Dizolo

Package leaflet: Information for the user

DIZOLO 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules

Fluconazole
Generic medicine
Please read all of this leaflet carefully before you take 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, pharmacist or nurse.
• 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 side effect, including 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 taking 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 substance is fluconazole.
Dizolo is used to treat fungal infections and can 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 mouth inflammation;
• genital candidiasis – infection of the vagina or penis;
• skin infections – for example athlete's foot, ringworm, genital itching, nail infections.

Dizolo 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 (from 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.

Dizolo 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 Dizolo

Do not take Dizolo

• if you are allergic to fluconazole, to other medicines 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 or terfenadine (antihistamine medicines 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 Dizolo

• 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 you develop severe skin reactions (itching, skin redness, 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, skin peeling, blisters, and/or mouth ulcers after taking fluconazole.

Severe skin reactions, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported with fluconazole treatment. Stop taking Dizolo 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 your fungal infection does not improve, as alternative antifungal therapy may be needed.

Other medicines and Dizolo
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor immediately if you are taking astemizole or 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 Dizolo (see section: "Do not take Dizolo if").

Some medicines may interact with Dizolo. Inform your doctor if you are taking any of the following medicines, as dose adjustment or monitoring may be needed to ensure these medicines continue to work as intended:

• rifampicin or rifabutin (antibiotics used to treat bacterial infections);
• abrocitinib (used to treat atopic dermatitis, also known as atopic eczema);
• alfentanil, fentanyl (anesthetics);
• amitriptyline, nortriptyline (antidepressants);
• amphotericin B, voriconazole (antifungals);
• blood-thinning medicines 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 carcinoma);
• ciclosporin, everolimus, sirolimus, or tacrolimus (used to prevent organ 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 lower 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);
• 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 medicines 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).

Dizolo with food and drink
You may take this medicine with or without food.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist 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 treatment cycles 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 may be pregnant, or if you are trying to become pregnant, unless specifically advised by your doctor. If you become pregnant while taking this medicine or within one week after the most recent dose, contact your doctor immediately.
Fluconazole taken during the first or second trimester of pregnancy may increase the risk of miscarriage. Fluconazole taken during the first trimester may increase the risk of birth defects affecting the baby’s heart, bones, and/or muscles.
Cases of babies born with birth defects affecting the skull, ears, and thigh and elbow bones have been reported in women treated for three months or more with high doses (400–800 mg daily) of fluconazole for coccidioidomycosis. The link between fluconazole and these cases is not fully established.
You may continue breastfeeding after taking a single 150 mg dose of Dizolo.
You must not breastfeed if you are taking repeated doses of Dizolo.

Driving and using machines
Be aware that dizziness or seizures may occur while driving or operating machinery.

Dizolo contains lactose (milk sugar) and sodium (salt)
This medicine contains a small amount of lactose (milk sugar). If your doctor has informed you that you have an intolerance to certain sugars, consult 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 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

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 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.
Elderly
The same dose as recommended for adults should be used, unless you have renal problems.
Patients with renal impairment
Your doctor may adjust the dosage according to kidney function.
If you take more Dizolo 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 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 almost time for your next dose, do not take the missed dose.
If you have any questions about the use of this medicine, consult 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 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 side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
If you experience any of the following symptoms, contact 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 patches;
• skin rashes;
• severe skin reactions, for example rashes causing blisters (which may affect the mouth and tongue).

Dizolo may 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 Dizolo and contact 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.
The 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.

The uncommon side effects (may affect up to 1 in 100 people) are:

• 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, 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 malaise, fever.

The rare side effects (may affect up to 1 in 1,000 people) are:

• lower than normal levels of white blood cells, which help fight infections, and of platelets, which are necessary for blood clotting;
• abnormal skin colouration (red or purplish), which may be caused by a reduction in platelets, other changes in blood cells;
• changes in blood chemistry (elevated cholesterol or fat levels);
• low potassium levels in the blood;
• chills;
• abnormal 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 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 colon) (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, pharmacist, or nurse. You can also report side effects directly via the national reporting system at the website: 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 stated on the label after "Exp.". The expiry date refers to the last day of that month.
Store below 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents 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 components are: Capsule contents: monohydrate lactose, pregelatinized starch, magnesium stearate, anhydrous colloidal silica, sodium lauryl sulfate. Capsule shell contents: 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. Pack containing 10 capsules of 100 mg.
Dizolo 150 mg hard capsules are white. Pack containing 2 capsules of 150 mg.
Dizolo 200 mg hard capsules are white. Pack containing 7 capsules of 200 mg.
Not all pack sizes may be marketed.

Marketing Authorization Holder
LANOVA FARMACEUTICI S.r.l. Via Conca D’oro, 212 – 00141 Rome, Italy

Manufacturer
Laboratorio Farmaceutico C.T. S.r.l. - Via Dante Alighieri, 71 - 18038 Sanremo (Imperia)
LACHIFARMA S.r.l. – Salentino Chemical Laboratory – S.S. 16, Industrial Zone – 73010 Zollino (LE)