CETRAXAL 100mg/ml ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

Cetraxalxal 100 mg/ml Oral Suspension

Ciprofloxacin

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Cetraxal and what is it used for
2. What you need to know before taking Cetraxal
3. How to take Cetraxal
4. Possible side effects
5. Storage of Cetraxal
6. Package contents and additional information

1. What is Cetraxal and what is it used for

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

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or the common cold.

It is essential to follow the instructions regarding dosage, administration interval, and treatment duration as indicated by your doctor.

Do not store or reuse this medication. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medications down the drain or in the trash.

Adults

Cetraxal is used in adults to treat the following bacterial infections:

• respiratory tract infections
• long-term or recurrent ear or sinus infections
• urinary tract infections
• testicular infections
• female genital organ infections
• gastrointestinal and intra-abdominal infections
• skin and soft tissue infections
• bone and joint infections
• treatment of infections in patients with a very low white blood cell count (neutropenia)
• prevention of infections in patients with a very low white blood cell count (neutropenia)
• prevention of infections caused by the bacteria Neisseria meningitidis
• inhalation exposure to anthrax

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 Cetraxal.

Children and Adolescents

Cetraxal 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 those that have reached the kidneys (pyelonephritis)
• inhalation exposure to anthrax

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

2. What you need to know before taking Cetraxal

Do not take Cetraxal:

• if you are allergic to the active ingredient, other quinolones, soy lecithin, or any of the other components of Cetraxal (listed in section 6).

• if you are taking tizanidine (see section 2: Use of Cetraxal with other medications).

Warnings and Precautions

Before starting to take this medication

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

Tell your doctor if:

• you have ever had kidney problems, as your treatment may need to be adjusted
• you suffer from epilepsy or other neurological disorders
• you have a history of tendon problems during previous treatment with antibiotics like Cetraxal
• you are diabetic, as you may be at risk of hypoglycemia with ciprofloxacin
• you suffer from myasthenia gravis (a type of muscle weakness), as symptoms may worsen
• if you have been diagnosed with an aneurysm of a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm).
• if you have had a previous episode of aortic dissection (tear in the aortic wall).
• If you have been diagnosed with a heart valve disorder (regurgitation of the heart valves).
• If you have a family history of aortic dissection or aneurysm, 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), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, high blood pressure, or atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection).

• if you have heart problems. Caution should be exercised when administering ciprofloxacin if you have been born with or have a family history of prolonged QT interval (seen on an ECG, 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), are a woman, or are elderly, or are taking other medications that result in abnormal ECG changes (see section 2: Taking Cetraxal with other medications).

• 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.

While taking Cetraxal:

Inform your doctor immediately if any of the following situations occur while taking Cetraxal. Your doctor will decide whether it is necessary to interrupt treatment with Cetraxal.

• Severe and sudden allergic reaction(anaphylactic reaction or shock, 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 experiencing dizziness when standing up. If this occurs, do not take any more Cetraxal and contact your doctor immediately.

• Severe, disabling, and potentially irreversible side effects.Antibacterial medications containing fluoroquinolones or quinolones, including Cetraxal, have been associated with very rare but severe 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 Cetraxal, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or not continue treatment, 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 higher if you are an elderly person (over 60 years old), have received an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even several months after stopping treatment with Cetraxal. At the first sign of pain or inflammation of a tendon (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Cetraxal, contact your doctor, and rest the affected area. Avoid any unnecessary exercise, as this could increase the risk of tendon rupture.

• If you experience severe and sudden chest, abdominal, or back painthat may be symptoms of aortic dissection or aneurysm, go to the emergency room immediately. The risk may increase if you are receiving systemic corticosteroid treatment.

• If you have epilepsyor another neurological disorder, such as cerebral ischemia or infarction, you may experience central nervous system side effects. If this occurs, stop taking Cetraxal and contact your doctor immediately.

