Moxifloxacino pensa 400 mg comprimidos recubiertos con pelicula efg

Prospecto:information for the user

Moxifloxacino Pensa 400 mg film-coated tablets EFG

Read this prospectus carefully before starting to take this medicine,because it contains important information for you.

• Keep this prospectus, as you may need to read it again. If you have any doubts, consult yourdoctor orpharmacist.

-This medicine has been prescribedonlyto you, and you must not give it to others even if they havethe same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist,evenif they are not listed in this prospectus. See section 4.

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

2.What you need to knowbeforestarting totake Moxifloxacino Pensa

3.How to take Moxifloxacino Pensa

4.Possible adverse effects

5Storage of Moxifloxacino Pensa

6.Contents of the package and additional information

Moxifloxacino Pensa contains moxifloxacino as the active ingredient, which belongs to the group of antibiotics known as fluoroquinolonas. Moxifloxacino Pensa acts by eliminating bacteria that cause infections.

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

• Paranasal sinus infection, sudden worsening of chronic inflammation of the airways, or community-acquired pneumonia (except severe cases).
• Mild to moderate upper genital tract infections in females (inflammatory pelvic disease), including fallopian tube infection and uterine mucous membrane infection.

For this type of infection, Moxifloxacino Pensa is not sufficient as a single treatment, so your doctor will need to prescribe another antibiotic for the treatment of mild to moderate upper genital tract infections in females (see section “2. What you need to know before starting to take Moxifloxacino Pensa” “Warnings and precautions”, “Consult your doctor before takingMoxifloxacino Pensa”).

If the following diseases have shown improvement during initial treatment with moxifloxacino solution for infusion, your doctor may prescribe Moxifloxacino Pensa tablets to complete the treatment:

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

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

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

Do not take Moxifloxacino Pensa:

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

• If you are pregnant or breastfeeding.
• If you are under 18 years old.
• If you have a history of tendon alterations or injuries related to antibiotic quinolone treatment (see sectionWarnings and precautionsand section4. Possible side effects).
• If you have a hereditary disease or have suffered:

• any disease related to an abnormal heart rhythm (observed on ECG, heart 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 heart failure,
• have a history of heart rhythm alterations
• are taking other medications that cause ECG disturbances (see sectionOther medications and Moxifloxacino Pensa). This is because moxifloxacino can cause changes in the ECG, such as a prolongation of the QT interval, that is, a delay in the conduction of electrical signals in the heart.

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

Warnings and precautions

Before starting to take this medication:

Do not take fluoroquinolone or quinolone antibiotics, including Moxifloxacino Pensa, if you have had a severe reaction to a quinolone or fluoroquinolone in the past. If this is your case, inform your doctor as soon as possible.

Consult your doctor before taking moxifloxacino

• Moxifloxacinomay modify the heart ECG, especially if you are a woman or an elderly patient. If you are currently taking any medication that causes a decrease in blood potassium levels,consult your doctor before taking this medication. (see alsoNo take Moxifloxacino PensaandOther medications and Moxifloxacino Pensa)

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

• If you suffer fromepilepsyor another condition that may causeseizures, consult your doctor before taking Moxifloxacino Pensa.

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

• If you havemyasthenia gravis(abnormal muscle fatigue leading to weakness and severe 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 alarge blood vessel aneurysm(aortic aneurysm or a large peripheral artery aneurysm).

• If you have had a previous episode ofaortic dissection(tear in the aorta wall).

• If you have a family history ofaortic aneurysm or aortic dissection, congenital heart valve diseaseor other risk factors or predisposing conditions (e.g., Marfan syndrome or Ehlers-Danlos vascular syndrome, Turner syndrome or Sjögren syndrome (an autoimmune inflammatory disease), or vascular conditions such as Takayasu arteritis, giant cell arteritis, Behçet disease, hypertension, known atherosclerosis, rheumatoid arthritis (a joint disease) or endocarditis (a heart infection)).

• If you arediabeticbecause you may experience a risk ofblood sugar level changeswith moxifloxacino.

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

• If you have acomplicated upper genital tract infection in women(associated with a Fallopian tube and ovarian abscess or pelvic abscess), for which your doctor considers intravenous treatment, oral moxifloxacino treatment is not appropriate.

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

• If you have been diagnosed with heart valve insufficiency (valve regurgitation).

During treatment with Moxifloxacino Pensa

If you noticepalpitations or irregular heartbeatsduring the treatment period, inform your doctor immediately. This may perform an ECG to measure heart rate.

Therisk of heart problemsmay increase with increasing doses. Therefore, take the recommended dose.

