Leaflet: information for the user

Actira 400 mg/ 250 ml solution for infusion

For use in adults

Moxifloxacino

Read this leaflet carefully before starting to take this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist or nurse.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1. What is Actira and for what it is used

2. What you need to know before starting to use Actira

3. How to use Actira

4. Possible adverse effects

5. Storage of Actira

6. Contents of the package and additional information

Actira contains moxifloxacino as the active ingredient, which belongs to the group of antibiotics known as fluoroquinolonas. Actira acts by eliminating bacteria that cause infections, provided that such bacteria are sensitive to moxifloxacino.

Actira is indicated for adults for the treatment of the following bacterial infections:

• Community-acquired pneumonia.

Soft tissue and skin infections

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

Do not use Actira

• If you are allergic to the active ingredient moxifloxacino, 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 sectionsWarnings and precautionsand 4.Adverse reactions).
• If you have a hereditary disease or have suffered from a 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 disorders or are taking other medications that cause certain ECG disturbances (see sectionOther medications and Actira).

This is because Actira may cause changes in the ECG, such as a prolongation of the QT interval, i.e., a delay in the conduction of electrical signals in the heart.

• If you have a severe liver disease or the levels of liver enzymes (transaminases) are 5 times above the upper limit of normal.

Warnings and precautions

Before starting to take this medication

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

Consult your doctor before Actira is administered for the first time

• Actira maymodify the heart ECG, especially if you are a woman or an elderly patient. If you are currently taking anymedication that causes a decrease in blood potassium levels, consult your doctor before Actira is administered(see also sectionsDo not take ActiraandOther medications and Actira).

• If you have ever developeda severe skin rash or skin peeling, blisters and/or mouth soresafter taking moxifloxacino.

• If you suffer fromepilepsyor another condition that may causeseizures,inform your doctor before Actira is administered.

• If you have or have ever had anymental health problems, consult your doctor before Actira is administered.

• If you suffer frommyasthenia gravis, the use of Actira may worsen your disease symptoms. If you think you are affected, consult your doctor immediately.

• If you have been diagnosed with alarge blood vessel aneurysm or a "bulge" of a large blood vessel(aortic aneurysm or a large peripheral blood vessel aneurysm).

• If you have had a previous episode ofaortic dissection(tear in the aorta wall).

• If you have been diagnosed withheart valve insufficiency(heart valve regurgitation).

• If you have a family history ofaortic aneurysm or aortic dissection, congenital heart valve diseaseor other risk factors or predisposing conditions (e.g., Marfan syndrome or Ehlers-Danlos vascular 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).

• If you arediabeticbecause you may experience a risk ofchanges in blood sugar levelswith moxifloxacino.

• If you or a family member suffers fromglucose-6-phosphate dehydrogenase deficiency(rare hereditary disease), inform your doctor, who will indicate if Actira is suitable for you.

• Actira should only be administered intravenously (in the vein) and should not be injected into arteries.

During treatment with Actira

-If you noticepalpitations or irregular heartbeatsduring the treatment period, you should inform your doctor immediately. He may perform an ECG to measure heart rhythm.

• Therisk of heart problemsmay increase with increasing dose and infusion rate in your veins.

• In rare cases, you may experience asevere and sudden allergic reaction(anaphylactic reaction) even with the first dose, with symptoms that may include chest tightness, dizziness, nausea, or fainting, or feeling dizzy when standing up.If this occurs, the treatment withActirainfusion solution must be stopped immediately.

• Actira 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 4Adverse reactions). Please consult your doctor before continuing treatment if you suddenly feel unwell or notice that the whites of your eyes turn yellow, dark urine, itching, bleeding tendency, or changes in thoughts or insomnia.

• Severe skin reactions

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), acute generalized pustular psoriasis (PGAP), and drug reaction with eosinophilia and systemic symptoms (DRESS or drug hypersensitivity syndrome), 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.

• Antibiotics quinolones, including Actira, may causeseizures. If this occurs, treatment with Actira should be discontinued.

• Severe, prolonged, and potentially irreversible adverse effects. Fluoroquinolone or quinolone antibacterial medications, including Actira, have been associated with rare but severe adverse effects, some of which have been of long duration (persistent for months or years), incapacitating, or potentially irreversible. This includes tendon pain, muscle and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pins and needles, numbness, tingling, 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 Actira, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or discontinue treatment, considering also the use of another class of antibiotics.

