Erelan 400 mg film-coated tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Erelan 400 mg film-coated tablets EFG

For use in adults

Moxifloxacin

Read the entire 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 or pharmacist.
This medicine has been prescribed for you only, and you should not give it 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 or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

What Erelan is and what it is used for
What you need to know before taking Erelan
How to take Erelan
Possible side effects
How to store Erelan
Contents of the pack and other information

1. What Erelan is and what it is used for

Erelan contains the active substance moxifloxacin, which belongs to a 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 flu or the common cold.

It is important that you follow your doctor's instructions regarding dosage, dosing intervals, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing your treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

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

Sinus infection, sudden worsening of long-term inflammation of the airways, or community-acquired pneumonia (excluding severe cases).
Mild to moderate infections of the female upper genital tract (pelvic inflammatory disease), including infection of the fallopian tubes and infection of the uterine mucosal membrane.

For these types of infections, moxifloxacin tablets alone are not sufficient as monotherapy; therefore, in addition to moxifloxacin tablets, your doctor will also prescribe another antibiotic for the treatment of mild to moderate female upper genital tract infections (see section 2).

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

Community-acquired pneumonia, skin and soft tissue infections.

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

2. What you need to know before taking Erelan

Do not take Erelan:

If you are allergic to moxifloxacin or to any of the other ingredients of this medicine (listed in section 6).
If you are pregnant or breastfeeding.
If you are under 18 years of age.
If you have or have had:
any hereditary condition or illness associated with an abnormal heart rhythm (observed on ECG, the electrical recording of the heart);
imbalances in blood electrolytes (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 disturbances;

you are taking other medicines that cause changes in the ECG (see section “Other medicines and Erelan”). This is because moxifloxacin may cause changes in the ECG, such as QT interval prolongation, which means a delay in the electrical conduction in the heart.
If you have severe liver disease or if your liver enzyme levels (transaminases) are increased to five times above the upper limit of normal.

Warnings and precautions

Before starting this medicine

Do not take antibacterial medicines containing fluoroquinolones or quinolones, including Erelan, if you have previously experienced a serious adverse reaction to a quinolone or fluoroquinolone. If this applies to you, inform your doctor as soon as possible.

Talk to your doctor or pharmacist before taking Erelan:

If you have diabetes, because moxifloxacin may increase your risk of changes in blood sugar levels.
If you have ever developed a severe skin rash, skin peeling, blisters and/or mouth sores after taking moxifloxacin.
Moxifloxacin may alter the heart’s ECG, especially if you are female or elderly. If you are currently taking any medication that lowers blood potassium levels, consult your doctor before taking Erelan (see also section “Do not take Erelan” and “Other medicines and Erelan”).
If you have been diagnosed with an enlarged or “bulge” in a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm).
If you have previously experienced aortic dissection (a tear in the wall of the aorta).
If you have been diagnosed with heart valve insufficiency (heart valve regurgitation).
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 vascular Ehlers-Danlos syndrome, Turner syndrome, or Sjögren's syndrome (an inflammatory autoimmune disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, known hypertension or atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).
If you have epilepsy or another condition that may cause seizures, consult your doctor before taking Erelan.
If you have or have ever 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 suspect this is affecting you, consult your doctor immediately.
If you or a family member has glucose-6-phosphate dehydrogenase deficiency (a rare inherited condition), inform your doctor, who will determine whether Erelan is suitable for you.
If you have a complicated upper female genital tract infection (e.g., associated with a tubo-ovarian or pelvic abscess), for which your doctor considers intravenous treatment necessary, treatment with moxifloxacin tablets is not appropriate.
For the treatment of mild to moderate upper female genital tract infection, your doctor should prescribe another antibiotic in addition to moxifloxacin. If you do not notice improvement in symptoms after three days of treatment, consult your doctor.

While taking Erelan:

If you experience sudden, severe pain in your abdomen or back, which may be symptoms of aortic dissection or aneurysm, go immediately to an emergency department. The risk may increase if you are receiving systemic corticosteroid treatment.
If you develop sudden shortness of breath, especially when lying down, or notice swelling in your ankles, feet, or abdomen, or experience palpitations (a sensation of rapid or irregular heartbeat), inform your doctor immediately.

