MOXIFLOXACIN QUALIGEN 400 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

MoxifloxacinQualigen 400 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Package Leaflet Contents

1. What Moxifloxacin Qualigen is and what it is used for
2. What you need to know before taking Moxifloxacin Qualigen
3. How to take Moxifloxacin Qualigen
4. Possible side effects
5. Storage of Moxifloxacin Qualigen
6. Package Contents and Additional Information

1. What Moxifloxacin Qualigen is and what it is used for

Moxifloxacin Qualigen contains moxifloxacin as the active ingredient, which belongs to the group of antibiotics called fluoroquinolones. Moxifloxacin Qualigen acts by eliminating bacteria that cause infections.

Moxifloxacin Qualigen is indicated in patients 18 years and older for the treatment of the following bacterial infections when caused by bacteria susceptible to moxifloxacin. Moxifloxacin Qualigen should only be used to treat these infections when usual antibiotics cannot be used or have not worked.

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

Mild or moderate upper female genital tract infections (pelvic inflammatory disease), including fallopian tube infection and uterine mucous membrane infection. For this type of infection, Moxifloxacin Qualigen is not sufficient as the only treatment; therefore, in addition to Moxifloxacin Qualigen, your doctor will prescribe another antibiotic for the treatment of mild or moderate upper female genital tract infections (see section 2. What you need to know before taking Moxifloxacin Qualigen, Warnings and Precautions, Consult your doctor or pharmacist before taking Moxifloxacin Qualigen).

If the following diseases have shown improvement during initial treatment with moxifloxacin solution for infusion, your doctor may prescribe Moxifloxacin Qualigen to complete the treatment: Community-acquired pneumonia, skin and soft tissue infections. Moxifloxacin Qualigen should not be used to initiate treatment for any type of skin and soft tissue infection or severe pneumonia.

2. What you need to know before taking Moxifloxacino Qualigen

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

Do not take Moxifloxacino Qualigen:

• If you are allergic (hypersensitive) to the active ingredient moxifloxacino or to other quinolones or to any of the other components of this medicine (see section 6. Contents of the pack and additional information) of Moxifloxacino Qualigen 400 mg film-coated tablets.
• If you are pregnant or breastfeeding.
• If you are under 18 years old.
• If you have a history of tendon disorders or injuries related to treatment with quinolone antibiotics (see sections Warnings and precautionsand 4. Possible side effects).
• If you have a hereditary disease or have suffered from a disease related to an abnormal heart rhythm (observed in ECG, heart electrical record), suffer from electrolyte imbalances in the blood (especially low potassium or magnesium levels in the blood), have a very slow heart rate (called "bradycardia"), have a weak heart (heart failure), have a history of rhythm disorders or are taking other medications that cause ECG disorders (see section Taking Moxifloxacino Qualigen with other medicines).

This is because Moxifloxacino Qualigen can cause changes in the ECG, such as a prolongation of the QT interval, i.e., a delay in the conduction of electrical signals in the heart.

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

Warnings and precautions

Before starting to take this medicine

You must not take antibacterial medicines that contain fluoroquinolones or quinolones, including Moxifloxacino Qualigen, if you have experienced a severe adverse reaction previously when taking a quinolone or a fluoroquinolone. If this is the case, you should inform your doctor as soon as possible.

Consult your doctor or pharmacist before starting to take Moxifloxacino Qualigen:

• Moxifloxacino Qualigen may modify the heart's ECG, especially if you are a woman or an elderly patient. If you are currently taking any medication that leads to a decrease in blood potassium levels, consult your doctor before taking Moxifloxacino Qualigen (see also sections Do not take Moxifloxacino Qualigenand Taking Moxifloxacino Qualigen with other medicines).
• If you have been diagnosed with an aneurysm of a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm).
• If you have suffered a previous episode of aortic dissection (tear in the aortic wall).
• If you have been diagnosed with heart valve insufficiency (regurgitation of the heart valves).
• If you have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing disorders (e.g., connective tissue disorders such as Marfan syndrome or Ehlers-Danlos vascular syndrome, Turner syndrome, or Sjögren's syndrome (an autoimmune inflammatory disease) or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, arterial hypertension, atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection).
• If you suffer from epilepsyor any other condition that may cause seizures, consult your doctor before taking Moxifloxacino Qualigen.
• If you have or have ever had any mental health problems, consult your doctor before taking Moxifloxacino Qualigen.
• If you have myasthenia gravis, your symptoms may worsen if you take Moxifloxacino Qualigen. If you think this affects you, consult your doctor immediately.
• If you or a family member has a glucose-6-phosphate dehydrogenase deficiency(a rare hereditary disease), inform your doctor, who will indicate whether Moxifloxacino Qualigen is suitable for you.
• If you have a complicated upper female genital tract infection(associated with an abscess in the fallopian tubes and ovary or pelvic abscess), for which your doctor considers intravenous treatment necessary, Moxifloxacino Qualigen is not appropriate.
• For the treatment of a mild to moderate upper female genital tract infection, your doctor must prescribe another antibiotic along with Moxifloxacino Qualigen. If you do not notice an improvement in symptoms after three days of treatment, consult your doctor.
• If you are diabetic because you may experience a risk of change in blood sugar levels with moxifloxacino.
• If you have ever developed a severe skin rash or skin peeling, blisters, and/or sores in the mouth after taking moxifloxacino.

