PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Moxifloxacin Pensa 400 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What Moxifloxacin Pensa is and what it is used for
What you need to know before taking Moxifloxacin Pensa
How to take Moxifloxacin Pensa
Possible side effects
How to store Moxifloxacin Pensa
Contents of the pack and other information

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

Moxifloxacina Pensa contains the active substance moxifloxacin, which belongs to a group of antibiotics called fluoroquinolones. Moxifloxacina Pensa works by killing the bacteria that cause infections.
Moxifloxacina Pensa is used in patients aged 18 years and older to treat the following bacterial infections when caused by bacteria sensitive to moxifloxacin.
Moxifloxacina Pensa should only be used to treat these infections when commonly used antibiotics cannot be used or have not been effective:

Sinus infection, sudden worsening of a long-term airway inflammation, or pneumonia acquired outside the hospital (excluding severe cases).
Mild to moderate infections of the upper female genital tract (pelvic inflammatory disease), including infections affecting the Fallopian tubes and uterine mucosa.

Moxifloxacina Pensa tablets alone are not sufficient for the treatment of this type of infection. Therefore, your doctor must prescribe an additional antibiotic to treat infections of the upper female genital tract, alongside Moxifloxacina Pensa tablets (see section 2, “What you need to know before taking Moxifloxacina Pensa”, “Warnings and precautions”, “Tell your doctor before taking Moxifloxacina Pensa”).
If the following bacterial infections have shown improvement during initial treatment with Moxifloxacina Pensa infusion solution, your doctor may prescribe Moxifloxacina Pensa tablets to complete the course of treatment:

Pneumonia acquired outside the hospital
Skin and soft tissue infections. Moxifloxacina Pensa tablets must not be used to initiate therapy for any type of skin and soft tissue infection or for severe lung infections.

2. What you need to know before taking Moxifloxacina Pensa

Contact your doctor if you suspect you belong to any of the patient groups described below.
Do not take Moxifloxacina Pensa:

If you are allergic to the active substance moxifloxacin, to any other quinolone antibiotic, or to any of the other ingredients of this medicine (listed in section 6).
If you are pregnant or breastfeeding.
If you are under 18 years of age.
If you have previously experienced tendon disease or tendon disorders related to treatment with quinolone antibiotics (see sections “Warnings and precautions” and “4. Possible side effects”).
If you were born with, or have had:
any condition causing abnormal heart rhythm (detected on ECG, the electrical recording of the heart)
you have an imbalance of salts in the blood (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 abnormal heart rhythm, or
you are taking other medicines that cause changes in the ECG (see section “Other medicines and Moxifloxacina Pensa”). This is because Moxifloxacina Pensa can cause ECG changes, specifically prolongation of the QT interval, which means a delay in the conduction of electrical signals.
If you have severe liver disease or increased liver enzymes (transaminases) more than 5 times the upper limit of normal.

Warnings and precautions
Before taking this medicine
Do not take antibacterial medicines containing fluoroquinolones/quinolones, including
moxifloxacin, if in the past you have had any serious adverse reaction during treatment with a quinolone or fluoroquinolone. In such a case, inform your doctor as soon as possible.
Inform your doctor before taking Moxifloxacina Pensa
Moxifloxacina Pensa can alter your ECG, especially if you are a woman or elderly. If you are taking medicines that reduce potassium levels in the blood, consult your doctor before taking Moxifloxacina Pensa (see also section “Do not take Moxifloxacina Pensa” and “Other medicines and Moxifloxacina Pensa”).

