Fluconazol mabo 50 mg capsulas duras efg
Introduction
PATIENT INFORMATION LEAFLET
Fluconazole Mabo 50 mg Hard Capsules EFG
Read this 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. Do not pass it on to others even if their symptoms are the same.
- If you think you have suffered a side effect, you can help us by reporting it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
- What Fluconazole Mabo is and what it is used for
- Before taking Fluconazole Mabo
- How to take Fluconazole Mabo
- Possible side effects
- Storage of Fluconazole Mabo
- Further information
1. What is Fluconazol Mabo and what is it used for
Fluconazole Mabo is one of the medications in the group called “antifungals”. The active ingredient is fluconazole.
Fluconazole Mabo is used to treat infections caused by fungi, and it may also be used to prevent the appearance of a fungal infection. The most common cause of fungal infections is a yeast calledCandida.
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 Fluconazole Mabo 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 to17 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 Fluconazole Mabo 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.
2. Before taking Fluconazol Mabo
Do not take Fluconazol Mabo if:
- You are allergic (hypersensitive) to fluconazole, to other medications you have taken to treat fungal infections, or to any of the other components of Fluconazol Mabo. Symptoms may include itching, skin redness, or difficulty breathing.
- You are taking astemizole, terfenadine (antihistamines 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 to treat infections).
Be especially careful with Fluconazol Mabo
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.
- If you have ever had a severe skin rash or skin peeling, blisters, and/or mouth sores after taking fluconazole.
- If severe skin reactions (itching, skin redness, or difficulty breathing) occur.
- If 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 fluconazole treatment. Stop taking fluconazole and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.
Use of other medications
Inform your doctor immediately if you are taking astemizole, terfenadine (an antihistamine 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 medications should not be taken with Fluconazol Mabo (see section: “Do not take Fluconazol Mabo if”).
There are some medications that may interact with Fluconazol Mabo.
Make sure your doctor knows if you are taking any of the following medications:
- Rifampicin or rifabutin (antibiotics for infections).
- Alfentanil, fentanil (used as anesthetics).
- Amitriptyline, nortriptyline (used as antidepressants).
- Ampicillin B, voriconazole (antifungals).
- Medications that make blood less viscous, to prevent clot formation (warfarin or similar medications).
- Benzodiazepines (midazolam, triazolam or similar medications) used to help sleep or for anxiety.
- Carbamazepine, phenytoin (used to treat seizures).
- Nifedipine, isradipine, amlodipine, felodipine, and losartan (for hypertension).
- Ciclosporin, everolimus, sirolimus, or tacrolimus (to prevent transplant rejection).
- Cyclophosphamide, vinca alkaloids (vincristine, vinblastine or similar medications) used to treat cancer.
- Halofantrine (used to treat malaria).
- Statins (atorvastatin, simvastatin, and fluvastatin or similar medications) 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).
- Medications 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 medication, including those purchased without a prescription.
Taking Fluconazol Mabo with food and drinks
You can take the medication with or without food.
Pregnancy and breastfeeding
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 fluconazole treatment cycles, consult your doctor about the need to use appropriate contraceptive methods during treatment, which should be maintained for one week after the last dose.
Do not take fluconazole if you are pregnant, think you may be pregnant, or intend to become pregnant or breastfeed, unless your doctor has told you to.If you become pregnant while taking this medication or within one week of 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 during the first trimester may slightly 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 medication.
Driving and operating machines
When driving or operating machines, be aware that occasional dizziness or seizures may occur.
Fluconazol Mabo contains lactose
This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.
Fluconazol Mabo contains sodium
This medication contains less than 23 mg of sodium (1 mmol) per capsule; it is essentially “sodium-free”.
3. How to Take Fluconazol Mabo
Follow exactly the administration instructions of Fluconazol Mabo indicated by your doctor.Consult your doctor or pharmacist if you have any doubts.
The capsules should be swallowed whole with the help of a glass of water. It is better to take your medication at the same time every day.
