MOXIFLOXACIN TILLOMED 400 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

MoxifloxacinTillomed 400 mg film-coated tablets EFG

For use in adults

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the Package Leaflet

1. What is Moxifloxacin Tillomed and what is it used for
2. What you need to know before taking Moxifloxacin Tillomed
3. How to take Moxifloxacin Tillomed
4. Possible side effects
5. Storage of Moxifloxacin Tillomed
6. Package contents and additional information

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

This medication contains the active ingredient moxifloxacin, which belongs to the group of antibiotics known as fluoroquinolones. Moxifloxacin works by eliminating bacteria that cause infections.

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

• Sinus infection, sudden worsening of long-term inflammation of the airways or lung infection (pneumonia) acquired outside the hospital in the community (except for severe cases).
• Mild or moderate infections of the upper female genital tract (pelvic inflammatory disease), including infection of the Fallopian tubes and infection of the uterine mucous membrane.

For this type of infection, this medication is not sufficient as the only treatment. Therefore, in addition to moxifloxacin, your doctor will need to prescribe another antibiotic for the treatment of mild or moderate infections of the upper female genital tract (see section 2 What you need to know before taking Moxifloxacin Tillomed, Warnings and precautions, Consult your doctor before taking Moxifloxacin Tillomed).

If the following diseases have shown improvement during initial treatment with moxifloxacin solution for infusion, your doctor may prescribe this medication to complete the treatment:

• Lung infection (pneumonia) acquired outside the hospital
• Infections of the skin and soft tissues.

This medication should not be used to initiate treatment for any type of skin and soft tissue infection or severe lung infections.

2. What you need to know before taking Moxifloxacino Tillomed

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

Do not take Moxifloxacino Tillomed

• If you are allergic to the active ingredient moxifloxacin or to other quinolones or to any of the other components of this medicine (included in section 6).
• If you are pregnant or breastfeeding.
• If you are under 18 years old.
• If you have a history of tendon disorders or injuries related to treatment with quinolone antibiotics (see sections Warnings and precautions and 4. Possible side effects).
• If you suffer from any inherited disease or have:
• • any disease related to an abnormal heart rhythm (observed in ECG, heart electrical record),
  • suffer from electrolyte imbalances in the blood (especially low levels of potassium or magnesium in the blood),
  • have a very slow heart rate (called "bradycardia"),
  • have a weak heart (heart failure),
  • have a history of heart rhythm disorders
• If you are taking other medicines that cause ECG disorders (see section Other medicines and Moxifloxacino Tillomed). This is because moxifloxacin can cause changes in the ECG, such as a prolongation of the QT interval, i.e., a delay in the conduction of electrical signals in the heart.
• If you suffer from severe liver disease or increased liver enzyme levels (transaminases) 5 times above the upper limit of normal.

Warnings and precautions

Before starting to take this medicine

You should not take antibacterial medicines that contain fluoroquinolones or quinolones, including Moxifloxacino Tillomed, if you have experienced any serious side effect previously when taking a quinolone or a fluoroquinolone. If this is your case, you should inform your doctor as soon as possible.

Consult your doctor before taking Moxifloxacino Tillomed

• If you are diabetic because you may experience a risk of change in blood sugar levels with moxifloxacin.
• If you have ever developed a severe skin rash or skin peeling, blisters, and/or sores in the mouth after taking moxifloxacin.
• Moxifloxacino may modify the ECG of the heart, especially if you are a woman or an elderly patient. If you are currently taking any medication that leads to a decrease in blood potassium levels, consult your doctor before taking moxifloxacin (see also sections Do not take Moxifloxacino Tillomed and Other medicines and Moxifloxacino Tillomed).
• If you suffer from epilepsy or any other condition that may cause you to have seizures, consult your doctor before taking moxifloxacin.
• If you have or have ever had any mental health problems, consult your doctor before taking moxifloxacin.
• If you have myasthenia gravis (abnormal muscle fatigue leading to weakness and severe cases of paralysis), your symptoms may worsen if you take moxifloxacin. If you think this affects you, consult your doctor immediately.
• If you or a member of your family has a deficiency of glucose-6-phosphate dehydrogenase (a rare inherited disease), inform your doctor, who will indicate if moxifloxacin is suitable for you.
• If you have a complicated infection of the upper female genital tract (e.g., associated with an abscess in the Fallopian tubes and ovary or pelvic), for which your doctor considers intravenous treatment necessary, treatment with moxifloxacino tablets is not appropriate.
• For the treatment of a mild to moderate infection of the upper female genital tract, your doctor should prescribe another antibiotic along with moxifloxacino. If you do not notice an improvement in symptoms after three days of treatment, consult your doctor.
• If you have been diagnosed with an enlargement or a "lump" of a large blood vessel (aortic aneurysm or large peripheral vessel aneurysm).
• If you have suffered a previous episode of aortic dissection (tear in the aortic wall).
• If you have been diagnosed with heart valve insufficiency (regurgitation of the heart valves).
• 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 Ehlers-Danlos syndrome, Turner syndrome, or Sjogren's syndrome (an autoimmune inflammatory disease) or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, arterial hypertension, or atherosclerosis), rheumatoid arthritis (a joint disease), or endocarditis (a heart infection).

