Fluconazole aurovitas

Package leaflet: Information for the user

Fluconazole Aurovitas, 100 mg, hard capsules
Fluconazole Aurovitas, 200 mg, hard capsules
Fluconazolum
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Table of contents of the leaflet:

1. What Fluconazole Aurovitas is and what it is 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 Fluconazole Aurovitas is and what it is used for

Fluconazole Aurovitas belongs to a group of antifungal medicines. The active substance is
fluconazole. Fluconazole Aurovitas is used to treat fungal infections and may also be used to prevent Candida yeast infections. The most common cause of fungal infections are yeasts of the genus known in Latin as Candida.
Adults
Your doctor may prescribe this medicine for the following fungal infections:

• cryptococcal meningitis – a fungal infection of the brain,
• coccidioidomycosis – a respiratory tract disease,
• infections caused by Candida yeasts detected in the blood, internal organs (e.g. heart, lungs) or urinary tract,
• mucosal yeast infections (thrush) – infection of the mucous membranes of the mouth, throat, and denture-related stomatitis,
• genital yeast infections – infections of the vagina or penis,
• skin mycoses – e.g. athlete's foot, body ringworm, groin infection (tinea cruris), nail infections.

Fluconazole Aurovitas may also be used for:

• prevention of recurrent cryptococcal meningitis,
• prevention of recurrent mucosal yeast infections,
• prevention of recurrent vaginal Candida infections,
• prevention of Candida yeast infections (in patients with weakened or impaired immune systems).

Children and adolescents (aged 0 to 17 years)
Your doctor may prescribe this medicine to treat the following fungal infections:

• mucosal yeast infections (thrush) – infections of the mucous membranes of the mouth or throat,
• infections caused by Candida yeasts detected in the blood, internal organs (e.g. heart, lungs) or urinary tract,
• cryptococcal meningitis – a fungal infection of the brain.

Fluconazole Aurovitas may also be used for:

• prevention of Candida yeast infections (in patients with weakened or impaired immune systems),
• prevention of recurrent cryptococcal meningitis.

2. Important information before taking Fluconazole Aurovitas

When not to take Fluconazole Aurovitas

• If the patient is 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 the patient is taking astemizole or terfenadine (antihistamine medicines used to treat allergies).
• If the patient is taking cisapride (used to treat stomach disorders).
• If the patient is taking pimozide (used to treat mental disorders).
• If the patient is taking quinidine (used to treat heart rhythm disorders).
• If the patient is taking erythromycin (an antibiotic used to treat infections).

Warnings and precautions
Before starting to take Fluconazole Aurovitas, discuss with your doctor or
pharmacist:

• if the patient has kidney or liver problems,
• if the patient has heart conditions, including heart rhythm disorders,
• if the patient has blood abnormalities in potassium, calcium or magnesium levels,
• if the patient experiences severe skin reactions (itching, skin redness, difficulty breathing),
• if the patient develops symptoms of "adrenal insufficiency", when 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 the patient has ever developed a severe skin rash or skin peeling, blisters and/or mouth ulcers after taking Fluconazole Aurovitas.

Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have occurred in patients treated with Fluconazole Aurovitas. If the patient experiences any of the symptoms of severe skin reactions described in section 4, treatment with Fluconazole Aurovitas must be stopped immediately and medical help should be sought without delay.
Consult a doctor or pharmacist if the fungal infection does not improve, as alternative antifungal treatment may be necessary.

Fluconazole Aurovitas and other medicines
Inform your doctor immediately if you are taking astemizole, terfenadine (antihistamines used for allergies), cisapride (used for stomach disorders), pimozide (used for mental disorders), quinidine (used for heart rhythm disorders), or erythromycin (an antibiotic used to treat infections), as these should not be used together with Fluconazole Aurovitas (see section "When not to take Fluconazole Aurovitas").