The following is the usual dose of this medication for different types of infections:
Adults
Condition | Dose |
To treat cryptococcal meningitis | 400 mg on the first day and then 200 mg to 400 mg once a day for6 to8 weeks or longer if necessary. In some cases, the dose is increased to 800 mg |
To prevent the recurrence of cryptococcal meningitis | 200 mg once a day until your doctor tells you to stop |
To treat coccidioidomycosis | 200 mg to 400 mg once a day for 11 months to 24 months or longer if necessary. In some cases, the dose is increased to 800 mg |
To treat internal fungal infections caused byCandida | 800 mg on the first day and then 400 mg once a day until your doctor tells you to stop |
To treat mucosal infections that affect the lining of the mouth, throat, or associated with dental prostheses | 200 mg to 400 mg on the first day and, afterwards, 100 mg to 200 mg until your doctor tells you to stop |
To treat mucosal candidiasis – the dose depends on the location of the infection | 50 mg to 400 mg once a day for7 to30 days until your doctor tells you to stop |
To prevent mucosal infections that affect the lining of the mouth and throat | 100 mg to 200 mg once a day, or 200 mg three times a week, as long as you are at risk of developing an infection |
To treat genital candidiasis | 150 mg as a single dose |
To reduce the recurrence of vaginal candidiasis | 150 mg every three days for a total of 3 doses (days 1, 4, and 7) and then once a week as long as you are at risk of developing an infection |
To treat fungal skin or nail infections | Depending on the location of the infection 50 mg once a day, 150 mg once a week,300 to400 mg once a week for1 to4 weeks (for athlete's foot, up to 6 weeks may be necessary, for nail infections, continue treatment until a healthy nail grows) |
To prevent the spread of an infection caused byCandida(if your immune system is weak and does not function properly) | 200 mg to 400 mg once a day as long as you are at risk of developing an infection |
Adolescents aged 12 to 17 years
Follow the dose indicated by your doctor (the adult dose or the pediatric 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.
Condition | Daily dose |
Mucosal candidiasis and throat infections caused byCandida– the dose and duration of treatment depend on the severity of the infection and its location. | 3 mg per kg of body weight (the first day may be 6 mg per kg of body weight) |
Cryptococcal meningitis or internal fungal infections caused byCandida | 6 mg to 12 mg per kg of body weight |
To prevent a child from contracting an infection caused byCandida(if your immune system does not function properly) | 3 mg to 12 mg per kg of body weight |
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 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 Mabo 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 Mabo
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.
4. Possible Adverse Effects
Some people developallergic reactionsalthough severe allergic reactions are rare..If any of the following symptoms appear, inform your doctor immediately.
- Abnormal heartbeat, difficulty breathing, or chest tightness.
- Swelling of the eyelids, face, or lips.
- Itching all over the body, redness of the skin, or red spots with itching.
- Skin rash.
- Severe skin reactions, such as a rash that causes blisters (this may affect the mouth and tongue).
- Generalized rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
Fluconazol Mabo may affect your liver. Signs indicating liver problems include:
- Tiredness.
- Loss of appetite.
- Vomiting.
- Yellowing of the skin or the white part of the eyes (jaundice).
If you experience any of these symptoms, stop taking Fluconazol Mabo 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.
The following are common side effects that affect 1 to 10 of every 100 patients:
- Headache.
- Stomach discomfort, diarrhea, nausea, vomiting.
- Abnormal liver function test results.
- Rash.
The following are infrequent side effects that affect 1 to 10 patients per 1,000:
- Reduced red blood cells, which may cause pale skin and weakness or difficulty breathing.
- Loss of appetite.
- Inability to sleep, numbness.
- Convulsions, dizziness, sensation 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).
- Rashes, blisters (pustules), itching, increased sweating.
- Tiredness, general feeling of discomfort, fever.
The following are rare side effects, affecting 1 to 10 patients per 10,000:
- White blood cells that help fight infections and blood cells that help stop bleeding, lower than normal.
- Red or purple discoloration of the skin, which may be due to a low number of 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 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 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.
If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use,www.notificaram.es.
By reporting side effects, you can contribute to providing more information about the safety of this medicine.
5. Conservation of Fluconazol Mabo
Keep this medication out of the sight and reach of children.
Do not use Fluconazol Mabo after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.
No special storage conditions are required.
Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.
6. ADDITIONAL INFORMATION
Composition of Fluconazol Mabo 50 mg Hard Capsules EFG
- The active ingredient is fluconazole. Each hard capsule contains 50 mg of fluconazole.
- The other components (excipients) are: Capsule content:monohydrate lactose (lactose), cornstarch, anhydrous colloidal silica, magnesium stearate, and sodium lauryl sulfate.Capsule composition:indigotin (E-132), quinoline yellow (E-104), titanium dioxide (E-171), and gelatin.
Appearance of Fluconazol Mabo 50 mg Hard Capsules and Contents of the Package
The capsules have a white body and a green cap.
They are presented in packages of 7 hard capsules.
Holder of the Marketing Authorization and Responsible for Manufacturing
Holder of the Marketing Authorization:
MABO-FARMA S.A.
Calle Rejas 2, 1st floor28821, Coslada, Madrid
Spain
Responsible for Manufacturing:
TOLL MANUFACTURING SERVICES, S.L.
C/ Aragoneses, 2.
28108, Alcobendas, (Madrid) SPAIN
Last Review Date of this Leaflet: July 2024
The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS):http://www.aemps.gob.es/
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