Prospecto:information for the patient

Erelan 400 mg film-coated tablets EFG

For use in adults

Moxifloxacino

Read this prospectus carefully before starting to take this medication,because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult yourdoctoror pharmacist.

-This medication has been prescribedonlyto you, and you should not give it to other people even if they havethe same symptomsas you, as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist, evenifthey are not listed in this prospectus. See section 4.

2.What you need to knowbeforestarting totake Erelan

3.How to take Erelan

4.Possible adverse effects

5Storage of Erelan

6.Contents of the package and additional information

Erelan contains the active ingredient moxifloxacino, which belongs to the group of antibiotics known as fluoroquinolonas. Moxifloxacino acts by eliminating bacteria that cause infections.

Erelan is indicated for patients 18 years and older for the treatment of the following bacterial infections when caused by bacteria, when moxifloxacino is active against these bacteria. Erelan should be used only to treat these infections when usual antibiotics cannot be used or have not been effective:

• Paranasal sinus infection, sudden worsening of chronic inflammation of the airways, or community-acquired pneumonia (except severe cases).
• Mild to moderate upper genital tract infections in females (inflammatory pelvic disease), including fallopian tube infection and uterine mucous membrane infection.

For this type of infection, moxifloxacino tablets are not sufficient as a single treatment, so your doctor will also prescribe another antibiotic for the treatment of mild to moderate upper genital tract infections in females (see section 2).

If the following diseases have shown improvement during initial treatment with moxifloxacino infusion solution, your doctor may prescribe moxifloxacino 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.

Do not take Erelan:

• If you are allergic to moxifloxacino or any of the other components of this medication (listed in section 6).
• If you are pregnant or breastfeeding.
• If you are under 18 years old.
• If you have a history of tendon damage or lesions related to antibiotic treatment with quinolones (see section “Warnings and precautions” and section 4).
• If you have:

• Any hereditary disease or have suffered from a disease related to an abnormal heart rhythm (observed on ECG, heart electrical recording);
• Electrolyte imbalances in the blood (especially low levels of potassium or magnesium in the blood);
• A very low heart rate (called “bradycardia”);
• A weak heart (heart failure);
• A history of heart rhythm disturbances;

or

• You are taking other medications that cause ECG disturbances (see section “Other medications and Erelan”). This is because moxifloxacino can cause changes in the ECG, such as a prolongation of the QT interval, that is, a delay in the conduction of electrical signals in the heart.
• 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 starting to take this medication

Do not take fluoroquinolone or quinolone antibiotics, including Erelan, if you have had a severe reaction to a quinolone or fluoroquinolone in the past. If this is your case, 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 changes in blood sugar levels with moxifloxacino.
• If you have ever developed a severe skin rash or skin peeling, blisters, and/or mouth sores after taking moxifloxacino.

• Moxifloxacino can modify the heart ECG, especially if you are a woman or an elderly patient. If you are currently taking any medication that causes a decrease in blood potassium levels, 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 enlarged or “bulge” of a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm).
• If you have had a previous episode of aortic dissection (tear in the aortic wall).
• If you have been diagnosed with heart valve insufficiency (regurgitation of heart valves).
• If you have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., Marfan syndrome or Ehlers-Danlos vascular syndrome, Turner syndrome, or Sjögren syndrome (an autoimmune inflammatory disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet disease, hypertension, or known atherosclerosis, rheumatoid arthritis (a joint disease) or endocarditis (a heart infection)).
• If you suffer from epilepsy or another condition that may cause 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 moxifloxacino. If you think this affects you, consult your doctor immediately.
• If you or a family member has glucose-6-phosphate dehydrogenase deficiency (a rare hereditary disease), inform your doctor, who will indicate whether Erelan is suitable for you.
• If you have a complicated upper genital tract infection (e.g., associated with a fallopian tube and ovarian abscess or pelvic abscess), for which your doctor considers intravenous treatment, Erelan is not suitable.
• For the treatment of mild to moderate upper genital tract infection, your doctor should prescribe another antibiotic in addition to moxifloxacino. If you do not notice an improvement in symptoms after three days of treatment, consult your doctor.