• In rare cases, you may experiencenerve damage symptoms (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 Actira and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

• You may experiencemental health problems, evenafter the first administration ofantibiotics quinolones, including Actira.In rare cases, mental health problems and depression have evolved into suicidal thoughts and self-harm behaviors such as attempted suicide (see section4. Adverse reactions). If youdevelop these reactions, treatment with Actira should be discontinued.

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

• In rare cases, you may experiencejoint pain and swelling, inflammation, or tendon rupture(see sections Do not use Actira and 4. Adverse reactions). 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 may occur in the first 48 hours of treatment and even several months after stopping treatment with Actira. At the first sign of tendon pain or swelling (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Actira, contact your doctor, and keep the painful area at rest. Avoid unnecessary exercise, as this may increase the risk of tendon rupture.

• If you experience asevere and sudden pain in the chest, abdomen, or back, which may be symptoms of aortic dissection or aneurysm, seek immediate emergency care. You may be at higher risk if you are receiving systemic corticosteroids.

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

• If you are an elderly person and havekidney problems, be careful to ensure adequate fluid intake, as dehydration may increase the risk of kidney failure.

-If yourvision worsensor ifyour eyes appear to be affected in any other way, consult an ophthalmologist immediately(see sectionsDriving and operating machineryand 4.Adverse reactions).

• Fluoroquinolones may cause anincrease in your blood sugar levelsabove normal levels (hyperglycemia), ordecrease in your blood sugar levelsbelow normal levels (hypoglycemia), which in severe cases may cause a loss of consciousness(hypoglycemic coma)(see section4. Adverse reactions). If you suffer from diabetes, your blood sugar levels should be carefully controlled.

• Antibiotics quinolones may increase thesensitivity of the skin to sunlight or UV. You should avoid prolonged exposure to sunlight or direct sunlight and should not use sunbeds or any type of UV lamp during Actira administration (see section 4. Adverse reactions).

• There is limited experience with the use of Actira intravenous/oral sequential in the treatment of hospital-acquired pneumonia.

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

Children and adolescents

Do not give this medication to children and adolescents under 18 years old because its efficacy and safety have not been established for this age group (see sectionDo not use Actira).

Other medications and Actira

Inform your doctor or pharmacist if you are using, have used recently, or may need to use other medications in addition to Actira.

With Actira, you should be aware of the following:

• If you are using Actira andother medications that affect the heart, there is a higher risk of heart rhythm disorders. Therefore, you should not use Actira at the same time as the following medications: antiarrhythmic medications (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), antipsychotics (e.g., phenothiazines, pimozide, sertindole, haloperidol, sulpiride), tricyclic antidepressants, some antimicrobials (e.g., saquinavir, enoxacin, erythromycin administered intravenously, pentamidine, antimalarials, particularly halofantrine), some antihistamines (e.g., terfenadine, astemizole, mizolastine), and other medications (e.g., cisapride, vincamine intravenously, bepridil, and difemanil).
• While using Actira, you should inform your doctor if you are taking other medications that may decrease blood potassium levels(e.g., diuretics and thiazide type, 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 disorders.
• If you are currently takingoral anticoagulants(e.g., warfarin), your doctor may need to monitor your blood clotting time.

Actira with food and beverages

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

Pregnancy, lactation, and fertility

Do not use Actira during pregnancy or lactation.

If you are pregnant or lactating, or if you think you may be pregnant orintend to become pregnant, consult your doctor or pharmacist before using this medication.

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

Driving and operating machinery

Actira may cause dizziness or vertigo, you may experience a sudden and temporary loss of vision, or you may faint. If you experience these symptoms, do not drive vehicles or operate machinery.

Actira contains sodium

This medication contains 787 milligrams (approximately 34 millimoles) of sodium (main component of table salt/for cooking) in each 250 ml infusion solution. This is equivalent to 39.35% of the recommended daily maximum sodium intake for an adult.

Actira will always be administered by a doctor or healthcare professional.

The recommended dose in adults is one vial/bag, once a day.

Actira is administered via intravenous route. Your doctor must ensure that the infusion is administered at a constant flow for 60 minutes.

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

Your doctor will decide the duration of treatment with Actira. In some cases, your doctor may initiate treatment with Actira infusion solution and then continue with treatment using Actira tablets.

The duration of treatment depends on the type of infection and how you respond to treatment, but the recommended durations of use are as follows:

• Community-acquired pneumonia: 7 - 14 days.

Most patients with pneumonia switch to oral treatment with Actira tablets at 4 days.

• Soft tissue and skin infections: 7 - 21 days.

