CIPROFLOXACIN KABI 2 mg/ml SOLUTION FOR INFUSION

2. What you need to know before Ciprofloxacin Kabi is administered to you

Do not use Ciprofloxacin Kabi:

• If you are allergic to the active ingredient, other quinolones, or any of the other components of this medication (listed in section 6).
• If you are taking tizanidine (see section 2: Use of other medications).

Warnings and precautions

Before starting treatment with this medication

You should not take antibacterial medications that contain fluoroquinolones or quinolones, including Ciprofloxacin Kabi, if you have experienced a severe adverse reaction in the past when taking a quinolone or fluoroquinolone. If this is the case, you should inform your doctor as soon as possible.

Consult your doctor, pharmacist, or nurse before starting treatment with Ciprofloxacin Kabi if:

• you have had kidney problems in the past, as your treatment may need to be adjusted
• you suffer from epilepsy or other neurological conditions
• you have a history of tendon problems during previous treatment with antibiotics like Ciprofloxacin Kabi
• you are diabetic, as you may be at risk of hypoglycemia with ciprofloxacin
• you suffer from severe myasthenia (a type of muscle weakness), as your symptoms may worsen
• you have been diagnosed with an enlarged or "bulging" of a large blood vessel (aortic aneurysm or large peripheral vessel aneurysm)
• you have had a previous episode of aortic dissection (tear in the aortic wall)
• if you have been diagnosed with heart valve insufficiency (regurgitation of the heart valves)

• you have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., Marfan syndrome, 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, high blood pressure, or atherosclerosis), rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)

• you have heart problems. This type of medication should be used with caution if you have been born with or have a family history of prolonged QT interval (detected on an ECG, electrocardiogram, or heart electrical recording), if you suffer from electrolyte imbalance in the blood (especially low potassium or magnesium levels in the blood), if you have a very slow heart rate (called bradycardia), if you have a weak heart (heart failure), a history of heart attack (myocardial infarction), if you are a woman or of advanced age, or if you are taking other medication that causes abnormal changes in the electrocardiogram (see section 2 "Use of Ciprofloxacin Kabi with other medications")
• you or a family member has a deficiency in glucose-6-phosphate dehydrogenase (G6PD), as you may be at risk of anemia with ciprofloxacin.

For the treatment of some genital tract infections, your doctor may prescribe another antibiotic in addition to ciprofloxacin. If there is no improvement in symptoms after 3 days of treatment, please consult your doctor.

While being treated with Ciprofloxacin Kabi

Inform your doctor immediately if any of the following situations occur during treatment with Ciprofloxacin Kabi. Your doctor will decide whether it is necessary to interrupt treatment with Ciprofloxacin Kabi.

• Severe and sudden allergic reaction(anaphylactic reaction or shock, angioedema). There is a reduced possibility that, even with the first dose, you may experience a severe allergic reaction, with the following symptoms: chest tightness, dizziness, nausea, or fainting, or dizziness when standing up. If this occurs, inform your doctor immediately, as administration of Ciprofloxacin Kabi should be discontinued.

Rarely, joint pain and swelling and tendon inflammation or rupturemay occur. The risk is higher 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 discontinuing treatment with Ciprofloxacin Kabi. At the first sign of pain or tendon inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Ciprofloxacin Kabi, contact your doctor, and rest the affected area. Avoid any unnecessary exercise, as this could increase the risk of tendon rupture.

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

• If you start experiencing 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.

• If you suffer from epilepsy or other neurological conditions, such as cerebral ischemia or infarction, you may experience adverse effects associated with the central nervous system. If seizures occur, stop taking Ciprofloxacin Kabi 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 your feet and legs or hands and arms. If this occurs, stop taking Ciprofloxacin Kabi and inform your doctor immediately to prevent the development of a potentially irreversible disorder.
• You may experience psychiatric reactionsafter the first administration of ciprofloxacin. If you suffer from depression or psychosis, your symptoms may worsen with treatment with Ciprofloxacin Kabi. If this occurs, stop taking Ciprofloxacin Kabi and contact your doctor immediately.
• Quinolone antibiotics may cause an increase in your blood sugar levelsabove normal levels (hyperglycemia) or a decrease in your blood sugar levelsbelow normal levels, which can lead to loss of consciousness (hypoglycemic coma) in severe cases (see section 4). This is important for people with diabetes. If you have diabetes, you should carefully monitor your blood sugar levels.
• Diarrheamay develop during the use of antibiotics, including Ciprofloxacin Kabi, or even several weeks after stopping their use. If it becomes intense or persistent, or if you notice that your stools contain blood or mucus, inform your doctor immediately. Treatment with Ciprofloxacin Kabi should be discontinued immediately, as it can be life-threatening. Do not take medications that stop or slow down bowel movements.
• If your vision worsensor if you experience any other eye disorders during treatment with Ciprofloxacin Kabi, consult an ophthalmologist immediately.
• Your skin becomes more sensitive to sunlight or ultraviolet (UV) lightduring treatment with Ciprofloxacin Kabi. Avoid exposure to intense sunlight or artificial ultraviolet light, such as tanning beds.
• While taking Ciprofloxacin Kabi, inform your doctor or laboratory personnel if you need to undergo a blood or urine test.

