Moxifloxacin Tevagen 400 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Moxifloxacino Tevagen 400 mg film-coated tablets EFG

For use in adults

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

Moxifloxacino Tevagen is indicated in patients 18 years of age and older for the treatment of the following bacterial infections when caused by bacteria for which moxifloxacin is active. Moxifloxacino Tevagen should only be used to treat such infections when standard antibiotics cannot be used or have not been effective:

• Sinus infection, acute exacerbation of chronic inflammation of the airways, or community-acquired pneumonia (except severe cases).
• Mild to moderate infections of the upper female genital tract (pelvic inflammatory disease), including infection of the fallopian tubes and infection of the uterine mucosal membrane.

For these types of infections, Moxifloxacino Tevagen is not sufficient as monotherapy; therefore, in addition to Moxifloxacino Tevagen, your doctor must prescribe another antibiotic for the treatment of upper female genital tract infections (see section 2, "Warnings and precautions").

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

• Community-acquired pneumonia
• Skin and soft tissue infections

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

2. What you need to know before taking Moxifloxacino Tevagen

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

Do not take Moxifloxacino Tevagen

• if you are allergic to moxifloxacin, to other quinolone antibiotics, or to any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or breastfeeding.
• if you are under 18 years of age.
• if you have a history of tendon disorders or tendon damage related to treatment with quinolone antibiotics (see section 2 “Warnings and precautions” and section 4).
• if you were born with or have suffered

any condition associated with an abnormal heart rhythm (seen on ECG, the electrical recording of the heart), have imbalances in blood electrolytes (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, or are taking other medicines that cause abnormal changes in the ECG (see section 2 “Other medicines and Moxifloxacino Tevagen”).

This is because Moxifloxacino Tevagen may cause changes in the ECG, such as QT interval prolongation, meaning a delay in the electrical conduction 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 taking Moxifloxacino Tevagen

• Moxifloxacino Tevagen may alter the heart's ECG, especially if you are a woman or an elderly patient. If you are currently taking any medication that causes low potassium levels in the blood, consult your doctor before taking Moxifloxacino Tevagen (see also section 2 “Do not take Moxifloxacino Tevagen” and “Other medicines and Moxifloxacino Tevagen”).
• If you have epilepsy or another condition that may cause seizures, consult your doctor before taking Moxifloxacino Tevagen.
• If you have or have ever 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 applies to you, inform your doctor immediately.
• If you have been diagnosed with enlargement or a “bulge” in a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm).
• If you have previously experienced an episode of aortic dissection (a 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 predisposing conditions (e.g., connective tissue disorders such as Marfan syndrome, vascular Ehlers-Danlos syndrome, Turner syndrome, or Sjögren’s syndrome (an inflammatory autoimmune disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet’s disease, known hypertension or atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).
• If you or a family member has glucose-6-phosphate dehydrogenase deficiency (a rare inherited condition), inform your doctor, who will advise whether Moxifloxacino Tevagen is suitable for you.
• If you have a complicated upper female genital tract infection (e.g., associated with a tubo-ovarian or pelvic abscess), for which your doctor considers intravenous treatment necessary, treatment with Moxifloxacino Tevagen is not appropriate.
• For the treatment of a mild to moderate upper female genital tract infection, your doctor should prescribe another antibiotic in addition to Moxifloxacino Tevagen. If you do not notice symptom improvement after three days of treatment, consult your doctor.
• If you are diabetic, because you may be at risk of changes in blood sugar levels with moxifloxacin.
• If you have ever developed a severe skin rash or skin peeling, blisters and/or mouth sores after taking moxifloxacin.

Before starting this medicine

Do not take antibacterial medicines containing fluoroquinolones or quinolones, including Moxifloxacino Tevagen, if you have previously experienced a serious adverse reaction to a quinolone or fluoroquinolone. If this applies to you, inform your doctor as soon as possible.

During treatment with this medicine

• If you notice palpitations or irregular heartbeats during treatment, inform your doctor immediately. Your doctor may perform an ECG to assess your heart rhythm.

• The risk of heart problems may increase with higher doses. Therefore, the recommended dose should be taken.

• If you experience a sudden, severe pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go immediately to an emergency department. The risk may increase if you are receiving systemic corticosteroid treatment.

