ERELAN 400 mg FILM-COATED TABLETS

Introduction

Package Leaflet:information for the patient

Erelan 400 mg film-coated tablets EFG

For use in adults

Moxifloxacin

Read the entire package leaflet carefully before starting to take this medication,as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Erelan and what is it used for

1. What you need to know before taking Erelan
2. How to take Erelan
3. Possible side effects

5 Storage of Erelan

1. Contents of the pack and additional information

1. What is Erelan and what is it used for

Erelan contains the active substance moxifloxacin, which belongs to the group of antibiotics known as fluoroquinolones. Moxifloxacin works by eliminating bacteria that cause infections.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or the common cold.

It is essential that you follow the instructions regarding dosage, administration interval, and treatment duration as indicated by your doctor.

Do not store or reuse this medication. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw away medications down the drain or in the trash.

Erelan is indicated in patients 18 years and older for the treatment of the following bacterial infections when caused by bacteria susceptible to moxifloxacin. Erelan should only be used to treat these infections when usual antibiotics cannot be used or have not worked:

• Sinus infection, sudden worsening of long-term airway inflammation, or community-acquired pneumonia (except severe cases).
• Mild or moderate upper female genital tract infections (pelvic inflammatory disease), including fallopian tube infection and uterine membrane infection.

For this type of infection, moxifloxacin tablets are not sufficient as sole treatment; therefore, in addition to moxifloxacin tablets, your doctor will prescribe another antibiotic for the treatment of mild or moderate upper female genital tract infections (see section 2).

If the following conditions have shown improvement during initial treatment with moxifloxacin solution for infusion, your doctor may prescribe moxifloxacin tablets to complete the treatment:

• Community-acquired pneumonia, skin and soft tissue infections.

Erelan 400 mg tablets should not be used to initiate treatment for any type of skin and soft tissue infection or severe pneumonia.

2. What you need to know before you start taking Erelan

Do not take Erelan:

• If you are allergic to moxifloxacin or any of the other components of this medication (included in section 6).
• If you are pregnant or breastfeeding.
• If you are under 18 years old.
• If you have or have had:

• any inherited disease or have suffered from any disease related to an abnormal heart rhythm (observed in ECG, electrical record of the heart);
• electrolyte imbalances in the blood (especially low levels of potassium or magnesium in the blood);
• a very slow heart rate (called "bradycardia");
• a weak heart (heart failure);
• a history of heart rhythm disorders;

or

• you are taking other medications that cause disorders in the ECG (see section "Other medications and Erelan"). This is because moxifloxacin can cause changes in the ECG, such as a prolongation of the QT interval, i.e., a delay in the conduction of electrical signals in the heart.
• If you have a severe liver disease or increased levels of liver enzymes (transaminases) 5 times above the upper limit of normal.

Warnings and precautions

Before you start taking this medication

You should not take antibacterial medications that contain fluoroquinolones or quinolones, including Erelan, if you have experienced any severe adverse reaction previously when taking a quinolone or a fluoroquinolone. If this is the case, you should inform your doctor as soon as possible.

Consult your doctor or pharmacist before starting to take Erelan:

• If you are diabetic because you may experience a risk of change in blood sugar levels with moxifloxacin.
• If you have ever developed a severe skin rash or skin peeling, blisters, and/or sores in the mouth after taking moxifloxacin.

