FLUCONAZOLE AUROVITAS 150 mg HARD CAPSULES

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 all of this leaflet carefully before you start 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

1. What is Fluconazole Aurovitas and what is it used for
2. What you need to know before you take Fluconazole Aurovitas
3. How to take Fluconazole Aurovitas
4. Possible side effects
5. Storage of Fluconazole Aurovitas
6. Contents of the pack and other information

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

This medicine is one of a group of medicines called “antifungals”. The active substance is fluconazole.

This medicine is used to treat infections caused by fungi, and it can also be used to prevent the appearance 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 in the brain,
• coccidioidomycosis – a disease of the bronchopulmonary system,
• infections caused by Candidalocalized in the bloodstream, in body organs (e.g. heart, lungs) or in the urinary tract,
• candidiasis of the mucous membranes – an infection that affects the lining of the mouth, throat or associated with dental prostheses,
• genital candidiasis – an infection of the vagina or penis,
• skin infections – e.g. athlete's foot, ringworm, jock itch, nail infections.

It may also be prescribed for you to:

• prevent the recurrence of cryptococcal meningitis,
• prevent the recurrence of mucous membrane infections,
• reduce the repeated appearance of vaginal infections,
• prevent the spread of Candidainfections (if your immune system is weak and not working properly).

Children and adolescents (0 to 17 years)

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

• candidiasis of the mucous membranes – an infection that affects the lining of the mouth or throat,
• infections caused by Candidalocalized in the bloodstream, in body organs (e.g. heart, lungs) or in the urinary tract,
• cryptococcal meningitis – a fungal infection in the brain.

It may also be prescribed for you to:

• prevent the spread of Candidainfections (if your immune system is weak and not working properly),
• prevent the recurrence of cryptococcal meningitis.

2. What you need to know before you take Fluconazole Aurovitas

Do not take Fluconazole Aurovitas:

• if you are allergic to fluconazole, to other medicines that you have taken to treat fungal infections or to any of the other ingredients of this medicine (listed in section 6). The symptoms can include itching, skin rash or difficulty breathing,
• if you are taking astemizole, terfenadine (antihistamine medicines for treating allergies),
• if you are taking cisapride (used to treat stomach upset),
• if you are taking pimozide (used to treat mental illness),
• if you are taking quinidine (used to treat heart rhythm disturbances),
• if you are taking erythromycin (an antibiotic for treating infections).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

• if you have liver or kidney problems,
• if you suffer from heart disease, including heart rhythm problems,
• if you have abnormal levels of potassium, calcium or magnesium in your blood,
• if severe skin reactions occur (itching, skin rash 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 or skin peeling and/or blisters and/or sores in the mouth after taking fluconazole.

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

Talk to your doctor or pharmacist if the fungal infection does not improve, it may be necessary to use an alternative antifungal treatment.

Other medicines and Fluconazole Aurovitas

Immediatelyinform your doctor if you are taking astemizole, terfenadine (an antihistamine for treating allergies), cisapride (used for stomach upset), pimozide (used for treating mental illness), quinidine (used for treating heart rhythm disturbances) or erythromycin (an antibiotic for treating infections), as these medicines should not be taken with this medicine (see section: “Do not take Fluconazole Aurovitas”).

There are some medicines that may interact with this medicine. Make sure your doctor knows if you are taking any of the following medicines, as it may be necessary to adjust the dose or monitor to check that the medicines are still having the desired effect:

• rifampicin or rifabutin (antibiotics for infections)
• abrocitinib (used to treat atopic dermatitis, also known as eczema)
• alfentanil, fentanyl (used as anesthetics)
• amitriptyline, nortriptyline (used as antidepressants)
• amphotericin B, voriconazole (antifungals)
• medicines that make the blood less viscous, to prevent the formation of 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)
• cyclosporine, 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 and fluvastatin or similar medicines) used to reduce high cholesterol levels
• methadone (used for pain)
• celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (Non-Steroidal Anti-Inflammatory Drugs (NSAIDs))
• oral contraceptives
• prednisone (steroid)
• zidovudine, also known as AZT; saquinavir (used in HIV-infected patients)
• medicines for diabetes, such as chlorpropamide, glibenclamide, glipizide or tolbutamide
• theophylline (used to control asthma)
• tofacitinib (used for rheumatoid arthritis)
• tolvaptan (used to treat hyponatremia [low sodium levels in the blood] or to slow down kidney function deterioration)
• vitamin A (nutritional supplement)
• ivacaftor (alone or in combination 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 use any other medicines.

Taking Fluconazole Aurovitas with food, drinks and alcohol

You can take the medicine with or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice 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 becoming pregnant.