In patients with severe skin and soft tissue infections, the mean duration of intravenous treatment is around 6 days and the mean global duration of treatment (infusion followed by tablets) is 13 days.

It is essential to complete the treatment, even if you start feeling better after a few days. If you interrupt treatment too soon, the infection may not be fully cured, the infection may recur, your condition may worsen, and you may also develop antibiotic resistance.

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

If you use more Actira than you should

If you are concerned that you may have received too much Actira, consult your doctor immediately.

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

If you forget to use Actira

If you are concerned that you may have missed a dose of Actira, consult your doctor immediately.

If you interrupt treatment with Actira

If you interrupt treatment with Actira too soon, your infection may not be fully cured. Consult your doctor if you plan to stop treatment with Actira infusion solution before completing the full treatment.

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

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

Themost serious side effectsobserved during treatment with Actira are listed below:

If you notice

• an abnormally fast heart rate (rare side effect)
• a sudden feeling of discomfort or note a yellowish discoloration of the whites of the eyes, dark urine, itching, a tendency to bleed, or alterations in thought or vigilance (may be signs and symptoms of fulminant liver inflammation that may potentially lead to fatal liver failure (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, ulcers in the mouth, throat, nose, genitals, and eyes, and may be preceded by fever and flu-like symptoms (very rare side effects, potentially life-threatening)
• a red, scaly, and generalized rash with bumps under the skin and blisters accompanied by fever at the start of treatment (acute generalized pustular psoriasis) (the frequency of this side effect is "unknown")
• generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and involvement of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug-induced hypersensitivity syndrome) (the frequency of this side effect is “unknown”)
• syndrome associated with alterations in water elimination 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)
• inflammation of blood vessels (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 very rarely life-threatening shock (e.g., difficulty breathing, low blood pressure, rapid pulse) (rare side effect)
• swelling, including respiratory tract swelling (rare side effect, potentially fatal)
• 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 (in very rare cases, have evolved into self-harm, suicidal thoughts, or attempts) (rare side effect)
• madness (which may lead to self-harming behaviors, such as suicidal thoughts or attempts) (very rare side effect)
• severe diarrhea with blood and/or mucosities (antibiotic-associated colitis, including pseudomembranous colitis) that, in very rare cases, may lead to life-threatening complications (rare side effect)
• tendon pain and inflammation (tendinitis) (rare side effect) or tendon rupture (very rare side effect)
• 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 may be life-threatening and lead to kidney problems (a condition called rhabdomyolysis) (frequency of this side effect is "unknown")

Stop taking Actira and contact 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 from very rare to rare),

contact an ophthalmologist immediately.

If you have experienced potentially fatal irregular heartbeats (Torsade de Pointes) or cardiac arrest while taking Actira (very rare side effects), inform your doctor immediately that you have been taking Actira and do not restart treatment.

In rare cases, symptoms of myasthenia gravis may worsen. 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 side effect),inform your doctor immediately.

If you are an elderly patient with kidney problems and observe a decrease in urine production, swelling in the legs, ankles, or feet, fatigue, nausea, drowsiness, shortness of breath, or confusion (these may be signs and symptoms of renal insufficiency, a rare side effect),consult your doctor immediately.

The following side effects have been observed during treatment with Actira according to the probability they present:

Frequent(may affect up to 1 in 10 people)

• nausea
• diarrhea
• dizziness
• abdominal and stomach pain
• vomiting
• headache
• increase in a specific liver enzyme in the blood (transaminases)
• bacterial or fungal infections, e.g., oral and vaginal infections caused by Candida.
• pain or inflammation at the injection site
• change in heart rhythm (ECG), in patients with low potassium levels in the blood

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

• muscle cramps
• muscle contractions
• hallucinations
• increased blood pressure
• swelling (of hands, feet, ankles, lips, mouth, and throat)
• decreased blood pressure
• kidney function alterations (including increased results in laboratory tests for the kidneys, such as urea and creatinine)
• inflammation of the liver
• inflammation of the mouth
• ringing or buzzing in the ears
• jaundice (yellowish discoloration of the whites of the eyes or skin)
• skin sensitivity alterations
• abnormal dreams
• concentration disturbances
• difficulty swallowing
• olfactory disturbances (including loss of smell)
• balance and coordination disturbances (due to dizziness)
• total or partial loss of memory
• hearing loss, including deafness (usually reversible)
• increased uric acid levels in the blood
• emotional instability
• speech alterations
• syncope
• muscle weakness

