Moxifloxacin CINFA 400 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

moxifloxacin cinfa 400 mg film-coated tablets EFG

For use in adults

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

Leaflet contents

1. What moxifloxacin cinfa is and what it is used for
2. What you need to know before taking moxifloxacin cinfa
3. How to take moxifloxacin cinfa
4. Possible adverse effects
5. How to store moxifloxacin cinfa
6. Contents of the pack and other information

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

moxifloxacino cinfa contains moxifloxacin as the active substance, which belongs to a group of antibiotics called fluoroquinolones. Moxifloxacin works by killing bacteria that cause infections.

Moxifloxacino Cinfa is indicated in patients aged 18 years and older for the treatment of the following infections when caused by bacteria known to be susceptible to moxifloxacin. Moxifloxacino Cinfa should only be used to treat such infections when commonly recommended antibiotics cannot be used or have not been effective:

• Acute bacterial sinusitis, acute exacerbation of chronic bronchitis, or community-acquired pneumonia (excluding severe cases).

• Mild to moderate infections of the female upper genital tract (pelvic inflammatory disease), including infection of the fallopian tubes (salpingitis) and infection of the uterine mucosal membrane (endometritis). For this type of infection, Moxifloxacino tablets alone are not sufficient as monotherapy; therefore, in addition to Moxifloxacino tablets, your doctor must prescribe another antibiotic for the treatment of mild to moderate female upper genital tract infections (see section 2, What you need to know before taking Moxifloxacino Cinfa: Warnings and precautions).

If the following conditions have shown improvement during initial treatment with moxifloxacin infusion solution, your doctor may prescribe Moxifloxacino tablets to complete the course of treatment: community-acquired pneumonia, skin and soft tissue infections.

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

2. What you need to know before taking moxifloxacino cinfa

Consult your doctor if you are unsure whether you belong to any 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 ingredients of this medicine (listed in section 6).
• If you are pregnant or breastfeeding.
• If you are under 18 years of age.
• If you have a history of tendon disorders or tendon injuries related to treatment with quinolone antibiotics (see sections Warnings and precautions and 4. Possible side effects).
• If you have a hereditary condition or have suffered from a disease associated with abnormal heart rhythm (as seen on electrocardiogram, the heart's electrical recording), have electrolyte imbalances (especially low potassium or magnesium levels in blood), have a very slow heart rate (called “bradycardia”), have a weak heart (heart failure), have a history of heart rhythm disturbances, or are taking other medications that cause changes in the electrocardiogram (ECG) (see section “Other medicines and moxifloxacino cinfa”).

This is because moxifloxacino may cause changes in the ECG, such as QT interval prolongation, meaning delayed electrical signal conduction in the heart.

• If you have severe liver disease or if your liver enzyme levels (transaminases) increase to more than 5 times the upper limit of normal.

Warnings and precautions

Before starting this medicine

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

Consult your doctor or pharmacist before starting moxifloxacino cinfa.

• If you are diabetic, because you may be at risk of changes in blood sugar levels with moxifloxacino.
• If you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking moxifloxacino.
• Moxifloxacino may alter the heart ECG, especially if you are female or elderly. If you are currently taking any medication that causes low potassium levels in blood, consult your doctor before taking moxifloxacino; see sections “Do not take moxifloxacino cinfa” and “Other medicines and moxifloxacino cinfa”.
• If you suffer from epilepsy or any other condition that may cause seizures, consult your doctor before taking moxifloxacino.
• If you have or have ever had any mental health condition, consult your doctor before taking moxifloxacino.
• If you have myasthenia gravis, your symptoms may worsen if you take moxifloxacino. If you think this applies to you, consult your doctor immediately.
  • If you have been diagnosed with enlargement or a “bulge” in a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm).
  • If you have previously experienced an episode of aortic dissection (tear in the wall of the aorta).
  • If you have been diagnosed with heart valve insufficiency (cardiac valve regurgitation).
  • If you have a family history of aortic dissection or aneurysm, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., connective tissue disorders such as Marfan syndrome, vascular 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, high blood pressure, known atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).
• If you or a family member have glucose-6-phosphate dehydrogenase deficiency (a rare inherited disorder), inform your doctor, who will determine whether moxifloxacino is suitable for you.
• If you have a complicated upper female genital tract infection (e.g., associated with a tubo-ovarian or pelvic abscess), for which your doctor considers intravenous treatment necessary, treatment with moxifloxacino tablets is not appropriate.
• For the treatment of a mild to moderate upper female genital tract infection, your doctor should prescribe another antibiotic in combination with moxifloxacino. If you do not notice symptom improvement within three days of treatment, consult your doctor.

