Package Insert: Information for the User

Ofloxacino Altan 2 mg/ml Infusion Solution EFG

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• 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, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

1. What is Ofloxacino Altan and what is it used for

2. What you need to know before starting to use Ofloxacino Altan

3. How to use Ofloxacino Altan

4. Possible adverse effects

5. Storage of Ofloxacino Altan

6. Contents of the package and additional information

This medication contains ofloxacino, an antibiotic that belongs to a group called fluoroquinolonas. This medication works by killing the bacteria that cause infections.

This medication is indicated for the treatment of the following infections in adult patients:

• Urinary tract infections (kidney infections).
• Genital tract infections in men and women, including cases where these infections spread to the bloodstream.
• Chest or lung infections.
• Skin and soft tissue infections. Soft tissue is beneath the skin and includes muscle.

No use Ofloxacino Altan:

• If you are allergic to ofloxacin, other quinolones, or any of the other components of this medication (listed in section 6).

The signs of an allergic reaction include: hives, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.

• If you have epilepsy or are at risk of seizures.
• If you have a history of tendon disorders related to the administration of fluoroquinolones that can affect areas such as the wrist or Achilles tendon.
• If you have a known metabolic disorder called glucose-6-phosphate dehydrogenase deficiency.
• If you are under 18 years old or still in the growth period.
• If you are pregnant or breastfeeding (see section "Pregnancy and breastfeeding").

Warnings and precautions

Before starting to use this medication

Do not use fluoroquinolone or quinolone antibacterial medications, including Ofloxacino Altan, if you have experienced a severe adverse reaction to a quinolone or fluoroquinolone in the past. If this is the case, inform your doctor as soon as possible.

Consult your doctor, pharmacist, or nurse before starting to use this medication

• If you have any liver or kidney problems.
• If you have heart disease or problems with heartbeats.
• If you have received a transplant.
• If you have nerve problems (peripheral neuropathy).
• If you are taking medications that can affect the heart or reduce blood pressure (see section "Other medications and Ofloxacino Altan").
• If you were born or have a family history of prolonged QT interval (seen on ECG, heart electrical recording).
• If you have a blood electrolyte imbalance (especially low levels of potassium or magnesium in the blood).
• If you have a very slow heart rate (called 'bradycardia').
• If you have a weak heart (heart failure).
• If you have a history of heart attack (myocardial infarction).
• If you are a woman or an elderly person.
• If you are taking other medications that cause abnormal changes in ECG (see section "Other medications and Ofloxacino Altan").
• If you have or have had any mental health problems.
• If you have porphyria (a rare disease that affects metabolism).

• If you are undergoing surgery with general anesthesia, while being treated with Ofloxacino Altan.
• If you have a condition called myasthenia gravis, which causes muscle weakness and excessive muscle fatigue.
• If your doctor has told you that you cannot tolerate some sugars.
• If you have been diagnosed with an aneurysm of a large blood vessel (aortic aneurysm or aneurysm of a large peripheral blood vessel).
• If you have had a previous episode of aortic dissection (tear in the aorta wall).
• If you have been diagnosed with heart valve insufficiency (regurgitation of heart valves).
• If you have a family history of aortic dissection or aneurysm, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., 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, atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).

There have been rare reports of potentially fatal skin eruptions (Stevens-Johnson syndrome, Toxic Epidermal Necrolysis) with the use of Ofloxacino Altan. Symptoms may include: flu-like symptoms followed by painful red or purple rash that spreads and forms blisters. If you develop any of the above symptoms, stop using the medication and inform your doctor immediately (see section 4).

Do not use Ofloxacino Altan if you suspect you have a SARM infection.

Avoid exposure to intense sunlight and do not use UV lamps or tanning beds while taking Ofloxacino Altan, as your skin may be more sensitive to light.

Consult an ophthalmologist immediately if you experience any vision changes or have any eye problems.

If you experience pain in your fingers or toes while taking Ofloxacino Altan, inform your doctor or nurse immediately.

If you are having urine tests, it is essential to inform your doctor that you are being treated with this medication, as it may alter the results.

If you are unsure if any of the above cases apply to you, speak with your doctor, pharmacist, or nurse before taking this medication.

During treatment with this medication

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

In rare cases, you may experience symptoms ofnerve damage (neuropathy), such as pain, burning, tingling, numbness, and/or weakness, especially in your feet and legs or hands and arms. If this happens, stop using Ofloxacino Altan and inform your doctor immediately to prevent the development of a potentially irreversible condition.

