 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 known as "antifungals". The active substance is
fluconazole.
Maicox 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.
Your doctor may prescribe this medicine to treat the following fungal infections:
Adults

• Cryptococcal meningitis, a fungal infection of the brain;
• Coccidioidomycosis, a disease affecting the bronchopulmonary system;
• Infections caused by Candida found in the bloodstream, in organs (e.g. heart, lungs) or in the urinary tract;
• Mucocutaneous 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.

Maicox may be prescribed to:

• prevent recurrence of cryptococcal meningitis;
• prevent recurrence of mucocutaneous 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 for your child to treat the following fungal infections:

• mucocutaneous candidiasis, infection of the oral mucosa, throat infection;
• infections caused by Candida 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 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 Maicox

Do not take Maicox

• if you are allergic (hypersensitive) 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, 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 (an antibiotic used to treat 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 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 Maicox.

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

Other medicines and Maicox
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicine.
Inform your doctor immediately if you are taking any of the following medicines: astemizole, terfenadine (antihistamines used to treat allergies), cisapride (used to treat stomach disorders), pimozide (used to treat mental disorders), quinidine (used to treat heart arrhythmias), or erythromycin (an antibiotic used to treat bacterial infections), as these must not be taken with Maicox (see section "Do not take Maicox").

Some medicines may interact with Maicox. 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 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 carcinoma);
• 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 HIV patients);
• diabetes medicines such as chlorpropamide, glibenclamide, glipizide, or tolbutamide;
• theophylline (used to control asthma);
• tofacitinib (used to treat rheumatoid arthritis);
• vitamin A (dietary supplement);
• ibrutinib (used to treat certain cancers);
• ivacaftor (used to treat cystic fibrosis);
• amiodarone (used to treat irregular heartbeat "arrhythmia");
• hydrochlorothiazide (a diuretic);
• tolvaptan (used to treat patients with polycystic kidney disease).

Maicox with food and drinks
You may take Maicox with or without food.

Pregnancy and breastfeeding
Do not take Maicox if you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, unless instructed otherwise by your doctor.
Fluconazole taken during the first trimester of pregnancy may increase the risk of miscarriage.
Low-dose fluconazole taken during the first trimester may slightly increase the risk of congenital malformations affecting bones and/or muscles.
You may continue breastfeeding after a single dose of Maicox up to 150 mg.
You must not breastfeed if you are taking repeated doses of Maicox.

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

Maicox contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Maicox

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 each day.
The recommended doses of Maicox to take, 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 pediatric 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 from 0 to 4 weeks of age:

• Use in children from 3 to 4 weeks of age 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. The doctor may sometimes prescribe doses different from these. Always take the medicine as indicated by your doctor.

Use in elderly patients
The same dose as recommended for adults should be used unless you have renal problems.
Use in patients with renal impairment
The doctor may adjust the dosage according to kidney function.
If you take more Maicox than you should
Taking too many capsules at once could cause you problems. Contact your doctor immediately or go to the nearest hospital.
In case of accidental overdose, symptoms may include hearing, seeing, sensing, and thinking things that are not real (hallucinations and paranoid behaviour). Symptomatic treatment may be appropriate (with adequate supportive measures and possibly gastric lavage).
If you forget to take Maicox
Do not take a double dose to make up for the forgotten dose. If you forget to take a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and take the next dose at the regular time.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Stop taking Maicox 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).

Some people may experience allergic reactions, although serious 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 (which may affect the mouth and tongue).

Maicox 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 Maicox and contact your doctor immediately.
Other side effects:
If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Common side effects (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 side effects (may affect up to 1 in 100 people) are:

• reduction in red blood cells, which may cause paleness, weakness, or shortness of breath;
• 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);
• swelling, blisters (urticaria), itching, increased sweating;
• tiredness, general malaise, fever.

Rare side effects (may affect up to 1 in 1,000 people) are:

• lower than normal levels of white blood cells (which help fight infections) and platelets (which enable blood clotting);
• skin discoloration (red or purplish), which may be caused by a reduction in platelets or other changes in blood cells;
• changes in blood chemistry (high levels of cholesterol, fats);
• low potassium levels in the blood;
• chills;
• abnormal electrocardiogram (ECG), changes in heart rhythm and heart rate;
• liver failure;
• allergic reactions (sometimes severe), including 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 rash, fever, swollen glands, increase in a type of white blood cells (eosinophilia), and inflammation of internal organs (liver, lungs, heart, kidneys, and colon) (drug reaction or rash with eosinophilia and systemic symptoms (DRESS)).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via 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 below 25°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. Package contents and other information

What Maicox contains
Each hard capsule contains:

• The active substance is: fluconazole 100 mg, 150 mg or 200 mg;
• The other components are: Capsule contents: lactose, colloidal silicon dioxide, maize starch, magnesium stearate, sodium lauryl sulfate;

Capsule shell:
100 mg hard capsules: titanium dioxide (E171), yellow iron oxide (E172), patent blue V (E131), orange yellow (E110), gelatin.
150 mg hard capsules: titanium dioxide (E171), yellow iron oxide (E172), indigotine (E132), quinoline yellow (E104), gelatin.
200 mg hard capsules: titanium dioxide (E171), indigotine (E132), quinoline yellow (E104), gelatin.

Description of the appearance of Maicox and package contents
Maicox 100 mg hard capsules, ivory/green in colour, size 2, available in blisters containing 10 capsules.
Maicox 150 mg hard capsules, dark ivory/green in colour, size 1, available in blisters containing 2 capsules.
Maicox 200 mg hard capsules, dark green/dark green in colour, size 0, available in blisters containing 7 capsules.

Not all pack sizes may be marketed.

Marketing Authorization 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 on MM/YYYY