CIPROFLOXACIN KERN PHARMA 2 mg/ml SOLUTION FOR INFUSION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ciprofloxacin Kern Pharma 2 mg/ml solution for infusion EFG

Ciprofloxacin

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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What Ciprofloxacin Kern Pharma is and what it is used for
2. What you need to know before you use 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 other information

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

Ciprofloxacin Kern Pharma contains the active substance ciprofloxacin. Ciprofloxacin is an antibiotic that belongs to the group of fluoroquinolones. Ciprofloxacin works by killing the bacteria that cause infections. It only works with specific strains of bacteria.

Antibiotics are used to treat bacterial infections and do not work for viral infections such as the flu or the common cold.

It is essential that you follow the instructions regarding the dose, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medication. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw away medications down the drain or in the trash.

Adults

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

• Some respiratory tract infections.
• Some long-term or recurrent ear or sinus infections.
• Urinary tract infections.
• Genital tract infections in both men and women.
• Gastrointestinal and intra-abdominal infections.
• Skin and soft tissue infections.
• Bone and joint infections.
• Treatment after inhalation of anthrax pathogens.

Ciprofloxacin can be used to treat patients with a low count of certain white blood cells (neutropenia) who have a fever, which is suspected to be due to a bacterial infection.

In case you have a severe infection or if the infection is caused by more than one type of bacteria, you may be given additional antibiotic treatment, in addition to Ciprofloxacin Kern Pharma.

Children and adolescents

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

• Lung and bronchial infections in children and adolescents with cystic fibrosis
• Complicated urinary tract infections, including those that affect the kidneys (pyelonephritis)
• Treatment after inhalation of anthrax pathogens.

Ciprofloxacin Kern Pharma may also be used to treat severe infections in children and adolescents when necessary.

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

Do not use Ciprofloxacin 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 Ciprofloxacin Kern Pharma).

Warnings and precautions

Before you start using this medication

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

Talk to your doctor, pharmacist, or nurse before you are given 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, consult your doctor.

During treatment with this medication

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

• 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 ciprofloxacin administration should be discontinued.
• Severe, disabling, and potentially irreversible adverse effectsAntibacterial medications that contain fluoroquinolones or quinolones, including ciprofloxacin, 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. This includes pain in the tendons, muscles, and joints of the upper and lower limbs, difficulty walking, abnormal sensations such as pinching, tingling, numbness, or burning (paresthesia), sensory disorders such as decreased vision, taste, smell, or hearing, depression, memory loss, 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 not, also considering the use of an antibiotic from another class.
• In rare cases, pain and swelling may occur in the joints and inflammation or rupture of the tendons.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 ciprofloxacin treatment. At the first sign of pain or inflammation of a tendon (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking ciprofloxacin, contact your doctor, and rest the affected area. Avoid any unnecessary exercise, as this could increase the risk of tendon rupture.
• If you feel a sudden and intense pain in the abdomen, chest, or back, which can 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 the ankles, feet, or abdomenor the appearance of heart palpitations(feeling of rapid or irregular heartbeat), inform your doctor immediately.
• If you suffer from epilepsyor other neurological conditions, such as cerebral ischemia or 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 nerve damage (neuropathy)symptoms such as pain, burning, tingling, numbness, and/or weakness, especially in the feet and legs or hands and arms. If this occurs, stop taking ciprofloxacin and inform your doctor immediately to prevent the development of potentially permanent damage.
• You may experience psychiatric reactionsafter the first administration of ciprofloxacin. If you suffer from depressionor psychosis, your symptoms may worsen with ciprofloxacin treatment. In rare cases, depression or psychosis can progress to suicidal thoughts, attempted suicide, and completed suicide. If this occurs, stop using ciprofloxacin and contact your doctor immediately.
• Quinolone antibioticsmay 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 lead to loss of consciousness (hypoglycemic coma) (see section 4). This is important for people with diabetes. If you have diabetes, your blood sugar levels should be carefully monitored.
• Diarrheamay develop during the use of antibiotics, including Ciprofloxacin Kern Pharma, or even several weeks after stopping their use. If it becomes intense or persistent, or if you notice that the stool contains blood or mucus, inform your doctor immediately. Ciprofloxacin treatment should be discontinued immediately, as it can be life-threatening. Do not take medications that stop or delay bowel movements.
• If your vision worsensor if your eyes are affected in any other way, consult an ophthalmologist immediately.
• Your skin becomes more sensitive to sunlight or ultraviolet (UV) lightduring treatment with ciprofloxacin. Avoid exposure to intense sunlight or artificial ultraviolet light, such as tanning booths.
• While using ciprofloxacin, inform your doctor or laboratory personnel if you need to undergo a blood or urine test.
• If you suffer from kidney problems, inform your doctor, as your dose may need to be adjusted.
• Ciprofloxacin can cause liver damage. If you notice symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or stomach pain, discontinue ciprofloxacin administration immediately.
• Ciprofloxacin can cause a decrease in the white blood cell countand 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.

