OFLOXACIN ALTAN 2 mg/ml SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Ofloxacino Altan 2 mg/ml solution for infusion EFG

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Ofloxacino Altan and what is it used for
2. What you need to know before you use Ofloxacino Altan
3. How to use Ofloxacino Altan
4. Possible side effects
5. Storage of Ofloxacino Altan
6. Contents of the pack and other information

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

This medicinal product contains ofloxacin, an antibiotic belonging to a group called fluoroquinolones. This medicinal product works by killing the bacteria that cause infections.

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

• Urinary tract infections (kidney infection).
• 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 under the skin and includes muscle.

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

Do not use Ofloxacino Altan:

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

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

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

Warnings and precautions

Before you start using this medicinal product

You should not use antibacterial medicines that contain fluoroquinolones or quinolones, including Ofloxacino Altan, if you have experienced any serious side effects in the past when using a quinolone or fluoroquinolone. If this is the case, you should inform your doctor as soon as possible.

Talk to your doctor, pharmacist, or nurse before you start using this medicinal product

• If you have any liver or kidney problems.
• If you have any heart problems or problems with your heart rhythm.
• If you have had a transplant.
• If you have nerve problems (peripheral neuropathy).
• If you are taking medicines that can affect your heart or lower your blood pressure (see section "Other medicines and Ofloxacino Altan").
• If you were born with or have a family history of prolonged QT interval (seen on an ECG, the electrical recording of the heart).
• If you have a salt imbalance in your blood (especially low potassium or magnesium levels in your blood).
• If you have a very slow heart rate (called 'bradycardia').
• If you have a weak heart (heart failure).
• If you have had a heart attack (myocardial infarction).
• If you are a woman or an elderly person.
• If you are taking other medicines that can cause abnormal changes in your ECG (see section "Other medicines 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 going to have an operation with general anesthesia while being treated with Ofloxacino Altan.
• If you suffer from 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 enlarged or bulging large blood vessel (aortic aneurysm or large peripheral vessel aneurysm).
• If you have had a previous episode of aortic dissection (tear in the aortic wall).
• If you have been diagnosed with heart valve problems (heart valve regurgitation).
• If you have a family history of aortic dissection or aneurysm, congenital heart valve problems, or other risk factors or predisposing disorders (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, atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).

Very rare reports of potentially life-threatening skin rashes (Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis) have been communicated with the use of Ofloxacino Altan. The symptoms can include: flu-like symptoms followed by a painful red or purple rash that spreads and blisters form. If you develop any of the above symptoms, you should stop using the medicinal product and inform your doctor immediately (see section 4).

Ofloxacino Altan is not recommended if it is suspected that you have a MRSA infection.

While being treated with Ofloxacino Altan, avoid exposure to intense sunlight and do not use UV lamps or sunbeds, as your skin may be more sensitive to light.

Consult an ophthalmologist immediately if you experience any changes in your vision or have any problems with your eyes.

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

If you are going to have any urine tests, it is important that you inform your doctor that you are being treated with this medicinal product, as it may alter the results.

If you are not sure if any of the above applies to you, talk to your doctor, pharmacist, or nurse before taking this medicinal product.

During treatment with this medicinal product

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

Rarely, you may experience symptoms of nerve 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 disorder.

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

If you start to experience sudden shortness of breath, especially when lying down, or if you notice swelling in your ankles, feet, or abdomen, or the appearance of heart palpitations (feeling of rapid or irregular heartbeat), inform your doctor immediately.

Severe, long-lasting, and potentially irreversible side effects

Antibacterial medicines that contain fluoroquinolones or quinolones, including Ofloxacino Altan, have been associated with very rare but serious side effects, some of which were long-lasting (persisting for months or years), disabling, or potentially irreversible. This includes pain in the tendons, muscles, and joints of the upper and lower limbs, difficulty walking, abnormal sensations such as pins and needles, tingling, prickling, 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 side effects after using Ofloxacino Altan, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or not, also considering the use of an antibiotic from another class.

