Zoloder

Package leaflet: Information for the user

Zoloder 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules

fluconazole
Generic medicine
Please read all of this leaflet carefully before you start 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 side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Zoloder is and what it is used for

Zoloder belongs to a group of medicines called "antifungals". The active substance is fluconazole.
Zoloder 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 (e.g. 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.

Zoloder may be prescribed to you to:

• prevent recurrence of cryptococcal meningitis;
• prevent recurrence of mucosal candidiasis;
• reduce recurrences of vaginal candidiasis;
• prevent Candida infections (if your immune system is weakened 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 (e.g. heart, lungs), or urinary tract;
• cryptococcal meningitis – a fungal infection of the brain.

Zoloder may be prescribed to you to:

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

2. What you need to know before taking Zoloder

Do not take Zoloder

• 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 cardiac arrhythmias);
• if you are taking erythromycin (an antibiotic used to treat bacterial infections).

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

• if you have previously developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers after using Zoloder;
• if you have liver or kidney problems;
• if you suffer from heart diseases, including cardiac arrhythmia;
• if you have abnormal levels of potassium, calcium, or magnesium in your blood;
• if severe skin reactions occur (such as itching, skin redness, or difficulty breathing);
• if symptoms of adrenal insufficiency appear, a condition in which the adrenal glands do not produce adequate amounts of certain steroid hormones such as cortisol (this may cause chronic or long-lasting fatigue, muscle weakness, loss of appetite, weight loss, or abdominal pain).

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

Other medicines and Zoloder
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Inform 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 cardiac arrhythmias), or erythromycin (an antibiotic used to treat bacterial infections), as these must not be taken with Zoloder (see section: "Do not take Zoloder").

Some medicines may interact with Zoloder. Inform your doctor if you are taking any of the following medicines, as dose adjustment or monitoring may be necessary to ensure these medicines continue to have the desired effect:

• 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);
• medicines that thin the blood to prevent clot formation (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);
• 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 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 patients with HIV);
• diabetes medicines such as chlorpropamide, glyburide, 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 irregular heartbeats – 'arrhythmias');
• hydrochlorothiazide (a diuretic);
• ibrutinib (used to treat blood cancer);
• lurasidone (used to treat schizophrenia).

Zoloder 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.
Do not take Zoloder if you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, unless otherwise advised by your doctor.
If you are planning to become pregnant, 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 appropriate contraception during treatment, which should continue for one week after the last dose.
Fluconazole taken during the first or second trimester of pregnancy may increase the risk of spontaneous abortion. Fluconazole taken during the first trimester of pregnancy may increase the risk of congenital malformations affecting the baby’s heart, bones, and/or muscles.
Cases of infants born with birth defects involving 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 Zoloder.
You must not breastfeed if you are taking repeated doses of Zoloder.

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

Zoloder contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e., essentially ‘sodium-free’.

3. How to take Zoloder

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

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.

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.

Use in the elderly
The same dose as recommended for adults should be used, unless you have renal problems.

Use in patients with renal impairment
Your doctor may adjust the dosage according to kidney function.

If you take more Zoloder 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, feeling, 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 Zoloder
Do not take a double dose to make up for forgotten 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 everyone gets them.
Stop taking ZOLODER 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).

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, contact your doctor or pharmacist. If you experience any of the following symptoms, contact your doctor immediately:

• Sudden shortness of breath, difficulty breathing, or tightness in the chest;
• 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 (may affect the mouth and tongue).

Zoloder 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 Zoloder 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.
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 rashes.

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, 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 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 levels or other changes in blood cells;
• Changes in blood chemistry (high levels of cholesterol, fats);
• 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, severe skin reactions, swelling of the lips and face;
• Hair loss.

Frequency not known (frequency cannot be estimated from 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 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 Zoloder

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.
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 Zoloder 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 Zoloder and package contents
Zoloder 100 mg hard capsules are yellow. Pack containing 10 capsules of 100 mg.
Zoloder 150 mg hard capsules are white. Pack containing 2 capsules of 150 mg.
Zoloder 200 mg hard capsules are white. Pack containing 7 capsules of 200 mg.
Not all pack sizes may be marketed.

Marketing Authorization Holder
EFFIK ITALIA S.p.A.
Via dei Lavoratori, 54, 20092 Cinisello Balsamo, Milan

Manufacturer
Laboratorio Farmaceutico C.T. S.r.l. - Via Dante Alighieri, 71 - 18038 Sanremo (Imperia)