During treatment with Moxifloxacino Qualigen

• If you notice palpitations or irregular heartbeatsduring the treatment period, you should inform your doctor immediately. Your doctor may perform an ECG to measure your heart rate.
• The risk of heart problemsmay increase with the increase in dose. Therefore, you should take the recommended dose.
• If you feel a sudden and severe pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go to the emergency room immediately. The risk may increase if you are receiving systemic corticosteroid treatment.
• If you start to experience a sudden onset of shortness of breath, especially when lying down, or if you notice swelling in the ankles, feet, or abdomen, or the appearance of heart palpitations (feeling of rapid or irregular heartbeat), you should inform your doctor immediately.
• In rare cases, you may experience a severe allergic reaction(anaphylactic shock) even with the first dose and develop the following symptoms: chest tightness, feeling of dizziness, feeling of nausea or fainting, or feeling dizzy when standing up. If you experience these symptoms, stop taking Moxifloxacino Qualigen and consult your doctor immediately.
• Moxifloxacino Qualigen may cause a rapid and severe liver inflammation, which can lead to life-threatening liver failure (including fatal cases, see section 4. Possible side effects). If you develop symptoms such as a sudden feeling of discomfort and/or discomfort associated with a yellowish color of the whites of the eyes, dark urine, skin itching, tendency to bleed, or brain disease induced by liver damage (symptoms of reduced liver function or severe liver inflammation), consult your doctor before continuing treatment.
• Quinolone antibiotics, including Moxifloxacino Qualigen, may cause seizures. If this occurs, treatment with Moxifloxacino Qualigen should be discontinued, and you should contact your doctor immediately.
• Severe, long-lasting, and potentially irreversible adverse effects. Antibacterial medicines that contain fluoroquinolones or quinolones, including Moxifloxacino Qualigen, have been associated with very rare but serious adverse effects, some of which were long-lasting (persistent for months or years), disabling, or potentially irreversible. This includes pain in the tendons, muscles, and joints of the upper and lower limbs, difficulty walking, abnormal sensations such as pinching, tingling, tingling, numbness, or burning (paresthesia), sensory disorders such as decreased vision, taste, smell, and hearing, depression, decreased memory, intense fatigue, and severe sleep disorders.

If you experience any of these side effects after taking Moxifloxacino Qualigen, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or not, also considering the use of an antibiotic of another class.

• In rare cases, you may experience nerve damage symptoms(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 Qualigen and inform your doctor immediately to prevent the development of a potentially irreversible disorder.
• You may experience mental health problemseven after the first administration of quinolone antibiotics, including Moxifloxacino Qualigen. In very rare cases, mental health problems and depression have evolved into suicidal thoughts and self-harming behaviors such as suicide attempts (see section 4. Possible side effects). If you develop these reactions, you should discontinue treatment with Moxifloxacino Qualigen and inform your doctor immediately.
• You may develop diarrheaduring or after taking antibiotics, including Moxifloxacino Qualigen. If the diarrhea is severe or persistent, or if you notice blood or mucus in the stool, stop taking Moxifloxacino Qualigenimmediately and consult your doctor. In these situations, you should not take medications that interrupt or slow down intestinal movement.
• In rare cases, pain and swelling in the joints and inflammation or rupture of the tendonsmay occur. The risk is higher if you are an elderly person (over 60 years old), have received an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even several months after stopping treatment with Moxifloxacino Qualigen. At the first sign of pain or tendon inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Moxifloxacino Qualigen, contact your doctor, and rest the affected area. Avoid any unnecessary exercise, as this may increase the risk of tendon rupture.
• If you are elderly and have kidney problems, be careful to drink enough fluids, as dehydration can increase the risk of kidney failure.
• If your vision worsens or if you have any other eye disordersduring treatment with Moxifloxacino Qualigen, consult an ophthalmologist immediately (see sections 2 Driving and use of machines and 4. Possible side effects).
• Fluoroquinolone antibiotics 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 can 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 the sensitivity of the skin to sunlight or UV. You should avoid prolonged exposure to sunlight or direct sunlight and should not use sunbeds or any type of UV lamp during treatment with Moxifloxacino Qualigen.
• The efficacy of moxifloxacino solution for infusion in the treatment of severe burns, deep tissue infections, and diabetic foot infections with osteomyelitis (bone marrow infections) has not been established.

