CIPROFLOXACIN KABI

Package leaflet: Information for the user

Ciprofloxacin Kabi 100 mg/50 ml solution for infusion, 200 mg/100 ml solution for infusion, 400 mg/200 ml solution for infusion

Generic medicine
Read this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, nurse, or healthcare professional.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor, pharmacist, nurse, or healthcare professional. See section 4.

Contents of this leaflet:

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

1. What Ciprofloxacina Kabi is and what it is used for

Ciprofloxacina Kabi contains the active substance ciprofloxacin. Ciprofloxacin is an antibiotic belonging to the family of fluoroquinolones. Ciprofloxacin works by killing bacteria that cause infections. It is effective only against specific strains of bacteria.

Adults
Ciprofloxacina Kabi is used in adults to treat the following bacterial infections:

• Respiratory tract infections
• Long-lasting or recurrent ear or sinus infections
• Urinary tract infections
• Testicular infections
• Genital infections in women
• Gastrointestinal tract infections and intra-abdominal infections
• Skin and soft tissue infections
• Bone and joint infections
• Treatment of infections in patients with very low white blood cell counts (neutropenia)
• Prevention of infections in patients with very low white blood cell counts (neutropenia)
• Inhalational anthrax exposure

If you have severe infections or an infection caused by more than one type of bacteria, you may be given treatment with another antibiotic in addition to Ciprofloxacina Kabi.

Children and adolescents
Ciprofloxacina Kabi is used in children and adolescents, under the supervision of a medical specialist, to treat the following bacterial infections:

• Lung and bronchial infections in children and adolescents with cystic fibrosis
• Complicated urinary tract infections, including infections involving the kidneys (pyelonephritis)
• Inhalational anthrax exposure

Ciprofloxacina Kabi may also be used to treat other specific severe infections in children and adolescents when the physician considers it necessary.

2. What you should know before taking Ciprofloxacin Kabi

DO NOT take Ciprofloxacin Kabi if

• you are allergic to ciprofloxacin, to other quinolone-type antibiotics, or to any of the other ingredients of this medicine (listed in section 6)
• you are taking tizanidine (see section 2: Other medicines and Ciprofloxacin Kabi).

Warnings and precautions
Before taking Ciprofloxacin Kabi Inform your doctor, pharmacist, nurse, or healthcare
professional:

• if you have had kidney problems, as your treatment may need to be adjusted

• if you suffer from epilepsy or other neurological disorders

• if you have had tendon problems during previous treatments with antibiotics similar to Ciprofloxacin Kabi

• if you are diabetic, as there may be a risk of hypoglycaemia with ciprofloxacin

• if you suffer from severe myasthenia (a type of muscle weakness), as symptoms may worsen

• if you have been diagnosed with an enlargement or “bulging” of a large blood vessel (aortic aneurysm or peripheral aneurysm of a large blood vessel)

• if you have previously experienced episodes of aortic dissection (a tear in the wall of the aorta)

• if you have a family history of aortic aneurysm, aortic dissection, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, vascular Ehlers-Danlos syndrome, or if you suffer from vascular diseases such as Takayasu arteritis, giant cell arteritis, Behcet’s syndrome, high blood pressure, or known atherosclerosis).

• if you have heart problems. Particular caution is required when using this type of medicine if you were born with or have a family history of prolonged QT interval (seen on ECG, an electrical recording of the heart), have an electrolyte imbalance 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 attack (myocardial infarction), if you are a woman or an elderly patient, or if you are taking other medicines that may cause abnormal changes on the ECG (see section 2 “Other medicines and Ciprofloxacin Kabi”).

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

• if you or a family member knows of having glucose-6-phosphate dehydrogenase (G6PD) deficiency, as you may be at risk of anaemia with ciprofloxacin.

For the treatment of certain genital tract infections, your doctor may prescribe another antibiotic in addition to ciprofloxacin. If there are no signs of improvement after 3 days of treatment, consult your doctor.
During treatment with Ciprofloxacin Kabi
Inform your doctor immediately if any of the following conditions occur during treatment with
Ciprofloxacin Kabi. Your doctor will decide whether treatment with Ciprofloxacin Kabi should be
discontinued.

