FLUCONAZOLE QUALIGEN 150 mg HARD CAPSULES
How to use FLUCONAZOLE QUALIGEN 150 mg HARD CAPSULES
Translated with AI
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.
Show originalContents of the leaflet
Introduction
Package Leaflet: Information for the User
Fluconazole Qualigen 150 mg hard capsules EFG
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist, or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
Contents of the pack and other information:
- What is Fluconazole Qualigen and what is it used for.
- What you need to know before you take Fluconazole Qualigen.
- How to take Fluconazole Qualigen.
- Possible side effects.
- Storing Fluconazole Qualigen.
- Contents of the pack and further information.
1. What is Fluconazole Qualigen and what is it used for
Fluconazole Qualigen is one of a group of medicines called “antifungals”. The active substance is fluconazole.
Fluconazole is used to treat infections caused by fungi, and it can also be used to prevent fungal infections.
Adults
Your doctor may prescribe this medicine for the following types of fungal infections:
- Cryptococcal meningitis – a fungal infection in the brain.
- Coccidioidomycosis – a disease affecting the bronchopulmonary system.
- Infections caused by Candidain the bloodstream, in organs (e.g., heart, lungs), or in the urinary tract.
- Mucosal candidiasis – an infection affecting 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 infections.
It may also be prescribed for:
- preventing the recurrence of cryptococcal meningitis.
- preventing the recurrence of Candidamucosal infections.
- reducing the frequency of recurrent vaginal Candidainfections.
- preventing Candidainfections (if your immune system is weak and not working properly).
Children and adolescents (0 to 17 years)
Your doctor may prescribe this medicine for the following types of fungal infections:
- Mucosal candidiasis – an infection affecting the lining of the mouth or throat.
- Candidainfections in the bloodstream, in organs (e.g., heart, lungs), or in the urinary tract.
- Cryptococcal meningitis – a fungal infection in the brain.
It may also be prescribed for:
- preventing Candidainfections (if your immune system is weak and not working properly).
- preventing the recurrence of cryptococcal meningitis.
2. What you need to know before you take Fluconazole Qualigen
Do not take Fluconazole Qualigen
- if you are allergic (hypersensitive) to fluconazole, to other medicines used to treat fungal infections, or to any of the other ingredients of this medicine (listed in section 6). Symptoms may include itching, skin redness, or difficulty breathing.
- if you are taking astemizole, terfenadine (antihistamines for allergies).
- if you are taking cisapride (used for stomach upset).
- if you are taking pimozide (used for mental illness).
- if you are taking quinidine (used for heart arrhythmias).
- if you are taking erythromycin (an antibiotic for infections).
Warnings and precautions
Tell your doctor or pharmacist before you start taking Fluconazole Qualigen
- if you have liver or kidney problems.
- if you have a heart condition, including heart rhythm problems.
- if you have abnormal levels of potassium, calcium, or magnesium in your blood.
- if you experience severe skin reactions (itching, skin redness, or difficulty breathing).
- if you experience signs of “adrenal insufficiency”, where the adrenal glands do not produce enough of certain hormones, such as cortisol (chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain).
- if you have ever had a severe skin rash, skin peeling, or blisters after taking fluconazole.
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 immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.
Talk to your doctor or pharmacist if the fungal infection does not improve; you may need an alternative antifungal treatment.
Other medicines and Fluconazole Qualigen
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
Immediatelyinform your doctor if you are taking astemizole, terfenadine (an antihistamine for allergies), cisapride (used for stomach upset), pimozide (used for mental illness), quinidine (used for heart arrhythmias), or erythromycin (an antibiotic for infections), as these medicines should not be taken with fluconazole (see section: “Do not take Fluconazole Qualigen”).
There are some medicines that may interact with fluconazole.
