Alozof
Italy
Table of Contents
Package leaflet: Information for the user
Alozof 100 mg hard capsules, 150 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Alozof is and what it is used for
- What you need to know before taking Alozof
- How to take Alozof
- Possible side effects
- How to store Alozof
- Contents of the pack and other information
1. What Alozof is and what it is used for
Alozof belongs to a group of medicines called "antifungals". The active substance is fluconazole.
Alozof 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.
Adults
Your doctor may prescribe this medicine to treat the following fungal infections:
- cryptococcal meningitis – a fungal infection of the brain;
- coccidioidomycosis – a disease affecting the bronchopulmonary system;
- infections caused by Candida found in the bloodstream, organs (for example 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 – for example athlete's foot, ringworm, genital itching, nail infections. Alozof 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 of age)
Your doctor may prescribe this medicine to treat the following fungal infections:
- mucosal candidiasis – infection of the oral mucosa, throat infection;
- infections caused by Candida found in the bloodstream, organs (for example heart, lungs) or urinary tract;
- cryptococcal meningitis – a fungal infection of the brain.
Alozof 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 should know before taking Alozof
Do not take Alozof if you
- are allergic 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.
- are taking astemizole or terfenadine (antihistamine medicines used to treat allergies);
- are taking cisapride (used to treat stomach disorders);
- are taking pimozide (used to treat mental disorders);
- are taking quinidine (used to treat heart arrhythmias);
- are taking erythromycin (an antibiotic used to treat bacterial infections).
Warnings and precautions
Talk to your doctor or pharmacist before taking Alozof.
- If you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers after taking Alozof.
Severe skin reactions have been reported, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), associated with Alozof treatment. Stop taking Alozof and contact your doctor immediately if you notice any of the symptoms related to severe skin reactions described in section 4.
- If the fungal infection does not improve, alternative antifungal therapy may be required.
Tell your doctor especially if
- you have liver or kidney problems;
- you suffer from heart diseases, including heart arrhythmia;
- you have abnormal levels of potassium, calcium, or magnesium in your blood;
- severe skin reactions occur (itching, skin redness, or difficulty breathing);
- 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).
Other medicines and Alozof
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 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 Alozof (see section: “Do not take Alozof if you”).
Some medicines may interact with Alozof. 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 clotting (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, 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);
- ivacaftor (used to treat cystic fibrosis);
- amiodarone (used to treat "arrhythmias", irregular heartbeats);
- hydrochlorothiazide (a diuretic).
Alozof with food and drink
You may take this medicine with or without food.
Pregnancy, breastfeeding, and fertility
Do not take Alozof if you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, unless 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 should not take Alozof during pregnancy unless prescribed by your doctor.
You may continue breastfeeding after taking a single dose of Alozof up to 150 mg.
You should not breastfeed if you are taking repeated doses of Alozof.
Driving and using machines
Be aware that dizziness or seizures may occur while driving or using machinery.
Alozof contains:
Lactose: this medicine contains a small amount of lactose (milk sugar). If your doctor has informed you that you have an intolerance to certain sugars, contact them before taking this medicine.
Sodium: this medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e., essentially 'sodium-free'.
3. How to take Alozof
Take this medicine exactly as instructed 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 this medicine, depending on the infection, are listed below:
Adults
| Condition | Dosage |
| Treatment of cryptococcal meningitis | 400 mg on the first day, then 200–400 mg once daily for 6–8 weeks or longer, if necessary. Sometimes doses are increased up to 800 mg |
| Prevention of recurrence of cryptococcal meningitis | 200 mg once daily until you are told to stop |
| Treatment of coccidioidomycosis | 200–400 mg once daily for 11 months to 24 months or longer, if necessary. Sometimes doses are increased up to 800 mg |
| Endemic Candida fungal infections | 800 mg on the first day, then 400 mg once daily until you are told to stop |
| Treatment of oral mucosal infections, throat infections, and denture-related stomatitis | 200–400 mg on the first day, then 100–200 mg once daily until you are told to stop |
| Mucosal candidiasis – dosage depends on the site of infection | 50–400 mg once daily for 7–30 days until you are told to stop |
| Prevention of recurrence of oral mucosal infections and throat infections | 100–200 mg once daily, or 200 mg three times weekly, for as long as you remain at risk of infection |
| Genital candidiasis | 150 mg as a single dose |
| Reducing recurrences of vaginal candidiasis | 150 mg every three days for a total of 3 doses (day 1, 4, and 7), followed by once weekly for 6 months while you are at risk of infection |
| Skin mycosis and nail infections | Depending on the site of infection: 50 mg once daily; 150 mg once weekly; or 300–400 mg once weekly for 1 to 4 weeks (athlete’s foot may require up to 6 weeks; nail infection treatment continues until the infected nail is fully replaced) |
| Prevention of Candida infections (if your immune system is weakened or not functioning properly) | 200–400 mg once daily while you are at risk of infection |
Use in adolescents from 12 to 17 years
Always take the dose prescribed by your doctor (either the adult dose or the children's dose).
