CIPROFLOXACIN VIR 500 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ciprofloxacin VIR 500 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack

1. What Ciprofloxacin VIR is and what it is used for
2. Before you take Ciprofloxacin VIR
3. How to take Ciprofloxacin VIR
4. Possible side effects
5. Storing Ciprofloxacin VIR
6. Further information

1. What CIPROFLOXACIN VIR is and what it is used for

Ciprofloxacin VIR is an antibiotic that belongs to the family of fluoroquinolones. The active substance is ciprofloxacin. Ciprofloxacin works by killing the bacteria that cause infections. It only works with 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 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

In case you suffer from a 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 VIR.

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)
• inhalation exposure to anthrax

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

2. Before you take Ciprofloxacin VIR

Do not take Ciprofloxacin VIR:

• if you are allergic (hypersensitive) to the active substance, to other quinolones, or to any of the other ingredients of Ciprofloxacin VIR (see section 6)
• if you are taking tizanidine (see section 2: Use of other medicines)

Be cautious with Ciprofloxacin VIR:

Before starting to take this medicine

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

Tell your doctor if:

• you have ever had kidney problems, as your treatment may need to be adjusted
• you suffer from epilepsy or other neurological conditions
• you have a history of tendon problems during previous treatment with antibiotics like Ciprofloxacin VIR
• you suffer from severe myasthenia (a type of muscle weakness)
• you have a history of abnormal heart rhythms (arrhythmias)
• if you have been diagnosed with an enlarged or "bulging" of a large blood vessel (aortic aneurysm or large peripheral vessel aneurysm)
• if you have had a previous episode of aortic dissection (tear in 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 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, or atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection))

Tell your doctor if you or a family member has a confirmed deficiency of glucose-6-phosphate dehydrogenase (G6PD), as you may be at risk of anemia with ciprofloxacin.

During treatment with this medicine

Immediately inform your doctor if any of the following situations occur while taking Ciprofloxacin VIR. Your doctor will decide whether it is necessary to interrupt treatment with Ciprofloxacin VIR.

• Severe and sudden 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 the following symptoms: chest tightness, dizziness, nausea, or fainting, or you may experience dizziness when standing up. If this happens, do not take any more Ciprofloxacin VIR and contact your doctor immediately.

• Severe, disabling, and potentially irreversible side effects.Antibacterial medicines that contain fluoroquinolones or quinolones, including Ciprofloxacin VIR, have been associated with very rare but severe side effects, some of which were long-lasting (persisting 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 VIR, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or not, also considering the use of an antibiotic from another class.

• In rare cases, you may experience pain and swelling of the joints and inflammation or rupture of the 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 being treated with corticosteroids. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even several months after stopping treatment with Ciprofloxacin VIR. At the first sign of pain or inflammation of a tendon (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Ciprofloxacin VIR, contact your doctor, and rest the affected area. Avoid any unnecessary exercise, as this may increase the risk of tendon rupture.

• If you feel a strong and sudden pain in the chest, abdomen, or back, which can be symptoms of aortic dissection or aneurysm, go to the emergency room immediately. The risk may be increased if you are receiving systemic corticosteroid treatment.
• If you start experiencing sudden 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.

• If you suffer from epilepsyor other neurological conditions, such as cerebral ischemia or infarction, you may experience side effects associated with the central nervous system. If this occurs, stop taking Ciprofloxacin VIR and contact your doctor immediately.

• In rare cases, 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 happens, stop taking Ciprofloxacin VIR and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

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

• You may develop diarrheawhile taking antibiotics, including ciprofloxacin, or even several weeks after stopping them. If the diarrhea becomes severe or persistent, or if you notice that the stools contain blood or mucus, stop taking Ciprofloxacin VIR immediately, as this can be life-threatening. Do not take medicines that stop or slow down bowel movements, and consult your doctor.

• If you experience any vision changesor have any eye problems, 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 booths.

• While taking Ciprofloxacin VIR, inform your doctor or laboratory staff if you need to undergo a blood or urine test.

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

• Ciprofloxacin can cause a decrease in the white blood cell count and 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.

Use of other medicines

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

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 VIR").

It is known that the following medicines interact with ciprofloxacin in your body. If you take Ciprofloxacin VIR at the same time as these medicines, this may affect the therapeutic effect of these medicines. It may also increase the likelihood of experiencing side effects.

Tell your doctor if you are taking:

• warfarin 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)
• clozapine (an antipsychotic)
• ropinirole (for Parkinson's disease)
• phenytoin (for epilepsy)

Ciprofloxacin may increaseblood levels of the following medicines:

• pentoxifylline (for circulatory disorders)
• caffeine

Some medicines decreasethe effect of ciprofloxacin. Tell your doctor if you are taking or want to take:

• antacids
• mineral supplements
• sucralfate
• a polymeric phosphate binder (e.g., sevelamer)
• medicines or supplements that contain calcium, magnesium, aluminum, or iron

If these preparations are essential, take Ciprofloxacin VIR approximately twohours before or four hours aftertaking these preparations.

Taking Ciprofloxacin VIR 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

It is recommended to avoid using ciprofloxacin during pregnancy. Inform your doctor if you plan to become pregnant.

Do not take Ciprofloxacin VIR 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 VIR before driving a vehicle or using a machine. If in doubt, consult your doctor.

3. How to take Ciprofloxacin VIR

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

Treatment usually lasts from 5 to 21 days, but may last longer for severe infections. Take the tablets exactly as your doctor has indicated. If you are unsure about how many Ciprofloxacin VIR tablets to take or how to take them, ask your doctor or pharmacist.