• If you have kidney problems, inform your doctor, as your dose may need to be adjusted.

• Ciprofloxacin Kabi can cause liver damage. If you notice symptoms such as loss of appetite, yellowing of the skin (jaundice), dark urine, itching, or stomach pain, discontinue Ciprofloxacin Kabi immediately.
• Ciprofloxacin Kabi can cause a decrease in your white blood cell count and may decrease your resistance to infections. If you experience an infection with symptoms such as fever and severe deterioration of your general condition, or fever with symptoms of local infection such as sore throat/pharynx/mouth, or urinary problems, consult your doctor immediately. They will perform a blood test to examine the possible decrease in white blood cells (agranulocytosis). It is essential that you inform your doctor about your medication.

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

Antibacterial medications that contain fluoroquinolones or quinolones, including Ciprofloxacin Kabi, have been associated with very rare but severe adverse effects, some of which were long-lasting (persistent for months or years), disabling, or potentially irreversible. These include tendon pain, muscle and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pins and needles, tingling, numbness, or burning (paresthesia), sensory disorders such as decreased vision, taste, smell, and hearing, depression, memory loss, intense fatigue, and severe sleep disorders.

If you experience any of these adverse effects after taking Ciprofloxacin Kabi, contact your doctor immediately, before continuing treatment. You and your doctor will decide whether to continue or discontinue treatment, also considering the use of an antibiotic from another class.

Use of Ciprofloxacin Kabi with other medications.

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

Do not use Ciprofloxacin Kabi at the same time as tizanidine, as this may cause adverse effects such as low blood pressure and drowsiness (see section 2 "Do not use Ciprofloxacin Kabi").

It is known that the following medications interact with Ciprofloxacin Kabi in your body. Taking Ciprofloxacin Kabi at the same time as these medications may affect their therapeutic effect or increase the likelihood of adverse effects.

Inform your doctor if you are taking:

• Vitamin K antagonists (e.g., warfarin, acenocoumarol, phenprocoumon, or fluindione) or other oral anticoagulants (to thin the blood)
• probenecid (for gout)
• methotrexate (for certain types of cancer, psoriasis, rheumatoid arthritis)
• theophylline (for respiratory problems)
• tizanidine (for muscle spasticity in multiple sclerosis)
• olanzapine (an antipsychotic)
• clozapine (an antipsychotic)
• ropinirole (for Parkinson's disease)
• phenytoin (for epilepsy)

• cyclosporines (for skin diseases, rheumatoid arthritis, or organ transplantation)
• other medications that may alter your heart rhythm, medications that belong to the group of antiarrhythmics (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (that belong to the group of macrolides), some antipsychotics.
• zolpidem (for sleep disorders)
• metoclopramide (for nausea and vomiting)
• omeprazole (for stomach ulcers)

Ciprofloxacin Kabi may increaseblood levels of the following medications:

• pentoxifylline (for circulatory disorders)
• caffeine

• duloxetine (for depression, diabetic nerve damage, or incontinence)
• lidocaine (for heart conditions or anesthetic use)
• sildenafil (e.g., for erectile dysfunction)
• agomelatine
• glibenclamide (for diabetes)

Taking Ciprofloxacin Kabi with food and drinks

Food and drinks do not affect your treatment with Ciprofloxacin Kabi.

Pregnancy and 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 medication.

It is recommended to avoid using Ciprofloxacin Kabi during pregnancy.

