Label: Patient Information

Moxifloxacino Tevagen 400 mg Film-Coated Tablets EFG

For use in adults

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

• Keep this label, 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 label.Seesection4.

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

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

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

For this type of infection, Moxifloxacino Tevagen is not sufficient as a single treatment, so your doctor will also prescribe another antibiotic for the treatment of upper genital tract infections (see section 2 "Warnings and precautions").

If the following bacterial infections have shown improvement during initial treatment with moxifloxacino solution for infusion, your doctor may prescribe Moxifloxacino Tevagen to complete the treatment:

• Pneumonia acquired outside the hospital
• Skin and soft tissue infections

Moxifloxacino Tevagen should not be used as initial treatment for any type of skin and soft tissue infection or for severe pneumonia.

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

Do not take Moxifloxacino Tevagen

• if you are allergic to moxifloxacino, other quinolone antibiotics, or any of the other components of this medication (listed in section 6).
• if you are pregnant or breastfeeding.
• if you are under 18 years of age.
• if you have a history of tendon damage or tendonitis related to antibiotic treatment with quinolones (see section 2 “Warnings and precautions” and section 4).
• if you were born with or have had any disease related to abnormal heart rhythm (observed on ECG, heart electrical recording), have electrolyte imbalances in the blood (especially low levels of potassium or magnesium in the blood), have a very slow heart rate (called “bradycardia”), have heart failure, have a history of heart rhythm disorders, or are taking other medications that cause abnormal ECG readings (see section 2 “Other medications and Moxifloxacino Tevagen”).

This is because Moxifloxacino Tevagen may cause changes in 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 elevated liver enzymes (transaminases) 5 times above the upper limit of normal.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Moxifloxacino Tevagen

• Moxifloxacino Tevagen 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 causes a decrease in blood potassium levels, consult your doctor before taking Moxifloxacino Tevagen (see also section 2 “Do not take Moxifloxacino Tevagen” and “Other medications and Moxifloxacino Tevagen”).
• If you have epilepsy or any other condition that may cause seizures, consult your doctor before taking Moxifloxacino Tevagen.
• If you have or have had any mental health problems, consult your doctor before taking Moxifloxacino Tevagen.
• If you have myasthenia gravis, your symptoms may worsen if you take Moxifloxacino Tevagen. If you think this affects you, inform your doctor immediately.
• 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 wall of the aorta).
• 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 conditions (e.g., connective tissue disorders such as Marfan syndrome, 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 atherosclerosis, known arthritis, or endocarditis (a heart infection)).
• If you or a family member has glucose-6-phosphate dehydrogenase deficiency (a rare hereditary disease), inform your doctor and they will tell you if Moxifloxacino Tevagen 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 in the pelvis), for which your doctor considers intravenous treatment, Moxifloxacino Tevagen is not suitable for treatment.
• For the treatment of mild to moderate upper genital tract infection, your doctor must prescribe another antibiotic in addition to Moxifloxacino Tevagen. If you do not notice an improvement in symptoms after three days of treatment, consult your doctor.
• If you are diabetic, as 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.

Before starting to take this medication

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

During treatment with this medication

• If you experience palpitations or irregular heartbeats during treatment, inform your doctor immediately. They may perform an ECG to measure heart rhythm.
• The risk of cardiac problems may increase with higher doses. Therefore, take the recommended dose.
• If you experience severe and sudden pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go to an emergency service immediately. The risk may be increased if you are receiving systemic corticosteroids.
• If you start to experience sudden onset of shortness of breath, especially when lying down, or if you notice swelling in the legs, feet, or abdomen, or the onset of palpitations (sensation of rapid or irregular heartbeat), inform your doctor immediately.

