Package Insert: Information for the Patient

MoxifloxacinoTillomed 400 mg Film-Coated Tablets

For use in adults

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

2. What you need to know before starting to take Moxifloxacino Tillomed

3. How to take Moxifloxacino Tillomed

4. Possible adverse effects

5. Storage of Moxifloxacino Tillomed

6. Contents of the package and additional information

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

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

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

This type of infection requires more than one treatment. Therefore, in addition to moxifloxacino, your doctor will prescribe another antibiotic for the treatment of mild or moderate upper genital tract infections in females (see section 2 What you need to know before starting to take Moxifloxacino Tillomed, Warnings and precautions, Consult your doctor before taking Moxifloxacino Tillomed).

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

• Community-acquired pneumonia
• Skin and soft tissue infections.

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

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

Do not take Moxifloxacino Tillomed

• If you are allergic to the active ingredient moxifloxacino or to other quinolones or to any of the other components of this medication (including in section 6).
• If you are pregnant or breastfeeding.
• If you are under 18 years old.
• If you have a history of tendon damage or lesions related to antibiotic quinolone treatment (see sections Warnings and precautions and 4. Possible side effects)..
• If you have a hereditary disease or have:
• • any disease related to an abnormal heart rhythm (observed on ECG, heart electrical recording),
  • have electrolyte imbalances in the blood (especially low levels of potassium or magnesium in the blood),
  • have a very slow heart rate (called "bradycardia"),
  • have a weak heart (heart failure),
  • have a history of heart rhythm alterations
• If you are taking other medications that cause ECG disturbances (see section Other medications and Moxifloxacino Tillomed). This is because moxifloxacino can cause changes in the ECG, such as a prolongation of the QT interval, that is, a delay in the conduction of electrical signals in the heart.
• If you have severe liver disease or increased levels of liver enzymes (transaminases) 5 times above the upper limit of normal.

Warnings and precautions

Before starting to take this medication

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

Consult your doctor before taking Moxifloxacino Tillomed

• If you are diabetic because you may experience a risk of changes in blood sugar levels with moxifloxacino.
• If you have ever developed a severe skin rash or skin peeling, blisters, and/or mouth sores after taking moxifloxacino.
• Moxifloxacino may modify the heart ECG, especially if you are a woman or an elderly patient. If you are currently taking any medication that causes a decrease in blood potassium levels, consult your doctor before taking moxifloxacino (see also sections Do not take Moxifloxacino Tillomed andOther medications and Moxifloxacino Tillomed).
• If you suffer from epilepsy or another condition that may cause seizures, consult your doctor before taking moxifloxacino.
• If you have or have had any mental health problems, consult your doctor before taking moxifloxacino.
• If you have myasthenia gravis (abnormal muscle fatigue leading to weakness and severe paralysis), your symptoms may worsen if you take moxifloxacino. If you think this affects you, consult your doctor immediately.
• If you or a family member suffers from glucose-6-phosphate dehydrogenase deficiency (a rare hereditary disease), inform your doctor, who will indicate whether moxifloxacino is suitable for you.
• If you have a complicated upper genital tract infection (e.g., associated with an abscess in the Fallopian tubes and ovaries or pelvis), for which your doctor considers intravenous treatment necessary, it is not appropriate to treat with moxifloxacino tablets.
• For the treatment of mild to moderate upper genital tract infection, 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 aneurysm of a large artery (aortic aneurysm or aneurysm of a large peripheral artery).
• If you have had a previous episode of aortic dissection (tear in the aortic wall).
• If you have been diagnosed with heart valve insufficiency (regurgitation of heart valves).
• If you have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., Marfan syndrome or Ehlers-Danlos syndrome, Turner syndrome or Sjögren's syndrome (an autoimmune inflammatory disease) or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, or known atherosclerosis, rheumatoid arthritis (a joint disease) or endocarditis (a heart infection)).