Do not use Ciprofloxacin Kabi during breastfeeding, as ciprofloxacin is excreted in breast milk and may harm your baby.

Driving and using machines

Ciprofloxacin Kabi may decrease your alertness. Some neurological effects may occur. Therefore, make sure you know how you react to Ciprofloxacin Kabi before driving a vehicle or using a machine. If in doubt, consult your doctor.

Ciprofloxacin Kabi contains sodium.

This medication contains 347 mg of sodium (the main component of table salt) per 100 ml. This is equivalent to 17% of the maximum recommended daily dietary intake for an adult.

3. How to use Ciprofloxacin Kabi

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

Your doctor will explain exactly how much Ciprofloxacin Kabi should be administered to you, how often, and for how long. This will depend on the type of infection you have and its severity.

Inform your doctor if you have kidney problems, as it may be necessary to adjust your dose. The treatment usually lasts from 5 to 21 days, but it can last longer for severe infections.

Your doctor will administer each dose through slow infusion, into a vein, and into the bloodstream. In children, the infusion duration is 60 minutes. In adult patients, the infusion time is 60 minutes for 400 mg of Ciprofloxacin Kabi and 30 minutes for 200 mg of Ciprofloxacin Kabi. The slow administration of the infusion prevents immediate adverse reactions.

Remember to drink plenty of fluids while taking Ciprofloxacin Kabi.

If you take more Ciprofloxacin Kabi than you should

In case you have received more Ciprofloxacin Kabi than you should, you may experience dizziness, tremors, headache, fatigue, abdominal discomfort, or confusion.

Please inform your doctor or nurse if you experience any of these symptoms.

If you miss a dose of Ciprofloxacin Kabi

You should not be given a double dose to make up for missed doses.

If you stop treatment with Ciprofloxacin Kabi

It is essential that you complete the full treatment, even if you start to feel better after a few days. If you stop using this medication too soon, your infection may not be completely cured, and the symptoms may return or worsen. You may develop resistance to the antibiotic.

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

4. Possible side effects

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

The following section contains the most serious side effects that you may recognize yourself:

Stop taking Ciprofloxacin Kabi and contact your doctor immediatelyto consider another treatment with antibiotics if you notice any of the following serious side effects:

Uncommon(may affect up to 1 in 100 people)

• seizures (see section 2: Warnings and precautions).

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

• severe allergic reaction with symptoms such as chest tightness, dizziness, nausea, or fainting, or experiencing dizziness when standing up (anaphylactic shock) (see section 2: Warnings and precautions)
• tendon rupture, which particularly affects the long tendon in the back of the ankle (Achilles tendon) (see section 2: Warnings and precautions).

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

• severe allergic reaction with symptoms such as chest tightness, dizziness, nausea, or fainting, or experiencing dizziness when standing up (anaphylactic reaction) (see section 2: Warnings and precautions)
• muscle weakness, tendon inflammation that can lead to tendon rupture, especially the long tendon in the back of the ankle (Achilles tendon) (see section 2: Warnings and precautions)
• skin rashes with a risk of death, usually in the form of blisters or ulcers in the mouth, throat, nose, eyes, and other mucous membranes, such as the genitals, which can progress to generalized blistering or skin peeling (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Frequency not known(cannot be estimated from the available data)

• unusual sensations of pain, burning, tingling, numbness, or muscle weakness in the limbs (neuropathy) (see section 2: Warnings and precautions)
• a drug reaction that causes skin rash, fever, inflammation of internal organs, blood alterations, and systemic disease (DRESS - Drug Reaction with Eosinophilia and Systemic Symptoms, PEGA - Generalized Acute Exanthematous Pustulosis).
• syndrome associated with inadequate water secretion and low sodium concentrations (SIADH, by its English acronym).

