DIZOLO <100 MG Hard capsule

Зміст інструкції

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

DIZOLO 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, pharmacist or nurse.
• 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, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Dizolo is and what it is used for

Dizolo belongs to a group of medicines called "antifungals". The active ingredient is fluconazole.
Dizolo 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 Candida and 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.

Dizolo 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 Candida infections (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 Candida and found in the bloodstream, in organs (for example heart, lungs) or in the urinary tract;
• cryptococcal meningitis - a fungal infection of the brain.

Dizolo may be prescribed for:

• preventing Candida infections (if your immune system is weak or not functioning properly);
• preventing the recurrence of cryptococcal meningitis.

2. What you need to know before taking Dizolo

Do not take Dizolo

• if you are allergic 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 Dizolo

• 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 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 fluconazole.

Severe skin reactions including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have been reported related to treatment with fluconazole. Stop taking Dizolo and contact your doctor immediately if you notice any of the symptoms related to the 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 Dizolo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
Tell your doctor immediatelyif 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 Dizolo (see section: ''Do not take Dizolo if").
There are some medicines that can interact with Dizolo. 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 for the treatment of rheumatoid arthritis)
• tolvaptan, used to treat hyponatremia (low sodium levels in the blood) or to slow the decline in kidney function
• vitamin A (food supplement)
• ivacaftor (alone or in combination with other drugs used to treat cystic fibrosis)
• amiodarone (used for the treatment of “arrhythmias”, irregular heartbeats)
• hydrochlorothiazide (a diuretic)
• ibrutinib (used for the treatment of blood cancer)
• lurasidone (used for the treatment of schizophrenia).

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

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, 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, consult 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 are or think you might be 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 of the newborn having 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 Dizolo 150 mg.
You should not breastfeed if you are taking repeated doses of Dizolo.

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

Dizolo contains lactose (milk sugar) and sodium (salt)
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 your doctor before taking this medicine.
Dizolo contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.

3. How to take Dizolo

Take this medicine following exactly the instructions of your doctor. If you have doubts, consult 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 below:

Adults

Adolescents from 12 to 17 years
Always take the dose prescribed by your doctor (either the adult dose or the children's 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 infants aged 0 to 4 weeks
Use in infants aged 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 of age:
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.

Elderly
The same dose as provided for adults should be used unless you have kidney problems.

Patients with kidney problems
Your doctor may adjust the dosage based on kidney function.

If you take more Dizolo 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 Dizolo
Do not take a double dose to make up for the 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 the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking Dizolo 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 reactionsalthough severe allergic reactions are rare.
If you experience any side effect, including those not listed in this leaflet, contact your
doctor or pharmacist.
If you experience any of the following symptoms inform 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 spots;
• rashes;
• severe skin reactions, such as rashes that cause blisters (may affect the mouth and tongue).

Dizolo may 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 Dizolo and inform your doctor immediately.

Other side effects:
If any side effect gets worse, or if you notice any side effect not listed here
The side effects common(may affect up to 1 in 10 people) are:

• headache;
• stomach upset, diarrhea, nausea, vomiting;
• increases in liver function values in blood tests;
• rashes.

The side effects notcommon(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);
• swellings, blisters (urticaria), itching, increased sweating;
• fatigue, general feeling of discomfort, fever.

The side effects rare (may affect up to 1 in 1,000 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 which 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, pharmacist or nurse. 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 Dizolo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the label after Exp.. The expiry
date refers to the last day of that month.
Store at a temperature not exceeding 30°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Dizolo contains

• The active substance is fluconazole. Each hard capsule contains fluconazole 100 mg, 150 mg or 200 mg.
• The other ingredients are: Capsule content: lactose monohydrate, pregelatinized starch, magnesium stearate, anhydrous colloidal silica, sodium lauryl sulfate. Capsule shell content:gelatin, titanium dioxide (E 171), yellow iron oxide (E 172) (only in 100 mg capsules).

Description of the appearance of Dizolo and contents of the pack
Dizolo 100 mg hard capsules are yellow. Box containing 10 capsules of 100 mg.
Dizolo 150 mg hard capsules are white. Box containing 2 capsules of 150 mg.
Dizolo 200 mg hard capsules are white. Box containing 7 capsules of 200 mg.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
LANOVA FARMACEUTICI S.r.l. Via Conca D’oro, 212 – 00141 Roma

Manufacturer
Laboratorio Farmaceutico C.T. S.r.l. - Via Dante Alighieri, 71 - 18038 Sanremo (Imperia)
LACHIFARMA S.r.l. – Laboratorio Chimico Salentino – S.S. 16 Zona Industriale – 73010 ZOLLINO (LE)