CIPROFLOXACIN NORMON 2 mg/ml SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Ciprofloxacin Normon 2 mg/ml Solution for Infusion EFG

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 Normon is and what it is used for
2. What you need to know before you use Ciprofloxacin Normon

1. How to use Ciprofloxacin Normon
2. Possible side effects
3. Storage of Ciprofloxacin Normon
4. Contents of the pack and other information

1. What Ciprofloxacin Normon is and what it is used for

Ciprofloxacin is an antibiotic that belongs to the fluoroquinolone family.

The active substance is ciprofloxacin. 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 flu or common cold.

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

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

Adults

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

• Respiratory tract infections.
• Long-term or recurrent ear or sinus infections.
• Urinary tract infections.
• Testicular infections.
• Female genital organ infections.
• Gastrointestinal and intra-abdominal infections.
• Skin and soft tissue infections.
• Bone and joint infections.
• Treatment of infections in patients with a very low white blood cell count (neutropenia).
• Prevention of infections in patients with a very low white blood cell count (neutropenia).
• Inhalation exposure to anthrax.

In case you suffer from 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 Normon.

Children and Adolescents

Ciprofloxacin Normon 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 have reached the kidneys (pyelonephritis).
• Inhalation exposure to anthrax.

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

2. What you need to know before you use Ciprofloxacin Normon

Do not use Ciprofloxacin Normon

• 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: Use of other medications).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Ciprofloxacin Normon.

Do 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.

Inform your doctor if:

• You have had kidney problems because your treatment needs 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.
• You suffer from myasthenia gravis (a type of muscle weakness).
• You have a history of abnormal heart rhythms (arrhythmias).
• You have been diagnosed with an aneurysm of a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm).
• You have had a previous episode of aortic dissection (tear in the aortic wall).
• 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 disorders (e.g., connective tissue disorders such as Marfan syndrome or 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, or atherosclerosis known rheumatoid arthritis (a joint disease) or endocarditis (a heart infection)).

While being treated with Ciprofloxacin Normon

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

• 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 Normon should be discontinued.

• Rarely, pain and swelling in the joints and inflammation or rupture of tendons may occur. The risk is higher if you are an elderly person (over 60 years), have received an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even several months after stopping treatment with ciprofloxacin. 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 severe and sudden pain in the abdomen or back that may be symptoms of aortic dissection or aneurysm, go immediately to the emergency room. The risk may increase if you are receiving systemic corticosteroid treatment.

• If you start experiencing sudden shortness of breath, especially when lying down, or if you notice swelling in the 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 this occurs, stop taking Ciprofloxacin Normon and contact your doctor immediately.

• You may experience psychiatric reactions after the first administration of ciprofloxacin. If you suffer from depression or psychosis, your symptoms may worsen with treatment with Ciprofloxacin Normon. If this occurs, stop taking Ciprofloxacin Normon 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 the feet and legs or hands and arms. If this happens, stop taking ciprofloxacin and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

• Diarrhea may develop during the use of antibiotics, including Ciprofloxacin Normon, or even several weeks after stopping their use. If it becomes intense or persistent, or if you notice that the stools contain blood or mucus, inform your doctor immediately. Treatment with Ciprofloxacin Normon should be discontinued immediately, as it can be life-threatening. Do not take medications that stop or slow down bowel movements.

• Consult an ophthalmologist immediately if you experience any vision changes or have any eye problems.

• While taking Ciprofloxacin Normon, inform your doctor or laboratory personnel if you need to undergo a blood or urine test.

• Ciprofloxacin Normon 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 Normon immediately.

• Ciprofloxacin Normon can cause a decrease in the 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.

• Inform your doctor if you or a family member has a proven deficiency of glucose-6-phosphate dehydrogenase (G6PD), as you may be at risk of anemia with ciprofloxacin.

• Your skin becomes more sensitive to sunlight or ultraviolet (UV) light during treatment with Ciprofloxacin Normon. Avoid exposure to intense sunlight or artificial UV light, such as tanning beds.

• Quinolone antibiotics may 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.

