Leaflet: information for the user

Ciprofloxacino Normon 500 mg film-coated tablets EFG

Read this leaflet carefully before you start taking 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 only, and you must not give it to others even if they have the same symptoms as you, 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 Ciprofloxacino Normon is and what it is used for

2. What you need to know before taking Ciprofloxacino Normon

3. How to take Ciprofloxacino Normon

4. Possible side effects

5. Storage of Ciprofloxacino Normon

6. Contents of the pack and additional information

Ciprofloxacino Normon is an antibiotic that belongs to the family of fluoroquinolones. The active ingredient is ciprofloxacin. It acts by eliminating the bacteria that cause infections. It only acts on specific strains of bacteria.

Adults

Ciprofloxacino 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
• male and female genital tract infections,
• gastrointestinal and intrabdominal infections,
• skin and soft tissue infections,
• bone and joint infections,
• prevention of infections caused by the bacteriaNeisseria meningitidis,
• exposure to anthrax by inhalation.

Ciprofloxacin may be used to treat patients with low white blood cell counts (neutropenia) who have suspected bacterial fever.

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 Ciprofloxacino Normon.

Children and adolescents

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

• respiratory and bronchial infections in children and adolescents with cystic fibrosis,
• complicated urinary tract infections, including kidney infections (pyelonephritis),
• exposure to anthrax by inhalation.

This medication may also be used to treat severe infections in children and adolescents when necessary.

Do not takeCiprofloxacino Normon

• if you are allergic (hypersensitive) to the active ingredient, to other quinolones or to any of the other components of this medicine (see section 6),

• if you are taking tizanidine (see section 2: Use of other medicines).

Warnings and precautions

Before starting to take this medicine

You should not take antibacterial medicines that contain fluoroquinolones or quinolones, including Ciprofloxacino Normon, 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.

Consult your doctor before starting to takeCiprofloxacino Normon

• if you have ever had kidney problems because your treatment needs to be adjusted,
• if you suffer from epilepsy or other neurological conditions,
• if you have a history of tendon problems during previous treatment with antibiotics such as Ciprofloxacino Normon,
• if you suffer from myasthenia gravis (a type of muscle weakness),
• if you have heart problems. You should be cautious when ciprofloxacin is administered if you were born or have a family history of prolonged QT interval (seen on the ECG, heart electrical recording), have electrolyte imbalance in the blood (especially low levels of potassium and magnesium in the blood), have a very slow heart rate (known as bradycardia), have a delicate heart (cardiac arrest), have a history of heart attacks (myocardial infarction), you are a woman or an elderly person or are taking other medicines that result in abnormal ECG changes (see section 2 Use of other medicines).
• if you have been diagnosed with an enlarged or a "bulge" of a large blood vessel (aortic aneurysm or aneurysm of a large peripheral vessel).
• if you have had a previous episode of aortic dissection (tear in the wall of the aorta).
• if you have been diagnosed with heart valve insufficiency (regurgitation of heart valves).
• if 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, known atherosclerosis, rheumatoid arthritis (a joint disease) or endocarditis (a heart infection)).

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, please consult your doctor.

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

During treatment with this medicine

Inform your doctor immediately if any of the following situations occur. Your doctor will decide if treatment should be stopped.

• 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 experiencing dizziness when standing up.Do not take more Ciprofloxacino Normonand contact your doctor immediately.

• Severe, incapacitating, prolonged, and potentially irreversible adverse effects.Ciprofloxacin has 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 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 not with the treatment, also considering the use of another class of antibiotic.

• In rare cases, you may experiencejoint pain and swelling, and inflammation or rupture of 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 taking corticosteroids. Tendon inflammation and rupture can occur in the first 48 hours of treatment and even several months after stopping ciprofloxacin treatment. If you experience any pain or inflammation of a tendon (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 a sudden and severe pain in the abdomen or back, which may be symptoms of aortic dissection or aneurysm, go to the emergency room immediately. 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 if you experience palpitations (rapid or irregular heartbeat), you should inform your doctor immediately.

• If you suffer fromepilepsyor otherneurological conditions, such as ischemia or cerebral infarction, you may experience adverse effects associated with the central nervous system. If this occurs, stop taking this medicine and contact your doctor immediately.

• In rare cases, you may experience symptoms ofnerve damage (neuropathy)such as pain, burning, numbness, tingling, and/or weakness, especially in your 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.

• You may experiencepsychiatric reactionsfor the first time when taking this medicine. If you suffer from depression or psychosis, your symptoms may worsen with treatment with this medicine. In rare cases, depression or psychosis may progress to suicidal thoughts, attempts, or completed suicide. If this occurs, stop taking this medicine and contact your doctor immediately.

• Quinolone antibiotics 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 important for people with diabetes. If you have diabetes, your blood sugar levels should be carefully controlled.