While taking Erelan:

• If you experience severe and sudden abdominal or back pain, which may be symptoms of aortic dissection or aneurysm, go to the emergency room immediately.This risk may be increased if you are receiving systemic corticosteroid treatment.
• If you start experiencing sudden onset of shortness of breath, especially when lying down, or if you notice swelling in your legs, feet, or abdomen, or if you experience palpitations (sensation of rapid or irregular heartbeat), inform your doctor immediately.

During treatment with Erelan

• If you notice palpitations or irregular heartbeat during the treatment period, inform your doctor immediately. Your doctor may perform an ECG to measure your heart rate.
• The risk of heart problems may increase with higher doses. Therefore, take the recommended dose.
• In rare cases, you may experience a sudden and severe allergic reaction (anaphylactic reaction) even with the first dose, and develop the following symptoms: chest tightness, dizziness, nausea, or fainting, or feeling dizzy when standing. If you experience these symptoms, stop taking Erelan and consult your doctor immediately.
• Moxifloxacino can cause rapid and severe liver inflammation, which may lead to liver failure that puts your life at risk (including fatal cases, see section 4). Please consult your doctor before continuing treatment if you develop symptoms such as sudden and severe discomfort and/or discomfort associated with yellowing of the white of the eyes, dark urine, itching, bleeding tendency, or liver damage-induced cerebral disease (symptoms of reduced liver function or rapid and severe liver inflammation). Antibiotics, including quinolones, may cause seizures. If this occurs, stop taking Erelan and 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 your 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 rare cases, mental health problems and depression have evolved into suicidal thoughts and self-harm behaviors such as attempted suicide (see section 4). If you develop these reactions, stop taking 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 your stool, stop taking Erelan immediately and consult your doctor. In these situations, do not take medications that slow down or stop intestinal movement.
• In rare cases, you may experience pain and swelling in your joints and inflammation or tendon rupture. The risk is higher if you are an elderly patient (over 60 years old), have received an organ transplant, have kidney problems, or are taking corticosteroids. Tendon inflammation and rupture can occur in the first 48 hours of treatment and even several months after stopping Erelan. If you experience any pain or inflammation in a tendon (e.g., in your 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 may increase the risk of tendon rupture.
• If you are an elderly patient with kidney problems, be careful to ensure adequate fluid intake, as dehydration may increase the risk of kidney failure.
• If your vision worsens or if your eyes appear to be affected, consult an ophthalmologist immediately (see section “Driving and operating machinery” 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 may cause a loss of consciousness (hypoglycemic coma) (see section 4. Possible side effects).If you have diabetes, your blood sugar levels should be closely monitored.
• Quinolone antibiotics may increase skin sensitivity to sunlight or UV. You should avoid prolonged exposure to sunlight or direct sunlight and not use sunbeds or any type of UV lamp during moxifloxacino administration.
• 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, including Stevens-Johnson syndrome, toxic epidermal necrolysis (NET), and generalized acute pustular psoriasis (PEGA), and drug reaction with eosinophilia and systemic symptoms (DRESS or hypersensitivity syndrome) have been reported with the use of moxifloxacino.

• SSJ / NET may initially appear on the trunk as red, ring-shaped spots or circular patches often with central blisters. They may also appear as ulcers in the mouth, throat, nose, genitals, and eyes (red and swollen eyes). These severe skin eruptions often precede fever and/or flu-like symptoms. The eruptions may progress to widespread skin peeling and potentially life-threatening complications.
• PEGA appears at the beginning of treatment as a red, scaly, and generalized rash with subcutaneous nodules and blisters accompanied by fever. The most common location: primarily localized in skin folds, trunk, and upper limbs.
• DRESS initially presents with flu-like symptoms and a rash on the face, followed by a widespread rash with high body temperature, elevated liver enzymes in blood tests, and increased eosinophil levels, and lymph node enlargement.

