FLUCONAZOLE TECNIGEN 50 mg HARD CAPSULES
How to use FLUCONAZOLE TECNIGEN 50 mg HARD CAPSULES
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
Package Leaflet: Information for the User
Fluconazole TecniGen 50 mg hard capsules EFG
Fluconazole
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Contents of the package leaflet:
- What is Fluconazole TecniGen and what is it used for.
- Before taking Fluconazole TecniGen.
- How to take Fluconazole TecniGen.
- Possible side effects.
- Storage of Fluconazole TecniGen.
- Further information.
1. What is FLUCONAZOLE TecniGen and what is it used for
Fluconazole TecniGen is one of a group of medicines called “antifungals”. The active substance is fluconazole.
Fluconazole TecniGen 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.
Adults
Your doctor may prescribe this medicine 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 Candidathat are in the bloodstream, in organs of the body (e.g. heart, lungs) or in the urinary tract.
- Mucosal candidiasis – an infection that affects 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 infection.
They may also prescribe Fluconazole TecniGen for:
- Preventing the recurrence of cryptococcal meningitis.
- Preventing the recurrence of mucosal infections.
- Reducing the repeated occurrence of vaginal yeast infections.
- 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 to treat the following types of fungal infections:
- Mucosal candidiasis – an infection that affects the lining of the mouth or throat.
- Infections caused by Candidathat are 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 TecniGen 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 taking Fluconazole TecniGen
Do not take Fluconazole TecniGen if
- You are allergic (hypersensitive) to fluconazole, to other medicines you have taken to treat fungal infections, or to any of the other ingredients of Fluconazole TecniGen. Symptoms can include itching, skin rash or difficulty breathing.
- You are taking astemizole, terfenadine (antihistamine medicines for treating allergies).
- You are taking cisapride (used for stomach upset).
- You are taking pimozide (used for treating mental illness).
- You are taking quinidine (used for treating heart arrhythmias).
- You are taking erythromycin (an antibiotic for treating infections).
Be careful with Fluconazole TecniGen
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.
- Severe skin reactions occur (itching, skin rash or difficulty breathing).
- If you have ever had a severe skin rash or peeling of the skin, blisters and/or sores in the mouth after taking fluconazole.
- If 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 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.
Using other medicines
Tell your doctor immediatelyif you are taking astemizole, terfenadine (an antihistamine for treating allergies), cisapride (used for stomach upset), pimozide (used for treating mental illness), quinidine (used for treating heart arrhythmias) or erythromycin (an antibiotic for treating infections), as these medicines should not be taken with Fluconazole TecniGen (see section: “Do not take Fluconazole TecniGen if”).
There are some medicines that can interact with Fluconazole TecniGen. 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).
- Medicines that make the blood less viscous, to prevent clot formation (warfarin or similar medicines).
- Benzodiazepines (midazolam, triazolam or similar medicines) used to help you sleep or for anxiety.
- Carbamazepine, phenytoin (used for treating 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 for treating cancer.
- Halofantrine (used for treating malaria).
- Statins (atorvastatin, simvastatin and fluvastatin or similar medicines) used for reducing 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 for controlling 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.
Taking Fluconazole TecniGen with food and drinks
You can take the medicine with or without food.
Pregnancy and breastfeeding
Tell your doctor if you are pregnant, trying to become pregnant or are breastfeeding. You should not take fluconazole if you are pregnant, think you may be pregnant or are planning to become pregnant or breastfeed, unless your doctor has told you to.
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.
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.
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 operating machinery, keep in mind that dizziness or seizures may occasionally occur.
Important information about some of the ingredients of Fluconazole TecniGen
This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.
This medicine contains less than 23 mg of sodium (1mmol) per capsule; this is, essentially “sodium-free”.
3. How to TAKE FLUCONAZOLE TecniGen
Follow the instructions for taking Fluconazole TecniGen exactly as indicated by your doctor. Ask 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 best to take your medicines at the same time every day.
