Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Metoclopramide hydrochloride 5mg/5ml Oral Solution
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Metoclopramide hydrochloride anhydrous may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Metoclopramide is an antiemetic. It works on a part of your brain that prevents you from feeling sick (nausea) or being sick (vomiting). Adult population: Metoclopramide is used in adults: to prevent delayed nausea and vomiting that may occur after chemotherapy to prevent nausea and vomiting caused by radiotherapy to treat nausea and vomiting including nausea and vomiting which may occur with a migraine. Metoclopramide can be taken with oral painkillers in case of migraine to help painkillers work more effectively. Paediatric population: Metoclopramide is indicated in children (aged 1-18 years) if other treatments do not work or cannot be used to prevent delayed nausea and vomiting that may occur after chemotherapy. You must talk to a doctor if you do not feel better or if you feel worse.
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2.
What you need to know before you take it
e Metoclopramide
Do not take Metoclopramide if: you are allergic to metoclopramide or any of the other ingredients of this medicine (listed in section 6) you have bleeding, obstruction or a tear in your stomach or gut you have or may have a rare tumour of the adrenal gland, which sits near the kidney (pheochromocytoma) you have ever had involuntary muscle spasms (tardive dyskinesia), when you have been treated with a medicine you have epilepsy you have Parkinson's disease you are taking levodopa (a medicine for Parkinson's disease) or dopaminergic agonists (see below "Other medicines and Metoclopramide") you have ever had an abnormal blood pigment levels (methaemoglobinemia) or NADH cytochrome-b5 deficiency.
Do not give Metoclopramide to a child less than 1 year of age (see below "Children and adolescents"). Do not take Metoclopramide if any of the above statements apply to you, or that have applied to you in the past. If in doubt, consult your doctor or pharmacist before taking Metoclopramide. Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Metoclopramide if: you have a history of abnormal heart beats (QT interval prolongation) or any other heart problems you have problems with the levels of salts in your blood, such as potassium, sodium and magnesium you are using other medicines known to affect the way your heart rate. you have any neurological (brain) problems you have liver or kidney problems. The dose may be reduced (see section 3). Your doctor may perform blood tests to check your blood pigment levels. In cases of abnormal levels (methaemoglobinemia), the treatment should be immediately and permanently stopped. You must wait at least 6 hours between each metoclopramide dose, even in case of vomiting and rejection of the dose, in order to avoid overdose. Do not exceed 3-month treatment because of the risk of involuntary muscle spasms. Children and adolescents Uncontrollable movements (extrapyramidal disorders) may occur in children and young adults. This solution must not be used in children below 1 year of age because of the increased risk of the uncontrollable movements (see above "Do not take Metoclopramide if").
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Other medicines and Metoclopramide Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This is because some medicines can affect the way Metoclopramide works or Metoclopramide can affect how other medicines work. These medicines include the following: levodopa or other medicines used to treat Parkinson's disease (see above "Do not take Metoclopramide if") anticholinergics (medicines used to relieve stomach cramps or spasms) morphine derivatives (medicines used to treat severe pain) sedative medicines any medicines used to treat mental health problems digoxin (medicine used to treat heart failure) cyclosporine (medicine used to treat certain problems with the immune system) mivacurium and suxamethonium (medicines used to relax muscles) fluoxetine and paroxetine (medicine used to treat depression). rifampicin, a medicine used to treat tuberculosis or other infections, may reduce the amount of metoclopramide in the blood if administered at the same time. Metoclopramide with alcohol Alcohol should not be consumed during treatment with metoclopramide because it increases the effect of drowsiness and sleepiness. Pregnancy, breast-feeding and fertility Pregnancy: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. If necessary, Metoclopramide may be taken during pregnancy. Your doctor will decide whether or not you should be given this medicine. Breast-feeding: Metoclopramide is not recommended if you are breast-feeding because metoclopramide passes into breast milk and may affect your baby. Driving and using machines You may feel drowsy, dizzy or have uncontrollable twitching, jerking or writhing movements and unusual muscle tone causing distortion of the body after taking Metoclopramide. This may affect your vision and also interfere with your ability to drive and use machines. Metoclopramide contains: Sodium benzoate (E211): This medicine contains 1.25mg sodium benzoate in each 5ml which is equivalent to 0.25mg/ml. Sodium: This medicine contains less than 1 mmol sodium (23 mg) per 5ml, that is to say essentially 'sodium-free'.
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3.
