Ciprofloxacin CINFA 500 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

ciprofloxacin cinfa 500 mg film-coated tablets EFG

ciprofloxacin hydrochloride

Read all of this leaflet carefully before you start taking this medicine, as 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 other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

Adults

Ciprofloxacin cinfa 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

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

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 along with 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)
• inhalational 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 starting to take ciprofloxacin cinfa

Do not take ciprofloxacin cinfa

• if you are allergic to ciprofloxacin, to other quinolones, or to 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 taking this medicine

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

Quinolone antibiotics can cause an increase in your blood sugar levels above normal (hyperglycaemia), or a decrease in your blood sugar levels below normal, which in severe cases may lead to loss of consciousness (hypoglycaemic coma) (see section 4). This is particularly important for people with diabetes. If you have diabetes, your blood sugar level should be closely monitored.

Talk to your doctor before starting to take ciprofloxacin cinfa

• if you have ever had kidney problems, as your treatment may need adjustment,
• 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 hypoglycaemia with ciprofloxacin,
• if you have myasthenia gravis (a type of muscle weakness), as symptoms may worsen,
• if you have been diagnosed with an enlarged blood vessel or a “lump” in a large blood vessel (aortic aneurysm or peripheral large-vessel aneurysm),
• if you have previously experienced aortic dissection (tearing of the aortic wall),
• if you have been diagnosed with heart valve insufficiency (regurgitation of heart valves),
• if you have a family history of aortic dissection or aortic aneurysm, congenital heart valve disease, 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 inflammatory autoimmune disease), vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, known hypertension, atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)),
• if you have heart problems. Caution is required when administering ciprofloxacin if you were born with or have a family history of QT interval prolongation (seen on ECG, the electrical recording of the heart), have electrolyte imbalances in the blood (especially low potassium or magnesium levels), have a very slow heart rate (known as bradycardia), have a weak heart (heart failure), have a history of heart attacks (myocardial infarction), are female or elderly, or are taking other medicines that cause abnormal changes in the ECG (see section 2: “Other medicines and ciprofloxacin cinfa”),
• if you or a family member has glucose-6-phosphate dehydrogenase (G6PD) deficiency, as you may be at risk of anaemia with ciprofloxacin.

For the treatment of certain 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 occur while you are taking ciprofloxacin. Your doctor will decide whether it is necessary to stop treatment with ciprofloxacin.

• If you experience sudden and severe pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go immediately to an emergency department.

The risk may increase if you are receiving systemic corticosteroid treatment.

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

• Sudden and severe 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 feel dizzy upon standing. If this happens, do not take any more ciprofloxacin and contact your doctor immediately.

Severe, disabling, long-lasting, and potentially irreversible adverse effects

• Antibacterial medicines containing fluoroquinolones or quinolones, including ciprofloxacin, 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 tendon, muscle, and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, numbness, or burning (paraesthesia), sensory disturbances such as decreased 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 cinfa, 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.

• Rarely, joint pain and swelling, or tendon inflammation or rupture may occur. The risk is higher if you are elderly (over 60 years), have had an organ transplant, have kidney problems, or are taking corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment or even several months after stopping ciprofloxacin. At the first sign of tendon pain or swelling (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking ciprofloxacin cinfa, contact your doctor, and rest the affected area. Avoid unnecessary physical activity, as this may increase the risk of tendon rupture.

• If you have epilepsy or another neurological condition, such as cerebral ischaemia or stroke, you may experience adverse effects related to the central nervous system. If seizures occur, stop taking ciprofloxacin 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 and inform your doctor immediately to prevent potentially irreversible damage.

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

• Diarrhoea may develop while you are taking antibiotics, including ciprofloxacin, or even several weeks after stopping them. If diarrhoea becomes severe or persistent, or if you notice blood or mucus in your stools, stop taking ciprofloxacin and contact your doctor immediately, as this could be life-threatening. Do not take medicines that stop or delay intestinal movements.

