CIPROFLOXACIN PENSA 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Ciprofloxacin Pensa 500 mg Film-Coated Tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. What you need to know before taking Ciprofloxacin Pensa
2. How to take Ciprofloxacin Pensa
3. Possible side effects
   1. Storage of Ciprofloxacin Pensa

1. Package Contents and Additional Information

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

Ciprofloxacin Pensa contains the active substance ciprofloxacin. Ciprofloxacin is an antibiotic belonging to the fluoroquinolone family. Ciprofloxacin works by killing the bacteria that cause infections. It only works with specific strains of bacteria.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or the common cold.

It is essential that you follow the instructions regarding dosage, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medication. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw away medications down the drain or in the trash.

Adults

Ciprofloxacin 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 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 cases of 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.

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 those that have reached the kidneys (pyelonephritis)
• inhalation exposure to anthrax

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

2. What you need to know before taking Ciprofloxacin Pensa

Do not take Ciprofloxacin Pensa

• if you are allergic to the active substance, other quinolones, or any of the other components of this medication (listed in section 6)
• if you are taking tizanidine (see section 2: Other medications and Ciprofloxacin Pensa)

Warnings and Precautions

Before starting to take this medication

Do not take ciprofloxacin if you have experienced a severe adverse reaction in the past when taking a quinolone or fluoroquinolone. If this is the case, inform your doctor as soon as possible.

Consult your doctor before starting to take Ciprofloxacin 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 treatment with antibiotics like ciprofloxacin
• if you are diabetic, as you may be at risk of hypoglycemia with ciprofloxacin
• if you have severe myasthenia (a type of muscle weakness), as symptoms may worsen
• if you have been diagnosed with an aortic aneurysm or a large peripheral vessel aneurysm
• if you have had a previous episode of aortic dissection (tear in the aortic wall)
• if you have a family history of aortic aneurysm or aortic dissection, congenital heart valve disorders, or other risk factors or predisposing conditions (e.g., Marfan syndrome, 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))
• if you have been diagnosed with heart valve insufficiency (regurgitation of the heart valves)
• if you have heart problems. Caution should be exercised when administering ciprofloxacin if you have been born with or have a family history of prolonged QT interval (seen on the ECG, electrical recording of the heart), have electrolyte imbalance (especially low potassium or magnesium levels in the blood), have a very slow heart rate (known as bradycardia), have a delicate heart (heart failure), have a history of heart attacks (myocardial infarction), are a woman or an elderly person, or are taking other medications that result in abnormal ECG changes (see section 2: Other medications and Ciprofloxacin Pensa)
• if you or a family member has a deficiency of 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 Ciprofloxacin Pensa

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

• If you experience severe and sudden abdominal, chest, or back painthat may be symptoms of aortic dissection or aneurysm, go to the emergency room immediately. The risk may increase if you are receiving systemic corticosteroid treatment.

• If you start experiencing sudden onset of 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), inform your doctor immediately.

• 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, do not take any more ciprofloxacin and contact your doctor immediately.

• Severe, disabling, and potentially irreversible side effects.Antibacterial medications containing 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, or 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, considering the use of an antibiotic from another class.

• In rare cases, joint and tendon pain and swelling, or tendon inflammation or rupturemay occur. 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 ciprofloxacin treatment. 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 it may increase the risk of tendon rupture.

• If you have epilepsyor another neurological condition, such as cerebral ischemia or infarction, you may experience central nervous system side effects. If seizures occur, stop taking ciprofloxacin and contact your doctor immediately.

• In rare cases, you may experience nerve damage (neuropathy)symptoms such as pain, burning, tingling, numbness, 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 disorder.

• You may experience psychiatric reactionsthe first time you take ciprofloxacin. If you have depressionor psychosis, your symptoms may worsen with ciprofloxacin treatment. In rare cases, depression or psychosis may progress to suicidal thoughts, attempted suicide, or completed suicide. If this occurs, contact your doctor immediately.

