Fluconazole Doc Generici
Italy
Table of Contents
- Patient Information Leaflet
- FLUCONAZOLE DOC Generici 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules
- 1. What FLUCONAZOLO DOC Generici is and what it is used for
- 2. What you need to know before taking FLUCONAZOLO DOC Generici
- 3. How to take FLUCONAZOLO DOC Generici
- 4. Possible side effects
- 5. How to store FLUCONAZOLE DOC Generici
- 6. Package contents and other information
Patient Information Leaflet
FLUCONAZOLE DOC Generici 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules
Equivalent medicine
Please read all of 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 give it to others, even if they have the same symptoms as yours, because it could 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:
- What FLUCONAZOLE DOC Generici is and what it is used for
- What you need to know before taking FLUCONAZOLE DOC Generici
- How to take FLUCONAZOLE DOC Generici
- Possible side effects
- How to store FLUCONAZOLE DOC Generici
- Contents of the pack and other information
1. What FLUCONAZOLO DOC Generici is and what it is used for
FLUCONAZOLO DOC Generici belongs to a group of medicines known as "antifungals". The active substance is fluconazole.
FLUCONAZOLO DOC Generici 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 occurring 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 – e.g. athlete’s foot, ringworm, genital itching, nail infections.
FLUCONAZOLO DOC Generici may be prescribed to you for:
- Preventing recurrence of cryptococcal meningitis.
- Preventing recurrence of mucosal candidiasis.
- Reducing recurrences of vaginal candidiasis.
- Preventing 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 occurring in the bloodstream, organs (e.g. heart, lungs), or urinary tract.
- Cryptococcal meningitis – a fungal infection of the brain.
FLUCONAZOLO DOC Generici may be prescribed to you for:
- Preventing Candida infections (if your immune system is weakened or not functioning properly).
- Preventing recurrence of cryptococcal meningitis.
2. What you need to know before taking FLUCONAZOLO DOC Generici
Do not take FLUCONAZOLO DOC Generici
- if you are allergic to the active substance 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, 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 erythromycin (an antibiotic used to treat bacterial infections)
- if you are taking quinidine (used to treat "arrhythmias", irregular heartbeats)
Warnings and precautions
Talk to your doctor or pharmacist before taking FLUCONAZOLO DOC Generici
- if you have liver or kidney problems
- if signs of adrenal gland problems (adrenal insufficiency) appear, whereby 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 suffer from heart disease, including cardiac arrhythmia
- if you have abnormal levels of potassium, calcium, or magnesium in your blood
- if severe skin reactions occur (itching, skin redness, or difficulty breathing)
Other medicines and FLUCONAZOLO DOC Generici
Inform your doctor immediately if you are taking astemizole, terfenadine (antihistamine
used to treat allergies), cisapride (used to treat stomach disorders), pimozide (used to treat
mental disorders), quinidine, amiodarone (used to treat cardiac arrhythmias), or erythromycin
(an antibiotic used to treat bacterial infections), as these must not be taken with
FLUCONAZOLO DOC Generici (see section: “Do not take FLUCONAZOLO DOC Generici if you”).
Some medicines may interact with FLUCONAZOLO DOC Generici. Inform your doctor if you are taking any of the following medicines:
- hydrochlorothiazide (a diuretic)
- rifampicin or rifabutin (antibiotics used to treat bacterial infections)
- alfentanil, fentanyl (anaesthetics)
- 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, felodipine, and losartan (used to treat high blood pressure)
- 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, 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)
- vitamin A (dietary supplement)
- ivacaftor (used to treat cystic fibrosis)
- amiodarone (used to treat "arrhythmias", irregular heartbeats) (see section “Do not take FLUCONAZOLO DOC Generici”)
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
FLUCONAZOLO DOC Generici with food and drink
You may take this medicine with or without food.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
You may continue breastfeeding after taking a single dose of FLUCONAZOLO DOC Generici up to 200 mg.
You must not breastfeed if you are taking repeated doses of FLUCONAZOLO DOC Generici.
Driving and using machines
Be aware that dizziness or seizures may occur while driving or operating machinery.
FLUCONAZOLO DOC Generici contains lactose
This medicine contains lactose (milk sugar).