• A severe and sudden allergic reaction (an anaphylactic reaction/anaphylactic shock, angioedema). There is a remote possibility that a severe allergic reaction may occur even with the first dose, with symptoms such as chest tightness, dizziness, feeling unwell or faint, or lightheadedness when standing. In this case, inform your doctor immediately, because administration of Ciprofloxacin Kabi must be discontinued.

• Occasionally, Ciprofloxacin Kabi may cause joint pain and swelling and tendinitis, especially if you are elderly or receiving corticosteroid treatment. At the first sign of pain or inflammation, administration of Ciprofloxacin Kabi must be stopped. Rest the affected area. Avoid unnecessary physical activity, as this may increase the risk of tendon rupture.

• If you suffer from epilepsy or other neurological disorders, such as cerebral ischaemia or stroke, you may experience adverse effects on the central nervous system. If a seizure occurs, stop treatment with Ciprofloxacin Kabi and contact your doctor immediately.

• You may experience symptoms of neuropathy, such as pain, burning, tingling, numbness, and/or weakness. In this case, stop treatment with Ciprofloxacin Kabi and contact your doctor immediately.

• Psychiatric reactions may occur after the first dose of ciprofloxacin. If you suffer from depression or psychosis, your symptoms may worsen during treatment with Ciprofloxacin Kabi. In this case, stop treatment with Ciprofloxacin Kabi and contact your doctor immediately.

• Hypoglycaemia has been reported very commonly in diabetic patients, particularly in the elderly population. If this occurs, contact your doctor immediately.

• During treatment with antibiotics, including Ciprofloxacin Kabi, or even several weeks afterwards, diarrhoea may develop. If it worsens or persists, or if you notice blood or mucus in your stools, inform your doctor immediately. Treatment with Ciprofloxacin Kabi must be stopped immediately, as this may be a life-threatening condition. Do not take medicines that block or reduce intestinal movements.

• If your vision deteriorates or if your eyes are otherwise affected in any way, consult an ophthalmologist immediately.

• During treatment with Ciprofloxacin Kabi, your skin may become more sensitive to sunlight or ultraviolet (UV) light. Avoid exposure to strong sunlight and artificial UV light, such as sunbeds.

• Inform your doctor or laboratory staff that you are taking Ciprofloxacin Kabi if you need to have blood or urine tests.

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

• Ciprofloxacin Kabi may cause liver damage. If you notice symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or abdominal pain, Ciprofloxacin Kabi must be stopped immediately.

• Ciprofloxacin Kabi may cause a reduction in the number of white blood cells, which may result in decreased resistance to infections. If you develop an infection with symptoms such as fever and marked deterioration in your general condition, or fever with symptoms of a localized infection such as sore throat, throat or mouth pain, or urinary problems, you must consult your doctor immediately. A blood test will be performed to check for a possible reduction in white blood cells (agranulocytosis). It is important that you inform your doctor about this medicine.

Other medicines and Ciprofloxacin Kabi
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not use Ciprofloxacin Kabi together with tizanidine, as it may cause adverse effects such as low blood pressure and drowsiness (see section 2: “Do not take Ciprofloxacin Kabi”).
The following medicines interact with Ciprofloxacin Kabi in the body. Taking Ciprofloxacin Kabi together with these medicines may affect their therapeutic effect and 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 or 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)
• ciclosporin (for skin conditions, rheumatoid arthritis and in organ transplants)
• other medicines that may alter heart rhythm: medicines belonging to the class of antiarrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (belonging to the macrolide class), some antipsychotics.
• zolpidem (for sleep disorders)
• metoclopramide (for nausea and vomiting)
• omeprazole (for stomach ulcers).

Ciprofloxacin Kabi may increase blood levels of the following medicines:

• pentoxifylline (for circulatory disorders)
• caffeine
• duloxetine (for depression, nerve damage caused by diabetes or incontinence)
• lidocaine (for heart conditions or use in anaesthesia)
• sildenafil (e.g. for erectile dysfunction)
• agomelatine
• glibenclamide (for diabetes).

