PATIENT INFORMATION LEAFLET

Loitin 10 mg/ml powder for oral suspension

Fluconazole

Read this 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Loitin is one of the medications in the group called “antifungals”. The active principle is fluconazole.

Loitin is used to treat infections caused by fungi, and it may also be used to prevent the appearance of an infection byCandida. The most common cause of fungal infections is a yeast calledCandida.

Adults

Your doctor may prescribe this medication to treat the following types of fungal infections:

• Cryptococcal meningitis – a fungal infection in the brain.
• Coccidioidomycosis – a disease of the bronchopulmonary system.
• Infections caused byCandidalocated in the bloodstream, in organs of the body (e.g. heart, lungs) or in the urinary tract.
• Mucosal candidiasis – an infection that affects 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, inguinal ringworm, nail infection.

Your doctor may also prescribe Loitin for:

• To prevent the recurrence of cryptococcal meningitis.
• To prevent the recurrence of mucosal infections byCandida.
• To reduce the recurrence of vaginal infections byCandida.
• To prevent the transmission of infections caused byCandida(if your immune system is weak and does not function properly).

Children and adolescents (0 to 17 years)

Your doctor may prescribe this medication to treat the following types of fungal infections:

• Mucosal candidiasis – an infection that affects the lining of the mouth or throat.
• Infections caused byCandidalocated in the bloodstream, in organs of the body (e.g. heart, lungs) or in the urinary tract.
• Cryptococcal meningitis – a fungal infection in the brain.

Your doctor may also prescribe Loitin for:

• To prevent the transmission of infections caused byCandida(if your immune system is weak and does not function properly).
• To prevent the recurrence of cryptococcal meningitis.

Do not take Loitin

• if you are allergic (hypersensitive) to fluconazole, other medications you have taken to treat fungal infections, or any of the other components of Loitin. Symptoms may include itching, skin redness, or difficulty breathing.
• if you are taking astemizole, terfenadine (antihistamines for treating allergies).
• if you are taking cisapride (used to treat stomach discomfort).
• if you are taking pimozide (used to treat mental health conditions).
• if you are taking quinidine (used to treat heart arrhythmias).
• if you are taking erythromycin (an antibiotic for treating infections).

Warnings and precautions

Consult your doctor or pharmacist before starting to take 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 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 fatigue or prolonged weakness, muscle weakness, loss of appetite, weight loss, abdominal pain).

- if you have ever experienced severe skin rash or 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 in relation to Loitin treatment. Stop taking Loitin and seek medical attention immediately if you notice any symptoms related to these severe skin reactions described in section 4.

Speak with your doctor or pharmacist if the fungal infection does not improve, as an alternative antifungal treatment may be necessary.

Other medications and Loitin

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Informimmediatelyyour doctor if you are taking astemizole, terfenadine (an antihistamine for treating allergies), cisapride (used for stomach discomfort), pimozide (used to treat mental health conditions), quinidine (used to treat heart arrhythmias), or erythromycin (an antibiotic for treating infections), as these medications should not be taken with Loitin (see section: “Do not take Loitin”).

There are some medications that may interact with Loitin.

Ensure your doctor knows if you are taking any of the following medications, as it may be necessary to adjust the dose or monitor for effectiveness:

• Rifampicin or rifabutin (antibiotics for infections).
• Alfentanil, fentanil (used as anesthetics).
• Abrocitinib (used to treat atopic dermatitis, also known as eczema).
• Amitriptyline, nortriptyline (used as antidepressants).
• Amphotericin B, voriconazole (antifungals).
• Medications that make blood less viscous to prevent clot formation (warfarin or similar medications).
• Benzodiazepines (midazolam, triazolam, or similar medications) used to help sleep or for anxiety.
• Carbamazepine, phenytoin (used to treat seizures).
• Nifedipine, isradipine, amlodipine, verapamil, felodipine, and losartan (for hypertension).
• Olaparib (used to treat ovarian cancer).
• Ciclosporin, everolimus, sirolimus, or tacrolimus (to prevent transplant rejection).
• Cyclophosphamide, vinca alkaloids (vincristine, vinblastine, or similar medications) used to treat cancer.
• Halofantrine (used to treat malaria).
• Statins (atorvastatin, simvastatin, and fluvastatin, or similar medications) used to reduce high cholesterol levels.
• Methadone (used for pain).
• Celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (Nonsteroidal Anti-Inflammatory Drugs – NSAIDs).
• Oral contraceptives.
• Prednisone (steroid).
• Zidovudine, also known as AZT; saquinavir (used in HIV-infected patients).
• Medications 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 slow renal function decline).
• Vitamin A (nutritional supplement).

