Fluconazole Combix 150 mg hard capsules EFG
Spain
Table of Contents
- Package leaflet: Information for the user
- Introduction
- 1. What Fluconazol Combix is and what it is used for
- 2. What you need to know before taking Fluconazol Combix
- 3. How to take Fluconazole Combix
- 4. Possible adverse effects
- 5. Storage of Fluconazole Combix
- 6. Contents of the Pack and Additional Information
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Fluconazole Combix 150 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, consult 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 these effects are not listed in this leaflet.
Leaflet contents
- What Fluconazole Combix is and what it is used for
- What you need to know before taking Fluconazole Combix
- How to take Fluconazole Combix
- Possible side effects
- How to store Fluconazole Combix
- 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 organs of the body (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)
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 organs of the body (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 irregular heart rhythms.
- you have abnormal levels of potassium, calcium, or magnesium in your blood.
- you develop severe skin reactions (itching, skin redness, or difficulty breathing).
- you have ever had a severe skin rash, skin peeling, 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).
- blood-thinning medicines to prevent clot formation (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, and 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.
Fluconazol Combix with food and drink
You may take this medicine with or without food.
Pregnancy, breastfeeding, and fertility
Tell 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 pregnancy.
For longer treatment courses with fluconazole, consult your doctor about using appropriate contraceptive methods during treatment, which should be continued for one week after the last dose.
Do not take Fluconazol Combix 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.
Fluconazole taken during the first or second trimester of pregnancy may increase the risk of miscarriage. Fluconazole use during the first trimester may increase the risk of congenital abnormalities affecting the heart, bones, and/or muscles in the baby.
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.
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.
Fluconazol Combix contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take Fluconazole Combix
Follow exactly the instructions for use of this medicine as given by your doctor. 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 capsules at the same time of day each time.
The usual doses of this medicine for different types of infections are indicated below:
Adults
Condition | Dosage |
To treat cryptococcal meningitis. | 400 mg on the first day, followed by 200 mg to 400 mg once daily for 6 to 8 weeks, or longer if necessary. The dose may occasionally be increased up to 800 mg. The dose may occasionally be increased up to 800 mg. |
To prevent recurrence of cryptococcal meningitis. | 200 mg once daily until directed otherwise by your doctor. |
To treat coccidioidomycosis. | 200 mg to 400 mg once daily for 11 to 24 months, or longer if necessary. The dose may occasionally be increased up to 800 mg. |
To treat systemic fungal infections caused by Candida. | 800 mg on the first day, followed by 400 mg once daily until directed otherwise by your doctor. |
To treat mucosal infections affecting the lining of the mouth, throat, or associated with dental prostheses. | 200 mg to 400 mg on the first day, followed by 100 mg to 200 mg daily until directed otherwise by your doctor. |
To treat mucosal candidiasis – dosage depends on the site of infection. | 50 mg to 400 mg once daily for 7 to 30 days, or until directed otherwise by your doctor. |
To prevent mucosal infections affecting the lining of the mouth and throat. | 100 mg to 200 mg once daily, or 200 mg three times per week, for as long as the risk of developing an infection persists. |
To treat genital candidiasis. | 150 mg as a single dose |
To reduce recurrent episodes of vaginal candidiasis. | 150 mg every third day for a total of 3 doses (day 1, 4, and 7), followed by once weekly for as long as the risk of developing an infection persists. |
To treat fungal skin or nail infections. | Depending on the site of infection: 50 mg once daily, 150 mg once weekly, or 300 to 400 mg once weekly for 1 to 4 weeks (for athlete's foot, up to 6 weeks may be needed; for nail infections, continue treatment until a healthy nail has grown). |
To prevent Candida infection (if your immune system is weakened and not functioning properly). | 200 mg to 400 mg once daily for as long as the risk of developing an infection persists. |
Adolescents aged 12 to 17 years
Follow the dose indicated by your doctor (either 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.
Condition | Daily dose |
Mucosal candidiasis and throat infections caused by Candida – the dose and duration of treatment depend on the severity of the infection and its location. | 3 mg per kg of body weight (on the first day, 6 mg per kg of body weight may be given). |
Cryptococcal meningitis or internal fungal infections caused by Candida. | 6 mg to 12 mg per kg of body weight. |
To prevent the child from becoming infected with Candida (if their immune system is not functioning properly). | 3 mg to 12 mg per kg of body weight. |
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, skip the missed dose and take the next dose at the scheduled time.
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 enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
Some people may develop allergic reactions, although serious 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.
- 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 effect 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 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 (wheals), itching, increased sweating.
- Tiredness, 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 white blood cells that help defend against infections, and blood cells that help stop bleeding.
- Reddish or purplish skin discolouration, which may be due to low platelet count, 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 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 effect 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 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. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.
6. Contents of the Pack and Additional Information
Composition of Fluconazole Combix
- The active substance is fluconazole. Each hard capsule contains 150 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), and patent blue (E131).
Appearance of the Product and Contents of the Pack
The 150 mg hard gelatin capsule has a blue body and cap, with "150 mg" printed in black ink. The capsule size is No. 1.
PVDC/PVC-Aluminum blisters.
Packs containing 1 or 4 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 Patient Information Leaflet was approved in February 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/