Leaflet: information for the patient

Ciprofloxacin pensa 500 mg film-coated tablets

Read this leaflet carefully before you start taking this medicine, as 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.

2.What you need to know before you start taking Ciprofloxacin Pensa

3.How to take Ciprofloxacin Pensa

4.Possible side effects

1. Storage of Ciprofloxacin Pensa

6.Contents of the pack and additional information

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

Adults

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

• respiratory tract infections
• prolonged 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 count (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 ciprofloxacin.

Children and adolescents

Ciprofloxacin 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 kidney infections (pyelonephritis)
• exposure to anthrax by inhalation

Ciprofloxacin may also be used to treat severe infections in children and adolescents when deemed necessary by their doctor.

Do not take Ciprofloxacino Pensa

• if you are allergic to the active ingredient, other quinolones, or any of the other components of this medication (listed in section 6)
• if you are taking tizanidina (see section 2: Other Medications and Ciprofloxacino Pensa)

Warnings and Precautions

Before starting to take this medication

Do not take ciprofloxacin if you have had a severe reaction to it or any other quinolone in the past. If this is the case, inform your doctor as soon as possible.

Consult your doctor before starting to take Ciprofloxacino Pensa

• if you have ever had kidney problems, as your treatment may need to be adjusted
• if you have epilepsy or other neurological conditions
• if you have a history of tendon problems during previous antibiotic treatment with ciprofloxacin
• if you are diabetic, as you may be at risk of hypoglycemia with ciprofloxacin
• if you have myasthenia gravis (a type of muscle weakness), as symptoms may worsen
• if you have been diagnosed with an aneurysm (a bulge in a blood vessel) or a "bump" in a large blood vessel (aortic aneurysm or peripheral aneurysm)
• if you have had a previous episode of aortic dissection (tear in the aorta)
• if you have a family history of aortic aneurysm or dissection, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome, or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, atherosclerosis, rheumatoid arthritis, or endocarditis)
• if you have heart valve insufficiency (regurgitation)
• if you have heart problems. Be cautious when taking ciprofloxacin if you have been born or have a family history of prolonged QT interval (seen on ECG), have electrolyte imbalances (especially low potassium or magnesium levels), have a slow heart rate (bradycardia), have a heart condition (heart failure), have a history of heart attacks (myocardial infarction), are a woman or elderly, or are taking other medications that cause abnormal ECG changes (see section 2: Other Medications and Ciprofloxacino Pensa)
• if you or a family member has a deficiency in glucose-6-phosphate dehydrogenase (G6PD), you may be at risk of anemia with ciprofloxacin

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.

While taking Ciprofloxacino Pensa

Inform your doctor immediately if any of the following situations occur while taking ciprofloxacin. Your doctor will decide if it is necessary to stop the treatment with ciprofloxacin.

• If you experience asevere and sudden pain in the abdomen, chest, or backthat may be symptoms of aortic dissection or aneurysm, go to the emergency room immediately. The risk may increase if you are receiving systemic corticosteroids.

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

• Severe and sudden allergic reaction (anaphylactic shock, angioedema)(a severe and sudden allergic 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 more ciprofloxacin and contact your doctor immediately.

• Severe and incapacitating adverse effects, of prolonged duration, and potentially irreversible.Ciprofloxacin and other fluoroquinolone or quinolone antibiotics 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 extremities, 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, considering also the use of another class of antibiotic.

• In rare cases, you may experiencepain and swelling in the joints 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 in a tendon (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking ciprofloxacin, contact your doctor, and keep the affected area at rest. Avoid any unnecessary exercise, as this may increase the risk of tendon rupture.

• If you haveepilepsyor anotherneurological condition, such as ischemia or cerebral infarction, you may experience adverse effects associated with the central nervous system. If seizures occur, stop taking ciprofloxacin 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 ciprofloxacin and inform your doctor immediately to prevent the development of a potentially irreversible condition.