• In rare cases, you may experience a severe and sudden allergic reaction (anaphylactic reaction) even with the first dose and develop the following symptoms: chest tightness, dizziness, nausea, or fainting, or feeling dizzy when standing up.In case of these symptoms, stop taking Moxifloxacino Tevagen and consult your doctor immediately.
• Moxifloxacino Tevagen may cause a rapid and severe inflammation of the liver, which may lead to potential fatal liver failure (including fatal cases, see section 4). Please consult your doctor before continuing treatment if you develop symptoms such as sudden onset of discomfort and/or nausea associated with yellowing of the whites of the eyes, dark urine, itching, bleeding tendency, or cerebral damage caused by liver damage (symptoms of reduced liver function or rapid and severe liver inflammation).
• Quinolone antibiotics, including Moxifloxacino Tevagen, may cause seizures.If this occurs, stop taking Moxifloxacino Tevagen and contact your doctor immediately.
• In rare cases, you may experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness, and/or weakness, especially in the feet and legs or hands and arms. If this happens, stop taking Moxifloxacino Tevagen and inform your doctor immediately to prevent the development of a potentially irreversible disorder.
• You may experience mental health problems, even after the first administration of quinolone antibiotics, including Moxifloxacino Tevagen. In rare cases, mental health problems and depression have evolved into suicidal thoughts and self-harm behaviors such as attempted suicide (see section 4). If you develop these reactions, stop taking Moxifloxacino Tevagen and inform your doctor immediately.
• You may experience diarrhea during or after taking antibiotics, including Moxifloxacino Tevagen. If this becomes intense or persistent, or if you notice that your stools contain blood or mucus, stop taking Moxifloxacino Tevagen immediately and consult your doctor. In these situations, do not take medications that inhibit or slow down intestinal movement.
• In rare cases, you may experience pain and swelling in the joints and 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. Inflammation and tendon rupture can occur in the first 48 hours of treatment and even several months after stopping treatment with Moxifloxacino Tevagen. If you experience any signs of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder, or knee), stop taking Moxifloxacino Tevagen, 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 experience severe and sudden pain in the abdomen, chest, or back, go to an emergency service immediately.
• If you are an elderly person and have kidney problems, be careful to ensure adequate fluid intake, as dehydration may increase the risk of kidney failure.
• If your vision worsens or if your eyes appear to be affected in any other way, consult an ophthalmologist immediately (see sections 2 "Driving and operating machinery" and 4).
• Antibiotics such as fluoroquinolones can cause an increase in blood sugar levels above normal levels (hyperglycemia) or a decrease in blood sugar levels below normal levels (hypoglycemia), which in severe cases can cause a loss of consciousness (hypoglycemic coma) (see section 4. Possible side effects). If you have diabetes, your blood sugar levels must be carefully controlled.
• Quinolone antibiotics can increase the sensitivity of the skin to sunlight or UV light. Avoid prolonged exposure to sunlight or direct sunlight and do not use sunbeds or any type of UV lamp during treatment with Moxifloxacino Tevagen.
• The efficacy of moxifloxacino solution for infusion in the treatment of severe burns, deep tissue infections, and diabetic foot infections with osteomyelitis (bone marrow infections) has not been established.

Severe skin reactions

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

•SSJ/TEN may initially appear on the trunk as red, ring-shaped spots or circular patches 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 reactions often precede fever and/or flu-like symptoms. The reactions may progress to widespread skin peeling and complications that may be life-threatening or fatal.

•GAP appears at the beginning of treatment as a red, scaly, and generalized rash with subcutaneous nodules and blisters accompanied by fever. The most common location: mainly localized in skin folds, trunk, and upper limbs.

The drug reaction with eosinophilia and systemic symptoms (DRESS) appears initially with flu-like symptoms and a rash on the face, followed by a widespread rash with high body temperature, elevated liver enzymes in blood tests, and elevated levels of a type of white blood cell (eosinophilia), and enlarged lymph nodes. If you develop a severe skin rash or any of these symptoms, stop taking moxifloxacino and contact your doctor or seek medical attention immediately.

Severe, long-lasting, and potentially irreversible adverse effects

Fluoroquinolone or quinolone antibiotics, including Moxifloxacino Tevagen, have been associated with rare but severe adverse effects, some of which were long-lasting (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 Tevagen, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or not with the treatment, also considering the use of an antibiotic of another class.

Children and adolescents

Do not administer this medication to children or adolescents under 18 years of age, as its safety and efficacy have not been established in this age group (see section “Do not take Moxifloxacino Tevagen”).

Use of Moxifloxacino Tevagen with other medications

Inform your doctor or pharmacist if you are taking/using or have taken recently or may need to take/use any other medication.

With Moxifloxacino Tevagen, you should be aware of the following:

• If you are taking Moxifloxacino Tevagen and othermedications that affect the heart, there is a higher risk of abnormal heart rhythm. Therefore, do not take Moxifloxacino Tevagen 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 antimicrobial agents (e.g. saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarials, particularly halofantrine),
• some antihistamines (e.g. terfenadine, astemizole, mizolastine),
• andother medications (e.g. cisapride, intravenous vincamine, bepridil, and difemanil).

• You should inform your doctor if you are taking other medications that may decrease blood potassium levels (e.g. some diuretics, laxatives, enemas [high doses], or corticosteroids [anti-inflammatory medications], amphotericin B) or medications that may cause a decrease in heart rate, as these may also increase the risk of severe heart rhythm disorders while taking Moxifloxacino Tevagen.
• Anymedication that contains magnesium or aluminum, such as antacids for indigestion, or any medication that containsiron or zinc, medications that contain didanosineormedications that contain sucralfatefor treating gastrointestinal disorders may reduce the action of Moxifloxacino Tevagen. Therefore, take your Moxifloxacino Tevagen tablets 6 hours before or after taking other medications.
• The oral administrationof any medication that contains activated charcoalat the same time as Moxifloxacino Tevagen reduces the action of Moxifloxacino Tevagen. Therefore, it is recommended not to use these medications simultaneously.
• If you are currently takingoral anticoagulants(e.g. warfarin), your doctor may need to monitor your blood clotting time.