During treatment with Moxifloxacino Tillomed

• If you notice palpitations or irregular heartbeatsduring the treatment period, you should inform your doctor immediately. He or she may perform an ECG to measure your heart rate.

• The risk of heart problemsmay increase with the increase in dose. Therefore, you should take the recommended dose.

• Rarely, you may experience a severe sudden allergic reaction(anaphylactic reaction or shock) even with the first dose. Symptoms include: chest tightness, feeling of dizziness, feeling of nausea or fainting, or feeling dizzy when standing up. If you experience these symptoms, stop taking moxifloxacino and consult your doctor immediately.

• Moxifloxacino may cause a rapid and severe liver inflammation, which can lead to life-threatening liver failure (including fatal cases, see section 4. Possible side effects). If you develop a sudden feeling of discomfort and/or discomfort associated with a yellowish color of the whites of the eyes, dark urine, skin itching, tendency to bleed, or brain disease induced by liver damage (symptoms of reduced liver function or severe liver inflammation) please consult your doctor before taking any more tablets.

Severe skin reactions

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), have been reported with the use of moxifloxacino.

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

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

• The quinolone antibiotics, including moxifloxacino, may cause seizures. If this occurs, treatment with moxifloxacino should be discontinued, and you should contact your doctor immediately.

• Rarely, you may experience symptoms of nerve damage (neuropathy)such as pain, burning, tingling, numbness, and/or weakness, especially in feet and legs or hands and arms. If this happens, stop taking Moxifloxacino Tillomed and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

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

• You may develop diarrheaduring or after taking antibiotics, including moxifloxacino. If the diarrhea is severe or persistent, or if you notice blood or mucus in your stool, stop taking moxifloxacino immediately and consult your doctor. In these situations, you should not take medicines that interrupt or slow down intestinal movement.

• Rarely, pain and swelling in the joints and inflammation or rupture of the tendonsmay occur. The risk is higher if you are an elderly person (over 60 years old), have received an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even several months after stopping treatment with Moxifloxacino Tillomed. At the first sign of pain or inflammation of a tendon (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Moxifloxacino Tillomed, contact your doctor, and rest the affected area. Avoid any unnecessary exercise, as this could increase the risk of tendon rupture.

• If you are an elderly patient and have kidney problems, make sure to drink plenty of fluids while taking moxifloxacino. If you become dehydrated, this can increase the risk of kidney failure.

• If your vision worsensor if your eyes seem to be affected, consult an ophthalmologist immediately (see sections 2. Driving and use of machines and 4. Possible side effects).

• Fluoroquinolones may cause an increase in your blood sugar level above normal levels (hyperglycemia) or a decrease in your blood sugar level below normal levels (hypoglycemia), which in severe cases can lead to loss of consciousness (hypoglycemic coma) (see section 4. Possible side effects). If you have diabetes, your blood sugar level should be carefully monitored.

• Quinolone antibiotics may increase the sensitivity of the skin to sunlight or UV. You should avoid prolonged exposure to sunlight or direct sunlight and should not use sunbeds or any type of UV lamp during the administration of moxifloxacino.

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

Severe, disabling, and potentially irreversible side effects

Antibacterial medicines that contain fluoroquinolones or quinolones, including Moxifloxacino Tillomed, have been associated with very rare but serious side effects, some of which were long-lasting (persisting for months or years), disabling, or potentially irreversible. This includes pain in the tendons, muscles, and joints of the upper and lower limbs, difficulty walking, abnormal sensations such as pins and needles, tingling, prickling, numbness, or burning (paresthesia), sensory disorders such as decreased vision, taste, smell, and hearing, depression, decreased memory, intense fatigue, and severe sleep disorders.

