Fluconazole Stada 150 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Fluconazole Stada 150 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 or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these are not listed in this leaflet. See section 4.

Leaflet contents

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

2. What you need to know before taking Fluconazole Stada

3. How to take Fluconazole Stada

4. Possible adverse effects

5. How to store Fluconazole Stada

6. Contents of the pack and other information

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

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

Fluconazole is used to treat fungal infections, 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.
• 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 Candida infections.
• Reduce repeated episodes of vaginal Candida infections.
• Prevent 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.
• 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 Candida infections (if your immune system is weakened and not functioning properly).
• Prevent recurrence of cryptococcal meningitis.

2. What you need to know before taking Fluconazole Stada

DO NOT take Fluconazole Stada

• if you are allergic (hypersensitive) 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

Consult your doctor or pharmacist before taking Fluconazole Stada

• if you have liver or kidney problems.
• if you suffer from a heart condition, including heart rhythm disorders.
• if you have abnormal levels of potassium, calcium, or magnesium in your blood.
• if severe skin reactions occur (such as itching, skin redness, or difficulty breathing).
• if you have ever developed 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.

• if signs of "adrenal insufficiency" appear, 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 the fungal infection does not improve, an alternative antifungal treatment may be necessary.

Taking Fluconazole Stada with other medicines

Inform your doctor or pharmacist if you are currently taking, have recently taken, or might need to take any other medicine.

Inform your doctor immediately if you are taking astemizole, terfenadina (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 Fluconazole Stada”).

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 clotting (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 reduce 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 (diuretic).
• Ibrutinib (used to treat blood cancer).
• Lurasidone (used to treat schizophrenia).

Taking Fluconazole Stada with food and drink

You may take this medicine with or without food.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, 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 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, plan to become pregnant, or are breast-feeding, 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 use during the first trimester may increase the risk of congenital abnormalities affecting the 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.

Breast-feeding may be continued after a single 150 mg dose of fluconazole. You must not continue breast-feeding if you are taking repeated doses of fluconazole.

Driving and using machines

When driving or operating machinery, bear in mind that dizziness or seizures may occasionally occur.

Fluconazole Stada contains lactose and sodium

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take Fluconazol Stada

Follow exactly the instructions given by your doctor for taking this medicine. 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 medicine at the same time each day.

The recommended doses of this medicine for different types of infections are listed below:

Adults

Use in children and adolescents

Adolescents aged 12 to 17 years

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

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.

• 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 Stada than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the medication package and leaflet to the healthcare professional.

Taking too many capsules at once may make you feel unwell. 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 Stada

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 questions 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 everyone will experience them.

Stop taking fluconazole and seek medical attention immediately 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 with 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 tightness in the chest.
• 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:

• Tiredness.
• 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 contact 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) are:

• Headache.
• Stomach discomfort, diarrhoea, nausea, vomiting.
• Elevated results in blood tests indicating liver function.
• Rash.

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

• Reduction in red blood cells, which may cause pale skin and lead to weakness or difficulty breathing.

• Decreased appetite.

• Difficulty sleeping, feeling numb.

• 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.

• Tiredness, general feeling of being unwell, fever.

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

• Lower than normal levels of white blood cells, which help defend against infections, and blood cells that help stop bleeding.
• Red or purple skin discolouration, which may be due to low platelet count or other changes in blood cells.
• Changes in blood tests (high levels of cholesterol, fats).
• Low levels of potassium in the blood.
• Tremors.
• Abnormal electrocardiogram (ECG), changes in heart rate or rhythm.
• Liver function failure.
• Allergic reactions (sometimes severe), including widespread blistering rash and peeling of the skin, 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 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 may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fluconazole Stada

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

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

No special storage conditions are required.

Store in the original container.

Medicines must not be disposed of via wastewater or household waste. Return empty containers and any unused medicines to the SIGRE Point at your pharmacy. If in doubt, 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 Stada

• The active substance is fluconazole. Each hard capsule contains 150 mg of fluconazole.

  • The other components (excipients) are:

• Capsule contents: monohydrate lactose, corn starch, colloidal silicon dioxide, magnesium stearate and sodium lauryl sulfate.

• Capsule composition: yellow iron oxide (E172), titanium dioxide (E171), water and gelatin.

Appearance of the product and contents of the pack

Fluconazole Stada 150 mg capsules are presented as hard gelatin capsules with yellow cap and body.

Available in packs of 1, 4 or 100 (clinical pack) hard capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Laboratorios Liconsa, S.A.

Avda. Miralcampo, Nº 7,

Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara), Spain

or

Toll Manufacturing Services, S.L.

Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

Date of the most recent review of this leaflet: March 2024

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