Fluconazol tarbis 200 mg capsulas duras efg
Como usar Fluconazol tarbis 200 mg capsulas duras efg
Introduction
Package Insert: Information for the User
Fluconazole Tarbis 200 mg Hard Capsules EFG
Read this package insert carefully before starting to take this medication, as it contains important information for you.
- Keep this package insert as you may need to refer to it again.
- If you have any questions, consult your doctor or pharmacist.
- This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.
1. What is Fluconazol Tarbis and what is it used for
Fluconazol Tarbis is one of the medications in the group called “antifungals”. The active ingredient is fluconazol.
Fluconazol Tarbis 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 called Candida.
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 by Candida localized 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 Tarbis for:
-To prevent the recurrence of cryptococcal meningitis.
-To prevent the recurrence of mucosal infections.
-To reduce the recurrence of vaginal infections caused by Candida.
-To prevent the transmission of infections caused by Candida (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 by Candida localized 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 Tarbis for:
-To prevent the transmission of infections caused by Candida (if your immune system is weak and does not function properly).
-To prevent the recurrence of cryptococcal meningitis.
2. What you need to know before starting Fluconazol Tarbis
Do not take Fluconazol Tarbis if:
- You are allergic to fluconazole, other medications you have taken to treat fungal infections, or any of the other components of this medication (listed in section 6). Symptoms may include itching, skin redness, or difficulty breathing.
- You are taking astemizole, terfenadine (antihistamines for allergies).
- You are taking cisaprida (used to treat stomach discomfort).
- You are taking pimozida (used to treat mental illnesses).
- You are taking quinidina (used to treat heart arrhythmias).
- You are taking eritromicina (an antibiotic for infections).
Warnings and precautions
Consult your doctor or pharmacist before starting to take Fluconazol Tarbis 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 redness, or difficulty breathing).
-If you have ever had a severe skin rash or skin peeling, blisters, and/or mouth sores after taking Fluconazol Tarbis.
-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 relation to Fluconazol Tarbis treatment. Stop taking Fluconazol Tarbis and seek medical attention immediately if you notice any symptoms related to these severe skin reactions described in section 4.
Use of Fluconazol Tarbis with other medications
Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.
Notify your doctor immediately if you are taking astemizole, terfenadine (an antihistamine for allergies), cisaprida (used for stomach discomfort), pimozida (used to treat mental illnesses), quinidina (used to treat heart arrhythmias), or eritromicina (an antibiotic for infections), as these medications should not be taken with Fluconazol Tarbis (see section: “Do not take Fluconazol Tarbis if”).
There are some medications that may interact with Fluconazol Tarbis.
Ensure your doctor knows if you are taking any of the following medications:
- Rifampicina or rifabutina (antibiotics for infections).
- Alfentanilo, fentanilo (used as anesthetics).
- Amitriptilina, nortriptilina (used as antidepressants).
- Anfotericina B, voriconazol (antifungals).
- Medications that make blood less viscous, to prevent clot formation (warfarina or similar medications).
- Benzodiazepinas (midazolam, triazolam or similar medications) used to help sleep or for anxiety.
- Carbamazepina, fenitoína (used to treat seizures).
- Nifedipino, isradipino, amlodipino, felodipino, and losartan (for hypertension).
- Ciclosporina, everolimus, sirolimus, or tacrolimus (to prevent transplant rejection).
- Ciclofosfamida, alcaloides de la vinca (vincristina, vinblastina or similar medications) used to treat cancer.
- Halofantrina (used to treat malaria).
- Estatinas (atorvastatina, simvastatina, and fluvastatina or similar medications) used to reduce high cholesterol levels.
- Metadona (used for pain).
- Celecoxib, flurbiprofeno, naproxeno, ibuprofeno, lornoxicam, meloxicam, diclofenaco (Nonsteroidal Anti-Inflammatory Drugs – NSAIDs).
- Oral contraceptives.
- Prednisona (steroid).
- Zidovudina, also known as AZT; saquinavir (used in patients infected with HIV).
- Medications for diabetes, such as clorpropamida, glibenclamida, glipizida, or tolbutamida.
- Teofilina (used to control asthma).
- Vitamin A (nutritional supplement).
Taking Fluconazol Tarbis with food, drinks, and alcohol
You can take the medication with or without food.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.
If you plan 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 suitable contraceptive methods during treatment, which should be maintained for one week after the last dose.
Do not take Fluconazol Tarbis if you are pregnant, think you may be pregnant, or plan to become pregnant or breastfeed, unless your doctor has instructed you to do so.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 increase the risk of a baby being born with congenital anomalies affecting the heart, bones, and/or muscles.
Cases of babies born with congenital anomalies 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 machinery
When driving or operating machinery, be aware that occasional dizziness or seizures may occur.
