Moxifloxacin Normon 400 mg film-coated tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Moxifloxacino Normon 400 mg film-coated tablets EFG

Read the entire 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 could harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Leaflet contents

What Moxifloxacino Normon is and what it is used for
What you need to know before taking Moxifloxacino Normon
How to take Moxifloxacino Normon
Possible side effects
How to store Moxifloxacino Normon
Contents of the pack and other information

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

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

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold.

It is important that you follow the instructions regarding dose, dosing interval, and duration of treatment as given by your doctor.

Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via the wastewater system or household waste.

Moxifloxacino Normon is indicated in patients aged 18 years and older for the treatment of the following bacterial infections when caused by bacteria against which moxifloxacin is active. Moxifloxacin should only be used to treat such infections when commonly used antibiotics cannot be used or have not worked.

Sinus infection (sinusitis), acute exacerbation of chronic bronchitis, or community-acquired pneumonia (except severe cases).
Mild to moderate infections of the female upper genital tract (pelvic inflammatory disease), including infection of the fallopian tubes and infection of the uterine mucosal membrane. For this type of infection, moxifloxacin alone is not sufficient treatment; therefore, in addition to moxifloxacin, your doctor must prescribe another antibiotic (see section 2, 2. What you need to know before taking Moxifloxacino Normon, Warnings and precautions, Consult your doctor before taking Moxifloxacino Normon).

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

Moxifloxacin should 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 Normon

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

Do not take Moxifloxacino Normon:

If you are allergic (hypersensitive) to the active substance moxifloxacin 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 damage 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 (observed on ECG, the heart's electrical recording), have electrolyte imbalances in the blood (especially low potassium or magnesium levels), 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 ECG changes (see section Other medicines and Moxifloxacino Normon). This is because moxifloxacin may cause changes in the ECG, such as QT interval prolongation, meaning a delay in the electrical conduction in the heart.
If you have severe liver disease or if your liver enzyme levels (transaminases) increase to five times above the upper limit of normal.

Warnings and precautions

Before starting this medicine

You must not take antibacterial medicines containing fluoroquinolones or quinolones, including Moxifloxacino Normon, 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 taking Moxifloxacino Normon

Moxifloxacin 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 the blood, consult your doctor before taking moxifloxacin. (See also sections Do not take Moxifloxacino Normon and Other medicines and Moxifloxacino Normon)
If you have ever developed a severe skin rash, skin peeling, blisters and/or mouth sores after taking moxifloxacin.
If you have epilepsy or another condition that may cause seizures, consult your doctor before taking moxifloxacin.
If you have or have ever had any mental health problems, consult your doctor before taking moxifloxacin.
If you have myasthenia gravis, your symptoms may worsen if you take moxifloxacin. 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 (tearing of the aortic wall).
If you have been diagnosed with heart valve insufficiency (regurgitation of heart valves).
If you have a family history of aortic aneurysm or aortic dissection or congenital heart valve disease, or other risk factors or predisposing disorders (e.g., connective tissue disorders such as Marfan syndrome, vascular Ehlers-Danlos syndrome, Turner syndrome, or Sjögren's syndrome (an inflammatory autoimmune disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, known hypertension or atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).
If you are diabetic, because you may be at risk of changes in blood sugar levels with moxifloxacin.
If you or a family member has glucose-6-phosphate dehydrogenase deficiency (a rare inherited condition), inform your doctor, who will determine whether moxifloxacin is suitable for you.
If you have a complicated upper female genital tract infection (associated with a tubo-ovarian or pelvic abscess), for which your doctor considers intravenous treatment necessary, treatment with moxifloxacin tablets is not appropriate.
For the treatment of a mild to moderate upper female genital tract infection, your doctor should prescribe another antibiotic in addition to moxifloxacin. If after three days of treatment you do not notice an improvement in symptoms, consult your doctor.

During treatment with Moxifloxacino Normon

If you notice palpitations or irregular heartbeat during treatment, you must inform your doctor immediately. Your doctor may perform an ECG to monitor 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, and develop symptoms such as chest tightness, dizziness, nausea, fainting, or vertigo when standing. If these symptoms occur, stop taking moxifloxacin and consult your doctor immediately.
Moxifloxacin 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, bleeding tendency, or brain disease caused by liver damage (symptoms of reduced liver function or rapid and severe liver inflammation).
Severe skin reactions

Severe skin reactions have been reported with moxifloxacin use, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalized exanthematous pustulosis (AGEP), and drug reaction with eosinophilia and systemic symptoms (DRESS syndrome or drug hypersensitivity syndrome).

