Leaflet: information for the user

ciprofloxacin cinfa 500 mg coated tablets EFG

ciprofloxacin hydrochloride

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

-Keep this leaflet, as you may need to read it again.

-If you have any questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you start taking ciprofloxacin cinfa

3.How to take ciprofloxacin cinfa

4.Possible side effects

5.Storage of ciprofloxacin cinfa

6.Contents of the pack and additional information

Ciprofloxacin Cinfa contains the active ingredient ciprofloxacin. Ciprofloxacin is an antibiotic that belongs to the family of fluoroquinolones.Ciprofloxacin acts by eliminating the bacteria thatcause infections. It only acts 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 bacteriaNeisseria meningitidis
• Exposure to carbuncle by inhalation.

Ciprofloxacin may be used to treat patients with low white blood cell count (neutropenia) who have suspected bacterial fever.

In cases of severe infection or infection caused by multiple types of bacteria, it is possible that you will be administered 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:

• Pulmonary and bronchial infections in children and adolescents with cystic fibrosis
• Complicated urinary tract infections, including kidney infections (pyelonephritis)
• Exposure to carbuncle by inhalation.

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

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 starting to take this medicine

You should not take fluoroquinolone or quinolone antibacterial medicines, 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.

Quinolone antibiotics can 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 cause a loss of consciousness (hypoglycemic coma) (see section 4). This is particularly important for people with diabetes. If you have diabetes, your blood sugar levels should be carefully controlled.

Consult your doctor before starting to take 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 myasthenia gravis (a type of muscle weakness), as symptoms may worsen,
• if you have been diagnosed with an enlarged or “bulge” of a large blood vessel (aortic aneurysm or a large peripheral vessel aneurysm),
• if you have had a previous episode of aortic dissection (tear in the wall of the aorta),
• if you have been diagnosed with heart valve insufficiency (regurgitation of heart valves),
• if you have a family history of aortic dissections, heart valve diseases, or other risk factors or predisposing conditions (e.g., connective tissue disorders such as 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, known atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)),
• if you have heart problems. You should exercise caution when taking ciprofloxacin if you have been born or have a family history of prolonged QT interval (seen on ECG, heart electrical recording), have electrolyte imbalances in the blood (especially low levels of potassium or magnesium), have a very slow heart rate (known as bradycardia), have a heart that is easily damaged (heart failure), have a history of heart attacks (myocardial infarction), you are a woman or an elderly patient, or you are taking other medicines that cause abnormal ECG changes (see section 2: “Other medicines and ciprofloxacin cinfa”),
• if you or a family member has glucose-6-phosphate dehydrogenase (G6PD) deficiency, 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 to stop taking ciprofloxacin.

• If you experience sudden and intense pain in the abdomen, chest, or back, which may be symptoms of aortic dissections or aneurysms, go to an emergency service immediately.

You may be at increased risk if you are receiving systemic corticosteroid treatment.

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

• Severe and sudden allergic reaction(anaphylactic reaction or 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 experience dizziness when standing up.If this happens, do not take any more ciprofloxacin and contact your doctor immediately.

Severe and incapacitating adverse effects, of prolonged duration, and potentially irreversible

• Fluoroquinolone or quinolone antibacterial medicines, including ciprofloxacin, 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, or burning (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 ciprofloxacin cinfa, contact your doctor immediately, before continuing treatment. You and your doctor will decide whether to continue or not with the treatment, also considering the use of another class of antibiotic.

• In rare cases, you may experiencejoint pain and swelling, inflammation, or tendon rupture.The risk is higher if you are an elderly person (over 60 years old), have received an organ transplant, have kidney problems, or are taking corticosteroids. Tendon inflammation and rupture can occur in the first 48 hours of treatment and even several months after stopping ciprofloxacin treatment. If you experience any pain or inflammation of a tendon (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking ciprofloxacin cinfa, 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 haveepilepsyor anotherneurological condition, such as ischemia or cerebral infarction, you may experience adverse effects associated with the central nervous system. Ifyou experience seizures, stop taking ciprofloxacin and contact your doctor immediately.

