Ciprofloxacin Pensa 500 mg film-coated tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ciprofloxacin Pensa 500 mg film-coated tablets EFG

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

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

Leaflet contents

What Ciprofloxacin Pensa is and what it is used for
What you need to know before taking Ciprofloxacin Pensa
How to take Ciprofloxacin Pensa
Possible side effects
How to store Ciprofloxacin Pensa
Contents of the pack and other information

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

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

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

It is important that you follow your doctor's instructions regarding dosage, dosing intervals, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

Adults

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

respiratory tract infections
long-lasting 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 bacterium Neisseria meningitidis
inhalational anthrax exposure

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

If you have a severe infection or an infection caused by more than one type of bacteria, you may receive additional antibiotic treatment alongside 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 infections that have reached the kidneys (pyelonephritis)
inhalational anthrax exposure

Ciprofloxacin may also be used to treat serious infections in children and adolescents when considered 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, to other quinolones, or to any of the other ingredients of this medicine (listed in section 6)
if you are taking tizanidine (see section 2: Other medicines and Ciprofloxacin Pensa)

Warnings and precautions

Before starting this medicine

Do not take ciprofloxacin if you have previously experienced a serious adverse reaction when taking quinolones or fluoroquinolones. If this applies to you, inform your doctor as soon as possible.

Talk to your doctor before starting to take Ciprofloxacin Pensa

if you have ever had kidney problems, as your treatment may require dose adjustment
if you suffer from epilepsy or other neurological conditions
if you have a history of tendon problems during previous treatment with antibiotics such as 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 enlargement or a "bulge" in a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm)
if you have previously experienced aortic dissection (tearing of the aortic wall)
if you have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing disorders (e.g., connective tissue disorders such as Marfan syndrome or vascular Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome (an inflammatory autoimmune disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, known hypertension, known atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection))
if you have been diagnosed with heart valve insufficiency (heart valve regurgitation)
if you have heart problems. Caution is required when administering ciprofloxacin if you were born with or have a family history of QT interval prolongation (seen on ECG, the electrical recording of the heart), have electrolyte imbalances in the blood (especially low potassium or magnesium levels), have a very slow heart rate (known as bradycardia), have a weak heart (heart failure), have a history of heart attacks (myocardial infarction), are female or elderly, or are taking other medicines that cause abnormal ECG changes (see section 2: Other medicines and Ciprofloxacin Pensa)
if you or a family member has glucose-6-phosphate dehydrogenase (G6PD) deficiency, as you may be at risk of anemia with ciprofloxacin.

For the treatment of certain 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 occur while you are taking ciprofloxacin. Your doctor will decide whether treatment with ciprofloxacin should be discontinued.

If you experience severe and sudden pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go immediately to an emergency department. The risk may increase if you are receiving systemic corticosteroid treatment.
If you develop sudden onset of shortness of breath, especially when lying down, or notice swelling in your ankles, feet, or abdomen, or experience palpitations (a sensation of rapid or irregular heartbeat), inform your doctor immediately.
Sudden and severe allergic reaction (anaphylactic reaction or shock, angioedema). There is a small chance that even with the first dose, you may experience a severe allergic reaction with symptoms such as chest tightness, dizziness, nausea, or fainting, or feel dizzy upon standing. If this happens, do not take any more ciprofloxacin and contact your doctor immediately.
Severe, disabling, long-lasting, and potentially irreversible adverse effects. Antibacterial medicines containing fluoroquinolones or quinolones, including ciprofloxacin, have been associated with very rare but serious adverse effects, some of which were long-lasting (persisting for months or years), disabling, or potentially irreversible. These include tendon, muscle, and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, numbness, or burning (paresthesia), sensory disturbances such as decreased vision, taste, smell, or hearing, depression, memory loss, severe fatigue, and serious 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 treatment, possibly considering the use of an antibiotic from another class.

