Fluconazole Zentiva
ItalyTable of Contents
PACKAGE LEAFLET: INFORMATION FOR THE USER
Fluconazole Zentiva 50 mg hard capsules, 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules
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, talk to your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Fluconazole Zentiva is and what it is used for
- What you need to know before taking Fluconazole Zentiva
- How to take Fluconazole Zentiva
- Possible side effects
- How to store Fluconazole Zentiva
- Contents of the pack and other information
1. What is Fluconazolo Zentiva and what is it used for?
Fluconazolo Zentiva belongs to a group of medicines known as "antifungals". The active substance is
fluconazole.
Fluconazolo Zentiva is used to treat fungal infections and may 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.
Fluconazolo Zentiva 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.
Fluconazolo Zentiva may also be prescribed to:
- prevent Candida infections (if your immune system is weakened or not functioning properly);
- prevent recurrence of cryptococcal meningitis.
2 What you should know before taking Fluconazolo Zentiva
Do not take Fluconazolo Zentiva if you:
- are allergic to the active substance, 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;
- 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 irregular heartbeat – “arrhythmia”);
- are taking erythromycin (an antibiotic used to treat bacterial infections).
Warnings and precautions
Talk to your doctor or pharmacist before taking Fluconazolo Zentiva.
Inform your doctor if:
- you have liver or kidney problems;
- you suffer from heart diseases, including cardiac arrhythmia;
- you have abnormal levels of potassium, calcium, or magnesium in your blood;
- you develop severe skin reactions (itching, skin redness, or difficulty breathing);
- you develop signs of “adrenal insufficiency”, a condition in which the adrenal glands do not produce adequate amounts of certain steroid hormones such as cortisol (chronic or long-lasting fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain).
Other medicines and Fluconazolo Zentiva
Inform 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 (an antihistamine used to treat allergies), cisapride (used to treat stomach disorders), pimozide (used to treat mental disorders), quinidine (used to treat irregular heartbeat – “arrhythmia”), or erythromycin (an antibiotic used to treat bacterial infections), as these must not be taken with Fluconazolo Zentiva (see section “Do not take Fluconazolo Zentiva if you”).
There are some medicines that may interact with Fluconazolo Zentiva. Inform your doctor if you are taking any of the following medicines:
- rifampicin or rifabutin (antibiotics used to treat bacterial infections);
- alfentanil, fentanyl (used as anaesthetics);
- amitriptyline, nortriptyline (used as 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 or 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, glibenclamide, glipizide, or tolbutamide;
- theophylline (used to control asthma);
- vitamin A (dietary supplement);
- ivacaftor (used to treat cystic fibrosis);
- amiodarone (used to treat irregular heartbeat “arrhythmias”);
- hydrochlorothiazide (a diuretic).
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
You must not take Fluconazolo Zentiva during pregnancy unless prescribed by your doctor.
You may continue breastfeeding after taking a single dose of Fluconazolo Zentiva up to 150 mg.
You must not breastfeed if you are taking repeated doses of Fluconazolo Zentiva.
Driving and using machines
Be aware that dizziness and seizures may occur when driving or using machines.
Fluconazolo Zentiva contains lactose and sodium
Fluconazolo Zentiva capsules contain lactose. If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially ‘sodium-free’.
3 How to take Fluconazolo Zentiva
Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The dose will depend on your individual needs and the condition being treated.
Swallow the capsule whole with a glass of water. It is best to take the capsules at the same time each day.
You may take the medicine with or without food.
The recommended doses of this medicine according to the infection are listed below:
Adults
| Condition | Dosage |
| Treatment of cryptococcal meningitis | 400 mg on the first day, then 200 to 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 to 400 mg once daily for 11 months up 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 mg to 400 mg on the first day, then 100 mg to 200 mg once daily until you are told to stop |
| Mucosal candidiasis – dosage depends on the site of infection | 50 mg to 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 mg to 200 mg once daily, or 200 mg three times weekly while at risk of developing an 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), then once weekly for 6 months while at risk of developing an infection |
| Treatment of skin mycoses and nail infections | Depending on the site of infection: 50 mg once daily, 150 mg once weekly, or 300 mg to 400 mg once weekly for 1 to 4 weeks (athlete’s foot may require up to 6 weeks; treatment of nail infections continues until the infected nail is fully replaced) |
| Prevention of Candida infections (if your immune system is weakened or not functioning properly) | 200 to 400 mg once daily while at risk of developing an infection |
Adolescents from 12 to 17 years
Always take the dose prescribed by your doctor (either the adult or pediatric dosage).
