Package Leaflet: Information for the Patient

Moxifloxacino Normon 400 mg Film-Coated Tablets EFG

Read 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. Do not pass it on to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Moxifloxacino Normon is and what it is used for

2. What you need to know before you start taking Moxifloxacino Normon

3. How to take Moxifloxacino Normon

4. Possible side effects

5. Storage of Moxifloxacino Normon

6. Contents of the pack and additional information

Moxifloxacino Normon 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 Normon is indicated for patients 18 years of age and older for the treatment of the following bacterial infections when caused by bacteria where moxifloxacino is active against these bacteria. Moxifloxacino should only be used to treat these infections when usual antibiotics cannot be used or have not been effective.

Acute exacerbation of chronic inflammation of the airways or sinusitis, 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 is not sufficient as a single treatment, so your doctor should also prescribe another antibiotic for the treatment of mild to moderate upper genital tract infections (see section22. What you need to know before starting to take Moxifloxacino Normon, Warnings and precautions, Consult your doctor before taking Moxifloxacino Normon).

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

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

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

Do not take Moxifloxacino Normon:

• If you are allergic (hypersensitive) to the active ingredient moxifloxacino or to other quinolones or to any of the other components of this medication (including those listed in section 6).
• If you are pregnant or breastfeeding.
• If you are under 18 years old.
• If you have a history of tendon damage or lesions related to antibiotic quinolone treatment (see sectionsWarnings and precautionsand4. Possible side effects). If you have a hereditary disease or have suffered from a disease related to an abnormal heart rhythm (observed on ECG, heart electrical recording), you have electrolyte imbalances in the blood (especially low levels of potassium or magnesium in the blood), you have a very slow heart rate (called "bradycardia"), you have a weak heart (heart failure), you have a history of heart rhythm disorders or are taking other medications that cause ECG disturbances (see sectionOther medications and Moxifloxacino Normon). This is because moxifloxacino can 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-containing antibacterial medications, including Moxifloxacino Normon, if you have had a severe reaction to a quinolone or fluoroquinolone in the past. If this is the case, inform your doctor as soon as possible.

Consult your doctor or pharmacist before taking Moxifloxacino Normon

• Moxifloxacinomay modify the heart ECG, especially if you are a woman or an elderly patient. If you are currently taking any medication that can cause a decrease in blood potassium levels, consult your doctor before taking this moxifloxacino. (see also sectionsDo not take Moxifloxacino NormonandOther medications andMoxifloxacino Normon)
• If you have ever developed asevere skin rash or skin peeling, blisters, and/or mouth soresafter taking moxifloxacino.
• If you suffer from epilepsy or 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 aneurysmor a"bump"of a large blood vessel(aortic aneurysm or a large peripheral vessel aneurysm).
• If you have had a previous episode ofaortic dissection(tear in the aorta wall).
• If you have been diagnosed withheart valve insufficiency(heart valve regurgitation).
• If you have a family history ofaortic aneurysm or aortic dissection or congenital heart valve diseaseor other risk factors or predisposing 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, or known atherosclerosis, rheumatoid arthritis (a joint disease) or endocarditis (a heart infection)).
• If you arediabeticbecause you may experience a risk ofchange in blood sugar levelswith moxifloxacino.
• If you or a family member has glucose-6-phosphate dehydrogenase deficiency (a rare hereditary disease), inform your doctor, who will indicate whether moxifloxacino is suitable for you.
• If you have acomplicated upper genital tract infection in women(associated with a Fallopian tube and ovary abscess or pelvic abscess), for which your doctor considers intravenous treatment necessary, oral moxifloxacino treatment 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 Normon

• If you noticepalpitations or irregular heartbeatsduring the treatment period, inform your doctor immediately. They may perform an ECG to measure heart rhythm.
• Therisk of heart problemsmay increase with increasing doses. Therefore, take the recommended dose.
• In rare cases, you may experience asevere and sudden allergic reaction(anaphylactic reaction) even with the first dose, and develop the following symptoms: chest tightness, dizziness, nausea, or fainting, or feeling dizzy when standing up. In case of these symptoms, discontinue moxifloxacino administration and consult your doctor immediately.
• Moxifloxacino may cause arapid and severe liver inflammation, which may lead to liver failure that puts your life at risk (including fatal cases, see section 4Possible side effects). Please consult your doctor before continuing treatment if you develop symptoms such as sudden discomfort and/or discomfort associated with yellowing of the white of the eyes, dark urine, itching, or a tendency to bleed, liver function disorder 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 drug hypersensitivity syndrome), have been reported with the use of moxifloxacino.

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

• Quinolone antibiotics, including moxifloxacino, may causeseizures. If this occurs, moxifloxacino treatment should be discontinued and you should contact your doctor immediately.
• Severe and incapacitating side effects, of prolonged duration, and potentially irreversible.Fluoroquinolone or quinolone-containing antibacterial medications, including Moxifloxacino Normon, have been associated with rare but severe side effects, some of which were of long duration (persistent for months or years), incapacitating, or potentially irreversible. This includes tendon pain, muscle and joint pain in the upper and lower 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 side effects after taking Moxifloxacino Normon, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or discontinue treatment, also considering the use of another class of antibiotic.

