PATIENT INFORMATION LEAFLET

Ciprofloxacin Kern Pharma 2 mg/ml Infusion Solution EFG

Ciprofloxacin

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Ciprofloxacin Kern Pharma is and what it is used for

2. What you need to know before using Ciprofloxacin Kern Pharma

3. How to use Ciprofloxacin Kern Pharma

4. Possible side effects

5. Storage of Ciprofloxacin Kern Pharma

6. Contents of the pack and additional information

Ciprofloxacino Kern Pharma contains the active substance ciprofloxacin. Ciprofloxacin is an antibiotic that belongs to the group of fluoroquinolones. Ciprofloxacin acts by eliminating the bacteria that cause infections. It only acts on specific strains of bacteria.

Adults

Ciprofloxacino Kern Pharma is used in adults to treat the following bacterial infections:

• Some respiratory tract infections.
• Some long-lasting or recurrent ear or sinus infections.
• Urinary tract infections.
• Female and male genital tract infections.
• Gastrointestinal and intrabdominal infections.
• Skin and soft tissue infections.
• Bone and joint infections.
• Treatment after inhaling carbuncle pathogens.

Ciprofloxacin can be usedin thetreatment of patientswith a low countof certain white blood cells (neutropenia)who havea fever, whichis suspected to becaused by a bacterial infection.

In case of a severe infection or if the infection is caused by more than one type of bacteria, it is possible that you will be administered an additional antibiotic treatment, in addition to Ciprofloxacino Kern Pharma.

Children and adolescents

Ciprofloxacino Kern Pharma is used in children and adolescents, under specialized medical supervision, to treat the following bacterial infections:

• Pulmonary and bronchial infections in children and adolescents with cystic fibrosis
• Complicated urinary tract infections, including kidney infections (pyelonephritis)
• Treatment after inhaling carbuncle pathogens.

Ciprofloxacino Kern Pharma may also be used for the treatment of severe infections in children and adolescents when necessary.

No use Ciprofloxacino Kern Pharma

• If you are allergic to ciprofloxacin, other quinolones, or any of the other components of this medication (listed in section 6).
• If you are taking tizanidine (see section 2: Other medications and Ciprofloxacino Kern Pharma).

Warnings and precautions

Before this medication is started

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

Speak with your doctor, pharmacist, or nurse before ciprofloxacin is administered:

• If you have ever had kidney problems, as your treatment may need to be adjusted.
• If you have epilepsy or other neurological conditions.
• If you have a history of tendon problems during previous antibiotic treatment with ciprofloxacin.
• If you are diabetic, as you may be at risk of hypoglycemia with ciprofloxacin.
• If you have myasthenia gravis (a type of muscle weakness), as your symptoms may worsen.
• If you have been diagnosed with an aneurysm of a large blood vessel (aortic aneurysm or peripheral aneurysm).
• If you have had a previous episode of aortic dissection (tear in the aorta).
• 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 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, hypertension, known atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).
• If you have heart problems. You should exercise caution when using this type of medication if you were born with or have a family history of prolonged QT interval (seen on an ECG, which is a recording of the heart's electrical activity), have an imbalance of blood salts (especially low levels of potassium or magnesium in the blood), have a very slow heart rate (bradycardia), have a weak heart (heart failure), have a history of heart attacks (myocardial infarction), are a woman or elderly, or are taking other medications that can affect the ECG (see section 2: "Use of other medications and Ciprofloxacino").
• If you or a family member has a confirmed deficiency of glucose-6-phosphate dehydrogenase (G6PD), as you may be at risk of anemia with ciprofloxacin.

Your doctor may prescribe another antibiotic in addition to ciprofloxacin for the treatment of some genital tract infections.If you do not see improvement in your symptoms after 3 days of treatment, consult your doctor.

During treatment with this medication

Inform your doctor immediately if any of the following situations occur during treatment with ciprofloxacin:

• Severe and sudden allergic reaction(anaphylactic reaction or 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 ciprofloxacin administration should be discontinued..
• Severe, incapacitating, and potentially irreversible adverse effectsThe antibacterial medications that contain fluoroquinolones or quinolones, including ciprofloxacin, 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 and joint pain in the upper and lower extremities, difficulty walking, abnormal sensations such as pins and needles, numbness, tingling, or burning (paresthesia), sensory disorders such as decreased vision, taste, smell, and hearing, depression, decreased memory, intense fatigue, and severe sleep disorders.If you experience any of these adverse effects after taking ciprofloxacin, contact your doctor immediately, before continuing treatment. You and your doctor will decide whether to continue or discontinue treatment, considering the use of another class of antibiotic.
• In rare cases, pain and swelling in the joints and inflammation or rupture of tendons may occur.The risk is higher if you are elderly (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 discontinuing ciprofloxacin treatment. If you experience any pain or inflammation in a tendon (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking ciprofloxacin, contact your doctor, and keep the affected area at rest. Avoid any unnecessary exercise, as this may increase the risk of tendon rupture.
• If you experience sudden and intense pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, seek immediate medical attention. The risk may be increased if you are receiving systemic corticosteroids.
• If you start experiencing sudden shortness of breath, especially when lying down, or if you notice swelling in your ankles, feet, or abdomen, or palpitations, inform your doctor immediately.
• If you have epilepsy or another neurological condition, such as ischemia or cerebral infarction, you may experience adverse effects associated with the central nervous system. If this occurs, stop using ciprofloxacin and contact your doctor immediately.
• In rare cases, you may experience symptoms of nerve damage (neuropathy), such as pain, burning, numbness, tingling, and/or weakness, especially in your feet and legs or hands and arms. If this occurs, stop taking ciprofloxacin and inform your doctor immediately to prevent potential permanent damage.
• You may experience psychiatric reactions after the first administration of ciprofloxacin. If you have depression or psychosis, your symptoms may worsen with ciprofloxacin treatment.In rare cases, depression or psychosis may progress to suicidal thoughts, attempts, and completed suicide.If this occurs, stop using ciprofloxacin and contact your doctor immediately.
• Antibiotics, including quinolones, can cause an increase in your blood sugar levels above normal levels (hyperglycemia), or a decrease in your blood sugar levels below normal levels, which in severe cases can cause a loss of consciousness (hypoglycemic coma) (see section 4). This is particularly important for people with diabetes. If you have diabetes, your blood sugar levels should be carefully controlled.
• You may develop diarrhea during the use of antibiotics, including Ciprofloxacino Kern Pharma, or even several weeks after stopping them. If this becomes intense or persistent, or if you notice that your stools contain blood or mucus, inform your doctor immediately. Ciprofloxacin treatment should be discontinued immediately, as it may put your life at risk. Do not take medications that slow down or delay bowel movements.
• If your vision worsens or your eyes are affected in any other way, consult an ophthalmologist immediately.
• Your skin may become more sensitive to sunlight or ultraviolet (UV) light during ciprofloxacin treatment. Avoid exposure to intense sunlight or artificial UV light, such as tanning beds.
• Inform your doctor or laboratory personnel if you are undergoing blood or urine tests while using ciprofloxacin.
• If you have kidney problems, inform your doctor, as your dose may need to be adjusted.
• Ciprofloxacin can cause liver damage. If you experience symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or stomach pain, discontinue ciprofloxacin treatment immediately.
• Ciprofloxacin can cause a decrease in 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. A blood test will be performed to examine the possible decrease in white blood cells (agranulocytosis). It is essential to inform your doctor about your medication.

Use of other medications

Inform your doctor or pharmacist that you are using, have used recently, or may need to use any other medication.

Do not use ciprofloxacin at the same time as tizanidine, as this may cause adverse effects, such as low blood pressure and drowsiness (see section 2: “Do not administer Ciprofloxacino Kern Pharma”).

We know that the following medications interact with ciprofloxacin in your body. If you use ciprofloxacin at the same time as these medications, this may affect the therapeutic effect of these medications. It may also increase the likelihood of adverse effects.

Inform your doctor if you are taking:

• Anticoagulants (e.g., warfarin, acenocoumarol, femprocoumon, 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)
• Ciclosporin (for skin diseases, rheumatoid arthritis, and organ transplantation)
• Other medications that can affect heart rhythm:antiarrhythmics (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (which belong to the macrolide group), some antipsychotics.
• Zolpidem (for sleep disorders)

Ciprofloxacin may increase the levels of the following medications in your blood:

• Pentoxifylline (for circulatory disorders)
• Caffeine
• Duloxetine (for depression, diabetic nerve damage, or incontinence)
• Lidocaine (for heart disease or anesthesia)
• Sildenafil (e.g., for erectile dysfunction)
• Agomelatine (for depression)

Use of Ciprofloxacino Kern Pharma with food and drinks

Foods and drinks do not affect your treatment with ciprofloxacin.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before ciprofloxacin is administered.