If you have ever developed a severe skin rash or skin peeling, skin rash with blisters and/or mouth ulcers after taking moxifloxacin
- If you suffer from epilepsy or a condition that makes you prone to seizures, consult your doctor before taking Moxifloxacina Pensa.
- If you have or have previously had mental health problems, consult your doctor before taking Moxifloxacina Pensa.
- If you suffer from severe myasthenia gravis (abnormal muscle fatigue leading to weakness and paralysis in severe cases), taking Moxifloxacina Pensa may worsen the symptoms of the disease. If you think you may be affected, contact your doctor immediately.
- If you have been diagnosed with enlargement or "bulging" of a large blood vessel (aortic aneurysm or large peripheral aneurysm).
- if you have previously experienced episodes of aortic dissection (a tear in the wall of the aorta).
- if you have been diagnosed with insufficiency of one of the heart valves (aortic or mitral regurgitation);
- if you have a family history of aortic aneurysm or aortic dissection, or congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome [an autoimmune inflammatory disease], or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet's syndrome, known high blood pressure or atherosclerosis, rheumatoid arthritis [a joint disease], or endocarditis [a heart infection]).
- If you are diabetic, as moxifloxacin may cause changes in blood sugar levels
- If you, or someone in your family, suffer from glucose-6-phosphate dehydrogenase deficiency (a rare inherited disorder), inform your doctor, who will advise whether Moxifloxacina Pensa is suitable for you.
- In case of complicated infection of the upper female genital tract (e.g. associated with tubo-ovarian or pelvic abscess), for which your doctor considers intravenous treatment necessary, treatment with Moxifloxacina Pensa tablets is not appropriate.
- For the treatment of mild or moderate infections of the upper female genital tract, your doctor should prescribe another antibiotic in addition to Moxifloxacina Pensa. If symptoms do not improve after 3 days of treatment, consult your doctor.

While taking Moxifloxacina Pensa
If you experience palpitations or irregular heartbeat during treatment,
inform
your doctor immediately. An ECG may be performed to assess your heart rhythm.
The risk of heart problems may increase with higher doses. Therefore, you must
adhere
to the recommended dosage.
There is a remote possibility of a severe and sudden allergic reaction (an anaphylactic reaction/anaphylactic shock), even after the first dose, with the following symptoms:
chest tightness, dizziness, nausea or fainting, dizziness upon standing. In such a case, stop taking Moxifloxacina Pensa and consult your doctor immediately.
Moxifloxacina Pensa may cause severe and rapidly progressing liver inflammation, which may lead to life-threatening liver failure (including fatal cases, see
section 4. “Possible side effects”). Contact your doctor before continuing treatment if you rapidly develop signs such as feeling unwell and/or nausea
associated with yellowing of the whites of the eyes, dark urine, itching, tendency to
bleeding, or hepatic encephalopathy (symptoms of reduced liver function or severe and rapidly progressing liver inflammation).
Severe skin reactions
Severe skin reactions have been reported with moxifloxacin, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP).

SJS/TEN may initially appear as reddish spots or circular patches, often with central blisters on the trunk. In addition, ulcers in the mouth, throat, nose, genitals, and eyes (red and swollen eyes) may occur. These severe skin rashes are often preceded by fever and/or flu-like symptoms. The skin rashes may progress to widespread skin peeling and life-threatening complications or may be fatal.
AGEP appears at the beginning of treatment as a red, scaly rash with bumps under the skin and blisters accompanied by fever. The most common location: mainly in skin folds, trunk, and upper limbs.

