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CLEBORIL PEDIATRIC 62.5 micrograms oral drops in solution

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About the medicine

How to use CLEBORIL PEDIATRIC 62.5 micrograms oral drops in solution

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the User

Cleboril Pediatric 62.5 micrograms/ml Oral Solution in Drops

clebopride

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

  • Keep this package leaflet, as you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
  • If you experience any side effects, consult your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

  1. What Cleboril Pediatric is and what it is used for
  2. What you need to know before taking Cleboril Pediatric
  3. How to take Cleboril Pediatric
  4. Possible side effects
  5. Storage of Cleboril Pediatric
  6. Contents of the pack and further information

1. What Cleboril Pediatric is and what it is used for

Cleboril Pediatric contains clebopride and belongs to a group of medicines that act on an area of the brain that prevents nausea or vomiting.

Cleboril Pediatric is indicated in children from 1 year of age for the symptomatic treatment of nausea and vomiting, including those induced by antineoplastic chemotherapy.

Doctor consultation

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2. What you need to know before taking Cleboril Pediatric

Do not take Cleboril Pediatric:

  • If you are allergic to clebopride or any of the other ingredients of this medicine (listed in section 6).
  • If you have bleeding, obstruction, or perforation of the gastrointestinal tract, as stimulation of gastric motility may be harmful.
  • If you suffer from abnormal and involuntary movements (tardive dyskinesia) that appear in people being treated with a type of medicine called neuroleptics.
  • If you suffer from seizures (epilepsy).
  • If you suffer from Parkinson's disease or other extrapyramidal disorders (which cause alterations in muscle tone, posture, and the appearance of involuntary movements).

Warnings and precautions

Consult your doctor or pharmacist before taking Cleboril Pediatric:

  • If you have severe liver or kidney disease (severe hepatic or renal insufficiency), as it may increase the effect of this medicine.
  • If you have certain tumors, such as breast tumors or prolactin-secreting pituitary adenoma, as it may increase the level of a hormone called prolactin in the blood.

Children and adolescents

In children and adolescents, the use of higher doses than recommended may increase the possibility of extrapyramidal reactions (alterations in muscle tone, posture, and the appearance of involuntary movements).

In newborns, cases of acquired methemoglobinemia (a blood disorder that affects the ability to transport oxygen) due to orthopramides (a group of medicines to which Cleboril Pediatric belongs) have been described.

Other medicines and Cleboril Pediatric

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

It is especially important that you inform your doctor if you are taking any of the following medicines:

  • Phenothiazines, butyrophenones, and other antidopaminergics (used to treat certain mental illnesses) as Cleboril Pediatric may increase the effect of these medicines on the central nervous system.
  • Digoxin (used to treat heart diseases) and cimetidine (used in situations where it is necessary to decrease acid production by the stomach) as Cleboril Pediatric decreases their effects.
  • Hypnotics (medicines that improve sleep initiation and duration), anxiolytics (reduce anxiety), or narcotics (used to treat moderate or severe pain) as Cleboril Pediatric may potentiate their sedative effects.
  • Anticholinergics (such as atropine, used to relieve stomach cramps or spasms, to treat Parkinson's disease, or to prevent travel sickness) or narcotic analgesics (opioids) as they neutralize the action of Cleboril Pediatric on gastrointestinal motility.
  • MAOIs (used to treat depression), as their use with Cleboril Pediatric may increase the risk of adverse effects.

Taking Cleboril Pediatric with alcohol

Alcohol should be avoided while being treated with Cleboril Pediatric, as it may potentiate its sedative effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

There is not enough information on the use of this medicine in pregnant or breastfeeding women. As a precaution, it is recommended to avoid its use during pregnancy, especially in the first three months, and breastfeeding.

Driving and using machines

During treatment with Cleboril Pediatric, you should avoid situations that require a special state of alertness, such as driving vehicles or handling dangerous machinery.

Cleboril Pediatric contains benzoic acid (E-210) and sodium.

This medicine contains 1 mg of benzoic acid (E-210) per ml.

This medicine contains less than 1 mmol of sodium (23 mg) per 5 ml dose; i.e., it is essentially "sodium-free".

3. How to take Cleboril Pediatric

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Posology

Use in children only

The recommended dose is 4 to 5 drops of Cleboril Pediatric (12.5 micrograms to 15.62 micrograms) per kg of body weight and day, divided into 3 doses per day.

Generally, the recommended dose is:

From 1 to 4 years: 0.5 ml to 1 ml (10 to 20 drops) 3 times a day.

From 4 to 6 years: 1.5 ml (30 drops) 3 times a day.

From 6 to 8 years: 2 ml (40 drops) 3 times a day.

From 8 to 10 years: 2.5 ml (50 drops) 3 times a day.

From 10 to 12 years: 3 ml (60 drops) 3 times a day.