TakingMoxifloxacinoTevagenwithfoodanddrinks

The effect of Moxifloxacino Tevagen is not altered by food, including dairy products.

Pregnancy, lactation, and fertility

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

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

Animal studies have not indicated that taking this medication damages fertility.

Driving and operating machinery

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

Moxifloxacino Tevagen contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions indicated by your doctor or pharmacist for this medication. In case of doubt, consult your doctor or pharmacist again.

Dosage

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

Administration form

Moxifloxacino Tevagen tablets are for oral use. Take the tablet whole (to mask the bitter taste) and with plenty of liquid.

You can take Moxifloxacino Tevagen with or without food. It is recommended that you take the tablet approximately at the same time every day.

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

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

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

When Moxifloxacino Tevagen film-coated tablets are used to complete a treatment initiated with moxifloxacino infusion solution, the recommended durations of use are:

• Community-acquired pneumonia: 7-14 days

Most patients with pneumonia were switched to oral treatment with moxifloxacino film-coated tablets in 4 days.

• Soft tissue and skin infections: 7-21 days

Most patients with soft tissue and skin infections were switched to oral treatment with moxifloxacino film-coated tablets in 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 worsenand also may cause bacterial resistance to the antibiotic.

Do not exceed the recommended dose and duration of treatment (see section 2 “Warnings and precautions”).

If you take moreMoxifloxacinoTevagen than you should

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

In case of overdose or accidental ingestionconsult 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 forgot to take Moxifloxacino Tevagen

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

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

If you interrupt the treatment with Moxifloxacino Tevagen

If you interrupt the treatment with this medication too soon, your infection may not be completely cured. Consult your doctor if you want 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.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. During treatment with moxifloxacino, the following more serious side effects have been observed:more serious side effectsare detailed below:

If you notice:

Rare: may affect up to 1 in 1,000 patients

• an abnormally fast heart rate
• a sudden, severe, generalised allergic reaction, including, very rarely, shock that can be fatal (for example, difficulty breathing, decreased blood pressure, rapid pulse)
• inflammation, including inflammation of the airways (potentially fatal)
• seizures
• problems associated with the nervous system, such as pain, burning, tingling, numbness, and/or weakness in the limbs
• depression (in very rare cases leading to self-harm, such as suicidal thoughts or attempts)
• severe diarrhoea containing blood and/or mucus (colitis, including pseudomembranous colitis associated with antibiotics), which in very rare cases can lead to fatal complications
• tendon pain and inflammation (tendinitis)

Very rare: may affect up to 1 in 10,000 patients

• you suddenly feel unwell or notice a yellowish colour of the white of the eyes, dark urine, itching, a tendency to bleed, or disturbances in thought or vigilance (these may be signs and symptoms of fulminant liver inflammation that can lead to fatal liver failure (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 centre, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, and may be preceded by fever and symptoms similar to the flu (very rare side effects, with possible life-threatening risk) 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 (hypoglycaemic coma) (very rare side effect)
• inflammation of blood vessels (the signs may be red patches on the skin, usually on the lower legs, or effects such as joint pain)
• dementia (may lead to self-harm, such as suicidal thoughts or attempts)
• tendon rupture
• a red, scaly, and generalised rash with protuberances under the skin and blisters accompanied by fever at the start of treatment (generalised acute pustular psoriasis) (the frequency of this side effect is “unknown”)
• -generalised rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and affection of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome) (the frequency of this side effect is “unknown”)
• muscle weakness, sensitivity, or pain, particularly if you also feel unwell, have a fever, or your urine is dark. These symptoms may be caused by abnormal muscle breakdown that can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis) (the frequency of this side effect is “unknown”)

Stop taking Moxifloxacino Tevagen and consult your doctor immediatelyas you may need urgent medical help.

Additionally, if you notice:

• transient loss of vision (very rare side effect),

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

contact an ophthalmologist immediately.

If you have experienced potentially fatal irregular heartbeats (Torsade de Pointes) or heart arrhythmia while taking Moxifloxacino Tevagen (very rare side effects),inform your doctor immediately that you are taking Moxifloxacino Tevagen and do not start the treatment again.

