CLEBORIL 100 micrograms/ml ORAL SOLUTION

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.

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.

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.

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