MOXIFLOXACIN PENSA 400 mg FILM-COATED TABLETS

Introduction

Package Leaflet:information for the user

Moxifloxacin Pensa 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, ask 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.

Contents of the package leaflet

1. What is Moxifloxacin Pensa and what is it used for
2. What you need to know before taking Moxifloxacin Pensa
3. How to take Moxifloxacin Pensa
4. Possible side effects

5 Storage of Moxifloxacin Pensa

1. Contents of the pack and additional information

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

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

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

• Sinus infection, sudden worsening of long-term inflammation of the airways, 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 Pensa is not sufficient as the only treatment; therefore, in addition to Moxifloxacin Pensa, 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 Pensa" "Warnings and precautions" "Consult your doctor before taking Moxifloxacin Pensa").

If the following diseases have shown improvement during initial treatment with moxifloxacin solution for infusion, your doctor may prescribe Moxifloxacin Pensa film-coated tablets to complete the treatment:

• Community-acquired pneumonia,
• skin and soft tissue infections.

Moxifloxacin Pensa film-coated tablets 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 you start taking Moxifloxacino Pensa

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

Do not take Moxifloxacino Pensa:

If you are allergic to the active ingredient moxifloxacino or to other quinolones or to any of the other components of this medication (included in section 6).

• 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 section Warnings and precautionsand section 4. Possible adverse effects).
• If you suffer from any inherited disease or have suffered:

• any disease related to an abnormal heart rhythm (observed in ECG, electrical record of the heart),
• suffer from 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 disorders
• are taking other medications that produce disorders in the ECG (see section Other medications and Moxifloxacino Pensa). This is because moxifloxacino can cause changes in the ECG, such as a prolongation of the QT interval, i.e., delay in the conduction of electrical signals in the heart.

• If you suffer from a severe liver disease or increased levels of liver enzymes (transaminases) 5 times above the upper limit of normality.

Warnings and precautions

Before starting to take this medication:

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

Consult your doctor before taking moxifloxacino

• Moxifloxacino may modify the ECG of the heart, especially if you are a woman or an elderly patient. If you are currently taking any medication that leads to a decrease in potassium levels in the blood, consult your doctor before taking this medication. (see also Do not take Moxifloxacino Pensaand Other medications and Moxifloxacino Pensa)

• If you have ever developed a severe skin rash or skin peeling, blisters, and/or sores in the mouthafter taking moxifloxacino.

• If you suffer from epilepsyor any other condition that may cause you to have seizures, consult your doctor before taking Moxifloxacino Pensa.

• If you have or have ever had any mental health problems, consult your doctor before taking Moxifloxacino Pensa.

• If you have myasthenia gravis(abnormal muscle fatigue leading to weakness and severe cases of paralysis), your symptoms may worsen if you take moxifloxacino. If you think this affects you, consult your doctor immediately.

• If you have been diagnosed with an enlargement or a “lump” of a large blood vessel(aortic aneurysm or large peripheral vessel aneurysm).

• If you have suffered a previous episode of aortic dissection(tear in the aortic wall).

• If you have a family history of aortic aneurysm or aortic dissection, congenital heart valve diseaseor 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 are diabeticbecause you may experience a risk of change in blood sugar levelswith moxifloxacino.

• If you or a family member suffers from glucose-6-phosphate dehydrogenase deficiency(a rare inherited disease), inform your doctor, who will indicate if moxifloxacino is suitable for you.

• If you have a complicated infection of the upper female genital tract(associated with an abscess in the fallopian tubes and ovary or pelvis), for which your doctor considers intravenous treatment necessary, treatment with moxifloxacino tablets is not appropriate.

• For the treatment of a mild to moderate infection of the upper female genital tract, your doctor should prescribe another antibiotic along with Moxifloxacino Pensa. If after three days of treatment you do not notice an improvement in symptoms, consult your doctor.

• If you have been diagnosed with a heart valve insufficiency (regurgitation of the heart valves).