Severe skin reactions

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), have been reported with the use of moxifloxacino.

• SSJ/TEN may initially appear on the trunk as reddish grains in a target shape or circular spots often with central blisters. Ulcers may also appear in the mouth, throat, nose, genitals, and eyes (red and swollen eyes). These severe skin rashes are often preceded by fever and/or flu-like symptoms. The rashes can progress to a generalized peeling of the skin and complications that can be life-threatening or fatal.
• AGEP appears at the beginning of treatment as a red, scaly, and generalized rash with bumps under the skin and blisters accompanied by fever. The most common location: mainly localized in skin folds, trunk, and upper limbs.

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

Children and adolescents

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

Taking Moxifloxacino Qualigen with other medicines

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

With Moxifloxacino Qualigen, you should consider the following:

• If you are taking Moxifloxacino Qualigen and other medicines that affect the heart, there is a greater risk of heart rhythm disorders. Therefore, you should not take Moxifloxacino Qualigen at the same time as the following drugs: Medicines that belong to the class of antiarrhythmics (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), antipsychotics (e.g., phenothiazines, pimozide, sertindole, haloperidol, sultoprid), tricyclic antidepressants, some antimicrobials (e.g., saquinavir, sparfloxacin, erythromycin administered intravenously, pentamidine, antimalarials, particularly halofantrine), some antihistamines (e.g., terfenadine, astemizole, mizolastine), and other drugs (e.g., cisapride, intravenous vincamine, bepridil, and difemanil).
• While taking Moxifloxacino Qualigen, you should inform your doctor if you are taking other medicines that may decrease blood potassium levels (e.g., some diuretics, some laxatives, and enemas [high doses] or corticosteroids [anti-inflammatory medicines], amphotericin B) or cause a decrease in heart rate, as these may also increase the risk of severe heart rhythm disorders.
• Any other medicine that contains magnesium or aluminum (such as antacids for indigestion) or any medicine that contains iron or zinc, medicines that contain didanosine, or medicines that contain sucralfate for treating gastrointestinal disorders may reduce the action of Moxifloxacino Qualigen tablets. Therefore, take your Moxifloxacino Qualigen tablets 6 hours before or after taking other medicines.
• Taking medicinal activated charcoal at the same time as Moxifloxacino Qualigen tablets reduces the action of these tablets. Therefore, it is recommended not to use these medicines simultaneously.
• If you are currently taking oral anticoagulants (e.g., warfarin), your doctor may need to monitor your blood coagulation time.

Moxifloxacino Qualigen with food and drinks

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

Pregnancy, breastfeeding, and fertility

Do not use Moxifloxacino Qualigen during pregnancy or if you are 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.

Studies in animals do not suggest that this medicine affects fertility.

Driving and use of machines

Moxifloxacino Qualigen may cause dizziness or vertigo or a brief fainting spell; you may experience a sudden transient loss of vision. If you experience these symptoms, do not drive vehicles or operate machinery.

3. How to take Moxifloxacino Qualigen

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose in adults is one 400 mg film-coated tablet, once a day.

Moxifloxacino Qualigen tablets are for oral use. Take the tablet whole without chewing (to mask the bitter taste) and with plenty of liquid. Moxifloxacino Qualigen can be taken with or without food. It is recommended that you take the tablet at approximately the same time every day.

No dose adjustment is necessary in elderly patients, in patients with low body weight, or in patients with kidney problems.

