Azolix

Package leaflet: Information for the user

Azolix 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 other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including 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 taking 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 substance is fluconazole.
Azolix 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, 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.

Azolix may be prescribed to you:

• to prevent recurrence of cryptococcal meningitis;
• to prevent recurrence of mucosal candidiasis;
• to reduce recurrences of vaginal candidiasis;
• to prevent Candida infections (if your immune system is weak or not functioning properly).

Children and adolescents (0 to 17 years)
Your doctor may prescribe this medicine for your child 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.

Azolix may be prescribed to you:

• to prevent Candida infections (if your immune system is weak or not functioning properly);
• to prevent 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 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 Azolix

• if you have liver or kidney problems;
• if you suffer from heart diseases, including heart 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 symptoms of "adrenal insufficiency" appear, in which the adrenal glands do not produce sufficient 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, alternative antifungal therapy may be required;
• if you have ever developed a severe rash or skin peeling, blisters and/or mouth ulcers after taking Azolix.

Severe skin reactions, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported in association with Azolix treatment. Stop taking Azolix and contact your doctor immediately if you notice any of the symptoms related to severe skin reactions described in section 4.
Other medicines and Azolix
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), or cisapride (used to treat stomach disorders), or pimozide (used to treat mental disorders), or quinidine (used to treat heart arrhythmias), or erythromycin (an antibiotic used to treat bacterial infections), as these must not be taken with Azolix (see section "Do not take Azolix").
There are some medicines that may interact with Azolix. Inform your doctor if you are taking any of the following medicines:

• rifampicin or rifabutin (antibiotics used to treat 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 epileptic seizures);
• nifedipine, isradipine, amlodipine, verapamil, felodipine, and losartan (used to treat hypertension - high blood pressure);
• olaparib (used to treat ovarian cancer);
• 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).

Azolix with food and drink
You may take Azolix with or without food.
Pregnancy and breastfeeding
Do not take Azolix if you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, unless otherwise instructed 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 the baby being born with bone and/or muscle malformations.
You may continue breastfeeding after a single dose of Azolix up to 150 mg.
You must not breastfeed if you are taking repeated doses of Azolix.
Driving and using machines
Be aware that dizziness or seizures may occur while driving or operating machinery.
Azolix contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Azolix

Take this medicine exactly as your doctor has told you. If you are unsure, 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 Azolix 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 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. The doctor may sometimes prescribe doses different from these. Always take the medicine as directed by the doctor.

Use in elderly patients
The same dose as that recommended for adults should be used, unless you have kidney problems.
Use in patients with kidney problems
The doctor may adjust the dosage according to kidney function.
If you take more Azolix 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 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 Azolix
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 gets them.
Stop taking Azolix and contact your doctor immediately if you experience 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 severe allergic reactions are rare.
If you experience any of the following symptoms, inform your doctor immediately:

• sudden shortness of breath, difficulty breathing, or chest tightness;
• 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).

Azolix can 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 Azolix and inform your doctor immediately.
Other side effects:
If any of the side effects worsen, or if you notice any side effect 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;
• fatigue, 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 defend against infections, and of platelets, which are necessary for blood clotting;
• altered skin colouration (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 large intestine) (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, talk to 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 Azolix

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging 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 Azolix 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 Azolix and pack sizes
Azolix 100 mg hard capsules, ivory/green in colour, size 2, available in blisters containing 10 capsules.
Azolix 150 mg hard capsules, ivory/dark green in colour, size 1, available in blisters containing 2 capsules.
Azolix 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 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 on MM/YYYY