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CLEBORIL 100 micrograms/ml ORAL SOLUTION

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About the medicine

How to use CLEBORIL 100 micrograms/ml ORAL 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 100 micrograms/ml Oral Solution

cleboprida

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet, 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. It may harm them, even if their symptoms are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

1. What Cleboril is and what it is used for

Cleboril contains cleboprida and belongs to a group of medicines called prokinetics, which regulate gastrointestinal motility.

Cleboril is indicated for:

  • Symptomatic treatment of functional gastrointestinal motility disorders in adults and adolescents.
  • Symptomatic treatment of postoperative or chemotherapy-induced nausea and vomiting in adults and adolescents.
Doctor consultation

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2. What you need to know before you take Cleboril

Do not take Cleboril:

  • If you are allergic to cleboprida 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:

  • 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, because it may increase the level of a hormone called prolactin in the blood.
  • In children, adolescents, and the elderly, the use of doses higher than recommended may increase the possibility of extrapyramidal reactions (alterations in muscle tone, posture, and the appearance of involuntary movements).

Children and adolescents

This medicine must not be used in children under 12 years of age. In newborns, cases of acquired methemoglobinemia (a blood disorder that affects the ability to transport oxygen) due to orthopramides (the group of medicines to which Cleboril belongs) have been described.

Other medicines and Cleboril

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

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

  • Phenothiazines, butyrophenones, and other antidopaminergic medicines (used to treat certain mental illnesses) as Cleboril may increase the effect of these medicines on the central nervous system.
  • Digoxin (used to treat heart conditions) and cimetidine (used in situations where it is necessary to decrease acid production by the stomach) as Cleboril 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 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) because they neutralize the action of Cleboril on gastrointestinal motility.
  • MAOIs (used to treat depression), as their use with Cleboril may increase the risk of adverse effects.

Taking Cleboril with alcohol

Avoid taking alcohol while being treated with Cleboril, 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 women or whether it is excreted in breast milk. As a precautionary measure, it is preferable to avoid its use during pregnancy, especially during the first three months, and during breastfeeding.

Driving and using machines

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

Cleboril contains benzoic acid (E-210) and sodium

This medicine contains 1 mg of benzoic acid (E-210) in each 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

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

The recommended dose in adults is 5 ml of oral solution (500 micrograms of cleboprida) 3 times a day, before each meal.

Use in children and adolescents:

The recommended dose in adolescents (from 12 years to less than 18 years) is 2.5 ml of oral solution (250 micrograms of cleboprida) 3 times a day, before each meal.

Children under 12 years

This medicine must not be used in children under 12 years of age.

Method of use and route of administration

This medicine is for oral administration.

Use only the double spoon included in the packaging, on the 2.5 ml or 5 ml side, depending on the dose to be administered.

If you take more Cleboril 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 appropriate medications.

If you forget to take Cleboril

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

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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 people)

  • 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 people)

  • 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, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects 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

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 packaging after EXP. The expiry date is the last day of the month stated.

Discard 6 months after opening the packaging.

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 other information

Composition of Cleboril

  • The active substance is cleboprida. Each ml contains 100 micrograms of cleboprida (as cleboprida malate)
  • The other ingredients (excipients) are benzoic acid (E-210), sodium hydroxide (for pH adjustment), and purified water.

Appearance of the product and contents of the pack

Cleboril is presented as a clear, slightly yellowish, and homogeneous oral solution, in bottles of 125 or 250 ml of oral solution and a double spoon, of 2.5 ml on one side and 5 ml on the other.

Metal wire surgical loop with two oval-shaped loops connected by a short twisted segment

Marketing authorisation holder and manufacturer

Marketing authorisation 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 last revision of this 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 100 micrograms/ml ORAL SOLUTION

Discuss questions about CLEBORIL 100 micrograms/ml ORAL SOLUTION, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Bulat Garipov

General medicine 15 years exp.

Dr. Bulat Garipov is a radiologist with more than 15 years of experience, specializing in magnetic resonance imaging (MRI). Throughout his professional career, he has worked in leading diagnostic imaging centers, both in on-site practice and teleradiology, which has allowed him to develop a broad and versatile approach to radiology.

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Additionally, Dr. Garipov is open to new collaboration opportunities in radiology and teleradiology projects. He offers his expertise in MRI, providing both first and second readings of studies, as well as advanced image interpretation, ensuring accurate and high-quality diagnostics.

You could consult Dr. Bulat Garipov in cases where accurate interpretation of MRI studies or a second expert opinion is required. His expertise is especially valuable in cases of suspected neurological conditions, back and joint pain, vascular disorders, as well as in the diagnosis of abdominal and pelvic diseases. The doctor also provides support in complex or unclear clinical situations, including the review of previously performed studies, which helps improve diagnostic accuracy and determine the optimal treatment strategy. A teleradiology format is available, allowing you to receive a professional opinion remotely.

