AZOLIX 100 mg Kapsułka Twarda

Treść ulotki

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

Azolix 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 they have the same symptoms as you, as it may 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 Azolix is and what it is used for
• 2. What you need to know before you take Azolix
• 3. How to take Azolix
• 4. Possible side effects
• 5. How to store Azolix
• 6. Contents of the pack and other information

1. What Azolix is and what it is used for

Azolix belongs to a group of medicines called “antifungals”. The active ingredient is
fluconazole.
Azolix 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, 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.

Azolix 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, 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.

Azolix 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 Azolix

Do not take Azolix

• if you are allergic (hypersensitive) to fluconazole, to other medicines 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 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 Azolix

• 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 mouth ulcers after taking Azolix.

Severe skin reactions have been reported including drug reaction with eosinophilia and systemic symptoms
(DRESS) related to treatment with Azolix. Stop taking Azolix 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 Azolix
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 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) because they cannot be taken with Azolix (see section “Do not take Azolix”).
There are some medicines that can interact with Azolix. 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 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);
• vitamin A (food supplement);
• ibrutinib (used to treat some 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).

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

Pregnancy and breastfeeding
Do not take Azolix if you are pregnant, suspect you might 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 breastfeeding after taking a single dose of Azolix up to 150 mg.
You should not breastfeed if you are taking repeated doses of Azolix.

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

Azolix 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 Azolix

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 recommended doses of Azolix 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 (or 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. Your 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 Azolix than you should
Taking too many capsules all at once could cause you problems. Seek immediate medical attention 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 Azolix
Do not take a double dose to make up for a 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 have
forgotten.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Azolix 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).

Some people experience allergic reactions, although severe 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).

Azolix 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 Azolix 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;
• increases in 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 faint, 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 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;
• chills;
• 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 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 Azolix

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 Azolix 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 the appearance of Azolix and contents of the pack
Azolix 100 mg hard capsules of ivory/green color, size 2, is available in blisters containing 10 capsules
Azolix 150 mg hard capsules of ivory/dark green color, size 1, is available in blisters containing 2
capsules
Azolix 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 onMM/AAAA