During treatment with Erelan

If you notice palpitations or irregular heartbeats during treatment, inform your doctor immediately. Your doctor may perform an ECG to monitor your heart rhythm.
The risk of heart problems may increase with higher doses. Therefore, the recommended dose should be taken.
Rarely, you may experience a sudden, severe allergic reaction (anaphylactic reaction or shock), even after the first dose, with symptoms such as chest tightness, dizziness, nausea, fainting, or vertigo upon standing. If these symptoms occur, stop taking Erelan and contact your doctor immediately.
Moxifloxacin 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 sudden malaise and/or jaundice (yellowing of the whites of the eyes), dark urine, skin itching, tendency to bleed, or brain dysfunction due to liver damage (symptoms of reduced liver function or rapid and severe liver inflammation). Quinolone antibiotics, including moxifloxacin, may cause seizures. If this occurs, stop taking Erelan and contact your doctor immediately.
Rarely, 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 occurs, stop taking Erelan and inform your doctor immediately to prevent potentially irreversible damage.
You may experience mental health problems even after the first dose of quinolone antibiotics, including moxifloxacin. In very rare cases, mental health issues and depression have progressed to suicidal thoughts and self-harming behaviors, including suicide attempts (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 moxifloxacin. If diarrhea is severe or persistent, or if you notice blood or mucus in your stool, stop taking Erelan immediately and consult your doctor. In such cases, do not take medications that stop or slow intestinal movement.
Rarely, joint pain and swelling, tendon inflammation, or tendon rupture may occur. The risk is higher if you are elderly (over 60 years), have had an organ transplant, have kidney problems, or are taking corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment or even several months after stopping Erelan. At the first sign of tendon pain or swelling (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Erelan, contact your doctor, and rest the affected area. Avoid unnecessary physical activity, as this may increase the risk of tendon rupture.
If you are elderly and have kidney problems, ensure adequate fluid intake, as dehydration may increase the risk of kidney failure.
If your vision worsens or your eyes appear affected, consult an ophthalmologist immediately (see section “Driving and use of machines” and section 4).
Fluoroquinolones may cause an increase in blood sugar levels above normal (hyperglycemia) or a decrease below normal (hypoglycemia), which in severe cases may lead to 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 light. Avoid prolonged exposure to sunlight or direct sunlight, and do not use sunbeds or any type of UV lamp during moxifloxacin treatment.
The efficacy of moxifloxacin infusion solution has not been established in the treatment of severe burns, deep tissue infections, or diabetic foot infections with osteomyelitis (bone marrow infection).

Severe skin reactions

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

SJS/TEN may initially appear on the trunk as reddish, target-like spots or circular lesions, often with central blisters. Mouth, throat, nose, genital, and eye ulcers (red, swollen eyes) may also occur. These severe skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread skin peeling and life-threatening or fatal complications.
AGEP appears at the start of treatment as a widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. The most common locations are skin folds, trunk, and upper limbs.
Drug reaction with eosinophilia and systemic symptoms (DRESS) initially presents with flu-like symptoms and a facial rash, followed by a widespread rash, high fever, elevated liver enzymes in blood tests, increased levels of a type of white blood cell (eosinophilia), and enlarged lymph nodes.

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

Severe, disabling, long-lasting, and potentially irreversible adverse effects

Antibacterial medicines containing fluoroquinolones or quinolones, including [medicinal product name], have been associated with very rare but serious adverse effects, some of which are long-lasting (persisting for months or years), disabling, or potentially irreversible. These include tendon, muscle, and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, numbness, or burning (paresthesia), sensory disturbances such as reduced vision, taste, smell, or hearing, depression, memory decline, severe fatigue, and serious 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 treatment, possibly considering an antibiotic from another class.

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age, as efficacy and safety have not been established in this age group (see section “Do not take Erelan”).