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

Antibacterial 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, tickling, numbness, or burning (paresthesia), sensory disorders such as decreased vision, taste, smell, or 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 not, considering the use of an antibiotic from another class.

Other medications and Ciprofloxacin Normon

Inform your doctor or pharmacist if you are taking or have recently taken any other medications, including those purchased without a prescription.

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

It is known that the following medications interact with Ciprofloxacin Normon in your body. If you take Ciprofloxacin Normon 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.

Inform your doctor if you are taking:

• warfarin 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)
• clozapine (an antipsychotic)
• ropinirole (for Parkinson's disease)
• phenytoin (for epilepsy)

Ciprofloxacin Normon may increase blood levels of the following medications:

• pentoxifylline (for circulatory disorders)
• caffeine

Taking Ciprofloxacin Normon with food and drinks

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

Pregnancy and breastfeeding

It is preferable to avoid using Ciprofloxacin Normon during pregnancy. Inform your doctor if you plan to become pregnant.

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

Driving and using machines

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

Ciprofloxacin Normon contains sodium

This medication contains 354 mg of sodium (main component of table/cooking salt) per 100 ml of solution. This is equivalent to 17.7% of the maximum recommended daily sodium intake for an adult.

3. How to use Ciprofloxacin Normon

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

Inform your doctor if you have kidney problems because 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 Normon and 30 minutes for 200 mg of Ciprofloxacin Normon. The slow administration of the infusion prevents immediate adverse reactions.

Remember to drink plenty of fluids while taking Ciprofloxacin Normon.

If you interrupt treatment with Ciprofloxacin Normon

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, Ciprofloxacino Normon can cause adverse effects, although not all people will suffer from them.

If you consider that any of the adverse effects you are suffering from is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Frequent Adverse Effects(it is likely that they will affect between 1 and 10 out of every 100 people):

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

Infrequent Adverse Effects(it is likely that they will affect between 1 and 10 out of every 1,000 people):

• fungal superinfections (infections caused by fungi)
• high levels of eosinophils, a type of white blood cell, increase or decrease in a blood coagulation factor (thrombocytes)
• loss of appetite (anorexia)
• hyperactivity, agitation, confusion, disorientation, hallucinations
• headache, dizziness, sleep problems or taste disorders, tingling and numbness, unusual sensitivity to sensory stimuli, convulsions (see section 2: Take special care with Ciprofloxacino Normon), dizziness, vertigo.
• vision problems
• hearing loss
• increased heart rate (tachycardia)
• expansion of blood vessels (vasodilation), decrease in blood pressure
• abdominal pain, digestive problems such as slow digestion (indigestion/heartburn), flatulence
• liver function alteration, increase in 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

• increase in blood alkaline phosphatase levels (a blood-determined substance)

Rare Adverse Effects(it is likely that they will affect between 1 and 10 out of every 10,000 people):

• inflammation of the intestine (colitis) related to the use of antibiotics (can be fatal in very rare cases) (see section 2: Take special care with Ciprofloxacino Normon)
• changes in blood cell count (leukopenia, leukocytosis, neutropenia, anemia), decrease in the number of red and white blood cells and platelets (pancytopenia) that can be life-threatening, bone marrow depression that can be life-threatening to the patient (see section 2: Take special care with Ciprofloxacino Normon)
• allergic reaction, swelling (edema) or rapid swelling of the skin and mucous membranes

• (angioedema), severe allergic reaction (anaphylactic shock) with risk of death (see section 2: Take special care with Ciprofloxacino Normon)
• increase in blood sugar levels (hyperglycemia)
• anxiety reactions, strange dreams, depression, mental disorders (psychotic reactions) (see section 2: Take special care with Ciprofloxacino Normon)
• decreased skin sensitivity, tremors, migraine, disorders of the sense of smell
• tinnitus, (ringing in the ears) hearing impairment
• fainting, inflammation of blood vessels (vasculitis)
• difficulty breathing, including asthmatic symptoms
• pancreatitis
• hepatitis, liver cell death (hepatic necrosis), which very rarely leads to liver failure with risk of death
• sensitivity to light (see section 2: Take special care with Ciprofloxacino Normon), non-specific blistering, small bleeding points under the skin (petechiae)
• muscle pain, joint inflammation, increased muscle tone, cramps, tendon rupture – especially the long tendon in the back of the ankle (Achilles tendon) (see section 2: Take special care with Ciprofloxacino Normon)
• blood or crystals in the urine, (see section 2: Take special care with Ciprofloxacino Normon), inflammation of the urinary tract
• excessive sweating
• abnormal levels of the coagulation factor (prothrombin) or increased concentrations of the amylase enzyme