Method of administration

This medicine is for oral administration.

The drops will be administered directly or dissolved in half a glass of water, before the main meals.

Use only the dosing device provided with the package. Do not use any type of spoon.

Transparent syringe with milliliter measurement marks and recommended doses according to patient age

Dosing device for children and infants

If you take more Cleboril Pediatric than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 91 5620420, indicating the medicine and the amount taken.

In case of overdose, drowsiness, disorientation, and extrapyramidal reactions (alterations in muscle tone, posture, and the appearance of involuntary movements) may appear, which normally disappear when treatment is discontinued.

If symptoms persist, gastric lavage and symptomatic medication will be performed. Extrapyramidal reactions are controlled with the administration of medicines for Parkinson's disease.

If you forget to take Cleboril Pediatric

Do not take a double dose to make up for forgotten doses.

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

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported in clinical trials and during post-marketing experience:

Rare side effects (may affect up to 1 in 1,000 patients)

  • Alterations in muscle tone, posture, and the appearance of involuntary movements (extrapyramidal disorders)
  • Parkinsonism
  • Abnormal and involuntary movements (dystonias, most frequently reported in the neck, tongue, or face; dyskinesia; tardive dyskinesia, in elderly patients after prolonged treatments).
  • Sedation
  • Tremor
  • Drowsiness

Very rare side effects (may affect up to 1 in 10,000 patients)

  • Increased levels of prolactin in the blood (hyperprolactinemia)
  • Milk secretion outside of the lactation period (galactorrhea)
  • Increased breast size in males (gynecomastia)
  • Difficulty achieving or maintaining an erection (erectile dysfunction)
  • Absence of menstruation (amenorrhea)

These side effects have been reported after prolonged treatments.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. 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 help provide more information on the safety of this medicine.

5. Storage of Cleboril Pediatric

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

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the package after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Cleboril Pediatric

  • The active substance is clebopride. Each ml (20 drops) contains 62.5 micrograms of clebopride (as clebopride malate).
  • The other ingredients (excipients) are benzoic acid (E-210), sodium hydroxide, and purified water.

Appearance of the product and pack contents

Cleboril Pediatric is presented as a colorless, transparent, and homogeneous solution with a characteristic odor, in amber glass bottles with a "Pilfer Proof" plastic cap, 90 ml capacity, and a dosing syringe.

Marketing authorization holder and manufacturer

Marketing authorization holder

Almirall, S.A.

General Mitre, 151

08022 – Barcelona

Manufacturer

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

08740 Sant Andreu de la Barca - Barcelona (Spain)

or

Manufacturer

Almirall Hermal GmbH

Scholtzstraße, 3 21465

Reinbek Germany

Date of the last revision of this package leaflet:November 2023

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

Online doctors for CLEBORIL PEDIATRIC 62.5 micrograms oral drops in solution

Discuss questions about CLEBORIL PEDIATRIC 62.5 micrograms oral drops in solution, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Doctor

Tarek Agami

General medicine 11 years exp.

Dr. Tarek Agami is a general practitioner registered in both Portugal and Israel, with broad experience in family and preventive medicine. He offers online consultations for adults and children, providing personalised support for primary care needs, chronic disease management, and everyday health concerns.

Dr. Agami received clinical training and worked in leading medical institutions in Israel (Kaplan Medical Center, Barzilai Medical Center, Wolfson Medical Center) and Portugal (European Healthcare City, Viscura Internacional, Hospital Dr. José Maria Grande, Hospital Vila Franca de Xira). His approach combines international medical standards with individualised attention to each patient.

Main areas of consultation:

  • Diagnosis and treatment of acute and chronic conditions (high blood pressure, diabetes, respiratory infections, cardiovascular symptoms)
  • Evaluation of symptoms and guidance on further diagnostic testing
  • Preventive check-ups and regular health monitoring
  • Medical support during travel or after relocation
  • Treatment adjustments and lifestyle recommendations based on your personal history
Dr. Agami provides medical support for patients using GLP-1 medications (such as Ozempic or Mounjaro) as part of a weight loss strategy. He offers individualised treatment planning, regular follow-up, dose adjustment, and advice on combining medication with sustainable lifestyle changes. Consultations follow the medical standards accepted in Portugal and Israel.

Dr. Agami is committed to evidence-based, patient-centred care, ensuring that each person receives trusted medical support tailored to their health goals.

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Doctor

Lina Travkina

Family medicine 13 years exp.

Dr. Lina Travkina is a licensed family and preventive medicine doctor based in Italy. She provides online consultations for adults and children, supporting patients across all stages of care – from acute symptom management to long-term health monitoring and prevention.