• You may experience psychiatric reactionsthe first time you take Cetraxal. If you experience depressionor psychosis, your symptoms may worsen with Cetraxal treatment. In rare cases, depression or psychosis may progress to suicidal thoughts and self-harming behaviors, such as attempted suicide or completed suicide (see section 4. Possible side effects). If you experience depression, psychosis, suicidal thoughts, or self-harming behaviors, stop taking Cetraxal and contact your doctor immediately.

• 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.

• 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 occurs, stop taking Cetraxal and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

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

While taking Cetraxal, inform your doctor or laboratory personnel if you need to undergo a blood or urine test.

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

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

• Cetraxal may cause a decrease in your white blood cell count and may decrease your resistance to infections. If you experience an infection with symptoms such as fever or 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 essential to inform your doctor about your medication.

• Your skin becomes more sensitive to sunlight or ultraviolet (UV) light when taking Cetraxal. Avoid exposure to intense sunlight or artificial UV light, such as tanning beds.

If your visionworsens or if you have any other eye disorders, consult an ophthalmologist immediately.

• If you start experiencing sudden shortness of breath, especially when lying down, or if you notice swelling in your ankles, feet, or abdomen, or the appearance of heart palpitations (feeling of rapid or irregular heartbeat), inform your doctor immediately.

Use of Cetraxal with other medications

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, including those obtained without a prescription.

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

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

Tell 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 medications that may alter your heart rhythm: antiarrhythmic medications (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (belonging to the macrolide group), some antipsychotics
• zolpidem (for sleep disorders)

Cetraxal may increaseblood levels of the following medications:

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

Some medications decreasethe effect of Cetraxal. 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)
• medications or supplements containing calcium, magnesium, aluminum, or iron

If these preparations are essential, take Cetraxal approximately twohours before or fourhours after taking these preparations.

Taking Cetraxal with food and drinks

Although you can take Cetraxal with meals, you should not eat or drink any dairy products (such as milk or yogurt) or beverages with added calcium when taking the oral suspension, as this may affect the absorption of the active ingredient.

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 medication.

It is recommended to avoid using Cetraxal during pregnancy.

Do not take Cetraxal during breastfeeding, as ciprofloxacin is excreted in breast milk and may harm your baby.

Driving and using machines

Cetraxal may decrease your alertness. Some neurological effects may occur. Therefore, make sure you know how you react to Cetraxal before driving a vehicle or using a machine. If in doubt, consult your doctor.

Cetraxal contains soy lecithin

Soy lecithin

This medication contains soy lecithin derived from soybean oil. You should not use it if you are allergic to peanuts or soy.

3. How to take Cetraxal

Follow the administration instructions for this medication exactly as indicated by your doctor. He will explain exactly how much Cetraxal you should take, how often, and for how long. This will depend on the type of infection you have and its severity. In case of doubt, consult your doctor or pharmacist again.

Inform your doctor if you have kidney problems because it may be necessary to adjust your dose.

Treatment usually lasts from 5 to 21 days, but it can last longer for severe infections. Take the oral suspension exactly as your doctor has indicated. Ask your doctor or pharmacist if you are not sure how much to take and how to take Cetraxal.

Taking the suspension

Follow these instructions:

1. Shake the bottle well before each administration.
2. Open the suspension bottle. The first time, place the accompanying stopper plug.
3. Insert the dosing syringe.
4. Extract the amount of product indicated by your doctor.
5. Administer the indicated dose directly with the dosing syringe.
6. Wash the dosing syringe after each intake.
7. Do not remove the stopper plug and close the bottle.

You can take Cetraxal with or between meals. The calcium you take as part of a meal will not seriously affect absorption. However, do nottake the Cetraxal suspension with dairy products such as milk or yogurt, or with fruit juices enriched with minerals (e.g., calcium-enriched orange juice).

Remember to drink a large amount of liquids while taking Cetraxal.

Try to take the medication at the same time every day.