There are also other medicines that may interact with Fluconazole Aurovitas. If the patient is taking any of the following medicines, ensure that the doctor is informed, as dose adjustment or monitoring may be necessary to ensure the medicines remain effective:

• rifampicin or rifabutin (antibiotics used to treat infections),
• abrocitinib (used to treat atopic dermatitis, also known as atopic eczema),
• alfentanil, fentanyl (anaesthetic medicines),
• amitriptyline, nortriptyline (antidepressants),
• amphotericin B, voriconazole (antifungal medicines),
• medicines that reduce blood clotting and prevent blood clots (warfarin, indanedione or similar medicines),
• benzodiazepines (midazolam, triazolam or similar medicines) used to aid sleep or for calming,
• carbamazepine, phenytoin (used to treat epilepsy), nifedipine, isradipine, amlodipine, verapamil, felodipine and losartan (used to treat high blood pressure),
• olaparib (used to treat ovarian cancer),
• cyclosporine, 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 cholesterol levels,
• methadone (a painkiller),
• celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (non-steroidal anti-inflammatory drugs - NSAIDs),
• oral contraceptives,
• prednisolone (a steroid),
• zidovudine, also known as AZT; saquinavir (used in HIV patients),
• antidiabetic medicines such as chlorpropamide, glibenclamide, glipizide or tolbutamide,
• theophylline (used for asthma),
• tofacitinib (used to treat rheumatoid arthritis),
• tolvaptan (used to treat hyponatremia (low blood sodium levels) or to slow the worsening of kidney function),
• vitamin A (dietary supplement),
• ivacaftor (used alone or in combination with other medicines for the treatment of cystic fibrosis),
• amiodarone (used for heart rhythm disorders "cardiac arrhythmias"),
• hydrochlorothiazide (a diuretic and blood pressure-lowering medicine),
• ibrutinib (used to treat blood cancer),
• lurasidone (used to treat schizophrenia).

Tell your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.

Taking Fluconazole Aurovitas with food, drink and alcohol
This medicine can be taken with or without food.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before taking this medicine.
If the patient plans to become pregnant, it is recommended to wait one week after taking a single dose of fluconazole before attempting conception.
For longer treatment courses with fluconazole, discuss with your doctor the need for appropriate contraception during treatment and for one week after the last dose.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should not take Fluconazole Aurovitas unless specifically advised by a doctor.
If the patient becomes pregnant while taking this medicine or within one week after the last dose, she should contact her doctor immediately.
Fluconazole taken during the first or second trimester of pregnancy may increase the risk of miscarriage. Fluconazole taken during the first trimester of pregnancy may increase the risk of congenital heart, bone and/or muscle abnormalities in the newborn.
Cases of infants born with craniofacial, ear, femoral and/or elbow malformations have been reported in mothers treated for coccidioidomycosis with high doses of fluconazole (400–800 mg daily) for at least 3 months. The relationship between fluconazole use and these cases is not fully established.

Breastfeeding may continue after a single 150 mg dose of fluconazole. Breastfeeding should be avoided if the patient is taking repeated doses of Fluconazole Aurovitas.

Driving and using machines
When driving or operating machinery, bear in mind that dizziness or seizures may occur rarely.

Fluconazole Aurovitas contains lactose monohydrate, a type of sugar.
If the patient has been previously diagnosed with an intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Fluconazole Aurovitas contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. the medicine is considered "sodium-free".

3. How to take Fluconazole Aurovitas

This medicine should always be taken exactly as directed by the physician. If in doubt, consult
the doctor or pharmacist.
If the required dose cannot be achieved with capsules of this strength, other fluconazole-containing
medicines in capsules of different strengths are available on the market and may be used for this purpose.
The capsule should be swallowed 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:
Pressing the center of the capsule cavity may deform or damage the capsule, as shown in Figure A. To avoid such damage, press on the edges of the cavity to remove the capsule, as shown in Figure B.

Fig. A Fig. B
The recommended dosage, depending on the type of infection, is given below.
Adults

Use in children and adolescents The capsules are not suitable for use in infants and
young children. Other formulations of this medicine may be more appropriate; consult a doctor or
pharmacist.
Adolescents aged 12 to 17 years
Administer the dose prescribed by the doctor (as in adult patients or as in children).
Children up to 11 years of age
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 aged 0 to 4 weeks
Children aged 3 to 4 weeks:
The same dose as above, but administered every other day. The maximum dose is 12 mg/kg body weight every 48 hours.
Children under 2 weeks of age:
The same dose as above, administered every 3 days. The maximum dose is 12 mg/kg body weight every 72 hours.

Elderly patients
The usual adult dose should be administered, unless the patient has renal impairment.

Patients with renal impairment
The physician may adjust the dosage depending on renal function.

Overdose of Fluconazole Aurovitas
Taking too many capsules at once may cause feeling unwell. Immediate contact should be made with the emergency department of the nearest hospital. Symptoms of overdose may include disturbances in hearing, vision, and sensation, as well as thinking about things that are not real (hallucinations and paranoid behaviors). Symptomatic treatment may be indicated (supportive treatment to maintain vital functions and gastric lavage, if necessary).