• Moxifloxacino may modify the ECG of the heart, especially if you are a woman or an elderly patient. If you are currently taking any medication that leads to a decrease in potassium levels in the blood, consult your doctor before taking Erelan (see also section "Do not take Erelan" and "Other medications and Erelan").
• If you have been diagnosed with an increase in size or a "lump" of a large blood vessel (aortic aneurysm or large peripheral vessel aneurysm).
• If you have suffered a previous episode of aortic dissection (tear of the aortic wall).
• If you have been diagnosed with heart valve insufficiency (regurgitation of the heart valves).
• If you have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing disorders (e.g., connective tissue disorders such as Marfan syndrome or Ehlers-Danlos vascular syndrome, Turner syndrome, or Sjögren's syndrome (an autoimmune inflammatory disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, arterial hypertension, or atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).
• If you suffer from epilepsy or any other condition that may cause you to have seizures, consult your doctor before taking Erelan.
• If you have or have had any mental health problems, consult your doctor before taking Erelan.
• If you have myasthenia gravis (abnormal muscle fatigue leading to weakness and in severe cases paralysis), your symptoms may worsen if you take moxifloxacin. If you think this affects you, consult your doctor immediately.
• If you or a family member has a deficiency of glucose-6-phosphate dehydrogenase (a rare inherited disease), inform your doctor, who will indicate if Erelan is suitable for you.
• If you have a complicated infection of the upper female genital tract (e.g., associated with an abscess in the fallopian tubes and ovary or pelvis), for which your doctor considers intravenous treatment necessary, treatment with moxifloxacin tablets is not appropriate.
• For the treatment of a mild to moderate infection of the upper female genital tract, your doctor should prescribe another antibiotic along with moxifloxacin. If you do not notice an improvement in symptoms after three days of treatment, consult your doctor.

While taking Erelan:

• If you feel a strong and sudden pain in the abdomen or back, which can be symptoms of aortic dissection or aneurysm, go immediately to an emergency service. The risk may increase if you are receiving systemic corticosteroid treatment.
• If you start experiencing a sudden onset of shortness of breath, especially when lying down, or if you notice swelling in the ankles, feet, or abdomen, or the appearance of heart palpitations (feeling of rapid or irregular heartbeat), you should inform your doctor immediately.

During treatment with Erelan

• If you notice palpitations or irregular heartbeats during the treatment period, you should inform your doctor immediately. He or she may perform an ECG to measure your heart rate.
• The risk of heart problems may increase with the increase in dose. Therefore, you should take the recommended dose.
• In rare cases, you may experience a sudden severe allergic reaction (anaphylactic reaction or shock) even with the first dose and develop the following symptoms: chest tightness, feeling of dizziness, feeling of nausea or fainting, or feeling dizzy when standing. If you experience these symptoms, stop taking Erelan and consult your doctor immediately.
• Moxifloxacino may cause rapid and severe liver inflammation, which can lead to life-threatening liver failure (including fatal cases, see section 4). Please consult your doctor before continuing treatment if you develop symptoms such as a sudden feeling of discomfort and/or discomfort associated with a yellowish color of the whites of the eyes, dark urine, skin itching, tendency to bleed, or brain disease induced by liver damage (symptoms of reduced liver function or rapid and severe liver inflammation). Quinolone antibiotics, including moxifloxacino, may cause seizures. If this occurs, treatment with Erelan should be discontinued, and you should contact your doctor immediately.
• In rare cases, you may experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness, and/or weakness, especially in the feet and legs or hands and arms. If this happens, stop taking Erelan and inform your doctor immediately to prevent the development of a potentially irreversible disorder.
• You may experience mental health problems even after the first administration of quinolone antibiotics, including moxifloxacino. In very rare cases, mental health problems and depression have evolved into suicidal thoughts and self-harming behaviors such as suicide attempts (see section 4). If you develop these reactions, you should discontinue treatment with Erelan and inform your doctor immediately.
• You may develop diarrhea during or after taking antibiotics, including moxifloxacino. If the diarrhea is severe or persistent, or if you notice blood or mucus in the stool, stop taking Erelan immediately and consult your doctor. In these situations, you should not take medications that interrupt or slow down intestinal movement.
• In rare cases, pain and swelling in the joints and inflammation or rupture of the tendons may occur. The risk is higher if you are an elderly person (over 60 years old), have received an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even several months after stopping treatment with Erelan. At the first sign of pain or inflammation of a tendon (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Erelan, contact your doctor, and keep the affected area at rest. Avoid any unnecessary exercise, as this could increase the risk of tendon rupture.
• If you are elderly and have kidney problems, be careful to drink enough fluids, as dehydration can increase the risk of kidney failure.
• If your vision worsens or if your eyes seem to be affected, consult an eye doctor immediately (see section "Driving and using machines" and section 4).
• Fluoroquinolones may cause an increase in blood sugar levels above normal levels (hyperglycemia) or a decrease in blood sugar levels below normal levels (hypoglycemia), which in severe cases can cause loss of consciousness (hypoglycemic coma) (see section 4. Possible adverse effects). If you have diabetes, your blood sugar levels should be carefully monitored.
• Quinolone antibiotics may increase the sensitivity of the skin to sunlight or UV. You should avoid prolonged exposure to sunlight or direct sunlight and should not use sunbeds or any type of UV lamp during the administration of moxifloxacino.
• The efficacy of moxifloxacino solution for infusion in the treatment of severe burns, deep tissue infections, and diabetic foot infections with osteomyelitis (bone marrow infections) has not been established.