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

Moxifloxacino may cause arapid and severe liver inflammation, which may lead to liver failure that puts your life at risk (including fatal cases, see section 4. Possible side effects). Please consult your doctor before continuing treatment if you develop symptoms such as sudden discomfort and/or discomfort associated with yellowing of the whites of the eyes, dark urine, itching, or a tendency to bleed, liver damage-induced cerebral disease (symptoms of reduced liver function or severe liver inflammation).

Severe skin reactions

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis (NET), and generalized acute pustular psoriasis (PEGA) and drug reaction with eosinophilia and systemic symptoms (DRESS or drug hypersensitivity syndrome), have been reported with the use of moxifloxacino.

• SSJ / NET may initially appear on the trunk as red, ring-shaped lesions or circular patches often with central blisters. They may also appear ulcers in the mouth, throat, nose, genitals, and eyes (red and swollen eyes). These severe skin eruptions often precede fever and/or flu-like symptoms. The eruptions may progress to generalized skin peeling and complications that may put your life at risk or be fatal.
• PEGA appears at the beginning of treatment as a red, scaly, and generalized rash with subcutaneous nodules and blisters accompanied by fever. The most common location: mainly localized in skin folds, trunk, and upper limbs.
• DRESS initially appears with flu-like symptoms and a rash on the face, followed by a widespread rash with high body temperature, increased liver enzymes in blood tests, and increased eosinophils, and enlarged lymph nodes.

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

Antibiotics, including moxifloxacino, may cause seizures. If this occurs, treatment with moxifloxacino must be stopped and you must contact your doctor immediately.

Severe, prolonged, and potentially irreversible effects

Fluoroquinolone or quinolone antibiotics, including Moxifloxacino Pensa, have been associated with rare but severe side effects, some of which were persistent for months or years, disabling, or potentially irreversible. This includes tendon pain, muscle and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pinpricks, numbness, tingling, or burning (paresthesia), sensory disturbances such as decreased vision, taste, smell, and hearing, depression, decreased memory, intense fatigue, and severe sleep disturbances.

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

In rare cases, you may experience symptoms ofnerve damage (neuropathy)such as pain, burning, numbness, tingling, and/or weakness, especially in the 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 condition.

You may experiencemental health problemseven after the first administration of quinolone antibiotics, including moxifloxacino. In rare cases, mental health problems and depression have evolved into suicidal thoughts and self-harm behaviors such as attempted suicide (see section 4. Possible side effects). If you develop these reactions, treatment with moxifloxacino must be stopped and you must inform your doctor immediately.

You may developdiarrheaduring or after taking antibiotics, including Moxifloxacino Pensa. If 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, do not take medications that slow down or stop intestinal movement.

In rare cases, you may experiencejoint pain and swelling, inflammation, or tendon rupture(see sectionNo take Moxifloxacino Pensaand section 4. Possible side effects). The risk is higher if you are an elderly person (over 60 years old), have received an organ transplant, have kidney problems, or are taking corticosteroids. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even several months after stopping treatment with Moxifloxacino Pensa. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Moxifloxacino Pensa, contact your doctor, and keep the painful area at rest. Avoid unnecessary exercise, as this may increase the risk of tendon rupture.

If you experiencesevere abdominal, chest, or back pain, which may be symptoms of aortic dissection or aneurysm, seek immediate medical attention. You may be at increased risk if you are taking corticosteroids.

If you start experiencing sudden shortness of breath, especially when lying down, or if you notice swelling in the ankles, feet, or abdomen, or palpitations, inform your doctor immediately.

If you are an elderly person with kidney problems, be careful to ensure adequate fluid intake, as dehydration may increase the risk of kidney failure.

If yourvision worsensor if your eyes appear to be affected, consult an ophthalmologist immediately (see sections 2. Driving and operating machineryand 4.. Possible side effects).

Fluoroquinolones may causean increase in your blood sugar levelsabove normal levels (hyperglycemia), ordecrease in your blood sugar levelsbelow normal levels (hypoglycemia), which in severe cases may cause loss of consciousness (hypoglycemic coma) (see section 4.. Possible side effects). If you are diabetic, your blood sugar levels must be carefully controlled.

Quinolone antibioticsmay increase skin sensitivity to sunlight or UV. Avoid prolonged exposure to sunlight or direct sunlight and do not use sunbeds or any type of UV lamp during Moxifloxacino Pensa administration (see section 4. Possible side effects).

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

Children and adolescents

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

Other medications and Moxifloxacino Pensa

Inform your doctor or pharmacist if you aretaking, havetakenrecentlyor may have to take any other medication.