During treatment with Moxifloxacino Pensa

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 an increase in dose. Therefore, you should take the recommended dose.

In rare cases, you may experience a severe allergic reaction(anaphylactic reaction or shock) even with the first dose, and develop the following symptoms: chest tightness, dizziness, nausea, or fainting, or feel dizzy when standing up. If you experience these symptoms, stop taking Moxifloxacino Pensa and consult your doctor immediately.

Moxifloxacino may cause a rapid and severe liver inflammation, which can lead to liver failure that puts your life at risk (including fatal cases, see section 4 Possible adverse effects). Please consult your doctor before continuing treatment if you develop symptoms such as sudden 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).

Severe skin reactions

Severe skin reactions have been reported, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), and drug reaction with eosinophilia and systemic symptoms (DRESS or drug hypersensitivity syndrome) 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 start 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.
• Drug reaction with eosinophilia and systemic symptoms (DRESS) appears initially with pseudo-flu-like symptoms and a rash on the face, later a widespread rash with high body temperature, increased liver enzyme levels in blood tests, and increased eosinophilia and swelling of the lymph nodes.

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

Quinolone antibiotics, including Moxifloxacino Pensa, may cause seizures. If this occurs, treatment with moxifloxacino should be discontinued and you should contact your doctor immediately.

Severe, disabling, and potentially irreversible adverse effects

Antibacterial medications that contain fluoroquinolones or quinolones, including Moxifloxacino Pensa, have been associated with very rare but severe 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, prickling, 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 adverse effects after taking Moxifloxacino Pensa, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or not with the treatment, also considering the use of an antibiotic of another class.

In rare cases, you may experience symptoms of nerve damage (neuropathy)such as pain, burning, tingling, numbness, and/or weakness, especially in feet and legs or hands and arms. If this happens, stop taking Moxifloxacino Pensa 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. In very rare cases, mental health problems and depression have evolved into suicidal thoughts and self-harming behaviors such as attempted suicide (see section 4 Possible adverse effects). If you develop these reactions, you should discontinue treatment with moxifloxacino and inform your doctor immediately.

You may develop diarrheaduring or after taking antibiotics, including Moxifloxacino Pensa. If the diarrhea is severe or persistent, or if you notice blood or mucus in the stool, stop taking Moxifloxacino Pensa immediately 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 appear (see section Do not take Moxifloxacino Pensaand 4. Possible adverse effects). The risk is greater 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 discontinuing treatment with Moxifloxacino Pensa. At the first sign of pain or inflammation of a tendon (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Moxifloxacino Pensa, contact your doctor, and rest the affected area. Avoid any unnecessary exercise, as this could increase the risk of tendon rupture.

If you feel a strong and sudden pain in the abdomen, chest, or back, which can 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 experiencing 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.

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 worsensor if your eyes seem to be affected, consult an ophthalmologist immediately (see sections 2 Driving and using machinesand 4. Possible adverse effects).

Fluoroquinolones may cause an increase in your blood sugar levelsabove normal levels (hyperglycemia) or a decrease in your blood sugar levelsbelow normal levels (hypoglycemia), which in severe cases can cause loss of consciousness (hypoglycemic coma) (see section 4. Possible adverse effects). If you have diabetes, your blood sugar levels should be carefully controlled.

Quinolone antibiotics may increase the sensitivity of the skin to sunlight or UV. You should avoid prolonged exposure to sunlight or direct sunlight and not use sunbeds or any type of UV lamp during the administration of Moxifloxacino Pensa (see section 4. Possible adverse effects).

The efficacy of moxifloxacino has not been established in the treatment of severe burns, deep tissue infections, and diabetic foot infections with osteomyelitis (bone marrow infections).

Children and adolescents

Do not give this medication to children and adolescents under 18 years old because the efficacy and safety have not been established for this age group (see section Do not take Moxifloxacino Pensa).