In rare cases, joint pain and swelling, or tendon inflammation or rupture may occur. The risk is higher if you are elderly (over 60 years), have had an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment or even several months after stopping ciprofloxacin. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking ciprofloxacin, contact your doctor, and rest the affected area. Avoid unnecessary physical activity, as this may increase the risk of tendon rupture.
If you suffer from epilepsy or another neurological condition, such as cerebral ischemia or stroke, you may experience adverse effects related to the central nervous system. If seizures occur, stop taking ciprofloxacin and contact your doctor immediately.
Rarely, you may experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness, and/or weakness, especially in the feet and legs or hands and arms. If this occurs, stop taking ciprofloxacin and inform your doctor immediately to prevent the development of a potentially irreversible disorder.
You may experience psychiatric reactions the first time you take ciprofloxacin. If you suffer from depression or psychosis, your symptoms may worsen with ciprofloxacin treatment. In rare cases, depression or psychosis may progress to suicidal thoughts, suicide attempts, or completed suicide. If this occurs, contact your doctor immediately.
Quinolone antibiotics may cause an increase in your blood sugar level above normal (hyperglycemia), or a decrease in your blood sugar level below normal, which in severe cases may lead to unconsciousness (hypoglycemic coma) (see section 4). This is important for people with diabetes. If you have diabetes, your blood sugar level should be carefully monitored.
Diarrhea may develop while you are taking antibiotics, including ciprofloxacin, or even several weeks after stopping them. If diarrhea becomes severe or persistent, or if you notice blood or mucus in your stools, stop taking ciprofloxacin and contact your doctor immediately, as this could be life-threatening. Do not take medicines that stop or delay intestinal movements.
If your vision worsens or if you experience any other eye disturbances, consult an ophthalmologist immediately.
Your skin becomes more sensitive to sunlight or ultraviolet (UV) light when taking ciprofloxacin. Avoid exposure to intense sunlight or artificial UV light, such as tanning beds.
While taking ciprofloxacin, inform your doctor or laboratory staff if you need to undergo a blood or urine test.
If you have kidney problems, inform your doctor, as your dose may need adjustment.
Ciprofloxacin may cause liver damage. If you notice symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or stomach pain, consult your doctor immediately.
Ciprofloxacin may cause a decrease in white blood cell count and possibly reduce your resistance to infections. If you develop an infection with symptoms such as fever and severe deterioration in your general condition, or fever with signs of local infection such as sore throat/pharynx/mouth or urinary problems, consult your doctor immediately. A blood test will be performed to check for possible low white blood cell count (agranulocytosis). It is important to inform your doctor about your medication.

Other medicines and Ciprofloxacin Pensa

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

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

The following medicines are known to interact with ciprofloxacin in your body. Taking ciprofloxacin at the same time as these medicines may affect their therapeutic effect or increase the likelihood of adverse effects.

Tell 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 medicines that may alter your heart rhythm: medicines belonging to the antiarrhythmic group (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 increase blood levels of the following medicines:

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

Some medicines decrease the 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)
medicines or supplements containing calcium, magnesium, aluminum, or iron

If these preparations are essential, take ciprofloxacin approximately two hours before or four hours after taking these preparations.

Taking Ciprofloxacin Pensa with food and drinks

Although you may take ciprofloxacin with meals, do not consume any dairy products (such as milk or yogurt) or calcium-fortified drinks at the same time as 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 medicine.

It is preferable to avoid using ciprofloxacin during pregnancy.

Do not take ciprofloxacin while breastfeeding, as ciprofloxacin is excreted in breast milk and may harm your baby.

Driving and using machines

Ciprofloxacin may reduce your level of alertness. Some neurological effects may occur. Therefore, make sure you know how you react to ciprofloxacin before driving a vehicle or operating machinery. If in doubt, consult your doctor.

3. How to take Ciprofloxacin Pensa

Your doctor will explain exactly how much ciprofloxacin you should take, how often, and for how long. This will depend on the type and severity of your infection.

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. Always follow your doctor’s or pharmacist’s instructions regarding this medicine. Consult your doctor or pharmacist again if you have any doubts about how many ciprofloxacin tablets to take or how to take them.

Swallow the tablets with plenty of liquid. Do not chew the tablets, as they have an unpleasant taste.
Try to take the tablets at the same time each day.
You may take the tablets with or between meals. Calcium consumed as part of a meal will not significantly affect the absorption of the medicine. However, do not take ciprofloxacin tablets with dairy products such as milk or yoghurt, or with fortified fruit juices (for example, calcium-fortified orange juice).

Remember to drink plenty of fluids while taking this medicine.

If you take more Ciprofloxacin Pensa than you should

If you take more than prescribed, seek medical help immediately. If possible, take the tablets or the pack with you to show the doctor.

You may also call the Toxicology Information Service. Telephone: 91 562 0420.

If you forget to take Ciprofloxacin Pensa

Take the missed dose as soon as possible, then continue your treatment as prescribed. However, if it is almost time for your next dose, do not take the missed dose and continue your treatment as usual. Do not take a double dose to make up for a missed dose. Make sure you complete the full course of treatment.

If you stop taking Ciprofloxacin Pensa

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

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

The following section includes the most serious adverse effects that you can recognize yourself:

Stop taking ciprofloxacin and contact your doctor immediately to consider alternative antibiotic treatment if you experience any of the following serious adverse 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, sudden allergic reaction with symptoms such as chest tightness, dizziness, nausea, or fainting, or experiencing dizziness upon standing (anaphylactic reaction or shock) (see section 2: Warnings and precautions)
Muscle weakness, tendon inflammation that may lead to tendon rupture, especially of the long tendon at the back of the ankle (Achilles tendon) (see section 2: Warnings and precautions)
Life-threatening skin rashes, typically presenting as blisters or ulcers in the mouth, throat, nose, eyes, and other mucous membranes such as the genitals, which may progress to widespread 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 causing skin rash, fever, internal organ inflammation, blood abnormalities, and systemic illness (DRESS - Drug Reaction with Eosinophilia and Systemic Symptoms, GEP - Generalized Exanthematous Pustulosis)