With moxifloxacino, you should be aware of the following:

• If you are taking Moxifloxacino Pensa and othermedications that affect the heart, there is a higher risk of heart rhythm alterations. Therefore, do not take moxifloxacino at the same time as the following medications:
• antiarrhythmic medications (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide),
• antipsychotics (e.g., phenothiazines, pimozide, sertindol, 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, vincamine intravenously, bepridil, and difemanil).

• Inform your doctor if you are taking other medications that may decrease blood potassium levels (e.g., diuretics and thiazide type, 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 alterations while taking Moxifloxacino Pensa.

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

• The oral administration ofactivated charcoalat the same time as Moxifloxacino Pensa tablets reduces their action.It is recommended not to use these medications simultaneously.

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

Moxifloxacino Pensawith food and drinks

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

Pregnancy, lactation, and fertility

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

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

Driving and operating machinery

Moxifloxacino may cause dizziness or vertigo or a brief 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.

Follow exactly the administration instructions of this medication 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 to take the tablet approximately at the same time every day.

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

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

- Sudden worsening of chronic obstructive pulmonary disease, including bronchitis: 5– 10 days.

- Community-acquired pneumonia (excluding severe cases): 10 days.

- Acute bacterial sinusitis: 7 days.

- Mild to moderate upper genital tract infections in females (pelvic inflammatory disease), including fallopian tube infection and uterine mucous membrane infection: 14 days.

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

- Community-acquired pneumonia: 7-14 days. Most patients with pneumonia switched from intravenous to oral treatment after 4 days.

- 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 essential to complete the treatment, even if you start feeling better after a few days. If you interrupt the treatment too soon, the infection may not be fully cured, the infection may recur, or your condition may worsen, and it may also lead to bacterial resistance to the antibiotic.

Do not exceed the recommended dose and duration of treatment (see section 2.What you need to know before starting to take 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, bring the remaining medication, the packaging, or this leaflet to show the doctor or pharmacist what you have taken.

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

If you forget to take Moxifloxacino Pensa

In case of forgotten dose, take it as soon as you remember on the same day. If you miss a dose, take the normal dose (one tablet) the next day.

Do not take a double dose to compensate for the missed dose. If you are unsure of what to do, consult your doctor or pharmacist.

If you interrupt the treatment with Moxifloxacino Pensa

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

If you have any other questions about the use of thismedication, ask your doctororpharmacist.

Like all medicines, this medicine 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 feel unwell or notice yellowing of the white of the eyes, dark urine, itching, a tendency to bleed, or alterations in thought or vigilance (these may be signs and symptoms of a fulminant liver inflammation that can lead to life-threatening liver failure (very rare side effect, fatal cases have been observed).

•severe skin eruptions including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as red target-shaped macules or circular patches often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers, and may be preceded by fever and flu-like symptoms (very rare side effects, potentially life-threatening)

•a red, scaly, and generalized rash with bumps under the skin and blisters accompanied by fever at the start of treatment (acute generalized pustular psoriasis) (the frequency of this side effect is "unknown")

•generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and organ damage (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug-induced hypersensitivity syndrome) (the frequency of this side effect is “unknown”)

•syndrome associated with water loss and low sodium levels (SIADH) (very rare side effect)

•loss of consciousness due to severe low blood sugar levels (hypoglycemic coma) (very rare side effect)

•inflammation of blood vessels (the signs may be red patches on the skin, usually on the legs or effects such as joint pain)

• a severe and sudden generalized allergic reaction, including very rarely life-threatening shock (for example, difficulty breathing, low blood pressure, rapid pulse)

• swelling including inflammation of the respiratory tract (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)

• dementia (which may potentially lead to self-harm, such as suicidal thoughts or attempts)

• severe diarrhea with blood and/or mucus (antibiotic-associated colitis, including pseudomembranous colitis), which in very rare cases may lead to life-threatening complications (rare side effects)

• muscle pain and inflammation (tendinitis) (rare side effect) or tendon rupture (very rare side effect)

• weaknessmuscle, sensitivity, or pain, particularly if you also feel unwell, have fever, or your urine is dark. These symptoms may be caused by abnormal muscle breakdown that can put your life at risk and cause kidney problems (a condition called rhabdomyolysis) (the frequency of this side effect is "unknown")

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),
• eye discomfort or pain, especially due to exposure to light (rare to very 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.

There have been cases of worsening of myasthenia gravis symptoms in very rare cases. If this happens,consult your doctor immediately.

If you have diabetes and notice that your blood sugar levels increase or decrease (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 may 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:

Frequent 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 the blood (transaminases);
• infections caused by resistant bacteria or fungi, e.g. oral and vaginal infections caused by Candida (candidiasis);
• change in heart rhythm (ECG) in patients with low potassium levels in the blood.