Severe skin reactions

Severe skin reactions have been reported, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), and drug reaction with eosinophilia and systemic symptoms (DRESS or drug hypersensitivity syndrome) with the use of moxifloxacino.

• Stevens-Johnson syndrome/toxic epidermal necrolysis may initially appear on the trunk as reddish targets or circular spots often with central blisters. Ulcers may also appear in the mouth, throat, nose, genitals, and eyes (red and swollen eyes). These severe skin rashes are often preceded by fever and/or flu-like symptoms. The rashes can progress to widespread skin peeling and life-threatening complications.
• Acute generalized exanthematous pustulosis appears at the beginning of treatment as a red, scaly, and generalized rash with bumps under the skin and blisters accompanied by fever. The most common location is mainly localized in skin folds, trunk, and upper limbs.
• Drug reaction with eosinophilia and systemic symptoms (DRESS) appears initially with pseudo-flu-like symptoms and a rash on the face, later, a widespread rash appears with high body temperature, increased levels of liver enzymes in blood tests, and increased levels of a type of white blood cell (eosinophilia) and increased lymph node size.

If you develop a severe rash or any of these skin symptoms, stop taking moxifloxacino and contact your doctor or seek medical attention immediately.

Severe, disabling, and potentially irreversible adverse effects

Antibacterial medications that contain fluoroquinolones or quinolones, including Erelan, have been associated with very rare but severe adverse effects, some of which were long-lasting (persistent for months or years), disabling, or potentially irreversible. This includes pain in the tendons, muscles, and joints of the upper and lower limbs, difficulty walking, abnormal sensations such as pins and needles, tingling, numbness, or burning (paresthesia), sensory disorders such as decreased vision, taste, smell, and hearing, depression, decreased memory, intense fatigue, and severe sleep disorders.

If you experience any of these adverse effects after taking Erelan, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or not continue treatment, also considering the use of an antibiotic of another class.

Children and adolescents

Do not give this medication to children and adolescents under 18 years old because the efficacy and safety for this age group have not been established (see section "Do not take Erelan").

Other medications and Erelan

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

With Erelan, you should consider the following:

• If you are taking moxifloxacino and other medications that affect the heart, there is a greater risk that heart rhythm disorders may occur. Therefore, you should not take moxifloxacino at the same time as the following medications:
• Medications that belong to the class of antiarrhythmics (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide);
• Antipsychotics (e.g., phenothiazines, pimozide, sertindole, haloperidol, sultopride);
• Tricyclic antidepressants;
• Certain antimicrobials (e.g., saquinavir, sparfloxacin, erythromycin administered intravenously, pentamidine, antimalarials, particularly halofantrine);
• Certain antihistamines (e.g., terfenadine, astemizole, mizolastine);
• Other medications (e.g., cisapride, intravenous vincamine, bepridil, and difemanil).
• You should inform your doctor if you are taking other medications that may decrease potassium levels in the blood (e.g., loop and thiazide diuretics, laxatives, and enemas (high doses), or corticosteroids (anti-inflammatory medications), amphotericin B) or cause a decrease in heart rate, as these may also increase the risk of severe heart rhythm disorders.
• Any other medication that contains magnesium or aluminum (such as antacids for indigestion), iron, zinc, or didanosine, or medications that contain sucralfate (for gastrointestinal disorders) may reduce the action of moxifloxacino tablets. Therefore, take your moxifloxacino tablets 6 hours before or after taking other medications.
• Taking oral activated charcoal at the same time as Erelan reduces the action of the latter. Therefore, it is recommended not to use these medications simultaneously.
• If you are currently taking oral anticoagulants (e.g., warfarin), your doctor may need to monitor your blood coagulation time.