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

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

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

The following side effects have been observedduring treatment with moxifloxacino that are detailed below according to their probability:

Frequent: may affect up to 1 in 10 patients

• nausea
• diarrhoea
• dizziness
• abdominal and stomach pain
• vomiting
• headache
• increased levels of certain liver enzymes in the blood (transaminases)
• infections caused by bacteria that are resistant or fungi, such as 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 1,000 patients

• muscle spasms
• muscle cramps
• hallucinations
• high blood pressure
• inflammation (of the hands, feet, ankles, lips, mouth, throat)
• low blood pressure
• renal disorders (including increased levels of certain laboratory results of the kidney such as urea and creatinine)
• liver inflammation
• mouth inflammation
• tinnitus/ringing in the ears
• jaundice (yellowish colour of the white of the eyes or skin)
• sensitivity disorder of the skin
• abnormal dreams
• concentration problems
• difficulty swallowing
• changes in taste (including loss of taste)
• balance disorder and poor coordination (due to dizziness)
• partial or total memory loss
• hearing and vision disorders, including deafness (usually reversible)
• increased levels of uric acid in the blood
• emotional instability
• speech disorders
• syncope
• muscle weakness

Very rare: may affect up to 1 in 10,000 patients

• joint inflammation
• abnormal heart rhythm
• increased sensitivity of the skin
• sensation of loss of personality (feeling of not being oneself)
• increased blood coagulation
• muscle stiffness
• significant decrease in certain white blood cells (agranulocytosis)
• decrease in the number of red blood cells and platelets (pancytopenia)

Frequency unknown(cannot be estimated from available data)

-increased sensitivity of the skin to sunlight or UV radiation (see also section 2. Warnings and precautions)

-well-defined, red, and clearly demarcated patches with or without blisters that appear in the hours following administration of moxifloxacino and disappear with residual post-inflammatory hyperpigmentation; they usually reappear in the same place on the skin or mucosa with subsequent exposure to moxifloxacino

In addition, very 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 Tevagen:

• increased intracranial pressure (symptoms include headache, visual disturbances such as blurred vision, blind spots, double vision, loss of vision)

• increased levels of sodium in the blood
• increased levels of calcium in the blood
• reduced count of a certain type of red blood cells (haemolytic anaemia)

The administration of quinolone and fluoroquinolone antibiotics has been associated with very 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 pinpricks, tingling, numbness, burning, or pain (neuropathy), depression, fatigue, sleep disorders, memory loss, and hearing, vision, taste, and smell disorders, 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), which could lead to rupture and be fatal, and heart valve insufficiency in patients who have received fluoroquinolones have been reported. See also section 2.

Reporting of adverse reactions:

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

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 box after "CAD or EXP". The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment

Composition of Moxifloxacino Tevagen

The active ingredient is moxifloxacino.

Each film-coated tablet contains 400 mg of moxifloxacino.

The other components are:

Core tablet: Microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate

Film coating: Hypromellose, Macrogol 4000, iron oxide red (E172), and titanium dioxide (E171).

Appearance of Moxifloxacino Tevagen and packaging contents

Moxifloxacino Tevagen film-coated tablets are slightly pink, elongated, and biconvex. The tablets are approximately 17 mm in length and 7.5 mm in width.

Moxifloxacino Tevagen is available in packaging of 5, 7, 10, 14, 25, (5x5), 70 (7x10), 80 (16x5), 100 (10x10), 100 film-coated tablets.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11. Edificio Albatros B, 1st Floor.

28108 Alcobendas (Madrid)

Spain

Responsible Manufacturer:

Merckle GmbH

Ludwig-Merckle-Straße 3, 89143 Blaubeuren

Germany

Or

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

Or

TEVA UK Ltd

Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG

United Kingdom

Or

Pharmachemie B.V.

Swensweg 5,2031 GA Haarlem

Netherlands

Or

Teva Operations Poland Sp.z.o.o

ul. Mogilska 80. 31-546, Krakow

Poland

This medicinal product is authorized in the EEA member states under the following names:

Germany:Moxifloxacin AbZ 400 mg Filmtabletten

Belgium:Moxifloxacine Teva

Denmark:Moxiva

Spain:Moxifloxacino Tevagen 400 mg film-coated tablets EFG

Hungary:Moxifloxacin-ratiopharm 400 mg filmtabletta

Italy:Moxifloxacina Teva 400 mg Compresse rivestite con film

United Kingdom:Moxifloxacin 400 mg Film-coated Tablets

Last review date of this leaflet::february 2021

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

You can access detailed and updated information on this medicine by scanning the QR code included in the packaging with your smartphone. You can also access this information on the following internet address:https://cima.aemps.es/cima/dochtml/p/76633/P_76633.html