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

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

If Moxifloxacino Qualigen is used to complete a course of therapy initiated with moxifloxacino solution for infusion, the duration of treatment is:

• Community-acquired pneumonia: 7-14 days.

Most patients with pneumonia switch to oral treatment with Moxifloxacino Qualigen after 4 days.

• Skin and soft tissue infections: 7-21 days.

In most patients with severe skin and soft tissue infections, the average duration of intravenous treatment is around 6 days.

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

Do not exceed the recommended dose and duration of treatment (see section 2. What you need to know before taking Moxifloxacino Qualigen).

If you take more Moxifloxacino Qualigen than you should

If you take more than the prescribed daily tablet, consult your doctor immediately and, if possible, take the remaining medication, packaging, or this leaflet and show it to your doctor or pharmacist what you have taken.

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

If you forget to take Moxifloxacino Qualigen

In case of forgetting a dose, you should take the tablet as soon as you remember it on the same day. If you do not take your tablet one day, take the normal dose (one tablet) the next day. Do not take a double dose to make up for forgotten doses.

If you are not sure what to do, consult your doctor or pharmacist.

If you stop taking Moxifloxacino Qualigen

If you stop taking this medication too early, your infection may not be completely cured. Consult your doctor if you intend to stop taking the tablets before completing the full treatment.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The most serious side effectsobserved during treatment with Moxifloxacino Qualigen are listed below:

If you notice

• Severe skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These can appear on the trunk as reddish spots in a target shape or circular patches, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, and can be preceded by fever and flu-like symptoms (very rare, potentially life-threatening side effects)
• A red, scaly, and widespread rash with bumps under the skin and blisters, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis) (the frequency of this side effect is "not known")
• 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)
• Pain and inflammation of the tendons (tendinitis) (rare side effect) or tendon rupture (very rare side effect)
• Muscle weakness, sensitivity, or pain, particularly if you also feel discomfort, have a fever, or your urine is dark. These symptoms can be caused by abnormal muscle breakdown, which can be life-threatening and cause kidney problems (a condition called rhabdomyolysis) (the frequency of this side effect is "not known")

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

:

• Common: may affect 1 to 10 in every 100 patients
• Uncommon: may affect 1 to 10 in every 1,000 patients
• Rare: may affect 1 to 10 in every 10,000 patients
• Very rare: may affect less than 1 in every 10,000 patients
• Frequency not known (cannot be estimated from available data)

Infections

Common: Infections caused by resistant bacteria or fungi, e.g., oral and vaginal infections caused by Candida.

Blood and lymphatic system disorders

Uncommon: Low red blood cell count, low white blood cell count, low levels of certain white blood cells (neutrophils), decrease or increase in certain blood cells necessary for blood coagulation, increase in certain white blood cells (eosinophils), decrease in blood coagulation.

Very rare: Increase in blood coagulation, significant decrease in certain white blood cells (agranulocytosis), decrease in the number of red and white blood cells and platelets (pancytopenia).

Allergic reactions

Uncommon: Allergic reactions.

Rare: Severe, sudden, and generalized allergic reaction, including very rare life-threatening shock (e.g., difficulty breathing, decreased blood pressure, rapid pulse), swelling (including possible swelling of the airways that can be life-threatening).

Abnormal laboratory test results

Uncommon: Increase in blood lipid levels (fats).

Rare: Increase in blood glucose levels, increase in blood uric acid levels.

Pschiatric disorders

Uncommon: Anxiety, restlessness/agitation.

Rare: Emotional instability, depression (in very rare cases leading to self-harm, such as suicidal thoughts or attempts), hallucinations.

Very rare: Feeling of loss of personality (not being oneself), dementia (possibly leading to self-harm, such as suicidal thoughts or attempts).

Nervous system disorders

Common: Headache, dizziness.

Uncommon: Tingling sensation (pins and needles) and/or numbness, alteration of taste (in very rare cases, loss of taste), confusion and disorientation, sleep disorders (predominantly insomnia), tremors, sensation of vertigo (feeling that everything is spinning and falling), somnolence.

Rare: Disorders of skin sensation, alteration of smell (including loss of smell), abnormal dreams, balance and coordination disorders (due to dizziness), convulsions, concentration disorders, speech disorders, total or partial loss of memory, problems associated with the nervous system, such as pain, burning, tingling, numbness, and/or weakness in the limbs.

Very rare: Increased skin sensitivity.

Eyes

Uncommon: Vision disorders, including double vision and blurred vision.

