CIPROFLOXACIN NORMON 250 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ciprofloxacin Normon 250 mg film-coated tablets EFG

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

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What Ciprofloxacin Normon is and what it is used for
2. What you need to know before you take Ciprofloxacin Normon
3. How to take Ciprofloxacin Normon
4. Possible side effects
5. Storage of Ciprofloxacin Normon
6. Contents of the pack and other information

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

Ciprofloxacin Normon is an antibiotic that belongs to the fluoroquinolone family. The active substance is ciprofloxacin. It works by killing the bacteria that cause infections. It only works with 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
• genital tract infections in men and women,
• gastrointestinal and intra-abdominal infections,
• skin and soft tissue infections,
• bone and joint infections,
• prevention of infections caused by the bacteria Neisseria meningitidis,
• inhalation exposure to anthrax.

Ciprofloxacin may be used in the treatment of patients with a low white blood cell count (neutropenia) who have fever 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 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 infections that have reached the kidneys (pyelonephritis),
• inhalation exposure to anthrax.

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

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

Do not takeCiprofloxacin Normon

• if you are allergic (hypersensitive) to the active substance, to other quinolones, or to any of the other ingredients of this medicine (see section 6),
• if you are taking tizanidine (see section 2: Use with other medicines).

Warnings and precautions

Before you start taking this medicine

You should not take antibacterial medicines that contain fluoroquinolones or quinolones, including Ciprofloxacin Normon, if you have experienced any severe side effects in the past when taking a quinolone or fluoroquinolone. If this is the case, you should inform your doctor as soon as possible.

Consult your doctor before you start takingCiprofloxacin Normon

• if you have ever had kidney problems because your treatment needs to be adjusted,
• if you suffer from epilepsy or other neurological disorders,
• if you have a history of tendon problems during previous treatment with antibiotics like Ciprofloxacin Normon,
• if you suffer from severe myasthenia (a type of muscle weakness),
• if you have heart problems. Caution should be exercised when administering ciprofloxacin if you were born with or have a family history of prolonged QT interval (seen on the ECG, electrical recording of the heart), have an electrolyte imbalance (especially low potassium and magnesium levels in the blood), have a very slow heart rate (known as bradycardia), have a fragile 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 with other medicines).
• if you have been diagnosed with an enlargement or a "bulge" of a large blood vessel (aortic aneurysm or large peripheral vessel aneurysm).
• if you have suffered a previous episode of aortic dissection (tear of the aortic wall).
• if you have been diagnosed with a heart valve defect (heart valve regurgitation).
• if you have a family history of aortic aneurysm or aortic dissection, congenital heart valve defects, 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, high blood pressure, 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 vision changes 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 whether it is necessary to interrupt treatment.

• 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, feeling of dizziness, nausea, or fainting, or experiencing dizziness when standing up. If this happens to you, do not take more Ciprofloxacin Normonand contact your doctor immediately.

• Severe, disabling, and potentially irreversible side effects.Antibacterial medicines that contain fluoroquinolones or quinolones, including ciprofloxacin, have been associated with very rare but severe side 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, burning, tingling, numbness, or burning, 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 side 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, you may experience pain and swelling 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 stopping treatment with ciprofloxacin. At the first sign of pain or tendon inflammation (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 severe pain in your abdomen or back, which can 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 your ankles, feet, or abdomen, or the appearance of heart palpitations (feeling of rapid or irregular heartbeat), you should inform your doctor immediately.

• If you suffer from epilepsyor other neurological disorders, such as cerebral ischemia or infarction, you may experience side 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 of nerve damage (neuropathy)such as pain, burning, tingling, numbness, 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 experience psychiatric reactionsthe first time you take this medicine. If you suffer from depression or psychosis, your symptoms may worsen with treatment with this medicine. In rare cases, depression or psychosis can progress to suicidal thoughts, suicide attempts, or completed suicide. If this happens, stop taking this medicine and contact your doctor immediately.

• 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.

• Diarrheamay develop while you are taking antibiotics, including this medicine, or even several weeks after you have stopped taking them. If the diarrhea becomes severe or persistent, or if you notice that the stool contains blood or mucus, stop taking this medicine immediately, as it can be life-threatening. Do not take medicines that stop or slow down bowel movements, and consult your doctor.

• While taking this medicine, inform your doctor or laboratory staff if you need to undergo a blood or urine test.

• This medicine 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 this medicine immediately and consult your doctor immediately.

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

• This medicine may cause a decrease in your 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, you should consult your doctor immediately. They will perform a blood test to examine the possible decrease in white blood cells (agranulocytosis). It is important that you inform your doctor about your medicine.

• 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) lightwhen taking this medicine. Avoid exposure to intense sunlight or artificial UV light, such as tanning booths.

Use of Ciprofloxacin Normon with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

It is known that the following medicines interact with this medicine in your body. If you take this medicine at the same time as these medicines, it may affect the therapeutic effect of these medicines. It may also increase the likelihood of you experiencing side effects.

Tell your doctor if you are taking

• vitamin K antagonists (e.g., 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),
• olanzapine (an antipsychotic),
• ropinirole (for Parkinson's disease),
• phenytoin (for epilepsy),
• metoclopramide (for nausea and vomiting),
• cyclosporine (for skin diseases, rheumatoid arthritis, and organ transplants),
• other medicines that may affect your heart rhythm: medicines 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.

This medicine may increasethe blood levels of the following medicines:

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

Some medicines decreasethe effect of this medicine. Inform your doctor if you are taking or plan to take:

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

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

Taking Ciprofloxacin Normon with food and drinks

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

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 in breast milk and may harm your baby.