If you experience any of these side effects after taking Moxifloxacino Tillomed, 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 an antibiotic from another class.

If you feel a strong and sudden pain in the abdomen, chest, or back, which can be symptoms of aortic dissection or aneurysm, go to the emergency room immediately. The risk may increase if you are receiving systemic corticosteroid treatment.

If you start to experience a sudden onset of shortness of breath, especially when lying down, or if you notice swelling in the ankles, feet, or abdomen, or the appearance of heart palpitations (feeling of rapid or irregular heartbeat), you should inform your doctor immediately.

Children and adolescents

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

Other medicines and Moxifloxacino Tillomed

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

When taking moxifloxacino, consider the following:

• If you are taking moxifloxacino and other medicines that affect the heart, there is a greater risk that heart rhythm disorders may occur. Therefore, you should not take moxifloxacino at the same time as the following drugs:
• • Medicines that belong to the class of antiarrhythmics (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide),
  • antipsychotics (e.g., phenothiazines, pimozide, sertindole, haloperidol, sultopride),
  • tricyclic antidepressants,
  • some antimicrobials (e.g., saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarials, particularly halofantrine),
  • some antihistamines (e.g., terfenadine, astemizole, mizolastine),
  • other drugs (e.g., cisapride, intravenous vincamine, bepridil, and difemanil).
• You should inform your doctor if you are taking other medicines that may decrease blood potassium levels (e.g., loop and thiazide diuretics, laxatives, and enemas (high doses) or corticosteroids (anti-inflammatory medicines), amphotericin B) or cause a decrease in heart rate, as these may also increase the risk of serious heart rhythm disorders while taking moxifloxacino.
• Any other medicine that contains magnesium or aluminum (such as antacids for indigestion), iron, or zinc, didanosine, or any medicine that contains sucralfate (for gastrointestinal disorders) may reduce the effect of moxifloxacino tablets. Take your moxifloxacino tablets 6 hours before or after taking the other medicines.
• Taking oral medicines that contain charcoal at the same time as moxifloxacino tablets reduces the effect of these tablets. It is recommended not to use these medicines simultaneously.
• If you are currently taking oral anticoagulants (e.g., warfarin), your doctor may need to monitor your blood coagulation time.

Moxifloxacino Tillomed with food and drinks

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

Pregnancy, breastfeeding, and fertility

Do not take moxifloxacino 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 fertility may be affected by taking this medicine.

Driving and use of machines

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

Moxifloxacino Tillomed contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Moxifloxacino Tillomed

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

The recommended dose in adults is one 400 mg film-coated tablet, once a day.

Moxifloxacino tablets are for oral use. Take the tablet whole without chewing (to mask the bitter taste) and with plenty of liquid. Moxifloxacino can be taken with or without food. It is recommended that you take the tablet at approximately the same time every day.

The same dose can be taken by elderly patients, patients with low body weight, and patients with kidney problems.

The duration of treatment with moxifloxacino will depend on the type of infection. Unless your doctor tells you otherwise, your treatment will be as follows:

• Sudden worsening of chronic bronchitis (acute exacerbation): 5-10 days.
• Lung infections (pneumonias), except for pneumonias that start during hospital stay: 10 days.
• Acute infections of the paranasal sinuses (acute bacterial sinusitis): 7 days.
• Mild or moderate infections of the upper female genital tract (pelvic inflammatory disease), including infection of the Fallopian tubes and infection of the uterine mucous membrane: 14 days.

When moxifloxacino film-coated tablets are used to complete a treatment started with moxifloxacino infusion solution, the recommended durations are:

• Community-acquired lung infections (pneumonias): 7-14 days. Most patients with pneumonia switched from intravenous to oral treatment with moxifloxacino film-coated tablets 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 with moxifloxacino film-coated tablets after 6 days.

It is important that you complete the full treatment, even if you start to feel better after a few days. If you stop treatment too soon, the infection may not be completely cured, the infection may return, or your condition may worsen. The bacteria that cause your infection may become resistant to moxifloxacino.

Do not exceed the recommended dose and duration of treatment (see section 2. What you need to know before taking Moxifloxacino Tillomed, Warnings and precautions).