If you take more Cetraxal than you should

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

You can also call the Toxicology Information Service, phone 91 562 04 20.

If you forget to take Cetraxal

• If there are 6 hours or more until your next dose, take the forgotten dose immediately. Then take the next dose at your usual time.
• If there are less than 6 hours until your next dose, do not take the forgotten dose. Take the next dose at your usual time.

If you interrupt treatment with Cetraxal

• It is important 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 symptoms may 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 side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

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

Stop taking Cetraxal and contact your doctor immediatelyto consider another treatment with antibiotics if you notice any of the following serious side 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 reaction or 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 alterations, and systemic disease (DRESS - Drug Reaction with Eosinophilia and Systemic Symptoms, PEAG - Generalized Acute Pustular Exanthema).

Other side effects that have been observed during treatment with Baycip 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
• an increase in the amount 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
• an increase in blood alkaline phosphatase levels

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

• muscle pain, joint inflammation, increased muscle tone, and muscle cramps
• inflammation of the intestine (colitis) associated with the use of antibiotics (can be fatal in very rare cases) (see section 2: Warnings and precautions)
• changes in blood cell count (leukopenia, leukocytosis, neutropenia, anemia), increase or decrease in blood clotting factor levels (thrombocytes)
• allergic reaction, swelling (edema), or rapid swelling of the skin and mucous membranes (angioedema) (see section 2: Warnings and precautions)
• an increase in blood sugar levels (hyperglycemia)
• a decrease in 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
• 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, hearing impairment
• an increase in heart rate (tachycardia)
• expansion of blood vessels (vasodilation), decrease in blood pressure, or fainting
• difficulty breathing, including asthmatic 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
• an increase in amylase enzyme levels

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 amount of white and red blood cells and platelets (pancytopenia), with a risk of death, and bone marrow depression, also with a risk of death
• an allergic reaction called a 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); brain pressure (intracranial pressure and pseudotumor cerebri)
• visual distortions of colors
• inflammation of the blood vessel wall (vasculitis)
• pancreatitis
• death of liver cells (liver necrosis), which can very rarely lead 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, by its English acronym).
• feeling very excited (mania) or feeling great optimism and hyperactivity (hypomania)
• abnormally fast heart rate, irregular heart rate with life-threatening risk, heart rhythm disorder (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 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 can include sleep disorders, anxiety, panic attacks, depression, and suicidal thoughts), and decreased hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

There have been reports of an increase in size and weakening or tearing of the aortic wall (aneurysms and dissections), which could lead to rupture and be fatal, and heart valve failure 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 prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines https://www.notificaram.es.

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

5. Conservation of Cetraxal

Keep this medication out of 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.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and unused medications at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medications. This way, you will help protect the environment.

6. Package contents and additional information

Cetraxal composition

• The active ingredient is ciprofloxacin. Each ml of oral solution contains 100 mg of ciprofloxacin (as base).
• The other components (excipients) are: soy lecithin (E-322), mannitol (E-421), polysorbate 20, ethylcellulose N-50, ammonium glycyrrhizate, sodium bicarbonate, sodium saccharin, sodium cyclamate, sorbic acid, nut flavor (contains propylene glycol (E-1520), glycerol triacetate (E-1518), ethanol, and glycerol (E-422)), condensed milk flavor (contains propylene glycol (E-1520)), and estasan 3575.

Cetraxal appearance and package contents

Yellowish oral suspension with a nut and condensed milk flavor and aroma.

Each package contains a bottle with 100 ml of suspension and a dosing syringe.

Marketing authorization holder and manufacturer

Laboratorios Salvat, S.A.

C/ Gall 30-36 - 08950

Esplugues de Llobregat

Barcelona (Spain)

Date of the last revision of this prospectusMay 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/

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 can 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 decrease 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 finishing a treatment, return all unused medications to the pharmacy, to ensure they are disposed of correctly.