Fluconazol Tarbis contains lactose
This medication contains a small amount of lactose (milk sugar). If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.
3. How to Take Fluconazol Tarbis
Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. 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 medication always at the same time of day.
The following indicates 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 subsequently 200 mg to 400 mg once a day for 6 to 8 weeks or more 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 from 11 months to 24 months or more 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 subsequently 400 mg once a day until your doctor tells you to stop. |
To treat mucosal infections that affect the covering of the mouth, throat, or associated with dental prostheses. | 200 mg to 400 mg on the first day, and then 100 mg to 200 mg until your doctor tells you to stop. |
To treat mucosal candidiasis – the dose depends on where the infection is located | 50 mg to 400 mg once a day for 7 to 30 days until your doctor tells you to stop. |
To prevent mucosal infections that affect the covering of the mouth and throat | 100 mg to 200 mg once a day, or 200 mg three times a week, as long as you continue to be 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 continue to be at risk of developing an infection. |
To treat fungal infections of the skin or nails | Depending on the location of the infection, 50 mg once a day, 150 mg once a week, 300 to 400 mg once a week for 1 to 4 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 continue to be at risk of developing an infection. |
Use in adolescents aged 12 to 17 yearsold
Follow the dose indicated by your doctor (the adult dose or the pediatric dose).
Use in children up to 11 years old
The maximum daily dose for children is 400 mg.
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 where it is located. | 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 Tarbis 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 Toxicological 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 Tarbis
Do not take a double dose to make up for the missed doses. If you have forgotten 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 interrupt treatment with Fluconazol Tarbis
If you have any other doubts about the use of this medication, ask your doctor or pharmacist.
4. Possible Adverse Effects
Like all medicines, this medicinecan cause side effects, although not everyone will experience them.
Some people developallergic reactionsalthough severe allergic reactions are rare.If any of the following symptoms appear,inform your doctor immediately.
- Abnormal heartbeats, 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 can affect the mouth and tongue).
Fluconazol Tarbis may affect your liver. Signs that indicate liver problems include:
-Fatigue.
-Loss of appetite.
-Vomiting.
-Yellowing of the skin or the white part of the eyes (jaundice).
If you experience any of these symptoms, stop takingFluconazol Tarbisandinform your doctor immediately.
Stop taking Fluconazol Tarbis 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).
Other side effects:
In addition, if you consider any of the side effects you experience 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 in every 100 patients:
- Headache.
- Stomach discomfort, diarrhea, nausea, vomiting.
- Abnormal liver function test results.
- Rash.
The following are uncommon side effects that affect 1 to 10 patients in every 1,000:
- Reduction in red blood cells, which can cause pale skin and weakness or difficulty breathing.
- Loss of 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).
- Rashes, blisters (pustules), itching, increased sweating.
- Fatigue, general feeling of discomfort, fever.
The following are rare side effects, affecting 1 to 10 patients in every 10,000:
- Low white blood cell count, which helps fight infections, and low platelet count, which helps stop bleeding.
- Red or purple discoloration of the skin, which may be due to a low platelet count, 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.
Reporting side effects
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not mentioned in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.
By reporting side effects, you can contribute to providing more information on the safety of this medicine.
5. Conservation of Fluconazole Tarbis
This medication does not require special conservation conditions.
Keep this medication 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.
Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications 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 medications you no longer need. By doing so, you will help protect the environment.
6. Contents of the packaging and additional information
Composition ofFluconazol Tarbis
The active ingredient is fluconazole.
Each hard capsule contains 200 mg of fluconazole.
The other components (excipients) are:
Capule content: lactose monohydrate (lactose), pregelatinized cornstarch (cornstarch), hydrated colloidal silica, magnesium stearate, sodium lauryl sulfate.
Capsule composition: gelatin, titanium dioxide (E171) and quinoline (E 104).
Appearance of the product and contents of the packaging
The capsules have a white body and a green cap.
It is presented in packaging with 7 hard capsules and a clinical pack with 500 hard capsules.
Holder of the marketing authorization and responsible for manufacturing
Holder of the marketing authorization:
TARBIS FARMA, S.L.
Gran Vía Carlos III, 94
08028 - Barcelona
Spain
Responsible for manufacturing:
Neuraxpharm Pharmaceuticals, S.L
Avda. Barcelona, 69
08970 Sant Joan Despí (Barcelona)
Last review date of this leaflet:February 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/
- País de registo
- Substância ativa
- Requer receita médicaSim
- Fabricante
- ComposiçãoLaurilsulfato de sodio (0,48 mg mg), Lactosa monohidrato (182,20 mg mg)
- Esta informação é apenas para referência e não constitui aconselhamento médico. Consulte sempre um médico antes de tomar qualquer medicamento. A Oladoctor não se responsabiliza por decisões médicas baseadas neste conteúdo.
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