Package Leaflet: Information for the User

moxifloxacino cinfa 400 mg film-coated tablets

For use in adults

Read this leaflet carefully before you start to take 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. Do 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.

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

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

Paranasal sinus infection, sudden worsening of chronic inflammation of the airways or community-acquired pneumonia (except severe cases).

Mild to moderate upper genital tract infections in females (inflammatory pelvic disease), including fallopian tube infection and uterine mucous membrane infection. For this type of infection, moxifloxacino tablets are not sufficient as a single treatment, so your doctor will also prescribe another antibiotic for the treatment of mild to moderate upper genital tract infections in females (see section 2 What you need to know before starting to take 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: community-acquired pneumonia, skin and soft tissue infections.

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

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

Do not take moxifloxacino cinfa

• If you are allergic to moxifloxacino or to other quinolones or to any of the other components of this medication (including 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 tendonitis related to the treatment with quinolone antibiotics (see sectionsWarnings and precautionsand 4.Adverse reactions).
• If you have a hereditary disease or have suffered from a disease related to an abnormal heart rhythm (observed in electrocardiogram, 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 section“Other medications and moxifloxacino cinfa”).

This is because moxifloxacino may cause changes in the ECG, such as a prolongation of the QT interval, that is, a delay in the conduction of electrical signals in the heart.

• If you have a severe liver disease or increased levels of liver enzymes (transaminases) 5 times above the upper limit of normal.

Warnings and precautions

Before starting to take this medication

Do not take fluoroquinolone or quinolone antibiotics, including moxifloxacino, if you have had a severe reaction to a quinolone or fluoroquinolone in the past. If this is your case, inform your doctor as soon as possible.

Consult your doctor or pharmacist before starting to take moxifloxacino cinfa.

• If you arediabeticbecause you may experience a risk of changes in blood sugar levels with moxifloxacino.
• If you have ever developed asevere skin rashor skin peeling, blisters, and/or mouth sores after taking moxifloxacino.
• Moxifloxacinomay modify the ECG of the heart, especially if you are a woman or an elderly patient. If you are currently taking anymedication that causes a decrease in blood potassium levels, consult your doctor before taking moxifloxacino (see sections “Do not take moxifloxacino cinfa”and “Other medications and moxifloxacino cinfa”).
• 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 have been diagnosed with alarge blood vessel aneurysm(aortic aneurysm or large peripheral vessel aneurysm).
  • If you have had a previous episode ofaortic dissection(tear in the aortic wall).
  • If you have been diagnosed with heart valve insufficiency (valve regurgitation).
  • If you have a family history ofaortic dissection or aneurysm, congenital heart valve disease, or other risk factors or conditions (e.g., 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, hypertension, known atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).
• If you or a family member has glucose-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(e.g. associated with a fallopian tube and ovarian abscess or pelvic abscess), for which your doctor considers intravenous treatment necessary, oral treatment with moxifloxacino is not appropriate.
• For the treatment of amild 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.

During treatment with moxifloxacino

• If you noticepalpitations or irregular heartbeatsduring the treatment period, you must inform your doctor immediately. Your doctor may perform an ECG to measure your heart rate.

• Therisk of heart problemsmay increase with increasing doses. Therefore, take the recommended dose.
• In rare cases, you may experience asevere 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 failure that puts your life at risk (including fatal cases, see section 4“Adverse reactions”). Please consult your doctor before continuing treatment if you develop symptoms such as sudden discomfort and/or discomfort associated with yellowing of the whites of the eyes, dark urine, itching, bleeding tendency, or liver damage-induced cerebral disease (symptoms of reduced liver function or rapid and severe liver inflammation).

Severe skin reactions

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

• SSJ/TEN may initially appear on the trunk as red, target-shaped spots or circular patches often with central blisters. They may also appear ulcers in the mouth, throat, nose, genitals, and eyes (red and swollen eyes). These severe skin eruptions often precede fever and/or flu-like symptoms. The eruptions may progress to generalized skin peeling and complications that may put your life at risk or be fatal.
• GAP 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.
• 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 medical attention immediately.

• Quinolone antibiotics, including moxifloxacino, may causeseizures. If this occurs, treatment with moxifloxacino must be stopped and you must contact your doctor immediately.
• Severe, prolonged, and potentially irreversible adverse effects.Fluoroquinolone or quinolone antibiotics, 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 pain, and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pins and needles, numbness, tingling, 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 type of antibiotic.

