Leaflet: information for the user

Moxifloxacino Aurovitas 400 mg film-coated tablets EFG

For use in adults

Read this leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isMoxifloxacino Aurovitasand for what it is used

2. What you need to know before starting to takeMoxifloxacino Aurovitas

3. How to takeMoxifloxacino Aurovitas

4. Possible side effects

5. Storage ofMoxifloxacino Aurovitas

6. Contents of the pack and additional information

Moxifloxacino Aurovitas contains the active ingredient moxifloxacino, which belongs to a group of antibiotics called fluoroquinolonas. Moxifloxacino works by eliminating bacteria that cause infections.

Moxifloxacino is indicated for patients 18 years of age and older for the treatment of the following bacterial infections when caused by bacteria, when moxifloxacino is active against these bacteria. Moxifloxacino 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 (excluding severe cases),
• Mild to moderate upper genital tract infections in females (inflammatory pelvic disease), including fallopian tube infection and uterine mucous membrane infection.

For the latter type of infections, moxifloxacino is not sufficient as a single treatment, so your doctor will need to prescribe another antibiotic for the treatment of upper genital tract infections(see section 2. What you need to know before starting to take Moxifloxacino Aurovitas, Warnings and precautions, Consult your doctor before taking Moxifloxacino Aurovitas).

If the following diseases have shown improvement during initial treatment with moxifloxacino solution for infusion, your doctor may prescribe moxifloxacino tablets to complete the treatment: Community-acquired pneumonia, skin and soft tissue infections.

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

Consult your doctor if you are unsure if you belong to one of the patient groups described below.

Do not take Moxifloxacino Aurovitas:

• If you are allergic to the active ingredient moxifloxacino, to other quinolones or to any of the other components of this medication (including those 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 quinolone treatment (see sectionsAdvertencias and precautionsand4. Possible side effects).
• If you have a hereditary disease or have suffered from a disease related to an abnormal heart rhythm (observed on ECG, heart electrical recording), have electrolyte imbalances in the blood (especially low levels of potassium or magnesium in the blood), have a very slow heart rate (called “bradycardia”), have a weak heart (heart failure), have a history of heart rhythm disorders or are taking other medications that cause ECG disturbances (see sectionOtros medicamentos and Moxifloxacino Aurovitas). This is because moxifloxacino 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 severe liver disease or increased levels of liver enzymes (transaminases) 5 times above the upper limit of normal.

Advertencias and precautions

Before taking this medication

•Do not take antibacterial medications that contain fluoroquinolones or quinolones, including moxifloxacino, if you have experienced a severe adverse 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 Moxifloxacino Aurovitas:

• 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 maymodify your heart ECG, especially if you are a woman or an elderly patient. If you are currently taking anymedication that lowers your potassium levels in the blood, consult your doctor before taking moxifloxacino (see also sectionsNo take Moxifloxacino AurovitasandOtros medicamentos and Moxifloxacino Aurovitas).
• If you suffer fromepilepsyor another condition that may causeseizures, consult your doctor before taking moxifloxacino.
• If you have or have ever had anymental health problems, consult your doctor before taking moxifloxacino.
• If you havemyasthenia gravis, your symptoms may worsen if you take moxifloxacino. If you think this affects you, consult your doctor immediately.
• If you or a family member suffers fromglucose-6-phosphate dehydrogenase deficiency(a rare hereditary disease), inform your doctor, who will indicate if moxifloxacino is suitable for you.
• If you have acomplicated upper genital tract infection in women(associated with a Fallopian tube and ovarian abscess or pelvic abscess), for which your doctor considers intravenous treatment, it is not suitable for treatment with moxifloxacino.
• For the treatment ofmild to moderate upper genital tract infection in women, 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.
• If you have been diagnosed with an enlarged or “bulge” of a large blood vessel (aortic aneurysm or aneurysm of a large peripheral vessel).
• 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 syndrome, Turner syndrome or Sjögren's syndrome (an autoimmune inflammatory disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension or atherosclerosis known, rheumatoid arthritis (a joint disease) or endocarditis (a heart infection)).