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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.

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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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Anna Biriukova

General medicine 6 years exp.

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

Cardiology – Diagnosis and treatment of:

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  • EKG interpretation, lipid profile evaluation, cardiovascular risk assessment (heart attack, stroke).
  • Post-COVID-19 cardiac monitoring and care.
Endocrinology – Diabetes, thyroid, metabolism:
  • Diagnosis and management of type 1 and type 2 diabetes, and prediabetes.
  • Individual treatment plans including oral medications and insulin therapy.
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  • Thyroid disorders – hypothyroidism, hyperthyroidism, autoimmune thyroid diseases (Hashimoto’s, Graves’ disease).
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Gastroenterology – Digestive health:
  • Abdominal pain, nausea, heartburn, gastroesophageal reflux (GERD).
  • Stomach and intestinal conditions: gastritis, irritable bowel syndrome (IBS), indigestion.
  • Management of chronic digestive disorders and interpretation of tests (endoscopy, ultrasound, labs).
General internal medicine and preventive care:
  • Respiratory infections – cough, colds, bronchitis.
  • Lab test analysis, therapy adjustments, medication management.
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Dr Biriukova combines internal medicine with specialist insight, offering clear explanations, personalised treatment plans, and comprehensive care tailored to each patient.
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Doctor

Alina Tsurkan

Family medicine 13 years exp.

Dr. Alina Tsurkan is a licensed family medicine physician based in Portugal, offering online consultations for adults and children. She provides professional primary care, with a focus on prevention, accurate diagnosis, and long-term management of acute and chronic conditions.

Dr. Tsurkan supports patients with a wide range of health issues, including:

  • Respiratory infections: cold, flu, bronchitis, pneumonia, and lingering coughs.
  • ENT conditions: sinusitis, tonsillitis, otitis (ear infections), sore throat, allergic rhinitis.
  • Eye conditions: allergic or infectious conjunctivitis, red eyes, irritation.
  • Digestive issues: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), constipation, bloating, nausea.
  • Urinary and reproductive health: urinary tract infections (UTIs), cystitis, prevention of recurrent infections.
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She also provides:

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Dr. Tsurkan’s approach is evidence-based and holistic. She works closely with each patient to develop an individualised care plan that addresses both symptoms and root causes. Her goal is to empower patients to take control of their health and maintain well-being through lifestyle adjustments, routine check-ups, and early intervention.

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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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Doctor

Alexander Nazarchuk

Allergology 7 years exp.

Dr. Alexander Nazarchuk is a physician specialising in allergology and internal medicine. He provides online consultations for adults, following the principles of evidence-based medicine — no outdated treatments or unnecessary tests, with clear explanations and a personalised approach. He helps patients with a wide range of allergic and therapeutic conditions, from common day-to-day complaints to complex cases involving allergies, gastrointestinal issues, cardiovascular concerns, respiratory symptoms, and more.

You can consult Dr. Nazarchuk for:

  • Test interpretation and guidance on diagnostic plans.
  • Allergic rhinitis, hay fever, bronchial asthma (including severe cases).
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  • Allergen-specific immunotherapy (AIT) – initiation and ongoing management.
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  • High blood pressure and adjustment of baseline antihypertensive therapy.
  • Hyperlipidaemia and elevated cholesterol.
  • Cough, nasal congestion, fever, sore throat.
  • Anaemia, including iron deficiency and related conditions.
  • Other issues related to allergology and internal medicine.

During consultations, Dr. Nazarchuk takes a thorough, structured approach — analysing symptoms, identifying potential causes, and helping patients make informed decisions. Whether treatment, further investigation, or monitoring is needed, he explains each step clearly so you understand your health and how best to manage it.

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Frequently Asked Questions

Is a prescription required for CLEBORIL 100 micrograms/ml ORAL SOLUTION?
CLEBORIL 100 micrograms/ml ORAL 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 100 micrograms/ml ORAL SOLUTION?
The active ingredient in CLEBORIL 100 micrograms/ml ORAL SOLUTION is clebopride. This information helps identify medicines with the same composition but different brand names.
How much does CLEBORIL 100 micrograms/ml ORAL SOLUTION cost in pharmacies?
The average pharmacy price for CLEBORIL 100 micrograms/ml ORAL SOLUTION is around 3.12 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures CLEBORIL 100 micrograms/ml ORAL SOLUTION?
CLEBORIL 100 micrograms/ml ORAL 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 100 micrograms/ml ORAL 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 100 micrograms/ml ORAL 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 100 micrograms/ml ORAL SOLUTION?
Other medicines with the same active substance (clebopride) include CLEBORIL 500 micrograms tablets, CLEBORIL PEDIATRIC 62.5 micrograms oral drops in solution, 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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