Very Rare Adverse Effects(it is likely that they will affect less than one in every 10,000 people):

• a special type of decrease in blood cell count (hemolytic anemia), a dangerous decrease in a type of white blood cell in the blood (agranulocytosis)
• severe allergic reactions with risk of death (anaphylactic reaction or anaphylactic shock, serum sickness) can be life-threatening (see section 2: Take special care with Ciprofloxacino Normon)
• coordination disorder, instability when walking (gait disorders), pressure in the brain (intracranial pressure)
• visual distortions of colors
• various skin rashes or exanthems (e.g., the potentially fatal Stevens-Johnson syndrome or toxic epidermal necrolysis)
• muscle weakness, tendon inflammation, worsening of myasthenia gravis symptoms (see section 2: Take special care with Ciprofloxacino Normon)

Unknown Frequency(cannot be estimated from the available data)

• nervous system problems such as pain, burning, tingling, numbness, and/or weakness in the limbs
• serious heart rhythm disorders, irregular heart rhythm (Torsades de Pointes)
• syndrome associated with deficient water secretion and low sodium concentrations (SIADH, by its English acronym).
• Loss of consciousness due to a severe decrease 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, difficulty walking, abnormal sensations such as pinching, tingling, prickling, burning, numbness, or pain (neuropathy), fatigue, decreased memory and concentration, mental health problems (such as sleep disorders, anxiety, panic attacks, depression, and suicidal thoughts) 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 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 prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Ciprofloxacino Normon

Keep this medicine out of sight and reach of children.

Bags:Store below 30°C. Store in the original packaging to protect it from light. Do not freeze or refrigerate.

Since ciprofloxacin is sensitive to light, the overwrap of the bag will only be removed immediately before administration.

Discard if alterations are observed in the container or in the liquid it contains.

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

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and unused medicines at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This way, you will help protect the environment.

6. Additional Information

Composition of Ciprofloxacino Normon

The active principle is ciprofloxacin.

Each 100 ml of solution contains 200 mg of ciprofloxacin as lactate.

Each 200 ml of solution contains 400 mg of ciprofloxacin as lactate.

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

Appearance of the Product and Container Contents

Infusion Solution

Ciprofloxacino Normon infusion solution is a clear, colorless or slightly yellowish solution.

It is presented in 100 and 200 ml plastic bags.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

This prospectus was approved in December 2020

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 decrease the effectiveness of antibiotics if you do not respect:

• the dose,
• the program
• the duration of treatment

1. Consequently, in order to maintain the effectiveness of this medicine:Use antibiotics only when they are 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 finishing a treatment, return all unused medicines to the pharmacy, to ensure they are disposed of correctly.

The following information is intended only for doctors or healthcare professionals

Ciprofloxacino Normon should be administered by intravenous infusion. In children, the infusion duration is 60 minutes. In adult patients, the infusion time is 60 minutes in the case of 400 mg of Ciprofloxacino Normon, and 30 minutes in the case of 200 mg of Ciprofloxacino Normon. 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 drugs has been confirmed, the infusion solution should be administered separately. Visual signs of incompatibility are, for example, precipitation, clouding, and color change.

Ciprofloxacino Normon 2 mg/ml infusion solution is compatible with physiological saline solution, Ringer's solution, 5 and 10% dextrose solution, glucosaline solution, and 10% fructose solution. Once the solution is prepared, it should be used within the next 24 hours.

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

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.

You can access detailed and updated information about this medicine by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/62646/P_62646.html.