During treatment with moxifloxacino

• If you experience palpitations or irregular heartbeat during treatment, inform your doctor immediately. Your doctor may perform an ECG to assess your heart rhythm.

• The risk of heart problems may increase with higher doses. Therefore, you must take the recommended dose.

• Rarely, you may experience a sudden, severe allergic reaction (anaphylactic reaction or shock), even after the first dose, with symptoms such as chest tightness, dizziness, nausea, fainting, or vertigo upon standing. If these symptoms occur, stop taking moxifloxacino and consult your doctor immediately.

• Moxifloxacino may cause 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 malaise and/or malaise associated with yellowing of the whites of the eyes, dark urine, skin itching, increased tendency to bleed, or brain dysfunction due to liver damage (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), acute generalized exanthematous pustulosis (AGEP), and drug reaction with eosinophilia and systemic symptoms (DRESS syndrome or drug hypersensitivity syndrome) have been reported with moxifloxacino use.

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

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

• Quinolone antibiotics, including moxifloxacino, may cause seizures. If this occurs, treatment with moxifloxacino must be stopped and you should contact your doctor immediately.
• Severe, disabling, long-lasting, and potentially irreversible adverse effects. Antibacterial medicines containing fluoroquinolones or quinolones, including moxifloxacino, have been associated with very rare but serious adverse effects, some of which are long-lasting (persisting for months or years), disabling, or potentially irreversible. These include tendon, muscle, and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, numbness, or burning (paresthesia), sensory disturbances such as decreased vision, taste, smell, or hearing, depression, memory loss, severe fatigue, and serious 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 treatment, possibly considering the use of an antibiotic from another class.

• Rarely, you may experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness, and/or weakness, especially in feet and legs or hands and arms. If this occurs, stop taking moxifloxacino and inform your doctor immediately to prevent potentially irreversible damage.
• You may experience mental health problems even after the first dose of quinolone antibiotics, including moxifloxacino. In very rare cases, mental health issues and depression have progressed to suicidal thoughts and self-harming behaviors such as suicide attempts (see section 4 “Possible side effects”). If you develop these reactions, treatment with moxifloxacino must be stopped and you should inform your doctor immediately.
• You may develop diarrhea during or after taking antibiotics, including moxifloxacino. If 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 stop or slow intestinal movement.
• Rarely, joint pain and swelling, and tendon inflammation or rupture may occur (see sections “Do not take moxifloxacino cinfa” and 4 “Possible side effects”). The risk is higher if you are elderly (over 60 years), have had an organ transplant, have kidney problems, or are taking corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment or even several months after stopping moxifloxacino. At the first sign of tendon pain or swelling (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking moxifloxacino, contact your doctor, and rest the affected area. Avoid unnecessary physical activity, as this may increase the risk of tendon rupture.
• If you experience sudden, severe chest, abdominal, or back pain, which may be symptoms of aortic dissection or aneurysm, go immediately to an emergency department. The risk may increase if you are receiving systemic corticosteroid treatment.
• If you develop sudden shortness of breath, especially when lying down, or notice swelling in your ankles, feet, or abdomen, or the onset of palpitations (sensation of rapid or irregular heartbeat), inform your doctor immediately.
• If you are elderly and have kidney problems, ensure adequate fluid intake, as dehydration may increase the risk of kidney failure.
• If your vision worsens or your eyes appear affected, consult an ophthalmologist immediately (see sections “Driving and use of machines” and 4. “Possible side effects”).
• Fluoroquinolones may cause an increase in blood sugar levels above normal (hyperglycemia), or a decrease in blood sugar levels below normal (hypoglycemia), which in severe cases may lead to loss of consciousness (hypoglycemic coma) (see section 4. “Possible side effects”). If you have diabetes, your blood sugar levels should be closely monitored.
• Quinolone antibiotics may increase skin sensitivity to sunlight or UV light. Avoid prolonged exposure to sunlight or direct sunlight and do not use sunbeds or any type of UV lamp during moxifloxacino treatment (see section 4. Possible side effects).
• The efficacy of moxifloxacino infusion solution in treating severe burns, deep tissue infections, and diabetic foot infections with osteomyelitis (bone marrow infection) has not been established.

