Moxifloxacin Pensa 400 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Moxifloxacino Pensa 400 mg film-coated tablets EFG

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

• Keep this leaflet as you may need to read it again. If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.

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

Contents of the leaflet

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

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

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

Moxifloxacin is indicated in patients aged 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 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).
• Mild to moderate upper female genital tract infections (pelvic inflammatory disease), including infection of the fallopian tubes and infection of the uterine mucous membrane.

For these types of infections, Moxifloxacin Pensa is not sufficient as monotherapy; therefore, in addition to Moxifloxacin Pensa, 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 Moxifloxacin Pensa”, “Warnings and precautions”, “Consult your doctor before taking Moxifloxacin Pensa”).

If the following conditions have shown improvement during initial treatment with moxifloxacin infusion solution, 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 must not be used to initiate treatment for any type of skin and soft tissue infection or for severe lung infections.

2. What you need to know before taking Moxifloxacino Pensa

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

Do not take Moxifloxacino Pensa:

???????If you are allergic to the active substance moxifloxacin or to other quinolones or to any of the other components 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 injuries related to treatment with quinolone antibiotics (see section Warnings and precautions and section 4. Possible side effects).

• If you have a hereditary disease or have experienced:

• any condition associated with abnormal heart rhythm (observed on ECG, the electrical recording of the heart),

• you suffer from imbalances in blood electrolytes (especially low levels of potassium or magnesium in the blood),

• you have a very slow heart rate (called “bradycardia”),

• you have a weak heart (heart failure),

• you have a history of heart rhythm disorders,

• you are taking other medications that cause disturbances in the ECG (see section Other medicines and Moxifloxacino Pensa). This is because moxifloxacin can cause changes in the ECG, such as QT interval prolongation, i.e., delayed electrical conduction in the heart.

• If you have severe liver disease or if your liver enzyme levels (transaminases) increase to 5 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 Pensa, if you have previously experienced a serious adverse reaction to quinolones or fluoroquinolones. If this applies to you, inform your doctor as soon as possible.

Consult your doctor before taking moxifloxacin

• Moxifloxacin can alter the heart 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 this medicine. (See also Do not take Moxifloxacino Pensa and Other medicines and Moxifloxacino Pensa)

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

• If you have epilepsy or any other condition that may cause 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, in severe cases, paralysis), your symptoms may worsen if you take moxifloxacin. If you think this applies to you, consult your doctor immediately.

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

• If you have previously experienced an episode of aortic dissection (tear in the wall of the aorta).

• If you have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing disorders (e.g., connective tissue disorders such as Marfan syndrome or 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, arterial hypertension, 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 condition), inform your doctor, who will determine whether moxifloxacin is suitable for you.

• If you have a complicated upper female genital tract infection (associated with a tubo-ovarian or pelvic abscess), for which your doctor considers intravenous treatment necessary, treatment with moxifloxacino tablets is not appropriate.

• For the treatment of a mild to moderate upper female genital tract infection, your doctor should prescribe another antibiotic in addition to 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 heart valve insufficiency (regurgitation of heart valves).

During treatment with Moxifloxacino Pensa

If you experience palpitations or irregular heartbeat during treatment, 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, with symptoms such as chest tightness, dizziness, nausea, fainting, or vertigo when standing up. If these symptoms occur, stop taking Moxifloxacino Pensa immediately and consult your doctor without delay.

Moxifloxacin 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 jaundice (yellowing of the whites of the eyes), dark urine, skin itching, increased tendency to bleed, or symptoms of liver-induced brain disease (signs of reduced liver function or severe liver inflammation).

Severe skin reactions

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

• SJS/TEN may initially appear on the trunk as red, target-like spots or circular lesions, often with central blisters. Ulcers may also develop in the mouth, throat, nose, genitals, and eyes (red, swollen eyes). 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 facial rash, followed by a widespread rash, high fever, elevated liver enzymes in blood tests, increased levels of a type of white blood cell (eosinophilia), and enlarged lymph nodes.

