PATIENT INFORMATION LEAFLET

Ciprofloxacin VIR 250 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Ciprofloxacino VIR is an antibiotic that belongs to the family of fluoroquinolones. The active ingredient is ciprofloxacin. 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
• 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

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 VIR.

Children and adolescents

Ciprofloxacin is used in children and adolescents, under specialized medical supervision, to treat the following bacterial infections:

• respiratory and bronchial infections in children and adolescents with cystic fibrosis
• complicated urinary tract infections, including kidney infections (pyelonephritis)
• exposure to carbuncle by inhalation

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

Do not take Ciprofloxacino VIR:

• if you are allergic (hypersensitive) to the active ingredient, to other quinolones or to any of the other components of Ciprofloxacino VIR (see section 6)
• if you are taking tizanidina (see section 2: Use of other medicines)

Be careful with Ciprofloxacino VIR:

Before starting to take this medicine

You should not take antibacterial medicines that contain fluoroquinolones or quinolones, including ciprofloxacin, if you have had a severe reaction to a quinolone or fluoroquinolone in the past. If this is the case, you should inform your doctor as soon as possible.

Inform your doctor if:

• you have ever had kidney problems because your treatment needs to be adjusted
• you suffer from epilepsy or other neurological conditions
• you have a history of tendon problems during previous treatment with antibiotics such as Ciprofloxacino VIR
• you suffer from myasthenia gravis (a type of muscle weakness)
• you have a history of abnormal heart rhythms (arrhythmias)
• if you have been diagnosed with an aneurysm of a large artery (aortic aneurysm or aneurysm of a large peripheral artery)
• if you have had a previous episode of aortic dissection (tearing of the aortic wall)
• if you have been diagnosed with heart valve insufficiency (regurgitation of the heart valves)
• if you have a family history of aortic aneurysm or aortic dissectioncongenital heart valve diseaseor other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome or Ehlers-Danlos syndrome,Sjögren's syndrome (an autoimmune inflammatory disease),or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension or known atherosclerosisarthritis (a joint disease) or endocarditis (a heart infection)).

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.

During treatment with this medicine

Inform your doctor immediately if any of the following situations occurwhile taking Ciprofloxacino VIR. Your doctor will decide whether to stop treatment with Ciprofloxacino VIR.

• 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 feeling dizzy when standing up.If this happens, do not take any more Ciprofloxacino VIR and contact your doctor immediately.

• Severe, incapacitating, prolonged, and potentially irreversible adverse effects.Antibacterial medicines that contain fluoroquinolones or quinolones, including Ciprofloxacino VIR, 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, burning or prickling (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 VIR, contact your doctor immediately, before continuing treatment. You and your doctor will decide whether to continue or stop treatment, also considering the use of another type of antibiotic.

• In rare cases, you may experiencejoint painand swellingand inflammation or rupture of tendons. The risk is higher if you are an elderly person (over 60 years old), have received an organ transplant. The first inflammation and tendon rupture can occur in the first 48 hours of treatment and even several months after stopping treatment with ciprofloxacin. If you experience any pain or inflammation of 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 experience asevere and sudden pain in the chest, abdomen or back, which may be symptoms of aortic dissection or aneurysm, go to the emergency department immediately. The risk may be increased if you are receiving systemic corticosteroids.

• If you start experiencing sudden shortness of breath, especially when lying down, or if you notice swelling in your legs, feet or abdomen, or palpitations (sensation of rapid or 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 Ciprofloxacino VIR 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 disorder.

• You may experiencepsychiatric reactionsfor the first time when you take ciprofloxacin. If you suffer fromdepressionorpsychosis, your symptoms may worsen with treatment with Ciprofloxacino VIR. If this occurs, stop taking Ciprofloxacino VIR and contact your doctor immediately.