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

Severe, long-lasting, and potentially irreversible adverse effects

Fluoroquinolone or quinolone antibiotics, including [medication name], have been associated with rare but severe adverse effects, some of which have been long-lasting (persistent for months or years), disabling, or potentially irreversible. This includes tendon pain, muscle pain, and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pinpricks, 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 discontinue treatment, considering the use of an antibiotic from another class.

Children and adolescents

Do not give this medication to children and adolescents under 18 years old because its efficacy and safety have not been established (see section “Do not take Erelan”).

Other medications and Erelan

Inform your doctor or pharmacist if you are taking, have taken recently, or may take any other medication that may interact with Erelan.

With Erelan, you should be aware of the following:

• If you are taking moxifloxacino and other medications that affect the heart, there is a higher risk of heart rhythm disturbances. Therefore, do not take moxifloxacino at the same time as the following medications:
• Antiarrhythmic medications (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide);
• Antipsychotics (e.g., phenothiazines, pimozide, sertindole, haloperidol, sulpiride);
• Tricyclic antidepressants;
• Some antimicrobials (e.g., saquinavir, enoxacin, erythromycin administered intravenously, pentamidine, antimalarials, particularly halofantrine);
• Some antihistamines (e.g., terfenadine, astemizole, mizolastine);
• Other medications (e.g., cisapride, vincamine intravenously, bepridil, and difemanil).
• You should inform your doctor if you are taking other medications that may decrease blood potassium levels (e.g., diuretics and thiazide-type 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 disturbances.
• Any other medication containing magnesium or aluminum (such as antacids for indigestion), iron, zinc, or didanosine, or medications containing sucralfate (for gastrointestinal disorders) may reduce the action of moxifloxacino tablets. Therefore, take your moxifloxacino tablets 6 hours before or after taking other medications.
• The oral administration of activated charcoal at the same time as Erelan reduces its action. 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 clotting 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, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Do not use Erelan during pregnancy or if you are breastfeeding.

Animal studies do not indicate that this medication may alter your fertility.

Driving and operating machinery

Moxifloxacino may cause dizziness or vertigo or a brief loss of consciousness. You may experience a sudden and temporary 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 a certain sugar intolerance, consult with them before taking this medication.

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

The recommended dose in adults is one 400 mg film-coated tablet, 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 to take the tablet approximately at 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:

• Acute exacerbation of chronic bronchitis: 5 – 10 days;
• Community-acquired pneumonia, except for severe cases: 10 days;
• Acute bacterial sinusitis: 7 days;
• Mild to moderate upper genital tract infections in females (pelvic inflammatory disease), including fallopian tube infection and uterine mucosal membrane infection: 14 days.

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

• Community-acquired pneumonia: 7-14 days;

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

• Soft tissue and skin infections: 7-21 days;

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

It is essential to complete the treatment, even if you start feeling better after a few days. If you interrupt the treatment too soon, the infection may not be fully cured, the infection may recur, or your condition may worsen, and you may also develop antibiotic resistance.

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

If you take more Erelan than you should

If you take more than one tablet per day as recommended, consult your doctor immediately and, if possible, bring the remaining medication, the packaging, or this leaflet to show the 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 forgotten dose, take the tablet as soon as you remember on the same day. If you miss a dose, 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 of what to do, consult your doctor or pharmacist.

If you interrupt the treatment with Erelan

If you interrupt the treatment too soon, your infection may not be fully cured. Consult your doctor if you plan to stop taking the tablets before completing the full treatment.