Erelan with food, drinks, and alcohol

The effect of Erelan is not altered by food, including dairy products.

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.

Do not use Erelan during pregnancy or while breastfeeding.

Animal studies do not indicate that fertility may be affected by taking this medication.

Driving and using machines

Moxifloxacino may cause dizziness or vertigo or a brief fainting spell; you may experience a sudden transient loss of vision. If you experience these symptoms, do not drive vehicles or operate machinery.

Erelan contains lactose monohydrate.

If your doctor has told you that you have an intolerance to certain sugars, consult with him or her before taking this medication.

3. How to take Erelan

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

The recommended dose in adults is one film-coated tablet of 400 mg, once a day.

Erelan tablets are for oral administration. Take the tablet whole without chewing (to mask the bitter taste) and with plenty of liquid. Erelan can be taken with or without food. It is recommended that you take the tablet at approximately the same time every day.

No dose adjustment is necessary in elderly patients, in patients with low body weight, or in patients with kidney problems.

The duration of treatment depends on the type of infection.

Unless your doctor has told you otherwise, the duration of treatment with Erelan is as follows:

• Sudden worsening of chronic bronchitis (acute exacerbation of chronic bronchitis): 5-10 days;
• Community-acquired lung infections (pneumonias), except in severe cases: 10 days;
• Acute infections of the paranasal sinuses (acute bacterial sinusitis): 7 days;
• Mild or moderate infections of the upper female genital tract (pelvic inflammatory disease), including fallopian tube infection and uterine mucous membrane infection: 14 days.

When Erelan tablets are used to complete treatment initiated with moxifloxacino solution for infusion, the recommended durations are:

• Community-acquired lung infections (pneumonias): 7-14 days;

Most patients with pneumonia switched from intravenous to oral treatment after 4 days.

• Skin and soft tissue infections: 7-21 days;

Most patients with skin and soft tissue infections switched from intravenous to oral treatment after 6 days.

It is essential to take the complete treatment, even if you start to feel better after a few days. If you interrupt treatment too early, the infection may not be completely cured, the infection may return, or your condition may worsen, and you may also develop bacterial resistance to the antibiotic.

Do not exceed the recommended dose and treatment duration (see section 2).

If you take more Erelan than you should

If you take more than one of the recommended tablets per day, consult your doctor immediately, and if possible, bring the remaining medication, packaging, or this leaflet and show it to your doctor or pharmacist what you have taken.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service. Phone: 91 562 04 20, indicating the medication and the amount used.

If you forget to take Erelan

In case of forgetting a dose, you should take the tablet as soon as you remember it on the same day. If you do not take your tablet one day, take the normal dose (one tablet) the next day. Do not take two tablets to make up for the missed dose.

If you are unsure what to do, consult your doctor or pharmacist.

If you interrupt treatment with Erelan

If you interrupt taking this medication too early, your infection may not be completely cured. Consult your doctor if you intend to stop taking the tablets before completing the full treatment.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The most serious side effects observed during treatment with Actira are listed below:

If you notice:

• An abnormally fast heart rate (rare side effect);
• A sudden feeling of discomfort or notice a yellowish color of the whites of the eyes, dark urine, skin itching, tendency to bleed, or alterations in thinking or wakefulness (these can be signs and symptoms of a fulminant liver inflammation that can potentially lead to potentially fatal liver failure (very rare side effect, with reported fatal cases)).
• Severe skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These can appear on the trunk as reddish spots in a target shape or circular patches, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, and can be preceded by fever and flu-like symptoms (very rare side effects, with possible life-threatening potential)
• A red, scaly, and generalized rash with bumps under the skin and blisters, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis) (the frequency of this side effect is "unknown")
• A generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and involvement of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome) (the frequency of this side effect is "unknown")
• Syndrome associated with alterations in water elimination and low sodium levels (SIADH) (very rare side effect)
• Loss of consciousness due to a severe decrease in blood sugar levels (hypoglycemic coma) (very rare side effect)
• Inflammation of blood vessels (the signs can be red spots on the skin, usually on the legs, or effects such as joint pain) (very rare side effect).
• Severe allergic reaction, sudden and generalized, including very rarely life-threatening shock (e.g., difficulty breathing, decreased blood pressure, rapid pulse) (rare side effect).
• Swelling, including swelling of the airways (rare side effect, potentially fatal).
• Seizures (rare side effect).
• Problems associated with the nervous system, such as pain, burning, tingling, numbness, and/or weakness in the limbs (rare side effect).
• Depression (in very rare cases, it has evolved into self-harm, suicidal thoughts, or suicide attempts) (rare side effect).
• Madness that can lead to self-destructive behaviors, such as suicidal thoughts or attempts) (very rare side effect).
• Severe diarrhea with blood and/or mucus (antibiotic-associated colitis, including pseudomembranous colitis) that, in very rare circumstances, can generate life-threatening complications (rare side effect).
• Pain and inflammation of the tendons (tendinitis) (rare side effect) or tendon rupture (very rare side effect).
• Muscle weakness, sensitivity, or pain, particularly if you also feel discomfort, have a fever, or your urine is dark. These symptoms can be caused by abnormal muscle breakdown that can be life-threatening and cause kidney problems (a condition called rhabdomyolysis) (the frequency of this side effect is "unknown")

Stop taking this medication and contact your doctor immediately, as you may need urgent medical attention.

Additionally, if you notice:

• Transient loss of vision (very rare side effect), contact an ophthalmologist immediately.

If you have experienced potentially life-threatening irregular heartbeats (Torsade de Pointes) or cardiac arrest while taking moxifloxacino (very rare side effects), inform your doctor immediately that you have taken this medication and do not restart treatment.

It has been observed, in very rare cases, that symptoms of myasthenia gravis can worsen. If this occurs, consult your doctor immediately.

If you have diabetes and notice that your blood sugar level increases or decreases (rare or very rare side effect), inform your doctor immediately.

If you are elderly with kidney problems and notice a decrease in urine production, swelling in the legs, ankles, or feet, fatigue, nausea, drowsiness, shortness of breath, or confusion (these can be signs and symptoms of kidney failure, a rare side effect), consult your doctor immediately.

The following are other side effectsthat have been observed during treatment with moxifloxacino, according to their probability:

Frequent(may affect up to 1 in 10 people)

• Nausea
• Diarrhea
• Dizziness
• Abdominal and stomach pain
• Vomiting
• Headache
• Increased liver enzyme in the blood (transaminases)
• Infections caused by resistant bacteria or fungi, e.g., oral and vaginal infections caused by Candida.
• Change in heart rhythm (ECG), in patients with low potassium levels in the blood

Uncommon(may affect up to 1 in 100 people)

• Rash.
• Gastric discomfort (indigestion/heartburn).
• Alteration of taste (in very rare cases, loss of taste).
• Sleep disorders (predominantly insomnia).
• Increased liver enzyme in blood (gamma-glutamyl-transferase and/or alkaline phosphatase).
• Low levels of certain white blood cells (leukocytes, neutrophils).
• Constipation.
• Itching.
• Feeling of vertigo (that everything is spinning and falling).
• Drowsiness.
• Flatulence.
• Change in heart rhythm (ECG).
• Alteration of liver function (including increased liver enzyme in blood, LDH).
• Decreased appetite and food intake.
• Low white blood cell count.
• Pains and discomfort such as back pain, limb pain, pelvic and thoracic pain.
• Increased certain blood cells necessary for blood coagulation.
• Sweating.
• Increased certain white blood cells (eosinophils).
• Anxiety.
• Discomfort (mainly weakness or fatigue).
• Tremors.
• Joint pain.
• Palpitations.
• Irregular and rapid heartbeat.
• Breathing difficulties, including asthmatic conditions.
• Increased certain digestive enzyme in the blood (amylase).
• Restlessness/agitation.
• Feeling of tingling (pins and needles) and/or numbness.
• Hives on the skin.
• Dilation of blood vessels.
• Confusion and disorientation.
• Decrease in blood cells necessary for blood coagulation.
• Visual disturbances, including double vision and blurred vision.
• Decreased blood coagulation.
• Increased lipids in the blood (fats).
• Low red blood cell count.
• Muscle pain.
• Allergic reactions.
• Increased bilirubin in the blood.
• Gastritis (inflammation of the stomach).
• Dehydration.
• Severe heart rhythm disorders.
• Dry skin.
• Chest pain.