• You may developdiarrheawhile taking antibiotics, including this medicine, or even several weeks after stopping them. If diarrhea becomes intense or persistent, or if you notice that your stools contain blood or mucus, stop taking this medicine immediately, as this can put your life at risk. Do not take medications that slow down or delay bowel movements and consult your doctor.

• While taking this medicine, inform your doctor or laboratory personnel if you need to undergo ablood or urine test.

• This medicine may causeliver damage. If you notice symptoms such as loss of appetite, jaundice (yellowish skin), dark urine, itching, or stomach pain, stop taking this medicine immediately and consult your doctor immediately.

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

• This medicine may cause a decrease in the number of white blood cells and mayreduce 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, you should consult your doctor immediately. A blood test will be performed to examine the possible decrease in white blood cells (agranulocytosis). It is essential that you inform your doctor about your medicine.

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

• Your skin becomes moresensitive to sunlight or ultraviolet (UV) lightwhen taking this medicine. Avoid exposure to intense sunlight or artificial ultraviolet light, such as tanning beds.

Use of Ciprofloxacino Normon with other medicines

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

Do not takeCiprofloxacino Normonat the same time as tizanidine, as this may cause adverse effects, such as low blood pressure and drowsiness (see section 2: Do not take Ciprofloxacino Normon).

The following medicines are known to interact with this medicine in your body. If you take this medicine at the same time as these medicines, this may affect the therapeutic effect of these medicines. It may also increase the likelihood of adverse effects.

Inform your doctor if you are taking

• anticoagulants (e.g., warfarin) or other oral anticoagulants (to thin the blood),
• probencid (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),
• olanzapine (an antipsychotic),
• ropinirole (for Parkinson's disease),
• phenytoin (for epilepsy),
• metoclopramide (for nausea and vomiting),
• ciclosporin (for skin diseases, rheumatoid arthritis, and organ transplants),
• other medicines that may alter your heart rhythm: antiarrhythmic medicines (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (which belong to the macrolide group), some antipsychotics.

This medicine mayincreasethe levels in the blood of the following medicines:

• pentoxifylline (for circulatory disorders),
• caffeine,
• duloxetine (for depression, diabetic neuropathy, or incontinence),
• lidocaine (for heart disease or anesthetic use),
• sildenafil (e.g., for erectile dysfunction).

Some medicinesreducethe effect of this medicine. Inform your doctor if you are taking or wish to take:

• antacids,
• omeprazole,
• mineral supplements,
• sucralfate,
• a polymeric phosphate chelator (e.g., sevelamer),
• medicines or supplements containing calcium, magnesium, aluminum, or iron

If these preparations are essential, take this medicine approximatelytwohours before orfour hours afteryou have taken these preparations.

Taking Ciprofloxacino Normon with food and drinks

Although you take this medicine with meals, you should not eat or drink any dairy products (such as milk or yogurt) or beverages with added calcium when taking the tablets, as they may affect the absorption of the active ingredient.

Pregnancy and breastfeeding

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

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

Driving and operating machinery

This medicine may reduce your alertness. You may experience some neurological effects. Therefore, make sure you know how you react to this medicine before driving a vehicle or operating a machine. If in doubt, consult your doctor.

Ciprofloxacino Normon contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

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

Your doctor will explain exactly how much of this medication you should take, 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 it may be necessary to adjust your dose.

The treatment usually lasts from5 to21 days, but may last longer for severe infections. Take the tablets exactly as your doctor has instructed. If you have doubts about how many tablets of Ciprofloxacino Normon to take and how to take them, ask your doctor or pharmacist how many tablets you should take and how to take them.

a. Swallow the tablets with a large amount of liquid. Do not chew the tablets because their taste is not pleasant.

b. Try to take the tablets at the same time every day.

c. You can take the tablets with or between meals. The calcium you take as part of a meal will not seriously affect the absorption of the medication. However,do nottake the Ciprofloxacino Normon tablets with dairy products such as milk or yogurt, or with fruit juices enriched with minerals (for example, orange juice enriched with calcium).

Remember to drink a large amount of liquids while taking this medication.

If you take moreCiprofloxacino Normonthan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to takeCiprofloxacino Normon

Take the normal dose as soon as possible and, afterwards, continue the treatment as prescribed. However, if it is almost time for your next dose, do not take the missed dose and continue as usual. Do not take a double dose to compensate for the missed doses.

Make sure to complete the treatment cycle.

If you interrupt the treatment withCiprofloxacino Normon

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

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

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

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

• nausea, diarrhea,
• joint pain in children.