Other side effects that have been observed during treatment with Ciprofloxacin Kabi are listed below according to their probability:

Common side effects(may affect up to 1 in 10 people):

• nausea, diarrhea, vomiting
• joint pain and inflammation in children
• local reaction at the injection site, skin rash
• temporary increase in blood substance levels (transaminases)

Uncommon side effects(may affect up to 1 in 100 people):

• joint pain in adults

• fungal superinfections
• increased eosinophil count, a type of white blood cell, increased or decreased blood clotting factor (thrombocytes)
• decreased appetite, loss of appetite (anorexia)
• hyperactivity, agitation, confusion, disorientation, hallucinations
• headache, dizziness, sleep problems or taste disorders, tingling and numbness, unusual sensitivity to sensory stimuli, seizures (see section 2: Warnings and precautions), vertigo

visual problems, including double vision

• hearing loss
• increased heart rate (tachycardia)
• blood vessel expansion (vasodilation), decreased blood pressure
• abdominal pain, digestive problems such as slow digestion (indigestion/acid reflux), flatulence
• liver function alteration, increased blood substance levels (bilirubin), jaundice (cholestatic jaundice)

itching, hives

• renal function impairment, renal failure
• muscle and bone pain, feeling of discomfort (asthenia), fever, fluid retention

increased blood alkaline phosphatase levels

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

• muscle pain, joint inflammation, increased muscle tone, cramps
• inflammation of the intestine (colitis) associated with antibiotic use (can be fatal in very rare cases) (see section 2: Warnings and precautions)

• changes in blood cell count (leukopenia, leukocytosis, neutropenia, anemia), decreased red and white blood cell and platelet count (pancytopenia) that can be life-threatening, bone marrow depression that can be life-threatening (see section 2: Warnings and precautions)

• allergic reaction, swelling (edema) or rapid swelling of the skin and mucous membranes (angioedema)

• increased blood sugar levels (hyperglycemia)

• decreased skin sensitivity, tremors, migraine, disorders of the sense of smell
• tinnitus (ringing in the ears), hearing impairment
• fainting, blood vessel inflammation (vasculitis)
• breathing difficulties, including asthma symptoms
• pancreatitis

hepatitis, liver cell death (necrosis), which can very rarely lead to liver failure with a risk of death and potential fatal outcome.

• photosensitivity (see section 2: Warnings and precautions), nonspecific blistering, small bleeding points under the skin (petechiae)
• blood or crystals in the urine (see section 2: Warnings and precautions), urinary tract inflammation
• excessive sweating
• increased amylase enzyme levels

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

• a special type of decreased blood cell count (hemolytic anemia), a life-threatening decrease in a type of white blood cell (agranulocytosis) (see section 2: Warnings and precautions).
• an allergic reaction called serum sickness-like reaction (see section 2: Warnings and precautions)

• coordination disorder, instability when walking (gait disorders), brain pressure (intracranial pressure and pseudotumor cerebri)
• color vision disturbance
• various skin rashes or exanthems (e.g., the potentially fatal Stevens-Johnson syndrome or toxic epidermal necrolysis)

Frequency not known(cannot be estimated from the available data)

• feeling very excited (mania) or feeling very optimistic and hyperactive (hypomania)

• abnormally fast heart rate, irregular heart rate that can be life-threatening, heart rhythm disorders (called "QT interval prolongation", detected in the ECG, heart electrical activity).
• Influence on blood coagulation (in patients treated with Vitamin K antagonists).
• Loss of consciousness due to a severe drop in blood sugar levels (hypoglycemic coma). See section 2.

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, limb pain, walking difficulties, abnormal sensations such as pinching, tingling, burning, numbness, or pain (neuropathy), fatigue, decreased memory and concentration, effects on mental health (including sleep disorders, anxiety, panic attacks, depression, and suicidal ideation), as well as alterations in hearing, vision, taste, and smell, have been associated with the administration of quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-existing risk factors.

There have been reports of increased size and weakening or tearing of the aortic wall (aneurysms and dissections), which could lead to rupture and be fatal, and cardiac valve failure in patients who have received fluoroquinolones. See also 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 is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Ciprofloxacin Kabi

Keep this medication out of sight and reach of children.

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

• Do not refrigerate or freeze.
• Store the infusion bag in the outer bag until use to protect it from light.
• Store the infusion vial in the external box until use to protect it from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Ciprofloxacin Kabi composition

• The active ingredient is ciprofloxacin (as ciprofloxacin hydrogen sulfate).
• The other ingredients are sodium chloride, sulfuric acid, sodium hydroxide for pH adjustment, and water for injection.

Product appearance and packaging contents

Ciprofloxacin Kabi is a sterile, transparent, and colorless solution.

This is packaged in a flexible and transparent polyolefin bag with an aluminum outer bag (Freeflex bags) or in a polyethylene vial (KabiPac).

50 ml of solution contains 100 mg of ciprofloxacin.

100 ml of solution contains 200 mg of ciprofloxacin.