If you experience a sudden, severe chest, abdominal, or back pain, which may be symptoms of aortic dissection or aneurysm, go to the emergency department immediately.The risk may be increased if you are taking corticosteroids systemically.

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

Severe, prolonged, and potentially irreversible adverse effects

Fluoroquinolone or quinolone antibacterial medications, including Ofloxacino Altan, have been associated with rare but severe adverse effects, some of which were of long duration (persistent for months or years), incapacitating, or potentially irreversible. This includes tendon pain, muscle pain, and joint pain in the upper and lower extremities, 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 using Ofloxacino Altan, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or discontinue treatment, considering the use of another type of antibiotic.

Children and adolescents

This medication should not be used in children or adolescents in the growth period.

Other medications and Ofloxacino Altan

Inform your doctor, pharmacist, or nurse if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription, homeopathic, herbal, or other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one or more of them.

Inform your doctor if you are taking or have taken recently some of the following medications:

• Metotrexato (used to treat rheumatism or cancer).

Other medications that may affect heart rhythm:

• Antiarrhythmic medications (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide).
• Tricyclic antidepressants.
• Some macrolide antimicrobials.
• Some antipsychotics.

The following medications may change how Ofloxacino Altan works or how some of these medications work:

• Medications used to prevent blood clotting.
• Medications used to treat high blood pressure or medications that reduce blood pressure.
• Anesthetics.
• Diuretics such as furosemide.
• Glibenclamide (used to treat diabetes).
• Probenecid (used to treat gout).
• Cimetidine (used for stomach ulcers or indigestion).

The following medications, when used with Ofloxacino Altan, may increase the risk of adverse effects:

• Other antibiotics (such as erythromycin, azithromycin, or clarithromycin).
• Depression medications (such as amitriptyline, clomipramine, or imipramine).
• Theophylline (used for respiratory problems).
• Medications used to control heartbeats (such as amiodarone, quinidine, procainamide, or disopyramide).
• Nonsteroidal anti-inflammatory drugs (NSAIDs), used for pain relief and inflammation (such as ibuprofen, diclofenac, or indomethacin).
• Corticosteroids (used for inflammation).
• Antipsychotics (used to treat psychiatric disorders such as schizophrenia and bipolar disorder).

Use of Ofloxacino Altan with food and drinks

Do not drink alcohol while taking Ofloxacino Altan, as it may make you feel dizzy or drowsy.

Pregnancy, breastfeeding, and fertility

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

This medication should not be administered if you are pregnant or during breastfeeding, as ofloxacin passes into breast milk.

Driving and operating machinery

This medication may cause dizziness, somnolence, and visual disturbances, so you should not drive or operate machinery while taking this medication.

Ofloxacino Altan contains sodium

This medication contains 334 mg of sodium (main component of table salt/for cooking) in each 100 ml vial. This is equivalent to 16.7% of the recommended daily maximum sodium intake for an adult.

Ofloxacino Altan will be administered normally by a doctor or nurse since it needs to be administered as a slow infusion (drip) in a vein.

When you are administered Ofloxacino Altan, if your vision is affected or if your eyes appear to be affected in any other way, consult an ophthalmologist immediately.

While undergoing treatment with ofloxacino, avoid direct exposure to sunlight and do not use tanning lamps or solariums.

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

The duration of treatment will be given by the type and/or severity of the infection and will be established by your doctor.

The treatment should not last more than 2 months.

Once your disease has improved, your doctor may change your medication to ofloxacino tablets.

The dose of ofloxacino depends on the type and severity of the infection.Your doctor will decide the amount of Ofloxacino Altan that you should use.

The recommended dose for adults is between 200 and 800 mg per day.

A daily dose of up to 400 mg of ofloxacino can be administered as a single dose.

Daily doses above 400 mg should be divided into two separate doses and administered at approximately equal intervals.

Your doctor should adjust the dose in case of liver or kidney disease.

Use in patients over 65 years old

Although it is not necessary to adjust the dose due to age, your doctor should pay special attention to kidney function and adjust the dose accordingly.

If you use more Ofloxacino Altan than you should

Your doctor will carefully calculate the amount of Ofloxacino Altan that you should be administered. Therefore, it is unlikely that your doctor or nurse will administer too much or too little of this medication to you. However, if you think you have been administered too much or too little Ofloxacino Altan, inform your doctor or nurse.