How to take it
Metoclopramide
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Adult population: The recommended single dose is 10 mg, repeated up to three times daily. The maximum recommended dose per day is 30 mg or 0.5 mg/kg body weight. The maximum recommended treatment duration is 5 days. To prevent delayed nausea and vomiting that may occur after chemotherapy (children aged 118 years): The recommended dose is 0.1 to 0.15 mg/kg body weight, repeated up to 3 times daily, taken orally. The maximum dose in 24 hours is 0.5 mg/kg body weight. Dosing table Age 1-3 years 3-5 years 5-9 years 9-18 years 15-18 years
Body Weight 10-14 kg 15-19 kg 20-29 kg 30-60 kg Over 60 kg
Dose 1 mg 2 mg 2.5 mg 5 mg 10 mg
Frequency Up to 3 times daily Up to 3 times daily Up to 3 times daily Up to 3 times daily Up to 3 times daily
You should not take this medicine for more than 5 days to prevent delayed nausea and vomiting that may occur after chemotherapy. Older people The dose may need to be reduced depending on kidney problems, liver problems and overall health. Adults with kidney problems Talk to your doctor if you have kidney problems. The dose should be reduced if you have moderate or severe kidney problems. Adults with liver problems Talk to your doctor if you have liver problems. The dose should be reduced if you have severe liver problems. Children and adolescents Metoclopramide must not be used in children aged less than 1 year (see section 2). VAR/IB-022
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Method of administration: You must wait at least 6 hours between each metoclopramide dose, even in the case of vomiting or rejection of the dose, in order to avoid overdose. This medicine must be taken orally. Use the measuring syringe provided in the pack to deliver the required dose. Instructions for the use of syringe: a) Open the bottle: press the cap and turn it anticlockwise (Figure 1). b) Separate the adaptor from the syringe (Figure 2). Insert the adaptor into the bottle neck (Figure 3). Ensure it is properly fixed. Take the syringe and put it in the adaptor opening (Figure 4).
c)
Turn the bottle upside down. Fill the syringe with a small amount of solution by pulling the piston down (Figure 5A), then push the piston upwards in order to remove any possible air bubbles (Figure 5B). Pull the piston down to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor (Figure 5C).
d)
Turn the bottle the right way up (Figure 6A). Remove the syringe from the adaptor (Figure 6B).
e)
Empty the contents of the syringe into the patient's mouth by pushing the piston to the bottom of the syringe (Figure 7). The contents of the syringe should be emptied into the side cheek of the patient's mouth to avoid a choking hazard. Leave the syringe adaptor in place after first use. Close the bottle with the plastic screw cap. Wash the syringe with water (Figure 8). Repeat the above steps if required dose is more than 5ml.
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If you take more Metoclopramide than you should Contact your doctor or pharmacist straight away. You may experience uncontrollable movements (extrapyramidal disorders), feel drowsy, loss of consciousness, be confused, have hallucinations and heart problems. Your doctor may prescribe you a treatment for these signs if necessary. If you forget to take Metoclopramide Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop the treatment and talk to your doctor, pharmacist or nurse straight away if you experience one or more of the following signs while taking this medicine: uncontrollable movements (often involving head or neck). These may occur in children or young adults and particularly when high doses are used. These signs usually occur at the beginning of treatment and may even occur after one single administration. These movements will stop when treated appropriately. high fever, high blood pressure, seizures /convulsions, sweating, increased salivation. These may be signs of a condition called neuroleptic malignant syndrome. itching or skin rashes, swelling of the face, lips or throat, difficulty in breathing. These may be signs of an allergic reaction, which may be severe. Very common (may affect more than 1 in 10 people) feeling drowsy. Common (may affect up to 1 in 10 people) depression uncontrollable movements such as tics, shaking, jerking movements or muscle contracture (stiffness, rigidity) symptoms similar to Parkinson's disease (rigidity, tremor) feeling restless blood pressure decrease (particularly with intravenous route) diarrhoea feeling weak. Uncommon (may affect up to 1 in 100 people) raised levels of a hormone called prolactin in the blood which may cause: milk production in men, and women who are not breast-feeding VAR/IB-022
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irregular periods hallucination decreased level of consciousness slow heartbeat (particularly with intravenous route) allergy visual disturbances and involuntary deviation of the eye ball.
Rare (may affect up to 1 in 1,000 people) confusional state seizures/convulsion (especially in patients with epilepsy). Not known (frequency cannot be estimated from the available data) abnormal blood pigment levels: which may change the colour of your skin abnormal development of breasts (gynaecomastia) involuntary muscle spasms after prolonged use, particularly in elderly patients, along with high fever, high blood pressure, convulsions, sweating, production of saliva. These may be signs of a condition called neuroleptic malignant syndrome changes in heart beat, which may be shown on an ECG test cardiac arrest (particularly with injection route) shock (severe decrease of heart pressure) (particularly with intravenous administration) fainting (particularly with intravenous route) allergic reactions (such as anaphylaxis, angioedema and urticaria). Symptoms may include rash, itching, difficulty breathing, shortness of breath, swelling of the face, lips, throat or tongue, coldness, clammy skin, palpitations, dizziness, weakness or fainting. Contact your doctor or other health care provider immediately or go to the nearest hospital emergency department immediately. very high blood pressure in patients with or without pheochromocytoma ideas about suicide. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. Reporting of side effects: If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5.