Use in 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.
| Condition | Daily dose |
| Oral and throat mucosal candidiasis – dosage and duration of treatment depend on severity and | 3 mg per kg of body weight once daily (on the first day, 6 mg per |
| site of infection | kg of body weight may be administered) |
| Cryptococcal meningitis or endemic Candida fungal infections | 6 mg to 12 mg per kg of body weight once daily |
| Prevention of recurrence of cryptococcal meningitis | 6 mg per kg of body weight once daily |
| Prevention of Candida infection in children (if their immune system is not functioning properly) | 3 mg to 12 mg per kg of body weight once daily |
Use in children from 0 to 4 weeks of age
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.
Your doctor may sometimes prescribe doses different from these. Always take the medicine exactly as
instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Use in elderly patients
The same dose as that recommended for adults should be used, unless you have kidney problems.
Use in patients with renal impairment
Your doctor may adjust the dosage according to kidney function.
If you take more Alozof 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 experiencing sensations, seeing, hearing, or thinking about 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 Alozof
Do not take a double dose to make up for missed doses. 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.
Some people may experience allergic reactions, although serious allergic reactions occur rarely.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist.
If you experience any of the following symptoms, contact your doctor immediately.
- Sudden breathlessness, 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).
Stop taking Alozof 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).
Alozof may affect the liver. Symptoms of liver problems include:
- Tiredness;
- Loss of appetite;
- Vomiting;
- Yellowing of the skin and whites of the eyes (jaundice).
If you experience any of these symptoms, stop taking Alozof and contact your doctor immediately.
Other side effects:
Common side effects (may affect up to 1 in 10 people):
- Headache;
- Stomach discomfort, diarrhoea, nausea, vomiting;
- Increased liver function test values in blood tests;
- Skin rash.
Uncommon side effects (may affect up to 1 in 100 people):
- Reduction in red blood cells, which may cause paleness, weakness, or breathlessness;
- 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):
- Lower than normal levels of white blood cells, which help defend against infections, and of platelets, which are necessary for blood clotting;
- Skin discoloration (red or purplish), which may be caused by reduced platelet count or other changes in blood cells;
- Changes in blood chemistry (elevated cholesterol and fat levels);
- Low potassium levels in the blood;
- Chills;
- Abnormal electrocardiogram (ECG), changes in heart rhythm and rate;
- Liver failure;
- Allergic reactions (sometimes severe), including rashes with widespread blistering and peeling of the skin, serious skin reactions, swelling of the lips and face;
- Hair loss.
Side effects with unknown frequency (frequency cannot be estimated from the available data):
- Hypersensitivity reaction with rash, fever, swollen glands, increase in a type of white blood cell (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, contact your doctor or pharmacist.
You can also report side effects directly via the national reporting system at: 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 Alozof
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label (Exp.). The expiry date refers to the last day of that month.
Do not store above 30°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 Alozof contains
- The active substance is fluconazole. Each hard capsule contains fluconazole 100 mg or 150 mg.
- The other components are: Capsule contents: monohydrate lactose, pregelatinized starch, magnesium stearate, anhydrous colloidal silica, sodium lauryl sulfate. Capsule shell contents: 100 mg hard capsules: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172). 150 mg hard capsules: gelatin, titanium dioxide (E 171).
Description of the appearance of Alozof and package contents
Alozof 100 mg capsules: PVC/Al blister containing 10 capsules
Alozof 150 mg capsules: PVC/Al blister containing 2 capsules
It is possible that not all pack sizes are marketed.
Marketing Authorization Holder
I.B.N. SAVIO S.r.l. - Via del Mare, 36 – Pomezia (Rm)
Manufacturer
Laboratorio Farmaceutico C.T. S.r.l. Via Dante Alighieri, 71 18038 Sanremo (Imperia)