If you take more Moxifloxacino Tillomed than you should

If you take more than one of the recommended tablets per day, consult your doctor immediately and try to 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service. Phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Moxifloxacino Tillomed

In case of forgetting a dose, you should take the tablet as soon as you remember it on the same day. If you do not remember it on the same day, take the normal dose (one tablet) the next day. Do not take a double dose to make up for forgotten doses.

If you are not sure what to do, consult your doctor or pharmacist.

If you stop taking Moxifloxacino Tillomed

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The most serious side effectsobserved during treatment with moxifloxacino are listed below:

If you notice

• an abnormally fast heart rate (rare side effect).
• You start to feel unwell or notice yellowing of the whites of the eyes, dark urine, itching of the skin, tendency to bleed, disorders of thought or insomnia (these can be signs or symptoms of fulminant liver inflammation with life-threatening liver failure (very rare side effect, with reported fatal cases)).
• Severe skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These can appear on the trunk as red, target-like patches or circular spots, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, 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 exanthematous pustulosis) (the frequency of this side effect is "not known").
• Syndrome associated with alterations in water elimination and low sodium levels (SIADH) (very rare side effect).
• Loss of consciousness due to a severe decrease in blood sugar levels (hypoglycemic coma) (very rare side effect).
• Inflammation of blood vessels (the signs can be red spots on the skin, usually on the legs, or effects such as joint pain) (very rare side effect).
• Severe allergic reaction, sudden and generalized, including very rarely life-threatening shock (e.g., difficulty breathing, low blood pressure, rapid pulse) (rare side effects).
• Swelling, including possible swelling of the airways (rare side effect, potentially life-threatening).
• 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 (possibly leading to self-harm, such as suicidal thoughts or attempts) (rare side effect).
• Dementia (may potentially lead to self-harming behaviors, such as suicidal thoughts or attempts) (rare side effect).
• Severe diarrhea with blood and/or mucus (antibiotic-associated colitis, including pseudomembranous colitis), which in rare circumstances can lead to life-threatening complications (rare side effects).
• Pain and inflammation of the tendons (tendinitis) (rare side effect) or tendon rupture (very rare side effect).
• Muscle weakness, sensitivity, or pain, particularly if you also feel discomfort, have a fever, or your urine is dark. These symptoms can be caused by abnormal muscle breakdown, which can be life-threatening and cause kidney problems (a condition called rhabdomyolysis) (the frequency of this side effect is "not known").

Stop taking moxifloxacino and inform your doctor immediatelyas you need urgent medical attention.

Additionally, if you notice

• Transient loss of vision (very rare side effect), contact an ophthalmologist immediately.

If you have experienced life-threatening irregular heart rate (Torsade de Pointes) or cardiac arrest while taking moxifloxacino (very rare side effects), inform the treating doctor that you have taken moxifloxacino and do not resume treatment.

In rare cases, a worsening of myasthenia gravis symptoms has been observed. If this occurs, consult your doctor immediately.

If you have diabetes and notice that your blood glucose levels are increased or decreased (rare or very rare side effect), inform your doctor immediately.

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

Other side effects observed during treatment with moxifloxacino are listed below according to their probability:

Frequent(may affect up to 1 in 10 people):

• 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.
• Change in heart rhythm (ECG), in patients with low potassium levels in the blood.

Infrequent(may affect up to 1 in 100 people):

• Rash.
• Gastric discomfort (indigestion/heartburn).
• Altered taste (in very rare cases, loss of taste).
• Sleep disorders (mainly insomnia).
• Increased levels of specific liver enzymes in blood (gamma-glutamyltransferase and/or alkaline phosphatase).
• Low levels of certain white blood cells (leukocytes, neutrophils).
• Constipation.
• Itching.
• Feeling of vertigo (feeling that everything is spinning or falling).
• Drowsiness.
• Flatulence.
• Change in heart rhythm (ECG).
• Liver function disorder (including increased levels of a liver enzyme in blood (LDH)).
• Decreased appetite or food intake.
• Low white blood cell count.
• Back, chest, pelvis, and limb pain.
• Increased levels of certain blood cells necessary for blood coagulation.
• Sweating.
• Increased levels of certain white blood cells (eosinophils).
• Anxiety.
• Discomfort (mainly weakness or fatigue).
• Agitation.
• Joint pain.
• Palpitations.
• Irregular or rapid heart rate.
• Breathing difficulties, including asthma.
• Increased levels of certain digestive enzymes in blood (amylase).
• Restlessness/agitation.
• Feeling of tingling (tingling) and/or numbness.
• Hives.
• Dilation of blood vessels.
• Confusion and disorientation.
• Decrease in certain blood cells necessary for blood coagulation.
• Vision disorders, including double vision and blurred vision.
• Decrease in blood coagulation.
• Increased blood lipid levels (fats).
• Low red blood cell count.
• Muscle pain.
• Allergic reactions.
• Increased bilirubin levels in blood.
• Stomach inflammation.
• Dehydration.
• Severe heart rhythm disorders.
• Dry skin.
• Chest pain.