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

• decrease in the number of red and white blood cells and platelets (pancytopenia)
• inflammation of the joints
• irregular heart rhythm
• increased skin sensitivity
• depersonalization disorder (feeling not oneself)
• increased blood coagulation
• muscle rigidity
• significant decrease in a specific type of white blood cells (agranulocytosis)

Frequency unknown(cannot be estimated from available data)

?increased skin sensitivity to sunlight or UV radiation (see also section 2, Warnings and precautions)

?well-defined, erythematous patches with/without blisters that appear in the hours following moxifloxacino administration and disappear with residual post-inflammatory hyperpigmentation; they usually reappear in the same skin or mucosa area with subsequent moxifloxacino exposure

The administration of quinolone and fluoroquinolone antibiotics has been associated with very rare cases of long-lasting or permanent adverse reactions, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pinpricks, tingling, itching, numbness, or pain (neuropathy), fatigue, memory and concentration impairments, mental health effects (which may include sleep disturbances, anxiety, panic attacks, depression, and suicidal thoughts), hearing loss, vision loss, taste loss, and smell loss, in some cases regardless of the presence of pre-existing risk factors.

Cases of increased aortic 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, Warnings and precautions).

The following symptoms have been observed more frequently in patients treated intravenously:

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

• increase in a specific liver enzyme in the blood (gamma-glutamil-transferase)

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

• severe diarrhea with blood and/or mucosities (antibiotic-associated colitis), which in very rare cases may lead to potentially life-threatening complications
• abnormal heart rhythm acceleration
• hallucinations
• low blood pressure
• kidney function alterations (including increased results in specific laboratory tests for the kidneys, such as urea and creatinine),
• renal insufficiency
• swelling (of hands, feet, ankles, lips, mouth, and throat)
• seizures

In addition, very rare cases of the following adverse effects have been reported, described after treatment with other quinolone antibiotics, and may also occur during treatment with Actira:increased intracranial pressure (symptoms include headache, visual disturbances such as blurred vision, blind spots, double vision, loss of vision),increased sodium and calcium levels in the blood, reduced count of a specific type of red blood cells (hemolytic anemia).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. 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 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 label of the bottlebagand on the box after CAD.The expiration date is the last day of the month indicated.

Do not store at a temperature below 15 °C.

Use immediately after the first opening and/or dilution.

This medication is for single use. Any unused solution must be discarded.

At refrigerator temperatures, precipitation may occur, which will redissolve at room temperature.

Do not use this medication if visible particles are observed or if the solution is cloudy.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of containers and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Actira

• The active ingredient is moxifloxacino. A bottle or bag contains 400 milligrams of moxifloxacino (in the form of hydrochloride). 1 milliliter contains 1.6 milligrams of moxifloxacino (in the form of hydrochloride).
• The other components are sodium chloride, hydrochloric acid 1 N (for pH adjustment), sodium hydroxide solution 2 N (for pH adjustment) and water for injection preparations (see sectionActira contains sodium).

Appearance of Actira and packaging contents

Actira is a yellow transparent infusion solution.

Actira is presented in cardboard boxes containing a 250 milliliter glass bottle with a chlorobutyl or bromobutyl rubber stopper. Actira is available in packaging with 1 bottle and in packaging with 5 bottles (comprising unit boxes containing 1 bottle).

Actira is packaged in cardboard boxes containing 250 milliliter polyolefin bags with a polypropylene mouth sealed with an aluminum foil wrapping. They are available in packaging of 5 and 12 bags.

Only some packaging sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing Authorization Holder:

Bayer Hispania, S.L.

Avda. Baix Llobregat, 3-5

08970 Sant Joan Despí (Barcelona).

Spain

Manufacturer responsible:

Bayer AG

Kaiser - Wilhelm - Allee

51368 Leverkusen

Germany

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

Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, Greece, Hungary, Ireland, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Slovakia, Slovenia, Sweden, United Kingdom:Avelox.

France:Izilox

Germany, Italy:Avalox

Spain:Actira

Last review date of thisleaflet:February 2025

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

The following information is intended solely for healthcare professionals:

Actira can be administered via a T-tube together with the following solutions: water for injection preparations, sodium chloride 0.9%, sodium chloride 1 molar, glucose 5%/10%/40%, xylitol 20%, Ringer's solution, lactate sodium solution (Hartmann's solution, Ringer-lactate solution).

Actira should not be co-administered with other drugs.

The following solutions are incompatible with Actira:

Sodium chloride solutions 10% and 20%,

Hydrogen carbonate sodium solutions 4.2 % and 8.4 %