ALOZOF 100 mg Hard Capsule

Зміст інструкції

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

Alozof 100 mg hard capsules, 150 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 Alozof is and what it is used for
• 2. What you need to know before you take Alozof
• 3. How to take Alozof
• 4. Possible side effects
• 5. How to store Alozof
• 6. 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 ingredient is fluconazole.
Alozof is used for the treatment of fungal infections and can be used to prevent infections from
candida. The most common cause of fungal infections is a yeast called Candida.

Adults
Your doctor may prescribe this medicine for the treatment of the following fungal infections:

• 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 (for example 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 - for example athlete's foot, ringworm, itching in the genital area, nail infections. Alozof may be prescribed for:
• preventing the recurrence of cryptococcal meningitis;
• preventing the recurrence of candidiasis of the mucous membranes;
• reducing the recurrence 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 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 (for example heart, lungs) or in the urinary tract;
• cryptococcal meningitis - a fungal infection of the brain.

Alozof 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 Alozof

Do not take Alozof if you

• are allergic to fluconazole, to other medicines you have used for the treatment of 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 in breathing.
• are taking astemizole, terfenadine (antihistamines 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 (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 rash or exfoliation of the skin, blisters and/or ulcers in the mouth after taking Alozof.

Severe skin reactions including drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported related to treatment with Alozof. 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, an alternative antifungal therapy may be necessary.

Tell your doctor especially if

• you have problems with your liver or kidneys;
• you suffer from heart disease, including heart arrhythmia;
• you have abnormal levels of potassium, calcium or magnesium in your blood;
• 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 enough 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.
Immediatelytell your doctor if you are taking 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), as they cannot be taken with Alozof (see section: “Do not take Alozof if you”).
There are some medicines that can interact with Alozof. 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 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, 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 (dietary supplement);
• ivacaftor (used to treat cystic fibrosis);
• amiodarone (used to treat “arrhythmias”, irregular heartbeats);
• hydrochlorothiazide (a diuretic)

Alozof with food and drink
You can take the medicine with or without food.

Pregnancy, breastfeeding and fertility
Do not take Alozof if you are pregnant, suspect you may be pregnant, or are breastfeeding, 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 malformations of the bones and/or muscles.
You should not take Alozof during pregnancy unless your doctor has prescribed it.
You can continue to breastfeed 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
You should be aware that dizziness or convulsions may occur while driving or using machines.

Alozof contains:
lactose:this medicine contains a minimal amount of lactose (milk sugar). If your doctor has told you that you have an intolerance to some 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 following exactly the instructions of your doctor. 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 this medicine to be taken depending on the infection are listed here
below:

Adults

Use in adolescents from 12 to 17 years
Always take the dose prescribed by the doctor (or 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

Use in infants from 0 to 4 weeks
Use in infants from 3 to 4 weeks:
The 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 weeks:
The 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.
The doctor may sometimes prescribe doses different from these. Always take the medicine as directed
by the doctor. If you have any doubts, consult your doctor or pharmacist.

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 Alozof 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 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 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 time to take the next dose, do not take the dose you have
forgotten.
If you have any doubts about using 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 experience allergic reactionsalthough serious allergic reactions are rare. If you get any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. If you get any of the following symptoms tell your doctor immediately.

• sudden shortness of breath, difficulty breathing or 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 patches;
• skin rashes;

• severe skin reactions, such as rashes that cause blisters (can affect the mouth and tongue).

Stop taking Alozof and tell your doctor immediately if you notice any of the following symptoms:

• Widespread rash, high temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity).

Alozof 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 get any of these symptoms, stop taking Alozof and tell your doctor immediately.

Other side effects:
Common side effects (may affect up to 1 in 10 people):

• headache;
• stomach upsets, diarrhoea, nausea, vomiting;
• increases in liver function values in blood tests;
• skin rashes.

Uncommon side effects (may affect up to 1 in 100 people):

• 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, feeling unwell, fever. Rare side effects (may affect up to 1 in 1,000 people):
• lower than normal levels of white blood cells, which help you fight infection, and platelets, which help your blood to clot;
• altered skin colour (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.

Side effects with unknown frequency(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 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 possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system 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 sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label (Exp.). The expiry date
refers to the last day of that month.
Do not store at a temperature above 30°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 Alozof contains

• The active ingredient is fluconazole. Each hard capsule contains fluconazole 100 mg or 150 mg.
• The other ingredients are: Capsule content:lactose monohydrate, pregelatinized starch, magnesium stearate, anhydrous colloidal silica, sodium lauryl sulfate. Capsule shell content: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 contents of the pack
Alozof 100 mg capsules: PVC/Al blister containing 10 capsules
Alozof 150 mg capsules: PVC/Al blister containing 2 capsules
Not all pack sizes may be marketed.

Marketing Authorisation 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)