• If your vision worsens or you experience any other eye problems, consult an ophthalmologist immediately.

• Your skin may become more sensitive to sunlight or ultraviolet (UV) light while taking ciprofloxacin. Avoid exposure to intense sunlight or artificial UV light, such as tanning beds.

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

• If you have kidney problems, inform your doctor, as your dose may need adjustment.

• 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, consult your doctor immediately.

• 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 signs of local infection such as sore throat/pharynx/mouth, or urinary problems, contact your doctor immediately. A blood test will be performed to check for possible reduction in white blood cells (agranulocytosis). It is important to inform your doctor about your medication.

Other medicines and ciprofloxacin cinfa

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

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 take ciprofloxacin cinfa”).

The following medicines are known to interact with ciprofloxacin in your body. Taking ciprofloxacin at the same time as these medicines may affect their therapeutic effect and may increase the risk of adverse 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),
• ciclosporin (for skin diseases, rheumatoid arthritis, and organ transplantation),
• other medicines that may alter your heart rhythm: medicines belonging to the antiarrhythmic group (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (macrolide group), some antipsychotics,
• zolpidem (for sleep disorders).

Ciprofloxacin may increase blood levels of the following medicines:

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

Some medicines decrease the 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 containing calcium, magnesium, aluminium, or iron.

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

Taking ciprofloxacin cinfa with food and drink

Although you may take ciprofloxacin with meals, do not consume any dairy products (such as milk or yoghurt) or calcium-fortified drinks at the same time as 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

It is preferable to avoid using ciprofloxacin during pregnancy.

Do not take ciprofloxacin 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 before driving or operating machinery. If in doubt, consult your doctor.

ciprofloxacin cinfa contains sodium

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

3. How to take ciprofloxacin cinfa

Follow exactly the instructions for use of this medicine as given by your doctor. If in 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 your dose may need to be adjusted.

Treatment usually lasts from 5 to 21 days, but may last longer for severe infections.

• 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 tablets with dairy products such as milk or yoghurt, or with fortified fruit juices (for example, calcium-fortified orange juice).

Remember to drink plenty of fluids while taking this medicine.

The score line is intended only for breaking the tablet if you have difficulty swallowing it whole.

If you take more ciprofloxacin cinfa than you should

If you take more than prescribed, seek medical help immediately. If possible, bring the tablets or the pack with you to show the doctor.

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

If you forget to take ciprofloxacin cinfa

Take the missed dose as soon as possible, and 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 forgotten doses. Be sure to complete the full course of treatment.

If you stop taking ciprofloxacin cinfa

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 develop resistance to the antibiotic.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The following section includes the most serious adverse effects that you can recognize yourself:

Stop taking ciprofloxacin and contact your doctor immediately to consider alternative antibiotic treatment if you experience 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 upon standing (anaphylactic reaction or shock) (see section 2: "Warnings and precautions"),
• muscle weakness, tendon inflammation which may lead to tendon rupture, especially of the long tendon at the back of the ankle (Achilles tendon) (see section 2: "Warnings and precautions"),
• skin rashes with risk of death, usually appearing as blisters or ulcers in the mouth, throat, nose, eyes, and other mucous membranes such as the genitals, which may progress to widespread 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 causing skin rash, fever, internal organ inflammation, blood abnormalities, and systemic illness (DRESS - Drug Reaction with Eosinophilia and Systemic Symptoms, AGEP - Acute Generalized Exanthematous Pustulosis).

Other adverse effects observed during treatment with ciprofloxacin are listed below according to their frequency:

Common (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,
• elevated levels of eosinophils, a type of white blood cell,
• loss of appetite,
• hyperactivity or restlessness,
• headache, dizziness, sleep disturbances, 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,
• impaired kidney function,
• muscle and bone pain, feeling unwell (asthenia), or fever,
• increased blood alkaline phosphatase (a blood parameter).