Other medications and Moxifloxacino Pensa

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

When taking moxifloxacino, consider the following:

• If you are taking Moxifloxacino Pensa and other medications that affect the heart, there is a greater risk that heart rhythm disorders may occur. Therefore, you should not take moxifloxacino at the same time as the following medications:
• medications that belong to the class of antiarrhythmics (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide),
• antipsychotics (e.g., phenothiazines, pimozide, sertindole, haloperidol, sultopride),
• tricyclic antidepressants,
• some antimicrobials (e.g., saquinavir, sparfloxacin, erythromycin administered intravenously, pentamidine, antimalarials, particularly halofantrine),
• some antihistamines (terfenadine, astemizole, mizolastine)
• other medications (e.g., cisapride, intravenous vincamine, bepridil, and difemanil).

• You should inform your doctor if you are taking other medications that may decrease potassium levels in the blood (e.g., loop and thiazide diuretics, laxatives and enemas (high doses), corticosteroids (anti-inflammatory medications), amphotericin B) or cause a decrease in heart rate, as these may also increase the risk of severe heart rhythm disorders while taking Moxifloxacino Pensa.

• Any other medication that contains magnesium or aluminum, such as antacids for indigestion, or any medication that contains iron or zinc, medications that contain didanosine or medications that contain sucralfate for gastrointestinal disordersmay reduce the action of moxifloxacino tablets. Therefore, take your Moxifloxacino Pensa tablets 6 hours before or after taking other medications.

• Taking activated charcoalorally at the same time as Moxifloxacino Pensa tablets reduces their action. It is recommended not to use these medications simultaneously.

• If you are currently taking oral anticoagulants(e.g., warfarin), your doctor may need to monitor your blood coagulation time.

Moxifloxacino Pensa with food and drinks

Moxifloxacino can be taken with or without food (including dairy products).

Pregnancy, breastfeeding, and fertility

Do not use Moxifloxacino Pensa if you are pregnant or 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 medication.

Animal studies do not indicate that fertility may be altered when taking this medication.

Driving and using machines

Moxifloxacino 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.

This medication may cause allergic reactions, as it contains Yellow Orange S (E 110) and Ponceau 4R (E 124). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Moxifloxacino Pensa contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per unit dose; it is essentially “sodium-free”.

3. How to take Moxifloxacino Pensa

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 Pensa tablets are for oral administration. Take the tablet whole without chewing (to mask the bitter taste) and with plenty of liquid. Moxifloxacino can be taken with or without food. It is recommended 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 is as follows:

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

When Moxifloxacino Pensa film-coated tablets are used to complete a treatment started with moxifloxacino solution for infusion (intravenous treatment), the recommended durations are:

• Pneumonia acquired outside the hospital: 7-14 days. Most patients with pneumonia switched from intravenous to oral treatment after 4 days.
• Skin and soft tissue infections: 7-21 days. Most patients with skin and soft tissue infections switched from intravenous to oral treatment after 6 days.

It is important to complete the full treatment, even if you start to feel better after a few days. If you interrupt treatment too soon, 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 Pensa, Warnings and precautions).

If you take more Moxifloxacino Pensa than you should

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

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

If you forget to take Moxifloxacino Pensa

In case of forgetting 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 a double dose to make up for the forgotten dose. If you are unsure of what to do, consult your doctor or pharmacist.

