Ciprofloxacin Vir 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ciprofloxacin VIR 500 mg film-coated tablets EFG

Read the entire 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 only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents

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. How to store Ciprofloxacin VIR
6. Further information

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

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

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 exposure to anthrax

If you have a severe infection or if the infection is caused by more than one type of bacteria, you may be given additional antibiotic treatment alongside 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)
• inhalational exposure to anthrax

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

2. Before taking 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 components of Ciprofloxacin VIR (see section 6)
• if you are taking tizanidine (see section 2: Use of other medicines)

Take special care with Ciprofloxacin VIR:

Before starting treatment with this medicine

You should not take antibacterial medicines containing fluoroquinolones or quinolones, including ciprofloxacin, if you have previously experienced a serious adverse reaction while taking a quinolone or fluoroquinolone. If this applies to you, inform your doctor as soon as possible.

Tell your doctor if:

• you have ever had kidney problems, as your treatment may need adjustment
• you suffer from epilepsy or other neurological conditions
• you have a history of tendon problems during previous treatment with antibiotics such as Ciprofloxacin VIR
• you have myasthenia gravis (a type of muscle weakness)
• you have a history of abnormal heart rhythms (arrhythmias)
• you have been diagnosed with enlargement or a "bulge" in a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm)
• you have previously experienced aortic dissection (tearing of the aortic wall)
• you have been diagnosed with heart valve insufficiency (cardiac valve regurgitation)
• 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, or Sjögren's syndrome (an inflammatory autoimmune disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, known hypertension or atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).

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

During treatment with this medicine

Inform your doctor immediately if any of the following situations occur while taking Ciprofloxacin VIR. Your doctor will decide whether treatment with Ciprofloxacin VIR should be discontinued.

• Severe 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 symptoms such as chest tightness, dizziness, nausea, or fainting, or dizziness upon standing. If this happens, do not take any more Ciprofloxacin VIR and contact your doctor immediately.

• Severe, disabling, long-lasting, and potentially irreversible adverse effects. Antibacterial medicines containing fluoroquinolones or quinolones, including Ciprofloxacin VIR, 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 pain in tendons, muscles, and joints of the upper and lower limbs, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, numbness, or burning (paresthesia), sensory disturbances such as reduced vision, taste, smell, or hearing, depression, memory impairment, severe fatigue, and serious sleep disorders.

If you experience any of these adverse effects after taking Ciprofloxacin VIR, 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 received 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 VIR. At the first sign of tendon pain or swelling (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Ciprofloxacin VIR, contact your doctor, and rest the affected area. Avoid unnecessary physical activity, as this may increase the risk of tendon rupture.

• If you experience sudden, severe pain in the chest, abdomen, or back, which may be symptoms of aortic dissection or aneurysm, seek immediate emergency medical attention. The risk may be increased if you are receiving systemic corticosteroid treatment.

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

• If you have epilepsy or another neurological condition, such as cerebral ischemia or stroke, you may experience adverse effects related to the central nervous system. If this occurs, stop taking Ciprofloxacin VIR 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 VIR and contact your doctor immediately to prevent potentially irreversible damage.

• You may experience psychiatric reactions the first time you take Ciprofloxacin VIR. If you have depression or psychosis, your symptoms may worsen during treatment with Ciprofloxacin VIR. In rare cases, depression or psychosis may progress to suicidal thoughts, suicide attempts, or completed suicide. If this occurs, contact your doctor immediately.

• Diarrhea may develop while 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 VIR immediately, as this may be life-threatening. Do not take medications that stop or delay intestinal movements and consult your doctor.

• If you experience any changes in vision or eye problems, consult an ophthalmologist immediately.

• Your skin may become 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 VIR, inform your doctor or laboratory staff if you need to undergo a blood or urine test.

• 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, stop taking Ciprofloxacin VIR immediately and consult your doctor.

• Ciprofloxacin may reduce your 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 local infection symptoms such as sore throat/pharynx/mouth or urinary problems, contact 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.

Use of other medicines

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

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

The following medicines are known to interact with ciprofloxacin in your body. Taking Ciprofloxacin VIR 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:

• 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 increase blood levels of the following medicines:

• pentoxifylline (for circulatory disorders)
• caffeine

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

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

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

Taking Ciprofloxacin VIR with food and drink

Although you may take ciprofloxacin with meals, do not consume any dairy products (such as milk or yoghurt) or drinks fortified with calcium at the same time as the tablets, as they may affect the absorption of the active substance.

Pregnancy and breastfeeding

It is preferable to avoid using ciprofloxacin during pregnancy. Inform your doctor if you are planning to become pregnant.

Do not take Ciprofloxacin VIR 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 VIR before driving or operating machinery. 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.

