LOITIN 10 mg/ml POWDER FOR ORAL SUSPENSION

Introduction

PATIENT INFORMATION LEAFLET

Loitin 10 mg/ml powder for oral suspension

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 to treat the following types of fungal infections:

• Cryptococcal meningitis – a fungal infection in the brain.
• Coccidioidomycosis – a disease of the bronchopulmonary system.
• Candidainfections in the bloodstream, organs (e.g. heart, lungs), or 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, jock itch, nail infections.

It may also be prescribed to:

• prevent the recurrence of cryptococcal meningitis.
• prevent the recurrence of Candidamucosal infections.
• reduce the occurrence of repeated vaginal Candidainfections.
• prevent the spread of Candidainfections (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 – an infection that affects the lining of the mouth or throat.
• Candidainfections in the bloodstream, organs (e.g. heart, lungs), or urinary tract.
• Cryptococcal meningitis – a fungal infection in the brain.

It may also be prescribed to:

• prevent the spread of Candidainfections (if your immune system is weak and not functioning properly).
• prevent the recurrence of cryptococcal meningitis.

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 (antihistamines used to treat allergies).
• if you are taking cisapride (used to treat stomach upset).
• if you are taking pimozide (used to treat mental illness).
• 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 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 signs of "adrenal insufficiency", where 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 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 medical attention immediately 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.

Inform your doctor immediatelyif you are taking astemizole, terfenadine (an antihistamine used to treat allergies), cisapride (used for stomach upset), pimozide (used to treat mental illness), quinidine (used to treat heart arrhythmias), or erythromycin (an antibiotic used to treat 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 used to treat infections).
• Alfentanil, fentanyl (used as anesthetics).
• Abrocitinib (used to treat atopic dermatitis, also known as eczema).
• Amitriptyline, nortriptyline (used as antidepressants).
• Amphotericin B, voriconazole (antifungals).
• Medicines that make the blood less viscous, to prevent the formation of 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 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 patients infected with HIV).
• 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 the decline in kidney function).
• 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 this 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, talk to 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.

Do 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 ingredients of Loitin

This medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

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

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

This medicine contains 2.96 mg of sodium benzoate in each 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 medicine contains less than 1 mmol of sodium (23 mg); this is essentially "sodium-free".

3. How to take Loitin

Follow the instructions for administration of this medicine exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

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

Instructions for preparing the suspension:

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

Instructions for use:

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

For the conversion of 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 be administered according to the recommended posology in mg and the product concentration.

If you take more Loitin than you should

Taking too much Loitin can make you feel unwell. Contact your doctor or go to the nearest hospital immediately. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken. The 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:

• widespread rash, high body temperature, and enlarged lymph nodes (DRESS 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, report immediately to your doctor.

• sudden whistling 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.
• 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, 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.
• inability to sleep, 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 1000 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 skin discoloration, which may be due to a low platelet count, 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 eruption 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 not mentioned in this prospectus. You can also report it 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 sight and reach of children.
• Do not use Loitin after the expiration date shown on the packaging and bottle, after CAD. The expiration date is the last day of the month indicated.
• Powder for oral suspension: no special storage conditions are required.Keep the bottle properly closed.
• Once reconstituted, store the suspension below 25°C.
• The validity period of the reconstituted suspension is 14 days below 25°C.

Medicines should not be thrown away through drains or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

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 flavor. See section 2 Important information about some of the components of Loitin.

Appearance of Loitin and Package Contents

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

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

A dosing cup is also provided to measure the correct dose.

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

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

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

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: June 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/

------------------------------------------------------------------------------------------------------------

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

Instructions for preparing the suspension:

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

1. Hit the bottle to loosen the powder
2. Add a small amount of water and shake vigorously. Add water until it reaches the marked level line on the bottle (this is achieved by adding 24 ml of water).
3. Shake well for one or two minutes to obtain a well-uniform suspension.
4. Write 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 the powder for oral suspension from mg/ml to ml/kg of body weight:

Loitin 10 mg/ml powder for oral suspension:

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

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