How to store it
Metoclopramide
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and bottle label after 'Exp'. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions. Discard after 60 days of first opening. Do not use this medicine if you notice that the solution becomes discoloured or shows any signs of deterioration. Seek the advice of your pharmacist. Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
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6.
Contents of the pack and other information
What Metoclopramide contains Each 5ml of oral solution contains 5mg metoclopramide hydrochloride (anhydrous). The other ingredients are: sodium benzoate (E211), citric acid monohydrate (E330), sodium citrate (E331), saccharin sodium (E954), lemon flavour 13499 (containing propylene glycol (E1520), natural flavouring substances and flavouring preparation) and purified water. What Metoclopramide looks like and contents of the pack Metoclopramide is a clear, colourless oral solution with lemon flavour supplied in an amber glass bottle with a tamper evident, child resistant plastic cap. The pack also comes with a 5ml oral syringe with 0.2ml graduation for measuring the dose and a syringe adaptor for bottle. Metoclopramide hydrochloride oral solution is supplied in a bottle containing 150ml solution. Marketing Authorisation Holder and Manufacturer: Thame Laboratories, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK. OR SyriMed, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK. If this leaflet is hard to see or read, please call +44 (0) 208 515 3700 for help. This leaflet was revised in 12/2025.
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Frequently asked questions about Metoclopramide hydrochloride 5mg/5ml Oral Solution
How do I take Metoclopramide hydrochloride 5mg/5ml Oral Solution?
Metoclopramide hydrochloride 5mg/5ml Oral Solution comes as oral solution containing 5mg / 5ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Metoclopramide hydrochloride 5mg/5ml Oral Solution?
The active substance in Metoclopramide hydrochloride 5mg/5ml Oral Solution is metoclopramide hydrochloride anhydrous.
Are there equivalent medicines to Metoclopramide hydrochloride 5mg/5ml Oral Solution?
Medicines with the same active substance, strength and form include: Metoclopramide 5 mg/5 ml Oral Solution Sugar-Free, Metoclopramide Hydrochloride 5mg/5ml Oral Solution. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Metoclopramide hydrochloride 5mg/5ml Oral Solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Metoclopramide hydrochloride 5mg/5ml Oral Solution without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: metoclopramide hydrochloride anhydrous
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Adult population
Metoclopramide is indicated in adults for:
• Prevention of delayed chemotherapy induced nausea and vomiting (CINV).
• Prevention of radiotherapy induced nausea and vomiting (RINV).
• Symptomatic treatment of nausea and vomiting, including acute migraine induced nausea and vomiting. Metoclopramide can be used in combination with oral analgesics to improve the absorption of analgesics in acute migraine.
Paediatric population
Metoclopramide is indicated in children (aged 1-18 years) for:
• Prevention of delayed chemotherapy induced nausea and vomiting (CINV) as a second line option.
4.2. Posology and method of administration
Posology
Adult population
The recommended single dose is 10 mg, repeated up to three times daily.
The maximum recommended daily dose is 30 mg or 0.5mg/kg body weight.
The maximum recommended treatment duration is 5 days.
Prevention of delayed chemotherapy induced nausea and vomiting (CINV) (paediatric patients aged 1-18 years)
The recommended dose is 0.1 to 0.15 mg/kg body weight, repeated up to three times daily by oral route. The maximum dose in 24 hours is 0.5 mg/kg body weight.
Dosing table
Age
Body Weight
Dose
Frequency
1-3 years
10-14 kg
1 mg
Up to 3 times daily
3-5 years
15-19 kg
2 mg
Up to 3 times daily
5-9 years
20-29 kg
2.5 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 5 days for prevention of delayed chemotherapy induced nausea and vomiting (CINV).
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%.
In patients with moderate to severe renal impairment (Creatinine clearance 15-60 ml/min), the dose should be reduced by 50% (see section 5.2).
Hepatic impairment:
In patients with severe hepatic impairment, the dose should be reduced by 50% (see section 5.2).
Paediatric population
Metoclopramide is contraindicated in children aged less than 1 year (see section 4.3).
Method of administration:
For oral use.
A minimal interval of 6 hours between two administrations is to be respected, even in case of vomiting or rejection of the dose (see section 4.4).
4.3. Contraindications
• Hypersensitivity to the active substance or any of the excipients listed in 6.1.
• Gastrointestinal haemorrhage, mechanical obstruction or gastrointestinal perforation for which the stimulation of gastrointestinal motility constitutes a risk.