Other medicines and Erelan

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

With Erelan, consider the following:

If you are taking moxifloxacin and other medicines that affect the heart, there is an increased risk of heart rhythm disturbances. Therefore, do not take moxifloxacin at the same time as the following medicines:
Antiarrhythmic drugs (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide);
Antipsychotics (e.g., phenothiazines, pimozide, sertindole, haloperidol, sultopride);
Tricyclic antidepressants;
Some antimicrobials (e.g., saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarials, particularly halofantrine);
Some antihistamines (e.g., terfenadine, astemizole, mizolastine);
Other drugs (e.g., cisapride, intravenous vincamine, bepridil, and difeminal).
Inform your doctor if you are taking other medicines that may lower blood potassium levels (e.g., loop and thiazide diuretics, laxatives and enemas (high doses), or corticosteroids (anti-inflammatory medicines), amphotericin B) or that may reduce heart rate, as these may also increase the risk of serious heart rhythm disturbances.
Any other medicine containing magnesium or aluminum (such as antacids for indigestion), iron, zinc, or didanosine, or medicines containing sucralfate (used to treat gastrointestinal disorders), may reduce the effect of moxifloxacin tablets. Therefore, take your moxifloxacin tablets at least 6 hours before or after taking these other medicines.
Taking medicinal activated charcoal orally at the same time as Erelan reduces its effect. Therefore, it is recommended not to use these medicines 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 affected 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 medicine.

Do not use Erelan during pregnancy or while breastfeeding.

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

Driving and use of machines

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

Erelan contains lactose monohydrate.

If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Erelan

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

The recommended dose in adults is one 400 mg film-coated tablet once daily.

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

Dose adjustment is not necessary in elderly patients, patients with low body weight, or patients with kidney problems.

The duration of treatment depends on the type of infection.

Unless your doctor has instructed otherwise, the treatment duration with Erelan is as follows:

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

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

Community-acquired lung infections (pneumonia): 7–14 days;

Most pneumonia patients 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 important that you complete the full course of treatment, even if you start to feel better after a few days. If you stop treatment too early, the infection may not be completely cured, it may return or worsen, and bacterial resistance to the antibiotic may develop.

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

If you take more Erelan than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and amount taken.

If you forget to take Erelan

If you miss a dose, take the tablet as soon as you remember 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 stop taking Erelan

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

If you have any further questions 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 everyone experiences them.

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

If you notice:

An abnormally fast heartbeat (rare adverse effect);
A sudden feeling of illness or notice yellowing of the whites of the eyes, dark urine, skin itching, tendency to bleed, or changes in thinking or alertness (these may be signs and symptoms of fulminant hepatitis inflammation which could potentially lead to potentially fatal liver failure (very rare adverse effect; fatal cases have been reported));
Severe skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as red, target-like macules or circular lesions often with blisters in the center, skin peeling, mouth, throat, nose, genital, or eye ulcers, and may be preceded by fever and flu-like symptoms (very rare adverse effects, potentially life-threatening);
A widespread red, scaly rash with bumps under the skin and blisters accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis) (frequency of this adverse effect is "not known");
Generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and involvement of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome) (frequency of this adverse effect is "not known");
Syndrome associated with disturbances in water excretion and low sodium levels (SIADH) (very rare adverse effect);
Loss of consciousness due to severely low blood sugar levels (hypoglycemic coma) (very rare adverse effect);
Inflammation of blood vessels (signs may include red skin spots, usually on the legs, or symptoms such as joint pain) (very rare adverse effect);
Sudden, severe generalized allergic reaction, including very rarely life-threatening shock (e.g., difficulty breathing, drop in blood pressure, rapid pulse) (rare adverse effect);
Swelling, including swelling of the airways (rare adverse effect, potentially fatal);
Seizures (rare adverse effect);
Nervous system problems such as pain, burning, tingling, numbness, and/or weakness in the limbs (rare adverse effect);
Depression (in very rare cases progressing to self-harm, suicidal thoughts/ideation, or suicide attempts) (rare adverse effect);
Psychosis that may lead to self-harming behaviors such as suicidal thoughts or suicide attempts (very rare adverse effect);
Severe diarrhea with blood and/or mucus (antibiotic-associated colitis, including pseudomembranous colitis), which in very rare circumstances may lead to life-threatening complications (rare adverse effect);
Tendon pain and inflammation (tendinitis) (rare adverse effect) or tendon rupture (very rare adverse effect);
Muscle weakness, tenderness, or pain, particularly if you also feel unwell, have fever, or dark urine. These symptoms may be caused by abnormal muscle breakdown that could be life-threatening and lead to kidney problems (a condition called rhabdomyolysis) (frequency of this adverse effect is "not known").

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

Additionally, if you notice:

Temporary loss of vision (very rare adverse effect), contact an ophthalmologist immediately.

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

In very rare cases, symptoms of myasthenia gravis have worsened. If this occurs, consult your doctor immediately.

