Fluconazole Kern Pharma 150 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Fluconazole Kern Pharma 150 mg hard capsules

Read the entire leaflet carefully before you start taking this medicine.

• 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 and you should not give it to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents

1. What Fluconazole Kern Pharma 150 mg hard capsules is and what it is used for.
2. Before you take Fluconazole Kern Pharma 150 mg hard capsules.
3. How to take Fluconazole Kern Pharma 150 mg hard capsules.
4. Possible side effects.
5. How to store Fluconazole Kern Pharma 150 mg hard capsules.
6. Further information.

1. What Fluconazole Kern Pharma 150 mg hard capsules is and what it is used for

Fluconazole Kern Pharma is one of the medicines belonging to the group called "antifungals". The active substance is fluconazole.

Fluconazole Kern Pharma is used to treat fungal infections and may also be used to prevent the occurrence of a fungal 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 Kern Pharma may also be prescribed to:

• Prevent recurrence of cryptococcal meningitis.
• Prevent recurrence of mucosal infections.
• Reduce the repeated occurrence of vaginal infections caused by Candida.
• Prevent 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 Kern Pharma may also be prescribed to:

• Prevent transmission of 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 Fluconazol Kern Pharma 150 mg hard capsules

Do not take Fluconazol Kern Pharma if

• You are allergic (hypersensitive) to fluconazole, to other antifungal medicines you have taken, or to any of the other ingredients of Fluconazol Kern Pharma. Symptoms may include itching, skin redness, or difficulty breathing.
• You are taking astemizole or terfenadine (antihistamines used to treat allergies).
• You are taking cisapride (used to treat stomach discomfort).
• You are taking pimozide (used to treat mental illnesses).
• You are taking quinidine (used to treat heart arrhythmias).
• You are taking erythromycin (an antibiotic used to treat infections).

Take special care with Fluconazol Kern Pharma

Tell your doctor if

• You have liver or kidney problems.
• You suffer from a heart condition, including heart rhythm disorders.
• You have abnormal levels of potassium, calcium, or magnesium in your blood.
• Severe skin reactions occur (such as itching, skin redness, or difficulty breathing).
• You have ever experienced a severe skin rash, peeling skin, 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 using this medicine and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

• If the fungal infection does not improve, alternative antifungal treatment may be necessary.

Use of 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 together with Fluconazol Kern Pharma (see section: “Do not take Fluconazol Kern Pharma if”).

Some medicines may interact with Fluconazol Kern Pharma.

Make sure your doctor knows if you are taking any of the following medicines:

• Rifampicin or rifabutin (antibiotics for infections).
• 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, felodipine, and losartan (for hypertension - high blood pressure).
• 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).
• Vitamin A (nutritional supplement).

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Taking Fluconazol Kern Pharma with food and drinks

You may take this medicine with or without food.

Pregnancy, breastfeeding, and fertility

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

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

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 Fluconazol Kern Pharma if you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, unless your doctor has instructed you to do so. 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 malformations affecting the heart, bones, and/or muscles in the baby.

Cases of babies born with congenital malformations 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.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Important information about some of the ingredients of Fluconazol Kern Pharma

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 him before taking this medicine.

3. How to take Fluconazole Kern Pharma 150 mg hard capsules

Follow exactly the administration instructions for Fluconazole Kern Pharma given by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

The usual dosage of this medicine for different types of infections is indicated below:

Adults

Adolescents aged 12 to 17 years

Follow the dose indicated by your doctor (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.

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.

Occasionally, doctors may prescribe doses different from those described. Always follow exactly the administration instructions given by your doctor. Consult your doctor or pharmacist if you have any doubts.

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 Kern Pharma than you should

Taking too many capsules at once may make you feel unwell. Contact your doctor or the nearest hospital immediately. You may also call the Toxicology Information Service at telephone number 91 562 04 20, stating the name of the medicine and the amount taken. Symptoms of a possible overdose may include hearing, seeing, feeling, and thinking things that are not real (hallucinations and paranoid behaviour). It may be appropriate to start symptomatic treatment (with supportive measures and gastric lavage if necessary).

If you forget to take Fluconazol Kern Pharma

Do not take a double dose to make up for forgotten 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 questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Fluconazole Kern Pharma may cause adverse effects, although not everyone experiences them.

Some people develop allergic reactions, although serious allergic reactions are rare. Stop taking Fluconazole and seek immediate medical attention if you notice any of the following symptoms:

• 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 a blistering rash (this may affect the mouth and tongue).
• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Fluconazole Kern Pharma capsules may affect your liver. Signs indicating liver problems include:

• Fatigue.
• Loss of appetite.
• Nausea and vomiting.
• Yellowing of the skin or whites of the eyes (jaundice).

If you experience any of these symptoms, stop taking Fluconazole Kern Pharma 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 effects not listed in this leaflet, inform your doctor or pharmacist.

The following are frequent adverse effects, affecting 1 to 10 out of every 100 patients:

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

The following are uncommon adverse effects, affecting 1 to 10 out of every 1,000 patients:

• Reduction in red blood cells, which may cause pale skin, weakness, or difficulty breathing.
• Decreased appetite.
• Inability to sleep, sensation of numbness.
• 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 malaise, fever.

The following are rare adverse effects, affecting 1 to 10 out of every 10,000 patients:

• Lower than normal levels of white blood cells, which help defend against infections, and blood cells that help stop bleeding.
• Reddish or purplish skin discoloration, possibly due to low platelet count, other changes in blood cells.
• Changes in blood tests (high levels of cholesterol, fats).
• 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 blistering rash with skin peeling, severe allergic reactions, swelling of the lips or face.
• Hair loss.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es.

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

5. Storage of Fluconazole Kern Pharma 150 mg hard capsules

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

Do not use Fluconazole Kern Pharma after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Fluconazole Kern Pharma

The active substance is fluconazole.

Each hard capsule contains 150 mg of fluconazole.

The other components (excipients) are:

Capsule contents: monohydrate lactose (lactose), pregelatinized corn starch (corn starch), hydrated colloidal silica, sodium lauryl sulfate, and magnesium stearate.
Capsule shell composition: gelatin, titanium dioxide (E-171), quinoline yellow (E-104), and indigo carmine (E-132).

Appearance of Fluconazole Kern Pharma and pack contents

The capsules have a green body and a green cap, and are packaged in aluminum/aluminum blisters.

They are available in packs containing 1 and 4 hard capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturer:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona

This leaflet was last reviewed in January 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/