200 ml of solution contains 400 mg of ciprofloxacin.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Fresenius Kabi España, S.A.U.

C/ Marina, 16-18

08005 Barcelona (Spain)

Manufacturer:

HP Halden Pharma AS

Svinesundsveien 80

1788 Halden

Norway

Fresenius Kabi Polska Sp. z o.o.

Wytwórnia Plynów Infuzyjnych

99-300 Kutno

Sienkiewicza 25

Poland

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

AT: Ciprofloxacin Kabi 100 mg/50 ml, -200 mg/ 100 ml, -400 mg/200 ml Infusionslösung

BE: Ciprofloxacin Fresenius Kabi 200 mg/100 ml, -400 mg/200 ml solution pour perfusion/Infusionslösung/ oplossing voor intraveneuze infusie

CY: Ciprofloxacin Kabi 200mg/100ml, -400 mg/ 200 ml δι?λυμα για ?γχυση

CZ: Ciprofloxacin Kabi

DE: Ciprofloxacin Kabi 100 mg/50 ml, -200 mg/100 ml, 400 mg/200 ml Infusionslösung

DK: Ciprofloxacin Fresenius Kabi 2 mg/ml infusionsvæske

EL: Ciprofloxacin Kabi 200 mg/ 100 ml, -400 mg/200 ml δι?λυμα για ?γχυση

ES: Ciprofloxacino Kabi 2 mg/ml solución para perfusión EFG

FI: Ciprofloxacin Fresenius Kabi 2 mg/ml infuusioneste, liuos

HU: Ciprofloxacin Kabi 200 mg/100 ml, -400 mg/200 ml oldatos infúzió

IS: Ciprofloxacin Fresenius Kabi

IT: Ciprofloxacin Kabi

MT: Ciprofloxacin Kabi 200 mg/100 ml, -400 mg/200 ml solution for infusion

NL: Ciprofloxacin Kabi 100 mg/50 ml, -200 mg/ 100 ml, -400 mg/200 ml oplossing voor infusie

PL: Ciprofloxacin Kabi 100 mg/50 ml, -200 mg/ 100 ml, -400 mg/200 ml roztwór do infuzji

PT: Ciprofloxacin Kabi

SE: Ciprofloxacin Fresenius Kabi 2 mg/ml infusionsvätska, lösning

SK: Ciprofloxacin Kabi 200 mg/ 100 ml, -400 mg/200 ml infúzny roztok

Date of the last revision of this leaflet:March 2025

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es

Medical advice/education

Antibiotics are used to cure bacterial infections. They are not effective against viral infections.

If your doctor has prescribed antibiotics, you need them precisely for your current illness.

Despite antibiotics, some bacteria may survive or grow. This phenomenon is known as resistance: some antibiotic treatments become ineffective.

Misuse of antibiotics increases resistance. You can even help bacteria become more resistant and, therefore, delay your recovery or reduce the effectiveness of antibiotics if you do not respect:

• the dose
• the frequency of administration
• the duration of treatment

Consequently, to maintain the effectiveness of this medication:

1. Use antibiotics only when prescribed.
2. Follow the prescription strictly.
3. Do not reuse an antibiotic without a medical prescription, even if you want to treat a similar illness.
4. Never give your antibiotic to another person; it may not be suitable for their illness.
5. After completing a treatment, return all unused medication to the pharmacy to ensure it is disposed of correctly.

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The following information is intended only for healthcare professionals

Ciprofloxacin Kabi should be administered through intravenous infusion. In children, the infusion duration is 60 minutes. In adult patients, the infusion time is 60 minutes for 400 mg of Ciprofloxacin Kabi and 30 minutes for 200 mg of Ciprofloxacin Kabi. Slow infusion into a large vein will minimize patient discomfort and reduce the risk of venous irritation. The infusion solution can be administered directly or after mixing with another compatible infusion solution.

Unless compatibility with other infusion solutions or medications has been confirmed, the infusion solution should always be administered separately. Visual signs of incompatibility are, for example, precipitation, clouding, and color change.

Incompatibility occurs with all infusion solutions or medications that are physically or chemically unstable at the pH of the solution (e.g., penicillins, heparin solutions), especially in combination with solutions adjusted to an alkaline pH (pH of ciprofloxacin infusion solutions: 4.0 - 4.9).

After starting intravenous treatment, it can also be continued orally.