• In rare cases, you may experience symptoms ofnerve damage(neuropathy) such as pain, burning, tingling, numbness, and/or weakness, especially in the feet and legs or hands and arms. If this happens, stop taking Moxifloxacino Normon 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 rare cases, mental health problems and depression have evolved into suicidal thoughts and self-harm behaviors such as attempted suicide (see section 4). If you develop these reactions, moxifloxacino treatment should be discontinued and you should inform your doctor immediately.
• You may developdiarrheaduring or after taking antibiotics, including moxifloxacino. If diarrhea is severe or persistent, or if you notice blood or mucus in your stool, discontinue 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 sectionDo not take Moxifloxacino Normonand4. Possible side effects). 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 within the first 48 hours of treatment and even several months after discontinuing Moxifloxacino Normon treatment. If you experience any signs of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Moxifloxacino Normon, contact your doctor, and keep the affected 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, seek immediate emergency care. You may be at increased risk 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 your 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 worsens or if your eyes appear to be affected, consult an ophthalmologist immediately (see sections 2Driving and operating machineryand4. Possible side effects).
• 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 loss of consciousness (hypoglycemic coma) (see section4. Possible side effects). If you are diabetic, your blood sugar levels should be carefully controlled.
• Quinolone antibiotics may increase thesensitivity of the skin to sunlight or UV. Avoid prolonged exposure to sunlight or direct sunlight and do not use sunbeds or any type of UV lamp during moxifloxacino administration (see section4. Possible side effects).
• The efficacy of moxifloxacino in the treatment of severe burns, deep tissue infections, and diabetic foot infections with osteomyelitis (bone marrow infections) has not been established.

Children and adolescents

Do not give this medication to children and adolescents under 18 years old, as its efficacy and safety have not been established (see sectionDo not take Moxifloxacino Normon)

Other medications and Moxifloxacino Normon

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take other medications in addition to Moxifloxacino Normon.

With moxifloxacino, you should be aware of the following:

• If you are taking moxifloxacino and othermedications 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, sparfloxacino, erythromycin administered intravenously, pentamidine, antimalarials, particularly halofantrine), some antihistamines (e.g., 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 can lower blood potassium levels (e.g., diuretics, laxatives, and enemas (high doses), corticosteroids, or amphotericin B), as these can also increase the risk of severe heart rhythm disorders.
• Any othermedication containing magnesium or aluminum, such as antacids for indigestion, or anymedication containing iron or zinc, ormedications containing didanosineormedications containing 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.

Moxifloxacino Normon with food and drinks

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

Pregnancy, lactation, and fertility

Do not use moxifloxacino during pregnancy or if you are breastfeeding. If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Animal studies do not indicate that this medication may affect your fertility.

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 Normon 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 for moxifloxacino as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dosein 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 dose adjustment is necessary in elderly patients, in patients with low body weight, or in patients with kidney problems.

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

• Acute exacerbation of chronic bronchitis (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 400 mg tablets are used to complete a treatment initiated with Moxifloxacino intravenous solution (intravenous treatment), the recommended durations are:

• Community-acquired pneumonia: 7-14 days.

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

• Soft tissue and skin infections: 7 – 21 days.

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

It is essential to complete the treatment, even if you start feeling better after a few days. If you interrupt the treatment too soon, the infection may not be fully 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 starting to take Moxifloxacino Normon, Warnings and precautions).

If you take more Moxifloxacino Normon 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 show the 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. Telephone: 91 562 04 20 indicating the medication and the amount used.

If you forget to take Moxifloxacino Normon

If you forget to take a dose, take it 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 two tablets to make up for the missed dose.

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

If you interrupt the treatment with Moxifloxacino Normon

If you interrupt the treatment too soon, your infection may not be fully cured. Consult your doctor if you plan to stop taking the tablets before completing the full treatment.

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

Like all medications, moxifloxacino may cause side effects, although not everyone will experience them.

The most serious side effects observed during treatment with moxifloxacino are listed below:

If you notice:

• 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 a 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, target-shaped macules or circular patches often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, and may be preceded by fever and flu-like symptoms (very rare side effects, potentially life-threatening).
• A red, scaly, and generalized rash with 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), enlarged lymph nodes, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug-induced hypersensitivity syndrome) (the frequency of this side effect is "unknown").
• 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 life-threatening shock (e.g., difficulty breathing, low blood pressure, rapid pulse) (rare side effect).
• Swelling, including respiratory tract swelling (rare side effect, potentially life-threatening).
• Seizures (rare side effect).
• Problems associated with the nervous system, such as pain, burning, tingling, numbness, and/or weakness in the extremities (rare side effect).
• Depression (in very rare cases, it has evolved into self-harm, suicidal thoughts, or attempts at suicide) (rare side effect).
• Madness that can lead to self-harming behaviors, such as suicidal thoughts or attempts) (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 be life-threatening and lead to kidney problems (a condition called rhabdomyolysis) (frequency of this side effect is "unknown").