During treatment with Moxifloxacino Tillomed

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

• Therisk of heart problemsmay increase with increasing dose. Therefore, the recommended dose should be taken.

• In rare cases, you may experience asevere allergic reaction(anaphylactic reaction) even with the first dose. Symptoms include: chest tightness, dizziness, nausea, or fainting, or feeling dizzy when standing up. If these symptoms occur, discontinue moxifloxacino administration and consult your doctor immediately.

• Moxifloxacino may cause arapid and severe inflammation of the liver, which may lead to liver failure that puts your life at risk (including fatal cases, see section 4. Possible side effects). If you develop sudden discomfort and/or discomfort associated with yellowing of the white of the eyes, dark urine, itching, or bleeding tendency or liver damage-induced cerebral disease, please consult your doctor before taking any more tablets.

Severe skin reactions

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

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

• Quinolone antibiotics, including moxifloxacino, may causeseizures. If this occurs, moxifloxacino treatment should be discontinued and you should contact your doctor immediately.

• In rare cases, you may experience symptoms ofnerve 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 experiencemental 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-harm behaviors such as attempted suicide (see section 4. Possible side effects). If you develop these reactions, treatment with moxifloxacino should be discontinued and you should inform your doctor immediately.

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

• In rare cases, you may experiencejoint pain and swelling, inflammation, or tendon rupture. The risk is higher if you are an elderly person (over 60 years old), have received an organ transplant, have kidney problems, or are taking corticosteroids. Tendon inflammation and rupture can occur in the first 48 hours of treatment and even several months after discontinuing Moxifloxacino Tillomed treatment. If you experience any signs of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Moxifloxacino Tillomed, contact your doctor, and keep the affected area at rest. Avoid any unnecessary exercise, as this may increase the risk of tendon rupture.

• If you are anelderly patientand havekidney problems, make sure to drink plenty of fluids while taking moxifloxacino. If you become dehydrated, this may increase the risk of kidney failure.

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

• The fluoroquinolones may cause an increase in your blood sugar levels above normal levels (hyperglycemia), or a decrease in your blood sugar levels below normal levels (hypoglycemia), which in severe cases may cause a loss of consciousness (hypoglycemic coma) (see section4.Possible side effects). If you have diabetes, your blood sugar levels should be carefully controlled.

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

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

Severe, prolonged, and potentially irreversible adverse effects

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

If you experience any of these adverse effects after taking Moxifloxacino Tillomed, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or discontinue treatment, also considering the use of another class of antibiotic.

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

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

Children and adolescents

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

Other medications and Moxifloxacino Tillomed

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

With moxifloxacino, you should be aware of the following:

• If you are taking moxifloxacino and other medications that affect the heart, there is a higher risk of abnormal heart rhythms. Therefore, do not take moxifloxacino at the same time as the following medications:
• • Antiarrhythmic medications (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide),
  • antipsychotics (e.g., phenothiazines, pimozide, sertindol, haloperidol, sulpiride),
  • tricyclic antidepressants,
  • some antimicrobials (e.g., saquinavir, sparfloxacin, erythromycin administered intravenously, pentamidine, antimalarials, particularly halofantrine),
  • some antihistamines (e.g., terfenadine, astemizole, mizolastine),
  • other medications (e.g., cisapride, vincamine intravenously, bepridil, and difemanil).
• Inform your doctor if you are taking other medications that may decrease blood potassium levels (e.g., diuretics and type thiazide, laxatives and enemas (high doses) or corticosteroids (anti-inflammatory medications), amphotericin B) or cause a decrease in heart rate, as these may also increase the risk of severe heart rhythm disturbances while taking moxifloxacino.
• Any other medication that contains magnesium or aluminum (such as antacids for indigestion), iron, or zinc, didanosine, or any medication that contains sucralfate (for treating gastrointestinal disorders)may reduce the action of moxifloxacino tablets. Take your moxifloxacino tablets 6 hours before or after taking the other medications.
• The oral administration of any medication that contains charcoal at the same time as moxifloxacino tablets reduces their action. It is recommended not to use these medications simultaneously.
• If you are currently taking oral anticoagulants (e.g., warfarin), your doctor may need to monitor your blood clotting time.

