Fluconazole Tecnigen 50 mg hard capsules EFG
Spain
Table of Contents
- Package leaflet: Information for the user
- Introduction
- 1. What FLUCONAZOL TecniGen is and what it is used for
- 2. What you need to know before taking Fluconazole TecniGen
- 3. HOW TO TAKE FLUCONAZOL TecniGen
- 4. Possible adverse effects
- 5. Storage of FLUCONAZOL TecniGen
- 6. Contents of the container and additional information
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Fluconazol TecniGen 50 mg hard capsules EFG
Fluconazole
Read the entire 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 other people, even if they have the same symptoms, as it may harm them.
- If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Leaflet contents:
- What Fluconazol TecniGen is and what it is used for.
- Before you take Fluconazol TecniGen.
- How to take Fluconazol TecniGen.
- Possible side effects.
- How to store Fluconazol TecniGen.
- Further information.
1. What FLUCONAZOL TecniGen is and what it is used for
Fluconazol TecniGen is a medicine belonging to a group of drugs known as "antifungals". The active substance is fluconazol.
Fluconazol TecniGen is used to treat fungal infections and may also be used to prevent the occurrence of a fungal infection. 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 of the brain.
- Coccidioidomycosis – a disease affecting the bronchopulmonary system.
- Infections caused by Candida located in the bloodstream, in body organs (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 TecniGen may also be prescribed to:
- Prevent recurrence of cryptococcal meningitis.
- Prevent recurrence of mucosal infections.
- Reduce the repeated occurrence of vaginal Candida infections.
- Prevent the spread 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 body organs (e.g., heart, lungs), or in the urinary tract.
- Cryptococcal meningitis – a fungal infection of the brain.
Fluconazol TecniGen may also be prescribed to:
- Prevent the spread 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 Fluconazole TecniGen
Do not take Fluconazole TecniGen if
- You are allergic (hypersensitive) to fluconazole, to other antifungal medicines you have taken, or to any of the other components of Fluconazole TecniGen. Symptoms may include itching, skin redness, or difficulty breathing.
- You are taking astemizole or terfenadine (antihistamine medicines used 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 used to treat infections).
Take special care with Fluconazole TecniGen
Tell your doctor if
- You have liver or kidney problems.
- You suffer from heart disease, including heart rhythm disorders.
- You have abnormal levels of potassium, calcium, or magnesium in your blood.
- Severe skin reactions occur (such as itching, skin redness, or difficulty breathing).
- You have ever had a severe skin rash, skin peeling, blisters, and/or mouth sores after taking fluconazole.
- 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 during treatment with fluconazole. Stop taking fluconazole and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.
Taking other medicines
Inform your doctor immediately if you are taking astemizole, terfenadine (an antihistamine 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 together with Fluconazole TecniGen (see section: “Do not take Fluconazole TecniGen if”).
Some medicines may 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 blood clots (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).
- Cyclosporine, 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, fluvastatin, or similar medicines) used to lower 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.
Taking Fluconazole TecniGen with food and drink
You may take this medicine with or without food.
Pregnancy and breastfeeding
Tell your doctor if you are pregnant, trying to become pregnant, or breastfeeding. You must not take fluconazole if you are pregnant, think you might be pregnant, plan to become pregnant, or are breastfeeding, unless your doctor has instructed you to do so.
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 the need to use appropriate 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 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
Be aware that dizziness or seizures may occasionally occur when driving or operating machinery.
Important information about some of the ingredients of Fluconazole TecniGen
This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him or her before taking this medicine.
This medicine contains less than 23 mg of sodium (1 mmol) per capsule; this is essentially “sodium-free”.
3. HOW TO TAKE FLUCONAZOL TecniGen
Follow exactly the instructions for administering Fluconazol TecniGen as given by your doctor. Consult your doctor or pharmacist if you have any doubts.
The capsules should be swallowed whole with a glass of water. It is best to take your medication at the same time each day.
The usual dosage of this medicine for different types of infections is 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 needed. Occasionally, the dose may 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. Occasionally, the dose may 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 fungal infections affecting the lining of the mouth, throat, or associated with dental prostheses | 200 mg to 400 mg on the first day, then 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 weekly, 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 three days for a total of 3 doses (day 1, 4, and 7), followed by 150 mg once weekly for as long as the risk of 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 or 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 (the adult dosage or the 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 a Candida-caused infection (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 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 TecniGen than you should
Taking too many capsules at once may make you feel unwell. Contact your doctor or 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, and thinking things that are not real (hallucinations and paranoid behavior). It may be appropriate to start symptomatic treatment (with supportive measures and gastric lavage if necessary).
If you forget to take Fluconazol TecniGen
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.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Fluconazole TecniGen can produce adverse effects, although not everyone experiences them.
Stop taking fluconazole 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 severe allergic reactions are rare. If any of the following symptoms occur, 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 itchy red spots.
- Skin rash.
- Severe skin reactions, such as blistering rash (this may affect the mouth and tongue).
Fluconazole TecniGen may affect your liver. Signs indicating liver problems include:
- Tiredness.
- Loss of appetite.
- Nausea or vomiting.
- Yellowing of the skin or whites of the eyes (jaundice).
If you experience any of these symptoms, stop taking Fluconazole TecniGen and inform 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 effects not listed in this leaflet, inform your doctor or pharmacist.
The following are frequent adverse effects, affecting 1 to 10 in every 100 patients:
- Headache.
- Stomach discomfort, diarrhoea, nausea, vomiting.
- Elevated results in blood tests indicating liver function.
- Rash.
The following are uncommon adverse effects, affecting 1 to 10 in every 1,000 patients:
- Reduction in red blood cells, which may cause pale skin, weakness, or difficulty breathing.
- Loss of appetite.
- Inability to sleep, feeling of numbness.
- 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 discomfort, fever.
The following are rare adverse effects, affecting 1 to 10 in every 10,000 patients:
- Lower than normal levels of white blood cells, which help fight infections, and blood cells that help stop bleeding.
- Reddish or purplish skin discolouration, which may be due to low platelet count or other changes in blood cells.
- Changes in blood tests (high levels of 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 blistering rash and 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 effects not mentioned in this leaflet, inform your doctor or pharmacist.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the container and additional information
Composition of Fluconazole TecniGen
The active substance is fluconazole.
Each hard capsule contains 200 mg of fluconazole.
The other components (excipients) are:
Capsule contents: 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 Fluconazole TecniGen 200 mg hard capsules and pack contents
The capsules have a white body and a white cap. They are supplied in packs of 7 hard capsules.
Marketing Authorization Holder and Manufacturing Responsible Party
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
Manufacturing Responsible Party:
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 leaflet was approved in January 2021
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/