It is preferable to avoid using ciprofloxacin during pregnancy.

Do not use ciprofloxacin during breastfeeding, as ciprofloxacin is excreted through breast milk and may cause harm to your baby.

Driving and operating machines

Ciprofloxacin may decrease your alertness. Some neurological effects may occur.

Therefore, ensure you know how you react to ciprofloxacin before driving a vehicle or operating a machine. If in doubt, consult your doctor.

Ciprofloxacino Kern Pharma contains sodium

This medication contains 353.9 mg (15.4 mmol) of sodium (main component of table salt/for cooking) per 100 ml of infusion solution. This is equivalent to 35.39% of the recommended daily maximum sodium intake for an adult.

Your doctor will explain exactly how much Ciprofloxacino Kern Pharma you should be given, 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 your dose may need to be adjusted.

Treatment usually lasts from5 to21 days, but may be longer for severe infections.

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

Remember to drink a large amount of liquids while this medication is being administered.

If your Ciprofloxacino Kern Pharma administration is interrupted

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

If you have any other questions about using this medication, ask your doctor or pharmacist.

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

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

Stop taking ciprofloxacin and contact your doctor immediatelyto consider alternative antibiotic treatment if you notice any of the following serious side effects:

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

• Seizures (see Section 2: Warnings and Precautions).

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

• Severe and sudden 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, particularly affecting the long tendon in the back of the ankle (Achilles tendon) (see Section 2: Warnings and Precautions).

Unknown frequency(cannot be estimated from 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, internal organ inflammation, hematological changes, and systemic disease (DRESS - Drug Reaction with Eosinophilia and Systemic Symptoms, PEGA - Acute Generalized Exanthematous Pustulosis).

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

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

• Nausea, diarrhea, vomiting.
• Joint pain in children.
• Local reaction at the injection site, skin rash.
• Temporary increase in blood levels of certain substances (transaminases).

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

• Muscle pain, joint inflammation, increased muscle tone, cramps.
• Intestinal inflammation (colitis) associated with antibiotic use (may be fatal in rare cases) (see Section 2: Special Precautions).
• Changes in blood cell count (leucopenia, leucocytosis, neutropenia, anemia), decreased platelet count, which may put the patient's life at risk, medullary depression that may put the patient's life at risk (see Section 2: Special Precautions).
• Allergic reaction, swelling (edema) or rapid swelling of the skin and mucous membranes (angioedema), (see Section 2: Special Precautions).
• Increased blood sugar levels (hyperglycemia).
• Decreased blood sugar levels (hypoglycemia) (see Section 2: Special Precautions).
• Anxiety reactions, strange dreams, depression (which may lead to suicidal thoughts, attempts, and completed suicide), mental alterations (psychotic reactions that may lead to suicidal thoughts, attempts, and completed suicide) (see Section 2: Special Precautions).
• Decreased skin sensitivity, tremors, migraines, disturbances of the sense of smell.
• Tinnitus, hearing loss.
• Fainting, inflammation of blood vessels (vasculitis).
• Difficulty breathing, including asthma-like symptoms.
• Pancreatitis.
• Hepatitis, liver cell death (necrosis), which very rarely leads to liver insufficiency with a risk of death (see Section 2: Special Precautions).
• Light sensitivity (see Section 2: Special Precautions), non-specific blistering, small hemorrhages under the skin (petechiae).
• Blood or crystals in the urine, urinary tract inflammation.
• Excessive sweating.
• Increased concentrations of the amylase enzyme.

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

• A type of severe decrease in blood cell count (hemolytic anemia), a dangerous decrease in a type of white blood cell count (agranulocytosis) (see Section 2: Special Precautions).
• Severe allergic reactions with a risk of death (serum sickness) (see Section 2: Special Precautions).
• Coordination disorders, instability when walking (gait disorders), increased intracranial pressure and pseudotumor cerebri.
• Distorted color vision.
• Diverse skin eruptions or exanthems.
• Worsening of myasthenia gravis symptoms (see Section 2: Special Precautions).

Unknown frequency(cannot be estimated from available data)

• Syndrome associated with deficient water secretion and low sodium concentrations (SIADH, by its English acronym).
• Feeling extremely excited (mania) or a feeling of great optimism and hyperactivity (hypomania).
• Abnormally fast heart rhythm, irregular heart rhythm and potentially fatal, alteration of the heart rhythm (known as "prolongation of the QT interval", observed in the ECG, which is a record of the heart's electrical activity).
• Influence on blood coagulation (in patients treated with vitamin K antagonists).
• Loss of consciousness due to severe decrease in blood sugar levels (hypoglycemic coma). See Section 2: Special Precautions.