Rare(may affect up to 1 in 1,000 people)

• Muscle cramps.
• Muscle spasms.
• Hallucinations.
• Increased blood pressure.
• Swelling (of hands, feet, ankles, lips, mouth, and throat).
• Decreased blood pressure.
• Kidney disorders (including increased kidney function tests, such as urea and creatinine).
• Liver inflammation.
• Mouth inflammation.
• Ringing/ noises in the ears.
• Jaundice (yellowish color of the whites of the eyes or skin).
• Alterations in skin sensation.
• Abnormal dreams.
• Concentration disorders.
• Difficulty swallowing.
• Alterations in smell (including loss of smell).
• Balance and coordination disorders (due to dizziness).
• Loss of memory, total or partial.
• Hearing impairments, including deafness (usually reversible).
• Increased uric acid in the blood.
• Emotional instability.
• Speech disorders.
• Fainting.
• Muscle weakness.

Very rare(may affect up to 1 in 10,000 people)

• Joint inflammation.

• Irregular heartbeat.

• Increased skin sensitivity.
• Depersonalization disorder (feeling that one is not oneself).
• Increased blood coagulation.
• Muscle stiffness.
• Significant decrease in certain white blood cells (agranulocytosis)
• Decrease in the number of red and white blood cells and platelets (pancytopenia).

Frequency unknown(cannot be estimated from available data)

• increased skin sensitivity to sunlight or UV radiation (see also section 2, Warnings and precautions)

clearly defined erythematous patches with/without blisters that appear in the hours following moxifloxacino administration and disappear with residual post-inflammatory hyperpigmentation; they usually reappear in the same place on the skin or mucous membranes with subsequent exposure to moxifloxacino.

Additionally, very rare cases of the following side effects have been reported after treatment with other quinolone antibiotics and may also occur during treatment with moxifloxacino:

• increased intracranial pressure (symptoms include headache, visual problems such as blurred vision, blind spots, double vision, loss of vision);

• increased sodium levels in the blood;
• increased calcium levels in the blood;
• reduced count of a certain type of red blood cell (hemolytic anemia);

The administration of quinolone and fluoroquinolone antibiotics has been associated with very rare cases of long-lasting (even months or years) or permanent adverse reactions, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pins and needles, tingling, burning, numbness, or pain (neuropathy), fatigue, decreased memory and concentration, effects on mental health (which can include sleep disorders, anxiety, panic attacks, depression, and suicidal ideation), as well as decreased hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

There have been reports of increased size and weakening or tearing of the aortic wall (aneurysms and dissections), which could lead to rupture and be fatal, and heart valve failure in patients who have received fluoroquinolones. See also section 2.

Reporting of side effects

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

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

5. Storage of Erelan

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the box after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the Sigre Collection Point in the pharmacy. This way, you will help protect the environment.

6. Package contents and additional information

Erelan composition

1. The active ingredient is moxifloxacino. Each film-coated tablet contains 400 milligrams of moxifloxacino (in the form of hydrochloride).
2. The other components are:

Tablet core: microcrystalline cellulose (E 460), lactose monohydrate 320, sodium croscarmellose (E 468), magnesium stearate (E 470b);

Coating: hypromellose (E 464), macrogol (E 1521), titanium dioxide (E 171), iron oxide (E 172).

Product appearance and package contents

Red, oblong, convex film-coated tablets, marked with "MC" and with core dimensions of 17.6 mm x 8 mm.

Film-coated tablets are available in Al/Al blister packs. Packs of 5, 7, 10, 50, 70, 80, or 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Medochemie Ltd

1-10 Constantinoupoleos street

3011 Limassol,

Cyprus

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Medochemie Iberia S.A., Sucursal en España

Avenida de las Águilas, nº 2 B; planta 5 oficina 6,

28044 Madrid

SPAIN

Date of the last revision of thisleaflet: June 2025.

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).