• 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 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 medicine. However, do not take Ciprofloxacin VIR tablets with dairy products such as milk or yogurt, or with fruit juices enriched with minerals (e.g., calcium-enriched orange juice).

Remember to drink plenty of fluids while taking Ciprofloxacin VIR.

If you take more Ciprofloxacin VIR than you should

If you take more than the prescribed amount, seek medical help immediately. If possible, take 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 Ciprofloxacin VIR

If you miss a dose, take it as soon as possible and then continue with the 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 stop taking Ciprofloxacin VIR

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 medicine too soon, your infection may not be completely cured, and your symptoms may worsen. You may develop resistance to the antibiotic.

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

4. Possible Adverse Effects

Like all medicines, Ciprofloxacino VIR can cause adverse effects, although not all people suffer from them.

If you consider that any of the adverse effects you suffer from is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Frequent Adverse Effects(it is likely that they will affect between 1 and 10 out of every 100 people):

• nausea, diarrhea
• joint pain in children

Infrequent Adverse Effects(it is likely that they will affect between 1 and 10 out of every 1,000 people):

• fungal superinfections
• a high concentration of eosinophils, a type of white blood cell
• loss of appetite (anorexia)
• hyperactivity or agitation
• headache, dizziness, sleep problems or taste disorders
• vomiting, abdominal pain, digestive problems such as slow digestion (indigestion/acid reflux) or flatulence
• increased levels of certain substances in the blood (transaminases and/or bilirubin)
• skin rash, itching or hives
• joint pain in adults
• renal impairment
• muscle and bone pain, feeling of discomfort (asthenia) or fever
• increased alkaline phosphatase in blood (a blood-determined substance)

Rare Adverse Effects(it is likely that they will affect between 1 and 10 out of every 10,000 people):

• inflammation of the intestine (colitis) related to the use of antibiotics (can be fatal in very rare cases) (see section 2: Take special care with Ciprofloxacino VIR)
• changes in blood cell count (leukopenia, leukocytosis, neutropenia, anemia), increase or decrease in blood coagulation factor quantities (thrombocytes)
• allergic reaction, swelling (edema) or rapid swelling of the skin and mucous membranes (angioedema)
• increased blood sugar (hyperglycemia)
• confusion, disorientation, anxiety reactions, strange dreams, depression or hallucinations
• tingling and numbness sensation, unusual sensitivity to sensory stimuli, decreased skin sensitivity, tremors, convulsions (see section 2: Take special care with Ciprofloxacino VIR) or dizziness
• vision problems
• tinnitus (ringing in the ears), hearing loss, hearing impairment
• increased heart rate (tachycardia)
• expansion of blood vessels (vasodilation), decreased blood pressure or fainting
• difficulty breathing, including asthmatic symptoms
• liver disorders, jaundice (cholestatic jaundice), hepatitis
• sensitivity to light (see section 2: Take special care with Ciprofloxacino VIR)
• muscle pain, joint inflammation, increased muscle tone or cramps
• renal failure, blood or crystals in the urine (see section 2: Take special care with Ciprofloxacino VIR), inflammation of the urinary tract
• fluid retention or excessive sweating
• abnormal levels of coagulation factor (prothrombin) or increased concentrations of amylase enzyme

Very Rare Adverse Effects(it is likely that they will affect less than 1 in 10,000 people):

• a special type of decrease in blood cell count (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: Take special care with Ciprofloxacino VIR)
• severe allergic reactions (anaphylactic reaction or anaphylactic shock, with a risk of death - serum sickness) (see section 2: Take special care with Ciprofloxacino VIR)
• mental disorders (psychotic reactions) (see section 2: Take special care with Ciprofloxacino VIR)
• migraine, coordination disorder, instability when walking (gait disorders), disorders of the sense of smell (olfactory disorders); pressure in the brain (intracranial pressure)
• visual color distortions
• inflammation of the blood vessel wall (vasculitis)
• pancreatitis
• death of liver cells (necrosis), which very rarely leads to liver failure with a risk of death
• small pinpoint hemorrhages under the skin (petechiae), various skin rashes or exanthems (e.g., Stevens-Johnson syndrome with a risk of death or toxic epidermal necrolysis)
• muscle weakness, tendon inflammation, tendon rupture - especially the long tendon of the back of the ankle (Achilles tendon) (see section 2: Take special care with Ciprofloxacino VIR), worsening of myasthenia gravis symptoms (see section 2: Take special care with Ciprofloxacino VIR)

Unknown Frequency(cannot be estimated from the available data)

• problems associated with the nervous system such as pain, burning, tingling, numbness, and/or weakness in the limbs
• serious heart rhythm disorders, irregular heart rhythm (Torsades de Pointes)
• syndrome associated with deficient water secretion and low sodium concentrations (SIADH, for its acronym in English)

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, prickling, burning, 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.

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 cardiac valve failure in patients who have received fluoroquinolones. See also section 2.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Medication Pharmacovigilance System: www.notificaRAM.es.

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

5. Conservation of Ciprofloxacino VIR

It does not require special storage conditions.

Keep out of the reach and sight of children.

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

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point of your usual pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Ciprofloxacino VIR

• The active ingredient is ciprofloxacin. Each tablet contains 500 mg of ciprofloxacin (as hydrochloride).
• The other components are Cornstarch, microcrystalline cellulose, povidone, anhydrous colloidal silica, magnesium stearate, titanium dioxide (E 171), hypromellose, macrogol 6000.

Appearance of the Product 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 Manufacturer

Marketing authorization holder and manufacturer:

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

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

28923 Alcorcón, Madrid

Spain

This prospectus was revised in March 2025

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