Special instructions for use
The medicinal product should not be used to treat chronic diseases such as gastroparesis, dyspepsia and gastroesophageal reflux disease, or as an adjunct to surgical or radiological procedures.

Patients under 30 years of age are more likely to develop dystonic-dyskinetic disorders when treated with metoclopramide.

The medicinal product should be used with caution in elderly patients due to the frequent occurrence of parkinsonism.

Neurological disorders.

Extrapyramidal disorders may occur, especially in children and/or when using high doses. These reactions are usually observed at the beginning of treatment and may occur after a single use. If extrapyramidal symptoms develop, metoclopramide should be discontinued immediately. In general, these effects disappear completely after discontinuation of treatment, but may require symptomatic treatment (benzodiazepines in children and/or anticholinergic antiparkinsonian drugs in adults).

Between each administration of metoclopramide, even in case of vomiting and dose rejection, an interval of at least 6 hours must be observed to avoid overdose. Long-term treatment with metoclopramide may lead to tardive dyskinesia, which is potentially irreversible, especially in the elderly. Treatment should not be continued for more than 3 months due to the risk of tardive dyskinesia. Treatment must be discontinued if clinical signs of tardive dyskinesia appear.

Neuroleptic malignant syndrome has been reported with metoclopramide in combination with neuroleptics, as well as with metoclopramide monotherapy. If symptoms of neuroleptic malignant syndrome occur, metoclopramide must be discontinued immediately and appropriate treatment must be initiated.

Particular caution should be exercised in patients with concomitant neurological diseases and in patients receiving treatment with other drugs acting on the central nervous system.

Symptoms of Parkinson's disease may also be exacerbated with the use of metoclopramide.

Methemoglobinemia.

Cases of methemoglobinemia have been reported, which may be related to NADH-cytochrome b5 reductase deficiency. In such cases, metoclopramide should be permanently discontinued immediately and appropriate measures (e.g., treatment with methylene blue) should be taken.

Cardiac disorders.

Severe adverse cardiovascular reactions, including cases of acute circulatory collapse, severe bradycardia, cardiac arrest, and prolongation of the QT interval have been reported following administration of metoclopramide by injection, especially after administration.

Intravenous drug should be administered by slow bolus injection (minimum 3 minutes) to reduce the risk of adverse reactions (e.g., hypotension, akathisia).

Impaired renal and hepatic function.

A dose reduction is recommended for patients with renal impairment or severe hepatic impairment.

The medicinal product should be used with caution in patients at risk, namely in elderly patients with cardiac conduction disorders, uncorrected electrolyte imbalance or bradycardia, and in patients taking other medicinal products that prolong the QT interval. The medicinal product should not be used to treat chronic diseases such as gastroparesis, dyspepsia and gastroesophageal reflux disease or as an adjunct to surgical or radiological procedures.

Do not leave the ampoules in the sun for a long time after they have been taken out of the package.

Use during pregnancy or breastfeeding.

Pregnancy.

A large amount of data on pregnant women (more than 1000 results from the use of the medicinal product) indicates the absence of any toxicity that leads to malformations or fetotoxicity. Metoclopramide can be used during pregnancy if there is a clinical need. Due to the pharmacological properties (like other neuroleptics), in case of metoclopramide use in the late stages of pregnancy, the occurrence of extrapyramidal syndrome in the newborn cannot be excluded. It is necessary to avoid the use of metoclopramide in the late stages of pregnancy. When using metoclopramide, it is necessary to monitor the newborn.

Breastfeeding.

Metoclopramide penetrates into breast milk in small amounts. Therefore, it is not recommended to use metoclopramide during breastfeeding. It is necessary to consider the possibility of canceling metoclopramide in women who are breastfeeding.

Ability to influence the reaction rate when driving a vehicle or other mechanisms.

When using the drug, you should refrain from potentially hazardous activities that require increased attention (driving a vehicle, working with other 

mechanisms).

Side effects
From the gastrointestinal tract: nausea, dyspepsia, dry mouth, constipation. When using metoclopramide in doses exceeding the daily dose, patients may experience diarrhea.

From the nervous system:

;extrapyramidal reactions, usually dystonia (including very rare cases of dyskinetic syndrome), especially in children and patients under 30 years of age, the risk of which increases when exceeding the daily dose of 0.5 mg / kg of body weight: spasm of the facial muscles, trismus, rhythmic protrusion of the tongue, bulbar type of speech, spasm of the extraocular muscles, including oculogyric crises, involuntary spasmodic movements, in particular in the head, neck and shoulders, tonic blepharospasm, unnatural positions of the head and shoulders, opisthotonus, muscle hypertonicity;
parkinsonism (tremor, muscle twitching, bradykinesia, muscle rigidity, akinesia, mask-like face) after long-term treatment with metoclopramide in some elderly patients, and in renal failure;
tardive dyskinesia, which may be irreversible, may occur with long-term therapy with metoclopramide, mainly in elderly patients (especially women), in patients with diabetes mellitus and usually develops after drug withdrawal. It is manifested by involuntary movements of the tongue, face, mouth, jaw, sometimes involuntary movements of the trunk and/or limbs;
neuroleptic malignant syndrome, including hyperpyrexia, altered consciousness, muscle rigidity, autonomic dysfunction and increased serum creatine phosphokinase levels. This syndrome is potentially fatal, if it occurs, metoclopramide should be stopped immediately and treatment (dantrolene, bromocriptine) should be started urgently;
fever, headache, dizziness, drowsiness, fatigue, asthenia, increased fatigue, depressed consciousness, fear, anxiety, confusion, tinnitus, akathisia.
There is also a risk of acute (short-term) neurological disorders, which is higher in children.

Mental: depression, hallucinations, confusion, anxiety, restlessness.

From the cardiovascular system: bradycardia, especially with intravenous administration, cardiac arrest within a short time after injection, which may be a consequence of bradycardia, atrioventricular block, sinus node block, especially with intravenous administration, prolongation of the QT interval, supraventricular extrasystole, ventricular extrasystole, ventricular tachycardia of the "pirouette" type, arterial hypotension, shock, syncope with intravenous administration, acute arterial hypertension in patients with pheochromocytoma.

There have been isolated reports of the possibility of developing severe cardiovascular reactions due to the use of metoclopramide, especially with intravenous administration.

From the blood and lymphatic system: methemoglobinemia, which may be associated with a deficiency of NADH-cytochrome-b5-reductase, especially in infants, sulfhemoglobinemia, which is associated mainly with the concomitant use of high doses of drugs that release sulfur.

From the immune system: hypersensitivity reactions including anaphylactic reactions, including Quincke's edema, anaphylactic shock. Due to the presence of sodium sulfite in the dosage form, isolated cases of hypersensitivity reactions may be observed, especially in patients with bronchial asthma, in the form of nausea, vomiting, wheezing, acute asthma attack, impaired consciousness or shock. These reactions may have an individual course.

From the skin and subcutaneous tissue: hypersensitivity reactions, including: skin rashes, hyperemia and itching of the skin, urticaria.

From the reproductive system and mammary gland function: after longer therapy with the drug, due to stimulation of prolactin secretion, hyperprolactinemia, gynecomastia, galactorrhea or menstrual irregularities, amenorrhea may occur; if these phenomena develop, the use of metoclopramide should be discontinued.

Laboratory parameters: increased liver enzyme levels.

In adolescents and patients with severe renal impairment (renal failure), as a result of which the excretion of metoclopramide is slowed down, the development of side effects is monitored especially closely. If they occur, stop using the drug immediately.

The risk of developing side effects from the nervous system increases with the use of the drug in high doses and with prolonged use.