MOXIFLOXACIN CINFA 400 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

moxifloxacino cinfa 400 mg film-coated tablets EFG

For use in adults

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 moxifloxacino cinfa and what is it used for
2. What you need to know before taking moxifloxacino cinfa
3. How to take moxifloxacino cinfa
4. Possible side effects
5. Storage of moxifloxacino cinfa
6. Package contents and additional information

1. What is moxifloxacino cinfa and what is it used for

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

moxifloxacino cinfa is indicated in patients 18 years and older for the treatment of the following infections when caused by bacteria, when moxifloxacino is active against such bacteria. moxifloxacino cinfa should only be used to treat such infections when usual antibiotics cannot be used or have not worked:

Sinus infection, sudden worsening of long-term airway inflammation or lung infection (pneumonia) acquired outside the hospital in the community (except severe cases).

Mild or moderate infections of the upper female genital tract (pelvic inflammatory disease), including fallopian tube infection and uterine mucous membrane infection. For this type of infection, moxifloxacino tablets are not sufficient as sole treatment; therefore, in addition to moxifloxacino tablets, your doctor will prescribe another antibiotic for the treatment of mild or moderate infections of the upper female genital tract (see section 2 What you need to know before taking moxifloxacino cinfa: Warnings and precautions).

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: lung infection (pneumonia) acquired outside the hospital, skin and soft tissue infections.

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

2. What you need to know before taking moxifloxacino cinfa

Consult your doctor if you are not sure if you belong to one of the patient groups described below.

Do not take moxifloxacino cinfa

• If you are allergic to moxifloxacino or other quinolones or to any of the other components of this medicine (included in section 6).
• If you are pregnant or breastfeeding.
• If you are under 18 years old.
• If you have a history of tendon disorders or injuries related to treatment with quinolone antibiotics (see sections Warnings and precautionsand 4. Possible side effects).
• If you suffer from any inherited disease or have suffered from any disease related to an abnormal heart rhythm (observed in an electrocardiogram, electrical recording of the heart), suffer from 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 electrocardiogram (ECG) disorders (see section “Other medicines and moxifloxacino cinfa”).

This is because moxifloxacino may 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 suffer from severe liver disease or increased liver enzyme levels (transaminases) 5 times above the upper limit of normal.

Warnings and precautions

Before starting to take this medicine

You should not take antibacterial medicines that contain fluoroquinolones or quinolones, including moxifloxacino, if you have experienced a 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 moxifloxacino cinfa.

• If you are diabeticbecause you may experience a risk of change in blood sugar levels with moxifloxacino.
• If you have ever developed a severe skin rashor skin peeling, blisters, and/or sores in the mouth after taking moxifloxacino.
• 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 blood potassium levels, consult your doctor before taking moxifloxacino, see sections “Do not take moxifloxacino cinfa”and “Other medicines and moxifloxacino cinfa”.
• If you suffer from epilepsyor any other condition that may cause seizures, consult your doctor before taking moxifloxacino.
• If you have or have ever had any mental health problem, consult your doctor before taking moxifloxacino.
• If you have myasthenia gravis, your symptoms may worsen if you take moxifloxacino. If you think this affects you, consult your doctor immediately.
• • If you have been diagnosed with an enlargement 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 in 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 dissection or aneurysms, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., connective tissue disorders such as Marfan syndrome, 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, atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).
• If you or a family member suffers from glucose-6-phosphate dehydrogenase deficiency (a rare inherited disease), inform your doctor; he will indicate if moxifloxacino 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 pelvic abscess), for which your doctor considers intravenous treatment necessary, moxifloxacino tablets are 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 moxifloxacino. If you do not notice an improvement in symptoms after three days of treatment, consult your doctor.

During treatment with moxifloxacino

• If you notice palpitations or irregular heartbeatsduring the treatment period, you should inform your doctor immediately. He may perform an ECG to measure your heart rate.

• The risk of heart problemsmay increase with an increase in dose. Therefore, you should take the recommended dose.
• In rare cases, you may experience a severe allergic reaction(anaphylactic shock) even with the first dose and develop the following symptoms: chest tightness, dizziness, nausea, or fainting, or feel dizzy when standing up. If you experience these symptoms, stop taking moxifloxacino and consult your doctor immediately.
• Moxifloxacino may cause a rapid and severe liver inflammation, which can lead to life-threatening liver failure (including fatal cases, see section 4 “Possible side effects”). Please consult your doctor before continuing treatment if you develop symptoms such as sudden discomfort and/or yellowing of the whites of the eyes, dark urine, skin itching, tendency to bleed, or brain disease caused by liver damage (symptoms of reduced liver function or rapid and severe liver inflammation).

