Fluconazole Normon 100 mg hard capsules EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Fluconazole Normon 100 mg hard capsules EFG
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, pharmacist, or nurse.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
- If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Contents of the leaflet:
- What Fluconazole Normon is and what it is used for
- Before taking Fluconazole Normon
- How to take Fluconazole Normon
- Possible side effects
- How to store Fluconazole Normon
- Further information
1. What Fluconazol Normon is and what it is used for
Fluconazol Normon is a medicine belonging to a group called "antifungals". The active substance is fluconazole.
Fluconazole is used to treat fungal infections, and it can also be used to prevent the occurrence of a Candida 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.
Fluconazole may also be prescribed to:
- Prevent recurrence of cryptococcal meningitis.
- Prevent recurrence of mucosal infections caused by Candida.
- Reduce repeated episodes of vaginal candidiasis.
- Prevent 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.
Fluconazole may also be prescribed to:
- Prevent Candida infections (if your immune system is weakened and not functioning properly).
- Prevent recurrence of cryptococcal meningitis.
2. Before taking Fluconazol Normon
Do not take Fluconazol Normon if
- You are allergic (hypersensitive) to fluconazole, to other antifungal medicines you have taken, or to any of the other ingredients of this medicine (listed in section 6).
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).
Warnings and precautions
Consult your doctor or pharmacist before starting to take Fluconazol Normon
- If you have liver or kidney problems.
- If you suffer from heart disease, including heart rhythm disorders.
- If you have abnormal levels of potassium, calcium, or magnesium in your blood.
- If severe skin reactions occur (such as itching, skin redness, or difficulty breathing).
- If symptoms of "adrenal insufficiency" appear, a condition in which the adrenal glands do not produce sufficient amounts of certain hormones such as cortisol (chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain).
If you have ever experienced a severe skin rash, peeling of the skin, blisters, and/or mouth sores after taking Fluconazol Normon.
Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during treatment with fluconazole. Stop using this medicine 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 your fungal infection does not improve, as alternative antifungal treatment may be needed.
Taking Fluconazol Normon with other medicines
Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any 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 Fluconazol (see section: “Do not take Fluconazol Normon if”).
Some medicines may interact with fluconazole.
Make sure your doctor knows if you are taking any of the following medicines, as dose adjustments or monitoring may be necessary to ensure these medicines remain effective:
- Rifampicin or rifabutin (antibiotics for infections).
- Abrocitinib (used to treat atopic dermatitis, also known as atopic eczema).
- Alfentanil, fentanyl (used as anesthetics).
- Amitriptyline, nortriptyline (used as antidepressants).
- Amphotericin B, voriconazole (antifungals).
- Medicines that reduce blood viscosity to prevent clot formation (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, 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, fluvastatin, or similar medicines) used to reduce 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, glibenclamide, glipizide, or tolbutamide.
- Theophylline (used to control asthma).
- Tofacitinib (used to treat rheumatoid arthritis).
- Tolvaptan (used to treat hyponatremia [low sodium levels in blood] or to delay the decline in kidney function).
- Vitamin A (nutritional supplement).
- Ivacaftor (alone or combined with medicines used to treat cystic fibrosis).
- Amiodarone (used to treat irregular heartbeats “arrhythmias”).
- Hydrochlorothiazide (a diuretic).
- Ibrutinib (used to treat blood cancer).
- Lurasidone (used to treat schizophrenia).
Taking Fluconazol Normon with food and drinks
You may take this medicine with or without food.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist 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 trying to conceive.
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.
You must not take Fluconazol if you are pregnant, think you may be pregnant, or intend to become pregnant, unless specifically instructed by your doctor. If you become pregnant while taking this medicine or within one week after 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 use during the first trimester may increase the risk of congenital abnormalities affecting the heart, bones, and/or muscles.
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. You may continue breastfeeding after a single 150 mg dose of fluconazole. You should not continue breastfeeding if you are taking repeated doses of fluconazole.
Driving and using machines
When driving or operating machinery, bear in mind that dizziness or seizures may occasionally occur.
Fluconazol Normon contains lactose and sodium
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him or her before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per capsule; therefore, it is essentially “sodium-free”.
3. How to take Fluconazole Normon
Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
The capsules should be swallowed whole with a glass of water. It is best to take your medicine at the same time each day.
