Leaflet: information for the user

Cetraxal 100 mg/ml oral suspension

Ciprofloxacin

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, consult 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 isCetraxaland what it is used for

2. What you need to know before starting to takeCetraxal

3. How to takeCetraxal

4. Possible side effects

5. Storage ofCetraxal

6. Contents of the pack and additional information

Cetraxal is an antibiotic that belongs to the family of fluoroquinolones. The active ingredient is ciprofloxacin. Ciprofloxacin acts by eliminating the bacteria that cause infections. It only acts on specific strains of bacteria.

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 intrabdominal 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 bacteriaNeisseria meningitidis
• exposure to carbuncle by inhalation

In the event of a severe infection or if the infection is caused by more than one type of bacteria, it is possible that you will be administered an 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 kidney infections (pyelonephritis)
• exposure to carbuncle by inhalation

Cetraxal may also be used for the treatment of severe infections in children and adolescents when necessary.

Do not take Cetraxal:

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

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

Warnings and precautions

Before starting to take this medicine

Do not take antibacterial medicines that contain fluoroquinolones or quinolones, including Cetraxal, if you have had a severe reaction to a quinolone or fluoroquinolone in the past. If this is the case, inform your doctor as soon as possible.

Inform your doctor if:

• you have ever had kidney problems, as your treatment needs to be adjusted in this case.
• you suffer from epilepsy or other neurological conditions.
• you have a history of tendon problems during previous antibiotic treatment with 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 your symptoms may worsen.
• if you have been diagnosed with an enlarged or "bulge" of a large blood vessel (aortic aneurysm or peripheral aneurysm of a large vessel).
• 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 ofaortic dissection or aneurysms, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., connective tissue disorders such as Marfan syndrome or 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, hypertension, or atherosclerosis known, rheumatoid arthritis (a joint disease) or endocarditis (a heart infection)

• if you have heart problems. Be cautious when administering 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 in the blood), have a very slow heart rate (known as bradycardia), have a fragile heart (heart failure), have a history of heart attacks (myocardial infarction), you are a woman or an elderly person, or are taking other medicines that result in abnormal ECG changes (see section 2. Taking Cetraxal with other medicines).

• if you or a family member has a deficiency in 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 occurwhile taking Cetraxal. Your doctor will decide whether to discontinue treatment with Cetraxal.

• Severe and sudden allergic reaction(anaphylactic reaction, 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 occurs, do not take more Cetraxal and contact your doctor immediately.

• Severe and incapacitating adverse effects, of prolonged duration, and potentially irreversible.Certain antibiotics that contain fluoroquinolones or quinolones, including Cetraxal, 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 pain, and joint pain in the upper and lower extremities, 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 Cetraxal, contact your doctor immediately, before continuing treatment. You and your doctor will decide whether to continue or discontinue treatment, considering also 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 discontinuing Cetraxal treatment. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Cetraxal, contact your doctor, and keep the affected area at rest. Avoid unnecessary exercise, as this may increase the risk of tendon rupture.

• If you experience asevere and sudden chest, abdominal, or back pain,which may be symptoms of aortic dissection or aneurysm,go to the emergency room immediately. You may be at increased risk if you are receiving systemic corticosteroids.

• If you suffer fromepilepsyor anotherneurological condition, such as ischemia or cerebral infarction, you may experience adverse effects associated with the central nervous system. If this occurs, stop taking Cetraxal and contact your doctor immediately.

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

• 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 important for people with diabetes. If you have diabetes, your blood sugar levels should be carefully controlled.

• In rare cases, you may experience symptoms ofnerve damage (neuropathy)such as pain, burning, numbness, tingling, 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.

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

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

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

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

• Cetraxal may cause a decrease in white blood cell count and possiblydecrease 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, 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.

• 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 yourvisionbecomes worse or if you experience any other eye changes, 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 if you experience palpitations (rapid or irregular heartbeat), inform your doctor immediately.

Use of Cetraxal with other medicines

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

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

We know that the following medicines interact with Cetraxal in your body. If you take Cetraxal at the same time as these medicines, this may affect the therapeutic effect of these medicines. It may also increase the likelihood of adverse effects.

Inform your doctor if you are taking:

• anticoagulant medications (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 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)

Cetraxal 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 medicinesdecreasethe effect of Cetraxal. Inform your doctor if you are taking or wish to take:

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

If these preparations are essential, take Cetraxal approximatelytwohours before orfourhours after taking these preparations.