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

• muscle pain, joint swelling, increased muscle tone, and cramps,
• inflammation of the intestine (colitis) associated with antibiotic use (may be fatal in very rare cases) (see section 2: "Warnings and precautions"),
• changes in blood cell counts (leukopenia, leukocytosis, neutropenia, anemia), increase or decrease in the levels of a blood clotting factor (platelets),
• 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, suicide attempts, or completed suicides) (see section 2: "Warnings and precautions"), or hallucinations,
• tingling and numbness sensations, unusual sensitivity to sensory stimuli, reduced skin sensitivity, tremors, or dizziness,
• vision problems (including double vision) (see section 2: "Warnings and precautions"),
• 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 asthma-like symptoms,
• liver disorders, jaundice (cholestatic jaundice), hepatitis,
• sensitivity to light (see section 2: "Warnings and precautions"),
• kidney failure, blood or crystals in urine, inflammation of the urinary tract,
• fluid retention or excessive sweating,
• increased levels of amylase enzyme.

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

• a specific type of reduction in red blood cell count (hemolytic anemia), a dangerous decrease in a type of white blood cells (agranulocytosis) (see section 2: "Warnings and precautions"), a reduction in both white and red blood cells and platelets (pancytopenia), with risk of death, and bone marrow suppression, also with 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, unsteadiness when walking (gait disorders), disturbances in the sense of smell (olfactory disorders); increased pressure in the brain (intracranial pressure and pseudotumor cerebri),
• visual distortions of colors,
• inflammation of blood vessel walls (vasculitis),
• pancreatitis,
• liver cell death (hepatic necrosis), which very rarely leads to life-threatening liver failure (see section 2: "Warnings and precautions"),
• small pinpoint bleeding under the skin (petechiae), various skin rashes or exanthems,
• worsening of symptoms of myasthenia gravis (see section 2: "Warnings and precautions").

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

• syndrome associated with inadequate water excretion and low sodium levels (SIADH),
• feeling extremely excited (mania) or sensation of excessive optimism and hyperactivity (hypomania),
• abnormally fast heart rate, irregular and life-threatening heart rhythm, disturbances in heart rhythm (called "QT interval prolongation," observed on ECG, the heart's electrical activity),
• effects on blood clotting (in patients treated with vitamin K antagonists),
• loss of consciousness due to severe drop 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-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, pins and needles, burning, numbness, or pain (neuropathy), fatigue, reduced memory and concentration, effects on mental health (which may include sleep disorders, anxiety, panic attacks, depression, and suicidal thoughts), as well as reduced 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 may 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of ciprofloxacin cinfa

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of ciprofloxacin Cinfa

• The active substance 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, gluten-free maize starch, sodium lauryl sulfate, magnesium stearate (E-470b), talc (E-553b), hypromellose (E-464), titanium dioxide (E-171), and macrogol 400.

Appearance of the medicine and contents of the pack

ciprofloxacin Cinfa 500 mg is presented as white, oval, film-coated tablets marked with the code “C500C” on one side and scored on the other.

The coated tablets are packaged in PVC-PVDC/aluminum blisters. Each pack contains 1, 8, 10, 14, 16, or 20 coated tablets.

Only some pack 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 latest review of this leaflet: January 2025

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

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

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

Medical advice / Patient 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.

Despite antibiotic treatment, some bacteria may survive or grow. This phenomenon is known as resistance: some antibiotic treatments become ineffective.

Inappropriate use of antibiotics increases resistance. You may even help bacteria become more resistant, thereby delaying your recovery or reducing the effectiveness of antibiotics if you do not follow:

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

Therefore, in order to maintain the effectiveness of this medicine:

1. Use antibiotics only when prescribed.
2. Follow the prescription exactly.
3. Do not reuse an antibiotic without a medical prescription, even if you wish to treat a similar illness.
4. Never give your antibiotics to another person; it may not be suitable for their condition.
5. After completing a course of treatment, return any unused medicines to the pharmacy to ensure they are properly disposed of.