The following effects may occur: confusion, feeling of dizziness, loss of consciousness, seizures (convulsions), nausea, or bleeding in the stool.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 915 620 420, indicating the medication and the amount taken. It may be necessary to go to the hospital. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to use Ofloxacino Altan

Your doctor or nurse will have instructions on when to administer the medication. It is unlikely that you will not be administered the medication as prescribed. If you think you may have forgotten a dose, consult your doctor or nurse.

If you interrupt the treatment with Ofloxacino Altan

Your doctor will indicate the appropriate dose and duration of treatment with this medication. Do not suspend treatment beforehand, as you may not achieve the desired effect.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

After taking this medicine, the following side effects have been reported as possible:

Inform your doctor or nurse immediately if you experience any of the following serious side effects:

- If you have an allergic reaction. Symptoms may include: hives, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.

Very rare (affects fewer than 1 in 10,000 people)

• Irregular or rapid heartbeat, you may also feel weak.
• Watery diarrhea that may have blood, possibly with stomach cramps and high fever.
• Seizures.
• Problems with hearing or loss of hearing.
• Liver problems that may cause yellowing of the eyes or skin (jaundice).
• Severe skin eruptions (Stevens-Johnson syndrome, toxic epidermal necrolysis) that may include blistering or peeling of the skin around the lips, eyes, mouth, nose, and genitals. Symptoms may include flu-like symptoms followed by painful red or purple rash that spreads and forms blisters. If you develop any of the above symptoms, stop using this medicine and inform your doctor immediately.
• Skin eruptions caused by intense sunlight.
• Feeling weak, dizzy, or lightheaded due to low blood pressure.
• Muscle weakness, joint and muscle pain.
• Feeling weak or irritable, sweating, and/or shaking. This could be due to low blood sugar levels.
• Feeling thirsty and urinating more frequently than usual. This could be due to high blood sugar levels.
• Swelling or discomfort in the tendons, such as the Achilles tendon.
• Severe kidney inflammation that may cause the kidneys to stop functioning. Symptoms may include hives, high temperature, and general aches.
• Severe depression or mental illness, in some cases with self-harming behaviors or suicidal thoughts.
• The administration of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-lasting (even months or years) or permanent side effects, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pinching, tingling, itching, burning, numbness, or pain (neuropathy), depression, fatigue, sleep disorders, memory impairment, and hearing, vision, taste, and smell impairment, in some cases regardless of pre-existing risk factors.

Rare (affects fewer than 1 in 1,000 people and more than 1 in 10,000 people)

• Numbness or tingling in the hands and feet or being very sensitive to touch.
• Delirium (acute confusional state).

Unknown (cannot be estimated from available data)

• Abnormal rapid heartbeat.
• Abnormal heartbeat that puts life at risk.
• Alteration of the heartbeat (called "prolongation of the QT interval", seen on the ECG, heart electrical activity).
• Indigestion, flatulence, constipation.
• Fever, pain (back, chest, limbs).
• Severe abdominal pain (pancreatitis).
• Impairment of hearing.
• Inflammation of the eye (uveitis).
• Problems with the liver.
• Problems with vision.
• Widespread redness of the skin with extensive peeling (dermatitis exfoliativa).
• Loss of appetite, yellowing of the eyes and skin, dark urine, itching, or stomach discomfort (abdomen). These may be signs of liver problems that may include fatal liver failure.

Inform your doctor if any of the following side effects become severe or last for more than a few days:

Possibly frequent (affects fewer than 1 in 100 people and more than 1 in 1,000 people)

• Feeling or being sick, diarrhea, or stomach pain.
• Headache, sleep problems, dizziness, or restlessness.
• Skin eruption or itching.

Rare (affects fewer than 1 in 1,000 people and more than 1 in 10,000 people)

• Loss of appetite.
• Feeling confused or anxious, nightmares, seeing things that are not there, depression, and mental illness, feeling drowsy, shaky, or having difficulty walking due to poor muscle control.
• Changes in vision.
• Changes or loss of sense of taste or smell.
• Changes in liver enzyme levels that are shown in blood tests.
• General feeling of discomfort.
• Pain, redness, or swelling in the vein or area where Ofloxacino Altan was injected.

Very rare (affects fewer than 1 in 10,000 people)

• Feeling tired, fainting, dizzy, and pale skin. These may be signs of anemia.
• You may feel weak, bruise easily, and get more infections than usual. This could be due to a blood disorder called "pancytopenia".
• Cough or shortness of breath, caused by inflammation of the lungs.

Unknown (cannot be estimated from available data)

• Persistent headache with or without blurred vision (benign intracranial hypertension).