If you stop taking Moxifloxacino Pensa

If you stop taking this medication too soon, 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 effects observed during treatment with moxifloxacino are listed below:

If you notice

• an abnormal rapid heart rate (rare side effect)
• that you suddenly start feeling unwell or notice yellowing of the whites of the eyes, dark urine, skin itching, tendency to bleed, or alterations in thought or wakefulness (these can be signs and symptoms of a severe liver inflammation that can lead to life-threatening liver failure)
• 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 side effects, potentially life-threatening)
• 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")
• a widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and involvement of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome) (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)
• 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)
• a severe and sudden generalized allergic reaction, including very rarely life-threatening shock (e.g., difficulty breathing, low blood pressure, rapid pulse) (rare side effect)
• swelling, including inflammation of the airways (rare side effect, potentially fatal)
• seizures (rare side effect)
• problems associated with the nervous system, such as pain, burning, tingling, numbness, and/or weakness in the limbs (rare side effect)
• depression (in very rare cases leading to self-harm, such as suicidal thoughts or attempts) (rare side effect)
• dementia (which can potentially lead to self-harm, such as suicidal thoughts or attempts) (very rare side effect)
• severe diarrhea with blood and/or mucus (antibiotic-associated colitis, including pseudomembranous colitis), which in very rare circumstances can become life-threatening complications (rare side effects)
• tendon pain and inflammation (tendinitis) (rare side effect) or tendon rupture (very rare side effect)
• muscle weakness, sensitivity, or pain, particularly if you also feel unwell, have a fever, or your urine is dark. These symptoms 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")

Stop taking Moxifloxacino Pensa and inform your doctor immediatelyas you may need urgent medical attention.

Additionally, if you notice

• transient loss of vision (very rare side effect),
• discomfort or pain in the eyes, especially due to light exposure (very rare to rare side effect).

contact an eye specialist immediately.

If you have experienced potentially life-threatening irregular heartbeats (Torsade de Pointes) or interruption of heartbeats while taking Moxifloxacino Pensa (very rare side effects), inform your doctor immediately that you have taken Moxifloxacino Pensa and do not restart treatment.

A worsening of myasthenia gravis symptoms has been observed in very rare cases. If this happens, consult your doctor immediately.

If you have diabetes and notice that your blood sugar level increases or decreases (rare or very rare side effects), inform your doctor immediately.

If you are elderly with existing kidney problems and observe a decrease in urine production, swelling in the legs, ankles, or feet, fatigue, nausea, drowsiness, difficulty breathing, or confusion (these can be signs and symptoms of kidney failure, a rare side effect), consult your doctor immediately.

The following are other side effectsthat have been observed during treatment with Moxifloxacino Pensa, according to their frequency:

Common side effects(may affect up to 1 in 10 patients):

• nausea;
• diarrhea;
• dizziness;
• stomach and abdominal pain;
• vomiting;
• headache (cephalalgia);
• increase in certain liver enzymes in blood (transaminases);
• infections caused by resistant bacteria or fungi, e.g., oral and vaginal infections caused by Candida (oral candidiasis);
• change in heart rhythm (ECG) in patients with low potassium levels in the blood.

Uncommon side effects(may affect up to 1 in 100 patients):

• rash;
• gastric discomfort (indigestion/acid reflux);
• alteration of taste (in very rare cases, loss of taste);
• sleep disorders (predominantly insomnia);
• increase in a liver enzyme in blood (gamma-glutamyltransferase and/or alkaline phosphatase);
• low levels of certain white blood cells (leukocytes, neutrophils);
• constipation;
• itching;
• feeling of vertigo (that everything is spinning or that you are falling);
• drowsiness;
• flatulence;
• change in heart rhythm (ECG);
• alteration of liver function (including increase in liver enzyme in blood, LDH);
• decreased appetite and food intake;
• low white blood cell count;
• pains and aches in the back, limbs, pelvis, and chest;
• increase in certain blood cells necessary for blood clotting;
• sweating;
• increase in certain white blood cells (eosinophils);
• anxiety;
• discomfort (mainly weakness or fatigue);
• tremors;
• joint pain;
• palpitations;
• irregular and rapid heartbeat;
• breathing difficulties, including asthmatic conditions;
• increase in a digestive enzyme in the blood (amylase);
• restlessness/agitation;
• tingling and/or numbness sensation;
• skin rash;
• dilation of blood vessels;
• confusion and disorientation;
• decrease in blood cells necessary for blood clotting;
• vision disorders, such as double vision and blurred vision;
• decrease in blood clotting;
• increase in blood lipids (fats);
• low red blood cell count;
• muscle pain;
• allergic reactions;
• increase in bilirubin in the blood;
• stomach inflammation (gastritis);
• dehydration;
• severe heart rhythm disorders;
• dry skin;
• chest pain.