Use of other medications

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

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

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

Tell your doctor if you are taking:

• Vitamin K antagonists (e.g., warfarin, acenocoumarol, phenprocoumon, 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)
• cyclosporine (for skin diseases, rheumatoid arthritis, and organ transplantation)
• other medications that may alter the 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)

Ciprofloxacin may increaseblood levels of the following medications:

• pentoxifylline (for circulatory disorders)
• caffeine
• duloxetine (for depression, diabetic nerve damage, or incontinence)
• lidocaine (for heart diseases or anesthesia use)
• sildenafil (e.g., for erectile dysfunction)
• agomelatine (for depression)

Use of Ciprofloxacin Kern Pharma with food and beverages

Food and beverages do not affect your treatment with ciprofloxacin.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before you are given this medication.

It is recommended to avoid the use of ciprofloxacin during pregnancy.

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

Driving and using machines

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

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

Ciprofloxacin Kern Pharma contains sodium

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

3. How to use Ciprofloxacin Kern Pharma

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

Tell your doctor if you have kidney problems, as your dose may need to be adjusted.

Treatment usually lasts from 5 to 21 days, but may last longer for severe infections.

Your doctor will administer each dose through 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 Ciprofloxacin Kern Pharma and 30 minutes for 200 mg of Ciprofloxacin Kern Pharma. The slow administration of the infusion prevents immediate adverse reactions.

Remember to drink plenty of fluids while you are being given this medication.

If Ciprofloxacin Kern Pharma administration is interrupted

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 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 or pharmacist.

4. Possible Adverse Effects

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

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

Stop taking ciprofloxacin and contact your doctor immediatelyto consider another treatment with antibiotics if you notice any of the following serious adverse 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 of 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 disorders, and systemic disease (DRESS - Drug Reaction with Eosinophilia and Systemic Symptoms, PEGA - Pustular Exanthematous Generalized Acute).

Other adverse 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 substance levels (transaminases)

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

• joint pain in adults
• fungal superinfections (infections caused by fungi)
• increased eosinophil count, a type of white blood cell, increased or decreased blood clotting factor (thrombocytes)
• decreased appetite
• 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
• vision problems, including double vision
• hearing loss
• increased heart rate (tachycardia)
• expansion of blood vessels (vasodilation), decreased blood pressure
• abdominal pain, digestive problems such as slow digestion (indigestion/heartburn), flatulence
• liver function disorder, increased blood substance levels (bilirubin), jaundice (cholestatic jaundice)
• itching, hives
• joint pain in adults
• renal function impairment, renal failure
• muscle and bone pain, feeling of discomfort (asthenia), fever, fluid retention
• increased blood alkaline phosphatase levels

