FLUCONAZOLE COMBIX 100 mg HARD CAPSULES

Introduction

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

Fluconazole Combix 100 mg hard capsules EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

Contents of the pack

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

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

Fluconazole Combix is one of a group of medicines called “antifungals”. The active substance is fluconazole.

Fluconazole Combix is used to treat infections caused by fungi, and it can also be used to prevent fungal infections from occurring. The most common cause of fungal infections is a yeast called Candida.

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

Adults

Your doctor may prescribe this medicine for the treatment of the following types of fungal infections:

• cryptococcal meningitis – a fungal infection in the brain.
• coccidioidomycosis – a disease of the bronchopulmonary system.
• Candidainfections located in the bloodstream, in organs of the body (e.g. heart, lungs) or in the urinary tract.
• mucosal candidiasis – an infection affecting the lining 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, jock itch, nail infections.

They may also prescribe Fluconazole Combix for:

• preventing the recurrence of cryptococcal meningitis.
• preventing the recurrence of mucosal infections.
• reducing the repeated occurrence of vaginal Candidainfections.
• preventing the spread of Candidainfections (if your immune system is weak and not working properly).

Children and adolescents (0 to 17 years)

Your doctor may prescribe this medicine for the treatment of the following types of fungal infections:

• mucosal candidiasis – an infection affecting the lining of the mouth or throat.
• Candidainfections located 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.

They may also prescribe Fluconazole Combix for:

• preventing the spread of Candidainfections (if your immune system is weak and not working properly).
• preventing the recurrence of cryptococcal meningitis.

2. What you need to know before you take Fluconazole Combix

Do not take Fluconazole Combix

• if you are allergic (hypersensitive) to fluconazole, to other medicines used to treat fungal infections or to any of the other ingredients of Fluconazole Combix. Symptoms may include itching, skin rash or difficulty breathing.
• if you are taking astemizole, terfenadine (antihistamines used to treat allergies).
• if you are taking cisapride (used to treat stomach upset).
• if you are taking pimozide (used to treat mental health conditions).
• if you are taking quinidine (used to treat heart rhythm disorders).
• 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 have a heart condition, including heart rhythm problems.
• you have abnormal levels of potassium, calcium or magnesium in your blood.
• you experience severe skin reactions (itching, skin rash or difficulty breathing).
• you have ever had a severe skin rash or peeling of the skin, blisters and/or sores in the mouth after taking Fluconazole Combix.
• the fungal infection does not improve, alternative antifungal treatment may be necessary.

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

Interaction of Fluconazole Combix with other medicines

Tell your doctor immediatelyif you are taking astemizole, terfenadine (antihistamines used to treat allergies), cisapride (used to treat stomach upset), pimozide (used to treat mental health conditions), quinidine (used to treat heart rhythm disorders) or erythromycin (an antibiotic used to treat infections), as these medicines should not be taken with Fluconazole Combix (see section: “Do not take Fluconazole Combix”).

There are some medicines that may interact with Fluconazole Combix.

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

• rifampicin or rifabutin (antibiotics used to treat infections).
• alfentanil, fentanyl (used as anaesthetics).
• amitriptyline, nortriptyline (used as antidepressants).
• amphotericin B, voriconazole (antifungals).
• medicines that make the blood less viscous, to prevent the formation of clots (warfarin or similar medicines).
• benzodiazepines (midazolam, triazolam or similar medicines) used to help you 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 relief).
• celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (Non-Steroidal Anti-Inflammatory Drugs – NSAIDs).
• oral contraceptives.
• prednisone (steroid).
• zidovudine, also known as AZT; saquinavir (used in HIV-infected patients).
• medicines for diabetes, such as chlorpropamide, glibenclamide, 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.

Fluconazole Combix with food and drink

You can take the medicine with or without food.

Pregnancy, breast-feeding and fertility

Tell your doctor if you are pregnant, trying to become pregnant or are breast-feeding.

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 adequate contraceptive methods during treatment, which should be continued for one week after the last dose.

Do not take Fluconazole Combix if you are pregnant, think you may be pregnant or are planning to become pregnant or breast-feed, unless your doctor has told you to do so.

Fluconazole taken during the first or second trimester of pregnancy may increase the risk of miscarriage. Fluconazole during the first trimester may increase the risk of a baby being born with congenital anomalies affecting the heart, bones and/or muscles.

There have been reports of babies born with congenital anomalies affecting the skull, ears and bones of the thigh and elbow 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.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

When driving or using machines, you should be aware that occasionally dizziness or seizures may occur.

Fluconazole Combix contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Fluconazole Combix

Follow exactly the administration instructions of this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

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

The following is the usual dose of this medicine for the different types of infections:

Adults

Adolescents from 12 to 17 years of age

Follow the dose indicated by your doctor (the adult dose or the child 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 daily dose is 12 mg per kg of body weight every 72 hours.

Sometimes 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.

Elderly patients

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 working.

If you take more Fluconazole Combix than you should

Taking too many capsules at once can make you feel unwell. Contact your doctor or the nearest hospital immediately. You can also call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken. The 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 initiate symptomatic treatment (with supportive measures and stomach lavage if necessary).

If you forget to take Fluconazole Combix

Do not take a double dose to make up for forgotten doses. If you have forgotten 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 further questions on the use of this medicine, ask your doctor or pharmacist.

If you stop taking Fluconazole Combix

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

4. Possible Adverse Effects

Like all medicines, Fluconazol Combix can cause adverse effects, although not all people suffer from 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 develop allergic reactions, although severe allergic reactions are rare.If any of the following symptoms appear, 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 red spots with itching.
• Skin rash.
• Severe skin reactions, such as a blistering rash (this can 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 the whites of the eyes (jaundice).

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

Other Adverse Effects:

Additionally, if you consider that any of the adverse effects you are suffering from is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

The following are frequent adverse effects that may affect up to 1 in 10 people:

• Headache.
• Stomach upset, diarrhea, discomfort, vomiting.
• Elevated blood test results indicating liver function.
• Rash.

The following are infrequent adverse effects that may affect up to 1 in 100 people:

• Reduction of red blood cells, which can make your skin pale and cause weakness or difficulty breathing.
• Decreased appetite.
• Insomnia, feeling of numbness.

- Convulsions, dizziness, feeling of spinning, tingling, pinching, or numbness, changes in taste sensation.

• Constipation, heavy digestion, gas, dry mouth.
• Muscle pain.
• Liver damage and yellowing of the skin and eyes (jaundice).
• Hives, blisters (hives), itching, increased sweating.
• Fatigue, general feeling of discomfort, fever.

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

• White blood cells that help defend against infections and blood cells that help stop bleeding, lower than normal.
• Red or purple skin discoloration, which may be due to a low platelet count, other changes in blood cells.
• Changes in blood tests (high cholesterol, fat levels).
• 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 rash with blisters and skin peeling, severe allergic reactions, swelling of the lips or face.
• Hair loss.

If you consider that any of the adverse effects you are suffering from is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

5. Storage of Fluconazol Combix

Keep out of sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Fluconazol Combix

• The active ingredient is fluconazole. Each hard capsule contains 100 mg of fluconazole.
• The other components are:

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

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

Appearance of the Product and Package Contents

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

PVDC/PVC-Aluminum blisters.

Packages 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 prospectus was approved in February 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/