Fluconazole Combix 50 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Fluconazole Combix 50 mg hard capsules EFG

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, 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, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet.

Leaflet contents

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

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

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

Fluconazol Combix is used to treat fungal infections, and it may also be used to prevent the occurrence of a fungal infection. The most common cause of fungal infections is a yeast called Candida.

Official recommendations on the appropriate use of antifungal agents should be taken into account.

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.

Fluconazol Combix may also be prescribed to:

• Prevent recurrence of cryptococcal meningitis.
• Prevent recurrence of mucosal infections.
• Reduce repeated episodes of vaginal Candida infections.
• Prevent transmission of Candida infections (if your immune system is weakened and not functioning properly).

Children and adolescents (0 to 17 years of age)

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.

Fluconazol Combix 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 Combix

Do not take Fluconazol Combix

• if you are allergic (hypersensitive) to fluconazole, to other antifungal medicines you have taken, or to any of the other ingredients of Fluconazol Combix. Symptoms may include itching, skin redness, or difficulty breathing.
• if you are taking astemizole or terfenadine (antihistamines 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

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 (itching, skin redness, or difficulty breathing).
• you have ever developed a severe skin rash, peeling of the skin, blisters, and/or mouth sores after taking Fluconazol Combix.
• your fungal infection does not improve, as alternative antifungal treatment may be needed.

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

Interaction of Fluconazol Combix with other medicines

Inform your doctor immediately if you are taking astemizole, terfenadine (antihistamines 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 Fluconazol Combix (see section: “Do not take Fluconazol Combix”).

Some medicines may interact with Fluconazol Combix.

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).
• 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 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).
• diabetes medicines, 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.

Fluconazol Combix with food and drink

You may take this medicine with or without food.

Pregnancy, breastfeeding, and fertility

Inform your doctor if you are pregnant, trying to become pregnant, or breastfeeding.

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

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

You must not take Fluconazol Combix if you are pregnant, think you may be pregnant, intend to become pregnant, or are breastfeeding, unless your doctor has instructed you to do so.

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.

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, be aware that dizziness or seizures may occasionally occur.

Fluconazol Combix contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine may cause allergic reactions as it contains carmoisine. It may cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Fluconazol Combix

Follow exactly the instructions for use of this medicine given by your doctor. If you are unsure, 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 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 prescribed by your doctor (adult or pediatric dosing).

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 daily 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 Combix 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, indicating the medication and the amount taken. Symptoms of a possible overdose may include hearing, seeing, feeling, or 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 Combix

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 questions about how to use this medicine, ask your doctor or pharmacist.

If you stop treatment with Fluconazol Combix

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

4. Possible adverse effects

Like all medicines, Fluconazol Combix may cause adverse effects, although not everyone experiences them.

Stop taking Fluconazol Combix 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 severe allergic reactions are rare. If any of the following symptoms occur, contact 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).

Fluconazol Combix may affect your liver. Signs indicating liver problems include:

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

If you experience any of these symptoms, stop taking Fluconazol Combix 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, which may affect up to 1 in 10 people:

• Headache.
• Stomach discomfort, diarrhoea, malaise, vomiting.
• Elevated blood test results indicating liver function abnormalities.
• Rash.

The following are uncommon adverse effects, which may affect up to 1 in 100 people:

• Reduction in red blood cells, which may cause pale skin, weakness, or difficulty breathing.
• Decreased appetite.
• Difficulty sleeping, numbness or tingling 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 (urticaria), itching, increased sweating.
• Fatigue, general feeling of being unwell, fever.

The following are rare adverse effects, which may affect up to 1 in 1,000 people:

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

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

5. Storage of Fluconazole Combix

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 refers to the last day of the month indicated.

Do not store above 30°C.

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

6. Package Contents and Additional Information

Composition of Fluconazole Combix

• The active substance is fluconazole. Each hard capsule contains 50 mg of fluconazole.
• The other components are:

Contents of the capsule: monohydrate lactose, corn starch, anhydrous colloidal silica, sodium lauryl sulfate, magnesium stearate.

Composition of the gelatin capsules: gelatin, sodium lauryl sulfate, titanium dioxide (E171), brilliant blue FCF (E 133), yellow iron oxide (E172), carmoisine (E 122).

Appearance of the product and contents of the container

The 50 mg hard gelatin capsule has a white body and a green cap. The capsule size is No. 4.

PVDC/PVC-Aluminum blisters.

Containers containing 7 hard capsules.

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2. Edificio 2.

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

25, parc d’activités des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

This leaflet was approved in February 2024

Detailed and up-to-date 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/