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PROKINYL LP 15 mg LP Capsule Blister/30

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PROKINYL LP 15 mg LP Capsule Blister/30

CIP / EAN code: 3400932975846

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Product information

Find indications, dosage and precautions in the sections below.

Automatic English translation of the French VIDAL document. Original numerical values and units are retained, including decimal commas.

VIDAL
Medicines
Update of 17/12/2024

PROKINYL LP®
metoclopramide


Forms and presentations

Prolonged-release capsule at 15 mg:  Box of 30, in thermoformed blister packs.


Composition

  per capsule
Metoclopramide hydrochloride 
15 mg
Excipients: ethyl acrylate, methyl methacrylate and trimethylammonioethyl methacrylate chloride copolymers (1:2:0,1) (12,5% solution) [Eudragit RS 12,5], talc, triethyl citrate, neutral microgranules (sucrose, corn starch). Capsule shell: gelatin.

Excipient with known effect: sucrose.


Indications

Prokinyl LP 15 mg, prolonged-release capsule is indicated in adults for:
  • the prevention of delayed nausea and vomiting induced by antimitotics;
  • the prevention of nausea and vomiting induced by radiotherapy;
  • the symptomatic treatment of nausea and vomiting, including nausea and vomiting induced by a migraine attack. In migraine attacks, metoclopramide may be used in combination with oral analgesics to improve their absorption.

Dosage and administration

Dosage

Reserved for adults.

The recommended dose is 15 mg per dose, 1 to 2 times a day.

The recommended maximum daily dose is 30 mg or 0,5 mg/kg.

The maximum recommended duration of treatment is 5 days.


Method of administration:

Oral use.

A minimum interval of 12 hours between 2 administrations must be respected, even in case of vomiting or rejection of the dose (see Warnings and Precautions for Use).

Special populations:
Elderly subjects:
In elderly subjects, a dose reduction should be considered, taking into account renal and hepatic function and the overall frailty of the state of health.
Renal impairment:
In patients with end-stage renal failure (creatinine clearance ≤ 15 ml/min), the daily dose must be reduced by 75 %.
In patients with moderate to severe renal impairment (creatinine clearance between 15 and 60 ml/min), the dose must be reduced by 50 % (see Pharmacokinetics).
Hepatic impairment:
In patients with severe hepatic impairment, the dose must be reduced by 50 % (see Pharmacokinetics).
Other pharmaceutical forms/dosages may be more appropriate for use in these populations.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients listed in section Composition.
  • When stimulation of gastrointestinal motility presents a danger: gastrointestinal haemorrhage, mechanical obstruction or digestive perforation.
  • In known or suspected carriers of pheochromocytoma, due to the risk of episodes of severe hypertension.
  • Known history of tardive dyskinesia with neuroleptics or metoclopramide.
  • Epilepsy (increased frequency and intensity of seizures).
  • Parkinson's disease.
  • In combination with levodopa or dopaminergic agonists (see Interactions).
  • Known history of methaemoglobinaemia with metoclopramide or of NADH cytochrome-b5 reductase deficiency.
  • In children under 1 year due to the increased risk of extrapyramidal disorders (see Warnings and Precautions for Use).
  • This medicine is contraindicated in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare hereditary diseases).

Warnings and precautions


Warnings:
Neurological disorders:
Extrapyramidal disorders may occur, particularly in children and young adults, and/or when high doses are used. These reactions generally occur at the start of treatment and may appear after a single administration. If these extrapyramidal symptoms appear, metoclopramide should be stopped immediately. These effects are generally completely reversible after stopping treatment, but may require symptomatic treatment (benzodiazepines in children and/or anticholinergic antiparkinsonian agents in adults).
An interval of at least 12 hours must be respected between each intake (see Posology and Method of administration), even in cases of vomiting or rejection of the dose, in order to avoid overdose.
Prolonged treatment with metoclopramide may cause tardive dyskinesias, potentially irreversible, particularly in elderly subjects. The duration of treatment must not exceed 3 months due to the risk of tardive dyskinesia (see Undesirable effects). If clinical signs of tardive dyskinesia appear, treatment must be stopped.
A neuroleptic malignant syndrome has been described with metoclopramide in combination with neuroleptics or as monotherapy (see Undesirable effects). Metoclopramide must be stopped immediately if symptoms of neuroleptic malignant syndrome occur and appropriate treatment must be initiated.
Particular attention should be paid to patients with underlying neurological pathologies and to patients treated with other medicinal products having a central action (see Contraindications).
Symptoms of Parkinson's disease may also be exacerbated by metoclopramide.
Methemoglobinemia:
Cases of methaemoglobinaemia, which may be due to a deficiency of NADH cytochrome-b5 reductase, have been reported. In this case, treatment must be stopped immediately and permanently, and appropriate measures must be taken (such as treatment with methylene blue).
Cardiac disorders:
Serious cardiovascular adverse effects including cases of severe bradycardia, cardiovascular collapse, cardiac arrest and QT interval prolongation have been reported with injectable administration of metoclopramide, particularly by the intravenous route (see Undesirable effects).
Metoclopramide must be administered with caution, particularly by the intravenous route, in elderly subjects, patients with cardiac conduction disorders (including QT interval prolongation), patients with an electrolyte imbalance, bradycardia, and those taking other medicinal products known to prolong the QT interval.
Intravenous injection must be given as a slow bolus (over a period of at least 3 minutes) in order to reduce the risk of adverse effects (e.g., arterial hypotension, akathisia).
Renal and hepatic impairment:
In cases of severe renal or hepatic impairment, it is recommended to reduce the dose (see Posology and Method of administration).