Ciprofloxacin Kabi with food and drink
Food and drink have no influence on treatment with Ciprofloxacin Kabi.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
It is preferable to avoid using Ciprofloxacin Kabi during pregnancy. Do not take Ciprofloxacin Kabi while breastfeeding, as ciprofloxacin is excreted in breast milk and may be harmful to your baby.
Driving and using machines
Ciprofloxacin Kabi may reduce alertness. Some neurological adverse events may occur. Therefore, check your response to Ciprofloxacin Kabi before driving a vehicle or operating machinery. If in doubt, consult your doctor.
Ciprofloxacin Kabi contains sodium
If you are on a low-sodium diet, please note that 100 ml of Ciprofloxacin Kabi contains 15.1 mmol (=347 mg) of sodium.

3. How to take Ciprofloxacin Kabi

Use this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Your doctor will explain exactly how much Ciprofloxacin Kabi you should receive, how often,
and for how long. This will depend on the type and severity of your infection.
Inform your doctor if you have kidney problems, as your dose may need adjustment.
Treatment usually lasts from 5 to 21 days, but may be longer for severe infections.
Your doctor will administer each dose as a slow intravenous infusion into your bloodstream.
For children, the infusion duration is 60 minutes. In adult patients, the infusion duration is 60 minutes for Ciprofloxacin Kabi 400 mg and 30 minutes for Ciprofloxacin Kabi 200 mg. Administering the infusion slowly helps prevent the occurrence of immediate adverse effects.
Remember to drink plenty of fluids during treatment with Ciprofloxacin Kabi.
If you take more Ciprofloxacin Kabi than you should
If you have received more Ciprofloxacin Kabi than prescribed, symptoms such as dizziness, tremors, headache, fatigue, abdominal discomfort, or confusion may occur.
Inform your doctor or nurse if you experience any of these symptoms.
If you forget to take a dose of Ciprofloxacin Kabi
Do not take a double dose to make up for the missed dose.
If you stop treatment with Ciprofloxacin Kabi
It is important that you complete the full course of treatment, even if you start to feel better after a few days. Stopping this medicine too early may mean the infection is not completely cured, and infection symptoms may return or worsen. You may also develop antibiotic resistance.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, nurse, or healthcare professional.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following section lists the most serious side effects that you can recognize on your own:
Stop taking Ciprofloxacin Kabi and contact your doctor immediately to consider treatment with another antibiotic if you notice any of the following 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, sudden allergic reaction with symptoms such as chest tightness, dizziness, feeling unwell or faint, or dizziness upon standing (anaphylactic shock) (see section 2: Warnings and precautions)
• Tendon rupture, particularly affecting the large tendon at 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, sudden allergic reaction with symptoms such as chest tightness, dizziness, feeling unwell or faint, or dizziness upon standing (anaphylactic reaction) (see section 2: Warnings and precautions)
• Muscle weakness, tendon inflammation which may lead to tendon rupture, particularly affecting the large tendon at the back of the ankle (Achilles tendon) (see section 2: Warnings and precautions)
• A severe, life-threatening skin rash, usually presenting as blisters or sores in the mouth, throat, nose, eyes, and other mucous membranes such as the genital area, which may progress to widespread blistering or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis)

Not known (frequency 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 causing skin rashes, fever, internal organ inflammation, blood abnormalities, and systemic illness (drug reaction with eosinophilia and systemic symptoms, DRESS; AGEP, acute generalized exanthematous pustulosis)
• Syndrome associated with impaired water excretion and low sodium levels (SIADH)

Other side effects observed during treatment with Ciprofloxacin Kabi are listed below, categorized by how likely they are to occur:

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

• Nausea, diarrhoea, vomiting
• Joint pain and joint inflammation in children
• Local reaction at the injection site, skin rash
• Temporary increase in certain blood substances (transaminases)