Severe skin reactions

Severe skin reactions have been reported, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), 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/TEN may initially appear on the trunk as reddish targets or circular patches 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.
• AGEP appears at the start of treatment as a red, scaly, and widespread 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) initially appears with flu-like symptoms and a rash on the face, later, a widespread rash appears with high body temperature, increased liver enzyme levels in blood tests, and increased eosinophilia and lymph node enlargement.

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

• Quinolone antibiotics, including moxifloxacino, may cause seizures. If this occurs, treatment with moxifloxacino should be discontinued, and you should contact your doctor immediately.
• Severe, disabling, long-lasting, and potentially irreversible side effects. Antibacterial medicines that contain fluoroquinolones or quinolones, including moxifloxacino, have been associated with very rare but severe side 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 pinching, tingling, prickling, 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 side effects after taking moxifloxacino, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or not, also considering the use of an antibiotic from another class.

• In rare cases, you may experience nerve damage symptoms(neuropathy) such as pain, burning, tingling, numbness, and/or weakness, especially in 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 experience mental 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-harming behaviors, such as attempted suicide (see section 4 “Possible side effects”). If you develop these reactions, you should discontinue treatment with moxifloxacino and inform your doctor immediately.
• You may develop diarrheaduring 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 moxifloxacino 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 tendon inflammation or rupturemay occur (see sections “Do not take moxifloxacino cinfa” and 4 “Possible side effects”). 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 discontinuing treatment with moxifloxacino. At the first sign of pain or tendon inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking moxifloxacino, contact your doctor, and rest the affected area. Avoid any unnecessary exercise, as this could increase the risk of tendon rupture.
• If you feel a strong and sudden pain in the chest, abdomen, or back, which can be symptoms of aortic dissection or aneurysm, go to the emergency room immediately. The risk may increase if you are receiving systemic corticosteroid treatment.
• If you start experiencing sudden 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.
• 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 worsensor if your eyes seem to be affected, consult an ophthalmologist immediately (see sections “Driving and using machines” and 4. “Possible side effects”).
• 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 side effects”). If you have diabetes, your blood sugar levels should be carefully 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 treatment with moxifloxacino (see section 4. Possible side effects).
• 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.

Children and adolescents

Do not give this medicine to children and adolescents under 18 years old because efficacy and safety have not been established for this age group (see section Do not take moxifloxacino cinfa).

Other medicines and moxifloxacino cinfa

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

With moxifloxacino, you should consider the following:

• If you are taking moxifloxacino and other medicines 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 medicines: medicines 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, some antimicrobials (e.g., saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarials, particularly halofantrine), some antihistamines (terfenadine, astemizole, mizolastine), and other medicines (e.g., cisapride, intravenous vincamine, bepridil, and difemanil).
• While taking moxifloxacino, you should inform your doctor if you are taking other medicines that may decrease blood potassium levels (e.g., loop and thiazide diuretics, laxatives, and enemas (high doses) or corticosteroids (anti-inflammatory medicines), amphotericin B) or cause a decrease in heart rate, as these may also increase the risk of severe heart rhythm disorders.
• Any other medicine that contains magnesium or aluminum, such as antacids for indigestion, or any medicine that contains iron or zinc, medicines that contain didanosine, or medicines that contain sucralfate for gastrointestinal disorders may reduce the effect of moxifloxacino tablets. Therefore, take your moxifloxacino tablets 6 hours before or after taking other medicines.
• Taking oral activated charcoal at the same time as moxifloxacino tablets reduces the effect of these tablets. 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 coagulation time.

Taking moxifloxacino cinfa with food and drinks

The effect of moxifloxacino 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 medicine.

Do not use moxifloxacino during pregnancy or while breastfeeding.

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

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.

moxifloxacino cinfa contains sodium.

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

3. How to take moxifloxacino cinfa

Follow the administration instructions of this medicine exactly as 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 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 indicated otherwise, the duration of treatment with moxifloxacino is as follows:

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

When moxifloxacino is used to complete treatment in patients who have shown improvement during initial treatment with moxifloxacino intravenously (infusion solution), the recommended durations are:

• Community-acquired pneumonia: 7-14 days.

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

• Complicated 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.

Moxifloxacino tablets should not be used to initiate treatment for any type of skin and soft tissue infection, as well as in severe cases of community-acquired pneumonia.

It is important that you complete the full 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. What you need to know before taking moxifloxacino cinfa, Warnings and precautions).