If you develop a severe skin rash or other skin-related symptoms, stop
taking moxifloxacin and contact your doctor or seek immediate medical assistance.
Quinolone antibiotics, including Moxifloxacina Pensa, may cause seizures. If
this occurs, treatment with Moxifloxacina Pensa must be discontinued.
Severe, prolonged, disabling, and potentially non-improving side effects
Fluoroquinolone/quinolone antibacterial medicines, including Moxifloxacina Pensa,
have been associated with very rare but serious side effects, some of which are prolonged (lasting months or years), disabling, or may not improve. These include tendon, muscle, and joint pain in arms and legs, difficulty walking, abnormal sensations such as tingling, prickling, itching, numbness, or burning (paresthesia), sensory organ disturbances such as changes in vision, taste, smell, and hearing, depression, memory impairment, severe fatigue, and severe sleep disturbances.
If you experience any of these side effects after taking Moxifloxacina Pensa, contact your doctor immediately before continuing treatment. Your doctor will decide with you whether to continue treatment and may consider using an antibiotic from another class.
Nerve damage symptoms (neuropathy), such as pain, burning, tingling, numbness, and/or weakness, may rarely occur, particularly in the feet and legs or hands and arms. In such cases, discontinue treatment with Moxifloxacina Pensa and inform your doctor immediately to prevent permanent nerve damage.
You may experience mental health problems even when taking quinolone antibiotics, including Moxifloxacina Pensa, for the first time. In very rare cases, depression or mental health problems have led to suicidal thoughts and self-harming behaviors, such as suicide attempts (see section “4. Possible side effects”). If you develop such reactions, treatment with Moxifloxacina Pensa must be discontinued.
Diarrhea may occur during or after taking antibiotics (including Moxifloxacina Pensa). If it worsens or persists, or if you notice blood or mucus in your stool, stop taking Moxifloxacina Pensa immediately and consult your doctor. In this situation, you should not take medicines that block or reduce intestinal movements.
Joint pain and swelling, and tendon inflammation or rupture may rarely occur (see section “Do not take Moxifloxacina Pensa” and “4. Possible side effects”). The risk is higher if you are elderly (over 60 years), have received an organ transplant, have kidney problems, or are taking corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment and up to several months after stopping treatment with Moxifloxacina Pensa. At the first signs of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder, or knee), stop treatment with Moxifloxacina Pensa, contact your doctor, and rest the affected area. Avoid unnecessary movements, as the risk of tendon rupture may increase.
If you experience sudden and severe abdominal, chest, or back pain, which may be a symptom of aortic aneurysm or dissection, go immediately to the emergency room. The risk may be higher if you are taking systemic corticosteroid medicines.
Inform your doctor immediately if you notice a sudden onset of shortness of breath, especially when lying down, or swelling of the ankles, feet, or abdomen, or new episodes of heart palpitations (sensation of rapid or irregular heartbeat).
If you are elderly and have kidney problems, try to drink sufficient fluids while taking Moxifloxacina Pensa, as dehydration may increase the risk of kidney failure.
If you notice a weakening of vision or if your eyes experience other types of effects while taking Moxifloxacina Pensa, consult an ophthalmologist immediately (see sections “Driving and use of machines” and “4. Possible side effects”).
Fluoroquinolone antibiotics may cause your blood sugar levels to rise above normal (hyperglycemia), or drop below normal (hypoglycemia), which in severe cases may potentially lead to loss of consciousness (hyperglycemic coma) (see section 4 “Possible side effects”). If you have diabetes, your blood sugar levels should be closely monitored.
Quinolone antibiotics may make your skin more sensitive to sunlight or UV light. Avoid prolonged exposure to sunlight, intense sunlight, and do not use sunbeds or
UV lamps during treatment with Moxifloxacina Pensa.
The effectiveness of moxifloxacin in treating severe burns, deep tissue infections, and diabetic foot infections with osteomyelitis (bone marrow infection) has not been demonstrated.
Children and adolescents
Do not administer this medicine to children and adolescents under 18 years of age
because efficacy and tolerability have not been established in this age group (see section “Do not take Moxifloxacina Pensa”).
Other medicines and Moxifloxacina Pensa
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Regarding Moxifloxacina Pensa, be aware that:

If you are taking Moxifloxacina Pensa and other medicines that affect the heart, there is an increased risk of heart rhythm disturbances. Therefore, do not take Moxifloxacina Pensa with the following medicines:
medicines belonging to the group of antiarrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide)
antipsychotics (e.g. phenothiazines, pimozide, sertindole, haloperidol, sulpiride)
tricyclic antidepressants
some antimicrobials (e.g. saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarials, particularly halofantrine)
some antihistamines (e.g. terfenadine, astemizole, mizolastine)
and other medicines (e.g. cisapride, intravenous vincamine, bepridil, difemanel).
You must inform your doctor if you are taking other medicines that may reduce potassium levels in the blood (e.g. certain diuretics, some laxatives and enemas [at high doses], or corticosteroids [anti-inflammatory medicines], amphotericin B) or that slow heart rate, as these may also increase the risk of serious heart rhythm disturbances during treatment with Moxifloxacina Pensa.
Medicines containing magnesium or aluminium, such as antacids for indigestion, iron, zinc or didanosine, or sucralfate for stomach disorders, may reduce the effect of Moxifloxacina Pensa tablets. If you take any of these medicines, take the Moxifloxacina Pensa tablet 6 hours before or 6 hours after.
Taking oral medicinal charcoal together with Moxifloxacina Pensa tablets reduces the effect of Moxifloxacina Pensa. Therefore, it is recommended not to use these medicines together.
If you are taking oral anticoagulants (e.g. warfarin), your doctor may need to frequently monitor your blood clotting time.