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

• Quinolone antibiotics can causean increase in your blood sugar levelsabove normal levels (hyperglycemia), ordecrease in your blood sugar levelsbelow 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 ciprofloxacin, 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 ciprofloxacin and contact your doctor immediately, as this may put your life at risk. Do not take medications that slow down or delay bowel movements.

• If yourvisionbecomes worse or if you experience any other eye changes, consult an ophthalmologist immediately.

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

• Inform your doctor or laboratory personnel if you are taking ciprofloxacin when you need to undergo ablood or urine test.

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

• Ciprofloxacin can causeliver damage. If you experience symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or stomach pain, consult your doctor immediately.

• Ciprofloxacin can 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, 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.

Other Medications and Ciprofloxacino Pensa

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

We know that the following medications interact with ciprofloxacin in your body. If you take ciprofloxacin 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)
• ropinirole (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 (macrolides), some antipsychotics
• zolpidem (for sleep disorders)

Ciprofloxacin mayincreasethe levels of the following medications in your blood:

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

Some medicationsdecreasethe effect of ciprofloxacin. Inform your doctor if you are taking or wish to take:

• antacids
• omeprazole
• mineral supplements
• sucralfate
• polymyxin E phosphate binders (e.g., sevelamer or lanthanum carbonate)
• medications or supplements containing calcium, magnesium, aluminum, or iron

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

Taking Ciprofloxacino Pensa with food and drinks

Although you take ciprofloxacin with meals, do 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

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

It is recommended to avoid using ciprofloxacin during pregnancy.

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

Driving and operating machinery

Ciprofloxacin may decrease your alertness. Some neurological effects may occur. Make sure you know how you react to ciprofloxacin before driving a vehicle or operating a machine. If in doubt, consult your doctor.

Your doctor will explain exactly how much ciprofloxacin 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 your dose may need to be adjusted.

Treatment usually lasts from 5 to 21 days, but may be longer for severe infections. Follow the administration instructions for this medication as indicated by your doctor or pharmacist. Consult your doctor or pharmacist again if you have any doubts about how many tablets of ciprofloxacin you should take and how to take them.

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

If you take more Ciprofloxacino Pensa than you should

• If you take a larger dose than prescribed, seek medical help immediately. If possible, bring the tablets or the box with you to show the doctor.

You can also call the Toxicological Information Service. Phone: 91 562 0420.

If you forget to take Ciprofloxacino Pensa

• Take the usual 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 the missed dose. Make sure to complete the treatment cycle.

If you interrupt treatment with Ciprofloxacino Pensa

• It is essential to complete the 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 fully cured, and symptoms may worsen again. You may develop antibiotic resistance.

If you have any other questions about using this medication, ask your doctor or pharmacist.

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

The following section contains the most serious side effects that you may be able to recognize yourself:

Stop taking ciprofloxacin and contact your doctor immediatelyto consider another antibiotic treatment if you notice any of the following serious side effects:

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

• Seizures (see section 2: Warnings and precautions)

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

• Severe and sudden allergic reaction with symptoms such as chest tightness, dizziness, nausea, or fainting, or experiencing dizziness when standing up (anaphylactic reaction or shock) (see section 2: Warnings and precautions)
• Muscle weakness, tendon inflammation that can lead to tendon rupture, especially the Achilles tendon (see section 2: Warnings and precautions)
• Skin eruptions with a risk of death, usually in the form of blisters or ulcers in the mouth, throat, nose, eyes, and other mucous membranes, such as the genitals, that can progress to generalized blistering or skin peeling (Stevens-Johnson syndrome, toxic epidermal necrolysis)

Frequency unknown: cannot be estimated from available data

• Unusual sensations of pain, burning, tingling, numbness, or muscle weakness in the limbs (neuropathy) (see section 2: Warnings and precautions)
• A drug reaction that causes skin rash, fever, internal organ inflammation, hematological changes, and systemic disease (DRESS - Drug Reaction with Eosinophilia and Systemic Symptoms, PEAG - Acute Generalized Pustular Exanthema)

Other side effects that have been observed during treatment with ciprofloxacin are listed below according to the probability that they present:

Frequent: may affect up to1 in 10 people

• Nausea, diarrhea
• Joint pain and inflammation in children

Occasional: may affect up to1 in 100 people

• Joint pain in adults
• Fungal superinfections
• Elevated eosinophil count, a type of white blood cell
• Loss of appetite
• Hypervigilance 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
• Impaired renal function
• Muscle and bone pain, feeling unwell (asthenia) or fever
• Increased alkaline phosphatase in the blood (a blood substance)

Rare: may affect up to1 in 1,000 people

• Muscle pain, joint inflammation, increased muscle tone, and cramps
• Intestinal inflammation (colitis) associated with antibiotic use (can be fatal in rare cases) (see section 2: Warnings and precautions)
• Changes in blood cell counts (leucopenia, leucocytosis, 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) (see section 2: Warnings and precautions)
• 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) (see section 2: Warnings and precautions) or hallucinations
• Unusual sensations of tingling and numbness, unusual sensitivity to sensory stimuli, decreased skin sensitivity, tremors, or dizziness
• Vision problems (including double vision) (see section 2: Warnings and precautions)
• Tinnitus (ringing in the ears), hearing loss, or hearing deterioration
• Increased heart rate (tachycardia)
• Expansion of blood vessels (vasodilation), decreased blood pressure, or fainting
• Difficulty breathing, including asthma-like symptoms
• Liver problems, jaundice (cholestatic jaundice), hepatitis
• Light sensitivity (see section 2: Warnings and precautions)
• Renal insufficiency, blood or crystals in the urine, urinary tract inflammation
• Fluid retention or excessive sweating
• Increased amylase enzyme levels

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

• A type of severe decrease in red blood cell count (hemolytic anemia), a dangerous decrease in a type of white blood cell count (agranulocytosis) (see section 2: Warnings and precautions), a decrease in the number of white blood cells and red blood cells and platelets (pancytopenia), with a risk of death, and bone marrow depression, also with a risk of death
• Allergic reaction called serum sickness-like reaction (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 disturbances (gait disorders), olfactory disorders (olfactory disorders); increased intracranial pressure and pseudotumor cerebri
• Distorted color vision
• Wall inflammation of blood vessels (vasculitis)
• Pancreatitis
• Death of liver cells (hepatic necrosis), which very rarely leads to liver insufficiency with a risk of death (see section 2: Warnings and precautions)
• Small pinpoint hemorrhages under the skin (petechiae), various skin eruptions, or exanthems
• Worsening of myasthenia gravis symptoms (see section 2: Warnings and precautions)

Frequency unknown:cannot be estimated from available data

• Syndrome associated with deficient water secretion and low sodium concentrations (SIADH, for its English acronym)
• Feeling extremely excited (mania) or feeling extremely optimistic and hyperactive (hypomania)
• Abnormally fast heart rhythm, irregular heart rhythm with a risk to life, alteration of heart rhythm (called "prolongation of the QT interval", observed in the ECG, heart electrical activity)
• Influence on blood coagulation (in patients treated with vitamin K antagonists)

-Severe 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, unusual sensations such as pinpricks, tingling, numbness, burning, or pain (neuropathy), fatigue, decreased memory and concentration, effects on mental health (which may include sleep disorders, anxiety, panic attacks, depression, and suicidal ideation), hearing loss, vision loss, taste and smell disturbances, 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 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 leaflet. You can also report them directly through the national notification system included in the Spanish System of 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 in the blister pack, 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 pointat the pharmacy. If in doubtask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Ciprofloxacino Pensa Composition

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

-The other components (excipients) are: maize starch, microcrystalline cellulose, povidone, anhydrous colloidal silica, magnesium stearate, titanium dioxide (E171), hypromellose, macrogol 6000.

Product appearance and packaging contents

Film-coated tablets, round, white, smooth.

Each package contains 1 or 14 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer responsible:

Industria Química y Farmacéutica VIR, S.A.

C/ Lagunanº 66-68-70, Pol. Ind. Urtinsa II

28923 Alcorcón (Madrid)

Spain

Last review date of this leaflet:March 2025

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

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

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

Consequently, 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.