The administration of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-lasting or permanent adverse reactions (even months or years) or side effects, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, unusual sensations such as pinching, tingling, burning, numbness, or pain (neuropathy), depression, fatigue, sleep disturbances, decreased memory, and decreased hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

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

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 the Vigilance 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.

Keep out of sight and reach of children.

Do not use Ciprofloxacino Kern Pharma after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Store below 25°C. Do not refrigerate or freeze as crystals may form if the medication becomes too cold. If you observe crystals in your medication, do not use it and inform your doctor, nurse, or pharmacist immediately.

Always store your medication in the outer packaging to protect it from light.

Flasks with outer packaging:Keep the flasks in the outer bag to protect them from light. Use immediately once the bag is removed (see section 6.3).

Flasks without outer packaging:Must be kept in the cardboard box to protect them from light. Use immediately once the cardboard box is removed (see section 6.3).

Open the flask and/or bag and use the medication at once. This is a single-dose container. No special precautions are required during the normal infusion period of 60 minutes.

Your medication should not be mixed with other medications that may also be administered by infusion. Ask your doctor, nurse, or pharmacist if you want more information about this.

Medicines should not be thrown away through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines you do not need. This will help protect the environment.

Composition of Ciprofloxacino Kern Pharma

The active ingredient is ciprofloxacin (in the form of lactate).

Each 100 ml contains 200 mg (milligrams) of ciprofloxacin. Each 200 ml contains 400 mg (milligrams) of ciprofloxacin.

The other components are lactic acid, sodium chloride, hydrochloric acid (for pH adjustment) and water for injection.

Appearance of Ciprofloxacino Kern Pharma and packaging content

Infusion solution.

This means it is ready to be administered in a plastic bag or bottle in the form of intravenous infusion (drip).

Each bag or bottle of Ciprofloxacino contains 100 ml or 200 ml of the medication.

Bags:

• The 100 ml bags come in carton boxes of 10.
• The 200 ml bags come in carton boxes of 5.

Bottles:

Each 100 ml bottle is placed inside a metalized plastic bag. It is available in packs of 10 or 20 bottles.

Alternatively:

The 100 ml bottles are placed in carton boxes. It is available in packs of 1, 10 or 20 bottles.

Each 200 ml bottle is placed inside a metalized plastic bag. It is available in packs of 5, 10 and 20 bottles.

Alternatively:

The 200 ml bottles are placed in carton boxes. It is available in packs of 1, 5, 10 or 20 bottles.

Only some sizes of packaging may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Kern Pharma, S.L.

Venus 72, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Responsible manufacturer

DEMO S.A., 21stkm National Road Athens-Lamia, 14568 Krioneri, Athens, Greece.

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

Ireland: Ciprofloxacin 2 mg/ml Solution for Infusion

Spain: Ciprofloxacino Kern Pharma 2 mg/ml infusion solution EFG

Greece:Ciprofloxacin/Noridem, Δι?λυμα για ?γχυση 2 mg/ml

Austria:Ciprofloxacin Noridem 2 mg/ml Infusionslösung

Germany: Ciprofloxacin 2mg/ml Infusionslösung

Last review date of this leaflet:October2024

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

Advice on proper use

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

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

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

Abuse of antibiotics increases the development of 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, in order to maintain the effectiveness of this medication:

1. Use antibiotics only when prescribed.

2. Follow the dosing instructions throughout the treatment period.

3. Do not reuse an antibiotic without a doctor's prescription, even if you want to treat a similar illness.

4. Never give your antibiotic to someone else; it may not be adapted to their illness.

5. After completing a treatment, return all unused medications to the pharmacy to ensure they are disposed of correctly.

The following information is intended only for medical professionals or healthcare professionals

Ciprofloxacino Kern Pharma should be administered by intravenous infusion. In children, the infusion duration is 60 minutes. In adult patients, the infusion time is 60 minutes for 400 mg of Ciprofloxacino Kern Pharma, and 30 minutes for 200 mg of Ciprofloxacino Kern Pharma. A slow infusion in a large vein will minimize patient discomfort and reduce the risk of venous irritation. The infusion solution can be administered directly or after mixing it 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 include precipitation, turbidity, 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 association with solutions adjusted to an alkaline pH (pH of ciprofloxacin infusion solutions: 3.9 to 4.5).

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