• If you develop sudden shortness of breath, especially when lying down, or notice swelling in your ankles, feet, or abdomen, or experience palpitations (a sensation of rapid or irregular heartbeat), inform your doctor immediately.

• Rarely, you may experience a sudden, severe allergic reaction (anaphylactic reaction or shock), even after the first dose, with symptoms such as chest tightness, dizziness, nausea, fainting, or vertigo when standing. If these symptoms occur, stop taking Moxifloxacino Tevagen and consult your doctor immediately.

• Moxifloxacino Tevagen may cause rapid and severe liver inflammation, which could lead to potentially fatal liver failure (including fatal cases, see section 4). Please consult your doctor before continuing treatment if you develop symptoms such as sudden malaise and/or nausea associated with yellowing of the whites of the eyes, dark urine, skin itching, tendency to bleed, or brain disease 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 treatment with Moxifloxacino Tevagen and contact your doctor immediately.

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

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

• You may develop diarrhea during or after taking antibiotics, including Moxifloxacino Tevagen. If it becomes severe or persistent, or if you notice blood or mucus in your stools, you must stop taking Moxifloxacino Tevagen immediately and consult your doctor. In these situations, do not take medications that inhibit or slow intestinal movement.

• Rarely, joint pain and swelling, or tendon inflammation or rupture may occur. The risk is higher if you are elderly (over 60 years), have had an organ transplant, have kidney problems, or are taking corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment or even several months after stopping Moxifloxacino Tevagen. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Moxifloxacino Tevagen, contact your doctor, and rest the affected area. Avoid unnecessary physical activity, as this may increase the risk of tendon rupture.

• If you experience sudden, severe pain in the abdomen, chest, or back, go immediately to an emergency department.

• If you are elderly and have kidney problems, ensure adequate fluid intake, as dehydration may increase the risk of kidney failure.

• If your vision worsens or your eyes appear otherwise affected, consult an ophthalmologist immediately (see sections 2 “Driving and use of machines” and 4).

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

• Quinolone antibiotics may increase skin sensitivity to sunlight or UV light. You should avoid prolonged exposure to sunlight or direct sunlight and must not use sunbeds or any type of UV lamp during treatment with Moxifloxacino Tevagen.

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

Serious skin reactions

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

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

Drug reaction with eosinophilia and systemic symptoms (DRESS) initially presents with flu-like symptoms and a facial rash, followed by a widespread rash, high fever, elevated liver enzymes in blood tests, increased levels of a type of white blood cell (eosinophilia), and enlarged lymph nodes. If you develop a severe rash or any of these skin symptoms, stop taking moxifloxacin and contact your doctor or seek immediate medical attention.

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

Antibacterial medicines containing fluoroquinolones or quinolones, including Moxifloxacino Tevagen, have been associated with very rare but serious adverse effects, some of which were long-lasting (persisting for months or years), disabling, or potentially irreversible. These include tendon, muscle, and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, numbness, or burning (paresthesia), sensory disturbances such as reduced vision, taste, smell, or hearing, depression, memory decline, severe fatigue, and serious 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 treatment, possibly considering the use of an antibiotic from another class.

Children and adolescents

Do not administer this medicine 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”).

Taking Moxifloxacino Tevagen with other medicines

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

With Moxifloxacino Tevagen, consider the following:

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

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

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

• tricyclic antidepressants,

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

• some antihistamines (e.g., terfenadine, astemizole, mizolastine),

• and other drugs (e.g., cisapride, intravenous vincamine, bepridil, and difemethil).

• Inform your doctor if you are taking other medicines that may reduce potassium levels in the blood (e.g., certain diuretics, some laxatives, enemas [high doses], or corticosteroids [anti-inflammatory drugs], amphotericin B) or medicines that may reduce heart rate, as these may also increase the risk of serious heart rhythm disturbances while taking Moxifloxacino Tevagen.

• Any medicines containing magnesium or aluminium, such as antacids for indigestion, or any medicines containing iron or zinc, medicines containing didanosine, or medicines containing sucralfate used to treat gastrointestinal disorders may reduce the effect of Moxifloxacino Tevagen. Therefore, take your Moxifloxacino Tevagen tablets 6 hours before or after taking these other medicines.

• The simultaneous oral intake of any medicine containing medicinal activated charcoal reduces the effect of Moxifloxacino Tevagen. Therefore, it is recommended not to use these medicines together.