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

Do not take Fluconazole Aurovitas if you are pregnant, think you may be pregnant or are planning to have a baby, or are breast-feeding, unless your doctor has told you to. If you become pregnant while taking this medicine or in the week following the last 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 a baby being born with congenital anomalies affecting the heart, bones and/or muscles.

Cases of babies born with congenital anomalies affecting the skull, ears and bones of the thigh and elbow 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 unclear.

You can continue breast-feeding after taking a single dose of 150 mg of this medicine.

Do not continue breast-feeding if you are taking repeated doses of this medicine.

Driving and using machines

When driving or operating machinery, you should take into account that dizziness or seizures may occasionally occur.

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

Fluconazole Aurovitas contains sodium

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

3. How to take Fluconazole Aurovitas

Follow exactly the instructions of use of this medicine indicated by your doctor or pharmacist.

In case of doubt, consult your doctor or pharmacist again.

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

Instructions for removing the capsule from the blister cavity:

Pressing the capsule cavity in the central part may result in deformations/breakages of the capsule as shown in figure A. To avoid such damage to the capsule, press the capsule cavity at one end to remove it from the blister as shown in figure B.

Fig. AFig. B

The following is the recommended dose of this medicine for the different types of infections:

Adults

Use in children and adolescents

Adolescents from 12 to 17 years of age

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

Children up to 11 years

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

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

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 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 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 change your dose, depending on how well your kidneys are working.

If you take more Fluconazole Aurovitas than you should

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

The 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 stomach lavage if necessary).

If you forget to take Fluconazole Aurovitas

Do not take a double dose to make up for forgotten doses. If you have forgotten to take a dose, take it as soon as you remember. If it is almost time for the next dose, do not take the forgotten dose.

If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. Stop taking Fluconazol Aurovitas and seek immediate medical attention if you notice any of the following symptoms:

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

Some people develop allergic reactions, although severe allergic reactions are rare.If any of the following adverse effects appear, talk to your doctor or pharmacist. This includes possible adverse effects not mentioned in this prospectus. If you suffer from 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 red spots with itching
• Skin rash
• Severe skin reactions, such as a rash that causes blisters (this can affect the mouth and tongue)

This medicine may affect your liver. Signs that indicate liver problems include:

• Fatigue
• Loss of appetite
• Vomiting
• Yellowing of the skin or the 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 that any of the adverse effects you are suffering from is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

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

• Headache
• Stomach upset, diarrhea, discomfort, vomiting
• Elevated blood test results indicating liver function
• Rash

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

• Reduction of red blood cells, which can make your skin pale and cause weakness or difficulty breathing
• Decreased appetite
• Insomnia, feeling of numbness
• Seizures, dizziness, feeling of spinning, tingling, pinching, or numbness, changes in taste sensation
• Constipation, heavy digestion, gas, dry mouth
• Muscle pain
• Liver damage and yellowing of the skin and eyes (jaundice)
• Hives, blisters (hives), itching, increased sweating
• Fatigue, general feeling of discomfort, fever

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

• White blood cells in the blood that help defend against infections and blood cells that help stop bleeding, lower than normal.
• Red or purple discoloration of the skin, which may be due to a low number of platelets, other changes in blood cells
• Changes in blood tests (high cholesterol, fat levels)
• Low potassium levels in the blood
• Tremors
• Abnormal electrocardiogram (ECG), changes in heart rate or rhythm
• Liver function failure
• Allergic reactions (sometimes severe), including widespread rash with blisters and skin peeling, severe allergic reactions, swelling of the lips or face
• Hair loss

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

• Hypersensitivity reaction with skin rash, fever, inflamed glands, increased eosinophils (a type of white blood cell), and inflammation of internal organs (liver, lungs, heart, kidneys, and large intestine) (drug reaction or eruption with eosinophilia and systemic symptoms [DRESS])

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Fluconazol Aurovitas

Keep out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Fluconazol Aurovitas

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

The composition of the capsules is titanium dioxide (E171), sodium lauryl sulfate, and gelatin.

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

Appearance of the Product and Package Contents

Fluconazol Aurovitas 50 mg hard capsules EFG

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

Fluconazol Aurovitas 100 mg hard capsules EFG

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

Fluconazol Aurovitas 150 mg hard capsules EFG

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

Fluconazol Aurovitas 200 mg hard capsules EFG

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

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

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

Only some package 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 medicine is authorized in the Member States of the European Economic Area with the following names:

Belgium: Fluconazol AB 50 mg/100 mg/150 mg/200 mg hard capsules

Luxembourg: Fluconazol AB 50 mg/100 mg/150 mg/200 mg hard capsules

Poland: Fluconazole Aurovitas

Portugal: Fluconazol Ritisca

Spain: Fluconazol Aurovitas 50 mg/100 mg/150 mg/200 mg hard capsules EFG.

Date of the Last Revision of this Prospectus:February 2024

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