Ofloxacino Altan may trigger porphyria (a rare disease affecting metabolism) in some patients.

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

Reporting of side effects

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

Keepthis medicationout of the sight and reach of children.

This medication does not require any special temperature for conservation.

Store in the original packaging to protect it from light and moisture.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of empty packaging and unused medications. This will help protect the environment.

Composition of Ofloxacino Altan

- The active ingredient is ofloxacin. Each ml contains 2 mg of ofloxacin (as hydrochloride).

Each 100 ml contains 200 mg of ofloxacin (as hydrochloride)

- The other components are: sodium chloride, hydrochloric acid, and water for injectable preparations.

Appearance of the product and contents of the package

This medication is presented in the form of a perfusion solution. Each package contains a poly (vinyl chloride) bag with 100 ml of solution.

Holder of the marketing authorization and responsible for manufacturing

Holder of the authorization

Altan Pharmaceuticals, S.A.

C/ Cólquide 6, Portal 2, 1st floor, office F

Edificio Prisma

28230 Las Rozas. MADRID (Spain)

Responsible for manufacturing

Altan Pharmaceuticals, S.A.

Poligono Industrial de Bernedo s/nº

01118 – Álava (Spain)

Last review date of this leaflet:February 2022

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

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This information is intended solely for healthcare professionals:

Administration form

The Ofloxacino Altan solution should only be administered by slow intravenous perfusion. This administration will be performed once or twice a day. The perfusion time of the Ofloxacino Altan solution should not be less than 30 minutes for 200 mg, which is especially important when ofloxacin is administered concomitantly with medications that may cause a decrease in blood pressure or with anesthetics containing barbiturates.

Generally, individual doses should be administered at approximately equal intervals.

The perfusion solution can be perfused directly or diluted with compatible solutions.

This medication is compatible with physiological saline solution, Ringer lactate, and solutions of glucose or fructose at 5%. Compatibility with other solutions has not been verified.

General recommendations for dosage. The dose of ofloxacin depends on the type and severity of the infection. A daily dose of up to 400 mg of ofloxacin as a single dose may be administered. In this case, it is preferable to administer the ofloxacin in the morning.

Daily doses exceeding 400 mg should be divided into two separate doses and administered at approximately equal intervals.

Adults:The usual intravenous doses in adults are:

Acute exacerbation of chronic bronchitis, community-acquired pneumonia: 200 mg twice a day.

Complicated skin and soft tissue infections: 400 mg twice a day.

The dose may be increased to 400 mg twice a day in severe or complicated infections.

*For prostatitis, a longer treatment duration may be considered after a new careful examination of the patient.

Oral ofloxacin tablets may also be used to complete a treatment course in patients who have shown improvement during the initial treatment with intravenous ofloxacin.

Once opened, the PVC bag of this medication should be used immediately.

Remove the overbag immediately before administration. Discard if any alterations are observed in the package or in the liquid.

The treatment duration is determined based on the response of the causative organisms and the clinical picture. As with all antibacterial agents, ofloxacin treatment should be continued for at least 3 days after fever and symptoms have subsided.

In most cases of acute infection, a treatment duration of 7 to 10 days is sufficient. Once the patient's condition has improved, the administration method should be changed from parenteral to oral, usually with the same total daily dose.

Treatment should not exceed two months in duration.

Dosage in patients with renal insufficiency

In patients with renal insufficiency, the following oral or intravenous doses are recommended:

*According to the indication or dose interval.

**The serum concentration of ofloxacin should be monitored in patients with severe renal insufficiency and in patients undergoing dialysis.

When creatinine clearance cannot be measured, it can be estimated using the Cockcroft-Gault formula for adults:

Patient weight (kg) x (140 - age in years)

Males: ClCr (ml/min) =

72 x serum creatinine (mg/dl)

or

Patient weight (kg) x (140 - age in years)

ClCr (ml/min) =

0.814 x serum creatinine (µmol/dl)

Females: ClCr (ml/min) =0.85 x (previous value)

Dosage in case of liver insufficiency(e.g., cirrhosis with ascites)

It is recommended not to exceed a maximum daily dose of 400 mg of ofloxacin, due to the possible reduction in excretion.

Pediatric population

Ofloxacin is not indicated for use in children or adolescents in growth.

Geriatric population

No adjustment of the ofloxacin dose is required in the elderly population. However, special attention should be paid to renal function in the elderly population, and the dose should be adjusted accordingly (see section 4.4 Prolongation of the QT interval).