Very rare: Transient loss of vision.

Ears

Rare: Ringing/noises in the ears, hearing impairment, including deafness (usually reversible).

Cardiac disorders

Common: Change in heart rhythm (ECG), in patients with low potassium levels in the blood.

Uncommon: Change in heart rhythm (ECG), palpitations, irregular and rapid heart rate, severe heart rhythm disorders, angina pectoris.

Rare: Abnormally rapid heart rate, fainting.

Very rare: Heart rhythm disorders, life-threatening irregular heart rate, cardiac arrest.

Vascular disorders

Uncommon: Dilation of blood vessels.

Rare: Hypertension, hypotension.

Respiratory disorders

Uncommon: Difficulty breathing, including asthmatic conditions.

Gastrointestinal disorders

Common: Nausea, vomiting, abdominal and stomach pain, diarrhea.

Uncommon: Decreased appetite and food intake, flatulence and constipation, gastric discomfort (indigestion/acid reflux), stomach inflammation, increase in a certain digestive enzyme in the blood (amylase). Rare: Difficulty swallowing, mouth inflammation, severe diarrhea with blood and/or mucus (antibiotic-associated colitis, including pseudomembranous colitis) that, in very rare circumstances, can lead to life-threatening complications.

Liver disorders

Common: Increase in certain liver enzymes in the blood (transaminases).

Uncommon: Alteration of liver function (including increase in a liver enzyme in the blood, LDH), increase in bilirubin in the blood, increase in a liver enzyme in the blood (gammaglutamyltransferase and/or alkaline phosphatase).

Rare: Jaundice (yellowing of the whites of the eyes or skin), liver inflammation.

Very rare: Fulminant liver inflammation with life-threatening liver failure (including fatal cases).

Skin disorders

Uncommon: Itching, rash, urticaria, dry skin.

Very rare: Skin and mucous membrane disorders (painful blisters in the mouth/nose or on the penis/vagina) or Stevens-Johnson syndrome (toxic epidermal necrolysis) with possible risk to life. Inflammation of blood vessels (the signs can be red spots on the skin, usually on the legs, or effects such as joint pain) (very rare side effect).

Musculoskeletal disorders

Uncommon: Joint and muscle pain.

Rare: Pain and inflammation of tendons (tendinitis), muscle cramps, muscle spasms, muscle weakness. Very rare: Tendon rupture, joint inflammation, muscle stiffness, worsening of myasthenia gravis symptoms.

Kidney disorders

Uncommon: Dehydration.

Rare: Kidney disorders (including increased laboratory test results for the kidney, such as urea and creatinine), kidney failure.

General disorders

Uncommon: Discomfort (mainly weakness or fatigue), back, limb, pelvis, and thorax pain, sweating.

Rare: Swelling (of hands, feet, ankles, lips, mouth, and throat).

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

Additionally, very rare cases of the following side effects have been reported after treatment with other quinolone antibiotics and may also occur during treatment with Moxifloxacino Qualigen: increased sodium and calcium levels in the blood, reduced count of a certain type of red blood cell (hemolytic anemia), increased skin sensitivity to sunlight or UV radiation.

There have been reports of increased size and weakening or tearing of the aortic wall (aneurysms and dissections), which could lead to rupture and be fatal, and heart valve disorders in patients who have received fluoroquinolones. See also section 2.

Reporting of side effects

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

5. Storage of Moxifloxacino Qualigen

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

Do not use this medication after the expiration date shown on the blister pack and carton after EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Moxifloxacino Qualigen

• The active ingredient is moxifloxacino. Each film-coated tablet contains 400 mg of moxifloxacino in the form of hydrochloride.
• The other ingredients are:

• Core of the tablet: microcrystalline cellulose, mannitol (E-421), colloidal silicon dioxide, sodium starch glycolate (potato), hydroxypropylcellulose, magnesium stearate.
• Coating: microcrystalline cellulose, sodium starch glycolate (potato), talc, magnesium stearate.

Appearance of the product and package contents

Film-coated tablets are pink, oblong, and biconvex.

The tablets are supplied in aluminum/aluminum blisters.

The tablets are available in packs of 5 and 7 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer

Pharmathen, S.A.

Devernakion, 6

Pallini 15351

Attiki

(Greece)

or

Pharmathen International, S.A.

Sapes Industrial Park,

Block No. 5

Rodopi 69300

(Greece)

Date of last revision of this leaflet: May 2025

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