Interactions

Drug interactions
Interaction studies have only been performed in adults.

Contraindicated:
  • Reciprocal antagonism between dopaminergic agonists or levodopa and metoclopramide (see Contraindications).

Not recommended:
  • Alcohol: alcohol increases the sedative effect of metoclopramide.

To be taken into account:
Due to the prokinetic effect of metoclopramide, the absorption of certain medicinal products may be altered.
  • Anticholinergics and morphine derivatives: reciprocal antagonism between anticholinergics and morphine derivatives and metoclopramide on digestive motility.
  • Central nervous system depressants (morphine derivatives, anxiolytics, sedating H1 antihistamines, sedating antidepressants, barbiturates, clonidine and related products): additive sedative effects of central nervous system depressants and metoclopramide.
  • Neuroleptics: risk of additive effects on the occurrence of extrapyramidal disorders.
  • Serotonergic medicinal products: increased risk of serotonin syndrome when combined with serotonergic medicinal products such as SSRIs.
  • Digoxin: metoclopramide may decrease the bioavailability of digoxin. Close monitoring of plasma digoxin concentrations is necessary.
  • Ciclosporin: metoclopramide increases the bioavailability of ciclosporin (Cmax increased by 46% and systemic exposure increased by 22%). Close monitoring of plasma ciclosporin concentrations is necessary. The clinical consequence is uncertain.
  • Mivacurium and suxamethonium: injection of metoclopramide may prolong the duration of neuromuscular blockade, by inhibition of plasma cholinesterase.
  • Potent CYP2D6 inhibitors: increased exposure parameters of metoclopramide when combined with potent CYP2D6 inhibitors such as fluoxetine and paroxetine. Although the clinical relevance is unknown, monitoring for adverse effects is required.

Fertility, pregnancy and breastfeeding

Pregnancy:

A large amount of data in pregnant women (more than 1000 pregnancies) has not revealed any malformative or foetotoxic effect. For pharmacological reasons (by analogy with other neuroleptics), if metoclopramide is administered late in pregnancy, a neonatal extrapyramidal syndrome cannot be excluded. If used, monitoring of the newborn should be implemented.


Breastfeeding:

Metoclopramide passes into breast milk in small amounts. Adverse effects in the breastfed newborn cannot be ruled out. Therefore, metoclopramide is not recommended during breastfeeding. Interruption of treatment during breastfeeding should be considered.


Driving and using machines

Prokinyl LP 15 mg has a major influence on the ability to drive vehicles and use machines.
Metoclopramide may cause somnolence, dizziness, dyskinesia and dystonia which may affect vision and also interfere with the ability to drive vehicles and use machines.

Adverse effects

Adverse effects are listed by system organ class. Adverse effects have been classified by frequency using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10 000 to < 1/1000); very rare (< 1/10 000); frequency not known (cannot be estimated from the available data).