Make sure your doctor knows if you are taking any of the following medicines, as a dose adjustment or monitoring may be necessary to ensure the medicines continue to have the desired effect:
- Rifampicin or rifabutin (antibiotics for infections). Abrocitinib (used to treat atopic dermatitis, also known as eczema).
- 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 to treat seizures).
- Nifedipine, isradipine, amlodipine, verapamil, felodipine, and losartan (for hypertension – high blood pressure).
- Olaparib (used to treat ovarian cancer).
- 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, and fluvastatin or similar medicines) used to reduce 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 to control asthma).
- Tofacitinib (used to treat rheumatoid arthritis).
- Tolvaptan (used to treat hyponatremia [low sodium levels in the blood] or to slow the worsening of kidney function).
- Vitamin A (nutritional supplement).
- Ivacaftor (alone or in combination with medicines used to treat cystic fibrosis).
- Amiodarone (used to treat irregular heartbeats).
- Hydrochlorothiazide (diuretic).
- Ibrutinib (used to treat blood cancer).
- Lurasidone (used to treat schizophrenia).
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
Taking Fluconazole Qualigen with food and drinks
You can take the medicine with or without food.
Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.
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.
Do not take fluconazole if you are pregnant, think you may be pregnant, or are planning to become pregnant, unless your doctor has told you to. If you become pregnant while taking this medicine or within one week of the last dose, consult your doctor.
Fluconazole taken during the first or second trimester of pregnancy may increase the risk of miscarriage. Fluconazole during the first trimester may increase the risk of the 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.
You can continue breastfeeding after taking a single dose of 150 mg of fluconazole. Do not continue breastfeeding if you are taking repeated doses of fluconazole.
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 Qualigen
This medicine contains a small amount of lactose (milk sugar). If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.
This medicine contains less than 23 mg of sodium (1 mmol) per capsule, which is essentially “sodium-free”.
3. How to take Fluconazole Qualigen
Follow the instructions for administration of this medicine exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.
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 are the recommended doses of this medicine for different types of infections:
Adults
Condition | Dose |
For treating cryptococcal meningitis | 400 mg on the first day and then 200 mg to 400 mg once daily for 6 to 8 weeks or longer if necessary. In some cases, the dose may be increased to 800 mg |
For preventing the recurrence of cryptococcal meningitis | 200 mg once daily until your doctor tells you to stop |
For treating coccidioidomycosis | 200 mg to 400 mg once daily from 11 months to 24 months or longer if necessary. In some cases, the dose may be increased to 800 mg |
For treating internal fungal infections caused by Candida | 800 mg on the first day and then 400 mg once daily until your doctor tells you to stop |
For treating mucosal infections affecting 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 once daily until your doctor tells you to stop |
For treating mucosal candidiasis – the dose depends on the location of the infection | 50 mg to 400 mg once daily for 7 to 30 days until your doctor tells you to stop |
For preventing the recurrence of mucosal infections affecting the lining of the mouth and throat | 100 mg to 200 mg once daily, or 200 mg 3 times a week, while the risk of developing an infection continues |
For treating genital candidiasis | 150 mg in a single dose |
For reducing the frequency of recurrent vaginal candidiasis | 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 |
For treating fungal skin or nail infections | Depending on the location of the infection, 50 mg once daily, 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) |
For preventing Candidainfections (if your immune system is weak and not working properly) | 200 mg to 400 mg once daily while the risk of developing an infection continues |
Adolescents 12 to 17 years of age
Follow the dose indicated by your doctor (either 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 Candidathroat infections – the dose and duration of treatment depend on the severity of the infection and its location | 3 mg per kilogram of body weight once daily (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 once daily |
For preventing the recurrence of cryptococcal meningitis | 6 mg per kilogram of body weight once daily |
For preventing Candidainfections in children (if their immune system is weak and not working properly) | 3 mg to 12 mg per kilogram of body weight once daily |
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 kilogram 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 kilogram of body weight every 72 hours.
Elderly patients
The usual adult dose, unless you have kidney problems.