• Quinolone antibiotics may cause an increase in your blood sugar levelsabove normal levels (hyperglycemia) or a decrease in your blood sugar levelsbelow 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 ciprofloxacin, or even several weeks after you have stopped taking them. If diarrhea becomes severe or persistent, or if you notice blood or mucus in your stool, stop taking ciprofloxacin and contact your doctor immediately, as this can be life-threatening. Do not take medications that stop or slow down bowel movements.

• If your visionworsens or if you have any other eye disorders, consult an ophthalmologist immediately.

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

• While taking ciprofloxacin, inform your doctor or laboratory personnel if you need to undergo a blood or urine test.

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

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

• Ciprofloxacin may cause a decrease in your white blood cell countand 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, 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.

Other medications and Ciprofloxacin Pensa

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

Do not take ciprofloxacin at 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 Pensa).

It is known 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 experiencing side effects.

Inform your doctor if you are taking:

• vitamin K antagonists (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)
• tizanidine (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)
• cyclosporine (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 (belonging to the macrolide group), some antipsychotics
• zolpidem (for sleep disorders)

Ciprofloxacin may increaseblood levels of the following medications:

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

Some medications decreasethe effect of ciprofloxacin. Inform your doctor if you are taking or plan to take:

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

If these preparations are essential, take ciprofloxacin approximately twohours before or fourhours after taking these preparations.

Taking Ciprofloxacin Pensa with food and drinks

Although you can 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 substance.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, 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 in breast milk and may harm your baby.

Driving and using machines

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

3. How to take Ciprofloxacino Pensa

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.

Tell your doctor if you have kidney problems, as it may be necessary to adjust your dose.

Treatment usually lasts from 5 to 21 days, but it can last longer for severe infections. Follow your doctor's or pharmacist's administration instructions for this medication exactly. Consult your doctor or pharmacist again if you have doubts about how many ciprofloxacin tablets you should take and how you should 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 nottake ciprofloxacin tablets with dairy products such as milk or yogurt, or with fruit juices enriched with calcium (e.g., calcium-enriched orange juice).

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

If you take more Ciprofloxacino Pensa than you should

• If you take a larger amount 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 Toxicology Information Service. Phone: 91 562 0420.

If you forget to take Ciprofloxacino Pensa

• 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 make up for missed doses. Make sure to complete the treatment cycle.

If you interrupt treatment with Ciprofloxacino Pensa

• It is essential 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 medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

The following section contains the most serious side effects that you may 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 shock or reaction) (see section 2: Warnings and precautions)
• Muscle weakness, tendon inflammation that can lead to tendon rupture, especially the long tendon in the back of the ankle (Achilles tendon) (see section 2: Warnings and precautions)
• Life-threatening skin rashes, usually in the form of blisters or ulcers in the mouth, throat, nose, eyes, and other mucous membranes, such as the genitals, which can progress to generalized blistering or skin peeling (Stevens-Johnson syndrome, toxic epidermal necrolysis)

Frequency not known: 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, inflammation of internal organs, blood disorders, and systemic disease (DRESS - Drug Reaction with Eosinophilia and Systemic Symptoms, PEAG - Generalized Acute Pustular Exanthem)

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

Common: may affect up to 1 in 10 people

• Nausea, diarrhea
• Joint pain and inflammation in children

Uncommon: may affect up to 1 in 100 people

• Joint pain in adults
• Fungal superinfections
• Elevated levels of eosinophils, a type of white blood cell
• Loss of appetite
• Hyperactivity or agitation
• Headache, dizziness, sleep problems, or taste disorders
• Vomiting, abdominal pain, digestive problems such as indigestion or flatulence
• Increased levels of certain substances in the blood (transaminases and/or bilirubin)
• Skin rash, itching, or hives
• Kidney function impairment
• Muscle and bone pain, feeling unwell (asthenia), or fever
• Increased alkaline phosphatase in blood