System organ class
Frequency Adverse effects
Blood and lymphatic system disorders
Frequency not known Methemoglobinemia, which may be due to a deficiency of NADH cytochrome-b5 reductase, particularly in newborns (see Warnings and Precautions for Use)
Sulfhaemoglobinaemia, mainly with concomitant administration of high doses of sulfate-releasing medicinal products
Cardiac disorders
Uncommon Bradycardia, particularly with the intravenous route
Frequency not known Cardiac arrest, occurring rapidly after parenteral administration, and which may follow bradycardia (see Warnings and Precautions for Use) ; atrioventricular block, sinus pause particularly with the intravenous route ; prolongation of the QT interval on electrocardiogram ; torsades de pointes
Endocrine disorders*
Uncommon Amenorrhoea, hyperprolactinaemia
Rare Galactorrhoea
Frequency not known Gynaecomastia
Gastrointestinal disorders
Common Diarrhoea
General disorders and administration site conditions
Common Asthenia
Immune system disorders
Uncommon Hypersensitivity
Frequency not known Anaphylactic reaction (including anaphylactic shock) particularly with the intravenous route
Nervous system disorders
Very common Somnolence
Common Extrapyramidal disorders (particularly in children and young adults and/or when the recommended dose is exceeded, including after a single dose administration) (see Warnings and Precautions for Use), parkinsonian syndrome, akathisia
Uncommon Dystonia (including visual disturbances and oculogyric crisis), dyskinesia, disturbances of consciousness
Rare Convulsion, particularly in epileptic patients
Frequency not known Tardive dyskinesia which may be persistent, during or after prolonged treatment, particularly in elderly subjects (see Warnings and Precautions for Use), neuroleptic malignant syndrome (see Warnings and Precautions for Use)
Psychiatric disorders
Common Depression
Uncommon Hallucination
Rare Confusional state
Vascular disorders
Common Hypotension, particularly with the intravenous route
Frequency not known Very high blood pressure.
Shock, syncope after use of the injectable form. Hypertensive crisis in patients with pheochromocytoma (see Contraindications)
* Endocrine disorders during prolonged treatment related to hyperprolactinaemia (amenorrhoea, galactorrhoea, gynaecomastia).

The following effects, sometimes associated, occur more frequently when high doses are used:
  • Extrapyramidal symptoms: acute dystonia and dyskinesia, parkinsonian syndrome, akathisia, including after administration of a single dose of the medicine, particularly in children and young adults (see Warnings and Precautions for Use).
  • Somnolence, impaired consciousness, confusion, hallucination.
Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres. Website: https://signalement.social-sante.gouv.fr.


Overdose

Symptoms:
Extrapyramidal symptoms, drowsiness, disturbances of consciousness, confusion, hallucinations, or even cardiorespiratory arrest may occur.
Action to be taken:
In case of extrapyramidal symptoms, whether or not linked to an overdose, treatment is symptomatic only (benzodiazepines in children, and/or anticholinergic antiparkinsonian agents in adults).
Symptomatic treatment and continuous monitoring of cardiovascular and respiratory function must be implemented according to the clinical condition.

Pharmacodynamics

Pharmacotherapeutic class: Gastrointestinal motility stimulant, ATC code: A03FA01 (A: alimentary tract and metabolism).

Mechanism of action:
Metoclopramide: dopamine antagonist neuroleptic.
Pharmacodynamic effects:
It prevents vomiting by blocking dopaminergic sites. It increases the amplitude of oesophageal contraction waves, the tone of the lower oesophageal sphincter, and the rate of gastric emptying. It normalises gastroduodenal peristalsis and increases small bowel peristalsis.

Pharmacokinetics

Distribution:
Metoclopramide is widely distributed in tissues. The volume of distribution is 2,2 to 3,4 l/kg. It binds little to plasma proteins. It crosses the placenta and passes into breast milk.
Prolonged-release microgranules allow, compared with the conventional dosage form:
  • to achieve lower maximum concentrations, reached at later times;
  • to maintain plasma concentrations of metoclopramide 12 hours after intake that are 50% higher.
Biotransformation:
Metoclopramide is poorly metabolized.
Elimination:
Metoclopramide is mainly eliminated in the urine in free or sulfoconjugated form. The elimination half-life is 5 to 6 hours. It increases in cases of renal or hepatic impairment.
Renal impairment:
The clearance of metoclopramide is decreased by up to 70 % in patients with severe renal impairment, while the plasma elimination half-life is increased (approximately 10 hours for a creatinine clearance of 10-50 ml/minute and 15 hours for a creatinine clearance < 10 ml/minute.
Hepatic impairment:
Accumulation of metoclopramide has been observed in patients with hepatic cirrhosis, associated with a decrease of 50 % in plasma clearance.

Storage conditions

Shelf life
3 years.

Store at a temperature not exceeding 30 °C.


HANDLING/DISPOSAL INSTRUCTIONS

No special requirements.


Prescription, supply and reimbursement

LIST I
Marketing authorisation (AMM) 3400932975846 (1987, SmPC rev 19.11.2024).
   
Price: 3,41 euros (30 capsules).
Social Security reimbursement at 30%. Collect.


TECHNI-PHARMA Laboratories
7, rue de l'Industrie. BP 717. 98014 Monaco cdx
Tel: 00 377 92 05 75 10

Source: VIDAL · Updated on 11/11/2026. This information does not replace advice from a healthcare professional.