Moxifloxacino Tillomed with food and drinks

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

Pregnancy, lactation, and fertility

Do not take moxifloxacino if you are pregnant or breastfeeding.

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

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

Driving and the use of machines

Moxifloxacino may cause dizziness or vertigo or a brief loss of consciousness. 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 medication.

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

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

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

• Acute exacerbation of chronic bronchitis: 5 – 10 days.
• Pulmonary infections (pneumonias), except for pneumonias that begin during hospital stay: 10 days.
• Acute bacterial sinusitis: 7 days.
• Mild or moderate upper genital tract infections in females (pelvic inflammatory disease), including fallopian tube infection and uterine mucous membrane infection: 14 days.

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

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

It is essential to complete the treatment, even if you start feeling better after a few days. If you interrupt the treatment too soon, the infection may not be completely cured, the infection may recur, or your condition may worsen. The bacteria causing 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 starting to take 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 get the remaining medication, the packaging, or this leaflet and show it to your doctor or pharmacist.

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

If you forget to take Moxifloxacino Tillomed

In case of forgotten dose, take the tablet as soon as you remember on the same day. If you do not remember on the same day, take the regular dose (one tablet) the next day. Do not take a double dose to compensate for the missed doses.

If you are unsure of what to do, consult your doctor or pharmacist.

If you interrupt the treatment with Moxifloxacino Tillomed

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

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

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

Themost 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, skin itching, bleeding tendency, thought disorders or insomnia (these may be signs or symptoms of fulminant liver inflammation with liver failure risk (very rare side effect, fatal cases have been observed)).
• Severe skin eruptions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as red, target-shaped macules or circular patches often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers, and may be preceded by fever and flu-like symptoms (very rare side effects, with possible life-threatening risk).
• A red, scaly, and generalized rash with subcutaneous nodules and blisters accompanied by fever at the beginning of treatment (acute generalized pustular psoriasis) (the frequency of this side effect is "unknown").
• Syndrome associated with water elimination alterations and low sodium levels (SIADH) (very rare side effect).
• Loss of consciousness due to severe decrease in blood sugar levels (hypoglycemic coma) (very rare side effect).
• Angioedema (the signs may be red patches on the skin, usually on the legs or effects such as joint pain).
• Severe allergic reaction, sudden and generalized, including rarely life-threatening shock (e.g., difficulty breathing, decreased blood pressure, rapid pulse) (rare side effects).
• Swelling, including possible respiratory tract swelling (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 extremities (rare side effect).
• Depression (may lead to self-harm, such as suicidal thoughts or attempts) (rare side effect).
• Dementia (may potentially lead to self-harm 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 cases may lead to life-threatening complications (rare side effects).
• Tendon pain and inflammation (tendinitis) (rare side effect) or tendon rupture (very rare side effect).
• Muscle weakness, sensitivity, or pain, particularly if accompanied by discomfort, fever, or dark urine. These symptoms may be caused by abnormal muscle degradation that may be life-threatening and lead to kidney problems (a condition called rhabdomyolysis) (frequency of this side effect is "unknown").

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

Additionally, if you notice

• transient loss of vision (very rare side effect),contact your ophthalmologist immediately.

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

In rare cases, 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, leg, ankle, or foot inflammation, fatigue, nausea, drowsiness, difficulty breathing, or confusion (these may 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.
• Abdominal pain and discomfort.
• Vomiting.
• Headache.
• Increased certain liver enzymes in the 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.