Driving and using machines

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

Ciprofloxacin Normon contains sodium

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

3. How to take Ciprofloxacin Normon

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

Your doctor will explain exactly what amount 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 because it may be necessary to adjust your dose.

Treatment usually lasts from 5 to 21 days, but it can last longer for severe infections. Take the tablets exactly as your doctor has indicated. If you have doubts about how many Ciprofloxacino Normon tablets you should take and how you should take them, ask your doctor or pharmacist how many tablets you should take and how you should take them.

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

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

• 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 not take Ciprofloxacino Normon tablets with dairy products such as milk or yogurt, or with fruit juices enriched with minerals (e.g., calcium-enriched orange juice).

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 Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to takeCiprofloxacino Normon

Take your normal dose as soon as possible and then continue 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 make up for missed doses.

Make sure to complete the treatment cycle.

If you interrupt treatment withCiprofloxacino Normon

It is important that you complete the full treatment, even if you start to feel better after a few days. If you stop taking this medication too soon, your infection may not be completely cured and symptoms may worsen. You may develop resistance to the antibiotic.

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

4. Possible adverse effects

Like all medications, this medication can produce adverse effects, although not all people suffer from them.

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

• nausea, diarrhea,
• pain in the joints in children.

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

• fungal superinfections,
• a high concentration of eosinophils, a type of white blood cell,
• loss of appetite (anorexia),
• hyperactivity or agitation,
• headache, dizziness, sleep problems or taste disorders,
• vomiting, abdominal pain, digestive problems such as slow digestion (indigestion/heartburn) or flatulence,
• an increase in the amount of certain substances in the blood (transaminases and/or bilirubin),
• skin rash, itching or hives,
• pain in the joints in adults,
• renal impairment,
• pain in muscles and bones, feeling of discomfort (asthenia) or fever,
• an increase in blood alkaline phosphatase.

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

• inflammation of the intestine (colitis) associated with antibiotic use (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), increase or decrease in blood coagulation factor levels (thrombocytes),
• allergic reaction, swelling (edema) or rapid swelling of the skin and mucous membranes (angioedema),
• increase in blood sugar (hyperglycemia),
• confusion, disorientation, anxiety reactions, strange dreams, depression (potentially leading to suicidal thoughts, suicide attempts, or completed suicides) or hallucinations,
• tingling and numbness, unusual sensitivity to stimuli, decreased skin sensitivity, tremors, convulsions (see section 2: Take special care with Ciprofloxacino Normon) or dizziness,
• vision problems (including double vision),
• tinnitus (ringing in the ears), hearing loss, deterioration of hearing,
• increased heart rate (tachycardia),
• expansion of blood vessels (vasodilation), decreased blood pressure or fainting,
• difficulty breathing, including asthma symptoms,
• liver disorders, jaundice (cholestatic jaundice), hepatitis,
• sensitivity to light (see section 2: Take special care with Ciprofloxacino Normon),
• muscle pain, tendon inflammation, tendon rupture – especially the long tendon at the back of the ankle (Achilles tendon) (see section 2: Take special care with Ciprofloxacino Normon), worsening of myasthenia gravis symptoms (see section 2: Take special care with Ciprofloxacino Normon).

Very rare adverse 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: Take special care with Ciprofloxacino Normon),
• severe allergic reactions (anaphylactic reaction or anaphylactic shock, with a risk of death - serum sickness) (see section 2: Take special care with Ciprofloxacino Normon)
• mental disorders (psychotic reactions potentially leading to suicidal thoughts, suicide attempts, or completed suicides) (see section 2: Take special care with Ciprofloxacino Normon),
• migraine, coordination disorder, instability when walking (gait disorders), disorders of the sense of smell (olfactory disorders); pressure in the brain (intracranial pressure),
• visual color distortions,
• inflammation of the blood vessel wall (vasculitis),
• pancreatitis,
• death of liver cells (liver necrosis), which can very rarely lead to liver failure with a risk of death,
• small pinpoint bleeding under the skin (petechiae), various skin rashes or exanthems (e.g., Stevens-Johnson syndrome with a risk of death or toxic epidermal necrolysis),
• muscle weakness, tendon inflammation, tendon rupture – especially the long tendon at the back of the ankle (Achilles tendon) (see section 2: Take special care with Ciprofloxacino Normon), worsening of myasthenia gravis symptoms (see section 2: Take special care with Ciprofloxacino Normon).

Frequency not known(cannot be estimated from available data):

• nervous system problems such as pain, burning, tingling, numbness, and/or weakness in the limbs,
• abnormal fast heart rhythm, life-threatening irregular heart rhythm, alteration of heart rhythm (called "prolongation of the QT interval", observed in the 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),
• loss of consciousness due to severely low 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, walking difficulty, abnormal sensations such as pinching, tingling, 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 attempts) and decreased hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

There have been reports of an increase in 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 or pharmacist, 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 www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Ciprofloxacino Normon

Keep this medication out of sight and reach of children.

It does not require special storage conditions.

Do not use this medication after the expiration date shown on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition ofCiprofloxacinoNormon

• The active ingredient is ciprofloxacin. Each tablet contains 250 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, ammonium methacrylate copolymer type A, and propylene glycol (E-1520).

Appearance of the product and package contents

Coated tablets, white or slightly cream-colored, round, biconvex, and scored on one side. Each package contains 1 and 14 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the last revision of this prospectus: December 2020

Detailed and updated information about this medication 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 medication 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/62299/P_62299.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 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. You can even help bacteria become more resistant and, therefore, delay your recovery or decrease the effectiveness of antibiotics if you do not respect:

• the dose,
• the schedule,
• the duration of treatment.

Consequently, to maintain the effectiveness of this medication:

1. 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 medications to the pharmacy, to ensure they are eliminated correctly.