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 can be life-threatening or fatal.
AGEP appears at the beginning of treatment as a widespread red, scaly rash with bumps under the skin 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 body temperature, elevated liver enzyme levels 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 moxifloxacin and contact your doctor or seek immediate medical attention.

Quinolone antibiotics, including moxifloxacin, may cause seizures. If this occurs, treatment with moxifloxacin must be stopped and you should contact your doctor immediately.
Severe, disabling, long-lasting, and potentially irreversible side effects. Antibacterial medicines containing fluoroquinolones or quinolones, including Moxifloxacino Normon, have been associated with very rare but serious adverse effects, some of which were long-lasting (persisting for months or years), disabling, or potentially irreversible. These include pain in tendons, muscles, and joints of the upper and lower limbs, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, numbness, or burning (paraesthesia), sensory disturbances such as reduced 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 Normon, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or discontinue 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 the feet and legs or hands and arms. If this occurs, stop taking Moxifloxacino Normon and inform your doctor immediately to prevent the development of a potentially irreversible disorder.
You may experience mental health problems even after the first dose of quinolone antibiotics, including moxifloxacin. In very rare cases, mental health problems and depression have progressed to suicidal thoughts and self-harming behaviors such as suicide attempts (see section 4). If you develop these reactions, treatment with moxifloxacin must be stopped and you must inform your doctor immediately.
You may develop diarrhea during or after taking antibiotics, including moxifloxacin. If diarrhea is severe or persistent, or if you notice blood or mucus in your stool, stop taking moxifloxacin immediately and consult your doctor. In these situations, you must not take medications that stop or slow intestinal movement.
Rarely, joint pain and swelling, or tendon inflammation or rupture may occur (see section Do not take Moxifloxacino Normon 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 and even several months after stopping Moxifloxacino Normon. At the first sign of tendon pain or swelling (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Moxifloxacino Normon, 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 be increased if you are receiving systemic corticosteroid treatment.
If you suddenly develop shortness of breath, especially when lying down, or notice swelling in your ankles, feet, or abdomen, or develop 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 2 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 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 carefully monitored.
Quinolone antibiotics may increase skin sensitivity to sunlight or UV light. You must avoid prolonged exposure to sunlight or direct sunlight and must not use sunbeds or any type of UV lamp during moxifloxacin treatment (see section 4. Possible side effects).
The efficacy of moxifloxacin has not been established in the treatment of severe burns, deep tissue infections, or diabetic foot infections with osteomyelitis (bone marrow infection).

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 in this age group (see section Do not take Moxifloxacino Normon).

Other medicines and Moxifloxacino Normon

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

With moxifloxacin, consider the following:

If you are taking moxifloxacin and other medicines that affect the heart, there is an increased risk of heart rhythm disturbances. Therefore, you must not take moxifloxacin at the same time as the following drugs: medicines belonging to the antiarrhythmic class (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), antipsychotics (e.g., phenothiazines, pimozide, sertindole, haloperidol, sultopride), tricyclic antidepressants, certain antimicrobials (e.g., saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarials, particularly halofantrine), certain antihistamines (e.g., terfenadine, astemizole, mizolastine), and other drugs (e.g., cisapride, intravenous vincamine, bepridil, and difemethilene).
While taking moxifloxacin, inform your doctor if you are taking other medicines that may reduce potassium levels in the blood (e.g., loop and thiazide diuretics, laxatives and enemas (high doses), corticosteroids (anti-inflammatory medicines), or amphotericin B) or cause a decrease in 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 used to treat gastrointestinal disorders, may reduce the effect of moxifloxacin tablets. Therefore, take your moxifloxacin tablets 6 hours before or after taking other medicines.
Taking medicinal activated charcoal orally at the same time as moxifloxacin tablets reduces their effect. Therefore, it is recommended not to use these medicines simultaneously.
If you are currently taking oral anticoagulants (e.g., warfarin), your doctor may need to monitor your blood clotting time.

Moxifloxacino Normon with food and drinks

The effect of moxifloxacin is not affected by food, including dairy products.