During treatment with Moxifloxacino Aurovitas

• If you experience a sudden, severe pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go immediately to an emergency service. You may increase the risk 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 the ankles, feet, or abdomen or the appearance of palpitations (sensation of rapid or irregular heartbeat), inform your doctor immediately.
• If you noticepalpitations or irregular heartbeatduring the treatment period, inform your doctor immediately. This may perform an ECG to measure your heart rate.
• Therisk of heart problemsmay increase with the increase in dose. Therefore, take the recommended dose.
• In rare cases, you may experience asevere, sudden 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.In case of these symptoms, stop taking moxifloxacino and consult your doctor immediately.
• Moxifloxacino may cause arapid and severe inflammation of the liver,which may lead to liver insufficiency that puts your life at risk (including fatal cases, see section4.Possible side effects). Please consult your doctor before continuing treatment if you develop symptoms such as sudden onset of discomfort and/or discomfort associated with yellowing of the white of the eyes, dark urine, itching, bleeding tendency, or liver damage-induced cerebral damage.
• Antibiotics quinolones, including moxifloxacino, may causeseizures. If this occurs, stop taking moxifloxacino and contact your doctor immediately.
• In rare cases, you may experiencenerve damage symptoms (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 moxifloxacino and inform your doctor immediately to prevent the development of a potentially irreversible disorder.
• You may experiencemental health problemseven 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-harm behaviors such as attempted suicide (see section4.Possible side effects). If you develop these reactions, stop taking moxifloxacino and inform your doctor immediately.
• You may developdiarrheaduring 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 moxifloxacino immediately and consult your doctor. In these situations, do not take medications that interrupt or slow down intestinal movement.
• In rare cases, pain and swelling in the joints and inflammation or tendon rupture 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 taking corticosteroids. Tendon inflammation and rupture can occur in the first 48 hours of treatment and even several months after stopping moxifloxacino treatment. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking moxifloxacino, contact your doctor, and keep the painful area at rest. Avoid unnecessary exercise, as this may increase the risk of tendon rupture.
• If you are an elderly person and havekidney problems, be careful to ensure adequate fluid intake, as dehydration may increase the risk of kidney insufficiency.
• If your vision worsens or if your eyes appear to be affected, consult an ophthalmologist immediately (see sections 2.Conducción and use of machinesand4.Possible side effects).

Severe skin reactions

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis (NET), 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, circular patches with central blisters. They may also appear 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 generalized skin peeling and complications that may put your life at risk or be fatal.
• 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: mainly localized in skin folds, trunk, and upper limbs.
• The drug reaction with eosinophilia and systemic symptoms (DRESS) initially appears with flu-like symptoms and a rash on the face, followed by a widespread rash with high body temperature, increased levels of liver enzymes in blood tests, and increased levels of a type of white blood cell (eosinophilia) and enlarged lymph nodes.

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

• Fluoroquinolone antibiotics may cause an increase in your blood sugar levels above normal levels (hyperglycemia), or a decrease in your blood sugar levels below normal levels, which in severe cases may cause loss of consciousness (hypoglycemic coma) (see section 4). This is important for people with diabetes. If you have diabetes, your blood sugar levels should be carefully controlled.
• Quinolone antibiotics may increase thesensitivity of the skin 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 treatment (see section 4. Possible side effects).

The efficacy of moxifloxacino in the treatment of severe burns, deep tissue infections, and diabetic foot infections with osteomyelitis (bone marrow infections) has not been established.

Severe, incapacitating, prolonged, and potentially irreversible effects

Fluoroquinolone or quinolone-containing antibacterial medications, including moxifloxacino, have been associated with rare but severe adverse effects, some of which were of long duration (persistent for months or years), incapacitating, or potentially irreversible. This includes tendon pain, muscle and joint pain in the upper and lower extremities, 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 moxifloxacino, contact your doctor immediately, before continuing treatment. You and your doctor will decide whether to continue or not with the treatment, also considering the use of another class of antibiotic.

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 for this age group (see sectionNo take Moxifloxacino Aurovitas).

Other medications and Moxifloxacino Aurovitas

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

With Moxifloxacino Aurovitas, 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 disorders. 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, sertindol, haloperidol, sulpiride), tricyclic antidepressants, some antimicrobials (e.g., saquinavir, sparfloxacino, erythromycin administered intravenously, pentamidine, antimalarials, particularly halofantrine), some antihistamines (terfenadine, astemizole, mizolastine), and other medications (e.g., cisaprida, vincamine intravenously, bepridil, and difemanil).
• While taking moxifloxacino, inform your doctor if you are taking other medications that may lower your potassium levels in the blood (e.g., 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, or any medication that contains iron or zinc, medications that contain 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.
• Theoral administration of activated charcoal medicinalat the same time as moxifloxacino tablets reduces their action. Therefore, it is recommended not to use these medications simultaneously.
• If you are currently takingoral anticoagulants(e.g., warfarin), your doctor may need to control your blood clotting time.