Children and adolescents

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

Other medicines and moxifloxacino cinfa

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

With moxifloxacino, consider the following:

• If you are taking moxifloxacino and other medicines that affect the heart, there is an increased risk of heart rhythm disturbances. Therefore, do not take moxifloxacino at the same time as the following medicines: medicines belonging 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 difemethilene).
• While taking moxifloxacino, inform your doctor if you are taking other medicines that may reduce potassium levels in blood (e.g., loop and thiazide diuretics, laxatives and enemas (high doses), or corticosteroids (anti-inflammatory medicines), amphotericin B) or that may reduce heart rate, as these may also increase the risk of serious heart rhythm disturbances.
• Any other medicine containing magnesium or aluminum, such as antacids for indigestion, or any medicine containing iron or zinc, medicines containing didanosine, or medicines containing sucralfate for gastrointestinal disorders may reduce the effect of moxifloxacino tablets. Therefore, take your moxifloxacino tablets 6 hours before or after taking these other medicines.
• Taking medicinal activated charcoal orally at the same time as moxifloxacino tablets reduces their effect. Therefore, it is recommended not to take these medicines simultaneously.
• If you are currently taking oral 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 affected by food, including dairy products.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not use moxifloxacino during pregnancy or while breastfeeding.

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

Driving and use of machines

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

moxifloxacino cinfa contains sodium.

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

3. How to take moxifloxacin cinfa

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

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

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

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

The duration of treatment depends on the type of infection. Unless your doctor has instructed otherwise, the treatment duration with moxifloxacin is as follows:

• Acute exacerbation of chronic bronchitis (acute exacerbation of chronic obstructive pulmonary disease, including bronchitis): 5 – 10 days.
• Community-acquired lung infections (pneumonia), except in severe cases: 10 days.
• Acute bacterial sinus infections (acute bacterial sinusitis): 7 days.
• Mild to moderate upper female genital tract infections (pelvic inflammatory disease), including fallopian tube infection and endometrial mucosal infection: 14 days.

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

• Community-acquired pneumonia: 7–14 days.
  Most patients with pneumonia switch from intravenous to oral therapy after 4 days.

• Complicated skin and soft tissue infections: 7–21 days.
  Most patients with skin and soft tissue infections switch from intravenous to oral therapy after 6 days.

Moxifloxacin tablets must not be used to initiate treatment for any type of skin and soft tissue infection, nor for severe cases of community-acquired pneumonia.

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

Do not exceed the recommended dose or treatment duration (see section 2. What you need to know before taking moxifloxacin cinfa, Warnings and precautions).

If you take more moxifloxacin cinfa than you should

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

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

If you forget to take moxifloxacin cinfa

If you miss a dose, take the tablet as soon as you remember on the same day. If you do not take your tablet one day, take the normal dose (one tablet) the next day. Do not take a double dose to make up for a missed dose.

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

If you stop taking moxifloxacin 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 course of treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

If you notice

• abnormally fast heartbeat (rare adverse effect)

• a sudden feeling of illness or notice yellowing of the whites of the eyes, dark urine, itchy skin, tendency to bleed, or disturbances in thinking or level of consciousness (these may be signs and symptoms of fulminant hepatitis that could potentially lead to potentially fatal liver failure) (very rare adverse effect; fatal cases have been reported)

• severe skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as red, target-like macules or circular spots, often with blisters in the center, skin peeling, mouth, throat, nose, genital, or eye ulcers, and may be preceded by fever and flu-like symptoms (very rare adverse effects, potentially life-threatening)

• a widespread red, scaly rash with bumps under the skin and blisters accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis) (frequency of this adverse effect is "not known")

• widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and involvement of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome) (frequency of this adverse effect is "not known")

• syndrome associated with impaired water excretion and low sodium levels (SIADH) (very rare adverse effect)

• loss of consciousness due to severely low blood sugar levels (hypoglycemic coma) (very rare adverse effect)

• inflammation of blood vessels (signs may include red skin spots, usually on the legs, or joint pain) (very rare adverse effect)

• sudden, severe, generalized allergic reaction, including very rarely life-threatening shock (e.g. difficulty breathing, drop in blood pressure, rapid pulse) (rare adverse effect)

• swelling, including swelling of the airways (rare adverse effect, potentially fatal)

• seizures (rare adverse effect)

• nervous system problems such as pain, burning, tingling, numbness, and/or weakness in the limbs (rare adverse effect)

• depression (in very rare cases, this has progressed to self-harm, suicidal thoughts/ideation, or suicide attempts) (rare adverse effect)

• psychosis that may lead to self-harming behaviors such as suicidal thoughts or suicide attempts (very rare adverse effect)

• severe diarrhea with blood and/or mucus (antibiotic-associated colitis, including pseudomembranous colitis), which in very rare circumstances may lead to life-threatening complications (rare adverse effect)

• tendon pain and inflammation (tendinitis) (rare adverse effect) or tendon rupture (very rare adverse effect)

• muscle weakness, tenderness, or pain, particularly if accompanied by malaise, fever, or dark urine. These symptoms may be caused by abnormal muscle breakdown that could be life-threatening and lead to kidney problems (a condition called rhabdomyolysis) (frequency of this adverse effect is "not known")

Stop taking moxifloxacin and contact your doctor immediately, as you may require urgent medical attention.