Interrupting treatment with Fluconazole Aurovitas
Do not take a double dose to make up for a missed dose. If a dose is missed, it should be taken as soon as remembered. However, if it is almost time for the next dose, the missed dose should be skipped.

If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If you notice any of the following symptoms, stop taking
Fluconazole Aurovitas and seek immediate medical help:
* widespread rash, high fever, and swollen lymph nodes (DRESS syndrome or
drug hypersensitivity syndrome).
Some patients may experience allergic reactions, although severe allergic reactions
are rare. If any adverse reactions occur, consult a doctor or pharmacist immediately. This includes any possible adverse reactions
not listed in this leaflet. If any of the following adverse reactions occur,
you must immediately inform your doctor:

• sudden wheezing, difficulty breathing, or chest tightness,
• swelling of the eyelids, face, or lips,
• itching all over the body, skin redness, or red, itchy blisters,
• skin rash,
• severe skin reactions, such as blistering rash (which may also affect the mouth and tongue).

Fluconazole Aurovitas may affect the liver. Liver-related symptoms include:

• feeling tired,
• loss of appetite,
• nausea and vomiting,
• yellowing of the skin or whites of the eyes (jaundice).

If any of the above adverse reactions occur, stop taking Fluconazole Aurovitas and contact your doctor immediately.
Other adverse reactions:
Additionally, if any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.
Common adverse reactions (may occur in up to 1 in 10 people):

• headache,
• abdominal pain, diarrhoea, nausea, vomiting,
• increased liver function test values,
• rash.

Uncommon adverse reactions (may occur in up to 1 in 100 people):

• reduced number of red blood cells, causing paleness, weakness, and shortness of breath,
• decreased appetite,
• insomnia, drowsiness,
• seizures, dizziness, balance disorders (sensation of spinning), sensory disturbances, most commonly tingling, pricking, or numbness, taste changes,
• constipation, indigestion, bloating, dry mouth,
• muscle pain,
• liver damage and yellowing of the skin and eyes (jaundice),
• blisters, urticaria, itching, increased sweating,
• feeling of fatigue, malaise, fever.

Rare adverse reactions (may occur in up to 1 in 1,000 people):

• reduced number of white blood cells involved in the body's defence against infections and blood cells that help stop bleeding,
• red or purple skin discolouration, possibly due to reduced platelet count or changes in other blood cells,
• changes in blood biochemical parameters (elevated cholesterol, blood lipids),
• decreased potassium levels in the blood,
• tremor,
• abnormalities in ECG, heart rhythm disorders,
• liver failure,
• allergic reactions (sometimes severe), including widespread blistering rash, skin peeling, severe skin reactions, swelling of the lips or face,
• hair loss.

Frequency unknown (frequency cannot be estimated from available data):

• hypersensitivity reaction with skin rash, fever, lymph node swelling, increased white blood cell count (eosinophilia), and inflammation of internal organs (liver, lungs, heart, kidneys, and large intestine) (drug reaction or eosinophilia and systemic symptoms (DRESS)).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Fluconazole Aurovitas

Keep out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the cardboard packaging after:
Expiry date. The expiry date refers to the last day of the stated month.
No special storage precautions are required for this medicinal product.
Medicines should not be disposed of 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 Fluconazole Aurovitas contains

• The active substance is fluconazole.
• Each capsule contains 100 mg or 200 mg of fluconazole.
• Other ingredients are: monohydrate lactose, maize starch, sodium lauryl sulfate, colloidal anhydrous silica, and magnesium stearate.
• The capsule shell contains: titanium dioxide (E 171), sodium lauryl sulfate, and gelatin.
• The printing ink contains: shellac, yellow iron oxide (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, printed with “FL” on the white or almost white opaque cap and “100” on the white or almost white opaque body, in yellow ink.
Fluconazole Aurovitas, 200 mg, hard capsules
Hard gelatin capsules, size “0”, filled with white or almost white powder, printed with “FL” on the white or almost white opaque cap and “200” on the white or almost white opaque body, in yellow ink.
Fluconazole Aurovitas is available in blister packs contained in cardboard cartons.
Pack sizes:
1, 2, 3, 4, 6, 7, 10, 12, 14, 20, 28, 30, 42, 50, 60, 100 and 500 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, lokal 27
01-909 Warsaw
Poland

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 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