Cetraxal 100 mg/ml oral suspension: detailed information

Patient Information Leaflet

Introduction

Patient Information Leaflet

Cetraxal 100 mg/ml oral suspension

Ciprofloxacin

Read the entire 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 and must not be given to other people, even if they have the same symptoms as you. It could harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

What Cetraxal is and what it is used for
What you need to know before taking Cetraxal
How to take Cetraxal
Possible side effects
How to store Cetraxal
Contents of the pack and other information

1. What Cetraxal is and what it is used for

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

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

It is important that you follow your doctor's instructions regarding dosage, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left after completing treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via the drain or in household waste.

Adults

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

respiratory tract infections
long-lasting or recurrent ear or sinus infections
urinary tract infections
infections of the testicles
infections of the female genital organs
gastrointestinal and intra-abdominal tract 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 bacterium Neisseria meningitidis
inhalational anthrax exposure

If you have a severe infection or if the infection is caused by more than one type of bacteria, you may receive additional antibiotic treatment alongside 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 infections that have reached the kidneys (pyelonephritis)
inhalational anthrax exposure

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

2. What you need to know before starting to take Cetraxal

Do not take Cetraxal:

if you are allergic to the active substance, 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 this medicine

You should not take antibacterial medicines containing fluoroquinolones or quinolones, including Cetraxal, 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.

Tell your doctor if:

you have ever had kidney problems, as your treatment may need adjustment
you suffer from epilepsy or other neurological conditions
you have a history of tendon problems during previous treatment with antibiotics such as Cetraxal
you are diabetic, as you may be at risk of hypoglycaemia with ciprofloxacin
you suffer from myasthenia gravis (a type of muscle weakness), as symptoms may worsen
you have been diagnosed with enlargement or a "bulge" in a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm)
you have previously experienced an episode of aortic dissection (tear in the wall of the aorta)
you have been diagnosed with heart valve insufficiency (regurgitation of heart valves)
you have a family history of aortic dissection or aneurysm, congenital heart valve disease, or other risk factors or predisposing disorders (e.g., connective tissue disorders such as Marfan syndrome or Ehlers-Danlos syndrome, Turner syndrome, or Sjögren's syndrome (an inflammatory autoimmune disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, known hypertension or atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection))
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 levels of potassium or magnesium), 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. Use of Cetraxal with other medicines).
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.

While taking Cetraxal:

Inform your doctor immediately if any of the following occur while taking Cetraxal. Your doctor will decide whether treatment with Cetraxal should be discontinued.

Sudden, 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 feeling dizzy upon standing. If this occurs, do not take any more Cetraxal and contact your doctor immediately.
Severe, disabling, long-lasting, and potentially irreversible adverse effects. Antibacterial medicines containing fluoroquinolones or quinolones, including Cetraxal, 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 pain in tendons, muscles, and joints of the upper and lower limbs, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, numbness, or burning (paraesthesia), sensory disturbances such as reduced vision, taste, smell, or hearing, depression, memory loss, severe fatigue, and serious sleep disturbances.

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 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 being treated with corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment or even several months after stopping Cetraxal. At the first sign of tendon pain or swelling (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Cetraxal, contact your doctor, and rest the affected area. Avoid unnecessary physical activity, as this may increase the risk of tendon rupture.
If you experience sudden, severe pain in the chest, abdomen, 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 suffer from epilepsy or another neurological condition, such as cerebral ischaemia or stroke, you may experience central nervous system-related adverse effects. If this occurs, stop taking Cetraxal and contact your doctor immediately.
You may experience psychiatric reactions the first time you take Cetraxal. If you suffer from depression or psychosis, your symptoms may worsen with Cetraxal treatment. In rare cases, depression or psychosis may progress to suicidal thoughts and self-harming behaviours such as suicide attempts or completed suicide (see section 4. Possible side effects). If you experience depression, psychosis, suicidal thoughts, or behaviours, stop taking Cetraxal and contact your doctor immediately.
Quinolone antibiotics may cause an increase in your blood sugar levels above normal (hyperglycaemia), or a decrease in blood sugar levels below normal, which in severe cases may lead to loss of consciousness (hypoglycaemic coma) (see section 4). This is important for people with diabetes. If you have diabetes, your blood sugar levels should be carefully monitored.
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 Cetraxal and contact your doctor immediately to prevent potentially irreversible damage.
Diarrhoea may develop while you are taking antibiotics, including Cetraxal, 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 Cetraxal immediately and contact your doctor immediately, as this could be life-threatening. Do not take medicines that stop or delay bowel movements.

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

If you have kidney problems, inform your doctor, as your dose may need adjustment.
Cetraxal may cause liver damage. If you notice symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or stomach pain, stop taking Cetraxal immediately and contact your doctor immediately.
Cetraxal may cause a decrease in white blood cell count and may reduce your resistance to infections. If you develop an infection with symptoms such as fever or a significant deterioration in your general condition, or fever with signs of local infection such as sore throat/pharyngitis/mouth sores, 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.
Your skin may become more sensitive to sunlight or ultraviolet (UV) light while taking Cetraxal. Avoid exposure to intense sunlight or artificial UV light, such as tanning beds.

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

- If you start experiencing sudden onset of breathlessness, especially when lying down, or notice swelling in your ankles, feet, or abdomen, or the onset of palpitations (sensation of rapid or irregular heartbeat), inform your doctor immediately.