Additionally, if you notice

• transient loss of vision (very rare adverse effect),
• eye discomfort or pain, especially due to light exposure (adverse effect ranging from very rare to rare),

contact an ophthalmologist immediately.

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

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

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

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

The following is a list of other adverse effects observed during treatment with moxifloxacin, categorized by frequency:

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 blood potassium levels

Uncommon (may affect up to 1 in 100 people)

• rash
• gastric discomfort (indigestion/heartburn)
• taste disturbance (in very rare cases, loss of taste)
• sleep disorders (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
• sensation of vertigo (spinning sensation and feeling of falling)
• drowsiness
• flatulence
• change in heart rhythm (ECG)
• impaired 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, limb, pelvic, and chest pain
• increase in certain blood cells necessary for blood clotting
• sweating
• increase in certain white blood cells (eosinophils)
• anxiety
• malaise (mainly weakness or fatigue)
• tremors
• joint pain
• palpitations
• irregular and rapid heartbeat
• breathing difficulty including asthmatic states
• increase in a specific digestive enzyme in blood (amylase)
• restlessness/agitation
• tingling sensation (pins and needles) and/or numbness
• skin hives
• dilation of blood vessels
• confusion and disorientation
• decrease in blood cells necessary for blood clotting
• visual disturbances, including double and blurred vision
• decreased blood clotting
• increase in blood lipids (fats)
• low red blood cell count
• muscle pain
• allergic reactions
• increased bilirubin in blood
• stomach inflammation (gastritis)
• dehydration
• severe disturbances in heart rhythm
• dry skin
• angina pectoris

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

• muscle cramps
• muscle spasms
• hallucinations
• increased blood pressure
• swelling (of hands, feet, ankles, lips, mouth, and throat)
• decreased blood pressure
• kidney abnormalities (including increased kidney function tests such as urea and creatinine)
• liver inflammation
• mouth inflammation
• ringing or noises in the ears
• jaundice (yellowing of the whites of the eyes or skin)
• skin sensitivity disturbances
• abnormal dreams
• concentration difficulties
• difficulty swallowing
• smell disturbances (including loss of smell)
• balance disorders and lack of coordination (due to dizziness)
• total or partial memory loss
• hearing impairments including deafness (usually reversible)
• increased uric acid in blood
• emotional instability
• speech disturbances
• fainting
• muscle weakness

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

• joint inflammation
• irregular heartbeat
• increased skin sensitivity
• depersonalization disorder (feeling detached from oneself)
• increased blood clotting
• muscle stiffness
• significant decrease in certain white blood cells (agranulocytosis)
• decrease in red blood cells, white blood cells, and platelets (pancytopenia)

Frequency not known (cannot be estimated from available data)

• increased sensitivity of the skin to sunlight or UV radiation (see also section 2, Warnings and precautions)
• clearly defined erythematous spots with or without blisters appearing within hours after administration of moxifloxacin and disappearing with post-inflammatory hyperpigmentation; these usually reappear in the same skin or mucosal site upon subsequent exposure to moxifloxacin

The administration of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-term (even months or years) or permanent adverse reactions, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pricking, tingling, "pins and needles", burning, numbness, or pain (neuropathy), fatigue, memory and concentration impairment, mental health effects (which may include sleep disorders, anxiety, panic attacks, depression, and suicidal thoughts), as well as decreased hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

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

Additionally, very rare cases of the following adverse effects, described after treatment with other quinolone antibiotics, may possibly also occur during treatment with moxifloxacin: increased intracranial pressure (symptoms include headache, visual disturbances such as blurred vision, "blind spots", double vision, vision loss), increased blood sodium and calcium levels, reduced count of a certain type of red blood cells (hemolytic anemia).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of moxifloxacin cinfa

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

Do not use this medicine after the expiry date stated on the blister pack and container after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to your pharmacy’s SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of moxifloxacino cinfa

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

Appearance of the product and contents of the pack

moxifloxacino cinfa 400 mg film-coated tablets are pink, coated, oblong tablets, unmarked and coded with the letters “MXF”.

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

Only certain 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 the most recent review of this leaflet: May 2025

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. 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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