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

Taking Moxifloxacino Tevagen with food and drink

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

Pregnancy, breastfeeding, and fertility

Do not use Moxifloxacino Tevagen 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 have not indicated that this medicine impairs fertility.

Driving and use of machines

Moxifloxacino Tevagen may cause dizziness, sudden transient vision loss, or brief fainting. If you experience these symptoms, do not drive or operate machinery.

Moxifloxacino Tevagen contains sodium

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

3. How to take Moxifloxacino Tevagen

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

Dosing

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

Method of administration

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

Moxifloxacino Tevagen may be taken with or without food. It is recommended to take the tablet at approximately the same time each day.

Dose adjustment is not required in elderly patients, patients with low body weight, or patients with kidney problems.

The duration of treatment depends on the type of infection. Unless your doctor has instructed otherwise, the treatment duration 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 female genital tract infections (pelvic inflammatory disease), including infection of the fallopian tubes and infection of the uterine mucous membrane: 14 days.

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

• Community-acquired pneumonia: 7–14 days

Most patients with pneumonia were switched to oral moxifloxacin film-coated tablets after 4 days.

• Skin and soft tissue infections: 7–21 days

Most patients with skin and soft tissue infections were switched to oral moxifloxacin film-coated tablets after 6 days.

It is important that you complete the full course of treatment, even if you start to feel better after a few days. If you stop treatment too early, the infection may not be completely cured, it may return or worsen, and bacterial resistance to the antibiotic may develop.

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

If you take more Moxifloxacino Tevagen than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Moxifloxacino Tevagen

If you miss a dose, take the tablet as soon as you remember on the same day. If you do not take your tablet one day, take your normal dose (one tablet) the next day. Do not take a double dose to make up for the missed dose.

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

If you stop taking Moxifloxacino Tevagen

If you stop treatment with this medicine too early, your infection may not be completely cured. Consult your doctor if you wish to stop taking the tablets before completing the full course of treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. During treatment with moxifloxacin, more serious adverse effects have been observed, as detailed below:

If you notice:

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

• abnormally fast heart rate
• sudden, severe, generalized allergic reaction including, very rarely, shock that may be fatal (e.g., difficulty breathing, decreased blood pressure, rapid pulse)
• swelling including swelling of the airways (potentially life-threatening)
• seizures
• nervous system problems 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/ideation or suicide attempts)
• severe diarrhoea containing blood and/or mucus (colitis, including antibiotic-associated pseudomembranous colitis), which in very rare circumstances may lead to fatal complications
• pain and inflammation of tendons (tendinitis)

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

• suddenly feeling unwell or noticing yellowing of the whites of the eyes, dark urine, skin itching, tendency to bleed, or disturbances in thinking or wakefulness (these may be signs and symptoms of fulminant liver inflammation that may lead to fatal liver failure (fatal cases have been observed))
• severe skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as red target-like spots or circular lesions, 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 adverse effects, potentially life-threatening)
• loss of consciousness due to a severe drop in blood sugar levels (hypoglycaemic coma) (very rare adverse effect)
• inflammation of blood vessels (signs may include red skin spots, usually on the lower legs, or symptoms such as joint pain)
• dementia (may lead to self-harm, such as suicidal thoughts/ideation, suicidal intent)
• tendon rupture
• a widespread red, scaly rash with bumps under the skin and blisters, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis) (the frequency of this adverse effect is "not known")
• widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome) (the frequency of this adverse effect is "not known")
• muscle weakness, tenderness, or pain, particularly if accompanied by malaise, fever, or dark urine. These symptoms may be caused by abnormal muscle breakdown, which can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis) (the frequency of this adverse effect is "not known")

Stop taking Moxifloxacino Tevagen and consult your doctor immediately as you may require urgent medical attention.

Additionally, if you notice:

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

contact an ophthalmologist immediately.

If you have experienced potentially life-threatening irregular heartbeats (Torsade de Pointes) or interruption of the heartbeat while taking Moxifloxacino Tevagen (very rare adverse effects), inform your doctor immediately that you are taking Moxifloxacino Tevagen and do not restart the treatment.