Children and adolescents

This medicinal product should not be used in children or adolescents who are still growing.

Other medicines and Ofloxacino Altan

Tell your doctor, pharmacist, or nurse if you are using, have recently used, or might use any other medicines, including those obtained without a prescription, homeopathic medicines, herbal remedies, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one of them.

Tell your doctor if you are taking or have recently taken any of the following medicines:

• Methotrexate (used to treat rheumatism or cancer).

Other medicines that can alter the heart rhythm:

• Medicines belonging to the group of antiarrhythmics (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide).
• Tricyclic antidepressants.
• Some antimicrobials belonging to the group of macrolides.
• Some antipsychotics.

The following medicines may change the way Ofloxacino Altan works or Ofloxacino Altan may change the way some of these medicines work:

• Medicines used to prevent blood clotting.
• Medicines used to treat high blood pressure or medicines that lower 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 medicines, when used with Ofloxacino Altan, may increase the possibility of side effects:

• Other antibiotics (such as erythromycin, azithromycin, or clarithromycin).
• Medicines for depression (such as amitriptyline, clomipramine, or imipramine).
• Theophylline (used for respiratory problems).
• Medicines used to control heart rhythms (such as amiodarone, quinidine, procainamide, or disopyramide).
• Non-steroidal 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).

Using 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, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicinal product.

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

Driving and using machines

This medicinal product may cause dizziness or drowsiness and vision disturbances; therefore, you should not drive or use machines while using this medicinal product.

Ofloxacino Altan contains sodium

This medicinal product contains 334 mg of sodium (a major component of cooking/table salt) in each 100 ml bag. This is equivalent to 16.7% of the maximum recommended daily intake of sodium for an adult.

3. How to use Ofloxacino Altan

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

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

While being treated with ofloxacin, avoid exposure to direct sunlight and do not use sunlamps or sunbeds.

Follow exactly the administration instructions of this medicinal product as indicated by your doctor. If in doubt, consult your doctor, pharmacist, or nurse again.

The duration of treatment will depend on the type and/or severity of the infection and will be determined by your doctor.

Treatment should not last more than 2 months.

Once your illness has improved, your doctor may switch your medicine to ofloxacin tablets.

The dose of ofloxacin depends on the type and severity of the infection. Your doctor will decide the amount of Ofloxacino Altan 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 ofloxacin 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 elderly patients over 65 years

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 of this medicinal product. But 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, convulsions (seizures), nausea, or bleeding in the stools.

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

If you forget to use Ofloxacino Altan

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

If you stop treatment with Ofloxacino Altan

Your doctor will indicate the appropriate dose and duration of treatment with this medicinal product. Do not stop treatment before completing the prescribed course, as you may not achieve the desired effect.

If you have any further questions on the use of this medicinal product, ask your doctor, pharmacist, or nurse.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

After administering this medicine, the following adverse effects have been reported as possible:

Report immediately to your doctor or nurse if you have any of the following serious adverse effects:

• If you have an allergic reaction. The signs may include: rash, swallowing or breathing problems, swelling of the lips, face, throat, or tongue.

Very Rare (affect less than 1 in 10,000 people)

• Irregular or rapid heartbeat, you may also feel weak.
• Watery diarrhea that may contain blood, possibly with stomach cramps and high fever.
• Seizures.
• Hearing or hearing loss problems.
• Liver problems that can cause the eyes or skin to turn yellow (jaundice).
• Severe skin rashes (Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis) that can include blistering or peeling of the skin around the lips, eyes, mouth, nose, and genitals. The symptoms may include flu-like symptoms followed by a painful red or purple rash that spreads and blisters. If you develop any of the above symptoms, you should stop using this medicine and inform your doctor immediately.
• Skin rashes caused by intense sunlight.
• Feeling weak, dizzy, or faint, due to low blood pressure.
• Muscle weakness, joint and muscle pain.
• Feeling weak or irritable, sweating and/or trembling. This could be due to a decrease in blood sugar levels.
• Feeling thirsty and urinating more often than usual. This could be due to an increase in blood sugar levels.
• Swelling or discomfort in the tendons, such as the Achilles tendon.
• Severe kidney inflammation, which can cause the kidneys to stop working. The signs may include a rash, high temperature, and general pain.
• Severe depression or mental illness, in some cases with self-harming 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 adverse reactions, such as tendon inflammation, tendon rupture, joint pain, pain in the limbs, difficulty walking, abnormal sensations such as pinching, tingling, 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 ideas), and decreased hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

Rare (affect less 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 confused state).