• In rare cases, you may experiencenerve damage symptoms(neuropathy) such as pain, burning, numbness, tingling, 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 section 4 “Adverse reactions”). If you develop these reactions, treatment with moxifloxacino must be stopped and you must 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 slow down or stop intestinal movement.
• In rare cases, you may experiencejoint pain and swelling, inflammation, or tendon rupture(see sections “Do not take moxifloxacino cinfa”and 4 “Adverse reactions”).The risk is higher if you are an elderly patient (over 60 years old), have received an organ transplant, have kidney problems, or are taking corticosteroids. Tendon inflammation and rupture can occur in the first 48 hours of treatment and even several months after stopping 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 any unnecessary exercise, as this may increase the risk of tendon rupture.
• If you experience asevere and sudden pain in the chest, abdomen, or back, which may be symptoms of aortic dissection or aneurysm,go to the emergency room immediately.The risk may increase if you are receiving systemic corticosteroids.
• If you start experiencing a sudden onset of shortness of breath, especially when lying down, or if you notice swelling in the ankles, feet, or abdomen, or palpitations (feeling of rapid or irregular heartbeat), inform your doctor immediately.
• If you are an elderly patient and havekidney problems, be careful to ensure adequate fluid intake, as dehydration may increase the risk of kidney failure.
• If yourvision worsensor if your eyes appear to be affected, consult an ophthalmologist immediately (see sections “Driving and operating machinery”and 4 “Adverse reactions””).
• Fluoroquinolones may cause an increase in your blood sugar levels above normal levels (hyperglycemia), or a decrease in your blood sugar levels below normal levels (hypoglycemia), which in severe cases may cause a loss of consciousness (hypoglycemic coma) (see section 4 “Adverse reactions””). If you have diabetes, your blood sugar levels must be carefully controlled.
• Quinolone antibioticsmay increase the skin's sensitivity to sunlight or UV. You must avoid prolonged exposure to sunlight or direct sunlight and not use sunbeds or any type of UV lamp during moxifloxacino treatment (see section 4 “Adverse reactions””).
• The efficacy of moxifloxacinosolution for infusionhas not been established in the treatment of severe burns, deep tissue infections, or diabetic foot infections with osteomyelitis (bone marrow infections).

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 sectionDo not take moxifloxacino cinfa).

Other medications and moxifloxacino cinfa

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

With moxifloxacino, 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, sertindole, haloperidol, sulpiride), tricyclic antidepressants, some antimicrobials (e.g., saquinavir, sparfloxacin, erythromycin administered intravenously, pentamidine, antimalarials, particularly halofantrine), some antihistamines (terfenadine, astemizole, mizolastine), and other medications (e.g., cisapride, vincamine intravenously, bepridil, and difemanil).
• While taking moxifloxacino, inform your doctor if you are taking other medications that may decrease blood potassium levels(e.g. diuretics and thiazide type, 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 othermedication that contains magnesium or aluminum, such as antacids for indigestion, or anymedication that contains iron or zinc,medications that contain didanosine or medications that contain sucralfate for gastrointestinal disordersmay reduce the action of moxifloxacino tablets. Therefore, take your moxifloxacino tablets 6 hours before or after taking other medications.
• The oral administration ofactivated charcoalat 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 monitor your blood clotting 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, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

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

Driving and operating machinery

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

moxifloxacino cinfa contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it 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 can be taken with or without food. It is recommended to take the tablet approximately at the same time every day.

No adjustment of the dose 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 (including chronic obstructive pulmonary disease): 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 is used to complete treatment in patients who have shown improvement during initial treatment with intravenous 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.

• Complicated skin and soft tissue infections: 7-21 days.

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

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

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, 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 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, bring the remaining medication, the packaging, or this leaflet to the doctor or pharmacist.

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 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 cinfa

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 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.

Themost 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 discoloration of the whites of the eyes, dark urine, itching, a tendency to bleed, or alterations in thought or state of consciousness (these may be signs and symptoms of a fulminant liver inflammation that may potentially lead to potentially fatal liver failure (very rare side effect, fatal cases have been observed))
• severe skin eruptions including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as red macules in the shape of a target or circular patches often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, and may be preceded by fever and flu-like symptoms (very rare side effects, potentially life-threatening)
• a red, scaly, and generalized rash with protuberances under the skin and blisters accompanied by fever at the beginning 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), enlargement of lymph nodes, and involvement of other body 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”)
• 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 may be red patches on the skin, usually on the legs or effects such as joint pain)

• severe allergic reaction, sudden, and generalized, including very rarely shock that puts your life at risk (e.g. difficulty breathing, drop in blood pressure, rapid pulse) (rare side effect)

• swelling, including swelling of the airways (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 limbs (rare side effect)
• depression (in very rare cases, they have evolved into self-harm, suicidal thoughts, or attempts at suicide) (rare side effect)
• mania that can lead to self-harming behaviors, such as suicidal thoughts or attempts at suicide) (very rare side effect)
• severe diarrhea with blood and/or mucus (antibiotic-associated colitis, including pseudomembranous colitis) that, in very rare cases, may lead to life-threatening complications (rare side effect)
• tendon pain and inflammation (tendinitis) (rare side effect) or tendon rupture (very rare side effect)
• muscle weakness, sensitivity, or pain, particularly if you also feel unwell, have a fever, or your urine is dark. These symptoms may be caused by abnormal muscle breakdown that may put your life at risk and lead to kidney problems (a condition called rhabdomyolysis) (the frequency of this side effect is "unknown")

Stop taking moxifloxacino and contact your doctor immediatelyas you may need urgent medical help.