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

• Joint pain in adults
• Fungal superinfections
• High concentration of eosinophils, a type of white blood cell; increase or decrease in platelets (a blood clotting factor)
• Loss of appetite (anorexia)
• Hyperactivity, restlessness, confusion, disorientation, hallucinations
• Headache, dizziness, sleep disturbances, taste disturbances, pins and needles sensation, unusual sensitivity to sensory stimuli (see section 2: Warnings and precautions), dizziness
• Visual disturbances, including double vision
• Hearing loss
• Rapid heartbeat (tachycardia)
• Blood vessel dilation (vasodilation), low blood pressure
• Abdominal pain, digestive problems such as stomach discomfort (indigestion/heartburn), intestinal gas
• Liver disorders, increased levels of a substance in the blood (bilirubin), jaundice (cholestatic jaundice)
• Itching, hives
• Reduced kidney function, kidney failure
• Muscle and bone pain, malaise (asthenia), fever, fluid retention
• Increased alkaline phosphatase in the blood (a certain substance in the blood)

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 (in rare cases may be fatal) (see section 2: Warnings and precautions)
• Changes in blood cell counts (leukopenia, leukocytosis, neutropenia, anaemia), a decrease in red blood cells, white blood cells, and platelets (pancytopenia), which may be fatal, bone marrow suppression, which may also be fatal (see section 2: Warnings and precautions)
• Allergic reaction, allergic swelling (edema), sudden swelling of the skin and mucous membranes (angioedema), increased blood sugar (hyperglycemia)
• Decreased blood sugar (hypoglycemia) (see section 2: Warnings and precautions)
• Anxiety reaction, unusual dreams, depression (which may lead to suicidal thoughts, suicide attempts, or completed suicide), mental disorders (psychotic reactions that may lead to suicidal thoughts, suicide attempts, or completed suicide) (see section 2: Warnings and precautions)
• Reduced skin sensitivity, tremor, migraine, disturbances in smell (olfactory disturbances)
• Tinnitus, decreased hearing
• Fainting, inflammation of blood vessels (vasculitis)
• Shortness of breath, including asthma-like symptoms
• Pancreatitis
• Hepatitis, death of liver cells (hepatic necrosis), which very rarely may lead to life-threatening liver failure with potentially fatal outcome
• Light sensitivity (see section 2: Warnings and precautions), pinpoint bleeding under the skin (petechiae)
• Blood or crystals in urine (see section 2: Warnings and precautions)
• Inflammation of the urinary tract
• Excessive sweating
• Increased levels of the enzyme amylase

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

• A specific type of reduction in red blood cells (haemolytic anaemia); a dangerous reduction in a type of white blood cells (agranulocytosis) which may be fatal (see section 2: Warnings and precautions)
• Allergic reaction known as serum sickness-like reaction (see section 2: Warnings and precautions)
• Coordination problems, unsteady gait (gait disturbances), increased pressure in the brain (intracranial hypertension including pseudotumor cerebri)
• Distortions in colour perception
• Various types of skin rashes and irritations (e.g., Stevens-Johnson syndrome or toxic epidermal necrolysis, potentially fatal)
• Worsening of symptoms of myasthenia gravis (see section 2: Warnings and precautions)

Not known (frequency cannot be estimated from the available data)

• Feeling extremely restless (mania) or feeling overly optimistic and hyperactive (hypomania)
• Abnormally fast heart rate, life-threatening irregular heart rhythm, changes in heart rhythm (known as "QT interval prolongation", seen on ECG, the heart's electrical activity)
• Increased international normalized ratio (in patients treated with vitamin K antagonists)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, nurse, or healthcare professional. You can also report side effects via the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ciprofloxacin Kabi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp.”.
The expiry date refers to the last day of the month.

• Do not refrigerate or freeze.
• Keep the infusion bag inside the overpouch until use to protect it from light.
• Keep the infusion bottles in the outer packaging until use to protect them from light.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Ciprofloxacin Kabi Contains

• The active substance is ciprofloxacin (as hydrogen sulfate).
• The other components are sodium chloride, sulfuric acid, sodium hydroxide as pH adjuster, and water for injections.