• You may developdiarrheawhile taking antibiotics, including ciprofloxacin, or even several weeks after stopping them. If the diarrhea becomes intense or persistent, or if you notice that your stools contain blood or mucus, stop taking Ciprofloxacino VIR immediately, as this may put your life at risk. Do not take medications that slow down or delay intestinal movements and consult your doctor.

• If you experience anyvision changesor have any eye problems, consult an ophthalmologist immediately.

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

• While taking Ciprofloxacino VIR, inform your doctor or laboratory personnel if you need to undergo ablood or urine test.

• Ciprofloxacin may causeliver damage. If you notice symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching or stomach pain, stop taking Ciprofloxacino VIR immediately and consult your doctor immediately.

• Ciprofloxacin 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, 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.

Use of other medicines

Inform your doctor or pharmacist if you are using or have recently used other medicines, including those purchased without a prescription.

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 VIR”).

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

Inform your doctor if you are taking:

• warfarina or other oral anticoagulants (to thin the blood)
• probenecid (for gout)
• metotrexato (for certain types of cancer, psoriasis, rheumatoid arthritis)
• teofilina (for respiratory problems)
• tizanidina (for muscle spasticity in multiple sclerosis)
• clozapina (an antipsychotic)
• ropinirol (for Parkinson's disease)
• fenitoína (for epilepsy)

Ciprofloxacin may increase the levels of the following medicines in the blood:

• pentoxifilina (for circulatory disorders)
• caffeine

Some medicines reduce the effect of ciprofloxacin. Inform your doctor if you are taking or want to take:

• anti-acids
• mineral supplements
• sucralfato
• a polyelectrolyte phosphate binder (e.g. sevelamer)
• medicines or supplements containing calcium, magnesium, aluminum or iron

If these preparations are essential, take Ciprofloxacino VIR approximately two hours before orfour hours afteryou have taken these preparations.

Taking Ciprofloxacino VIR 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

It is preferable to avoid the use of ciprofloxacin during pregnancy. Inform your doctor if you plan to become pregnant.

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

Driving and operating machinery

Ciprofloxacin may reduce your alertness. You may experience some neurological effects. Make sure you know how you react to Ciprofloxacino VIR before driving a vehicle or operating machinery. If in doubt, consult your doctor.

Your doctor will explain exactly how much Ciprofloxacino VIR 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 5 to 21 days, but may be longer for severe infections. Take the tablets exactly as your doctor has instructed. If you have any doubts about how many tablets of Ciprofloxacino VIR to take and how to take them, ask your doctor or pharmacist how many tablets to 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 unpleasant.
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 Ciprofloxacino VIR tablets with dairy products such as milk or yogurt, or with fruit juices fortified with minerals (for example, orange juice fortified with calcium).

Remember to drink a large amount of liquids while taking Ciprofloxacino VIR.

If you take more Ciprofloxacino VIR 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 Toxicology Information Service. Phone: 91 562 04 20.

If you forget to take Ciprofloxacino VIR

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

If you interrupt treatment with Ciprofloxacino VIR

• 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. You may develop antibiotic resistance.

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

Like all medicines, Ciprofloxacino VIR can cause side effects, although not everyone will experience them.

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Frequent side effects(it is likely that they will occur in 1 to 10 people in every 100):

• nausea, diarrhea
• joint pain in children

Less frequent side effects(it is likely that they will occur in 1 to 10 people in every 1,000):

• superficial fungal infections
• an elevated concentration of eosinophils, a type of white blood cell
• loss of appetite (anorexia)
• hyperactivity or agitation
• headache, dizziness, sleep problems or taste disturbances
• vomiting, abdominal pain, digestive problems such as slow digestion (indigestion/acid reflux) or flatulence
• an increase in the amount 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
• an increase in alkaline phosphatase in the blood (a substance determined in the blood)

Rare side effects(it is likely that they will occur in 1 to 10 people in every 10,000):

