Leaflet: information for the user

Cleboril 100 micrograms/ml oral solution

clebopride

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

Cleboril is indicated for:

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

Do not take Cleboril:

• If you are allergic to clebopride or any of the other components of this medication (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) that appear in people treated with a type of medication called neuroleptics.
• If you suffer from seizures (epilepsy).
• If you suffer from Parkinson's disease or other extrapyramidal disorders (which cause muscle tone alterations, posture changes, and involuntary movement appearance).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Cleboril:

• If you have severe liver or kidney disease (severe hepatic or renal insufficiency), as it may increase the effect of this medication.
• If you have some tumors, such as breast cancer or prolactin-secreting pituitary adenocarcinoma, as it may increase the level of a hormone called prolactin in the blood.
• In children, adolescents, and elderly people, the use of doses higher than recommended may increase the possibility of extrapyramidal reactions (muscle tone alterations, posture changes, and involuntary movement appearance).

Children and adolescents

This medication should not be used in children under 12 years old. In newborns, cases of acquired methemoglobinemia (blood disorder affecting oxygen transport capacity) due to orthopramides (group of medications to which Cleboril belongs) have been described.

Other medications and Cleboril

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

• Phenothiazines, butyrophenones, and other antipsychotics (used to treat certain mental disorders) as Cleboril may increase the effect of these medications on the central nervous system.
• Digoxin (used to treat heart diseases) and cimetidine (used in situations where stomach acid production needs to be reduced) as Cleboril decreases their effects.
• Hypnotics (medications that improve sleep onset 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 opioid analgesics (narcotics) because they neutralize the action of Cleboril on gastrointestinal motility.
• IMAO (used to treat depression), as its use with Cleboril may increase the risk of adverse effects.

Cleboril and alcohol

Avoid taking alcohol while on Cleboril treatment, as it may potentiate its sedative effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

No sufficient information is available on the use of this medication in pregnant women or if it is excreted in breast milk. Therefore, as a precaution, it is recommended to avoid its use during pregnancy, especially in the first three months, and during breastfeeding.

Driving and operating machinery

During Cleboril treatment, you should avoid situations that require a special state of alertness, such as driving or operating hazardous machinery.

Cleboril contains benzoic acid (E-210) and sodium

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

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

Follow exactly the administration instructions for this medication 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 clebopride) 3 times a day, before each meal.

Use in children and adolescents:

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

Children under 12 years

These medications should not be used in children under 12 years.

Form of use and route of administration

This medication is for oral administration.

Use only the double spoon included in the package, on the 2.5 ml or 5 ml side according to 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 Toxicological Information Service, phone 91 5620420, indicating the medication and the amount taken.

In case of overdose, somnolence, disorientation, and extrapyramidal reactions (muscle tone alterations, posture changes, and involuntary movement appearance) may appear, which usually disappear when treatment is suspended.

If symptoms persist, gastric lavage and symptomatic medication will be performed. Extrapyramidal reactions are controlled with the administration of suitable medications.

If you forgot to take Cleboril

Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience 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)

• Muscle tone, posture alterations, and involuntary movement (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
• Drowsiness

Very Rare Adverse Effects (may affect up to 1 in 10,000 patients)

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

These adverse effects have been reported after prolonged treatment

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Dispose of after 6 months of opening the packaging.

Do not dispose of medications through drains or trash. Deposit empty packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of empty packaging and unused medications. By doing so, you will help protect the environment.

Cleboril Composition

- The active principle is clebopride. Each ml contains 100 micrograms of clebopride (as clebopride malate)

- The other components (excipients) are benzoic acid (E-210), sodium hydroxide (for pH adjustment) and purified water.

Product appearance and packaging contents

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

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Almirall, S.A.

General Mitre, 151

08022 – Barcelona

Manufacturer responsible

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

08740 Sant Andreu de la Barca - Barcelona (Spain)

or

Manufacturer responsible

Almirall Hermal GmbH

Scholtzstraße, 3 21465

Reinbek Germany

Last review date of this leaflet:November 2023

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es