Cleboril 500 micrograms tablets
SpainTable of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Cleboril 500 micrograms tablets
clebopride
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 you should not give it to others, even if they have the same symptoms as you, because 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 Cleboril is and what it is used for
- What you need to know before taking Cleboril
- How to take Cleboril
- Possible side effects
- How to store 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 antineoplastic chemotherapy-induced nausea and vomiting in adults and adolescents.
2. What you need to know before taking Cleboril
Do not take Cleboril:
- If you are allergic to clebopride or to any of the other ingredients of this medicine (listed in section 6).
- If you have gastrointestinal bleeding, obstruction, or perforation, as stimulation of gastric motility may be harmful.
- If you suffer from abnormal and involuntary movements (tardive dyskinesia), which occur in people treated with a type of medicine called neuroleptics.
- If you have seizures (epilepsy).
- If you have Parkinson's disease or other extrapyramidal disorders (which cause disturbances in muscle tone, posture, and the appearance of involuntary movements).
Warnings and precautions
Talk to your doctor or pharmacist before taking Cleboril:
- If you have severe liver or kidney disease (severe hepatic or renal insufficiency), as this may increase the effect of this medicine.
- If you have certain tumors, such as breast tumors or prolactin-secreting pituitary adenocarcinoma, because this medicine may increase blood levels of a hormone called prolactin.
Children and adolescents
In children, adolescents, and elderly patients, the use of doses higher than recommended may increase the likelihood of extrapyramidal reactions (disturbances in muscle tone, posture, and appearance of involuntary movements).
In newborns, cases of acquired methemoglobinemia (a blood disorder affecting its ability to carry oxygen) due to orthopramides (the group of medicines to which Cleboril belongs) have been reported.
Other medicines and Cleboril
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to 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 enhance the effects of these medicines on the central nervous system.
- Digoxin (used to treat heart conditions) and cimetidine (used in situations where it is necessary to reduce stomach acid production), as Cleboril may reduce their effects.
- Hypnotics (medicines that help initiate and maintain sleep), anxiolytics (reduce anxiety), or narcotics (used to treat moderate to severe pain), as Cleboril may enhance their sedative effects.
- Anticholinergics (such as atropine, used to relieve stomach cramps or spasms, to treat Parkinson's disease, or to prevent motion sickness) or narcotic analgesics (opioids), as they may counteract Cleboril's action on gastrointestinal motility.
- MAOIs (used to treat depression), as their use together with Cleboril may increase the risk of adverse effects.
Taking Cleboril with alcohol
Avoid drinking alcohol while taking Cleboril, as it may enhance its sedative effects.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
There is insufficient 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 using Cleboril during pregnancy, especially during the first three months, and during breastfeeding.
Driving and using machines
During treatment with Cleboril, you should avoid situations requiring special alertness, such as driving vehicles or operating dangerous machinery.
Cleboril contains lactose and sodium
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; hence, it is essentially "sodium-free".
3. How to take Cleboril
Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose in adults is 1 tablet (500 micrograms of clebopride) 3 times daily, before each meal.
The recommended dose in adolescents (from 12 years to under 18 years) is half a tablet (250 micrograms of clebopride) 3 times daily, before each meal.
This medicine is for oral use.
The tablet may be divided into equal doses.
Take your dose with a 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 at telephone number 91 5620420, indicating the medicine and amount taken.
In case of overdose, symptoms such as drowsiness, disorientation, and extrapyramidal reactions (alterations in muscle tone, posture, and appearance of involuntary movements) may occur, which normally disappear upon discontinuation of treatment.
If symptoms persist, gastric lavage and symptomatic medication will be performed. Extrapyramidal reactions are controlled by administering 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 about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everybody gets them.
The following adverse effects have been reported in clinical trials and during post-marketing experience:
Rare adverse effects (may affect up to 1 in 1,000 patients)
- Disorders of muscle tone, posture, and occurrence of involuntary movements (extrapyramidal disorders)
- Parkinsonism
- Abnormal involuntary movements (dystonias, more frequently reported in the neck, tongue, or face; dyskinesia; tardive dyskinesia in elderly patients after prolonged treatment)
- Sedation
- Tremor
- Somnolence
Very rare adverse effects (may affect up to 1 in 10,000 patients)
- Increased levels of prolactin in blood (hyperprolactinaemia)
- Milk secretion outside the lactation period (galactorrhoea)
- Enlargement of the breasts in males (gynaecomastia)
- Difficulty in achieving or maintaining an erection (erectile dysfunction)
- Absence of menstruation (amenorrhoea)
These adverse effects have been reported after prolonged treatment.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects 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 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 stated on the container following EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This 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 components (excipients) are anhydrous lactose, povidone, microcrystalline cellulose, sodium carboxymethyl starch (from potato), colloidal silica, and magnesium stearate.
Appearance of the product and contents of the pack
Cleboril is presented as white, flat, circular, scored tablets, in PVC/aluminum blister packs containing 30 or 60 tablets.
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)
Date of the most recent review of this leaflet: November 2023
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es