Moxifloxacin Qualigen 400 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

MoxifloxacinoQualigen 400 mg film-coated tablets EFG

For use in adults

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

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

Contents of the leaflet

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

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

Moxifloxacino Qualigen contains moxifloxacin as the active substance, which belongs to the group of antibiotics known as fluoroquinolones. Moxifloxacino Qualigen works by killing bacteria that cause infections.

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

• Sinus infection, acute exacerbation of chronic bronchitis, or community-acquired pneumonia (excluding severe cases) occurring outside the hospital setting.

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

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

2. What you need to know before starting to take Moxifloxacino Qualigen

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

Do not take Moxifloxacino Qualigen:

• If you are allergic 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 suffer from a hereditary condition or have had a disease associated with an abnormal heart rhythm (seen on ECG, the heart's electrical recording), have electrolyte imbalances in the blood (especially low levels of potassium or magnesium in the blood), have a very slow heart rate (called "bradycardia"), have a weak heart (heart failure), have a history of heart rhythm disturbances, or are taking other medications that cause ECG abnormalities (see section Other medicines and Moxifloxacino Qualigen).

This is because Moxifloxacino Qualigen may cause changes in the ECG, such as QT interval prolongation, meaning a delay in the conduction of electrical signals 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 Qualigen, if you have previously experienced a serious adverse reaction to a quinolone or fluoroquinolone. If this applies to you, inform your doctor as soon as possible.

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

• Moxifloxacino Qualigen may alter the heart's ECG, especially if you are a woman or an elderly patient. If you are currently taking any medication that causes low blood potassium levels, consult your doctor before taking Moxifloxacino Qualigen (see also sections Do not take Moxifloxacino Qualigen and Other medicines and Moxifloxacino Qualigen).
• 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 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 applies to you, consult your doctor immediately.
• If you have been diagnosed with an enlargement or "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, congenital heart valve disease, or other predisposing risk factors or 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, high blood pressure, known 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 disorder), inform your doctor, who will determine whether Moxifloxacino Qualigen is suitable for you.
• If you have a complicated upper female genital tract infection (e.g., associated with a tubo-ovarian or pelvic abscess), for which your doctor considers intravenous treatment necessary, treatment with Moxifloxacino Qualigen 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 Moxifloxacino Qualigen. If you do not notice improvement in symptoms after three days of treatment, consult your doctor.

During treatment with Moxifloxacino Qualigen

• If you experience palpitations or irregular heartbeats 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, the recommended dose should be taken.

• 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 lightheadedness when standing. If these symptoms occur, stop taking Moxifloxacino Qualigen and consult your doctor immediately.

• Moxifloxacino Qualigen may cause rapid and severe liver inflammation, which may lead to life-threatening liver failure (including fatal cases, see section 4. Possible side effects). Please consult your doctor before continuing treatment if you develop symptoms such as sudden malaise and/or malaise associated with yellowing of the whites of the eyes, dark urine, skin itching, increased tendency to bleed, or brain disease caused by liver damage (symptoms of reduced liver function or rapid, severe liver inflammation).

• Severe skin reactions

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

• SJS/TEN may initially appear on the trunk as red, target-like spots or circular patches, often with central blisters. Mouth, throat, nose, genital, and eye ulcers (red, swollen eyes) may also occur. These severe skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread skin peeling and complications that may be life-threatening or fatal.

• AGEP appears at the beginning of treatment as a widespread, red, scaly rash with 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 rash on the face, 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.

• Quinolone antibiotics, including Moxifloxacino Qualigen, may cause seizures. If this occurs, treatment with Moxifloxacino Qualigen must be stopped and you must contact your doctor immediately.

• Severe, disabling, long-lasting, and potentially irreversible adverse effects. Antibacterial medicines containing fluoroquinolones or quinolones, including Moxifloxacino Qualigen, 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 tendon, muscle, and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, numbness, or burning (paresthesia), sensory disturbances such as 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 Qualigen, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue treatment, possibly considering the use of an antibiotic from another class.

