Fluconazole Qualigen 100 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fluconazole Qualigen 100 mg hard capsules EFG

Read the entire leaflet carefully before you start 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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Fluconazol Qualigen is and what it is used for

Fluconazol Qualigen is one of the medicines belonging to a group called "antifungals". The active substance is fluconazole.

Fluconazole is used to treat infections caused by fungi, and it can also be used to prevent the occurrence of a Candida infection. 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.
• Infections caused by Candida 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 the recurrence of cryptococcal meningitis.
• prevent the recurrence of mucosal infections caused by Candida.
• reduce the repeated occurrence of vaginal infections caused by Candida.
• prevent the transmission of Candida infections (if your immune system is weakened 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.
• Infections caused by Candida 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 transmission of Candida infections (if your immune system is weakened and not functioning properly).
• prevent the recurrence of cryptococcal meningitis.

2. What you need to know before taking Fluconazol Qualigen

Do not take Fluconazol Qualigen

• if you are allergic (hypersensitive) to fluconazole, to other antifungal medications 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

Consult your doctor or pharmacist before taking Fluconazol Qualigen

• if you have liver or kidney problems.
• if you have a heart condition, including heart rhythm disorders.
• if you have abnormal levels of potassium, calcium, or magnesium in your blood.
• if you develop severe skin reactions (such as itching, skin redness, or difficulty breathing).
• if you experience signs of "adrenal insufficiency", in which the adrenal glands do not produce sufficient amounts of certain 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, 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 with fluconazole treatment. 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 alternative antifungal treatment may be needed.

Other medicines and Fluconazol Qualigen

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

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 fluconazole (see section: “Do not take Fluconazol Qualigen”).

Some medicines may interact with fluconazole.

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 viscous, 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 to treat 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, 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 to treat rheumatoid arthritis).
• Tolvaptan (used to treat hyponatremia [low sodium levels in blood] or to delay the decline in kidney function).
• Vitamin A (nutritional supplement).
• Ivacaftor (alone or combined with medicines used to treat 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 taking or have recently taken any other medicines, including those obtained without a prescription.

Taking Fluconazol Qualigen with food and drink

You may take this medicine with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking any 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 fluconazole treatment courses, consult your doctor about the need to use appropriate contraceptive methods during treatment, which should be continued for one week after the last dose.

You must not take fluconazole if you are pregnant, think you may be pregnant, or plan to become pregnant, 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 miscarriage. Fluconazole use 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 fully established.

You may continue breastfeeding after a single 150 mg dose of fluconazole. You should not continue breastfeeding if you are taking repeated doses of fluconazole.

Driving and using machines

Be aware that dizziness or seizures may occasionally occur, which could affect your ability to drive or operate machinery.

Important information about some of the ingredients of Fluconazol Qualigen

This medicine contains a small amount of lactose (milk sugar). If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

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

3. How to take Fluconazole Qualigen

Follow exactly the instructions for use of this medicine provided by your doctor. 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 medication at the same time each day.

The following are the recommended doses of this medicine for different types of infections:

Adults

Adolescents aged 12 to 17 years

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

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 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 Qualigen than you should

Taking too many capsules at once may make you feel unwell. Contact your doctor immediately or go to the nearest hospital. You may also call the Toxicology Information Service at telephone number 91 562 04 20, stating the medication and the amount ingested. 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 Qualigen

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, skip 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 may cause adverse effects, although not everyone will experience them.

Stop taking Fluconazole Qualigen 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 may develop allergic reactions, although severe allergic reactions are rare. If any adverse effect occurs, speak to your doctor or pharmacist. This includes any possible adverse effect not mentioned in this leaflet. If you experience any of the following symptoms, inform your doctor 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).

Fluconazole 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 fluconazole 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 patients) are:

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

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

• reduction in red blood cells, which may cause pale skin, weakness, or difficulty breathing.
• decreased appetite.
• inability to sleep, numbness.
• seizures, dizziness, sensation of spinning, 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 unwellness, fever.

Rare adverse effects (may affect up to 1 in 1000 patients) are:

• abnormally low levels of white blood cells (which help defend against infections) and blood cells that help stop bleeding.
• reddish or purplish 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 extensive blistering rash and skin peeling, severe allergic reactions, swelling of 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 rash with eosinophilia and systemic symptoms [DRESS]).

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fluconazole Qualigen

Keep this medicine out of the sight and reach of children.

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

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and additional information

Composition of Fluconazol Qualigen

The active substance is fluconazole.

Each hard capsule contains 100 mg of fluconazole.

The other components (excipients) are:

Capsule contents: monohydrate lactose (lactose), pregelatinized corn starch (corn starch), anhydrous colloidal silicon dioxide, sodium lauryl sulfate, and magnesium stearate.

Capsule composition: titanium dioxide and quinoline yellow.

Appearance of Fluconazol Qualigen 100 mg hard capsules and pack contents

Fluconazol Qualigen 100 mg is presented as hard capsules. The capsule body is opaque white and the cap is opaque yellow.

It is available in packs containing 7 hard capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí, Barcelona

Spain

Manufacturer:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí, Barcelona

Spain

Date of latest revision of this leaflet: May 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/