• Ivacaftor (alone or combined with medications used to treat cystic fibrosis).
• Amiodarone (used to treat irregular heartbeats).

• Hydrochlorothiazide (diuretic).
• Ibrutinib (used to treat blood cancer).
• Lurasidone (used to treat schizophrenia).

Loitin with food and drinks

You can take the medication with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

If you plan to become pregnant, it is recommended that you wait one week after a single dose of fluconazole before becoming pregnant.

For longer fluconazole treatment cycles, consult your doctor about the need to use suitable contraceptive methods during treatment, which should be maintained for one week after the last dose.

You should not take Loitin if you are pregnant, think you may be pregnant, or plan to become pregnant, unless your doctor has told you to. If you become pregnant while taking this medication or within one week of 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 taken during the first trimester may increase the risk of congenital anomalies affecting the heart, bones, and/or muscles.

Cases of babies born with congenital anomalies affecting the skull, ears, and leg 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 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 operating machinery

When driving or operating machinery, be aware that occasional dizziness or seizures may occur.

Important information about some Loitin components

This medication contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Patients with diabetes mellitus should note that this medication contains 5.77 g (Loitin 10 mg/ml) or 5.46 (Loitin 40 mg/ml) of saccharose per 10 ml of oral suspension.

It may cause tooth decay if used for periods longer than 2 weeks.

This medication contains 2.96 mg of sodium benzoate per ml of oral suspension. Sodium benzoate may increase the risk of jaundice in newborns (up to 4 weeks of age).

Once reconstituted, a 20 ml dose of this medication contains less than 1 mmol of sodium (23 mg); this is essentially “sodium-free”.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

It is better to take your medications always at the same time of day.

The following are the recommended doses of this medication for different types of infections:

Adults

Adolescents 12 to 17 years of ageold

Follow the dose indicated by your doctor (adult or pediatric dosage).

Children up to 11 years old

The maximum daily dose for children is 400 mg.

The dose will be based on the child's weight in kilograms.

Use in children 0 to 4 weeks old

Use in children 3 to 4 weeks old:

• The same dose as described in the table, but administered once every 2 days. The maximum dose is 12 mg per kg every 48 hours.

Use in children under 2 weeks old:

• The same dose as described in the table, but administered once every 3 days. The maximum dose is 12 mg per kg every 72 hours.

Geriatric 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 functioning.

Instructions for preparing the suspension:

Your pharmacist should reconstitute the powder for oral suspension before giving it to you. However, if the pharmacist does not reconstitute this product, the instructions are provided in the "The following information is only for doctors and other healthcare professionals or for patients (if the pharmacist does not reconstitute this product)" section at the end of this leaflet.

Instructions for use:

Shake the suspension bottle with the cap closed before each use.

To convert the dose of the powder for oral suspension from mg/ml to ml/kg of body weight for pediatric patients, see section 6.

In adult patients, calculate the dose in ml to administer according to the recommended dose in mg and the product concentration.

If you take more Loitin than you should

Taking too much Loitin may 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 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 Loitin

Do not take a double dose to make up for the missed 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 medication, ask your doctor or pharmacist.

Like all medicines, this medicinecan cause side effects, although not everyone will experience 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 developallergic reactions,although severe allergic reactions are rare.If any side effect occurs, talk to your doctor or pharmacist. This includes any possible side effect not mentioned in this leaflet. If you experience any of the following symptoms, informyour doctor immediately.

• sudden heart palpitations, 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 indicating liver problems include:

-fatigue.

-loss of appetite.

-vomiting.

