Leaflet: information for the user

Ciprofloxacino Normon 2 mg/ml solution for infusion EFG

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 or pharmacist.
• This medicine has been prescribed for you and should not be given 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.

3. How to use Ciprofloxacino Normon

4. Possible side effects

5. Storage of Ciprofloxacino Normon

6. Contents of the pack and additional information

Ciprofloxacin is an antibiotic that belongs to the family of fluoroquinolones.

The active ingredient is ciprofloxacin. Ciprofloxacin acts by eliminating the bacteria that cause infections. It only acts on specific strains of bacteria.

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 tract 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).
• Exposure to carbuncle by inhalation.

In cases of severe infection or infection caused by multiple types of bacteria, it is possible that additional antibiotic treatment will be administered 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:

• Pulmonary and bronchial infections in children and adolescents with cystic fibrosis.
• Complicated urinary tract infections, including kidney infections (pyelonephritis).
• Exposure to carbuncle by inhalation.

Ciprofloxacin Normon may also be used for the treatment of severe infections in children and adolescents when necessary.

Do not use Ciprofloxacino Normon

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

Warnings and precautions

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

Do not take antibacterial medicines 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 must inform your doctor as soon as possible.

Inform your doctor if:

• You have ever 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 such as 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 enlarged or "bulge" of a large blood vessel (aortic aneurysm or large peripheral artery aneurysm).
• You have had a previous episode of aortic dissection (tear in the aorta wall).
• You have been diagnosed with heart valve insufficiency (regurgitation of heart valves).
• You have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease or other risk factors or predisposing conditions (e.g. 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 known atherosclerosis, rheumatoid arthritis (a joint disease) or endocarditis (a heart infection)).

While takingCiprofloxacino Normon

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

• Severe and sudden allergic reaction (anaphylactic reaction, 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 treatment with Ciprofloxacino Normon must be stopped.

• In rare cases, 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 taking corticosteroids. Tendon inflammation and rupture can occur in the first 48 hours of treatment and even several months after stopping treatment with ciprofloxacin. At the first sign of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder or knee), stop taking ciprofloxacin, contact your doctor and keep the painful area at rest. Avoid any unnecessary exercise, as this may increase the risk of tendon rupture.

• If you experience severe and sudden abdominal or back pain that may be symptoms of aortic dissection or aneurysm, go to an emergency service immediately.This risk may be increased if you are receiving systemic corticosteroids.

• If you start to experience sudden onset of shortness of breath, especially when lying down, or if you notice swelling in the ankles, feet or abdomen or the onset of palpitations (sensation of rapid or irregular heartbeat), inform your doctor immediately.

• If you suffer from epilepsy or other neurological conditions, you may experience adverse effects associated with the central nervous system. If this occurs, stop taking Ciprofloxacino 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 Ciprofloxacino Normon. If this occurs, stop taking Ciprofloxacino Normon and contact your doctor immediately.

• In rare cases, 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 occurs, stop taking ciprofloxacin and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

• Diarrhea may occur during the use of antibiotics, including Ciprofloxacino Normon, 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. Treatment with Ciprofloxacino Normon must be stopped immediately, as it may put your life at risk. Do not take medications that slow down or delay bowel movements.

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

• Inform your doctor or laboratory staff if you are taking Ciprofloxacino Normon when you have to undergo blood or urine tests.

• Ciprofloxacino Normon may cause liver damage. If you notice symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching or stomach pain, stop taking Ciprofloxacino Normon immediately.

• Ciprofloxacino Normon may cause a decrease in white blood cell count and possibly decrease your resistance to infections. If you suffer from 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.

• 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 Ciprofloxacino Normon. Avoid exposure to intense sunlight or artificial ultraviolet light, such as sunbeds.

• Quinolone antibiotics may cause an increase in your blood sugar level above normal levels (hyperglycemia), or a decrease in your blood sugar level below normal levels, which in severe cases may 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 level must be carefully controlled.

Severe, prolonged and potentially irreversible adverse effects

Fluoroquinolone or quinolone-containing antibacterial medicines, 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 pain in the tendons, muscles and joints of the upper and lower limbs, 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 stop treatment, considering the use of another class of antibiotic.

Other medicines and Ciprofloxacino Normon

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

Do not use Ciprofloxacino Normon 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 Normon”).

We know that the following medicines interact with Ciprofloxacino Normon in your body. If you take Ciprofloxacino Normon at the same time as these medicines, this may affect the therapeutic effect of these medicines. It may also increase the risk of 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)

Ciprofloxacino Normon mayincreasethe levels of the following medicines in the blood:

• pentoxifylline (for circulatory disorders)
• caffeine

TakingCiprofloxacinoNormon with food and drinks

Foods and drinks do not affect your treatment with Ciprofloxacino Normon.

Pregnancy and breastfeeding

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

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

Driving and operating machines

Ciprofloxacino Normon may reduce your alertness. Some neurological effects may occur. Therefore, make sure you know how you react to Ciprofloxacino Normon before driving a vehicle or operating a machine. If in doubt, consult your doctor.

CiprofloxacinoNormon contains sodium

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

Follow exactly the administration instructions for 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, 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, via 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 Normon, and 30 minutes for 200 mg of Ciprofloxacino Normon. The slow administration of the infusion prevents immediate adverse reactions.

Remember to drink an abundant amount of liquids while taking Ciprofloxacino Normon.