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
3. How to take FLUCONAZOLO DOC Generici
Always 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
| Condition | Dosage |
| Treatment of cryptococcal meningitis | 400 mg on the first day, then 200–400 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 | 200–400 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 | 200–400 mg on the first day, then 100–200 mg until you are told to stop |
| Mucosal candidiasis – dosage depends on the site of infection | 50–400 mg once daily for 7–30 days until you are told to stop |
| Prevention of oral mucosal infections, throat infections | 100–200 mg once daily, or 200 mg three times weekly while at risk of developing 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 infection |
| Skin mycosis and nail infections | Depending on the site of infection: 50 mg once daily, 150 mg once weekly, or 300–400 mg once weekly for 1–4 weeks. (Athlete’s foot may require up to 6 weeks; treatment of nail infections continues until the infected nail is replaced) |
| Prevention of Candida infections (if your immune system is weakened or not functioning properly) | 200–400 mg once daily while at risk of developing infection |
Use in children and adolescents
Adolescents from 12 to 17 years
Always take the dose prescribed by your doctor (either the adult dosage or the 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 (on the first day, 6 mg per kg of body weight may be administered) |
| Cryptococcal meningitis or endemic Candida fungal infections | 6 mg to 12 mg per kg of body weight |
| Prevention of Candida infection in children (if their immune system is not | 3 mg to 12 mg per kg of body weight |
| functioning properly) |
Use in children from 0 to 4 weeks of age
Use in children from 3 to 4 weeks of age:
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 that recommended for adults should be used, unless you have renal
impairment.
Patients with renal problems
Your doctor may adjust the dosage according to your kidney function.
If you take more FLUCONAZOLE DOC Generici than you should
Taking too many capsules at once could cause you problems. Immediately contact your
doctor 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 behavior). Symptomatic treatment may be appropriate (with adequate supportive measures and, if necessary, gastric lavage).
If you forget to take FLUCONAZOLE DOC Generici
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 almost time for your next dose, skip the missed dose and take the next dose at the regular time.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, FLUCONAZOLO DOC Generici may cause side effects,
although not everybody gets them.
Some people may experience allergic reactions, although serious allergic reactions are
rare. If you experience any side effects, including those not listed in
this leaflet, consult your doctor or pharmacist. If you experience any of the following symptoms,
contact your doctor immediately.
- sudden breathlessness, 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 (which may affect the mouth and tongue).
FLUCONAZOLO DOC Generici may affect the liver. Symptoms of liver problems
include:
- fatigue
- loss of appetite
- vomiting
- yellowing of the skin and whites of the eyes (jaundice).
FLUCONAZOLO DOC Generici may affect the adrenal glands and levels of
steroid hormones produced. Symptoms of adrenal gland problems include:
- fatigue
- muscle weakness
- loss of appetite
- weight loss
- abdominal pain
If you experience any of these symptoms, stop taking FLUCONAZOLO DOC Generici and
contact your doctor immediately.
Other side effects:
If any of the side effects worsen, or if you notice any side effects not listed in
this package leaflet, inform your doctor or pharmacist.
Common side effects (may affect up to 1 in 10 people) are:
- headache
- stomach upset, diarrhoea, nausea, vomiting
- increased liver function test values in blood tests
- skin rashes.
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, indigestion, 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.
Rare side effects (may affect up to 1 in 1,000 people) are:
- lower than normal levels of white blood cells, which help defend against infections, and of platelets, which are necessary for blood clotting
- altered skin colouration (red or purplish), which may be caused by a reduction in platelets, 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 skin rashes with widespread blistering and peeling of the skin, severe skin reactions, swelling of the lips and face
- hair loss.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet,
please contact your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at the following website:
http://www.agenziafarmaco.gov.it/it/responsabili . By reporting side effects, you can
help provide more information on the safety of this medicine.
5. How to store FLUCONAZOLE DOC Generici
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date stated on the label after “Exp”. The expiry date refers to the last day of the 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 FLUCONAZOLO DOC Generici contains
- The active substance is fluconazole.
- Each hard capsule contains 100 mg, 150 mg or 200 mg of fluconazole.
- The excipients are: anhydrous colloidal silica, magnesium stearate, talc, maize starch, povidone, anhydrous lactose, gelatin, titanium dioxide (E171) and indigo carmine (E132).
Description of the appearance of FLUCONAZOLO DOC Generici and package contents
FLUCONAZOLO DOC Generici 100 mg capsules are turquoise and white.
FLUCONAZOLO DOC Generici 150 mg capsules are blue and white.
FLUCONAZOLO DOC Generici 200 mg capsules are dark blue and white.
100 mg capsules are available in blisters of 7, 10, 14, 20, 28, 50 or 100 capsules.
150 mg capsules are available in blisters of 1, 2, 4, 6, 12, 50 or 100 capsules.
200 mg capsules are available in blisters of 7, 10, 14, 20, 28, 30, 50 or 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milan - Italy.
Manufacturer
La.Fa.Re. S.r.l. – Via Sacerdote Benedetto Cozzolino, 77 – 80056 Ercolano (NA) - Italy.
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Italy: FLUCONAZOLO DOC Generici hard capsules
This patient information leaflet was last approved on