Moxifloxacina Pensa with food and drinks
The effect of Moxifloxacina Pensa is not affected by food, including dairy products.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, do not take Moxifloxacina Pensa.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine.
Animal studies have not indicated that your fertility is impaired by this medicine.
Driving and use of machines
Moxifloxacina Pensa may cause dizziness or lightheadedness, sudden temporary loss of vision, or brief loss of consciousness. If you experience these effects, do not drive or operate machinery.
Moxifloxacina Pensa contains sunset yellow aluminium lake FCF (E-110) and aluminium lake Ponceau 4R (E-124)
These excipients may cause allergic reactions (possibly delayed).

3. How to take Moxifloxacina Pensa

Take this medicine exactly as instructed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
The recommended dose for adults is one 400 mg film-coated tablet once daily.
Moxifloxacina Pensa tablets are for oral use. Swallow the tablet whole (to avoid the bitter taste) with plenty of water or another drink. You may take Moxifloxacina Pensa with or without food. It is recommended to take the tablet at approximately the same time each day.
Dose adjustment is not necessary in elderly patients, patients with low body weight, or patients with renal impairment.
The duration of treatment with Moxifloxacina Pensa depends on the type of infection. Unless otherwise directed by your doctor, the recommended treatment duration for Moxifloxacina Pensa film-coated tablets is:

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

When Moxifloxacina Pensa film-coated tablets are used to complete a treatment course initially started with moxifloxacin infusion solution, the recommended durations are:

Community-acquired pneumonia (lung infection): 7–14 days. Most patients with pneumonia are switched to oral treatment with Moxifloxacina Pensa film-coated tablets within 4 days
Skin and soft tissue infections: 7–21 days. Most patients with skin and soft tissue infections are switched to oral treatment with Moxifloxacina Pensa film-coated tablets within 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 taking this medicine too early, your infection may not be completely cured, it may relapse or worsen, and you may also develop bacterial resistance to the antibiotic.
Do not exceed the recommended dose or duration of treatment (see section “2. What you need to know before taking Moxifloxacina Pensa”, “Warnings and precautions”).
If you take more Moxifloxacina Pensa than you should
If you take more than the prescribed dose of one tablet per day, contact a doctor immediately. If possible, bring any remaining tablets, the packaging, or this leaflet with you to show the doctor or pharmacist what you have taken.
If you forget to take Moxifloxacina Pensa
If you forget to take your tablet, take it as soon as you remember on the same day. If you miss a day, take your usual dose (one tablet) the next day.
Do not take a double dose to make up for a forgotten tablet. If you are unsure what to do, consult your doctor or pharmacist.
If you stop taking Moxifloxacina Pensa
If you stop taking this medicine too early, your infection may not be completely cured. Consult your doctor if you wish to stop taking the tablets before completing the treatment course.
If you have any doubts about how to use this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The most serious side effects observed during treatment with Moxifloxacina Pensa are listed below:
If you experience