Patients with kidney problems
Your doctor may adjust the dose depending on how well your kidneys are working.
If you take more Fluconazole Qualigen than you should
Taking too many capsules at once can make you feel unwell. Contact your doctor or go to the nearest hospital immediately. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine 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 stomach lavage if necessary).
If you forget to take Fluconazole Qualigen
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, this medicine can cause adverse effects, although not all people suffer from them.
Stop taking Fluconazol Qualigen and seek immediate medical attention if you notice any of the following symptoms:
- generalized rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
Some people develop allergic reactions,although severe allergic reactions are rare.If any adverse effect appears, talk to your doctor or pharmacist. This includes any possible adverse effect not mentioned in this leaflet. If you experience any of the following symptoms, reportimmediately to your doctor.
- sudden wheezing, 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 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 and inform your doctor immediately.
Other Adverse Effects:
Additionally, if you consider that any of the adverse effects you suffer from is serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.
Frequent adverse effects (may affect up to 1 in 10 patients) are:
- headache.
- stomach upset, diarrhea, discomfort, vomiting.
- high blood test results indicating liver function.
- rash.
Uncommon adverse effects (may affect up to 1 in 100 patients) are:
- reduction of red blood cells, which can make your skin pale and cause weakness or difficulty breathing.
- decreased appetite.
- inability to sleep, 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.
Rare adverse effects (may affect up to 1 in 1000 patients) are:
- white blood cells in the blood that help defend against infections and blood cells that help stop bleeding, lower than normal.
- red or purple skin discoloration, which may be due to a low platelet count, 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.
Frequency not known, but may occur (cannot be estimated from available data):
- hypersensitivity reaction with skin rash, fever, inflamed glands, increased eosinophils, and inflammation of internal organs (liver, lungs, heart, kidneys, and large intestine) (drug reaction or rash with eosinophilia and systemic symptoms [DRESS]).
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 not mentioned in this leaflet. 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 Qualigen
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiration date stated 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 via wastewater or household waste. 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 ofFluconazol Qualigen
The active ingredient is fluconazole.
Each hard capsule contains 150 mg of fluconazole.
The other ingredients (excipients) are:
Capsule content: lactose monohydrate (lactose), pregelatinized corn starch (corn starch), anhydrous colloidal silica, sodium lauryl sulfate, and magnesium stearate.
Capsule composition: titanium dioxide, quinoline, and carmine indigo
Appearance ofFluconazol Qualigen150mg hard capsules and package contents
Fluconazol Qualigen 150 mg is presented in the form of hard capsules. The body and cap of the capsules are opaque green.
It is presented in packages of 1 and 4 hard capsules.
Not all packages may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Neuraxpharm Spain, S.L.U.
Avda. Barcelona, 69
08970 Sant Joan Despí, Barcelona
Spain
Manufacturer:
Neuraxpharm Pharmaceuticals, S.L.
Avda. Barcelona, 69
08970 Sant Joan Despí, Barcelona
Spain
Date of the Last Revision of this Leaflet:May 2024
Detailed information about 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 price3.22 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.
- Alternatives to FLUCONAZOLE QUALIGEN 150 mg HARD CAPSULESDosage form: CAPSULE, 150 mg fluconazoleActive substance: fluconazoleManufacturer: Arafarma Group S.A.Prescription requiredDosage form: ORAL SOLUTION/SUSPENSION, 10 mg/mlActive substance: fluconazoleManufacturer: Vinci Farma, S.A.Prescription requiredDosage form: CAPSULE, 100 mgActive substance: fluconazoleManufacturer: Vinci Farma, S.A.Prescription required
Online doctors for FLUCONAZOLE QUALIGEN 150 mg HARD CAPSULES
Discuss questions about FLUCONAZOLE QUALIGEN 150 mg HARD CAPSULES, including use, safety considerations and prescription review, subject to medical assessment and local regulations.
Frequently Asked Questions
