CIPROFLOXACIN CINFA 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

ciprofloxacin cinfa 500 mg film-coated tablets EFG

ciprofloxacin hydrochloride

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

• Keep this package 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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is ciprofloxacin cinfa and what is it used for
2. What you need to know before you take ciprofloxacin cinfa
3. How to take ciprofloxacin cinfa
4. Possible side effects
5. Storage of ciprofloxacin cinfa
6. Contents of the pack and further information

1. What is ciprofloxacin cinfa and what is it used for

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

Adults

ciprofloxacin cinfa 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 bacterium 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 case 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, in addition to ciprofloxacin.

Children and adolescents

ciprofloxacin cinfa 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 cinfa may also be used to treat severe infections in children and adolescents when your doctor considers it necessary.

2. What you need to know before you take ciprofloxacin cinfa

Do not takeciprofloxacin cinfa

• if you are allergic to ciprofloxacin, other quinolones, or any of the other ingredients of this medicine (listed in section 6).
• if you are taking tizanidine (see section 2: “Other medicines and ciprofloxacin cinfa”).

Warnings and precautions

Before you start taking this medicine

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

Quinolone antibiotics may cause an increase in your blood sugar levels above normal levels (hyperglycemia) or a decrease in your blood sugar levels below 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.

Consult your doctor before taking ciprofloxacin cinfa

• 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 such as 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 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 dissections or aneurysms, congenital heart valve disorders, or other risk factors or predisposing conditions (e.g., Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, or Sjögren's syndrome (an autoimmune inflammatory disease), vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)),
• if you have heart problems. Caution should be exercised when administering ciprofloxacin if you were born with or have a family history of prolonged QT interval (seen on the ECG, the electrical recording of the heart), have an 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), you are a woman or an elderly patient, or are taking other medicines that result in abnormal ECG changes (see section 2: “Other medicines and ciprofloxacin cinfa”),
• 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.

During treatment with this medicine

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 sudden and severe abdominal, chest, or back pain, which may be symptoms of aortic dissection or aneurysm, go immediately to the emergency room.

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 small chance 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 medicines that contain fluoroquinolones or quinolones, including ciprofloxacin, have been associated with very rare but serious 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, tingling, prickling, numbness, or burning (paresthesia), 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 cinfa, 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, pain and swelling in the joints and inflammation or rupture of the tendonsmay occur. The risk is greater 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. At the first sign of pain or inflammation of a tendon (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking ciprofloxacin cinfa, contact your doctor, and rest the affected area. Avoid any unnecessary exercise, as this could increase the risk of tendon rupture.

• If you have epilepsyor other neurological conditions, such as cerebral ischemia or infarction, you may experience side effects associated with the central nervous system. If seizures occur, stop taking ciprofloxacin 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 and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

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

• Diarrheamay develop while you are taking antibiotics, including ciprofloxacin, or even several weeks after you have stopped taking them. If the diarrhea becomes severe or persistent, or if you notice that the stools contain blood or mucus, stop taking ciprofloxacin and contact your doctor immediately, as this can be life-threatening. Do not take medicines that stop or slow down bowel movements.

• If your visionworsens or if you have any other eye changes, consult an eye specialist 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, inform your doctor or laboratory personnel that you are taking this medicine if you need to have a blood or urine test.

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

• 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, consult your doctor immediately.

• 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, you should consult your doctor immediately. They will perform a blood test to examine the possible decrease in white blood cells (agranulocytosis). It is important that you inform your doctor about your medicine.

Other medicines and ciprofloxacin cinfa

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

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: “What you need to know before you take ciprofloxacin cinfa”).

It is known that the following medicines interact with ciprofloxacin in your body. If you take ciprofloxacin at the same time as these medicines, this may affect the therapeutic effect of these medicines. It may also increase the likelihood of you 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 medicines that may alter your heart rhythm: antiarrhythmic medicines (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (that belong to the macrolide group), some antipsychotics
• zolpidem (for sleep disorders).

Ciprofloxacin may increasethe blood levels of the following medicines:

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

Some medicines 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)
• medicines or supplements that contain calcium, magnesium, aluminum, or iron.

If these preparations are essential, take ciprofloxacin approximately 2 hours before or 4 hours afteryou have taken these preparations.

Taking ciprofloxacin cinfa 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 drinks 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is preferable to avoid the use of 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 ciprofloxacin affects you before driving a vehicle or using a machine. If in doubt, consult your doctor.

ciprofloxacin cinfa contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take ciprofloxacin cinfa

Follow the administration instructions for this medication exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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.