Pregnancy, breastfeeding, and fertility

Do not use moxifloxacin during pregnancy or while breastfeeding. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Driving and use of machinery

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

Moxifloxacino Normon contains sodium

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

3. How to take Moxifloxacino Normon

Follow exactly the instructions for administering moxifloxacino 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.

Moxifloxacino tablets are for oral use. Swallow the tablet whole without chewing (to mask the bitter taste) and with plenty of liquid. Moxifloxacino 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 otherwise directed by your doctor, the treatment duration with moxifloxacino 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 sinusitis (acute bacterial sinus infections): 7 days.
Mild to moderate upper female genital tract infections (pelvic inflammatory disease), including fallopian tube infection and infection of the uterine mucous membrane: 14 days.

When Moxifloxacino 400 mg tablets are used to complete a treatment initiated with Moxifloxacino perfusion solution (intravenous treatment), the recommended durations are:

Community-acquired lung infections (pneumonia): 7–14 days.

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

Skin and soft tissue infections: 7–21 days.

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

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

Do not exceed the recommended dose or 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 the recommended number of tablets per day, contact your doctor immediately and, if possible, bring the remaining medication, packaging, or this leaflet to show the 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 number: 91 562 04 20, indicating the medication and the amount used.

If you forget to take Moxifloxacino Normon

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

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

If you stop taking Moxifloxacino Normon

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, moxifloxacin 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:

An abnormally fast heartbeat (rare adverse effect).
A sudden feeling of illness or notice a yellowish discoloration of the whites of the eyes, dark urine, skin itching, tendency to bleed, or disturbances in thinking or consciousness (these may be signs and symptoms of fulminant liver inflammation 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 spots or circular lesions often with blisters in the center, skin peeling, mouth, throat, nose, genital, and 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").
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 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 a severe drop in blood sugar levels (hypoglycemic coma) (very rare adverse effect).
Inflammation of blood vessels (signs may include red skin spots, usually on the legs, or symptoms such as joint pain) (very rare adverse effect).
Severe, sudden, 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-related problems such as pain, burning, tingling, numbness and/or weakness in the limbs (rare adverse effect).
Depression (in very rare cases progressing 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:

Temporary 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 taken moxifloxacin and do not restart treatment.

In very rare cases, symptoms of myasthenia gravis may worsen. 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 the 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), contact your doctor immediately.

The following are other adverse effects observed during treatment with moxifloxacin, listed according to their 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 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/acid reflux).
Taste disturbance (in very rare cases, loss of taste).
Sleep disorders (mainly 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 (feeling of spinning and 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.
Vision disorders, including double and blurred vision.
Impaired blood clotting.
Increase in blood lipids (fats).
Low red blood cell count.
Muscle pain.
Allergic reactions.
Increased bilirubin in blood.
Inflammation of the stomach (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-related 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 blood uric acid.
Emotional instability.
Speech disturbances.
Fainting.
Muscle weakness.

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

Decrease in red blood cells, white blood cells, and platelets (pancytopenia).
Joint inflammation.
Irregular heartbeat.
Increased skin sensitivity.
Depersonalization disorder (feeling detached from oneself).
Increased blood clotting.
Muscle rigidity.
Significant decrease in certain white blood cells (agranulocytosis).

Frequency not known (cannot be estimated from available data)

Increased skin sensitivity 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 residual post-inflammatory hyperpigmentation; these typically 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 decline, mental health problems (e.g., sleep disorders, 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 aortic wall enlargement and weakening or tearing (aneurysms and dissections), which could lead to rupture and potentially be fatal, and cardiac 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 blood sodium and calcium levels, reduced count of a specific type of red blood cells (hemolytic anemia).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the national reporting system at www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Moxifloxacin Normon

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Moxifloxacino Normon

The active substance is moxifloxacin. Each film-coated tablet contains 400 mg of moxifloxacin (as moxifloxacin hydrochloride).

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

Appearance of the product and contents of the package

Moxifloxacino Normon 400 mg film-coated tablets are available in packs containing 5 and 7 tablets.

Pale red, elongated, biconvex film-coated tablets marked with "M400" on one side.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6
28760 Tres Cantos, Madrid
Spain

This leaflet was last approved in: January 2022

Detailed information on this medicinal product 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 on this medicinal product by scanning the QR code included in the package leaflet and outer packaging with your mobile phone (smartphone). You may also access this information at the following internet address:

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