Areas of medical care include:

  • Respiratory conditions: colds, flu, acute and chronic bronchitis, mild to moderate pneumonia, bronchial asthma.
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  • Chronic conditions: hypertension, diabetes, hypercholesterolemia, metabolic syndrome, thyroid disorders, excess weight.
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  • Chronic pain support: back, neck, joint, and muscle pain, tension syndromes, pain associated with osteochondrosis and chronic conditions.

Additional care areas:

  • Preventive consultations and check-up planning.
  • Medical advice and follow-up consultations.
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  • Nutritional and lifestyle support for vitamin deficiencies, anaemia, metabolic issues.
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  • Preconception counselling and postpartum support.
  • Immunity support and strategies to reduce frequency of infections.

Dr. Travkina combines evidence-based medicine with an attentive, personalised approach. Her consultations focus not only on treatment, but also on prevention, recovery, and long-term wellbeing.

If during the consultation it becomes clear that your case requires in-person assessment or specialised care outside of her scope, the session will be terminated and the payment fully refunded.

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Doctor

Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

  • fever, chills, fatigue and viral symptoms
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  • bronchitis and mild asthma flare-ups
  • nausea, diarrhoea, abdominal pain, digestive infections
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  • muscle or joint pain, mild injuries, sprains
  • headache, dizziness, migraine symptoms
  • stress-related symptoms, sleep disturbances
  • questions about test results and treatment plans
  • management of chronic conditions in stable phases
Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

Some situations are not suitable for online care. If a patient has loss of consciousness, severe chest pain, uncontrolled bleeding, seizures, major trauma or symptoms suggesting a stroke or heart attack, he will advise seeking immediate local emergency services. This improves safety and ensures patients receive the right level of care.

Dr. Lokchiri’s professional training includes:

  • Advanced Trauma Life Support (ATLS)
  • Basic and Advanced Cardiac Life Support (BLS/ACLS)
  • Pediatric Advanced Life Support (PALS)
  • Prehospital Trauma Life Support (PHTLS)
  • eFAST and critical care transthoracic echocardiography
  • aviation medicine
He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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Doctor

Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques. For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance. Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults. In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions. Patients commonly seek his care for: 

  • seasonal and perennial allergies
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  • general family medicine concerns

Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.

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Doctor

Andrei Popov

General medicine 7 years exp.

Dr. Andrei Popov is a family physician with specialized training in the management of chronic pain. He provides video consultations for adults in Spain and across Europe: whether you have been living with pain for months that no one has been able to properly explain, or you need to resolve a health issue without waiting weeks for an appointment.

His approach is clear: to listen, organize your case, and provide you with a practical roadmap based on evidence-based medicine and adapted to your medical history and personal needs.

Pain: how he can help

  • Chronic pain (more than 3 months
  • Migraine and recurrent or high-intensity headaches
  •  Neck, lower back, back and joint pain
  •  Post-traumatic pain after injuries or surgeries
  •  Pain of neurological origin: neuralgia, neuropathic pain, fibromyalgia

General medicine

  • Frequent respiratory infections (cold, flu, persistent cough)
  • Hypertension, diabetes and metabolic disorders
  • Review of laboratory tests and MRI/CT reports (explained in clear language)
  • Preventive medicine and health monitoring
  • Second opinions and treatment adjustments (when clinically appropriate)

What the consultation is like
 Each session lasts up to 30 minutes. We review symptoms, medical history, medications and any tests you provide, and you finish the consultation with a clear treatment plan, defined next steps, and criteria to understand when follow-up may be needed. If warning signs are detected, he will clearly advise whether you need in-person care or urgent medical attention.

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Frequently Asked Questions

Is a prescription required for CLEBORIL PEDIATRIC 62.5 micrograms oral drops in solution?
CLEBORIL PEDIATRIC 62.5 micrograms oral drops in solution requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in CLEBORIL PEDIATRIC 62.5 micrograms oral drops in solution?
The active ingredient in CLEBORIL PEDIATRIC 62.5 micrograms oral drops in solution is clebopride. This information helps identify medicines with the same composition but different brand names.
How much does CLEBORIL PEDIATRIC 62.5 micrograms oral drops in solution cost in pharmacies?
The average pharmacy price for CLEBORIL PEDIATRIC 62.5 micrograms oral drops in solution is around 1.53 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures CLEBORIL PEDIATRIC 62.5 micrograms oral drops in solution?
CLEBORIL PEDIATRIC 62.5 micrograms oral drops in solution is manufactured by Almirall S.A.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of CLEBORIL PEDIATRIC 62.5 micrograms oral drops in solution online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether CLEBORIL PEDIATRIC 62.5 micrograms oral drops in solution is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to CLEBORIL PEDIATRIC 62.5 micrograms oral drops in solution?
Other medicines with the same active substance (clebopride) include CLEBORIL 100 micrograms/ml ORAL SOLUTION, CLEBORIL 500 micrograms tablets, FLATORIL 500 micrograms/200 mg HARD CAPSULES. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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