If you interrupt treatment withCiprofloxacinoNormon

It is essential thatyou complete the 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, Ciprofloxacino Normon may cause side effects, although not everyone will experience them.

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Frequent side effects(it is likely that they will occur in 1 to 10 people in every 100):

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

Less frequent side effects(it is likely that they will occur in 1 to 10 people in every 1,000):

• mycotic superinfections (infections caused by fungi)
• high eosinophil count, a type of white blood cell, increased or decreased blood clotting factor (thrombocytes)
• loss of appetite (anorexia)
• hyperactivity, agitation, confusion, disorientation, hallucinations
• headache, dizziness, sleep problems or taste disturbances, paresthesia, and abnormal sensitivity to sensory stimuli, seizures (see section 2: Be careful with Ciprofloxacino Normon)
• vision problems
• hearing loss
• increased heart rate (tachycardia)
• vasodilation, decreased blood pressure
• abdominal pain, digestive problems such as slow digestion (indigestion/acid reflux), flatulence
• liver function alteration, increased bilirubin levels, jaundice (cholestatic icterus)
• itching, rashes
• joint pain in adults
• renal function impairment, renal insufficiency
• muscle and bone pain, feeling unwell (asthenia), fever, fluid retention

-increased alkaline phosphatase levels in the blood (a blood substance)

Rare side effects(it is likely that they will occur in 1 to 10 people in every 10,000):

• inflammation of the intestine (colitis) associated with antibiotic use (may be fatal in rare cases) (see section 2: Be careful with Ciprofloxacino Normon)
• changes in blood cell count (leucopenia, leucocytosis, neutropenia, anemia), decreased platelet count (pancytopenia) that may be life-threatening, bone marrow depression that may be life-threatening (see section 2: Be careful with Ciprofloxacino Normon)
• allergic reaction, swelling (edema) or rapid skin and mucous membrane swelling

• (angioedema), severe allergic reaction (anaphylactic shock) with risk of death (see section 2: Be careful with Ciprofloxacino Normon)
• increased blood sugar levels (hyperglycemia)
• anxiety reactions, strange dreams, depression, mental alterations (psychotic reactions) (see section 2: Be careful with Ciprofloxacino Normon)
• decreased skin sensitivity, tremors, migraine, olfactory disturbances
• tinnitus, (ringing in the ears) hearing deterioration
• syncope, inflammation of blood vessels (vasculitis)
• breathing difficulties, including asthma-like symptoms
• pancreatitis
• hepatitis, liver cell death (necrosis hepática), which very rarely leads to liver insufficiency with risk of death
• light sensitivity (see section 2: Be careful with Ciprofloxacino Normon), non-specific blister formation, small hemorrhages under the skin (petechiae)
• muscle pain, joint inflammation, increased muscle tone, cramps, tendon rupture – especially the Achilles tendon (see section 2: Be careful with Ciprofloxacino Normon)
• blood or crystals in the urine, (see section 2: Be careful with Ciprofloxacino Normon), urinary tract inflammation
• excessive sweating
• abnormal levels of coagulation factor (protrombina) or increased amylase enzyme concentrations

Very rare side effects(it is likely that they will occur in less than 1 person in every 10,000):

-a special type of anemia (hemolytic anemia), a dangerous decrease in a type of white blood cell (agranulocytosis)

-severe allergic reactions with risk of death (anaphylactic reaction or anaphylactic shock, serum sickness) that may be life-threatening (see section 2: Be careful with Ciprofloxacino Normon)

-coordination disorder, gait instability (gait disturbances), increased intracranial pressure

-color vision disturbances

-various skin eruptions 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: Be careful with Ciprofloxacino Normon)

Unknown frequency(cannot be estimated from available data)

• problems associated with the nervous system such as pain, burning, numbness, tingling, and/or weakness in the limbs
• serious cardiac rhythm disorders, irregular heart rhythm (Torsades de Pointes)
• syndrome associated with deficient water secretion and low sodium concentrations (SIADH, in English)
• loss of consciousness due to severe hypoglycemia (coma hypoglycémico). See section 2.

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) such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pinching, tingling, burning, numbness, or pain (neuropathy), fatigue, memory and concentration impairment, mental health problems (such as, for example, sleep disorders, anxiety, panic attacks, depression, and suicidal thoughts) and hearing, vision, taste, and smell impairment, in some cases regardless of the presence of pre-existing risk factors.

Cases of increased aortic 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 not mentioned in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Bags:Store below30°C. Store in the original packaging to protect it from light. Do not freeze or refrigerate.

Since ciprofloxacino is sensitive to light, only remove the overwrap from the bag immediately before administration.

Discard if any alterations are observed in the packaging or 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.

Medications should not be disposed of through drains or trash.Deposit the containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need.This will help protect the environment.

Ciprofloxacino Normon Composition

The active ingredient 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 contents of the package

Infusion solution

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

It is presented in plastic bags of 100 and 200 ml.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

This leaflet 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.

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

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

1. Consequently, in order to maintain the effectiveness of this medication:Use antibiotics only when prescribed.
2. Follow the prescription strictly.
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 another person; 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 Normon 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 Normon, and 30 minutes for 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 infused 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 be administered separately. Visual signs of incompatibility, such as precipitation, turbidity, and color change, may occur.

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 prepared, the solution should be used within 24 hours.

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

For detailed and updated information on this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) at http://www.aemps.gob.es.

You can access detailed and updated information on this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/62646/P_62646.html.