Fluconazole aurovitas

Package leaflet: Information for the user

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

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

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 infections caused by pathogenic fungi and may also be used to prevent Candida infections. The most common cause of fungal infections are yeasts of the genus known in Latin as Candida.
Adults
Your doctor may recommend using this medicine for the following fungal infections:

• cryptococcal meningitis – a fungal infection of the brain,
• coccidioidomycosis – a respiratory 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 fungal infections – e.g. athlete's foot, body ringworm, groin infection (jock itch), nail infections.

Fluconazole Aurovitas may also be used to:

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

Children and adolescents (aged 0 to 17 years)
Your doctor may recommend using 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 to:

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

2. Important information before taking Fluconazole Aurovitas

When not to take Fluconazole Aurovitas

• If the patient is allergic to fluconazole, to other antifungal medicines, or to any of the other ingredients of this medicine (listed in section 6). Symptoms may include itching, redness of the skin, or difficulty breathing.
• If the patient is taking astemizole or terfenadine (antihistamines 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 this with your doctor or
pharmacist:

• if the patient has kidney or liver function disorders,
• if the patient has heart diseases, including heart rhythm disorders,
• if the patient has abnormal blood levels of potassium, calcium, or magnesium,
• if the patient has severe skin reactions (itching, redness of the skin, difficulty breathing),
• if the patient develops symptoms of "adrenal insufficiency", when the adrenal glands do not produce sufficient 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 experienced severe skin rash or skin peeling, blisters and/or oral mucosal 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 discontinued immediately and medical help should be sought without delay.
Consult your 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 continued efficacy of the medicines:

• rifampicin or rifabutin (antibiotics for treating infections),
• abrocitinib (used to treat atopic dermatitis, also known as atopic eczema),
• alfentanil, fentanyl (anaesthetic medicines),
• amitriptyline, nortriptyline (antidepressants),
• amphotericin B, voriconazole (antifungal medicines),
• anticoagulant medicines that reduce blood clotting and prevent blood clots (warfarin, indanedione or similar medicines),
• benzodiazepines (midazolam, triazolam or other 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 other similar medicines) used to treat cancer,
• halofantrine (used to treat malaria),
• statins (atorvastatin, simvastatin, fluvastatin or other 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 in 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 the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Taking Fluconazole Aurovitas with food, drink and alcohol
This medicine may be taken during or independent of meals.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, 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 cycles 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 child, she should not take Fluconazole Aurovitas unless otherwise 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 malformations in the newborn.
Cases of infants born with congenital malformations of the skull, ears, and femur and elbow bones have been reported in mothers treated for coccidioidomycosis with high doses of fluconazole (400–800 mg daily) for at least three months. The relationship between fluconazole use and these cases is not clear.

Breastfeeding may be continued after a single 150 mg dose of fluconazole. Breastfeeding should not be continued if the patient is taking repeated doses of Fluconazole Aurovitas.

Driving and operating machinery
When driving or operating machinery, consider that dizziness or seizures may occur occasionally.

Fluconazole Aurovitas contains lactose monohydrate, a type of sugar.
If the patient has been previously diagnosed with 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, meaning the medicine is considered "sodium-free".

3. How to take Fluconazole Aurovitas

This medicine should always be taken exactly as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
If the required dose cannot be achieved with capsules of this strength, other fluconazole-containing medicines
are available on the market in capsules of different strengths, which may be used for this purpose.
The capsule should be swallowed whole with a glass of water. Capsules are best taken
at the same time each day.
Instructions for removing the capsule from the blister:
Pressing the center of the capsule cavity may cause deformation or damage to the capsule,
as shown in Figure A. To avoid such damage, press on the edges of the capsule cavity,
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; please consult a doctor or
pharmacist.
Adolescents aged 12 to 17 years
The dose prescribed by the doctor should be administered (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 from 0 to 4 weeks of age
Children aged 3 to 4 weeks:
The same dose as above, but administered every other day. The maximum dose is 12 mg/kg b.w. 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 b.w. every 72 hours.

Elderly patients
The usual adult dose is administered, unless the patient has renal function impairment.

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

Use of a higher than recommended dose 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, thinking about things that are not true (hallucinations and paranoid behavior). Symptomatic treatment may be indicated (supportive treatment to maintain vital functions and gastric lavage if necessary).

Discontinuation of Fluconazole Aurovitas
Do not take a double dose to make up for a missed dose. If a dose is missed, take it as soon as remembered. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular scheduled time.

If there are any further doubts regarding the use of this medicinal product, consult a physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following symptoms occur, stop taking
the medicine 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 inform the doctor immediately:

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

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

• feeling tired,
• loss of appetite,
• 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):

• decreased number of red blood cells, causing paleness, weakness and breathlessness,
• 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 tired, malaise, fever.

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

• decreased number of white blood cells involved in the body's defence against infections and blood cells helping to 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 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 lips or face,
• hair loss.

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

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions
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, 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 to provide more information on the safety of the medicine.

5. How to store Fluconazole Aurovitas

Keep the medicine out of the sight and reach of children.
Do not use this medicine 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 instructions for this medicinal product.
Medicines must 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 package 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, corn starch, sodium lauryl sulfate, colloidal anhydrous silica, and magnesium stearate.
• Capsule shell contains: titanium dioxide (E 171), sodium lauryl sulfate, and gelatin.
• 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
White or almost white hard gelatin capsules, size “2”, filled with white or almost white powder, with the imprint “FL” on the white or almost white opaque cap and “100” on the white or almost white opaque body, printed in yellow ink.
Fluconazole Aurovitas 200 mg, hard capsules
White or almost white hard gelatin capsules, size “0”, filled with white or almost white powder, with the imprint “FL” on the white or almost white opaque cap and “200” on the white or almost white opaque body, printed in yellow ink.
Fluconazole Aurovitas is available in blister packs contained in cardboard boxes.
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, local 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