Fluconazole Aurovitas 50 mg hard capsules EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the user

Fluconazole Aurovitas 50 mg hard capsules EFG

Fluconazole Aurovitas 100 mg hard capsules EFG

Fluconazole Aurovitas 150 mg hard capsules EFG

Fluconazole Aurovitas 200 mg hard capsules EFG

fluconazole

Read the entire leaflet carefully before you start 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Fluconazole Aurovitas is and what it is used for
2. What you need to know 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 Fluconazol Aurovitas is and what it is used for

This medicine belongs to a group of medicines called "antifungals". The active substance is fluconazole.

This medicine is used to treat fungal infections, and it can also be used to prevent the occurrence of candidiasis. The most common cause of fungal infections is a yeast called Candida.

Adults

Your doctor may prescribe this medicine to treat the following types of fungal infections:

• cryptococcal meningitis – a fungal infection of the brain,
• coccidioidomycosis – a disease affecting the bronchopulmonary system,
• Candida infections located in the bloodstream, in body organs (e.g., heart, lungs), or in the urinary tract,
• mucosal candidiasis – infection affecting the lining of the mouth, throat, or associated with dental prostheses,
• genital candidiasis – infection of the vagina or penis,
• skin infections – e.g., athlete's foot, ringworm, jock itch, nail infections.

Fluconazole may also be prescribed to:

• prevent recurrence of cryptococcal meningitis,
• prevent recurrence of mucosal infections,
• reduce repeated episodes of vaginal infections,
• prevent the occurrence of Candida infections (if your immune system is weak and not functioning properly).

Children and adolescents (0 to 17 years)

Your doctor may prescribe this medicine to treat the following types of fungal infections:

• mucosal candidiasis – infection affecting the lining of the mouth or throat,
• Candida infections located in the bloodstream, in body organs (e.g., heart, lungs), or in the urinary tract,
• cryptococcal meningitis – a fungal infection of the brain.

Fluconazole may also be prescribed to:

• prevent the occurrence of Candida infections (if your immune system is weak and not functioning properly),
• prevent recurrence of cryptococcal meningitis.

2. What you need to know before taking Fluconazole Aurovitas

Do not take Fluconazole Aurovitas:

• if you are allergic to fluconazole, to other antifungal medicines you have taken, 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 or terfenadine (antihistamine medicines used to treat allergies),
• if you are taking cisapride (used to treat stomach discomfort),
• if you are taking pimozide (used to treat mental illnesses),
• if you are taking quinidine (used to treat heart arrhythmias),
• if you are taking erythromycin (an antibiotic used to treat infections).

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:

• if you have liver or kidney problems,
• if you have a heart condition, including problems with heart rhythm,
• if you have abnormal levels of potassium, calcium, or magnesium in your blood,
• if you develop severe skin reactions (itching, skin redness, or difficulty breathing),
• if you develop signs of adrenal insufficiency, where the adrenal glands do not produce adequate amounts of certain steroid hormones such as cortisol (chronic or long-term fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain),
• if you have ever had a severe skin rash, skin peeling, blisters, and/or mouth sores after taking fluconazole.

Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during treatment with fluconazole. Stop taking fluconazole and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

Talk to your doctor or pharmacist if your fungal infection does not improve, as an alternative antifungal treatment may be needed.

Other medicines and Fluconazole Aurovitas

Inform your doctor immediately if you are taking astemizole, terfenadine (an antihistamine for allergies), cisapride (used for stomach discomfort), pimozide (used to treat mental illnesses), quinidine (used to treat heart arrhythmias), or erythromycin (an antibiotic for infections), as these medicines must not be taken with this medicine (see section: “Do not take Fluconazole Aurovitas”).

Some medicines may interact with this medicine. Make sure your doctor knows if you are taking any of the following medicines, as dose adjustments or monitoring may be needed to ensure these medicines remain effective:

• rifampicin or rifabutin (antibiotics for infections)
• abrocitinib (used to treat atopic dermatitis, also known as atopic eczema)
• alfentanil, fentanyl (used as anesthetics)
• amitriptyline, nortriptyline (used as antidepressants)
• amphotericin B, voriconazole (antifungals)
• medicines that make the blood less sticky to prevent blood clots (warfarin or similar medicines)
• benzodiazepines (midazolam, triazolam, or similar medicines) used to help sleep or for anxiety
• carbamazepine, phenytoin (used to treat seizures)
• nifedipine, isradipine, amlodipine, verapamil, felodipine, and losartan (for hypertension – high blood pressure)
• olaparib (used for ovarian cancer)
• ciclosporin, everolimus, sirolimus, or tacrolimus (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 high cholesterol levels
• methadone (used for 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-infected patients)
• medicines for diabetes, such as chlorpropamide, glyburide, glipizide, or tolbutamide
• theophylline (used to control asthma)
• tofacitinib (used for rheumatoid arthritis)
• tolvaptan (used to treat hyponatremia [low sodium levels in blood] or to delay worsening of kidney function)
• vitamin A (nutritional supplement)
• ivacaftor (alone or combined with medicines used for cystic fibrosis)
• amiodarone (used to treat irregular heartbeats, ‘arrhythmias’)
• hydrochlorothiazide (a diuretic)
• ibrutinib (used to treat blood cancer)
• lurasidone (used to treat schizophrenia).

