Fluconazole Sandoz 200 mg hard capsules EFG
Spain
Table of Contents
- Package leaflet: Information for the user
- Introduction
- 1. What Fluconazol Sandoz is and what it is used for
- 2. What you need to know before taking Fluconazole Sandoz
- 3. How to take Fluconazole Sandoz
- 4. Possible adverse effects
- 5. Storage of Fluconazole Sandoz
- 6. Package contents and additional information
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the patient
Fluconazole Sandoz 50 mg hard capsules EFG
Fluconazole Sandoz 100 mg hard capsules EFG
Fluconazole Sandoz 150 mg hard capsules EFG
Fluconazole Sandoz 200 mg hard capsules EFG
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
- 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 you should not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.
Leaflet contents
- What Fluconazole Sandoz is and what it is used for
- What you need to know before taking Fluconazole Sandoz
- How to take Fluconazole Sandoz
- Possible adverse effects
- How to store Fluconazole Sandoz
- Contents of the pack and other information
1. What Fluconazol Sandoz is and what it is used for
Fluconazole is one of the medicines 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 affecting the brain,
- Coccidioidomycosis: a disease affecting the bronchopulmonary system,
- Candida infections 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 Sandoz may also be prescribed to:
- Prevent recurrence of cryptococcal meningitis,
- Prevent recurrence of mucosal Candida infections,
- Reduce the repeated occurrence of vaginal Candida infections,
- Prevent transmission 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,
- Candida infections located in the bloodstream, in body organs (e.g., heart, lungs), or in the urinary tract,
- Cryptococcal meningitis: a fungal infection in the brain.
Your doctor may also prescribe Fluconazol Sandoz to:
- Prevent transmission 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 Sandoz
Do not take Fluconazole Sandoz:
- if you are allergic to fluconazole, to other antifungal medicines, 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 (antihistamine medicines used to treat allergies),
- if you are taking cisapride (used to treat stomach discomfort),
- if you are taking pimozide (used to treat mental illnesses),
- if you are taking quinidine (used to treat heart arrhythmias),
- if you are taking erythromycin (an antibiotic used to treat infections).
Warnings and precautions
Talk to your doctor or pharmacist before starting fluconazole 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,
- you develop severe skin reactions (itching, skin redness, or difficulty breathing),
- you develop signs of “adrenal insufficiency”, in which 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),
- you have ever had a severe skin rash, peeling skin, blisters, and/or mouth sores 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 with 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.
Other medicines and Fluconazole Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Inform your doctor immediately if you are taking, have recently taken, or might need to use the following medicines, as they may interact with fluconazole: astemizole, terfenadine (an antihistamine used to treat allergies), cisapride (used for stomach discomfort), pimozide (used to treat mental illnesses), quinidine (used to treat heart arrhythmias), or erythromycin (an antibiotic used to treat infections), since these medicines must not be taken with fluconazole (see section: “Do not take Fluconazole Sandoz”).
Some medicines may interact with fluconazole.
Make sure your doctor knows if you are taking any of the following medicines:
- rifampicin or rifabutin (antibiotics for infections),
- alfentanil, fentanyl (used as anaesthetics),
- 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, verapamil, felodipine, and losartan (for hypertension – high blood pressure),
- olaparib (used to treat ovarian cancer),
- ciclosporin, 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),
- 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 (used to treat cystic fibrosis),
- amiodarone (used to treat irregular heartbeats “arrhythmias”),
- hydrochlorothiazide (a diuretic),
- ibrutinib (used to treat blood cancer).
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.
Taking Fluconazole Sandoz with food and drink
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 using this 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.
Do 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.
Breastfeeding may continue after a single dose of up to 150 mg of fluconazole. You should not continue breastfeeding if you are taking repeated doses of fluconazole.
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.
Driving and using machines
When driving or operating machinery, bear in mind that dizziness or seizures may occasionally occur.
Fluconazole Sandoz contains lactose and sodium
This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.
This medicine contains less than 23 mg of sodium (1 mmol) per hard capsule; thus, it is essentially “sodium-free”.
3. How to take Fluconazole Sandoz
Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. 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 recommended dosage of this medicine for different types of infections is given below:
Adults
Condition | Dosage |
For the treatment of 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 directed otherwise by your physician |
For the treatment of 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 |
For the treatment of systemic fungal infections caused by Candida | 800 mg on the first day, followed by 400 mg once daily until directed otherwise by your physician |
For the treatment of mucosal fungal infections affecting the lining of the mouth, throat, or associated with dental prostheses | 200 mg to 400 mg on the first day, followed by 100 mg to 200 mg once daily until directed otherwise by your physician |
For the treatment of 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 physician |
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 per week, for as long as the risk of developing an infection persists |
For the treatment of genital candidiasis | 150 mg as a single dose |
To reduce recurrent episodes of vaginal candidiasis | 150 mg every third day 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 |
For the treatment of 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 infection caused by Candida (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 12 to 17 years of age
Follow the dose indicated by your doctor (the adult dose or the pediatric dose).
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 |
Oral mucosal candidiasis and throat infections caused by Candida – dose and duration of treatment depend on the severity of the infection and its location. | 3 mg per kg of body weight once daily (6 mg per kg of body weight on the first day 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 a Candida-caused infection (if their immune system is not functioning properly) | 3 mg to 12 mg per kg of body weight once daily |
Children from 0 to 4 weeks of age
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.
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 Sandoz than you should
Taking too many capsules at once may make you feel unwell. Contact your doctor or the nearest hospital immediately.
If you have taken more fluconazole than you should, contact your doctor, pharmacist, or 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 Sandoz
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 further questions 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 everyone experiences them.
Some people develop allergic reactions, although serious allergic reactions are rare. If any of the following adverse effects occur, speak with your doctor or pharmacist. This includes any adverse effect not mentioned in this leaflet. If you experience any of the following symptoms, inform your doctor immediately:
- sudden wheezing, difficulty breathing, or tightness in the chest,
- swelling of the eyelids, face, or lips,
- itching all over the body, skin redness, or itchy red spots,
- rash,
- severe skin reactions, such as blistering rash (this may affect the mouth and tongue).
Fluconazol Sandoz 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 Fluconazol Sandoz and contact 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.
Frequent adverse effects (may affect up to 1 in 10 patients):
- headache,
- stomach discomfort, diarrhoea, nausea, vomiting,
- elevated blood test results indicating liver function abnormalities,
- rash.
Uncommon adverse effects (may affect up to 1 in 100 patients):
- reduction in red blood cells, which may cause pale skin, weakness, or difficulty breathing,
- loss of appetite,
- inability to sleep, drowsiness,
- 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):
- abnormally low levels of white blood cells that help defend against infections and blood cells that help stop bleeding,
- reddish or purplish skin discolouration, possibly due to low platelet count, other changes in blood cells,
- changes in blood tests (elevated cholesterol or fat levels),
- 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 rash, severe allergic reactions, swelling of lips or face,
- hair loss.
Frequency not known (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]).
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).
Reporting of adverse effects
If you experience any adverse effect, consult your doctor or pharmacist, 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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Fluconazole Sandoz
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 is the last day of the month indicated.
Store in the original packaging.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Package contents and additional information
Composition of Fluconazole Sandoz
- The active substance is fluconazole. Each hard capsule contains 50, 100, 150, or 200 mg of fluconazole.
- The other components (excipients) are:
Capsule contents: lactose monohydrate (lactose), corn starch, colloidal silicon dioxide, magnesium stearate and sodium lauryl sulfate.
Capsule composition:
Fluconazole Sandoz 50 mg hard capsules: quinoline yellow (E104), titanium dioxide (E171), water, gelatin.
Fluconazole Sandoz 100 mg hard capsules: titanium dioxide (E171), water, gelatin.
Fluconazole Sandoz 150 mg hard capsules: iron oxide yellow (E172), titanium dioxide (E171), water, gelatin.
Fluconazole Sandoz 200 mg hard capsules: indigotine (E132), titanium dioxide (E171), water, gelatin.
Appearance of the product and contents of the container
Fluconazole Sandoz 50 mg hard capsules: opaque yellow hard gelatin capsule with cap and body, in packs containing 7 capsules or 500 (EC) capsules.
Fluconazole Sandoz 100 mg hard capsules: opaque white hard gelatin capsule with cap and body, in packs containing 7 capsules or 100 (EC) capsules.
Fluconazole Sandoz 150 mg hard capsules: opaque cream-yellow hard gelatin capsule with cap and body, in packs containing 1 capsule, 4 capsules or 100 (EC) capsules.
Fluconazole Sandoz 200 mg hard capsules: hard gelatin capsule with opaque blue cap and opaque white body, in packs containing 7 capsules or 100 (EC) capsules.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Sandoz Farmacéutica, S.A.
Parque Norte Business Center
Roble Building
C/ Serrano Galvache, 56
28033 Madrid
Spain
Manufacturer
LICONSA, S.A.
Avda. Miralcampo, No. 7
Miralcampo Industrial Estate
19200 Azuqueca de Henares (Guadalajara)
Spain
Date of latest revision of the package leaflet: March 2024
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/