• Rarely, you may experience symptoms of nerve damage (neuropathy), such as pain, burning, tingling, numbness, and/or weakness, especially in the feet and legs or hands and arms. If this occurs, stop taking Moxifloxacino Qualigen 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 Moxifloxacino Qualigen. 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. Possible side effects). If you develop these reactions, treatment with Moxifloxacino Qualigen must be stopped and you must inform your doctor immediately.
• You may develop diarrhea during or after taking antibiotics, including Moxifloxacino Qualigen. If diarrhea is severe or persistent, or if you notice blood or mucus in your stool, stop taking Moxifloxacino Qualigen immediately and consult your doctor. In these situations, do not take medications that stop or slow intestinal movement.
• Rarely, joint pain and swelling, and tendon inflammation or rupture may occur (see section Do not take Moxifloxacino Qualigen 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 Qualigen. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Moxifloxacino Qualigen, 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 pain in the chest, abdomen, or back, which may be symptoms of aortic dissection or aneurysm, go immediately to an emergency department. The risk may increase if you are receiving systemic corticosteroid treatment.
• If you 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 if your eyes appear affected, consult an ophthalmologist immediately (see sections 2. Driving and use of machines and 4. Possible side effects).
• Fluoroquinolones may cause increased blood sugar levels above normal (hyperglycemia) or decreased blood sugar levels below normal (hypoglycemia), which in severe cases may lead to loss of consciousness (hypoglycemic coma) (see section 4. Possible side effects). If you have diabetes, your blood sugar levels should be carefully monitored.
• Quinolone antibiotics may increase skin sensitivity to sunlight or UV light. You should avoid prolonged exposure to sunlight or direct sunlight and must not use sunbeds or any type of UV lamp during treatment with Moxifloxacino Qualigen (see section 4. Possible side effects).
• The efficacy of moxifloxacin infusion solution 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 medicine to children and adolescents under 18 years of age, as efficacy and safety have not been established for this age group (see section Do not take Moxifloxacino Qualigen).

Other medicines and Moxifloxacino Qualigen

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

Take the following into account with Moxifloxacino Qualigen:

• If you are taking Moxifloxacino Qualigen and other medicines that affect the heart, there is an increased risk of heart rhythm disturbances. Therefore, do not take Moxifloxacino Qualigen at the same time as the following medicines: drugs belonging to the antiarrhythmic class (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), antipsychotics (e.g., phenothiazines, pimozide, sertindole, haloperidol, sultopride), tricyclic antidepressants, some antimicrobials (e.g., saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarials, particularly halofantrine), some antihistamines (e.g., terfenadine, astemizole, mizolastine), and other drugs (e.g., cisapride, intravenous vincamine, bepridil, and difemethil).
• While taking Moxifloxacino Qualigen, inform your doctor if you are taking other medicines that may lower blood potassium levels (e.g., loop diuretics and thiazide diuretics, laxatives and enemas (high doses), or corticosteroids (anti-inflammatory medicines), amphotericin B) or that may reduce heart rate, as these may also increase the risk of serious heart rhythm disturbances.
• Any medicine containing magnesium or aluminum, such as antacids for indigestion, or any medicine containing iron or zinc, medicines containing didanosine, or medicines containing sucralfate for gastrointestinal disorders may reduce the effect of Moxifloxacino Qualigen tablets. Therefore, take your Moxifloxacino Qualigen tablets 6 hours before or after taking other medicines.
• Taking medicinal activated charcoal orally at the same time as Moxifloxacino Qualigen 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 Qualigen with food and drink

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

Pregnancy, breastfeeding, and fertility

Do not use Moxifloxacino Qualigen 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 your fertility could be affected by taking this medicine.

Driving and use of machines

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

3. How to take Moxifloxacino Qualigen

Follow exactly the instructions for use of this medicine provided 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 Qualigen tablets are for oral administration. Swallow the tablet whole without chewing (to mask the bitter taste) and with plenty of liquid. Moxifloxacino Qualigen 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 required 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 Qualigen is as follows:

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

When Moxifloxacino Qualigen is used to complete a treatment initiated with moxifloxacino perfusion solution, the recommended durations are:

• Community-acquired pneumonia (lung infections): 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, it may return, 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 Qualigen, Warnings and precautions).

If you take more Moxifloxacino Qualigen 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, the packaging, or this leaflet, and show it to your doctor or pharmacist to indicate 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 taken.

