METOCLOPRAMIDE HYDROCHLORIDE

8). The solution can be administered intravenously or intramuscularly. Intravenous doses should be administered as a slow bolus (over at least 3 minutes). All indications (adult patients) For prevention of PONV a single dose of 10mg is recommended.

For the symptomatic treatment of nausea and vomiting, including acute migraine induced nausea and vomiting and for the prevention of radiotherapy induced nausea and vomiting (RINV): the recommended single dose is 10 mg, repeated up to three times daily.

5 mg / kg body weight. The injectable treatment duration should be as short as possible and transfer to oral or rectal treatment should be made as soon as possible. 15 mg / kg body weight, repeated up to three times daily by intravenous route.

5 mg / kg body weight. 5 mg Up to 3 times daily 9 – 18 years 30 – 60 kg 5 mg Up to 3 times daily 15 – 18 years Over 60 kg 10 mg Up to 3 times daily The maximum treatment duration is 48 hours for treatment of established post operative nausea and vomiting (PONV).

The maximum treatment duration is 5 days for prevention of delayed chemotherapy induced nausea and vomiting (CINV). 4).

Special population Elderly:

In elderly patients a dose reduction should be considered, based on renal and hepatic function and overall frailty.

Renal impairment:

In patients with end stage renal disease (Creatinine clearance < 15 ml / min), the daily dose should be reduced by 75 %. 2). 2). Other pharmaceutical forms may be more appropriate for administration to this population. 3).

Adverse reactions listed by System Organ Class. Frequencies are defined using the following convention: very common ((≥1/10), common ((≥1/100, <1/10), uncommon ((≥1/1000, <1/100), rare ((≥1/10000, <1/1000), very rare (<1/10000), not known (cannot be estimated from the available data).

4) Psychiatric disorders Common Depression with light or severe symptoms including suicidal thoughts Uncommon Hallucination Rare Confusional state Not known Suicidal ideation Vascular disorder Common: Hypotension, particularly with intravenous formulation Not known Transient increase in blood pressure Shock, syncope after injectable use.

3) * Endocrine disorders during prolonged treatment in relation with hyperprolactinaemia (amenorrhoea, galactorrhoea, gynaecomastia). 4). − Drowsiness, decreased level of consciousness, confusion, hallucination. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Neurological Disorders Extrapyramidal disorders may occur, particularly in children and young adults, and/or when high doses are used. These reactions occur usually at the beginning of the treatment and can occur after a single administration.

Metoclopramide should be discontinued immediately in the event of extrapyramidal symptoms. These effects are generally completely reversible after treatment discontinuation, but may require a symptomatic treatment (benzodiazepines in children and / or anticholinergic anti-Parkinsonian medicinal products in adults).

2 should be respected between each metoclopramide administration, even in case of vomiting and rejection of the dose, in order to avoid overdose. Prolonged treatment with metoclopramide may cause tardive dyskinesia, potentially irreversible, especially in the elderly.

8). Treatment must be discontinued if clinical signs of tardive dyskinesia appear. 8). Metoclopramide should be discontinued immediately in the event of symptoms of neuroleptic malignant syndrome and appropriate treatment should be initiated.

3). Symptoms of Parkinson's disease may also be exacerbated by metoclopramide. Methaemoglobinemia Methemoglobinemia which could be related to NADH cytochrome b5 reductase deficiency has been reported. In such cases, metoclopramide should be immediately and permanently discontinued and appropriate measures initiated (such as treatment with methylene blue).

8). Special care should be taken when administering metoclopramide, particularly via the intravenous route to the elderly population, to patients with cardiac conduction disturbances (including QT prolongation), patients with uncorrected electrolyte imbalance, bradycardia and those taking other drugs known to prolong QT interval.

g. hypotension, akathisia). 2). Other precautions Metoclopramide may cause elevation of serum prolactin levels. Care should be exercised when using metoclopramide in patients with a history of atopy (including asthma) or porphyria. Special care should be taken when administering metoclopramide intravenously to patients with “sick sinus syndrome” or other cardiac conduction disturbances.

Excipients with known effect:

This medicine contains less than 1 mmol sodium (23 mg) per ampoule, that is to say essentially ‘sodium free’.

5) − Known history of methaemoglobinaemia with metoclopramide or of NADH cytochrome-b5 deficiency. 4).