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 an ophthalmologist immediately.

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

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

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

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

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

Frequent(may affect up to 1 in 10 people)

• nausea
• diarrhea
• dizziness
• abdominal and stomach pain
• vomiting
• headache
• increase in a liver enzyme in the blood (transaminases)
• infections caused by bacteria that are resistant or fungi, e.g. oral and vaginal infections caused byCandida.
• change in heart rhythm (ECG), in patients with low potassium levels in the blood

Rare(may affect up to 1 in 100 people)

• rash
• gastrointestinal upset (indigestion/heartburn)
• alteration of taste (in very rare cases, loss of taste)
• sleep disturbances (predominantly 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
• sensation of vertigo (feeling that everything is spinning and falling)
• drowsiness
• flatulence
• change in heart rhythm (ECG)
• alteration of liver function (including increase in a liver enzyme in the 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 coagulation
• sweating
• increase in certain white blood cells (eosinophils)
• anxiety
• discomfort (mainly weakness or fatigue)
• tremors
• joint pain
• palpitations
• irregular and rapid heart rate
• difficulty breathing, including asthma-like states
• increase in a certain digestive enzyme in the blood (amylase)
• restlessness/agitation
• sensation of pins and needles and/or numbness
• skin rashes
• dilation of blood vessels
• confusion and disorientation
• decrease in blood cells necessary for blood coagulation
• vision disturbances, including double vision and blurred vision
• decrease in blood coagulation
• increase in blood lipids (fats)
• low red blood cell count
• muscle pain
• allergic reactions
• increase in bilirubin in the blood
• inflammation of the stomach (gastritis)
• dehydration
• severe alterations in heart rhythm
• dry skin
• angina pectoris

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

• muscle cramps
• muscle contractions
• hallucinations
• increase in blood pressure
• swelling (of hands, feet, ankles, lips, mouth, and throat)
• decrease in blood pressure
• kidney function alterations (including increase in kidney function tests, such as urea and creatinine)
• inflammation of the liver
• inflammation of the mouth
• ringing in the ears
• jaundice (yellowish discoloration of the whites of the eyes or skin)
• skin sensitivity alterations
• abnormal dreams
• concentration disturbances
• difficulty swallowing
• alterations in the sense of smell (including loss of smell)
• balance and coordination disturbances (due to dizziness)
• total or partial loss of memory
• hearing loss (usually reversible)
• increase in uric acid in the blood
• emotional instability
• alteration of speech
• syncope
• muscle weakness

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

• inflammation of joints
• irregular heart rhythm
• increase in skin sensitivity
• disorder of depersonalization (feeling that one is not oneself)
• increase in blood coagulation
• muscle rigidity
• 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)

• increase in skin sensitivity to sunlight or UV radiation (see also section 2, Warnings and precautions)
• clearly demarcated erythematous patches with/without blisters that appear in the hours following administration of moxifloxacino and disappear with residual post-inflammatory hyperpigmentation; they usually reappear in the same skin or mucous area with subsequent exposure to moxifloxacino

The administration of quinolone and fluoroquinolone antibiotics has been associated with very rare cases of long-lasting or permanent adverse reactions (even months or years) or permanent, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pinpricks, tingling, itching, burning, numbness, 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) that could lead to rupture and be fatal, and heart valve insufficiency in patients who have received fluoroquinolones have been reported. See also section 2.

In addition, very rare cases of the following adverse effects have been reported, described after treatment with other quinolone antibiotics and that may also occur during treatment with moxifloxacino: increased intracranial pressure (the symptoms includeheadache, visual disturbances 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 cells (hemolytic anemia).

Reporting of adverse effects

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

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

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

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Moxifloxacin cinfa composition

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

Appearance of the product and content of the packaging

moxifloxacino cinfa 400 mg film-coated tablets are pink, film-coated, oval, unnotched, and marked with the code “MXF”.

moxifloxacino cinfa 400 mg are presented in packaging of 5, 7, or 100 (clinical packaging) tablets.

Only some packaging sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet: April 2024

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/

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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