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

• Rash.
• Indigestion/heartburn.
• Alteration of taste (in rare cases, loss of taste).
• Sleep disturbances (mainly insomnia).
• Increased specific liver enzymes in the blood (gamma-glutamyltransferase and/or alkaline phosphatase).
• Low levels of certain white blood cells (leukocytes, neutrophils).
• Constipation.
• Itching.
• Dizziness (sensation of spinning or falling).
• Somnolence.
• Flatulence.
• Change in heart rhythm (ECG).
• Liver function alteration (including increased liver enzyme in the blood (LDH)).
• Decreased appetite or food intake.
• Low white blood cell count.
• Back, chest, pelvis, and extremity pain.
• Increased certain blood cells necessary for blood coagulation.
• Sweating.
• Increased certain white blood cells (eosinophils).
• Anxiety.
• Discomfort (mainly weakness or fatigue).
• Agitation.
• Joint pain.
• Palpitations.
• Irregular or rapid heart rate.
• Difficulty breathing, including asthma-like states.
• Increased certain digestive enzymes in the blood (amylase).
• Restlessness/agitation.
• Sensation of tingling and/or numbness.
• Urticaria.
• vasodilation.
• Confusion and disorientation.
• Decreased certain blood cells necessary for blood coagulation.
• Vision disturbances, including double vision and blurred vision.
• Decreased blood coagulation.
• Increased blood lipids (fats).
• Low red blood cell count.
• Muscle pain.
• Allergic reactions.
• Increased bilirubin in the blood.
• Stomach inflammation.
• Dehydration.
• Severe alteration of heart rhythm.
• Dry skin.
• Angina pectoris.

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

• Muscle contracture.
• Muscle cramp.
• Illusions.
• Hypertension.
• Swelling (of hands, feet, ankles, lips, mouth, throat).
• Hypotension.
• Renal alterations (including increased laboratory test results for the kidneys, such as urea and creatinine).
• Liver inflammation.
• Mouth inflammation.
• Tinnitus.
• Ictericia (yellowing of the whites of the eyes or skin).
• Skin sensation disorder.
• Anomalous dreams.
• Concentration disturbances.
• Difficulty swallowing.
• Alteration of smell (including loss of smell).
• Balance and coordination disturbances (due to dizziness).
• Partial or total loss of memory.
• Deficit hearing, including deafness (usually reversible).
• Increased uric acid in the blood.
• Emotional instability.
• Alteration of speech.
• Syncopal episodes.
• 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 unknown(cannot be estimated from 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, rare cases of the following side effects have been reported, described after treatment with other quinolone antibiotics and that may also occur during treatment with Moxifloxacino Tillomed:

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

The administration of quinolone-containing antibiotics and fluoroquinolones has been associated with rare cases of long-lasting or permanent adverse reactions (even months or years) or permanent, 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 disturbances, memory loss, and hearing, vision, taste, and smell loss, 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 heart valve insufficiency in patients who have received fluoroquinolones (see also section 2).

Reporting of side effects

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

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

Do not use this medication after the expiration date that appears on the blister pack and on the carton after CAD. 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 drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of the containers and medicines you no longer need.By doing so, you will help protect the environment.

Composition of Moxifloxacino Tillomed

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

Appearance of Moxifloxacino Tillomed and content of the container

Each film-coated tablet is pale red in color, in the shape of a capsule, marked with “400” on one side and “M” on the other.

Moxifloxacino Tillomed 400 mg tablets are presented in blisters included in containers of 5, 7, 10, and 14 tablets.

Only some sizes of containers may be commercially marketed.

Marketing authorization holder

Laboratorios Tillomed Spain S.L.U.

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

28016 Madrid

Spain

Responsible for manufacturing

Wessling Hungary Kft

Anonymus Utca 6

Budapest 1045

Hungary

MIAS Pharma Limited

Suite 2, Stafford House,

Strand Road, Portmarnock,

Co. Dublin, Ireland

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

United Kingdom Moxifloxacin 400 mg Tablets

Germany Moxifloxacin Tillomed 400 mg Filmtabletten

Spain Moxifloxacino Tillomed 400 mg film-coated tablets

Last review date of this leaflet :June 2021

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