LOITIN 100 mg HARD CAPSULES

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Loitin 100 mg hard capsules

Fluconazole

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:

1. What is Loitin and what is it used for.
2. What you need to know before you take Loitin.
3. How to take Loitin.
4. Possible side effects.
5. Storing Loitin.
6. Contents of the pack and further information.

1. What is Loitin and what is it used for

Loitin is one of a group of medicines called “antifungals”. The active substance is fluconazole.

Loitin is used to treat infections caused by fungi, and it can also be used to prevent fungal infections from occurring. The most common cause of fungal infections is a yeast called Candida.

Adults

Your doctor may prescribe this medicine for you to treat the following types of fungal infections:

• Cryptococcal meningitis – a fungal infection in the brain.
• Coccidioidomycosis – a disease affecting the lungs.
• Candidainfections of the bloodstream, organs (such as the heart, lungs), or urinary tract.
• Mucosal candidiasis – an infection that affects the lining of the mouth, throat, or associated with dental prosthetics.
• 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 you to:

• prevent cryptococcal meningitis from coming back.
• prevent mucosal infections from coming back.
• reduce the repeated appearance of vaginal Candidainfections.
• prevent 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 you to treat the following types of fungal infections:

• Mucosal candidiasis – an infection that affects the lining of the mouth or throat.
• Candidainfections of the bloodstream, organs (such as the heart, lungs), or urinary tract.
• Cryptococcal meningitis – a fungal infection in the brain.

It may also be prescribed for you to:

• prevent Candidainfections (if your immune system is weak and not working properly).
• prevent cryptococcal meningitis from coming back.

2. What you need to know before you take Loitin

Do not take Loitin

• if you are allergic (hypersensitive) to fluconazole, to other medicines used to treat fungal infections, or to any of the other ingredients of Loitin. Symptoms may include itching, skin rash, or difficulty breathing.
• if you are taking astemizole, terfenadine (antihistamine medicines for allergies).
• if you are taking cisapride (used for stomach upset).
• if you are taking pimozide (used for mental health conditions).
• if you are taking quinidine (used for heart rhythm disorders).
• if you are taking erythromycin (an antibiotic for infections).

Warnings and precautions

Consult your doctor or pharmacist before taking Loitin

• 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 rash, or difficulty breathing).
• if you experience symptoms of “adrenal insufficiency”, where the adrenal glands do not produce enough of certain hormones, such as cortisol (persistent or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain).
• if you have ever had a severe skin rash or peeling of the skin, blisters, and/or sores in the mouth after taking Loitin.

Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in relation to Loitin treatment. Stop taking Loitin and seek immediate medical attention if you notice any of the 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 alternative antifungal treatment.

Other medicines and Loitin

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 (for stomach upset), pimozide (for mental health conditions), quinidine (for heart rhythm disorders), or erythromycin (an antibiotic for infections), as these medicines should not be taken with Loitin (see section: “Do not take Loitin”).

There are some medicines that may interact with Loitin.

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 with sleep or anxiety.
• Carbamazepine, phenytoin (used to treat seizures).
• Nifedipine, isradipine, amlodipine, verapamil, felodipine, and losartan (for 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 lower 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 down kidney function deterioration).
• Vitamin A (nutritional supplement).
• Ivacaftor (alone or in combination with medicines used to treat cystic fibrosis).
• Amiodarone (used to treat irregular heartbeats [arrhythmias]).
• Hydrochlorothiazide (diuretic).
• Ibrutinib (used to treat blood cancer).
• Lurasidone (used to treat schizophrenia).

Taking Loitin with food and drinks

You can take the medicine with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or 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 Loitin 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 a 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 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 you may occasionally experience dizziness or seizures.

Important information about some of the ingredients of Loitin

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; this is essentially “sodium-free”.

3. How to take Loitin

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

The capsules should be swallowed whole with 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 the different types of infections:

Adults

Adolescents 12 to 17 years of age

Follow the dose prescribed 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.

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 given 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 given 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 change your dose, depending on how well your kidneys are working.

If you take more Loitin than you should

Taking too many capsules at once can make you feel unwell. Contact your doctor immediately or go to the nearest hospital. 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 Loitin

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 your 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 Loitin and seek medical attention immediately if you notice any of the following symptoms:

• generalized rash, high body temperature, and enlarged 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 prospectus. If you experience any of the following symptoms, reportimmediately to your doctor.

• sudden wheezing when breathing, 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).

Loitin may affect your liver. Signs that indicate liver problems include:

• fatigue.
• loss of appetite.
• nausea and vomiting.
• yellowing of the skin or the 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 that any of the adverse effects you suffer from is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Frequent adverse effects (may affect up to 1 in 10 patients) are:

• headache.
• stomach upset, diarrhea, discomfort, nausea and vomiting.
• elevated 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.
• sleeplessness, 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 1,000 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 discoloration of the skin, which may be due to a low number of platelets, 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 (a type of white blood cell), 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 that does not appear in this prospectus. 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 Loitin

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 any unused medicines in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofLoitin

The active ingredient is fluconazole.

Each hard capsule contains 100 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 and quinoline

Appearance ofLoitin100mg Hard Capsules and Package Contents

Loitin 100 mg is presented in the form of hard capsules. The body of the capsules is white opaque and the head is yellow opaque.

It is presented in packages of 7 hard capsules and a clinical package of 100 capsules.

Not all package sizes may be marketed.

The information in this prospectus only applies to Loitin 100 mg hard capsules. For more information on other Loitin hard capsules or Loitin oral suspension powder, please read the prospectus for these products.

Other Presentations

Loitin 50 mg hard capsules in packages of 7 and 500 capsules.

Loitin 150 mg hard capsules in packages of 1, 4, and 100 capsules.

Loitin 200 mg hard capsules in packages 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 Last Revision of this Prospectus:April 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/