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

• skin rash;
• indigestion (acid reflux);
• alteration of taste (in very rare cases, loss of taste);
• sleep disturbances (predominantly insomnia);
• increase in a liver enzyme in the blood (gamma-glutamyltransferase and/or alkaline phosphatase);
• low levels of certain white blood cells (leukocytes, neutrophils);
• constipation;
• itching;
• sensation of vertigo (feeling of spinning or falling);
• drowsiness;
• flatulence;
• change in heart rhythm (ECG);
• liver function alteration (including increase of a liver enzyme in the blood, LDH);
• decreased appetite and food intake;
• low white blood cell count;
• joint and back pain, limb, pelvis, and chest pain;
• increase in certain blood cells necessary for blood coagulation;
• sweating;
• increase in eosinophils;
• anxiety;
• uncomfortable feeling (mainly weakness or fatigue);
• tremors;
• joint pain;
• irregular heartbeat;
• difficulty breathing, including asthma-like states;
• increase in a digestive enzyme in the blood (amylase);
• restlessness/agitation;
• sensation of tingling and/or numbness;
• skin rashes;
• dilation of blood vessels;
• confusion and disorientation;
• decrease in blood cells necessary for blood coagulation;
• eye disorders, such as double vision and blurred vision;
• decreased blood coagulation;
• increase in blood lipids (fats);
• low red blood cell count;
• muscle pain;
• allergic reactions;
• increase in bilirubin in the blood;
• inflammation of the stomach (gastritis);
• dehydration;
• severe alterations in heart rhythm;
• dry skin;
• angina pectoris.

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 function alterations (including increase in laboratory test results for the kidneys, such as urea and creatinine);
• inflammation of the liver;
• inflammation of the mouth;
• tinnitus/ringing in the ears;
• jaundice (yellowing of the white of the eyes or skin);
• skin sensitivity alterations;
• abnormal dreams;
• concentration disturbances;
• difficulty swallowing;
• alterations in the sense of smell (including loss of smell);
• balance and coordination disturbances (due to dizziness);
• total or partial loss of memory;
• hearing loss (including deafness, usually reversible);
• increase in uric acid in the blood;
• emotional instability;
• speech alteration;
• syncope;
• muscle weakness.

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

• inflammation of joints;
• irregular heart rhythm;
• increased skin sensitivity;
• feeling of depersonalization (not being oneself);
• increase in blood coagulation;
• 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 unknown (cannot be estimated from available data)

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

The administration of quinolone and fluoroquinolone antibiotics has been associated with very rare cases of long-lasting or permanent adverse reactions (including months or years), such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pinching, tingling, itching, burning, numbness, or pain (neuropathy), depression, fatigue, sleep disturbances, memory loss, and hearing, vision, taste, and smell loss, in some cases regardless of the presence of pre-existing risk factors.

Additionally, very rare cases of the following side effects have been reported, described after treatment with other quinolone antibiotics, and may also occur during treatment with Moxifloxacino Pensa: increased intracranial pressure (symptoms include headache, visual disturbances 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 aortic size and weakening or tearing of the aortic wall (aneurysms and dissections), which could lead to rupture and be fatal, and heart valve insufficiency in patients who have received fluoroquinolones have been reported. See also section 2.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this leaflet. You can also report them directly through the national notification systemwww.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on thecontainerafter 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 drains or trash.Deposit the containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, please ask your pharmacisthow to dispose ofthecontainers and medications you no longerneed.By doing so, you will help protect the environment.

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.
• The other componentsare:
• 1. -Core of the tablet: Mannitol (E 421), Microcrystalline cellulose, Croscarmellose sodium, Anhydrous colloidal silica, Magnesium stearate.
  2. -Film-coating: Polyvinyl alcohol (E 1203), Macrogol 4000 (E 1521), Talc (E 553b), Titanium dioxide (E 171), Yellow-orange (E 110), Red Ponceau 4R (E 124), Aluminium lake of indigo carmine (E 132).

Appearance of the product and content of the container

Film-coated tablets of pale pink color, oblong shape, convex form, marked with “MOXI” on one face and “400” on the other face.

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

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

Bluepharma - Indústria Farmacêutica, S.A.

S. Martinho do Bispo

3045-016 Coimbra

Portugal

This medicine is authorized in the member states of the European Economic Area with the following names:

Spain: Moxifloxacino Pensa 400 mg film-coated tablets EFG

Italy: Moxifloxacina Pensa

Last review date of thisleaflet:March 2024

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