Description of the Appearance of Ciprofloxacin Kabi and Contents of the Package
Ciprofloxacin Kabi is a sterile, clear, and colourless solution.
Ciprofloxacin is contained in a clear, flexible polyolefin bag with an aluminium overwrap
(Excel and Freeflex bags) or in a polyethylene bottle (Kabipac).
50 ml of solution contain 100 mg of ciprofloxacin.
100 ml of solution contain 200 mg of ciprofloxacin.
200 ml of solution contain 400 mg of ciprofloxacin.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Fresenius Kabi Italia S.r.l., Via Camagre 41, 37063 Isola della Scala (VR)
Manufacturer for bags only:
Fresenius Kabi Norge AS, Postboks 430, N-1753 Halden
Norway
Manufacturer for bottles in Kabipac only:
Fresenius Kabi Polska Sp.zo.o.
Wytwórnia Płynów Infuzyjnych
99-300 Kutno
Sienkiewicza 25
Poland

This medicinal product is authorized in EEA Member States under 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 for
perfusion/Infusionslösung/oplossing voor intraveneuze infusie
CY: Ciprofloxacin Kabi -200mg/100ml, -400 mg/200 ml διάλυμα για έγχυση
CZ: Ciprofloxacin Kabi 200 mg/100 ml, -400 mg/200 ml infuzní roztok
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 διάλυμα για έγχυση
ES: Ciprofloxacin Kabi 2 mg/ml solución para perfusión
FI: Ciprofloxacin Fresenius Kabi 2 mg/ml infuusioneste, liuos
HU: Ciprofloxacin Kabi 200 mg/100 ml, -400 mg/200 ml oldatos infúzió
IT: Ciprofloxacina Kabi 100 mg/50 ml, 200 mg/100 ml, 400 mg/200 ml soluzione per infusione
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 100 mg/50 ml, -200 mg/100 ml, -400 mg/200 ml Solução para perfusão
SE: Ciprofloxacin Fresenius Kabi 2 mg/ml infusionsvätska, lösning
SK: Ciprofloxacin Kabi 100 mg/50 ml, -200 mg/100 ml, -400 mg/200 ml infúzny intravenózny roztok
UK: Ciprofloxacin Kabi 100 mg/50 ml, -200 mg/100 ml, -400 mg/200 ml solution for infusion

Advice/Health Education
Antibiotics are used to treat bacterial infections. They are not effective against viral infections.
If your doctor has prescribed antibiotics, you need them specifically for your current illness.
Despite antibiotic treatment, certain bacteria may survive or multiply. This phenomenon is known as resistance: some antibiotic treatments become ineffective.
Improper use of antibiotics increases resistance. You may even promote the development of bacterial resistance and delay recovery or reduce the effectiveness of antibiotics if you do not adhere to:

• dosage
• frequency of administration
• duration of treatment

Therefore, to preserve the effectiveness of this medicine:

1. Use antibiotics only when prescribed.
2. Follow your doctor's instructions exactly.
3. Do not reuse an antibiotic without a medical prescription, even if you are treating a similar illness.
4. Never give your antibiotic to another person; it may not be suitable for their condition.
5. At the end of treatment, return all unused medicines to the pharmacy so they can be properly disposed of.

The following information is intended exclusively for healthcare professionals:
Ciprofloxacin Kabi must be administered by intravenous infusion. In children, the infusion duration is 60 minutes. In adult patients, the infusion duration is 60 minutes for Ciprofloxacin Kabi 400 mg and 30 minutes for Ciprofloxacin Kabi 200 mg. Slow infusion into a large vein reduces both patient discomfort and the risk of venous irritation. The infusion solution may be administered alone or after mixing with compatible infusion solutions.
The infusion solution may be administered alone or after mixing with other compatible infusion solutions. Physical signs of incompatibility include, for example, precipitation, cloudiness, and discoloration.
Incompatibility occurs with all medicinal products or infusion solutions that are physically or chemically unstable at the pH of the solution itself (e.g. penicillins and heparin solutions), particularly those buffered at alkaline pH (the pH of ciprofloxacin infusion solutions ranges from 4.0 to 4.9).
After initial intravenous administration, treatment may be continued orally.