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

• Muscle pain, joint inflammation, increased muscle tone, and cramps
• Antibiotic-associated colitis (may be life-threatening in very 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) (see section 2: Warnings and precautions)
• Increased blood sugar (hyperglycemia)
• Decreased blood sugar (hypoglycemia) (see section 2: Warnings and precautions)
• Confusion, disorientation, anxiety reactions, unusual dreams, depression (potentially leading to suicidal thoughts, attempts, or completed suicide) (see section 2: Warnings and precautions), or hallucinations
• Feeling of tingling, 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, impaired hearing
• Increased heart rate (tachycardia)
• Vasodilation, decreased blood pressure, or fainting
• Breathing difficulties, including asthma-like symptoms
• Liver disorders, jaundice (cholestatic jaundice), hepatitis
• Photosensitivity (see section 2: Warnings and precautions)
• Kidney failure, blood or crystals in the urine, inflammation of the urinary tract
• Fluid retention or excessive sweating
• Increased amylase enzyme levels

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

• A special type of decrease in red blood cell count (hemolytic anemia), a dangerous decrease in a type of white blood cell (agranulocytosis) (see section 2: Warnings and precautions), a decrease in the number of white and red blood cells and platelets (pancytopenia), with a risk of death, and bone marrow depression, also with a risk of death
• An 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 suicide) (see section 2: Warnings and precautions)
• Migraine, coordination disorder, instability when walking (gait disorders), disorders of the sense of smell (olfactory disorders); increased intracranial pressure (intracranial pressure and pseudotumor cerebri)
• Color vision distortions
• Vasculitis
• Pancreatitis
• Liver cell death (necrosis), which very rarely leads to liver failure with a risk of death (see section 2: Warnings and precautions)
• Small pinpoint hemorrhages under the skin (petechiae), various skin rashes or exanthems
• Worsening of myasthenia gravis symptoms (see section 2: Warnings and precautions)

Frequency not known: cannot be estimated from available data

• Syndrome associated with inadequate water secretion and low sodium levels (SIADH)
• Feeling very excited (mania) or feeling very optimistic and hyperactive (hypomania)
• Abnormally fast heart rate, life-threatening irregular heart rhythm, heart rhythm disorder (called "prolonged QT interval", observed in ECG, heart electrical activity)
• Influence on blood coagulation (in patients treated with vitamin K antagonists)

• 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, difficulty walking, abnormal sensations such as pinching, tingling, burning, numbness, or pain (neuropathy), fatigue, decreased memory and concentration, effects on mental health (including sleep disorders, anxiety, panic attacks, depression, and suicidal ideation), decreased hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

There have been reports of increased size and weakening or tearing of the aortic wall (aneurysms and dissections), which could lead to rupture and be fatal, and heart valve failure in patients who have received fluoroquinolones. See also section 2.

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the national reporting system included in the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Ciprofloxacino Pensa

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown 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 wastewater or household waste. Deposit the packaging and unused medications at the SIGRE Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

6. Package contents and additional information

Ciprofloxacino Pensa composition

• The active ingredient is ciprofloxacin. Each tablet contains 500 mg of ciprofloxacin (as hydrochloride).
• The other ingredients (excipients) are: cornstarch, microcrystalline cellulose, povidone, anhydrous colloidal silica, magnesium stearate, titanium dioxide (E171), hypromellose, macrogol 6000.

Product appearance and package contents

Coated tablets, round, white, smooth.

Each package contains 1 or 14 tablets.

Only some package sizes may be marketed

Marketing authorization holder and manufacturer

Marketing authorization holder:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer:

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna nº 66-68-70, Pol. Ind. Urtinsa II

28923 Alcorcón (Madrid)

Spain

Date of last revision of this leaflet:March 2025

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

Medical advice/education

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

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

Despite antibiotics, some bacteria may survive or grow. This phenomenon is known as resistance: some antibiotic treatments become ineffective.

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

• the dose
• the program
• the treatment duration

Consequently, to maintain the effectiveness of this medication:

1. Use antibiotics only when 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 completing a treatment, return all unused medications to the pharmacy to ensure they are disposed of correctly.