Fluconazole Aurobindo
Italy
Table of Contents
Package leaflet: Information for the user
Fluconazole Aurobindo 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 they have the same symptoms as you, because it could be harmful.
- If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Fluconazole Aurobindo is and what it is used for
- What you need to know before taking Fluconazole Aurobindo
- How to take Fluconazole Aurobindo
- Possible side effects
- How to store Fluconazole Aurobindo
- Contents of the pack and other information
1. What Fluconazolo Aurobindo is and what it is used for
Fluconazolo Aurobindo belongs to a group of medicines known as "antifungals". The active substance is fluconazole.
Fluconazolo Aurobindo 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 – e.g. athlete's foot, ringworm, genital itching, nail infections
Fluconazolo Aurobindo may also be prescribed 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 Aurobindo 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 need to know before taking Fluconazole Aurobindo
Do not take Fluconazole Aurobindo:
- 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, terfenadine (antihistamine medicines for 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 Fluconazole Aurobindo.
Tell your doctor if:
- you have liver or kidney problems
- you suffer from heart diseases, including heart arrhythmia
- you have abnormal levels of potassium, calcium, or magnesium in your blood
- severe skin reactions occur (such as itching, skin redness, or difficulty breathing)
- symptoms of “adrenal insufficiency” appear, 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 Fluconazole Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Tell 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 (used to treat heart arrhythmias), or erythromycin (an antibiotic used to treat bacterial infections), as these must not be taken with Fluconazole Aurobindo (see section: “Do not take Fluconazole Aurobindo”).
Some medicines may interact with Fluconazole Aurobindo. 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 anesthetics)
- amitriptyline, nortriptyline (used as antidepressants)
- amphotericin B, voriconazole (antifungals)
- medicines that thin the blood to prevent blood clots (warfarin, indanedione, 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)
- 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 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 (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)
- amiodarone (used to treat irregular heartbeats “arrhythmias”)
- hydrochlorothiazide (used to treat fluid retention)
Fluconazole Aurobindo with food and drink and alcohol
You may take this medicine with or without food.
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.
Driving and using machines
Be aware that dizziness or seizures may occasionally occur while driving or operating machinery.
Fluconazole Aurobindo contains lactose monohydrate, a type of sugar. If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.
3. How to take Fluconazole Aurobindo
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.
Instructions for removing the capsule from the blister pack cavity:
Pushing in the centre of the capsule cavity may cause deformation or rupture of the capsule, as shown in Fig. A. To avoid such damage, remove the capsule by pushing on the edge of the cavity as shown in Fig. B.
Fig. A Fig. B
The recommended doses of this medicine, depending on the infection, are listed below:
Adults
| Condition | Dose |
| 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. 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 – dose depends on site of infection | 50–400 mg once daily for 7–30 days until you are told to stop |
| Prevention of oral mucosal infections and throat infections | 100–200 mg once daily, or 200 mg three times weekly while at risk of infection |
| Genital candidiasis | 150 mg as a single dose |
| Reducing recurrences of vaginal candidiasis | 150 mg every third day for a total of 3 doses (day 1, 4, and 7), then once weekly for 6 months while at risk of infection |
| Skin mycoses and nail infections | Depending on 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 fully replaced) | |
| Prevention of Candida infections (if your immune system is weakened or not functioning properly) | 200–400 mg once daily while at risk of infection |
Use in children and adolescents
Adolescents from 12 to 17 years
Follow the dose prescribed by the doctor (dosage for both adults and children).
Children up to 11 years
The maximum dose in children is 400 mg per day.
The dose will be determined according to 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 |
| Prevent Candida infection in children (if their immune system is not functioning properly) | 3 mg to 12 mg per kg of body weight |
Use in children from 0 to 4 weeks of age
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.
Your doctor may sometimes prescribe doses different from those listed here. Always take the medicine exactly
as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Use in elderly patients
The same dose recommended for adults should be used unless you have renal problems.
Use in patients with renal problems
Your doctor may adjust the dosage according to renal function.
If you take more Fluconazolo Aurobindo 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 experiencing sensations, seeing, hearing, or believing things that are not real (hallucinations and paranoid behaviour). Symptomatic treatment may be advisable (with appropriate supportive measures and, if necessary, gastric lavage).