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

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

Severe, disabling, long-lasting, and potentially irreversible side effects

Antibacterial medicines containing fluoroquinolones or quinolones, including Moxifloxacino Pensa, have been associated with very rare but serious adverse effects, some of which were long-lasting (persisting for months or years), disabling, or potentially irreversible. These include pain in tendons, muscles, and joints of the upper and lower limbs, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, numbness, or burning (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 Pensa, 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 Pensa and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

You may experience mental health problems, even after the first dose of quinolone antibiotics, including moxifloxacin. In very rare cases, mental health problems and depression have progressed to suicidal thoughts and self-harming behaviors such as suicide attempts (see section 4. Possible side effects). If you develop these reactions, treatment with moxifloxacin must be stopped and you must inform your doctor immediately.

You may develop diarrhea during or after taking antibiotics, including Moxifloxacino Pensa. If diarrhea is severe or persistent, or if you notice blood or mucus in your stool, stop taking Moxifloxacino Pensa immediately and consult your doctor. In such cases, do not take medications that stop or slow intestinal movement.

Rarely, joint pain and swelling, tendon inflammation, or tendon rupture may occur (see section Do not take Moxifloxacino Pensa and section 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 or even several months after stopping 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 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 abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, seek emergency medical help immediately. The risk may be increased if you are receiving systemic corticosteroid treatment.

If you suddenly develop shortness of breath, especially when lying down, or notice swelling in your ankles, feet, or abdomen, or the onset of palpitations (feeling of rapid or irregular heartbeat), inform your doctor immediately.

If you are elderly and have kidney problems, take care to maintain 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 an increase in blood sugar levels above normal (hyperglycemia), or a decrease in 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 closely 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 Pensa (see section 4. Possible side effects).

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

Children and adolescents

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

Other medicines and Moxifloxacino Pensa

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

When taking moxifloxacin, consider the following:

• If you are taking Moxifloxacino Pensa and other medicines that affect the heart, there is an increased risk of heart rhythm disturbances. Therefore, you must not take moxifloxacin at the same time as the following medicines:

• medicines belonging to the antiarrhythmic class (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide),

• antipsychotics (e.g., phenothiazines, pimozide, sertindole, haloperidol, sultopride),

• tricyclic antidepressants,

• some antimicrobials (e.g., saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarials, particularly halofantrine),

• some antihistamines (terfenadine, astemizole, mizolastine),

• other medicines (e.g., cisapride, intravenous vincamine, bepridil, and difemethorene).

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

• Any other medicine containing magnesium or aluminium, 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 moxifloxacin tablets. Therefore, take your Moxifloxacino Pensa tablets 6 hours before or after taking these other medicines.

• Concomitant oral use of medicinal activated charcoal reduces the effect of Moxifloxacino Pensa tablets. It is recommended not to take these medicines at the same time.

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

Moxifloxacino Pensa with food and drink

Moxifloxacin may 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 medicine.

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

Driving and use of machines

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

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

Moxifloxacino Pensa contains sodium

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

3. How to take Moxifloxacino Pensa

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose in adults is one 400 mg film-coated tablet once daily.

Moxifloxacino Pensa tablets are for oral use. Swallow the tablet whole without chewing (to mask the bitter taste) and with plenty of liquid. Moxifloxacino may be taken with or without food. It is recommended that you take the tablet approximately at 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 is as follows:

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

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

• Community-acquired lung infection (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 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 taking Moxifloxacino Pensa, Warnings and precautions).

If you take more Moxifloxacino Pensa than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service. Telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Moxifloxacino Pensa

If you miss a dose, take it as soon as you remember on the same day. If you do not take your tablet one day, take the normal dose (one tablet) the next day.

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

If you stop taking Moxifloxacino Pensa

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 moxifloxacin are listed below:

If you notice

• an abnormally fast heart rate (rare side effect)
• that you suddenly feel unwell or notice yellowing of the whites of the eyes, dark urine, itchy skin, tendency to bleed, or changes in thinking or alertness (these may be signs and symptoms of fulminant liver inflammation which can lead to life-threatening liver failure) (very rare side effect; fatal cases have been reported)
• severe skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as red, target-shaped macules or circular spots often with blisters in the center, skin peeling, mouth ulcers, and sores 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 body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome) (frequency of this adverse effect is "not known")
• syndrome associated with impaired water excretion and low sodium levels (SIADH) (very rare adverse effect)
• loss of consciousness due to a severe drop in blood sugar levels (hypoglycemic coma) (very rare adverse effect)
• inflammation of blood vessels (signs may include red skin spots, usually on the legs, or joint pain) (very rare adverse effect)
• a sudden, severe generalized allergic reaction, including very rarely life-threatening shock (e.g., difficulty breathing, drop in blood pressure, rapid pulse) (rare side effect)
• swelling including airway inflammation (rare side effect, potentially fatal)
• seizures (rare side effect)
• nervous system problems 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 suicide attempts) (rare side effect)
• confusion (which potentially can lead to self-harm, such as suicidal thoughts or suicide attempts) (very rare side effect)
• severe diarrhea with blood and/or mucus (antibiotic-associated colitis, including pseudomembranous colitis), which in very rare circumstances may lead to life-threatening complications (rare side effects)
• pain and inflammation of tendons (tendinitis) (rare side effect) or tendon rupture (very rare side 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 Pensa and contact your doctor immediately as you may require urgent medical attention.

Additionally, if you notice

• temporary loss of vision (very rare side effect),
• eye discomfort or pain, especially due to light exposure (very rare to rare adverse effect),

contact an eye specialist immediately.

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

Worsening of myasthenia gravis symptoms has been observed in very rare cases. If this occurs, contact your doctor immediately.

If you have diabetes and notice that your blood sugar levels increase or decrease (rare or very rare side effects), contact your doctor immediately.

If you are elderly with pre-existing kidney problems and notice reduced urine output, 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), contact your doctor immediately.

The following are other adverse effects observed during treatment with Moxifloxacino Pensa, listed by frequency:

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

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

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

• rash;
• stomach discomfort (indigestion/acid reflux);
• 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 dizziness (spinning or 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;
• aches and pains in back, limbs, pelvis, and chest;
• increase in certain blood cells necessary for blood clotting;
• sweating;
• increase in certain white blood cells (eosinophils);
• anxiety;
• malaise (mainly weakness or fatigue);
• tremors;
• joint pain;
• palpitations;
• irregular and rapid heartbeat;
• breathing difficulty, including asthmatic states;
• increased digestive enzyme in blood (amylase);
• restlessness/agitation;
• tingling and/or numbness;
• skin hives;
• dilation of blood vessels;
• confusion and disorientation;
• decrease in blood cells necessary for blood clotting;
• visual disturbances, such as double vision and blurred vision;
• reduced 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;
• severe disturbances in heart rhythm;
• dry skin;
• angina.

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

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

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

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

Frequency not known (cannot be estimated from available data)

• increased skin sensitivity to sunlight or UV radiation (see also section 2, Warnings and precautions)
• clearly defined erythematous spots with or without blisters appearing within hours after administration of moxifloxacin and disappearing with post-inflammatory hyperpigmentation; these usually recur in the same skin or mucosal site upon subsequent exposure to moxifloxacin

Administration of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-term (even months or years) or permanent adverse reactions, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, burning, numbness or pain (neuropathy), fatigue, memory and concentration impairment, mental health effects (which may 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 adverse effects, described after treatment with other quinolone antibiotics, may possibly also occur during treatment with Moxifloxacino Pensa: increased intracranial pressure (symptoms include headache, visual disturbances such as blurred vision, blind spots, double vision, vision loss), increased blood sodium levels; increased blood calcium levels; reduced count of certain red blood cells (hemolytic anemia).

Cases of enlargement and weakening or tearing of the aortic wall (aneurysms and dissections), which could lead to rupture and be fatal, and heart valve insufficiency have been reported in patients receiving fluoroquinolones. See also section 2.

Reporting of adverse effects

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

5. Storage of Moxifloxacin Pensa

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

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

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be taken to a SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of any unused medicines and containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Moxifloxacino Pensa

• The active substance is moxifloxacin as hydrochloride. Each film-coated tablet contains 436.8 mg of moxifloxacin hydrochloride, equivalent to 400 mg of moxifloxacin.
• The other components are:
  1. • Tablet core: Mannitol (E 421), microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous 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), indigo carmine aluminum lake (E 132).

Appearance of the product and contents of the pack

Pale red, oval-shaped, biconvex, film-coated tablets, marked “MOXI” on one side and “400” on the other.

Film-coated tablets are available in PVC-PVDC/aluminum blisters containing 5 or 7 film-coated tablets.

Only certain 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 medicinal product 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 most recent revision of this product information: June 2025

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