• In rare cases, you may experience symptoms ofnerve damage (neuropathy)such as pain, burning, tingling, numbness, and/or weakness, especially in your 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 condition.

• You may experiencepsychiatric reactionsfor the first time when taking ciprofloxacin cinfa. If you havedepressionorpsychosis, your symptoms mayworsenwith ciprofloxacin treatment. In rare cases, depression or psychosis may progress to suicidal thoughts, attempts, or completed suicide. If this occurs, stop taking ciprofloxacin cinfa and contact your doctor immediately.

• You may developdiarrheawhile taking antibiotics, including ciprofloxacin, or even several weeks after stopping them. If diarrhea becomes severe or persistent, or if you notice that your stools contain blood or mucus, stop taking ciprofloxacinand contact your doctor immediately, as this may put your life at risk. Do not take any medicines that slow down or delay bowel movements.

• If yourvisionbecomes worse or if you experience any other eye changes, consult an ophthalmologist immediately.

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

• While takingciprofloxacin, inform your doctor or laboratory staff if you need to undergo ablood or urine test.

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

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

• Ciprofloxacinmay 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, you should consult your doctor immediately. A blood test will be performed to examine the possible decrease in white blood cells (agranulocytosis). It is essential to inform your doctor about your medication.

Other medicines and ciprofloxacin cinfa

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

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: “What you need to know before starting to takeciprofloxacin cinfa”).

We know 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 risk of adverse effects.

Inform your doctor if you are taking:

• anticoagulant medicines (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, or 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)
• ciclosporin (for skin diseases, rheumatoid arthritis, and organ transplants)
• other medicines that can alter your heart rhythm: antiarrhythmic medicines (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (which belong to the macrolide group), some antipsychotics
• zolpidem (for sleep disorders).

Ciprofloxacin mayincreasethe levels of the following medicines in your blood:

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

Some medicinesreducethe effect ofciprofloxacin. Inform your doctor if you are taking or wish to take:

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

If these preparations are essential, takeciprofloxacinapproximatelytwo hours before or four hours afteryou have taken these preparations.

Taking ciprofloxacin cinfa with food and drinks

Although you take ciprofloxacin with meals, you should 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

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medicine.

It is preferable to avoid the use of ciprofloxacin during pregnancy.

Do not take ciprofloxacin during breastfeeding, as ciprofloxacin is excreted through breast milk and may cause harm to 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 ciprofloxacin before driving a vehicle or operating 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; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication 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 from5 to21 days, but may last longer for severe infections.

• Swallow the tablets with a large amount of liquid. Do not chew the tablets as 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 (for example, orange juice enriched with calcium).

Remember to drink a large amount of liquids while taking this medication.

The groove is only for breaking the tablet if it is 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, bring 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to takeciprofloxacin cinfa

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 compensate for the missed dose. Make sure to complete the treatment cycle.

If you interrupt the treatment with ciprofloxacin cinfa

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 return or worsen. You may develop antibiotic resistance.

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

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

The following section contains the most serious side effects that you may be able to recognize yourself:

Stop taking ciprofloxacin and contact your doctor immediatelyto consider alternative antibiotic treatment if you notice any of the following serious side effects:

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

• convulsions (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 reaction or shock) (see section 2: “Warnings and precautions”),
• muscle weakness, tendon inflammation that can lead to tendon rupture, especially the Achilles tendon (see section 2: “Warnings and precautions”),
• skin eruptions 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, that can progress to generalized blistering or skin peeling (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Frequency unknown(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 reaction to a drug that causes skin rash, fever, internal organ inflammation, hematological changes, and systemic disease (DRESS - Drug Reaction with Eosinophilia and Systemic Symptoms, PEAG - Acute Generalized Pustular Erythroderma).

Other side 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 inflammation in children.

Infrequent(may affect up to 1 in 100 people):

-joint pain in adults,

-superinfections caused by fungi,

-elevated eosinophil count, a type of white blood cell,

-loss of appetite,

-hyperactivity or agitation,

-headache, dizziness, sleep problems or taste disturbances,

-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 dysfunction,

-muscle and bone pain, feeling unwell (asthenia) or fever,

-increased alkaline phosphatase in the blood (a substance determined in the blood).