Inform 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.

• Swallow the tablets with a large amount of liquid. Do not chew the tablets because their taste is not pleasant.
• Try to take the tablets at the same time every 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 medication. However, do not take 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.

The score line is only for breaking the tablet if you find it difficult to swallow it whole.

If you take moreciprofloxacin cinfathan you should

If you take a larger amount than prescribed, seek medical help immediately. If possible, take the tablets or the box with you to show the doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to takeciprofloxacin cinfa

Take the normal dose as soon as possible and then continue 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 interrupt treatment with ciprofloxacin cinfa

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 the symptoms may return or worsen. You may develop resistance to the antibiotic.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people experience them.

The following section contains the most serious adverse 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 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 and sudden allergic reaction with symptoms such as chest tightness, dizziness, nausea, or fainting, or experiencing dizziness when standing up (anaphylactic shock) (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"),
• skin rashes with a risk of death, 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 Exanthema).

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

Frequent(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,
• an elevated concentration of eosinophils, a type of white blood cell,
• decreased appetite,
• hyperactivity or agitation,
• headache, dizziness, sleep problems, 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,
• renal impairment,
• muscle and bone pain, feeling of discomfort (asthenia) or fever,
• increased blood alkaline phosphatase levels.

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 (can be fatal 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 (thrombocytopenia),
• allergic reaction, swelling (edema), or rapid swelling of the skin and mucous membranes (angioedema) (see section 2: "Warnings and precautions"),
• increased blood sugar levels (hyperglycemia),
• decreased blood sugar levels (hypoglycemia) (see section 2: "Warnings and precautions"),
• confusion, disorientation, anxiety reactions, unusual dreams, depression (potentially leading to suicidal thoughts, suicide attempts, or completed suicides) (see section 2: "Warnings and precautions"), or hallucinations,
• tingling and 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, deterioration of hearing,
• 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,
• sensitivity to light (see section 2: "Warnings and precautions"),
• renal failure, blood or crystals in the urine, inflammation of the urinary tract,
• fluid retention or excessive sweating,
• increased amylase enzyme levels in the blood.

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, suicide attempts, or completed suicides) (see section 2: "Warnings and precautions"),
• migraine, coordination disorder, instability when walking (gait disorders), disorders of the sense of smell (olfactory disorders); increased pressure in the brain (intracranial pressure and pseudotumor cerebri),
• visual distortions of colors,
• inflammation of the blood vessel wall (vasculitis),
• pancreatitis,
• death of liver cells (hepatic 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 deficient water secretion and low sodium levels (SIADH),
• feeling very excited (mania) or feeling very optimistic and hyperactive (hypomania),
• abnormally fast heart rate, irregular heartbeat with life-threatening risk, alteration of heart rhythm (called "QT interval prolongation", observed in the ECG, heart electrical activity),
• influence on blood coagulation (in patients treated with vitamin K antagonists),
• loss of consciousness due to a severe decrease in 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 (which may include sleep disorders, anxiety, panic attacks, depression, and suicidal ideas), as well as 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 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 is not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of ciprofloxacin cinfa

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of ciprofloxacin cinfa

• The active ingredient is ciprofloxacin (hydrochloride). Each coated tablet contains 500 mg of ciprofloxacin (hydrochloride).
• The other ingredients are: sodium croscarmellose, microcrystalline cellulose (E-460), colloidal anhydrous silica, gluten-free cornstarch, sodium lauryl sulfate, magnesium stearate (E-470b), talc (E-553b), hypromellose (E-464), titanium dioxide (E-171), and macrogol 400.

Appearance of the product and package contents

Ciprofloxacin cinfa 500 mg is presented in the form of coated tablets, white, oval, marked with the code "C500C" on one side and scored on the other.

The coated tablets are packaged in PVC-PVDC/Aluminum blisters. Each package contains 1, 8, 10, 14, 16, and 20 coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the last revision of this leaflet:January 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/

You can access detailed and updated information about this medication by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/62765/P_62765.html

QR code to: https://cima.aemps.es/cima/dochtml/p/62765/P_62765.html

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, therefore, delay your recovery or reduce the effectiveness of antibiotics if you do not respect:

• the dose,
• the program,
• the duration of treatment.

Consequently, to maintain the effectiveness of this medication:

1. Use antibiotics only when they are 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.