Taking Moxifloxacino Aurovitas with food, drinks, and alcohol

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

Pregnancy, lactation, and fertility

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

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.

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

Driving and operating machines

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

Moxifloxacino Aurovitas contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially “sodium-free”.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. 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.

Moxifloxacino tablets are for oral administration. Take the tablet whole without chewing (to mask the bitter taste) and with plenty of liquid. Moxifloxacino Aurovitas 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 moxifloxacino 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 mucous membrane infection: 14 days.

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

• Community-acquired pneumonia: 7 – 14 days.

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

• Soft tissue infections: 7 – 21 days.

Most patients with soft tissue infections changed 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 completely 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. What you need to know before starting to take Moxifloxacino Aurovitas, Warnings and Precautions).

If you take more Moxifloxacino Aurovitas than you should

If you take more than the prescribed daily tablet, consult your doctor immediately and, if possible, bring the remaining medication, the packaging, or this leaflet to show 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 Moxifloxacino Aurovitas

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 a double dose to compensate for the missed doses.

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

If you interrupt the treatment with Moxifloxacino Aurovitas

If you interrupt the treatment too soon, your infection may not be completely 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 moxifloxacino are listed below:

If you notice:

• Abnormally fast heart rate (rare side effect).
• You start to feel unwell or notice yellowing of the white of the eyes, dark urine, itching, bleeding tendency, thought disorders or insomnia (these may be signs or symptoms of fulminant liver inflammation with life-threatening liver failure (very rare side effect, fatal cases have been reported)).
• Severe skin eruptions including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as red, target-like 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 bumps 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”).
• SIADH syndrome associated with alterations in water elimination and low sodium levels (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 life-threatening shock (e.g., difficulty breathing, low blood pressure, rapid pulse) (rare side effects).
• Swelling, including possible respiratory tract swelling (rare side effect, potentially life-threatening).
• Seizures (rare side effect).
• Problems associated with the nervous system, such as pain, burning, tingling, numbness, and/or weakness in the extremities (rare side effect).
• Depression (may lead to self-harm, such as suicidal thoughts or attempts) (rare side effect).
• Dementia(may potentially lead to self-harm, such as suicidal thoughts or attempts) (rare side effect).
• Severe diarrhea with blood and/or mucus (antibiotic-associated colitis, including pseudomembranous colitis), which in rare cases may lead to life-threatening complications (rare side effects).
• 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 can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis) (the frequency of this side effect is “unknown”).

Stop taking Moxifloxacino Aurovitas and inform your doctor immediatelysince you need urgent medical attention.

Additionally, if you notice

• Transient loss of vision (very rare side effect),
• Eye discomfort or pain, especially due to exposure to light (side effect from very rare to rare).

Contact your ophthalmologist immediately.

If you have experienced irregular heart rate that may be life-threatening (Torsade de Pointes) or cardiac arrest while taking Moxifloxacino Aurovitas (very rare side effects),inform your doctor immediately that you have taken Moxifloxacino Aurovitas and do not resume treatment.

In rare cases, worsening of myasthenia gravis symptoms has been observed. If this occurs,consult your doctor immediately.

If you have diabetes and notice that your blood glucose levels are increased or decreased (rare or very rare side effect),inform your doctor immediately.

If you are an elderly patient with kidney problems and notice a decrease in urine production, leg, ankle, or foot inflammation, fatigue, nausea, drowsiness, difficulty breathing, or confusion (these may be signs or symptoms of kidney failure, a rare side effect),consult your doctor immediately.