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

-muscle pain, joint inflammation, increased muscle tone, and cramps,

-inflammation of the intestine (antibiotic-associated colitis) linked to the use of antibiotics (can be fatal in rare cases) (see section 2: “Warnings and precautions”),

-changes in blood cell counts (leucopenia, leucocytosis, neutropenia, anemia), increased or decreased levels of a blood clotting factor (thrombocytes),

-allergic reaction, swelling (edema) or rapid swelling of the skin and mucous membranes (angioedema) (see section 2: “Warnings and precautions”),

-increased blood sugar (hyperglycemia),

-decreased blood sugar (hypoglycemia) (see section 2: “Warnings and precautions”),

-confusion, disorientation, anxiety reactions, strange dreams, depression (potentially leading to suicidal thoughts, attempts, or completed suicides) (see section 2: “Warnings and precautions”), or hallucinations,

-sensations of 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, or deterioration of hearing,

-abnormally fast heart rate,

-expansion of blood vessels (vasodilation), decreased blood pressure, or fainting,

-difficulty breathing, including asthma-like symptoms,

-liver problems, jaundice (cholestatic jaundice), hepatitis,

-sensitivity to light (see section 2: “Warnings and precautions”),

-renal insufficiency, blood or crystals in the urine, urinary tract inflammation,

-fluid retention or excessive sweating,

-increased amylase levels.

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

-a type of severe decrease in red blood cell count (hemolytic anemia), a dangerous decrease in a type of white blood cell count (agranulocytosis) (see section 2: “Warnings and precautions”), a decrease in the number of white blood cells 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, attempts, or completed suicides) (see section 2: “Warnings and precautions”),

-migraine, coordination disorders, gait disturbances, olfactory disorders; increased intracranial pressure and pseudotumor cerebri,

-distorted color vision,

-inflammation of blood vessel walls (vasculitis),

-pancreatitis,

-liver cell death (hepatic necrosis), which very rarely leads to liver insufficiency with a risk of death (see section 2: “Warnings and precautions”),

-small pinpoint hemorrhages under the skin (petechiae), various skin eruptions or exanthems,

-exacerbation of myasthenia gravis symptoms (see section 2: “Warnings and precautions”).

Frequency unknown(cannot be estimated from available data):

-syndrome associated with deficient water secretion and low sodium concentrations (SIADH, for its English acronym),

-feeling extremely excited (mania) or a feeling of great optimism and hyperactivity (hypomania),

-abnormally fast heart rate, irregular heart rhythm with life-threatening risk, alteration of heart rhythm (called “prolongation of the QT interval”, observed in the ECG, heart electrical activity),

-influence on blood coagulation (in patients treated with vitamin K antagonists),

-loss of consciousness due to 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 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, 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 thoughts), 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 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 that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Usehttps://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

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

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Ciprofloxacin Cinfa Composition

• The active ingredient is ciprofloxacin (hydrochloride). Each coated tablet contains 500 mg of ciprofloxacin (hydrochloride).
• The other components are: sodium croscarmellose, microcrystalline cellulose (E-460), anhydrous colloidal silica, cornstarch gluten-free, 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 packaging contents

ciprofloxacin cinfa 500 mgis presented in the form of coated tablets, white in color, oval-shaped, 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 commercially marketed.

Marketing authorization holder and responsible manufacturer

Cinfa Laboratories, S.A.

Olaz-Chipi 10 Highway. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:January 2025

For detailed and updated information on this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information on this medication by scanning the QR code included in the leaflet and packaging with your 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

Advice/medical education

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

If your doctor has prescribed antibiotics, you need them specifically for your current illness.

Even with antibiotics, some bacteria may survive or grow. This phenomenon is known as resistance: some antibiotic treatments become ineffective.

Abuse of antibiotics increases resistance. You can even help bacteria become more resistant and delay your recovery or reduce the effectiveness of antibiotics if you do not respect:

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

As a result, in order to maintain the effectiveness of this medication:

1. Use antibiotics only when prescribed.
2. Follow the prescription strictly.
3. Do not reuse an antibiotic without a doctor's prescription, even if you want to treat a similar illness.
4. Never give your antibiotic to someone else; 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.