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 last longer for severe infections. Take the tablets exactly as your doctor has instructed. If you have any doubts about how many tablets of Ciprofloxacin VIR you should 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 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 VIR tablets with dairy products such as milk or yoghurt, or with fruit juices fortified with minerals (e.g. calcium-fortified 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 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 04 20.

If you forget to take Ciprofloxacin VIR

??Take the missed dose as soon as possible, then continue your treatment as prescribed. However, if it is almost time for your next dose, skip the missed dose and continue with your regular schedule. 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 VIR

??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 product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Ciprofloxacin VIR may produce adverse effects, although not everyone experiences them.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, please inform your doctor or pharmacist.

Frequent adverse effects (likely to affect between 1 and 10 out of every 100 people):

• nausea, diarrhoea
• joint pain in children

Uncommon adverse effects (likely to affect between 1 and 10 out of every 1,000 people):

• fungal superinfections (due to fungi)
• elevated levels of eosinophils, a type of white blood cell
• loss of appetite (anorexia)
• hyperactivity or agitation
• headache, dizziness, sleep disturbances, or taste disorders
• vomiting, abdominal pain, digestive problems such as slow digestion (indigestion/heartburn) or flatulence
• increased levels of certain substances in the blood (transaminases and/or bilirubin)
• skin rash, itching, or hives
• joint pain in adults
• impaired kidney function
• muscle and bone pain, feeling of malaise (asthenia), or fever
• increased blood alkaline phosphatase (a blood substance)

Rare adverse effects (likely to affect between 1 and 10 out of every 10,000 people):

• inflammation of the intestine (colitis) associated with antibiotic use (can be fatal in very rare cases) (see section 2: Take special care with Ciprofloxacin VIR)
• changes in blood cell counts (leucopenia, leucocytosis, neutropenia, anaemia), increase or decrease in levels of blood clotting factor (platelets)
• allergic reaction, swelling (oedema), or rapid swelling of the skin and mucous membranes (angioedema)
• increased blood sugar (hyperglycaemia)
• confusion, disorientation, anxiety reactions, strange dreams, depression, or hallucinations
• tingling and numbness sensations, unusual sensitivity to sensory stimuli, decreased skin sensitivity, tremors, seizures (see section 2: Take special care with Ciprofloxacin VIR), or dizziness
• vision problems
• tinnitus (ringing in the ears), hearing loss, or hearing impairment
• increased heart rate (tachycardia)
• dilation 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 Ciprofloxacin 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 Ciprofloxacin VIR), inflammation of the urinary tract
• fluid retention or excessive sweating
• abnormal levels of clotting factor (prothrombin) or increased amylase enzyme concentrations

Very rare adverse effects (likely to affect fewer than 1 in 10,000 people):

• a specific type of decreased blood cell count (haemolytic anaemia), a dangerous decrease in a type of white blood cells (agranulocytosis), a decrease in red and white blood cells and platelets (pancytopenia), with risk of death, and bone marrow suppression, also with risk of death (see section 2: Take special care with Ciprofloxacin VIR)
• severe allergic reactions (anaphylactic reaction or anaphylactic shock, with risk of death – serum sickness) (see section 2: Take special care with Ciprofloxacin VIR)
• mental disorders (psychotic reactions) (see section 2: Take special care with Ciprofloxacin VIR)
• migraine, coordination disorder, unsteadiness when walking (gait disorders), disturbances in the sense of smell (olfactory disorders); pressure in the brain (intracranial pressure)
• visual distortions of colours
• inflammation of the blood vessel walls (vasculitis)
• pancreatitis
• liver cell death (hepatic necrosis), which very rarely leads to liver failure with risk of death
• small pinpoint bleeding under the skin (petechiae), various skin rashes or exanthems (e.g., Stevens-Johnson syndrome with 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: Take special care with Ciprofloxacin VIR), worsening of symptoms of myasthenia gravis (see section 2: Take special care with Ciprofloxacin VIR)

Frequency not known (cannot be estimated from available data):

• nervous system-related problems such as pain, burning, tingling, numbness, and/or weakness in the limbs
• serious heart rhythm problems, irregular heartbeat (Torsades de Pointes)
• syndrome associated with insufficient water excretion and low sodium levels (SIADH).

The administration 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, tickling, 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.

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 via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ciprofloxacin VIR

No special storage conditions are required.

Keep out of the reach and sight of children.

Do not use Ciprofloxacin VIR 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 medicines and their containers at the SIGRE collection point located at your usual pharmacy. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Ciprofloxacin VIR

• The active substance is ciprofloxacin. Each tablet contains 500 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.

Appearance of the product and contents of the pack

Film-coated tablets, round, white and smooth.

Each pack contains 1 or 14 tablets. Clinical pack 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 leaflet was last reviewed in March 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es