Rare(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), (see section 2: Warnings and Precautions)
• increased blood sugar levels (hyperglycemia)
• decreased blood sugar levels (hypoglycemia) (see section 2: Warnings and Precautions)
• anxiety reactions, strange dreams, depression (which can lead to suicidal thoughts, attempted suicide, and completed suicide), mental disorders (psychotic reactions that can lead to suicidal thoughts, attempted suicide, and completed suicide) (see section 2: Warnings and Precautions)
• decreased skin sensitivity, tremors, migraine, disorders of the sense of smell
• ringing in the ears (tinnitus), hearing impairment
• fainting, inflammation of blood vessels (vasculitis)
• difficulty breathing, including asthma-like symptoms
• pancreatitis
• hepatitis, liver cell death (necrosis), which can very rarely lead to liver failure with a risk of death (see section 2: Warnings and Precautions)
• sensitivity to light (see section 2: Warnings and Precautions), non-specific blistering, small bleeding spots under the skin (petechiae)
• blood or crystals in the urine, inflammation of the urinary tract
• excessive sweating
• increased amylase enzyme levels

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

• a special type of decreased blood cell count (hemolytic anemia), a dangerous decrease in a type of white blood cell (agranulocytosis) (see section 2: Warnings and Precautions)
• severe allergic reactions with a risk of death (serum sickness) (see section 2: Warnings and Precautions)
• coordination disorder, instability when walking (gait disorders), pressure in the brain (intracranial pressure and pseudotumor cerebri)
• visual color distortions
• various skin rashes or exanthems
• worsening of myasthenia gravis symptoms (see section 2: Warnings and Precautions)

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

• Syndrome associated with deficient water secretion and low sodium levels (SIADH)
• feeling very excited (mania) or feeling very optimistic and hyperactive (hypomania)
• abnormally fast heart rhythm, irregular and potentially fatal heart rhythm, heart rhythm disorder (known as "prolonged 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 severely low blood sugar levels (hypoglycemic coma). See section 2: Warnings and Precautions.

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, difficulty walking, abnormal sensations such as pinching, tingling, burning, numbness, or pain (neuropathy), depression, fatigue, sleep disorders, decreased memory, and decreased hearing, vision, taste, and smell, in some cases regardless of the presence 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 insufficiency in patients who have received fluoroquinolones. See also section 2

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse 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 adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Ciprofloxacino Kern Pharma

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 medicine is cooled too much. If you notice crystals in your medication, do not use it and inform your doctor, nurse, or pharmacist immediately.

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

Bottles with outer wrapping:Keep the bottles in the outer bag to protect them from light. Use immediately once the bag is removed (see section 6.3).

Bottles without outer wrappingshould 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 bottle and/or bag and use the medicine immediately. It 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 medicines that can 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 sewage system or in the trash. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This will help protect the environment.

6. Additional Information

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 ingredients are lactic acid, sodium chloride, hydrochloric acid (for pH adjustment), and water for injectables.

Appearance of Ciprofloxacino Kern Pharma and Packaging Contents

Infusion solution.

This means that it is ready to be administered to you 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 your medicine.

Bags:

• The 100 ml bags come in cardboard boxes of 10.
• The 200 ml bags come in cardboard 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 cardboard boxes. It is available in packs of 10 or 20 bottles.

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

Alternatively:

The 200 ml bottles are placed in cardboard boxes. It is available in packs of 10 or 20 bottles.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Kern Pharma, S.L.

Venus 72, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturer

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

This medicine is authorized in the Member States of the European Economic Area under the following names:

Ireland: Ciprofloxacin 2 mg/ml Solution for Infusion

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

Greece: Ciprofloxacin/Noridem, Δίλυμα για έγχυση 2 mg/ml

Austria: Ciprofloxacin Noridem 2 mg/ml Infusionslösung

Germany: Ciprofloxacin 2mg/ml Infusionslösung

Date of Last Revision of this Leaflet:January 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://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. Even you can help bacteria become more resistant and, therefore, delay your recovery or reduce the effectiveness of antibiotics if you do not respect:

• the dose
• the program
• the duration of treatment

Consequently, to maintain the effectiveness of this medicine:

1. Use antibiotics only when prescribed.
2. Follow the prescription strictly.
3. Never 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 medicines to the pharmacy, to ensure they are disposed of correctly.

The following information is intended only for 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. Slow infusion into a large vein will minimize patient discomfort and reduce the risk of venous irritation. The infusion solution can be infused directly or after mixing with another compatible infusion solution.

Unless compatibility with other infusion solutions or medicines 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 medicines 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: 3.9 to 4.5).

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