Other adverse effects observed during treatment with ciprofloxacin are listed below by frequency:

Common: may affect up to 1 in 10 people

Nausea, diarrhea
Joint pain and joint inflammation in children

Uncommon: may affect up to 1 in 100 people

Joint pain in adults
Fungal superinfections (fungal infections)
Increased levels of eosinophils, a type of white blood cell
Loss of appetite
Hyperactivity or agitation
Headache, dizziness, sleep disturbances, or taste disorders
Vomiting, abdominal pain, digestive problems such as slow digestion (dyspepsia/heartburn) or flatulence
Increased levels of certain substances in the blood (transaminases and/or bilirubin)
Skin rash, itching, or hives
Impaired kidney function
Muscle and bone pain, feeling unwell (asthenia), or fever
Increased blood alkaline phosphatase levels (a blood test parameter)

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

Muscle pain, joint inflammation, increased muscle tone, and cramps
Inflammation of the intestine (colitis) associated with antibiotic use (may be fatal in very rare cases) (see section 2: Warnings and precautions)
Changes in blood cell counts (leukopenia, leukocytosis, neutropenia, anemia), increase or decrease in levels of a blood clotting factor (platelets)
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, suicide attempts, or completed suicides) (see section 2: Warnings and precautions), or hallucinations
Tingling and numbness sensations, unusual sensitivity to sensory stimuli, reduced 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 disorders, jaundice (cholestatic jaundice), hepatitis
Light sensitivity (see section 2: Warnings and precautions)
Kidney failure, blood or crystals in urine, inflammation of the urinary tract
Fluid retention or excessive sweating
Increased levels of amylase enzyme

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

A specific type of reduced red blood cell count (hemolytic anemia), a dangerous reduction in a type of white blood cells (agranulocytosis) (see section 2: Warnings and precautions), a reduction in white and red blood cells and platelets (pancytopenia), potentially life-threatening, and bone marrow suppression, also potentially life-threatening
Allergic reaction known as serum sickness-like reaction (see section 2: Warnings and precautions)
Mental disorders (psychotic reactions potentially leading to suicidal thoughts, suicide attempts, or completed suicides) (see section 2: Warnings and precautions)
Migraine, coordination disorder, unsteadiness when walking (gait disorders), disturbances in the sense of smell (olfactory disorders); pressure in the brain (increased intracranial pressure and pseudotumor cerebri)
Visual distortions of colors
Inflammation of blood vessel walls (vasculitis)
Pancreatitis
Liver cell death (hepatic necrosis), which very rarely leads to life-threatening liver failure (see section 2: Warnings and precautions)
Small pinpoint bleeding under the skin (petechiae), various skin rashes or exanthems
Worsening of symptoms of myasthenia gravis (see section 2: Warnings and precautions)

Frequency not known: cannot be estimated from available data

Syndrome associated with inadequate water excretion and low sodium levels (SIADH - Syndrome of Inappropriate Antidiuretic Hormone Secretion)
Feeling extremely excited (mania) or feeling overly optimistic and hyperactive (hypomania)
Abnormally fast heart rate, irregular and life-threatening heart rhythm, disturbances in heart rhythm (known as "QT interval prolongation", seen on ECG, the heart's electrical activity)
Effects on blood clotting (in patients treated with vitamin K antagonists)
Loss of consciousness due to severely low blood sugar levels (hypoglycemic coma). See section 2.

The use of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-term (even months or years) or permanent adverse reactions, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, burning, numbness, or pain (neuropathy), fatigue, memory and concentration impairment, effects on mental health (which may include 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.

Cases of enlargement and weakening or tearing of the aortic wall (aneurysms and dissections), which could lead to rupture and potentially be fatal, and heart valve insufficiency have been reported in patients receiving fluoroquinolones. See also section 2.

Reporting of adverse effects:

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

5. Storage of Ciprofloxacin Pensa

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging or on the blister, after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ciprofloxacin Pensa

The active substance 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.

Appearance of the product and contents of the pack

Film-coated tablets, round, white, smooth.

Each pack contains 1 or 14 tablets.

Only certain pack 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 the most recent revision of this leaflet: March 2025

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

Medical advice / Patient education

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

If your doctor has prescribed antibiotics, it is because they are specifically needed for your current illness.

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

Improper use of antibiotics increases resistance. You may even help bacteria become more resistant, thereby delaying your recovery or reducing antibiotic effectiveness if you do not comply with:

the dose
the schedule
the duration of treatment

Therefore, to maintain the effectiveness of this medicine:

Use antibiotics only when prescribed by a doctor.
Follow the prescription exactly.
Do not reuse an antibiotic without a medical prescription, even if you wish to treat a similar illness.
Never give your antibiotics to another person; they may not be suitable for their condition.
After completing a course of treatment, return all unused medicines to the pharmacy, to ensure they are properly disposed of.