If you forget to take Fluconazolo Aurobindo
Do not take a double dose to make up for a missed dose. 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 only the next scheduled dose.
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 everybody gets them.
Some people may experience allergic reactions, although serious allergic reactions are rare. If you experience any of the following symptoms, inform 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 rashes
- skin rashes
- severe skin reactions, for example rashes causing blisters (which may affect the mouth and tongue)
Fluconazole Aurobindo 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 Fluconazole Aurobindo and inform your doctor immediately.
Other side effects:
Additionally, 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, which 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, which 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, which 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 levels of potassium 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
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 Aurobindo
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of 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. Package contents and other information
What Fluconazolo Aurobindo contains
- The active substance is fluconazole.
- Each capsule contains 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole.
- The excipients are: monohydrate lactose, maize starch, sodium lauryl sulfate, anhydrous colloidal silica, and magnesium stearate.
The capsule shell contains titanium dioxide (E171), sodium lauryl sulfate, and gelatin.
The printing ink contains shellac, propylene glycol, and yellow iron oxide.
Description of the appearance of Fluconazolo Aurobindo and package contents
Fluconazolo 50 mg capsules
White to off-white, hard gelatin capsules of size '4', filled with white to off-white powder and printed with 'E' on the white to off-white opaque cap and '95' on the white to off-white body using yellow ink.
Fluconazolo Aurobindo 100 mg
White to off-white, hard gelatin capsules of size '2', filled with white to off-white powder and printed with 'E' on the white to off-white opaque cap and '96' on the white to off-white body using yellow ink.
Fluconazolo Aurobindo 150 mg hard capsules
White to off-white, hard gelatin capsules of size '1', filled with white to off-white powder and printed with 'E' on the white to off-white opaque cap and '97' on the white to off-white body using yellow ink.
Fluconazolo Aurobindo 200 mg
White to off-white, hard gelatin capsules of size '0', filled with white to off-white powder and printed with 'E' on the white to off-white opaque cap and '98' on the white to off-white body using yellow ink.
Fluconazolo Aurobindo capsules are available in:
PVC/PVDC-aluminum transparent blister packs:
Fluconazolo 50 mg / 100 mg / 150 mg / 200 mg: 1, 2, 3, 4, 5, 6, 7, 10, 14, 20, 21, 28, 30, 50, 60, 90, 100 capsules.
HDPE container:
Fluconazolo 50 mg / 100 mg: 30 and 1000 capsules
Fluconazolo 200 mg: 30 and 500 capsules
It is possible that not all pack sizes are marketed.
Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l.
Via S. Giuseppe 102
21047 Saronno (VA)
Italy
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000
Malta
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Austria: Fluconazol Aurobindo 50mg/ 100mg/ 150mg/ 200mg Hartkapseln
Czech Republic: Fluconazol Aurobindo 50mg/ 100mg/ 150mg tvrdé tobolky
Denmark: Fluconazol “Aurobindo”
Germany: Fluconazol Aurobindo 50mg/ 100mg/ 150mg/ 200mg Hartkapseln
Greece: Fluconazole Aurobindo 50mg/ 100mg/ 150mg mg καψάκια, σκληρά
Hungary: Fluconazol Aurobindo 50mg/ 100mg/ 150mg/ 200mg kemény kapszula
Ireland: Fluconazole Aurobindo 50mg/ 150mg/ 200mg capsules, hard
Italy: Fluconazolo Aurobindo 50mg/ 100mg/ 150mg/ 200mg capsule rigide
Netherlands: Fluconazol Aurobindo 50mg/ 150mg/ 200mg, capsules
Poland: Fluconazole Aurobindo
Portugal: Fluconazol Aurobindo 50mg/ 100mg/ 150mg/ 200mg cápsulas duras
Romania: Fluconazol Aurobindo 50mg/ 100mg/ 150mg capsules
Slovakia: Fluconazole Aurobindo 50mg/ 100mg/ 150mg/ 200mg tvrdé kapsuly
Spain: Fluconazol Aurobindo 50mg/ 100mg/ 150mg/ 200mg cápsulas duras
Sweden: Fluconazol Aurobindo 50mg/ 100mg/ 150mg/ 200mg kapslar, hårda
United Kingdom: Fluconazole 50mg/ 100mg/ 150mg/ 200mg capsules, hard
This patient information leaflet was last approved on