Other side effects observed during treatment with moxifloxacino are listed below in order of their probability:

Frequent(may affect up to 1 in 10 people):

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

Rare(may affect up to 1 in 100 people):

• Rash.
• Indigestion/heartburn.
• Alteration of taste (in rare cases, loss of taste).
• Sleep disturbances (mainly insomnia).
• Increased levels of specific liver enzymes in the blood (gamma-glutamyltransferase and/or alkaline phosphatase).
• Low levels of certain white blood cells (leukocytes, neutrophils).
• Constipation.
• Itching.
• Dizziness (sensation of spinning or falling).
• Drowsiness.
• Flatulence.
• Changes in heart rhythm (ECG).
• Alteration of liver function (including increased levels of a liver enzyme in the blood (LDH)).
• Decreased appetite or food intake.
• Low white blood cell count.
• Back, chest, pelvis, and limb pain.
• Increased levels of certain blood cells necessary for blood coagulation.
• Sweating.
• Increased levels of certain white blood cells (eosinophils).
• Anxiety.
• Uncomfortable feeling (mainly weakness or fatigue).
• Agitation.
• Joint pain.
• Palpitations.
• Irregular or rapid heart rate.
• Difficulty breathing, including asthma-like states.
• Increased levels of certain digestive enzymes in the blood (amylase).
• Restlessness/agitation.
• Sensation of pins and needles and/or numbness.
• Urticaria.
• vasodilation.
• Confusion and disorientation.
• Decreased levels of certain blood cells necessary for blood coagulation.
• Eye disorders, including double vision and blurred vision.
• Decreased blood coagulation.
• Increased levels of fats in the blood (lipids).
• Low red blood cell count.
• Muscle pain.
• Allergic reactions.
• Increased levels of bilirubin in the blood.
• Stomach inflammation.
• Dehydration.
• Severe changes in heart rhythm.
• Dry skin.
• Angina pectoris.

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

• Muscle contracture.
• Muscle cramp.
• Hallucinations.
• Hypertension.
• Swelling (of hands, feet, ankles, lips, mouth, throat).
• Hypotension.
• Renal alterations (including increased results in laboratory tests for the kidneys, such as urea and creatinine).
• Hepatitis.
• Oral inflammation.
• Tinnitus.
• Icterus (yellowing of the white of the eyes or skin).
• Disorder of skin sensation.
• Anomalous dreams.
• Concentration disorders.
• Difficulty swallowing.
• Alteration of smell (including loss of smell).
• Balance and coordination disorders (due to dizziness).
• Partial or total loss of memory.
• Defective hearing, including deafness (usually reversible).
• Increased levels of uric acid in the blood.
• Emotional instability.
• Alteration of speech.
• Loss of consciousness.
• Muscle weakness.

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

• Arthritis.
• Abnormal heart rhythm.
• Increased skin sensitivity.
• Feeling of loss of personality (not being 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 demarcated, red patches with or 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 mucous area with subsequent exposure to moxifloxacino.

Additionally, rare cases of the following side effects have been reported, described 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 levels of sodium and calcium in the blood, a special type of reduced red blood cell count (hemolytic anemia).

The administration of quinolone-containing antibiotics and fluoroquinolones has been associated with rare cases of long-lasting or permanent adverse reactions (including months or years), such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pinpricks, numbness, tingling, burning, or pain (neuropathy), depression, fatigue, sleep disturbances, decreased memory, and decreased hearing, vision, taste, and smell, 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) have been reported, which could lead to rupture and be fatal, and heart valve insufficiency in patients who have received fluoroquinolones. See also section 2.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require special storage conditions.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition ofMoxifloxacino Aurovitas

• The active ingredient is moxifloxacino. Each film-coated tablet contains 436.32 mg of moxifloxacino hydrochloride, equivalent to 400 mg of moxifloxacino.
• The other components are:

Tablet core: Microcrystalline cellulose, sodium carboxymethyl starch (type A) (derived from potato starch), povidone (K-30), and magnesium stearate.

Coating: Hypromellose, titanium dioxide (E-171), macrogol 4000, and iron oxide red (E-172).

Appearance of the product and contents of the package

Film-coated tablets of pale red color, elongated shape, marked with “E 18” on one side and smooth on the other.

Moxifloxacino film-coated tablets are available in blister packs.

Package sizes: 5, 7, 10, and 50 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicine is authorized in the member states of the European Economic Area with the following names:

Bélgica:Moxifloxacin AB 400 mg filmomhulde tabletten

Spain:Moxifloxacino Aurovitas 400 mg film-coated tablets EFG

Netherlands:Moxifloxican Aurobindo400 mg, filmomhulde tabletten

Poland:MoxifloxacinAurovitas

Portugal:MoxifloxacinaAurovitas

Czech Republic:MoxifloxacinAurovitas 400 mg potahované tablety

Last review date of this leaflet: May 2024

More detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es)