Fluconazole Aurovitas
How to use Fluconazole Aurovitas
Package Leaflet: Information for the User
Fluconazole Aurovitas, 100 mg, hard capsules
Fluconazole Aurovitas, 200 mg, hard capsules
Fluconazole
Read all of this leaflet carefully before taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
Contents of the pack and other information
- 1. What Fluconazole Aurovitas is and what it is used for
- 2. Before you take Fluconazole Aurovitas
- 3. How to take Fluconazole Aurovitas
- 4. Possible side effects
- 5. How to store Fluconazole Aurovitas
- 6. Contents of the pack and other information
1. What Fluconazole Aurovitas is and what it is used for
Fluconazole Aurovitas belongs to a group of medicines called antifungals. The active substance is fluconazole. Fluconazole Aurovitas is used to treat infections caused by fungi and can also be used to prevent fungal infections.
Adults
Your doctor may prescribe this medicine for the following fungal infections:
- Cryptococcal meningitis - a fungal infection of the brain,
- Coccidioidomycosis - a disease of the respiratory system,
- Candida infections detected in the blood, internal organs (e.g. heart, lungs) or urinary tract,
- Mucosal candidiasis (thrush) - infection of the mucous membranes of the mouth, throat, and mouth ulcers associated with the use of dentures,
- Candida genital infections - infections of the vagina or penis,
- Fungal skin infections - e.g. athlete's foot, fungal infections of the torso, groin, and fingernails.
Fluconazole Aurovitas can also be used to:
- prevent relapses of cryptococcal meningitis,
- prevent relapses of mucosal candidiasis (thrush),
- prevent relapses of vaginal candidiasis,
- prevent Candida infections (in patients with a weakened immune system).
Children and adolescents (from 0 to 17 years old)
Your doctor may prescribe this medicine to treat the following fungal infections:
- Mucosal candidiasis (thrush) - infection of the mucous membranes of the mouth or throat,
- Candida infections detected in the blood, internal organs (e.g. heart, lungs) or urinary tract,
- Cryptococcal meningitis - a fungal infection of the brain.
Fluconazole Aurovitas can also be used to:
- prevent Candida infections (if the patient's immune system is weak and not functioning properly),
- prevent relapses of cryptococcal meningitis.
2. Before you take Fluconazole Aurovitas
Do not take Fluconazole Aurovitas
- If you are allergic to fluconazole, other antifungal medicines, or any of the other ingredients of this medicine (listed in section 6). Symptoms may include itching, redness of the skin, or difficulty breathing.
- If you are taking astemizole, terfenadine (antihistamines 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 rhythm disorders).
- If you are taking erythromycin (an antibiotic used to treat infections).
Warnings and precautions
Before taking Fluconazole Aurovitas, tell your doctor or pharmacist:
- if you have kidney or liver problems,
- if you have heart disease, including heart rhythm disorders,
- if you have abnormalities in blood potassium, calcium, or magnesium levels,
- if you have severe skin reactions (itching, redness of the skin, difficulty breathing),
- if you have symptoms of "adrenal insufficiency", when the adrenal glands do not produce enough of certain steroid hormones, such as cortisol (chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain),
- if you have ever had a severe skin rash or skin peeling after taking Fluconazole Aurovitas.
Patients taking Fluconazole Aurovitas have experienced severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS). If you experience any of the severe skin reactions described in section 4, stop taking Fluconazole Aurovitas and seek medical help immediately.
Fluconazole Aurovitas with other medicines
Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Taking Fluconazole Aurovitas with food, drink, and alcohol
The medicine can be taken with or without food.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
When driving or operating machinery, consider that dizziness or seizures may occasionally occur.
Fluconazole Aurovitas contains lactose
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially "sodium-free".
3. How to take Fluconazole Aurovitas
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Instructions for removing a capsule from the blister pack:
Pressing on the middle part of the capsule pocket may cause deformation or damage to the capsule, as shown in Figure A. To avoid such damage, remove the capsule by pressing on the ends of the capsule pocket, as shown in Figure B.
Figure A
Figure B
Recommended dosing, depending on the type of infection, is presented below.
Adults
| Indication | Dosage |
| Treatment of cryptococcal meningitis | 400 mg on the first day, then 200 mg to 400 mg once daily for 6 to 8 weeks or longer if necessary. Sometimes the dose is increased to 800 mg |
| Prevention of relapses of cryptococcal meningitis | 200 mg once daily until the doctor decides to stop treatment |
| Treatment of coccidioidomycosis | 200 mg to 400 mg once daily for 11 months to 24 months or longer if necessary. Sometimes the dose may be increased to 800 mg |
| Treatment of Candida infections of internal organs | 800 mg on the first day, then 400 mg once daily until the doctor decides to stop treatment |
| Treatment of mucosal candidiasis (thrush) of the mouth, throat, and mouth ulcers associated with the use of dentures | 200 mg to 400 mg on the first day, then 100 mg to 200 mg until the doctor decides to stop treatment |
| Candida mucosal infections (thrush) - the dose depends on the location of the infection | 50 mg to 400 mg once daily for 7 to 30 days, until the doctor decides to stop treatment |
| Prevention of relapses of mucosal candidiasis (thrush) of the mouth and throat | 100 mg to 200 mg once daily, or 200 mg 3 times a week, if the patient is at high risk of relapse |
| Treatment of genital candidiasis | Single dose of 150 mg |
| Prevention of relapses of vaginal candidiasis | 150 mg every third day, for a total of 3 doses (days 1, 4, and 7), and then once a week for 6 months (if the patient is at high risk of relapse) |
| Treatment of fungal skin and nail infections | Depending on the location of the infection, 50 mg once daily, 150 mg once weekly, 300 to 400 mg once weekly for 1 to 4 weeks (in athlete's foot, treatment may be necessary for up to 6 weeks, in nail infections, treatment should be continued until the infected nail is replaced by a new one) |
Prevention of Candida infections (if the patient's immune system is weak and not functioning properly)
200 mg to 400 mg once daily, if the patient is at high risk of relapse
Use in children and adolescents
Capsules are not suitable for use in infants and young children. Other forms of this medicine may be more suitable; ask your doctor or pharmacist.
