AZONAL 100 mg Hard Capsules

Зміст інструкції

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

Azonal 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules

Fluconazole
Generic medicine

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

1. What Azonal is and what it is used for

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

Azonal 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.

Azonal 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 Azonal

Do not take Azonal

• 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). The symptoms may be itching, redness of the skin 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 (antibiotic used to treat bacterial infections).

Warnings and precautions
Talk to your doctor or pharmacist before taking Azonal

• 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 you develop severe skin reactions (itching, redness of the skin or difficulty breathing);
• if you experience signs of “adrenal insufficiency” where 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 you have ever developed a severe rash or skin exfoliation, blisters and/or ulcers in the mouth after taking Azonal.

Severe skin reactions including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have been reported related to treatment with Azonal. Stop taking Azonal and contact your doctor immediately if you notice any of the symptoms related to severe skin reactions described in section 4.
Talk to your doctor or pharmacist if the fungal infection does not improve, an alternative antifungal therapy may be necessary.

Other medicines and Azonal
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor immediatelyif 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 Azonal (see section “Do not take Azonal”).
There are some medicines that can interact with Azonal. Tell your doctor if you are taking any of the following medicines as a dose adjustment or monitoring may be necessary to ensure the medicines continue to have the desired effect:

• rifampicin or rifabutin (antibiotics for the treatment of bacterial infections);
• abrocitinib (used for the treatment of atopic dermatitis, also known as atopic eczema);
• 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 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 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 sodium levels in the blood) or to slow the decline in kidney function;
• vitamin A (dietary supplement);
• ivacaftor (alone or in combination with other drugs 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).

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

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, 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 conceive.
For longer cycles of therapy with fluconazole, ask your doctor to assess the need for adequate contraception during treatment, which should continue for one week after the last dose.
Do not take fluconazole if you think you are pregnant or are trying to become pregnant, unless your doctor has told you to. If you become pregnant while taking this medicine or within 1 week of the most recent dose, contact your doctor.
Fluconazole taken during the first or second trimester of pregnancy may increase the risk of miscarriage. Fluconazole taken during the first trimester of pregnancy may increase the risk that the newborn will have birth defects affecting 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 can continue to breastfeed after taking a single dose of Azonal 150 mg.
You should not breastfeed if you are taking repeated doses of Azonal.

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

Azonal 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.

Azonal contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, that is to say essentially ‘sodium-free’.

3. How to take Azonal

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 Azonal to be taken depending on the infection are listed below:
Adults

ConditionDose
Treatment of cryptococcal meningitis 400 mg on the first day, then 200 - 400 mg
once a day for 6 - 8 weeks or longer,
if necessary. Sometimes the doses
are increased up to 800 mg
Preventing the recurrence of cryptococcal meningitis 200 mg once a day until you
are told to stop
Treatment of coccidioidomycosis 200 - 400 mg once a day for 11
months to 24 months or longer if
necessary. Sometimes the doses are
increased up to 800 mg
Endemic fungal infections due to Candida800 mg on the first day, then 400 mg
once a day until you are told
to stop
Treatment of infections of the oral mucosa, infections of the
throat and inflammation of the mouth due to
dental prostheses
200 mg - 400 mg on the first day, then from
100 mg to 200 mg until you are
told to stop
Candidiasis of the mucous membranes – the dose depends on the site
of the infection

• 50 - 400 mg once a day for
• 7 - 30 days until you are told to stop 100 mg - 200 mg once a day, or 200 mg 3 times a week as long as you are at risk of contracting a Candida infection Genital candidiasis 150 mg in a single dose Preventing the recurrence of infections of the oral mucosa, infections of the throat

Reduce the recurrence of vaginal candidiasis 150 mg every three days for a total of
3 doses (day 1, 4 and 7), and then once a week for 6 months when you are at risk of
contracting an infection
Skin mycoses and nail infections Depending on the site of infection, 50 mg once
a day, 150 mg once a week, from
300 mg to 400 mg once a week for 1
to 4 weeks (Athlete's foot may require
up to 6 weeks, treatment of
nail infections lasts until the infected nail
is replaced.)

Adolescents from 12 to 17 years
Always take the dose prescribed by your doctor (or the adult or 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 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 infants under 2 weeksThe 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 Azonal than you should
Taking too many capsules all at once may cause you problems. Immediately inform your doctor or
go to the nearest hospital.
In case of accidental overdose, symptoms may include seeing, hearing, perceiving and thinking things that
are not real (hallucinations and paranoid behavior). Symptomatic treatment may be appropriate
(with adequate supportive measures and possibly gastric lavage).

If you forget to take Azonal
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
forgot.
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 Azonal 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;
• Skin rashes;
• Severe skin reactions, such as rashes that cause blisters (may affect the mouth and tongue).

Azonal can have effects on the liver. Symptoms of liver problems include:

• Fatigue;
• Loss of appetite;
• Vomiting;
• Yellowing of the skin and the whites of the eyes (jaundice).

If you experience any of these symptoms, stop taking Azonal 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;
• 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);
• Swelling, 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 from 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 colon) (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. 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 Azonal

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 Azonal contains
Each hard capsule contains:

• the active ingredient is: fluconazole 100 mg, 150 mg or 200 mg;
• the other ingredients are:

Capsule content:

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),
orange yellow (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 Azonal and contents of the pack
Azonal 100 mg hard capsules of ivory/green colour, size 2, is available in blisters containing 10 capsules
Azonal 150 mg hard capsules of dark ivory/green colour, size 1, is available in blisters containing 2 capsules
Azonal 200 mg hard capsules of dark green/dark green colour, size 0, is available in blisters containing 7
capsules
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurora Biofarma s.r.l., Via Nicola Antonio Porpora 127, Milano, 20131, Italy

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

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