Taking Cetraxal with food and drinks

Although you take Cetraxal with meals, do 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 lactation

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

It is preferable to avoid using Cetraxal during pregnancy.

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

Driving and operating machines

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

Cetraxal contains soy lecithin

Soy lecithin

This medicine contains lecithin derived from soy oil. Do not use it if you are allergic to peanuts or soy.

Follow exactly the administration instructions of this medication 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, as it may be necessary to adjust your dose.

The treatment usually lasts from 5 to 21 days, but may last longer for severe infections. Take the oral suspension exactly as your doctor has indicated. Ask your doctor or pharmacist if you are unsure how much to take and how to take Cetraxal.

Administration of the suspension

Follow these instructions:

1. Shake the bottle well before each administration.

2. Open the suspension bottle. The first time, place the stopper that comes with the packaging.

3. Insert the dosing syringe.

4. Extract the amount of product indicated by your doctor.

5. Administer the dose indicated directly with the dosing syringe.

6. Wash the dosing syringe after each dose.

7. Do not remove the stopper 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 not take the Cetraxal suspension with dairy products such as milk or yogurt, or with fruit juices enriched with minerals (for example, orange juice enriched with calcium).

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

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

If you interrupt the treatment with Cetraxal

• It is essentialthat you complete the treatment, even if you start to feel better after a few days. If you stop taking this medication too soon, your infection may not have been fully cured and symptoms may worsen again. 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 Cetraxal and contact your doctor immediatelyto consider another 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 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, internal organ inflammation, hematological changes, and systemic disease (DRESS - Drug Reaction with Eosinophilia and Systemic Symptoms, PEAG - Acute Generalized Exanthematous Pustulosis).

Other side effects that have been observed during treatment with Baycip are listed belowaccording to the probability that they present:

Frequent:may affect up to 1 in 10 people

• nausea, diarrhea
• joint pain and inflammation in children

Occasional:may affect up to 1 in 100 people

• joint pain in adults
• superinfections (by fungi)
• high 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/acid reflux) or flatulence
• increased levels of certain substances in the blood (transaminases and/or bilirubin)
• skin rash, itching, or hives
• renal function impairment
• 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 (colitis) associated with antibiotic use (can be fatal in rare cases) (see section 2: Warnings and precautions)
• changes in blood cell count (leucopenia, leucocytosis, neutropenia, anemia), increased or decreased levels of a blood clotting factor (thrombocytes)
• severe allergic reaction, swelling (edema), or rapid swelling of the skin and mucous membranes (angioedema) (see section 2: Warnings and precautions)
• high blood sugar (hyperglycemia)
• low 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
• 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
• increased heart rate (tachycardia)
• vasodilation, decreased blood pressure, or fainting
• breathing difficulties, including asthma-like symptoms
• liver problems, jaundice (icterus), hepatitis
• light sensitivity (see section 2: Warnings and precautions)
• renal insufficiency, blood or crystals in the urine, urinary tract inflammation
• fluid retention or excessive sweating
• increased 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 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
• a type of 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 (gait disorders), olfactory disorders (olfactory disorders); increased intracranial pressure and pseudotumor cerebri
• color vision distortions
• inflammation of the blood vessel wall (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
• emergence of symptoms of myasthenia gravis (see section 2: Warnings and precautions)
• Frequency not known: 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 feeling extremely optimistic and hyperactive (hypomania)
• abnormally fast heart rhythm, irregular heart rhythm with a risk to life, 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, unusual sensations such as pinching, tingling, burning, numbness, or pain (neuropathy), depression, fatigue, sleep disturbances, memory loss, and loss of 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 adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use https://www.notificaram.es.

By reporting adverse 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 usethis medicationafter the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

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), polisorbate 20, ethylcellulose N-50, glycyrrhizic acid, sodium bicarbonate, sodium saccharin, sodium cyclamate, sorbic acid, almond flavor (contains propylene glycol (E-1520), triacetin (E-1518), ethanol, and glycerol (E-422)), sweetened condensed milk flavor (contains propylene glycol (E-1520)), and estasan 3575.

Appearance of Cetraxal and contents of the package

Oral suspension of yellowish color and almond and sweetened condensed milk flavor and odor.

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

Marketing authorization holder and responsible manufacturer

Salvat Laboratories, S.A.

C/ Gall 30-36 - 08950

Esplugues de Llobregat

Barcelona (Spain)

Last review date of this leafletJanuary 2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

Advice/medical education

Antibiotics are used to cure 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 treatment 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.