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

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

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

Other adverse effects have been observed during treatment with moxifloxacin, listed below according to their frequency:

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 resistant bacteria or fungi, e.g., oral and vaginal infections caused by Candida
• changes in heart rhythm (ECG) in patients with low blood potassium levels

Uncommon: may affect up to 1 in 100 patients

• skin rash
• stomach discomfort (indigestion/heartburn)
• changes in taste (in very rare cases, loss of taste)
• sleep disturbances (predominantly insomnia)
• increased levels of certain liver enzymes in the blood (gamma-glutamyl transferase and/or alkaline phosphatase)
• low count of certain white blood cells (leucocytes, neutrophils)
• constipation
• itching
• sensation of dizziness (feeling of spinning or falling)
• drowsiness
• flatulence
• change in heart rhythm (ECG)
• disturbances in liver function (including increased levels of certain liver enzymes in the blood (LDH))
• decreased appetite and food intake
• low white blood cell count
• back, chest, pelvic, and limb pain and discomfort
• increased levels of certain blood cells necessary for blood clotting
• sweating
• increased levels of certain specialized white blood cells (eosinophilia)
• anxiety
• feeling unwell (predominantly weakness or fatigue)
• tremor
• joint pain
• palpitations
• irregular and rapid heartbeat
• difficulty breathing including asthmatic conditions
• increased levels of certain digestive enzymes in the blood (amylase)
• restlessness/agitation
• sensation of tingling and/or numbness
• hives on the skin
• dilation of blood vessels
• confusion and disorientation
• decreased count of certain blood cells necessary for blood clotting
• visual disturbances including double or blurred vision
• decreased blood clotting
• increased levels of lipids in the blood (fats)
• low red blood cell count
• muscle pain
• allergic reaction
• increased bilirubin in the blood
• inflammation of the stomach
• dehydration
• severe heart rhythm abnormalities
• dry skin
• angina pectoris

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

• muscle spasms
• muscle cramps
• hallucinations
• high blood pressure
• swelling (of hands, feet, ankles, lips, mouth, throat)
• low blood pressure
• kidney disorders (including increases in certain kidney laboratory test results such as urea and creatinine)
• liver inflammation
• mouth inflammation
• ringing/noise in the ears
• jaundice (yellowing of the whites of the eyes or skin)
• skin sensitivity disorder
• abnormal dreams
• difficulty concentrating
• difficulty swallowing
• changes in smell (including reduced sense of smell)
• balance disorder and poor coordination (due to dizziness)
• partial or complete memory loss
• ear disorders including hearing loss (usually reversible)
• increased blood uric acid
• emotional instability
• speech disorders
• fainting
• muscle weakness

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

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

Frequency not known (cannot be estimated from available data)

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

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

• increased pressure in the skull (symptoms include headache, visual problems such as blurred vision, "blind spots", double vision, vision loss)

• increased sodium levels in the blood

• increased calcium levels in the blood

• reduced count of a certain type of red blood cells (haemolytic anaemia)

Administration of antibiotics containing quinolones and fluoroquinolones 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 pricking, tingling, pins and needles, burning, numbness or pain (neuropathy), fatigue, decreased memory and concentration, effects on mental health (which may include sleep disorders, anxiety, panic attacks, depression and suicidal ideation), as well as decreased hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

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

Reporting of adverse effects:

If you experience any adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Moxifloxacin Tevagen

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

Do not use this medicine after the expiry date stated on the blister and the cardboard box after "EXP" or "CAD". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Moxifloxacin Tevagen

The active substance is moxifloxacin.

Each film-coated tablet contains 400 mg of moxifloxacin.

The other components are:

Tablet core: Microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.

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

Appearance of Moxifloxacin Tevagen and contents of the pack

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

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

Only certain pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Pharma, S.L.U.
C/ Anabel Segura, 11. Edificio Albatros B, 1st Floor.
28108 Alcobendas (Madrid)
Spain

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
The Netherlands

Or

Teva Operations Poland Sp. z o.o.
ul. Mogilska 80, 31-546 Kraków
Poland

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

Germany: Moxifloxacin AbZ 400 mg Filmtabletten
Belgium: Moxifloxacine Teva
Denmark: Moxiva
Spain: Moxifloxacino Tevagen 400 mg comprimidos recubiertos con película EFG
Hungary: Moxifloxacin-ratiopharm 400 mg filmtabletta
Italy: Moxifloxacina Teva 400 mg Compresse rivestite con film
United Kingdom: Moxifloxacin 400 mg Film-coated Tablets

Date of latest revision of the leaflet: April 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) at http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included on the packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/76633/P_76633.html