Unknown (cannot be estimated from available data)

• Abnormal rapid heartbeat.
• Life-threatening irregular heartbeat.
• Heart rhythm disorder (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).
• Hearing impairment.
• Eye inflammation (uveitis).
• Liver problems.
• Vision problems.
• Redness of the skin with extensive peeling (exfoliative dermatitis).
• Lack of appetite, yellowing of the eyes and skin, dark urine, itching or stomach discomfort (abdomen). These may be signs of liver problems that can include fatal liver failure.

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

Uncommon (affect less 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 rash or itching.

Rare (affect less than 1 in 1,000 people and more than 1 in 10,000 people)

• Lack of appetite.
• Feeling confused or anxious, nightmares, seeing things that are not there, depression, and mental illness, feeling drowsy, trembling, walking problems due to poor muscle control.
• Changes in vision.
• Changes or loss of taste or smell.
• Changes in liver enzyme levels shown in blood tests.
• General feeling of discomfort.
• Pain, redness, or swelling in the vein or at the injection site of Ofloxacino Altan.

Very Rare (affect less than 1 in 10,000 people)

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

Unknown (cannot be estimated from available data)

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

It is possible that Ofloxacino Altan may trigger a porphyria attack (a rare disease that affects metabolism) in some patients.

There have been reports of increased size and weakening or tearing of the aortic wall (aneurysms and dissections), which can cause a rupture and be fatal, and heart valve problems in patients who have received fluoroquinolones. See also section 2.

Adverse Effect Reporting

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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Ofloxacino Altan

Keep this medicine out of sight and reach of children.

This medicine does not require any special storage temperature.

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

Do not use this medicine after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away in drains or trash. Ask your pharmacist how to dispose of packaging and medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

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 ingredients are: sodium chloride, hydrochloric acid, and water for injectable preparations.

Appearance of the Product and Package Contents

This medicine is presented as a solution for infusion. Each package contains a PVC bag with 100 ml of solution.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Altan Pharmaceuticals, S.A.

C/ Cólquide 6, Portal 2, 1ª planta, oficina F

Edificio Prisma

28230 Las Rozas. MADRID (Spain)

Manufacturer

Altan Pharmaceuticals, S.A.

Poligono Industrial de Bernedo s/nº

01118 – Álava (Spain)

Date of the Last Revision of this Prospectus:May 2025

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

-----------------------------------------------------------------------------------------------

This information is intended only for healthcare professionals:

Method of Administration

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

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

The infusion solution can be infused directly or diluted with compatible solutions.

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

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

Daily doses of more than 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 can be increased to 400 mg twice a day in severe or complicated infections.

• for prostatitis, a longer treatment duration may be considered after a careful re-examination of the patient.

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

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

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

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

In most cases of acute infection, a 7- to 10-day treatment 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 2 months in duration.

Dosage in Patients with Renal Impairment

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

*according to the indication or dosage interval.

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

When creatinine clearance cannot be measured, it can be estimated with reference to serum creatinine levels using the following Cockcroft formula for adults:

Weight (kg) x (140-age in years)

Men: ClCr (ml/min) =

72 x serum creatinine (mg/dl)

or

Weight (kg) x (140-age in years)

ClCr (ml/min) =

0.814 x serum creatinine (µmol/dl)

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

Dosage in Case of Hepatic Impairment(e.g., cirrhosis with ascites)

It is recommended that the maximum daily dose of ofloxacin should not exceed 400 mg, due to possible reduced excretion.

Pediatric Population

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

Elderly Patients

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