CLEBORIL 500 micrograms tablets
How to use CLEBORIL 500 micrograms tablets
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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 500 micrograms tablets
clebopride
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 signs of illness 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:
- What Cleboril is and what it is used for
- What you need to know before you take Cleboril
- How to take Cleboril
- Possible side effects
- Storage of Cleboril
- Contents of the pack and other information
1. What Cleboril is and what it is used for
Cleboril contains clebopride 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.
2. What you need to know before you take Cleboril
Do not take Cleboril:
- 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 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.
Children and adolescents
In children, adolescents, and elderly people, the use of higher doses than recommended may increase the possibility of extrapyramidal reactions (alterations in muscle tone, posture, and appearance of involuntary movements).
In newborns, cases of acquired methemoglobinemia (a blood disorder that affects its 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 inform your doctor if you are taking any of the following medicines:
- Phenothiazines, butyrophenones, and other antidopaminergic agents (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 diseases) 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 the onset and duration of sleep), 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. For this reason, 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 lactose and sodium
This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".
3. How to take Cleboril
Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.
The recommended dose in adults is 1 tablet (500 micrograms of clebopride) 3 times a day, before each meal.
The recommended dose in adolescents (from 12 years to less than 18 years) is half a tablet (250 micrograms of clebopride) 3 times a day, before each meal.
This medicine is for oral administration.
The tablet can be divided into equal doses.
Take your dose with the help of some liquid, preferably water.
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 appearance of involuntary movements) may appear, which usually disappear when treatment is discontinued.
If symptoms persist, stomach lavage and symptomatic medication will be performed. Extrapyramidal reactions are controlled with the administration of appropriate medicines.
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.
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 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 the lactation period (galactorrhea)
- Increased breast size in men (gynecomastia)
- Difficulty in 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 carton after EXP. The expiry date is the last day of the month shown.
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 clebopride. Each tablet contains 500 micrograms of clebopride (as clebopride malate).
- The other ingredients (excipients) are anhydrous lactose, povidone, microcrystalline cellulose, sodium carboxymethyl starch (derived from potato), colloidal silica, and magnesium stearate.
Appearance and packaging of the product
Cleboril is presented in the form of white, flat, circular, and scored tablets, in PVC/Aluminum blister packs, containing 30 or 60 tablets.
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)
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
- Country of registration
- Average pharmacy price3.33 EUR
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to CLEBORIL 500 micrograms tabletsDosage form: ORAL SOLUTION/SUSPENSION, 10 mg clebopride/100 mlActive substance: cleboprideManufacturer: Almirall S.A.Prescription requiredDosage form: ORAL SOLUTION/SUSPENSION DROPS, 6.25 mg clebopride/100 mlActive substance: cleboprideManufacturer: Almirall S.A.Prescription requiredDosage form: CAPSULE, 0.5 mg clebopride + 200 mg simethiconeActive substance: cleboprideManufacturer: Almirall S.A.Prescription required
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