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

Like all medicines, this medicine 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 discoloration of the white of the eyes, dark urine, itching, tendency to bleed, or alterations in thought or state of consciousness (these may be signs and symptoms of a fulminant liver inflammation that may potentially lead to potentially fatal liver failure (very rare side effect, fatal cases have been observed)).
• Severe skin eruptions including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as red, target-shaped macules or circular patches often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, and may be preceded by fever and flu-like symptoms (very rare side effects, potentially life-threatening)
• A red, scaly, and generalized rash with protuberances under the skin and blisters accompanied by fever at the start of treatment (acute generalized pustular psoriasis) (the frequency of this side effect is "unknown")
• Generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug-induced hypersensitivity syndrome) (the frequency of this side effect is “unknown”
• Associated syndrome with alterations in water elimination and low sodium levels (SIADH) (very rare side effect)
• Loss of consciousness due to severe decrease in blood sugar levels (hypoglycemic coma) (very rare side effect)Inflammation of blood vessels (the signs may be red patches on the skin, usually on the legs or effects such as joint pain)
• Severe allergic reaction, sudden, and generalized, including very rarely shock that puts your life at risk (e.g., difficulty breathing, low blood pressure, rapid pulse) (rare side effect).
• Swelling, including respiratory tract swelling (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 attempts)
• Madness that can lead to self-harming behaviors, such as suicidal thoughts or attempts
• Severe diarrhea with blood and/or mucus (antibiotic-associated colitis, including pseudomembranous colitis) that, in very rare cases, may lead to life-threatening complications (rare side effect).
• Tendon pain and inflammation (tendinitis) (rare side effect) or tendon rupture (very rare side effect).
• Muscle weakness, sensitivity, or pain, particularly if you also feel unwell, have a fever, or your urine is dark. These symptoms may be caused by abnormal muscle breakdown that may put your life at risk and lead to kidney problems (a condition called rhabdomyolysis) (the frequency of this side effect is "unknown")

Stop taking this medicine and contact your doctor immediately as you may need urgent medical help.

Additionally, if you notice:

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

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

In rare cases, symptoms of myasthenia gravis may worsen. If this occurs,consult your doctor immediately.

If you have diabetes and notice that your blood sugar levels increase or decrease (rare or very rare side effect),inform your doctor immediately.

If you are an elderly person 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 may be signs and symptoms of kidney insufficiency, a rare side effect),consult your doctor immediately.

The following are other side effects that have been observed during treatment with moxifloxacino according to the probability that they present:

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

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

• Muscle cramps
• Muscle contractions
• Hallucinations
• Increased blood pressure
• Swelling (of hands, feet, ankles, lips, mouth, and throat)
• Decreased blood pressure
• Renal alterations (including increased renal function tests, such as urea and creatinine)
• Liver inflammation
• Mouth inflammation
• Tinnitus/ringing in the ears
• Ictericia (yellowish discoloration of the white of the eyes or skin)
• Alterations in skin sensation
• Abnormal dreams
• Concentration disorders
• Dysphagia (difficulty swallowing)
• Alterations in sense of smell (including loss of smell)
• Balance and coordination disorders (due to dizziness)
• Total or partial loss of memory
• Hearing loss (usually reversible)
• Increased uric acid levels in the blood
• Emotional instability
• Speech alteration
• Fainting
• Muscle weakness

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

• Joint inflammation

• Irregular heart rhythm

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

Frequencyunknown(cannot be estimated from available data)

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

Well-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 skin or mucosa location with subsequent moxifloxacino exposure.

Additionally, very rare cases of the following side effects have been reported, described after treatment with other quinolone antibiotics and that 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-containing antibiotics and fluoroquinolones has been associated with very rare cases of long-lasting or permanent adverse reactions (even months or years) or permanent, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pinpricks, tingling, numbness, burning, or pain (neuropathy), depression, fatigue, sleep disorders, memory loss, and hearing, vision, taste, and smell loss, in some cases regardless of the presence of pre-existing risk factors.

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:www.notificaRAM.es.

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

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe boxafter 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 drains or trash. Dispose of packaging and unused medications at thepharmacy's Take-Back Point. This will help protect the environment.

Composition of Erelan

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

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).

Appearance of the product and contents of the packaging

Film-coated tablets of red color, oblong convex shape, marked with “MC” and with core dimensions of 17.6 mm x 8 mm.

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

Only some pack sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Medochemie Ltd

1-10 Constantinoupoleos street

3011 Limassol,

Cyprus

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Medochemie Iberia S.A., Branch in Spain

Avenida de las Águilas, nº 2 B; 5th floor, office 6,

28044 Madrid

SPAIN

Last revision date of thisleaflet: April 2024.

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