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Taking Fluconazole Aurovitas with food, drinks, and alcohol

You may take this medicine with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

If you are planning to become pregnant, it is recommended that you wait one week after a single dose of fluconazole before trying to conceive.

For longer treatment courses with fluconazole, consult your doctor about the need to use adequate contraceptive methods during treatment, which should be continued for one week after the last dose.

You must not take Fluconazole Aurovitas if you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, unless specifically instructed by your doctor. If you become pregnant while taking this medicine or within one week after the most recent dose, consult your doctor.

Fluconazole taken during the first or second trimester of pregnancy may increase the risk of spontaneous abortion. Fluconazole taken during the first trimester may increase the risk of congenital abnormalities affecting the baby’s heart, bones, and/or muscles.

Cases of babies born with congenital abnormalities affecting the skull, ears, and thigh and elbow bones have been reported in women treated for three months or more with high doses (400–800 mg daily) of fluconazole for coccidioidomycosis. The relationship between fluconazole and these cases is not clear.

Breastfeeding may continue after a single dose of 150 mg of this medicine.

Breastfeeding must not continue if you are taking repeated doses of this medicine.

Driving and using machines

Bear in mind that dizziness or seizures may occasionally occur when driving or operating machinery.

Fluconazole Aurovitas contains lactose monohydrate, a type of sugar. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Fluconazole Aurovitas contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per hard capsule, which is essentially “sodium-free”.

3. How to take Fluconazole Aurovitas

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist.

If in doubt, consult your doctor or pharmacist again.

The capsules should be swallowed whole with a glass of water. It is best to take your capsules at the same time each day.

Instructions for removing the capsule from the blister cavity:

Pressing the capsule cavity in the center may cause deformation or breakage of the capsule, as shown in Figure A. To avoid such damage to the capsule, press the blister cavity at one end to push the capsule out, as shown in Figure B.

Fig. A   Fig. B

The recommended dosage of this medicine for different types of infections is given below:

Adults

Condition	Dosage
To treat cryptococcal meningitis	400 mg on the first day, followed by 200 mg to 400 mg once daily for 6 to 8 weeks, or longer if necessary. The dose may occasionally be increased up to 800 mg
To prevent recurrence of cryptococcal meningitis	200 mg once daily for as long as directed by your doctor
To treat coccidioidomycosis	200 mg to 400 mg once daily for 11 to 24 months, or longer if necessary. The dose may occasionally be increased up to 800 mg
To treat systemic fungal infections caused by Candida	800 mg on the first day, followed by 400 mg once daily for as long as directed by your doctor
To treat mucosal fungal infections affecting the lining of the mouth, throat, or associated with dentures	200 mg to 400 mg on the first day, followed by 100 mg to 200 mg once daily for as long as directed by your doctor
To treat mucosal candidiasis – dosage depends on the site of infection	50 mg to 400 mg once daily for 7 to 30 days, or as long as directed by your doctor
To prevent recurrence of mucosal infections affecting the lining of the mouth and throat	100 mg to 200 mg once daily, or 200 mg three times a week, for as long as the risk of developing infection persists
To treat genital candidiasis	150 mg as a single dose
To reduce recurrent episodes of vaginal candidiasis	150 mg every three days for a total of 3 doses (day 1, 4, and 7), followed by once weekly for 6 months, for as long as the risk of infection persists
To treat fungal skin or nail infections	Depending on the site of infection: 50 mg once daily, 150 mg once weekly, or 300 to 400 mg once weekly for 1 to 4 weeks (for athlete's foot, up to 6 weeks may be needed; for nail infections, continue treatment until a healthy nail has grown)
To prevent Candida infection (if your immune system is weakened and not functioning properly)	200 mg to 400 mg once daily for as long as the risk of developing infection persists

Use in children and adolescents

Adolescents aged 12 to 17 years

Follow the dose indicated by your doctor (either the adult or pediatric dosage).

Children up to 11 years of age

The maximum daily dose for children is 400 mg per day.

The dose will be based on the child's weight in kilograms.

Condition	Daily dose
Oral mucosal candidiasis and throat infections caused by Candida – dose and duration of treatment depend on the severity of the infection and its location.	3 mg per kg of body weight once daily (on the first day, 6 mg per kg of body weight may be given)
Cryptococcal meningitis or internal fungal infections caused by Candida	6 mg to 12 mg per kg of body weight once daily
To prevent recurrence of cryptococcal meningitis	6 mg per kg of body weight once daily
To prevent the child from acquiring an infection caused by Candida (if their immune system is not functioning properly)	3 mg to 12 mg per kg of body weight once daily

Use in children from 0 to 4 weeks of age

Use in children from 3 to 4 weeks of age:

The same dose as described in the table, 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 dose as described in the table, but administered once every 3 days. The maximum dose is 12 mg per kg of body weight every 72 hours.