If you forget to take Moxifloxacino Qualigen

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

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

If you stop taking Moxifloxacino Qualigen

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

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

4. Possible adverse effects

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

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

If you notice

• abnormally fast heartbeat (rare adverse effect)
• a sudden feeling of illness or notice yellowing of the whites of the eyes, dark urine, skin itching, tendency to bleed, or disturbances in thinking or level of consciousness (these may be signs and symptoms of fulminant hepatitis which could potentially lead to potentially fatal liver failure (very rare adverse effect; fatal cases have been observed))
• severe skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as reddish macules in the shape of targets or circular spots, often with blisters in the center, skin peeling, mouth ulcers, and ulcers in the throat, nose, genitals, and eyes, and may be preceded by fever and flu-like symptoms (very rare adverse effects, potentially life-threatening)
• a widespread red, scaly rash with bumps under the skin and blisters accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis) (frequency of this adverse effect is "not known")
• widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), 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 disturbances in water elimination 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, very rarely including 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 serious)
• seizures (rare adverse effect)
• nervous system problems such as pain, burning, tingling, numbness, and/or weakness in the limbs (rare adverse effect)
• depression (in very rare cases, this has progressed to self-harm, suicidal ideation/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 (very 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 you also feel unwell, have fever, or dark urine. These symptoms may be caused by abnormal muscle breakdown that can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis) (frequency of this adverse effect is "not known")

stop taking Moxifloxacino Qualigen and contact your doctor immediately as you may require urgent medical attention.

Additionally, if you notice

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

Contact an ophthalmologist immediately.

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

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

If you have diabetes and notice that your blood sugar levels increase or decrease (a 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), consult your doctor immediately.

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

Frequent (may affect up to 1 in 10 people)

• nausea
• diarrhea
• dizziness
• abdominal and stomach pain
• vomiting
• headache
• increased 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/heartburn)
• altered taste (in very rare cases, loss of taste)
• sleep disorders (mainly insomnia)
• increased liver enzyme in blood (gamma-glutamyl transferase and/or alkaline phosphatase)
• low levels of certain white blood cells (leukocytes, neutrophils)
• constipation
• itching
• sensation of vertigo (spinning sensation and feeling of falling)
• drowsiness
• flatulence
• change in heart rhythm (ECG)
• impaired liver function (including increased 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 conditions
• increased level of 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
• decreased blood clotting
• increased blood lipids (fats)
• low red blood cell count
• muscle pain
• allergic reactions
• increased bilirubin in blood
• inflammation of the stomach (gastritis)
• dehydration
• serious 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 disorders (including increased kidney function tests such as urea and creatinine)
• liver inflammation
• mouth inflammation
• ringing or noise in the ears
• jaundice (yellowing of the whites of the eyes or skin)
• disturbances in skin sensitivity
• abnormal dreams
• concentration disorders
• difficulty swallowing
• smell disorders (including loss of smell)
• balance disorders and lack of coordination (due to dizziness)
• total or partial memory loss
• hearing impairments including deafness (usually reversible)
• increased uric acid in blood
• emotional instability
• speech disorders
• fainting
• muscle weakness

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

• decreased number of red blood cells, white blood cells and platelets (pancytopenia)
• joint inflammation
• irregular heart rhythm
• increased skin sensitivity to light
• depersonalization disorder (feeling of not being oneself)
• increased blood clotting
• muscle rigidity
• significant decrease in certain white blood cells (agranulocytosis)

Frequency not known (cannot be estimated from available data)

• increased sensitivity of the skin to sunlight or UV radiation (see also section Warnings and precautions)

well-defined erythematous patches with or without blisters appearing within hours after administration of moxifloxacin and disappearing with post-inflammatory residual hyperpigmentation; these usually reappear in the same area of skin or mucosa 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, crawling, burning, numbness or pain (neuropathy), fatigue, decreased memory and concentration, effects on mental health (which may include sleep disorders, anxiety, panic attacks, depression and suicidal ideation), 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 also possibly occur during treatment with Moxifloxacino Qualigen: increased intracranial pressure (symptoms include headache, visual disturbances such as blurred vision, blind spots, double vision, vision loss), increased blood levels of sodium and calcium, reduced count of a specific type of red blood cells (hemolytic anemia).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines, www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Moxifloxacin Qualigen

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

Do not use this medicine after the expiry date which is stated on the blister pack and the carton after EXP. The expiry date refers to 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 unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Moxifloxacino Qualigen

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

• The other components are:

• Tablet core: microcrystalline cellulose, mannitol (E-421), colloidal silicon dioxide, sodium starch glycolate (potato), hydroxypropylcellulose, magnesium stearate.

• Film coating: microcrystalline cellulose, sodium starch glycolate (potato), talc, magnesium stearate.

Appearance of the product and pack contents

Pink, oblong, biconvex film-coated tablets.

The tablets are supplied in aluminum/aluminum blisters.

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

Only certain 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 latest review of this leaflet: May 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/ .