PATIENT INFORMATION LEAFLET

Ciprofloxacin Alter 250 mg Film-Coated Tablets

Ciprofloxacin

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do 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.

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

Adults

Ciprofloxacino Alter 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 carbuncle by inhalation.

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

In cases of severe infection or infection caused by multiple types of bacteria, additional antibiotic treatment may be administered in addition to Ciprofloxacino Alter.

Children and adolescents

Ciprofloxacino Alter 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.

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

Do not take Ciprofloxacino Alter

• If you are allergic (hypersensitive) to the active ingredient, to other quinolones or to any of the other components of this medication (see section 6).
• If you are taking tizanidina (see section 2: Taking Ciprofloxacino Alter with other medications).

Warnings and precautions

Before starting to take this medication

Do not take antibacterial medications that contain fluoroquinolones or quinolones, including Ciprofloxacino Alter, 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.

Consult your doctor before starting to take this medication

• If you have ever had kidney problems, as your treatment may need to be adjusted.
• If you suffer from epilepsy or other neurological conditions.
• If you have a history of tendon problems during previous antibiotic treatment with Ciprofloxacino Alter.
• If you suffer from myasthenia gravis (a type of muscle weakness).
• If you have heart problems. You should be cautious when administering ciprofloxacin if you were born or have a family history of prolonged QT interval (seen on the ECG, heart electrical recording), have electrolyte imbalances in the blood (especially low levels of potassium and magnesium 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 medications that result in abnormal ECG changes (see section 2: Taking Ciprofloxacino Alter with other medications).
• If you have been diagnosed with an enlarged or "bulge" of a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm).
• If you have had a previous episode of aortic dissection (tear in the aorta wall).
• If you have been diagnosed with heart valve insufficiency (valve regurgitation).
• 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., 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.

During treatment with this medication

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

• 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. If this happens, do not take any more Ciprofloxacino Alter and contact your doctor immediately.
• Severe, incapacitating, prolonged, and potentially irreversible adverse effects.Ciprofloxacin-containing antibacterial medications, including Ciprofloxacino Alter, 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 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 Ciprofloxacino Alter, 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 treatment with Ciprofloxacino Alter. At the first sign of tendon pain or swelling (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Ciprofloxacino Alter, 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 asevere and sudden pain in the abdomen, chest, or back,which may be symptoms of aortic dissection or aneurysm,go to an emergency service immediately.The risk may be increased if you are receiving systemic corticosteroid treatment.
• If you start experiencing a 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 (rapid and irregular heartbeat), you must inform your doctor immediately.
• If you suffer fromepilepsyor anotherneurological condition, such as ischemia or cerebral infarction, you may experience adverse effects associated with the central nervous system. If this occurs, stop taking this medication 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 the feet and legs or hands and arms. If this happens, stop taking Ciprofloxacino Alter and inform your doctor immediately to prevent the development of a potentially irreversible disorder.
• You may experience psychiatric reactions the first time you take this medication. If you suffer fromdepressionorpsychosis, your symptoms may worsen with treatment with this medication. In rare cases, depression or psychosis may progress to suicidal thoughts, attempts, or completed suicide. If this occurs, stop taking this medication and contact your doctor immediately.
• Quinolone antibiotics can cause anincrease in your blood sugar levelsabove normal levels (hyperglycemia), ordecrease in your blood sugar levelsbelow normal levels, which in severe cases may 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 must be carefully controlled.
• You may developdiarrheawhile taking antibiotics, including this medication, 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 medication immediately, as this may put your life at risk. Do not take medications that slow down or delay bowel movements and consult your doctor.
• While taking this medication, inform your doctor or laboratory personnel if you need to undergo ablood or urine test.
• This medication may causeliver damage. If you notice symptoms such as loss of appetite, jaundice (yellow discoloration of the skin), dark urine, itching, or stomach pain, stop taking Ciprofloxacino Alter immediately and consult your doctor immediately.
• If you have kidney problems, inform your doctor as your dose may need to be adjusted.
• This medication may cause a decrease in white blood cell count 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 must 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 tosunlight or ultraviolet (UV) lightwhen taking this medication. Avoid exposure to intense sunlight or artificial ultraviolet light, such as tanning beds.
• Consult an ophthalmologist immediately if you experience any visual disturbances or have any eye problems.

Taking Ciprofloxacino Alter with other medications

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

Do not take Ciprofloxacino Alter at the same time as tizanidina, as this may cause adverse effects, such as low blood pressure and drowsiness (see section 2: Taking Ciprofloxacino Alter).

We know that the following medications interact with this medication in your body. If you take this medication at the same time as these medications, this may affect the therapeutic effect of these medications. It may also increase the likelihood of adverse effects.

Inform your doctor if you are taking:

• anticoagulant medications (e.g., warfarin, acenocoumarol, phenprocoumon, or fluindione) or other oral anticoagulants (to thin the blood)
• probenecid (for gout)
• methotrexate (for certain types of cancer, psoriasis, rheumatoid arthritis)
• theophylline (for respiratory problems)
• tizanidina (for muscle spasticity in multiple sclerosis)
• olanzapine (an antipsychotic)
• clozapine (an antipsychotic)
• ropinirol (for Parkinson's disease)
• phenytoin (for epilepsy)
• metoclopramide (for nausea and vomiting)
• ciclosporina (for skin diseases, rheumatoid arthritis, and organ transplants)
• other medications that may alter your heart rhythm: antiarrhythmic medications (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (which belong to the macrolide group), some antipsychotics.

