Fluconazole Aurovitas

Package Leaflet: Information for the User

Fluconazole Aurovitas, 100 mg, hard capsules

Fluconazole Aurovitas, 200 mg, hard capsules

Fluconazolum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

• 1. What is Fluconazole Aurovitas and what is it used for
• 2. Important information before taking 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 is Fluconazole Aurovitas and what is it used for

Fluconazole Aurovitas belongs to a group of antifungal medicines. The active substance is flukonazol. Fluconazole Aurovitas is used to treat fungal infections 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, body ringworm, groin ringworm, nail fungus.

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. Important information before taking Fluconazole Aurovitas

When not to take Fluconazole Aurovitas

• If you are allergic to flukonazol, 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 (for stomach disorders).
• If you are taking pimozide (for mental disorders).
• If you are taking quinidine (for heart rhythm disorders).
• If you are taking erythromycin (an antibiotic used to treat infections).

Warnings and precautions

Before taking Fluconazole Aurovitas, you should discuss with 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 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.

There have been reports of severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), in patients taking Fluconazole Aurovitas. If you experience any symptoms of severe skin reactions, you should stop taking Fluconazole Aurovitas and seek medical attention 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, breastfeeding, or think you may be pregnant, you should consult your doctor or pharmacist before taking this medicine.

Driving and using machines

When driving or operating machinery, you should be aware that dizziness or seizures may occur.

Fluconazole Aurovitas contains lactose

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which is considered "sodium-free".

3. How to take Fluconazole Aurovitas

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Instructions for removing the capsule from the blister pack:

Pressing 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 the ends of the capsule pocket, as shown in Figure B.

Figure A
Figure B
The recommended dosage, depending on the type of infection, is presented below.

Adults

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 increased 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.

Dosage 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

Your doctor may prescribe a different dose, depending on your kidney function.

Taking more than the recommended dose of Fluconazole Aurovitas

Taking too many capsules at once may cause discomfort. You should contact the emergency department of your nearest hospital immediately. Symptoms of possible overdose may include hearing, vision, or feeling disturbances, thinking about untrue things (hallucinations and paranoid behavior). Symptomatic treatment (life-supporting treatment and gastric lavage, if necessary) may be indicated.

Stopping treatment with 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.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Fluconazole Aurovitas can cause side effects, although not everybody gets them.
If you notice any of the following symptoms, stop taking Fluconazole Aurovitas and seek medical attention 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, including any not listed in this leaflet, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Other side effects:

In addition, if any of the side effects get worse or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.

5. How to store Fluconazole Aurovitas

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.
There are no special storage instructions for this medicinal product.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Fluconazole Aurovitas contains

• The active substance is flukonazol.
• Each capsule contains 100 mg or 200 mg of flukonazol.
• The other ingredients are lactose monohydrate, corn 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 the imprint "FL" on the white or almost white opaque capsule cap and "100" on the white or almost white opaque capsule body, printed with yellow ink.
Fluconazole Aurovitas, 200 mg, hard capsules
Hard gelatin capsules, size "0", filled with white or almost white powder, with the imprint "FL" on the white or almost white opaque capsule cap and "200" on the white or almost white opaque capsule body, printed with 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 authorization holder and manufacturer

Marketing authorization 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 authorized 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 package leaflet: 02/2024