a very fast heartbeat (rare side effect);
a sudden feeling of illness or notice yellowing of the whites of the eyes, dark urine, skin itching, tendency to bleed, or disturbances in cognitive function or insomnia (these may be signs and symptoms of fulminant hepatitis which could lead to potentially fatal 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 as reddish spots or circular patches, often with central blisters on the trunk, skin peeling, mouth, throat, nose, genital or eye ulcers, and may be preceded by fever and flu-like symptoms (very rare side effects, potentially fatal);
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 side effect is "not known");
syndrome associated with reduced water excretion and low sodium levels (SIADH) (very rare side effect);
loss of consciousness due to a severe drop in blood sugar levels (hypoglycaemic coma) (very rare side effect);
inflammation of blood vessels (signs may include red spots on the skin, usually on the lower legs, or symptoms such as joint pain) (very rare side effect);
severe, sudden and generalized allergic reaction, very rarely including potentially fatal shock (e.g. breathing difficulties, drop in blood pressure, rapid pulse) (rare side effect);
swelling including swelling of the airways (rare side effect, potentially fatal);
seizures (rare side effect);
nervous system disorders such as pain, burning, tingling sensation, numbness and/or weakness in the extremities (rare side effect);
depression (which may in very rare cases lead to self-harm, such as suicidal ideation/suicidal thoughts, or suicide attempts) (rare side effect);
psychosis (which may lead to self-harm, such as suicidal ideation/suicidal thoughts, or suicide attempts) (very rare side effect);
severe diarrhoea with blood and/or mucus (antibiotic-associated colitis, including pseudomembranous colitis), which in very rare circumstances may progress to potentially fatal complications (rare side effects);
tendon pain and swelling (tendinitis) (rare side effect) or tendon rupture (very rare side effect);
muscle weakness, tenderness or pain, and particularly at the same time feeling unwell, high temperature or dark urine. These may be caused by abnormal muscle damage which can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis) (frequency of this side effect is "not known");

stop taking Moxifloxacina Pensa and contact your doctor immediately,
as urgent medical advice is required.
Additionally, if you experience:

temporary loss of vision (very rare side effect);
eye discomfort or pain, especially due to light exposure (very rare to rare adverse effect), seek immediate advice from an ophthalmologist.

If you have experienced a potentially fatal irregular heart rate (torsades de pointes) or
cardiac arrest while taking Moxifloxacina Pensa (very rare side effects), inform your doctor immediately that you have taken Moxifloxacina Pensa and do not restart treatment.
In very rare cases, worsening of symptoms of myasthenia gravis has been observed. If this occurs, contact your doctor immediately.
If you have diabetes and notice that your blood sugar levels rise or fall (rare or very rare side effect), inform your doctor immediately.
If you are elderly and already have kidney problems and notice reduced urine output, swelling in the legs, ankles or feet, fatigue, nausea, drowsiness, shortness of breath or confusion (these may be signs of kidney failure, a rare side effect), contact your doctor immediately.
Other side effects observed during treatment with Moxifloxacina Pensa are listed below according to their likelihood of occurrence:
Common (may affect up to 1 in 10 people)

nausea;
diarrhoea;
dizziness;
stomach upset and abdominal pain;
vomiting;
headache;
increase in a specific liver enzyme in the blood (transaminases);
infections caused by resistant bacteria or fungi, such as oral or vaginal infections caused by Candida;
change in heart rhythm (ECG) in patients with low potassium levels in the blood.

Uncommon (may affect up to 1 in 100 people)

skin rash;
stomach disorders (indigestion/heartburn);
changes in taste sensation (in very rare cases, loss of taste);
sleep disorders (mainly insomnia);
increase in a specific liver enzyme in the blood (gamma-glutamyl transferase and/or alkaline phosphatase);
decrease in certain white blood cells in the blood (leukocytes, neutrophils);
constipation;
itching;
sensation of dizziness (feeling of spinning or falling);
drowsiness;
flatulence;
change in heart rhythm (ECG);
impaired liver function (including increase in a specific liver enzyme in the blood (LDH));
reduced appetite and food intake;
low white blood cell count;
pain, such as back pain, chest pain, pelvic pain, pain in the extremities;
increase in blood cells specialized in clotting;
sweating;
increase in specialized white blood cells (eosinophils);
anxiety;
feeling unwell (mainly weakness or fatigue);
tremor;
joint pain;
palpitations;
irregular and rapid heartbeat;
breathing difficulties including asthmatic conditions;
increase in a specific digestive enzyme in the blood (amylase);
restlessness/agitation;
tingling sensation (prickling and stinging) and/or numbness;
urticaria;
dilation of blood vessels;
confusion and disorientation;
decrease in blood cells specialized in clotting;
visual disturbances including double vision and blurred vision;
reduced blood clotting;
increase in lipids (fats) in the blood;
decrease in red blood cells in the blood;
muscle pain;
allergic reaction;
increased bilirubin in the blood;
inflammation of the stomach;
dehydration;
severe abnormalities in heart rhythm;
dryness of the skin;
angina pectoris.

