Package Insert: Information for the User

Cleboril Pediatric 62.5 micrograms/mL Oral Drops Solution

Clebopride

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

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

Do not take Cleboril Pediátrico:

• 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 neuroléptics.
• If you suffer from seizures (epilepsy).
• If you suffer from Parkinson's disease or other extrapyramidal disorders (which cause muscle tone, posture, and involuntary movement alterations).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Cleboril Pediátrico:

• 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.

Children and adolescents

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

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

Other medications and Cleboril Pediátrico

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 antidopaminergic medications (used to treat certain mental illnesses) as Cleboril Pediátrico may increase the effect of these medications on the central nervous system.
• Digoxin (used to treat heart diseases) and cimetidine (used in situations where it is necessary to reduce stomach acid production) as Cleboril Pediátrico reduces their effects.
• Hypnotics (medications that improve sleep onset and duration), anxiolytics (reduce anxiety), or narcotics (used to treat moderate or severe pain) as Cleboril Pediátrico 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 Pediátrico on gastrointestinal motility.
• IMAO (used to treat depression), as its use with Cleboril Pediátrico may increase the risk of adverse effects.

Cleboril Pediátrico and alcohol

It is recommended to avoid taking alcohol while taking Cleboril Pediátrico, 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 breastfeeding.

Driving and operating machinery

During treatment with Cleboril Pediátrico, you should avoid situations that require special alertness, such as driving vehicles or operating hazardous machinery.

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

This medication contains 1 mg of benzoic acid (E-210) per 1 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 of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Dosage

Use in children only

The recommended dose is 4 to 5 drops of Cleboril pediatric (12.5 micrograms to 15.62 micrograms) per kilogram of weight and day, divided into 3 times a day.

Generally, the recommended dose is:

From 1 to 4 years0.5 ml to 1 ml(10 to 20 drops)3 times a day.

From 4 to 6 years1.5 ml30 drops3 times a day.

From 6 to 8 years2 ml40 drops3 times a day.

From 8 to 10 years2.5 ml50 drops3 times a day.

From 10 to 12 years3 ml60 drops3 times a day.

Administration form

This medication is for oral administration.

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

Use exclusively the dosing device provided, contained in the package. Do not use any type of spoon.

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 Toxicological Information Service, phone 91 5620420, indicating the medication and the amount taken.

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

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

If you forgot to take Cleboril Pediatric

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

If you have any other doubt 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)
• Drowsiness
• 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 the breasts 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 Medicines 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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Cleboril Pediatric

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

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Almirall, S.A.

General Mitre, 151

08022 – Barcelona

Responsible for manufacturing

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

08740 Sant Andreu de la Barca - Barcelona (Spain)

or

Responsible for manufacturing

Almirall Hermal GmbH

Scholtzstraße, 3 21465

Reinbek Germany

Last review date of this leaflet:November 2023

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