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

• Muscle contracture.
• Muscle cramp.
• Hallucinations.
• Hypertension.
• Swelling (of hands, feet, ankles, lips, mouth, throat).
• Hypotension.
• Kidney disorders (including increased laboratory test results for the kidneys, such as urea and creatinine).
• Liver inflammation.
• Mouth inflammation.
• Ringing/ noises in the ears.
• Jaundice (yellowing of the whites of the eyes or skin).
• Disorder of skin sensation.
• Abnormal dreams.
• Concentration disorders.
• Difficulty swallowing.
• Disorders of smell (including loss of smell).
• Disorders of balance and lack of coordination (due to dizziness).
• Partial or total loss of memory.
• Hearing impairment, including deafness (usually reversible).
• Increased uric acid levels in blood.
• Emotional instability.
• Speech disorders.
• Fainting.
• Muscle weakness.

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

• Joint inflammation.
• Abnormal heart rhythm.
• Increased skin sensitivity.
• Feeling of loss of personality (not being oneself).
• Increased blood coagulation.
• Muscle stiffness.
• Significant decrease in certain white blood cells (agranulocytosis).
• Decrease in the number of red and white blood cells and platelets (pancytopenia).

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

• Decrease in blood sugar levels leading to coma (hypoglycemic coma)
• Loss of appetite, vomiting, and confusion, and seizures, unconsciousness, death in severe cases of excessive release of a hormone that regulates the amount of water in our blood. [Inappropriate secretion of antidiuretic hormone (SIADH)].

Additionally, very rare cases of the following side effects have been reported after treatment with other quinolone antibiotics and may also occur during treatment with Moxifloxacino Tillomed:

• Increased pressure in the skull (symptoms include headache, vision problems such as blurred vision, blind spots, double vision, loss of vision),
• Increased sodium levels in blood,
• Increased calcium levels in blood,
• Reduced count of a certain type of red blood cell (hemolytic anemia),
• Increased skin sensitivity to sunlight or UV.

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

Cases of increased size and weakening or tearing of the aortic wall (aneurysms and dissections) have been reported, which could lead to rupture and be fatal, and cardiac valve insufficiency in patients who have received fluoroquinolones (see also section 2).

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Moxifloxacino Tillomed

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the blister pack and carton after EXP. The expiration date corresponds to the last day of this month.

No special storage conditions are required. Store in the original packaging to protect it from moisture.

1. Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and unused medication in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medication you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Moxifloxacino Tillomed

• The active ingredient is moxifloxacino. Each film-coated tablet contains 400 milligrams of moxifloxacino in the form of hydrochloride.
• Other components are:
• • Core of the tablet: lactose monohydrate, povidone K29/32, anhydrous lactose, sodium croscarmellose, anhydrous colloidal silica, and magnesium stearate.
  • Coating: hypromellose, titanium dioxide (E 171), macrogol 4000, and red iron oxide (E 172).

Appearance of Moxifloxacino Tillomed and package contents

Each film-coated tablet is pale red, capsule-shaped, marked with "400" on one side and "M" on the other.

Moxifloxacino Tillomed 400 mg film-coated tablets are available in blister packs included in packages of 5, 7, 10, and 14 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Laboratorios Tillomed Spain S.L.U.

C/ Cardenal Marcelo Spínola 8, 1st floor, door F

28016 Madrid

Spain

Manufacturer

Wessling Hungary Kft

Anonymus Utca 6

Budapest 1045

Hungary

MIAS Pharma Limited

Suite 2, Stafford House,

Strand Road, Portmarnock,

Co. Dublin, Ireland

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

United Kingdom Moxifloxacin 400 mg Tablets

Germany Moxifloxacin Tillomed 400 mg Filmtabletten

Spain Moxifloxacino Tillomed 400 mg film-coated tablets EFG

Date of the last revision of this leaflet: June 2021

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).