Elderly patients

The usual adult dose, unless you have kidney problems.

Patients with kidney problems

Your doctor may adjust your dose depending on how well your kidneys are functioning.

If you take more Fluconazol Aurovitas than you should

Taking too many capsules at once may make you feel unwell. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the medication packaging and leaflet to the healthcare professional.

Symptoms of a possible overdose may include hearing, seeing, feeling, and thinking things that are not real (hallucinations and paranoid behavior). It may be appropriate to initiate symptomatic treatment (with supportive measures and gastric lavage if necessary).

If you forget to take Fluconazol Aurovitas

Do not take a double dose to make up for missed doses. 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 doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Stop taking Fluconazole Aurovitas and seek immediate medical attention if you notice any of the following symptoms:

• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Some people may develop allergic reactions, although serious allergic reactions are rare. If any of the following adverse effects occur, speak to your doctor or pharmacist. This includes possible adverse effects not mentioned in this leaflet. If you experience any of the following adverse effects, inform your doctor or pharmacist immediately:

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

This medicine may affect your liver. Signs indicating liver problems include:

• fatigue
• loss of appetite
• vomiting
• yellowing of the skin or whites of the eyes (jaundice)

If you experience any of these symptoms, stop taking this medicine and inform your doctor immediately.

Other adverse effects:

Additionally, if you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

Frequent adverse effects (may affect up to 1 in 10 people):

• headache
• stomach discomfort, diarrhoea, nausea, vomiting
• elevated blood test results indicating liver function
• rash

Uncommon adverse effects (may affect up to 1 in 100 people):

• reduction in red blood cells, which may cause pale skin, weakness, or difficulty breathing
• decreased appetite
• inability to sleep, numbness sensation
• seizures, dizziness, spinning sensation, tingling, prickling, or numbness, changes in taste sensation
• constipation, indigestion, flatulence, dry mouth
• muscle pain
• liver damage and yellowing of the skin and eyes (jaundice)
• hives, blisters (wheals), itching, increased sweating
• fatigue, general feeling of being unwell, fever

Rare adverse effects (may affect up to 1 in 1,000 people):

• abnormally low levels of white blood cells, which help defend the body against infections, and blood cells that help stop bleeding
• red or purple skin discolouration, which may be due to low platelet count, other changes in blood cells
• changes in blood tests (high levels of cholesterol, fats)
• low blood potassium levels
• tremors
• abnormal electrocardiogram (ECG), changes in heart rate or rhythm
• liver function failure
• allergic reactions (sometimes severe), including widespread blistering and peeling rash, severe allergic reactions, swelling of the lips or face
• hair loss

Frequency not known but possible (cannot be estimated from available data):

• hypersensitivity reaction with skin rash, fever, swollen glands, increase in a type of white blood cells (eosinophilia), and inflammation of internal organs (liver, lungs, heart, kidneys, and large intestine) (drug reaction or eosinophilia and systemic symptoms [DRESS])

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fluconazole Aurovitas

Keep out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fluconazole Aurovitas

• The active substance is fluconazole.
• Each capsule contains 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole.
• The other components (excipients) are: monohydrate lactose, corn starch, sodium lauryl sulfate, anhydrous colloidal silica, and magnesium stearate.

The capsule shell composition includes titanium dioxide (E171), sodium lauryl sulfate, and gelatin.

The printing ink contains shellac and yellow iron oxide (E172).

Appearance of the product and contents of the pack

Fluconazole Aurovitas 50 mg hard capsules EFG

Opaque white to off-white hard gelatin capsules of size “4”, filled with white to off-white powder, printed with the letter “FL” on the opaque white to off-white cap and the number “50” on the opaque white to off-white body, using yellow ink.

Fluconazole Aurovitas 100 mg hard capsules EFG

Opaque white to off-white hard gelatin capsules of size “2”, filled with white to off-white powder, printed with the letter “FL” on the opaque white to off-white cap and the number “100” on the opaque white to off-white body, using yellow ink.

Fluconazole Aurovitas 150 mg hard capsules EFG

Opaque white to off-white hard gelatin capsules of size “1”, filled with white to off-white powder, printed with the letter “FL” on the opaque white to off-white cap and the number “150” on the opaque white to off-white body, using yellow ink.

Fluconazole Aurovitas 200 mg hard capsules EFG

Opaque white to off-white hard gelatin capsules of size “0”, filled with white to off-white powder, printed with the letter “FL” on the opaque white to off-white cap and the number “200” on the opaque white to off-white body, using yellow ink.

Fluconazole Aurovitas hard capsules are available in PVC/PVDC-Aluminum blisters.

Packs containing 1, 2, 3, 4, 6, 7, 10, 12, 14, 20, 28, 30, 42, 50, 60, 100, and 500 hard capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. De Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Ltd

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

or

Generis Farmaceutica, S.A.

Rua João de Deus, n. o 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 the most recent review of this leaflet: February 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es)