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

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

The following other adverse effects have been observed during treatment with moxifloxacin, categorized by their frequency:

Frequent (may affect up to 1 in 10 people)

Nausea
Diarrhea
Dizziness
Abdominal and stomach pain
Vomiting
Headache
Increase in a 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 blood potassium levels

Uncommon (may affect up to 1 in 100 people)

Rash
Gastric discomfort (indigestion/heartburn)
Taste disturbance (in very rare cases, loss of taste)
Sleep disorders (mainly insomnia)
Increase in a liver enzyme in the blood (gamma-glutamyl transferase and/or alkaline phosphatase)
Low levels of certain white blood cells (leukocytes, neutrophils)
Constipation
Itching
Dizziness (sensation of spinning or falling)
Drowsiness
Flatulence
Change in heart rhythm (ECG)
Impaired liver function (including increased liver enzymes in blood, LDH)
Decreased appetite and food intake
Low white blood cell count
Discomfort and pain such as back, limb, pelvic, and chest pain
Increase in certain blood cells necessary for blood clotting
Sweating
Increase in certain white blood cells (eosinophils)
Anxiety
Malaise (mainly weakness or fatigue)
Tremors
Joint pain
Palpitations
Irregular and rapid heartbeat
Breathing difficulty including asthmatic states
Increase in a certain digestive enzyme in the blood (amylase)
Restlessness/agitation
Tingling sensation (pins and needles) and/or numbness
Skin hives
Blood vessel dilation
Confusion and disorientation
Decrease in blood cells necessary for blood clotting
Vision disorders, including double and blurred vision
Decreased blood clotting
Increase in blood lipids (fats)
Low red blood cell count
Muscle pain
Allergic reactions
Increased bilirubin in blood
Inflammation of the stomach (gastritis)
Dehydration
Severe disturbances in heart rhythm
Dry skin
Angina pectoris

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 abnormalities (including increased kidney function tests such as urea and creatinine)
Liver inflammation
Mouth inflammation
Ringing or noises in the ears
Jaundice (yellowing of the whites of the eyes or skin)
Skin sensation disturbances
Abnormal dreams
Concentration difficulties
Difficulty swallowing
Smell disturbances (including loss of smell)
Balance disorders and lack of coordination (due to dizziness)
Total or partial memory loss
Hearing impairments including deafness (usually reversible)
Increased uric acid in blood
Emotional instability
Speech disturbances
Fainting
Muscle weakness

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

Joint inflammation
Irregular heartbeat
Increased skin sensitivity to light
Depersonalization disorder (feeling detached from oneself)
Increased blood clotting
Muscle stiffness
Significant decrease in certain white blood cells (agranulocytosis)
Decrease in red blood cells, white blood cells, and platelets (pancytopenia)

Frequency not known (cannot be estimated from available data)

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

Clearly demarcated erythematous patches with or without blisters appearing within hours after administration of moxifloxacin and disappearing with post-inflammatory hyperpigmentation; these typically recur in the same skin or mucosal area upon subsequent exposure to moxifloxacin.

Additionally, very rare cases of the following adverse effects, described after treatment with other quinolone antibiotics, may possibly also occur during treatment with moxifloxacin:

Increased pressure in the skull (symptoms include headache, visual problems such as blurred vision, "blind spots," double vision, vision loss);
Increased blood sodium levels;
Increased blood calcium levels;
Reduced count of a certain type of red blood cells (hemolytic anemia);

Administration of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-term (even months or years) or permanent adverse reactions, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pricking, tingling, "pins and needles," burning, numbness, or pain (neuropathy), fatigue, decreased memory and concentration, mental health effects (which may 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.

Cases of aortic enlargement and weakening or tearing of the aortic wall (aneurysms and dissections), which could lead to rupture and potentially be fatal, and heart valve insufficiency have been reported in patients receiving fluoroquinolones. See also section 2.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, 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 Erelan

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the Sigre Point in your pharmacy. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Erelan

The active substance is moxifloxacin. Each film-coated tablet contains 400 milligrams of moxifloxacin (as hydrochloride).
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).

Appearance of the product and contents of the pack

Film-coated red, oblong convex 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. Pack sizes of 5, 7, 10, 50, 70, 80 or 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and 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

Date of the most recent review of this leaflet: June 2025.

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