• inflammation of the intestine (colitis) linked to the use of antibiotics (may be fatal in very rare cases) (see section 2: Be especially careful with Ciprofloxacino VIR)
• changes in the count of blood cells (leucopenia, leucocytosis, neutropenia, anemia), increase or decrease in the amounts of blood clotting factor (thrombocytes)
• allergic reaction, swelling (edema) or rapid swelling of the skin and mucous membranes (angioedema)
• an increase in blood sugar (hyperglycemia)
• confusion, disorientation, anxiety reactions, strange dreams, depression or hallucinations
• tingling and numbness, unusual sensitivity to sensory stimuli, decreased skin sensitivity, tremors, convulsions (see section 2: Be especially careful with Ciprofloxacino VIR) or dizziness
• vision problems
• tinnitus (ringing in the ears), hearing loss, hearing deterioration
• an increase in heart rate (tachycardia)
• expansion of blood vessels (vasodilation), decreased blood pressure or fainting
• difficulty breathing, including asthma-like symptoms
• liver problems, jaundice (icterus cholestatic), hepatitis
• sensitivity to light (see section 2: Be especially careful with Ciprofloxacino VIR)
• muscle pain, joint inflammation, increased muscle tone or cramps
• renal insufficiency, blood or crystals in the urine (see section 2: Be especially careful with Ciprofloxacino VIR), urinary tract inflammation
• fluid retention or excessive sweating
• abnormal levels of blood clotting factor (prothrombin) or increased concentrations of amylase enzyme

Very rare side effects(it is likely that they will occur in less than 1 person in every 10,000):

• a special type of decrease in the count of blood cells (hemolytic anemia), a dangerous decrease in a type of white blood cell (agranulocytosis), a decrease in the amount of white and red blood cells and platelets (pancytopenia), with a risk of death, and bone marrow depression, also with a risk of death (see section 2: Be especially careful with Ciprofloxacino VIR)
• severe allergic reactions (anaphylactic reaction or anaphylactic shock, with a risk of death - serum disease) (see section 2: Be especially careful with Ciprofloxacino VIR)
• mental disorders (psychotic reactions) (see section 2: Be especially careful with Ciprofloxacino VIR)
• migraine, coordination disorders, gait disturbances (gait disorders), olfactory disorders (olfactory disorders); increased intracranial pressure
• distorted color vision
• inflammation of the blood vessel wall (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 long tendon at the back of the ankle (Achilles tendon) (see section 2: Be especially careful with Ciprofloxacino VIR), worsening of myasthenia gravis symptoms (see section 2: Be especially careful with Ciprofloxacino VIR)

Unknown frequency(cannot be estimated from available data)

• problems associated with the nervous system such as pain, burning, tingling, numbness and/or weakness in the limbs
• severe anomalies of the heart rhythm, irregular heart rhythm (Torsades de Pointes)
• Syndrome associated with deficient water secretion and low sodium concentrations (SIADH, in English).

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, numbness or pain (neuropathy), fatigue, decreased memory and concentration, 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 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 side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not mentioned in this leaflet. You can also report them directly through the Spanish Medicines Vigilance System for Human Use:www.notificaRAM.es.

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

No requires special conditions for conservation.

Keep out of reach and sight of children.

Do not use Ciprofloxacino VIR after the expiration date that appears on the packaging or in the blister, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of your usual pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Ciprofloxacino VIR Composition

• The active ingredient is ciprofloxacin. Each tablet contains 250 mg of ciprofloxacin (as hydrochloride).
• The other components are Corn Starch, Microcrystalline Cellulose, Povidone, Anhydrous Colloidal Silica, Magnesium Stearate, Titanium Dioxide (E 171), Hypromellose, Macrogol 6000.

Product Appearance and Packaging Content

Coated tablets, round, white, and smooth.

Each package contains 1 or 14 tablets. Clinical Package with 500 tablets.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder and Responsible Manufacturer:

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/ Laguna 66-68-70, Urtinsa II Industrial Estate

28923 Alcorcón, Madrid

Spain

This leaflet was revised inMarch 2025

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