Loitin 10 mg/ml powder for oral suspension

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

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 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, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if these effects are not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Loitin is and what it is used for.
2. What you need to know before taking Loitin.
3. How to take Loitin.
4. Possible side effects.
5. How to store Loitin.
6. 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 may 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 caused by Candida.
• reduce the repeated occurrence of vaginal infections caused by Candida.
• prevent the spread 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.
• 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 the spread 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 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 ingredients of Loitin. Symptoms may include itching, skin redness, or difficulty breathing.
• if you are taking astemizole or terfenadine (antihistamines 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 quinidina (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 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 signs 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 developed a severe skin rash, peeling skin, 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 of the 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 an 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 medicines.

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 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 required to ensure these medicines remain effective:

• Rifampicin or rifabutin (antibiotics for infections).

• Alfentanil, fentanyl (used as anesthetics).

• Abrocitinib (used to treat atopic dermatitis, also known as atopic eczema).

• Amitriptyline, nortriptyline (used as antidepressants).

• Amphotericin B, voriconazole (antifungals).

• Medicines that make the blood less viscous, 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, glyburide, 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 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, breastfeeding, think you may be pregnant, or plan 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.

You must not take Loitin if you are pregnant, think you may be pregnant, or intend to become pregnant, unless specifically instructed by your doctor. 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 miscarriage. Fluconazole taken during the first trimester may increase the risk of congenital malformations affecting the heart, bones, and/or muscles.

Cases of babies born with congenital malformations 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 must not continue breastfeeding if you are taking repeated doses of Loitin.

Driving and using machines

When driving or operating machinery, bear 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 advised you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Patients with diabetes mellitus should be aware 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.

Prolonged use for more than 2 weeks may cause dental caries.

This medicine 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).

After reconstitution, 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 exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist.

It is best to take your medicine at the same time each day.

The recommended doses of this medicine for different types of infections are as follows:

Adults

Adolescents aged 12 to 17 years

Follow the dose prescribed by your doctor (either 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.

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.

Instructions for preparing the suspension:

It is recommended that your pharmacist reconstitute the oral suspension powder 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 doctors and other 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 conversion of the oral suspension powder dose from mg/mL to mL/kg of body weight in pediatric patients, see section 6.

In adult patients, calculate the dose in mL to be administered according to the recommended dosage 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 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 how to use this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences 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 severe allergic reactions are rare. If any adverse effect occurs, speak with 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 blistering rash (this may affect the mouth and tongue).

Loitin may affect your liver. Signs indicating liver problems include:

• Tiredness.
• 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 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 effect 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, malaise, vomiting.
• Elevated blood test results indicating liver function.
• 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.
• 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.
• Tiredness, general feeling of being unwell, fever.

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

• Lower than normal levels of white blood cells, which help defend against infections, and blood cells that help stop bleeding.
• Reddish or purple skin discolouration, possibly due to low platelet count, other changes in blood cells.
• Changes in blood tests (high cholesterol, high 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 rash with skin peeling, severe allergic reactions, swelling of the 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 cell (eosinophilia), and inflammation of internal organs (liver, lungs, heart, kidneys, and large intestine) (drug reaction or rash with eosinophilia and systemic symptoms [DRESS]).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: 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 Loitin after the expiry date stated on the packaging and bottle, after EXP. The expiry date refers to the last day of the month indicated.
• Powder for oral suspension: no special storage conditions required. Keep the bottle properly closed.
• After reconstitution, store the suspension below 25°C.
• The reconstituted suspension is stable for 14 days when stored below 25°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Loitin

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

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

Appearance of Loitin and contents of the pack

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

Mixing the powder with water in each bottle yields 35 ml of suspension.

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

It is available in packs containing 1 bottle and in clinical packs containing 10 bottles.

The information in this leaflet refers only 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 leaflet for these products.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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: June 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/

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 be a white to off-white suspension with an orange flavour.

1. Tap the bottle to loosen the powder.
2. Add a small amount of water and shake vigorously. Then add water up to the level line 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. Write the expiry date of the reconstituted suspension on the bottle label (the reconstituted suspension expires after 14 days). Any remaining suspension must not be used after this date and should be returned to the pharmacist.

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

Loitin 10 mg/ml powder for oral suspension:

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

The maximum dose of 400 mg per day must not be exceeded in the paediatric 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, Loitin 40 mg/ml powder for oral suspension is recommended.