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 the severity and site of infection | 3 mg per kg of body weight once daily (6 mg per kg of body weight may be administered on the first day) |
| Cryptococcal meningitis or endemic fungal infections due to Candida | 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 aged 0 to 4 weeks
Use in children aged 3 to 4 weeks:
The same dose described above, 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 dose described above, administered once every 3 days. The maximum dose is 12 mg per kg of body weight every 72 hours.
Elderly
The same dose as for adults should be used unless you have kidney problems.
Patients with kidney problems
Your doctor may adjust the dose according to your kidney function.
If you take more Fluconazolo Zentiva than you should
Taking too many capsules at once may make you feel unwell. Inform your doctor immediately or go to the nearest emergency room.
Symptoms of accidental overdose may include experiencing sensations, seeing, hearing, or thinking things that are not real (hallucinations and paranoid behavior). Symptomatic treatment may be appropriate (with adequate supportive measures and, if necessary, gastric lavage).
If you forget to take Fluconazolo Zentiva
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 you remember. If it is almost time for your next dose, skip the missed dose and take the next dose at the usual time.
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 everybody experiences them.
Some people may experience allergic reactions, although serious allergic reactions are rare. If you experience any of the following symptoms, contact your doctor immediately:
- sudden breathlessness, difficulty breathing, or chest tightness;
- 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).
Fluconazolo Zentiva 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 Fluconazolo Zentiva 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 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, 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;
- red or purple skin discoloration possibly caused by reduced platelet count, 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 rhythm and rate;
- liver failure;
- allergic reactions (sometimes severe), including rashes with widespread blistering and skin peeling, severe skin reactions, swelling of the lips or face;
- hair loss.
Side effects with unknown frequency (frequency cannot be estimated from the available data):
- hypersensitivity reaction with skin rash, fever, swollen glands, increased levels of a type of white blood cell (eosinophilia), and inflammation of internal organs (liver, lungs, heart, kidneys, and large intestine) (drug reaction or eosinophilia and systemic symptoms (DRESS)).
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Fluconazolo Zentiva
Keep this medicine out of the sight and reach of children.
Store below 30 °C.
Keep in the original packaging to protect the medicine from moisture.
Do not use after the expiry date stated on the carton/blister after "Exp." The expiry date refers to the last day of that month.
Do not dispose of any medicines via 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 Fluconazolo Zentiva contains
The active substance is fluconazole.
Each capsule contains 50 mg of fluconazole.
Each capsule contains 100 mg of fluconazole.
Each capsule contains 150 mg of fluconazole.
Each capsule contains 200 mg of fluconazole.
The other components are: monohydrate lactose, pregelatinized starch, sodium lauryl sulfate, anhydrous colloidal silica, magnesium stearate, titanium dioxide (E171), gelatin.
The capsule ink contains shellac, black iron oxide (E172), polypropylene glycol, concentrated ammonia solution, potassium hydroxide.
Description of the appearance of Fluconazolo Zentiva and contents of the pack
Fluconazolo Zentiva 50 mg hard capsules: white, hard gelatin capsules marked with "50". Packaged in blisters and available in packs of 7, 28 or 100 capsules.
Fluconazolo Zentiva 100 mg hard capsules: white, hard gelatin capsules marked with “100”. Packaged in blisters and available in packs of 1, 7, 10, 28 or 100 capsules.
Fluconazolo Zentiva 150 mg hard capsules: white, hard gelatin capsules marked with "150". Packaged in blisters and available in packs of 1 or 2 capsules.
Fluconazolo Zentiva 200 mg hard capsules: white, hard gelatin capsules marked with "200". Packaged in blisters and available in packs of 7, 28 or 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Zentiva Italia S.r.l.
Viale Bodio 37/b
20158 Milan, Italy
Manufacturer:
Klocke Pharma Services GmbH - Strassburger Strasse 77, D-77767 Appenweier (Germany).
This medicine is authorised in EEA Member States under the following names:
Italy: Fluconazolo Zentiva 50 mg, 100 mg, 150 mg, 200 mg hard capsules