If you take more moxifloxacino cinfa than you should

If you take more than one of the recommended tablets per day, consult your doctor immediately and, if possible, take 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 ingested.

If you forget to take moxifloxacino cinfa

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 a double dose to make up for forgotten doses.

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

If you stop taking moxifloxacino cinfa

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 treatment.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most serious side effectsobserved during treatment with moxifloxacino 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 "not known")
• a generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlargement of the 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 "not known")
• 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, low 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 ideas/thoughts, or suicide attempts) (rare side effect)
• madness that can lead to self-harming behaviors, such as suicidal ideas/thoughts or suicide 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)
• 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 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 "not known")

stop taking moxifloxacino and contact your doctor immediatelyas you may need urgent medical attention.

Additionally, if you notice

• transient loss of vision (very rare side effect),
• discomfort or pain in the eyes, especially due to light exposure (very rare to 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), tell your doctor immediately that you have been taking moxifloxacino and do not restart treatment.

It has been observed, in very rare cases, that myasthenia gravis symptoms 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), tell 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:

Common(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 potassium levels in the blood

Uncommon(may affect up to 1 in 100 people)

• rash
• gastric discomfort (indigestion/acid reflux)
• alteration of taste (in very rare cases, loss of taste)
• sleep disorders (predominantly insomnia)
• increase in a 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 that you are going to fall)
• drowsiness
• flatulence
• change in heart rhythm (ECG)
• alteration of liver function (including increase in a liver enzyme in blood, LDH)
• decreased appetite and food intake
• low white blood cell count
• discomfort and pain such as back pain, limb pain, pelvic pain, and chest pain
• increase in certain blood cells necessary for blood clotting
• sweating
• increase in certain white blood cells (eosinophils)
• anxiety
• discomfort (mainly weakness or fatigue)
• tremors
• joint pain
• palpitations
• irregular and rapid heartbeat
• breathing difficulties, including asthmatic conditions
• increase in a certain digestive enzyme in the blood (amylase)
• restlessness/agitation
• tingling sensation (of pins and needles) and/or numbness
• skin rash
• dilation of blood vessels
• confusion and disorientation
• decrease in blood cells necessary for blood clotting
• vision disorders, including double vision and blurred vision
• decrease in blood clotting
• increase in blood lipids (fats)
• low red blood cell count
• muscle pain
• allergic reactions
• increase in bilirubin in the blood
• stomach inflammation (gastritis)
• dehydration
• severe heart rhythm disorders
• dry skin
• chest pain

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

• muscle cramps
• muscle spasms
• hallucinations
• increase in blood pressure
• swelling (of hands, feet, ankles, lips, mouth, and throat)
• decrease in 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 sensitivity
• abnormal dreams
• concentration disorders
• difficulty swallowing
• alterations in smell (including loss of smell)
• balance and coordination disorders (due to dizziness)
• total or partial memory loss
• hearing impairments, including deafness (usually reversible)
• increase in 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)
• increase in blood clotting
• muscle stiffness
• significant decrease in certain white blood cells (agranulocytosis)
• decrease in the number of red and white blood cells and platelets (pancytopenia)

Frequency not known(cannot be estimated from the available data)

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

The administration of antibiotics containing quinolones and fluoroquinolones 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 pinching, 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 ideas), 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.

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 pressure in the skull (symptoms include headache, visual problems such as blurred vision, "blind spots", double vision, loss of vision), increased sodium and calcium levels in the blood, reduced count of a certain type of red blood cell (hemolytic anemia).

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 Medicines and Healthcare Products Agency (AEMPS) https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of moxifloxacino cinfa

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

Do not use this medicine after the expiration date that appears on the blister pack and on the packaging after EXP. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of moxifloxacino cinfa

• The active ingredient is moxifloxacino. Each film-coated tablet contains 400 mg of moxifloxacino (in the form of moxifloxacino hydrochloride, 436.80 mg).
• The other ingredients are:
• • Core of the tablet: microcrystalline cellulose, sodium croscarmellose, povidone, corn starch, colloidal anhydrous silica, magnesium stearate, and hydrogenated ricin oil.
  • Coating: Opadry Y-1-7000 (hypromellose, macrogol 400, titanium dioxide (E-171), and red iron oxide (E-172)).

Appearance of the product and package contents

moxifloxacino cinfa 400 mg film-coated tablets are pink, film-coated, oblong, non-scored, and marked with the code "MXF".

moxifloxacino cinfa 400 mg is available in packs of 5, 7, or 100 (clinical pack) tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of last revision of this leaflet: May 2025

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/77662/P_77662.html

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