-yellowing of the skin or white of the eyes (jaundice).

If you experience any of these symptoms, stop taking Loitin andinform your doctor immediately.

Other side effects:

In addition, if you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

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

• headache.
• stomach discomfort, diarrhea, nausea, vomiting.
• abnormal liver function test results.
• skin rash.

Rare side effects (may affect up to1 in 100 patients) are:

• reduction in red blood cells, which can cause pale skin and weakness or difficulty breathing.
• loss of appetite.
• insomnia, numbness.
• convulsions, dizziness, feeling of spinning, tingling, pins and needles, changes in taste.
• constipation, heavy digestion, gas, dry mouth.
• muscle pain.
• liver damage and yellowing of the skin and eyes (jaundice).
• hives, blisters (pustules), itching, increased sweating.
• fatigue, general feeling of discomfort, fever.

Rare side effects (may affect up to 1 in 1000 patients) are:

• low white blood cell count, which helps fight infections, and low platelet count, which helps stop bleeding.
• red or purple discoloration of the skin, which may be due to a low platelet count, other blood cell changes.
• abnormal blood test results (high cholesterol, fats).
• low potassium levels in the blood.
• tremors.
• abnormal electrocardiogram (ECG), changes in heart rate or rhythm.
• liver 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, swollen 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 side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not appearing in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Do not use Loitin after the expiration date that appears on the packaging and bottle, after CAD. The expiration date is the last day of the month indicated.
• Oral suspension powder:does not require special storage conditions.Store the bottle properly closed.
• Once reconstituted, store the suspension below 25°C.
• The shelf life of the reconstituted suspension is 14 days below 25°C.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition ofLoitin

The active ingredient is fluconazole. Each 1 ml of reconstituted suspension contains 10 mg of fluconazole.

The other components are:sucrose, citric acid monohydrate (E-330), sodium citrate anhydrous (E-331), sodium benzoate (E-211), xanthan gum (E-415), colloidal silica (E-551), titanium dioxide (E-171) and orange aroma. See section 2Important information about some of the components of Loitin.

Appearance of Loitin and contents of the package

Loitin 10mg/ml oral powder for suspension is a white to off-white dry powder, packaged in a topaz-colored glass bottle. After adding water to the powder (following the instructions for healthcare professionals) it results in a white to off-white suspension with an orange flavor.

In each bottle, the mixture of the powder with water produces 35 ml of suspension.

A measuring cup is also supplied to measure the correct dose.

It is presented in packages with 1 bottle and in clinical packages with 10 bottles.

The information in this leaflet only corresponds to Loitin 10 mg/ml oral powder for suspension.

For information on Loitin 40 mg/ml oral powder for suspension or Loitin capsules, please read the leaflet for these products.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Dari Pharma, S.L.U.

Gran Via Carles III, 98, 10th floor

08028 Barcelona – Spain

Responsible for manufacturing:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Last review date of this leaflet: June 2024

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS):http://www.aemps.gob.es/

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This information is intended for healthcare professionals and patients (in case the pharmacist does not reconstitute this product):

Instructions for preparing the suspension:

La reconstituted suspension will consist of a white to off-white suspension with an orange flavor.

1.Shake the bottle to loosen the powder

2.Add a small amount of water and shake vigorously. Add water up to the level marked on the bottle (this is achieved by adding 24 ml of water).

3.Shake well for one or two minutes to obtain a uniform suspension.

4.Record the expiration date of the reconstituted suspension on the bottle label (the expiration date of the reconstituted suspension is 14 days). The remaining suspension cannot be used after this date and must be returned to the pharmacist.

Conversion of the dose of oral powder for suspension from mg/ml to ml/kg body weight:

Loitin 10 mg/ml oral powder for suspension:

In children, the dose of Loitin oral powder for suspension should be measured as accurately as possible according to the following equation:

The daily dose should not exceed 400 mg in the pediatric population. The use of Loitin 10 mg/ml oral powder for suspension is not recommended for doses > 15.0 ml. If doses exceed 15.0 ml, it is recommended to use Loitin 40 mg/ml oral powder for suspension.