Stop taking moxifloxacino and contact your doctor immediately as 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 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 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 may be signs and symptoms of kidney insufficiency, a rare side effect),consult your doctor immediately.

The following are other side effects that have been observed during treatment with moxifloxacino according to their probability:

Frequent (may affect up to 1 in 10 people)

• Nausea.
• Diarrhea.
• Dizziness.
• Abdominal and stomach pain.
• Vomiting.
• Headache.
• Elevation of 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.

Rare (may affect up to 1 in 100 people)

• Rash.
• Indigestion/acid reflux.
• Alteration of taste (in rare cases, loss of taste).
• Sleep disturbances (predominantly insomnia).
• Elevation of a liver enzyme in the blood (gamma-glutamyl-transferase and/or alkaline phosphatase).
• Low levels of certain white blood cells (leukocytes, neutrophils).
• Constipation.
• Itching.
• Dizziness (feeling like everything is spinning and falling).
• Drowsiness.
• Flatulence.
• Change in heart rhythm (ECG).
• Liver function alteration (including elevation of a liver enzyme in the blood, LDH).
• Decreased appetite and food intake.
• Low white blood cell count.
• Muscle and joint pain.
• Increased levels of certain blood cells necessary for blood coagulation.
• Sweating.
• Elevation of 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.
• Elevation of a certain digestive enzyme in the blood (amylase).
• Restlessness/agitation.
• Sensation of pins and needles and/or numbness.
• Rashes on the skin.
• Widening 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.
• Elevation of fats in the blood (lipids).
• Low red blood cell count.
• Muscle pain.
• Allergic reactions.
• Elevation of bilirubin in the blood.
• Stomach inflammation (gastritis).
• Dehydration.
• Severe alteration of heart rhythm.
• Dry skin.
• Angina pectoris.

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

• Muscle cramps.
• Muscle contractures.
• Hallucinations.
• Elevation of blood pressure.
• Swelling (of hands, feet, ankles, lips, mouth, and throat).
• Decrease in blood pressure.
• Alterations in kidney function (including elevation of kidney function tests, such as urea and creatinine).
• Liver inflammation.
• Mouth inflammation.
• Tinnitus (ringing in the ears).
• Ictericia (yellowish discoloration of the whites of the eyes or skin).
• Alterations in skin sensitivity.
• Abnormal dreams.
• Concentration disturbances.
• Difficulty swallowing.
• Alterations in sense of smell (including loss of sense of smell).
• Balance and coordination disturbances (due to dizziness).
• Complete or partial loss of memory.
• Decreased hearing, including deafness (usually reversible).
• Elevation of uric acid in the blood.
• Emotional instability.
• Alteration of speech.
• Fainting.
• Muscle weakness.

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

• Decrease in the number of red and white blood cells and platelets (pancytopenia).
• Joint inflammation.
• Irregular heart rhythm.
• Elevation of skin sensitivity.
• Depersonalization disorder (feeling like one is not oneself).
• Elevation of blood coagulation.
• Muscle stiffness.
• Significant decrease in a certain type of white blood cells (agranulocytosis).

Frequency unknown (cannot be estimated from available data)

• Elevation of 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 moxifloxacino administration and disappear with residual post-inflammatory hyperpigmentation; they usually reappear in the same location on the skin or mucosa 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 (including months or years), such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pinching, tingling, itching, burning, numbness, or pain (neuropathy), fatigue, decreased memory and concentration, mental health problems (such as sleep disturbances, anxiety, panic attacks, depression, and suicidal thoughts) 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 may also occur during treatment with moxifloxacino: elevation of 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 pharmacist or nurse, even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly through the national notification systemwww.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication

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

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

No special storage conditions are required.

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. In this way, you will help protect the environment.

Moxifloxacino Normon Composition

The active ingredient is moxifloxacino. Each film-coated tablet contains 400 mg of moxifloxacino (in the form of moxifloxacino hydrochloride).

The other components are: Tablet core: Croscarmelosa sodium, microcrystalline cellulose, anhydrous colloidal silica, talc, and magnesium stearate. Film-coating: Hydroxypropylcellulose (E-464), titanium dioxide (E-171), macrogol 6000, talc, and iron oxide red (E-172).

Product appearance and packaging content

Moxifloxacino Normon 400 mg film-coated tablets are available in packaging of 5 and 7 tablets.

Film-coated tablets of pale red color, elongated, biconvex, and marked with “M400” on one face.

Marketing authorization holder and responsible manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid

Spain

This prospectus has been approved in:January 2022

Detailed information about this medication 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 medication by scanning the QR code included in the prospectus and packaging with your smartphone. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/81027/P_81027.html