Adolescents from 12 to 17 years old
The dose prescribed by the doctor should be taken (as for adult patients or as for children).
Children up to 11 years old
The maximum dose in children is 400 mg per day. The dose will be determined based on the child's body weight in kilograms.
| Indication | Daily dose |
| Candida mucosal infections (thrush) of the mouth and throat - the dose and duration of treatment depend on the severity and location of the infection | 3 mg/kg body weight once daily (on the first day, a dose of 6 mg/kg body weight may be given) |
| Cryptococcal meningitis or Candida infections of internal organs | 6 to 12 mg/kg body weight once daily |
| Prevention of relapses of cryptococcal meningitis | 6 mg/kg body weight once daily |
| Prevention of Candida infections in children (if the immune system is not functioning properly) | 3 to 12 mg/kg body weight once daily |
Dosing in children from 0 to 4 weeks old
Children from 3 to 4 weeks old:The same dose as above, but given every other day. The maximum dose is 12 mg/kg body weight every 48 hours.
Children under 2 weeks old:The same dose as above, given every 3 days. The maximum dose is 12 mg/kg body weight every 72 hours.
Elderly patients
The usual adult dose is given, unless the patient has kidney problems.
Patients with kidney problems
The doctor may prescribe a different dose, depending on the patient's kidney function.
Taking more Fluconazole Aurovitas than prescribed
Taking too many capsules at once may cause discomfort. Seek immediate medical attention. Symptoms of possible overdose may include hearing, vision, or sensation disturbances, and thinking about things that are not true (hallucinations and paranoid behavior). Treatment may be supportive (life-supporting and stomach flushing, if necessary).
Missing a dose of Fluconazole Aurovitas
Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose.
4. Possible side effects
Like all medicines, Fluconazole Aurovitas can cause side effects, although not everybody gets them. If you experience any of the following symptoms, stop taking Fluconazole Aurovitas and seek medical help immediately:
- widespread rash, high fever, and swollen lymph nodes (DRESS or hypersensitivity syndrome),
Some patients may experience allergic reactions, but severe allergic reactions are rare. If you experience any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Other side effects:
If any of the following side effects get worse, or if you experience any side effects not listed in this leaflet, tell your doctor or pharmacist.
Reporting side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the national reporting system.
5. How to store Fluconazole Aurovitas
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 carton after EXP. The expiry date refers to the last day of that month.
6. Contents of the pack and other information
What Fluconazole Aurovitas contains
- The active substance is fluconazole.
- Each capsule contains 100 mg or 200 mg of fluconazole.
- The other ingredients are lactose monohydrate, maize starch, sodium lauryl sulfate, colloidal silicon dioxide, and magnesium stearate.
- The capsule shell containstitanium dioxide (E 171), sodium lauryl sulfate, and gelatin.
- The ink containsshellac, iron oxide yellow (E 172).
What Fluconazole Aurovitas looks like and contents of the pack
Fluconazole Aurovitas, 100 mg, hard capsules
Hard gelatin capsules, size "2", filled with white or almost white powder, with "FL" printed on the white or almost white opaque capsule cap and "100" printed on the white or almost white opaque capsule body, using yellow ink.
Fluconazole Aurovitas, 200 mg, hard capsules
Hard gelatin capsules, size "0", filled with white or almost white powder, with "FL" printed on the white or almost white opaque capsule cap and "200" printed on the white or almost white opaque capsule body, using yellow ink.
Fluconazole Aurovitas is available in blister packs in cartons.
Pack sizes:
1, 2, 3, 4, 6, 7, 10, 12, 14, 20, 28, 30, 42, 50, 60, 100, and 500 capsules, hard.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warszawa
Manufacturer/Importer:
APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Belgium:
Fluconazol AB 50 mg/100 mg/150 mg/200 mg harde capsules
Luxembourg:
Fluconazol AB 50 mg/100 mg/150 mg/200 mg harde capsules
Poland:
Fluconazole Aurovitas
Portugal:
Fluconazol Ritisca
Spain:
Fluconazol Aurovitas 50 mg /100 mg / 150 mg / 200 mg cápsulas duras EFG
Date of last revision of the leaflet: 02/2024
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- ImporterAPL Swift Services (Malta) Ltd. Generis Farmacêutica, S.A.
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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