Rare side effects(may affect up to 1 in 1,000 patients):

• muscle cramps;
• muscle contractures;
• hallucinations;
• increase in blood pressure;
• swelling (of hands, feet, ankles, lips, mouth, and throat);
• decrease in blood pressure;
• kidney disorders (including increase in laboratory test results for the kidneys, such as urea and creatinine);
• liver inflammation;
• mouth inflammation;
• ringing/ noises in the ears;
• jaundice (yellowing of the whites of the eyes or skin);
• alterations in skin sensitivity;
• abnormal dreams;
• concentration disorders;
• difficulty swallowing;
• alterations in smell (including loss of smell);
• balance and coordination disorders (due to dizziness);
• total or partial loss of memory;
• hearing impairments, including deafness (usually reversible);
• increase in uric acid in the blood;
• emotional instability;
• speech disorders;
• fainting;
• muscle weakness.

Very rare side effects(may affect up to 1 in 10,000 patients):

• joint inflammation;
• irregular heart rate;
• increase in skin sensitivity;
• feeling of depersonalization (not being oneself);
• increase in blood clotting;
• muscle stiffness;
• significant decrease in a type of white blood cell (agranulocytosis).
• decrease in the number of red and white blood cells and platelets (pancytopenia).

Frequency not known (cannot be estimated from the available data)

• increased sensitivity of the skin to sunlight or UV radiation (see also section 2, Warnings and precautions)
• well-defined erythematous patches with/without blisters that appear in the hours following administration of moxifloxacino and disappear with residual post-inflammatory hyperpigmentation; they usually reappear in the same place on the skin or mucous membranes with subsequent exposure to moxifloxacino

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 (which can include 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 Pensa: increased pressure in the skull (symptoms include headache, visual problems such as blurred vision, "blind spots", double vision, loss of vision), increased sodium levels in the blood; increased calcium levels in the blood; reduced count of certain red blood cells (hemolytic anemia).

Cases of increased size and weakening or tearing of the aortic wall (aneurysms and dissections) have been reported, which could lead to rupture and be fatal, and cardiac valve insufficiency 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 that does not appear in this leaflet. You can also report them directly through the national reporting system www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Moxifloxacino Pensa

Keep this medication out of sight and reach of children.

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

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Moxifloxacino Pensa

• The active ingredient is moxifloxacino as hydrochloride. Each film-coated tablet contains 436.8 mg of moxifloxacino hydrochloride, equivalent to 400 mg of moxifloxacino.
• Other components are:
• 1. - Tablet core: Mannitol (E 421), Microcrystalline cellulose, Sodium croscarmellose, Anhydrous colloidal silica, Magnesium stearate.
  2. - Film coating: Polyvinyl alcohol (E 1203), Macrogol 4000 (E 1521), Talc (E 553b), Titanium dioxide (E 171), Orange yellow (E 110), Ponceau 4R red (E 124), Aluminum lake indigo carmine (E 132).

Appearance of the product and package contents

Light reddish-pink, oblong, convex film-coated tablets marked with "MOXI" on one side and "400" on the other side.

The film-coated tablets are available in PVC-PVDC/Aluminum blisters, with 5 or 7 film-coated tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Bluepharma - Indústria Farmacêutica, S.A.

• Martinho do Bispo

3045-016 Coimbra

Portugal

This medication is authorized in the Member States of the European Economic Area under the following names:

Spain: Moxifloxacino Pensa 400 mg film-coated tablets EFG

Italy: Moxifloxacina Pensa

Date of the last revision of thisleaflet:June 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