Use of Cetraxal with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

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

The following medicines are known to interact with Cetraxal in your body. Taking Cetraxal at the same time as these medicines may affect their therapeutic effect and may increase the likelihood of adverse effects.

Inform your doctor if you are taking:

vitamin K antagonists (e.g., warfarin, acenocoumarol, phenprocoumon, or phenindione) 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 may alter your heart rhythm: medicines belonging to the antiarrhythmic group (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 increase blood levels of the following medicines:

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

Some medicines decrease the effect of Cetraxal. Inform your doctor if you are taking or intend 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 Cetraxal approximately two hours before or four hours after taking these preparations.

Taking Cetraxal with food and drink

Although you may take Cetraxal with meals, do not eat or drink any dairy products (such as milk or yoghurt) or drinks fortified with calcium at the same time as taking the oral suspension, as this 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 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 reduce your level of alertness. Some neurological effects may occur. Therefore, make sure you know how you react to Cetraxal before driving a vehicle or operating machinery. If in doubt, consult your doctor.

Cetraxal contains soy lecithin

Soy lecithin

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

3. How to take Cetraxal

Follow exactly the administration instructions for this medicine given by your doctor. He or she will explain precisely how much Cetraxal you should take, how often, and for how long. This will depend on the type and severity of your infection. If in doubt, consult your doctor or pharmacist again.

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. Take the oral suspension exactly as directed by your doctor. If you are unsure about the dose or how to take Cetraxal, ask your doctor or pharmacist.

Taking the suspension

Follow these instructions:

Shake the bottle well before each administration.
Open the suspension bottle. The first time, insert the stopper provided with the package.
Insert the dosing syringe.
Withdraw the amount of product prescribed by your doctor.
Administer the prescribed dose directly using the dosing syringe.
Wash the dosing syringe after each use.
Do not remove the stopper and close the bottle.

You may take Cetraxal with or between meals. Calcium consumed as part of a meal will not significantly affect absorption. However, do not take Cetraxal suspension with dairy products such as milk or yogurt, or with fruit juices fortified with minerals (e.g., calcium-fortified orange juice).

Remember to drink plenty of fluids while taking Cetraxal.

Try to take the medicine at the same time each day.

If you take more Cetraxal than you should

If you take more than prescribed, seek medical help immediately. If possible, bring the bottle or carton to show the doctor.

You may also call the Toxicology Information Service at telephone number 91 562 04 20.

If you forget to take Cetraxal

If there are 6 hours or more until your next dose, take the missed 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 missed dose. Take the next dose at your usual time.

If you stop taking Cetraxal

It is important to complete the full course of treatment, even if you start to feel better after a few days. If you stop taking this medicine too soon, your infection may not be completely cured and symptoms may return or worsen. You may also 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 will experience them.

The following section includes the most serious adverse effects you may notice yourself:

Stop taking Cetraxal 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 that 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, typically presenting 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 Baycip are listed below, categorized by their frequency:

Common: may affect up to 1 in 10 people

nausea, diarrhoea
joint pain and joint swelling in children

Uncommon: may affect up to 1 in 100 people

joint pain in adults
fungal superinfections (due to fungi)
elevated levels of eosinophils, a type of white blood cell
loss of appetite
hyperactivity or agitation
headache, dizziness, sleep disturbances, or taste disturbances
vomiting, abdominal pain, digestive problems such as slow digestion (dyspepsia/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 inflammation, 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 (leucopenia, leukocytosis, neutropenia, anaemia), increase or decrease in levels of a blood clotting factor (platelets)
allergic reaction, swelling (oedema), or rapid swelling of the skin and mucous membranes (angioedema) (see section 2: Warnings and precautions)
increased blood sugar (hyperglycaemia)
decreased blood sugar (hypoglycaemia) (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, 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 worsening of hearing
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 cells (haemolytic anaemia), a dangerous decrease in a type of white blood cells (agranulocytosis) (see section 2: Warnings and precautions), a decrease in both white and red blood cells and platelets (pancytopenia), with risk of death, and bone marrow suppression, also potentially fatal
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); pressure in the brain (intracranial pressure and pseudotumour cerebri)
visual distortions of colours
inflammation of blood vessel walls (vasculitis)
pancreatitis
death of liver cells (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 deficient water excretion and low sodium concentrations (SIADH – Syndrome of Inappropriate Antidiuretic Hormone Secretion)
feeling extremely excited (mania) or a sensation of great optimism and hyperactivity (hypomania)
abnormally fast heart rate, life-threatening irregular heart rhythm, disturbances in heart rhythm (known as “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 severely low blood sugar levels (hypoglycaemic 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 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), and 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 potentially 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, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Cetraxal

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

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

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

6. Contents of the pack and other information

Composition of Cetraxal

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

Appearance of Cetraxal and contents of the pack

Yellowish oral suspension with a walnut and condensed milk odour and taste.

Each pack contains one bottle with 100 ml of suspension and one dosing syringe.

Marketing Authorisation Holder and Manufacturer

Laboratorios Salvat, S.A.

C/ Gall 30-36 - 08950

Esplugues de Llobregat

Barcelona (Spain)

Date of the most recent review of this leaflet: May 2025

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

Advice/medical education

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

If your doctor has prescribed antibiotics, it is because they are specifically needed for your current illness.

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

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

the dose,
the schedule,
the duration of treatment.

Therefore, to maintain the effectiveness of this medicine:

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