Rare (may affect up to 1 in 1,000 people)

muscle spasms;
muscle cramps;
hallucinations;
high blood pressure;
swelling (swelling of hands, feet, ankles, lips, mouth, throat);
low blood pressure;
kidney impairment (including increased laboratory parameters indicating 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);
impaired skin sensitivity;
abnormal dreams;
difficulty concentrating;
difficulty swallowing;
changes in smell (including loss of smell);
balance disorders and poor coordination (due to dizziness);
partial or complete memory loss;
hearing impairment including deafness (usually reversible);
increased uric acid in the blood;
emotional instability;
difficulty speaking;
fainting;
muscle weakness.

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

joint inflammation;
heart rhythm abnormalities;
increased skin sensitivity;
depersonalization (feeling of not being oneself);
increased blood clotting;
muscle stiffness;
significant reduction in specialized white blood cells (agranulocytosis);
decrease in red blood cells, white blood cells and platelets (pancytopenia).

Very rare cases of prolonged (lasting months or years) or permanent adverse drug reactions, such as tendon inflammation, tendon rupture, joint pain, pain in arms or legs, difficulty walking, unusual sensations such as tingling, prickling, tickling, burning, numbness or pain (neuropathy), depression, fatigue, sleep disturbances, memory impairment and changes in hearing, vision, taste and smell, have been associated with the use of quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-existing risk factors.
Cases of dilation and weakening of the aortic wall or aortic wall tear (aneurysms and dissections), with possible rupture that may be fatal, as well as cases of regurgitation of blood from heart valves, have been reported in patients treated with fluoroquinolones. See also section 2.
Additionally, very rare cases of the following side effects, which cannot be ruled out from occurring also during treatment with Moxifloxacina Pensa, have been reported with other quinolone antibiotics: increased intracranial pressure (symptoms include headache, vision disturbances including blurred vision, blind spots, double vision, vision loss), increased sodium levels in the blood, increased calcium levels in the blood, a specific type of reduction in red blood cells (haemolytic anaemia), increased skin sensitivity to sunlight or UV light.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 blister and carton.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Moxifloxacina Pensa contains

The active substance is moxifloxacin as hydrochloride. Each film-coated tablet contains 436.8 mg of moxifloxacin as hydrochloride, equivalent to 400 mg of moxifloxacin.
The excipients are:
Tablet core: mannitol (E421), microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.
Film coating: polyvinyl alcohol (E1203), macrogol 4000 (E1521), talc (E553b), titanium dioxide (E171), sunset yellow aluminium lake (E110), Ponceau 4R aluminium lake (E124), indigo carmine aluminium lake (E132).

Description of the appearance of Moxifloxacina Pensa and pack sizes
Film-coated tablet, oblong, convex-shaped, dull red, marked with
“MOXI” on one side and “400” on the other.
Film-coated tablets are available in PVC-PVDC/Aluminium blisters containing 5 or 7
film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Pensa Pharma S.p.A., Via Ippolito Rosellini 12, 20124 Milano, Italy
Manufacturer: Bluepharma - Indústria Farmacêutica, S.A., S. Martinho do Bispo, 3045-016 Coimbra, Portugal

This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:
Spain: Moxifloxacina pensa 400 mg Comprimidos recubiertos con película EFG
Italy: Moxifloxacina pensa

Moxifloxacin PensA

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT