Loitin 50 mg hard capsules
SpainTable of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Loitin 50 mg hard capsules
Fluconazole
Read the entire leaflet carefully before you start taking this medicine, because 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 must not be given to other people, even if they have the same symptoms as you, since it could harm them.
- If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents:
- What Loitin is and what it is used for.
- What you need to know before taking Loitin.
- How to take Loitin.
- Possible side effects.
- How to store Loitin.
- Contents of the pack and other information.
1. What Loitin is and what it is used for
Loitin is one of the medicines belonging to a group called "antifungals". The active substance is fluconazole.
Loitin 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.
Loitin may also be prescribed to:
- prevent recurrence of cryptococcal meningitis.
- prevent recurrence of mucosal infections.
- reduce repeated episodes of vaginal Candida infections.
- prevent transmission of Candida infections (if your immune system is weak 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.
Loitin may also be prescribed to:
- prevent transmission of Candida infections (if your immune system is weak and not functioning properly).
- prevent recurrence of cryptococcal meningitis.
2. What you need to know before taking Loitin
Do not take Loitin
- if you are allergic (hypersensitive) to fluconazole, to other antifungal medicines you have taken, or to any of the other components of Loitin. Symptoms may include itching, skin redness, or difficulty breathing.
- if you are taking astemizole or 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 taking Loitin
- if you have liver or kidney problems.
- if you suffer from a heart condition, 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, 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).
- if you have ever had a severe skin rash, skin peeling, blisters, and/or mouth sores after taking Loitin.
Severe skin reactions, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported during treatment with Loitin. Stop taking Loitin and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.
Speak with your doctor or pharmacist if your fungal infection does not improve, as alternative antifungal treatment may be needed.
Other medicines and Loitin
Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicine.
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 Loitin (see section: “Do not take Loitin”).
Some medicines may interact with Loitin.
Ensure your doctor knows if you are taking any of the following medicines, as dose adjustments or monitoring may be needed 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 make the blood less sticky to prevent clotting (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 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, 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 Loitin 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 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 fluconazole treatment courses, 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 Loitin if you are pregnant, think you may be pregnant, or plan to become pregnant, unless your doctor has specifically instructed you to do so. 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 taking a single 150 mg dose of Loitin. You should not continue breastfeeding if you are taking repeated doses of Loitin.
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 components of Loitin
This medicine contains a small amount of lactose (milk sugar). 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 capsule; thus, it is essentially “sodium-free”.
3. How to take Loitin
Follow exactly the instructions for use of this medicine 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 following are the recommended doses of this medicine for different types of infections:
Adults
Condition | Dosage |
For 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 your doctor advises otherwise |
For 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 treatment of systemic fungal infections caused by Candida | 800 mg on the first day, followed by 400 mg once daily until your doctor advises otherwise |
For treatment of mucosal 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 |
For 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 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 |
For treatment of 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 |
For 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 aged 12 to 17 years
Follow the dose prescribed 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 and throat candidiasis 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 internal 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 |
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 Loitin 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, stating the medication and the amount ingested. 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 Loitin
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, this medicine may cause adverse effects, although not everyone will experience them.
Stop taking Loitin 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 serious 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 a rash causing blisters (this may affect the mouth and tongue).
Loitin 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 Loitin 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.
Frequent adverse effects (may affect up to 1 in 10 patients) are:
- headache.
- stomach discomfort, diarrhea, malaise, vomiting.
- elevated blood test results indicating liver function.
- 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 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 feeling of unwellness, fever.
Rare adverse effects (may affect up to 1 in 1000 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 discolouration, which may be due to a low platelet count, 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 rash with blisters 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 colon) (drug reaction or rash 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 a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es.
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Loitin
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.
Medicines must not be disposed of via wastewater drains or household waste. Unused containers and medicines should be returned to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Loitin
The active substance is fluconazole.
Each hard capsule contains 50 mg of fluconazole.
The other components (excipients) are:
Capsule contents: monohydrate lactose (lactose), pregelatinized corn starch (corn starch), anhydrous colloidal silica, sodium lauryl sulfate and magnesium stearate.
Capsule composition: titanium dioxide and quinoline yellow.
Appearance of Loitin 50 mg hard capsules and contents of the pack
Loitin 50 mg is presented in the form of capsules. The body and cap of the capsule are opaque yellow in color.
It is available in packs of 7 hard capsules and clinical pack of 500 capsules.
Not all pack sizes may be marketed.
The information in this leaflet applies only to Loitin 50 mg hard capsules. For further information on other Loitin hard capsules, or on Loitin oral suspension powder, please read the leaflet for those products.
Other presentations
Loitin 100 mg hard capsules: packs of 7 and 100 capsules.
Loitin 150 mg hard capsules: packs of 1, 4 and 100 capsules.
Loitin 200 mg hard capsules: packs of 7 and 100 capsules.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Dari Pharma, S.L.U.
Gran Via Carles III, 98, 10th floor
08028 Barcelona – Spain
Manufacturer:
Neuraxpharm Pharmaceuticals, S.L.
Avda. Barcelona, 69
08970 SANT JOAN DESPÍ (Barcelona)
Spain
Date of the most recent review of this leaflet: April 2024
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/