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

• superficial fungal infections,
• an elevated concentration of eosinophils, a type of white blood cell,
• loss of appetite (anorexia),
• hyperactivity or agitation,
• headache, dizziness, sleep problems or taste disturbances,
• vomiting, abdominal pain, digestive problems such as slow digestion (indigestion/acid reflux) or flatulence,
• an increase in certain substances in the blood (transaminases and/or bilirubin),
• skin rash, itching or hives,
• joint pain in adults,
• renal function impairment,
• muscle and bone pain, feeling unwell (asthenia) or fever,
• an increase in alkaline phosphatase in the blood (a blood substance).

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

• inflammation of the intestine (colitis) associated with the use of antibiotics (may be fatal in rare cases) (see section 2: Be careful with Ciprofloxacino Normon),
• changes in blood cell count (leucopenia, leucocytosis, neutropenia, anemia), increase or decrease in the amounts of blood clotting factor (thrombocytes),
• allergic reaction, swelling (edema) or rapid swelling of the skin and mucous membranes (angioedema),
• increased blood sugar (hyperglycemia),
• confusion, disorientation, anxiety reactions, strange dreams, depression (potentially leading to suicidal thoughts, attempts, or completed suicides) or hallucinations,
• tingling and numbness, unusual sensitivity to sensory stimuli, decreased skin sensitivity, tremors, convulsions (see section 2: Be careful with Ciprofloxacino Normon) or dizziness,
• vision problems (including double vision),
• tinnitus (ringing in the ears), hearing loss, hearing deterioration,
• increased heart rate (tachycardia),
• vasodilation, decreased blood pressure or fainting,
• difficulty breathing, including asthma-like symptoms,
• liver problems, jaundice (icterus colestático), hepatitis,
• light sensitivity (see section 2: Be careful with Ciprofloxacino Normon),
• muscle pain, joint inflammation, increased muscle tone or cramps,
• renal insufficiency, blood or crystals in the urine (see section 2: Be careful with Ciprofloxacino Normon), urinary tract inflammation,
• fluid retention or excessive sweating,
• an increase in amylase enzyme concentrations,

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

• a special type of decrease in blood cell count (hemolytic anemia), a dangerous decrease in a type of white blood cell (agranulocytosis), a decrease in the amount of white and red blood cells and platelets (pancytopenia), with a risk of death, and bone marrow depression, also with a risk of death (see section 2: Be careful with Ciprofloxacino Normon),
• severe allergic reactions (anaphylactic reaction or anaphylactic shock, with a risk of death - serum disease) (see section 2: Be careful with Ciprofloxacino Normon)
• mental disorders (psychotic reactions potentially leading to suicidal thoughts, attempts, or completed suicides) (see section 2: Be careful with Ciprofloxacino Normon),
• migraine, coordination disorder, gait instability (gait disorders), olfactory disorders; increased intracranial pressure,
• color vision distortions,
• inflammation of the blood vessel wall (vasculitis),
• pancreatitis,
• liver cell death (hepatic necrosis), which very rarely leads to liver insufficiency with a risk of death,
• small pinpoint hemorrhages under the skin (petechiae), various skin eruptions or exanthems (e.g., Stevens-Johnson syndrome with a risk of death or toxic epidermal necrolysis),
• muscle weakness, tendon inflammation, tendon rupture – especially of the long posterior tendon of the ankle (Achilles tendon) (see section 2: Be careful with Ciprofloxacino Normon), 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, tingling, numbness, and/or weakness in the extremities,
• abnormal heart rhythm, irregular heart rhythm with a risk to life, alteration of heart rhythm (called "prolongation of the QT interval", observed in ECG, heart activity),
• pustular rash,
• influence on blood coagulation (in patients treated with vitamin K antagonists), syndrome associated with deficient water secretion and low sodium concentrations (SIADH, in English),
• 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 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, itching, 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 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 or pharmacist, 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 Pharmacovigilance of Medicines for Human Use 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.

No special storage conditions are required.

Do not use this medication 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 in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofCiprofloxacino Normon

- The active ingredient is ciprofloxacin. Each tablet contains 500 mg of ciprofloxacin (hydrochloride).

- The other components (excipients) are: microcrystalline cellulose, sodium carboxymethyl starch (type A) (potato), povidone, magnesium stearate, talc, titanium dioxide (E-171), macrogol 6000, copolymer of ammonium methacrylate type A and propylene glycol (E-1520).

Appearance of the product and contents of the package

Coated tablets, white or slightly cream-colored, elongated, biconvex, and scored on one side.

Each package contains 1 and 14 tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

LABORATORIOS NORMON, S.A.

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

Last review date of this leaflet: December 2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

You can access detailed and updated information on this medicine 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/62300/P_62300.html.

Advice / medical education

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

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

Even with 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 delay your recovery or reduce the effectiveness of antibiotics if you do not respect:

- the dose,

- the program,

- the duration of treatment.

As a result, in order to maintain the effectiveness of this medicine:

1. 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 someone else; 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.