The usual doses of this medicine for different types of infections are 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 necessary. The dose may occasionally be increased up to 800 mg |
To prevent recurrence of cryptococcal meningitis | 200 mg once daily until your doctor advises otherwise |
To treat coccidioidomycosis | 200 mg to 400 mg once daily for 11 to 24 months or longer if necessary. The dose may occasionally 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 your doctor advises otherwise |
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 once daily until your doctor advises otherwise |
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 your doctor advises otherwise |
To prevent recurrence of mucosal infections affecting the lining of the mouth and throat | 100 mg to 200 mg once daily, or 200 mg three times a week, 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), then once weekly for as long as the risk of developing an infection persists |
To treat fungal infections of the skin or nails | 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-related infection (if your immune system is weakened and 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 (either the adult or 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 |
Oropharyngeal 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 once daily (on the first day, 6 mg per kg of body weight may be given) |
Cryptococcal meningitis or systemic fungal infections caused by Candida | 6 mg to 12 mg per kg of body weight once daily |
To prevent recurrence of cryptococcal meningitis | 6 mg per kg of body weight once daily |
To prevent the child from acquiring an infection caused by Candida (if their immune system is not functioning properly) | 3 mg to 12 mg per kg of body weight |
Use in children aged 0 to 4 weeks
Use in children aged 3 to 4 weeks:
- 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.
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 Normon than you should
Taking too many capsules at once may make you feel unwell. Contact your doctor immediately or go to the nearest hospital. 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 initiate symptomatic treatment (with supportive measures and gastric lavage if necessary).
If you forget to take Fluconazol Normon
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, do not take 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 Normon can cause adverse effects, although not everyone experiences them.
Stop taking Fluconazole and seek medical attention immediately 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 adverse effect occurs, speak to your doctor or pharmacist. This includes any possible adverse effect not mentioned in this leaflet. If you experience any of the following symptoms, 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 may affect your liver. Signs indicating liver problems include:
- Fatigue.
- Loss of appetite.
- Vomiting.
- Yellowing of the skin or whites of the eyes (jaundice).
If you experience any of these symptoms, stop taking this medicine 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 effect not listed in this leaflet, inform your doctor or pharmacist.
Frequent adverse effects (may affect up to 1 in 10 patients) are:
- Headache.
- Stomach discomfort, diarrhea, nausea, vomiting.
- Elevated blood test results indicating liver function abnormalities.
- Rash.
Uncommon adverse effects (may affect up to 1 in 100 patients) are:
- Reduction in red blood cells, which may cause pale skin, weakness, or difficulty breathing.
- Decreased appetite.
- Inability to sleep, numbness or tingling sensation.
- 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.
- Fatigue, general malaise, fever.
Rare adverse effects (may affect up to 1 in 1,000 patients) are:
- Lower than normal levels of white blood cells, which help defend against infections, and blood cells that help stop bleeding.
- Red or purple skin discoloration, which may be due to low platelet count, other changes in blood cells.
- Changes in blood tests (high levels of cholesterol, fats).
- Low blood potassium levels.
- Tremors.
- Abnormal electrocardiogram (ECG), changes in heart rate or rhythm.
- Liver function failure.
- Allergic reactions (sometimes severe), including widespread blistering and peeling of the skin, severe allergic reactions, swelling of the lips or face.
- Hair loss.
Frequency not known, but possible (cannot be estimated from available data):
- Hypersensitivity reaction with skin rash, fever, swollen glands, increase in a type of white blood cells (eosinophilia), and inflammation of internal organs (liver, lungs, heart, kidneys, and large intestine) (drug reaction with eosinophilia and systemic symptoms [DRESS]).
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is an 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 Fluconazole Normon
Keep this medicine out of the sight and reach of children.
Do not use this medicine 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.
Store in the original packaging.
Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Additional Information
Composition of Fluconazol Normon
The active substance is fluconazole.
Each hard capsule contains 100 mg of fluconazole.
The other components (excipients) are:
Capsule contents: lactose monohydrate, corn starch, colloidal silicon dioxide (E-551), magnesium stearate (E-572), and sodium lauryl sulfate (E-470a). See section 2.
Fluconazol Normon contains lactose and sodium.
Capsule shell composition: titanium dioxide (E171), water, and gelatin.
Appearance of Fluconazol Normon 100 mg hard capsules and contents of the pack
The capsules have an opaque white body and cap.
Available in packs of 7 or 100 (EC) capsules in PVC-PVDC/Aluminum blisters.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)
Manufacturer:
LICONSA, S.A.
Avda. Miralcampo, No. 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara), Spain
This leaflet was last approved in: August 2024
Detailed 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/