PATIENT INFORMATION LEAFLET

Fluconazole Combix 100 mg Hard Capsules EFG

Read this 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. Do not pass it on to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet.

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

2. What you need to know before taking Fluconazole Combix

3. How to take Fluconazole Combix

4. Possible side effects

5. Storage of Fluconazole Combix

6. Contents of the pack and additional information

Fluconazol Combix is one of the medications in the group called "antifungals". The active ingredient is fluconazole.

Fluconazol Combix is used to treat infections caused by fungi, and it may also be used to prevent the onset of a fungal infection. The most common cause of fungal infections is a yeast calledCandida.

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

Adults

Your doctor may prescribe this medication 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 byCandidalocated in the bloodstream, in organs of the body (e.g. heart, lungs) or in the urinary tract.
• Mucosal candidiasis – an infection that affects the mucous membrane 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, inguinal ringworm, nail infection.

Your doctor may also prescribe Fluconazol Combix for:

• To prevent the recurrence of cryptococcal meningitis.
• To prevent the recurrence of mucosal infections.
• To reduce the recurrence of vaginal infections caused byCandida.
• To prevent the transmission of infections caused byCandida(if your immune system is weak and does not function properly).

Children and adolescents (0 to 17 years)

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

• Mucosal candidiasis – an infection that affects the mucous membrane of the mouth or throat.
• Infections caused byCandidalocated in the bloodstream, in organs of the body (e.g. heart, lungs) or in the urinary tract.
• Cryptococcal meningitis – a fungal infection in the brain.

Your doctor may also prescribe Fluconazol Combix for:

• To prevent the transmission of infections caused byCandida(if your immune system is weak and does not function properly).
• To prevent the recurrence of cryptococcal meningitis.

Do not take Fluconazol Combix

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

Warnings and precautions

Inform your doctor if

• you have liver or kidney problems.
• you have a heart disease, including heart rhythm problems.
• you have abnormal levels of potassium, calcium, or magnesium in your blood.
• you experience severe skin reactions (itching, skin redness, or difficulty breathing).
• you have ever had a severe skin rash or skin peeling, blisters, and/or mouth sores after taking Fluconazol Combix.
• the fungal infection does not improve, an alternative antifungal treatment may be necessary.

Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with Fluconazol Combix treatment. Stop taking Fluconazol Combix and seek medical attention immediately if you notice any of the 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 to treat allergies), cisapride (used to treat stomach discomfort), pimozide (used to treat mental illnesses), quinidine (used to treat heart arrhythmias), or erythromycin (an antibiotic to treat infections), as these medicines should not be taken with Fluconazol Combix (see section: “Do not take Fluconazol Combix”).

There are some medicines that 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, fentanil (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 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, and fluvastatin or similar medicines) used to reduce high cholesterol levels.
• methadone (used for pain).
• celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (Nonsteroidal Anti-Inflammatory Drugs – NSAIDs).
• oral contraceptives.
• prednisone (steroid).
• zidovudine, also known as AZT; saquinavir (used in patients infected with HIV).
• medicines for diabetes, such as chlorpropamide, glibenclamide, glipizide, or tolbutamide.
• theophylline (used to control asthma).
• vitamin A (nutritional supplement).

Inform your doctor or pharmacist if you are taking or have recently taken any other medicine, including those purchased without a prescription.

Fluconazol Combix with food and drink

You can take the medicine with or without food.

Pregnancy, breastfeeding, and fertility

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

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

You should not take Fluconazol Combix if you are pregnant, think you may be pregnant, or are planning to become pregnant or breastfeed, unless your doctor has told you to.

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 abnormalities affecting the heart, bones, and/or muscles.

Cases of babies born with congenital abnormalities affecting the skull, ears, and leg 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 unclear.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

When driving or operating machinery, be aware that occasional dizziness or seizures may occur.

Fluconazol Combix contains lactose.If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

Follow exactly the administration instructions of this medication as indicated by your doctor. 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 better to take your capsules at the same time every day.

The usual dose of this medication for different types of infections is as follows:

Adults

Adolescents 12 to 17 years old

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

Children up to 11 years old

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 0 to 4 weeks old

Use in children 3 to 4 weeks old:

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 old:

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.

In some cases, doctors may prescribe different doses than those described. Follow exactly the administration instructions indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Older adults

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 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 can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken. 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 Combix

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

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

If you interrupt treatment with Fluconazol Combix

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

Like all medications, Fluconazol Combix may cause side effects, although not everyone will experience them.

Stop taking Fluconazol Combix and seek medical attention immediately if you notice any of the following symptoms:

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

Some people developallergic reactionsalthough severe allergic reactions are rare.If you experience any of the following symptoms,inform your doctor immediately.

• Abnormal heart palpitations, 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 blistering rash (this may affect the mouth and tongue).

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

• Fatigue.
• Loss of appetite.
• Vomiting.
• Yellowing of the skin or white of the eyes (jaundice).

If you experience any of these symptoms, stop taking Fluconazol Combix andinform your doctor immediately.

Other side effects:

In addition, if you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Below are the common side effects that may affect up to 1 in 10 people:

- Headache.

- Stomach discomfort, diarrhea, nausea, vomiting.

- Elevated blood test results indicating liver function.

- Rash.

Below are the uncommon side effects that may affect up to 1 in 100 people:

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

- Decreased appetite.

- Insomnia, numbness.

- Convulsions, dizziness, feeling of spinning, tingling, pins and needles, changes in taste.

- Constipation, heavy digestion, gas, dry mouth.

- Muscle pain.

- Liver damage and yellowing of the skin and eyes (jaundice).

- Hives, blisters (pustules), itching, increased sweating.

- Fatigue, general feeling of discomfort, fever.

Below are the rare side effects, which may affect up to 1 in 1,000 people:

- Low white blood cells that help us fight infections and blood cells that help stop bleeding, lower than normal.

- Red or purplish discoloration of the skin, which may be due to low platelets, other blood cell changes.

- Abnormal blood test results (high cholesterol, fats).

- Low potassium levels in the blood.

- Tremors.

- Abnormal electrocardiogram (ECG), changes in heart rate or rhythm.

- Liver failure.

- Allergic reactions (sometimes severe), including widespread rash with blisters and skin peeling, severe allergic reactions, swelling of the lips or face.

- Hair loss.

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

Keep out of the sight and reach of children.

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

Do not store at a temperature above 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Fluconazol Combix

- The active ingredient is fluconazole. Each hard capsule contains 100 mg of fluconazole.

- The other components are:

Hard capsule content:monohydrate lactose, cornstarch, anhydrous colloidal silica, sodium lauryl sulfate, magnesium stearate.

Composition of gelatin capsules:gelatin, sodium lauryl sulfate, titanium dioxide (E171), patent blue (E131), and erythrosine (E127).

Appearance of the product and contents of the packaging

The 100 mg hard gelatin capsule has a white body and a blue-colored cap. The capsule size is No. 2.

PVDC/PVC-Aluminum blisters.

Containers containing 7 hard capsules.

Marketing Authorization Holder

Combix, S.L.U. Laboratories

C/ Badajoz 2. Edificio 2.

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for Manufacturing

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

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/