The following is the usual dose of this medicine for the 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 for 6 to 8 weeks or longer if necessary. In some cases, the dose may be 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 longer if necessary. In some cases, the dose may be increased to 800 mg |
To treat internal fungal infections caused by Candida | 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 then 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 for 7 to 30 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 3 times a week, while the risk of developing an infection continues |
To treat genital candidiasis | 150 mg in a single dose |
To reduce the repeated occurrence of vaginal yeast infections | 150 mg every 3 days for a total of 3 doses (days 1, 4 and 7) and then once a week while the risk of developing an infection continues |
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 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, treatment should continue until a healthy nail grows) |
To prevent the spread of Candidainfections (if your immune system is weak and not working properly) | 200 mg to 400 mg once a day while the risk of developing an infection continues |
Adolescents 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.
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 kilogram of body weight (on the first day, 6 mg per kilogram of body weight may be given) |
Cryptococcal meningitis or internal fungal infections caused by Candida | 6 mg to 12 mg per kilogram of body weight |
To prevent the spread of Candidainfections in children (if their immune system is weak and not working properly) | 3 mg to 12 mg per kilogram 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 given every 2 days. The maximum dose is 12 mg per kilogram of body weight every 48 hours.
Use in children under 2 weeks of age:
- The same dose as described in the table, but given every 3 days. The maximum dose is 12 mg per kilogram of body weight every 72 hours.
Occasionally, doctors may prescribe different doses than those described. Follow the instructions for taking Fluconazole TecniGen exactly as indicated by your doctor. Ask your doctor or pharmacist if you have any doubts.
Elderly patients
The usual dose for adults, unless you have kidney problems.
Patients with kidney problems
Your doctor may change the dose, depending on how well your kidneys are working.
If you take more Fluconazole TecniGen 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, phone 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 behavior). It may be appropriate to initiate symptomatic treatment (with supportive measures and stomach lavage if necessary).
If you forget to take Fluconazole TecniGen
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 the next dose, do not take the missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.
4. Possible Adverse Effects
Like all medicines, Fluconazol TecniGen can cause adverse effects, although not all people suffer from them.
Stop taking fluconazol 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 develop allergic reactions, although severe allergic reactions are rare.If any of the following symptoms appear, inform your doctor immediately.
- Sudden wheezing when breathing, 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 rash that causes blisters (this can affect the mouth and tongue).
Fluconazol TecniGen may affect your liver. Signs that indicate 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 TecniGen 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 affect 1 to 10 out of every 100 patients:
- Headache.
- Stomach upset, diarrhea, discomfort, vomiting.
- Elevated blood test results indicating liver function.
- Rash.
The following are infrequent adverse effects that affect 1 to 10 patients out of every 1,000:
- Reduction of red blood cells, which can make your skin pale and cause weakness or difficulty breathing.
- Decreased appetite.
- Insomnia, feeling of numbness.
- Seizures, 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 affect 1 to 10 patients out of every 10,000:
- White blood cells in the blood that help defend against 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 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.
Reporting Adverse Effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines, www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.
5. Storage of FLUCONAZOL TecniGen
Keep this medicine out of the sight and reach of children.
Do not use Fluconazol TecniGen 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 thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.
6. Package Contents and Additional Information
Composition of Fluconazol TecniGen
The active ingredient is fluconazole.
Each hard capsule contains 200 mg of fluconazole.
The other components (excipients) are:
Capsule content: lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch (corn starch), corn starch, sodium lauryl sulfate, and magnesium stearate
Capsule composition: titanium dioxide (E-171), gelatin
Appearance of Fluconazol TecniGen 200 mg Hard Capsules and Package Contents
The capsules have a white body and a white cap. They are presented in packages of 7 hard capsules.
Marketing Authorization Holder and Manufacturer
Marketing authorization holder:
Tecnimede España Industria Farmacéutica, S.A.
Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,
28108 Alcobendas (Madrid) SPAIN
Manufacturer:
Medinfar Manufacturing, S.A.
Parque Industrial Armando Martins Tavares
Rua Outeiro Da Armada, nº 5.
Condeixa-a-Nova, 3150-194. Portugal
or
Atlantic Pharma-Produçoes Farmaceuticas, S.A.
Rua da Tapada Grande, Nº2 – Abrunheira. Sintra - 2710-089 – Portugal
This prospectus was approved in January 2021
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/
- Country of registration
- Average pharmacy price7.51 EUR
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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