This medication mayincreasethe levels in the blood of the following medications:

• 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 medicationsdecreasethe effect of this medication. Inform your doctor if you are taking or wish to take:

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

If these preparations are essential, take this medication approximatelytwohours before orfourhours after taking these preparations.

Taking Ciprofloxacino Alter with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

It is preferable to avoid using this medication during pregnancy.

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

Driving and operating machinery

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

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 Alter you should take and how to take them, ask your doctor or pharmacist how many tablets you should take and how to take them.

1. Swallow the tablets with a large amount of liquid. Do not chew the tablets because their taste is not pleasant.
2. Try to take the tablets at the same time every day.
3. 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 the Ciprofloxacino Alter 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 more Ciprofloxacino Alter than 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 take Ciprofloxacino Alter

Take the 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 compensate for the missed dose. Make sure to complete the treatment cycle.

If you interrupt treatment with Ciprofloxacino Alter

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 medication, ask your doctor or pharmacist.

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

Frequent:can affect up to 1 in 10 people

• nausea, diarrhea
• joint pain in children

Less frequent:can affect up to 1 in 100 people

• superficial fungal infections
• elevated eosinophil count, a type of white blood cell
• decreased appetite
• hyperactivity or agitation
• headache, dizziness, sleep problems or taste disturbances
• vomiting, abdominal pain, digestive problems such as slow digestion (indigestion/acid reflux) or flatulence
• increased levels of 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
• increased alkaline phosphatase in the blood (a blood substance)

Rare:can affect up to 1 in 1,000 people

• inflammation of the intestine (colitis) linked to antibiotic use (may be fatal in rare cases) (see section 2: Warnings and precautions)
• changes in blood cell count (leukopenia, leukocytosis, neutropenia, anemia), increased or decreased levels of a blood clotting factor (thrombocytes)
• allergic reaction, swelling (edema) or rapid swelling of the skin and mucous membranes (angioedema)
• increased blood sugar (hyperglycemia)
• decreased blood sugar (hypoglycemia) (see section 2: Warnings and precautions)
• 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, seizures (see section 2: Warnings and precautions) or dizziness
• vision problems (including double vision)
• tinnitus (ringing in the ears), hearing loss, hearing deterioration
• increased heart rate (tachycardia)
• blood vessel expansion (vasodilation), decreased blood pressure or fainting
• difficulty breathing, including asthma-like symptoms
• liver problems, jaundice (icterus cholestatic), hepatitis
• light sensitivity (see section 2: Warnings and precautions)
• muscle pain, joint inflammation, increased muscle tone or cramps
• renal insufficiency, blood or crystals in the urine (see section 2: Warnings and precautions), urinary tract inflammation
• fluid retention or excessive sweating
• increased amylase enzyme levels

Very rare:can affect up to 1 in 10,000 people

• a type of anemia (hemolytic anemia), a dangerous decrease in a type of white blood cell (agranulocytosis), a decrease in the number of white blood cells, red blood cells, and platelets (pancytopenia), with a risk of death, and bone marrow depression, also with a risk of death (see section 2: Warnings and precautions)
• severe allergic reactions (anaphylactic reaction or anaphylactic shock, with a risk of death, serum sickness) (see section 2: Warnings and precautions)
• mental disorders (psychotic reactions potentially leading to suicidal thoughts, attempts, or completed suicides) (see section 2: Warnings and precautions)
• migraine, coordination disorders, gait instability (gait disorders), olfactory disorders; increased intracranial pressure and pseudotumor cerebri
• color vision distortions
• inflammation of blood vessel walls (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 Achilles tendon (see section 2: Warnings and precautions), worsening of myasthenia gravis symptoms (see section 2: Warnings and precautions)

Frequency unknown:(cannot be estimated from available data):

• neurological problems such as pain, burning, tingling, numbness, and/or weakness in the extremities (peripheral neuropathy and polyneuropathy)
• abnormal heart rhythm, irregular heart rhythm with a risk of life, alteration of heart rhythm (called "prolongation of the QT interval", observed in ECG, heart electrical 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)
• coma due to 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 effects (which may include sleep disorders, anxiety, panic attacks, depression, and suicidal thoughts), also decreased hearing, vision, taste, and smell in some cases, regardless 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 adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse 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.

Do not use this medication after the expiration date that appears on the packaging or blister, 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 the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Ciprofloxacino Alter Composition

• The active ingredient is Ciprofloxacin. Each tablet contains 250 mg of ciprofloxacin (as hydrochloride).
• The other components are:Core:microcrystalline cellulose, sodium carboxymethyl starch (type A) (from potato), crospovidone, anhydrous colloidal silica, and magnesium stearate.Coating:hypromellose, titanium dioxide (E-171), and triacetin.

Appearance of the product and contents of the package

Ciprofloxacin Alter 250 mg film-coated tabletsare presented in the form oflenticular film-coated tablets, white in color, scored on one of their faces.

Each package contains 14 tablets.

Marketing authorization holder and responsible manufacturer

Laboratorios ALTER, S.A.

Mateo Inurria, 30

28036 Madrid

Last review date of this leaflet: March 2025

The 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/

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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. 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

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

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 adapted to their illness.
5. After completing a treatment, return all unused medications to the pharmacy to ensure they are disposed of correctly.