• A history of neuroleptic or metoclopramide-induced tardive dyskinesia.
• Epilepsy (increased crises/seizures frequency and intensity).
• Parkinson's disease.
• Confirmed or suspected phaeochromocytoma, due to the risk of severe hypertension episodes.
• Combination with levodopa or dopaminergic agonists (see section 4.5).
• Known history of methaemoglobinaemia with metoclopramide or of NADH cytochrome-b5 deficiency.
• Use in children less than 1 year of age due to an increased risk of extrapyramidal disorders (see section 4.4).
4.4. Special warnings and precautions for use
Special warnings
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).
The time interval of at least 6 hours specified in the section 4.2 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. Treatment should not exceed 3 months because of the risk of tardive dyskinesia (see section 4.8). 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 (see section 4.8). Metoclopramide should be discontinued immediately in the event of symptoms of neuroleptic malignant syndrome and appropriate treatment should be initiated.
Special care should be exercised in patients with underlying neurological conditions and in patients being treated with other centrally-acting drugs (see section 4.3)
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).
Cardiac Disorders
There have been reports of serious cardiovascular undesirable effects including cases of circulatory collapse, severe bradycardia, cardiac arrest and QT interval prolongation following administration of metoclopramide by injection, particularly via the intravenous route (see section 4.8).
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 interval prolongation), patients with uncorrected electrolyte imbalance, bradycardia and those taking other drugs known to prolong QT interval (eg. class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics (see section 4.8)).
Intravenous doses should be administered as a slow bolus (at least over 3 minutes) in order to reduce the risk of adverse effects (e.g. hypotension, akathisia).
Renal and Hepatic Impairment
In patients with renal impairment or with severe hepatic impairment, a dose reduction is recommended (see section 4.2).
Excipient warning:
Sodium benzoate (E211): This medicinal product contains 1.25mg sodium benzoate in each 5ml which is equivalent to 0.25mg/ml.
Sodium: This medicinal product contains less than 1 mmol sodium (23 mg) per 5ml, that is to say essentially 'sodium-free'.
4.5. Interaction with other medicinal products and other forms of interaction
Contraindicated combination
Levodopa or dopaminergic agonists and metoclopramide have a mutual antagonism (see section 4.3).
Combination to be avoided
Alcohol potentiates the sedative effect of metoclopramide.
Combination to be taken into account
Due to the prokinetic effect of metoclopramide, the absorption of certain drugs may be modified.
Anticholinergics and morphine derivatives
Anticholinergics and morphine derivatives may have both a mutual antagonism with metoclopramide on the digestive tract motility.
Central nervous system depressants (morphine derivatives, anxiolytics, sedative H1 antihistamines, sedative antidepressants, barbiturates, clonidine and related)
Sedative effects of Central Nervous System depressants and metoclopramide are potentiated.
Neuroleptics
Metoclopramide may have an additive effect with other neuroleptics on the occurrence of extrapyramidal disorders.
Serotonergic drugs
The use of metoclopramide with serotonergic drugs such as SSRIs may increase the risk of serotonin syndrome.
Digoxin
Metoclopramide may decrease digoxin bioavailability. Careful monitoring of digoxin plasma concentration is required.
Cyclosporine
Metoclopramide increases cyclosporine bioavailability (Cmax by 46% and exposure by 22%). Careful monitoring of cyclosporine plasma concentration is required. The clinical consequence is uncertain.
Mivacurium and suxamethonium
Metoclopramide injection may prolong the duration of neuromuscular block (through inhibition of plasma cholinesterase).
Strong CYP2D6 inhibitors
Metoclopramide exposure levels are increased when co-administered with strong CYP2D6 inhibitors such as fluoxetine and paroxetine. Although the clinical significance is uncertain, patients should be monitored for adverse reactions.
Rifampicin
In a published study conducted in 12 healthy volunteers, the administration of 600 mg rifampicin for 6 days resulted in reduced plasma metoclopramide exposure (AUC area under the curve) and maximum concentration (Cmax) by 68% and 35%, respectively. Although the clinical significance is uncertain when metoclopramide is combined with rifampicin, or with other strong inducers (e.g. carbamazepine, phenobarbital, phenytoin), patients should be monitored for possible lack of antiemetic effect.
4.6. Fertility, pregnancy and lactation
Pregnancy
A large amount of data on pregnant women (more than 1000 exposed outcomes) indicates no malformative toxicity nor foetotoxicity. Metoclopramide can be used during pregnancy if clinically needed. Due to pharmacological properties (as other neuroleptics), in case of metoclopramide administration at the end of pregnancy, extrapyramidal syndrome in newborn cannot be excluded.
Metoclopramide should be avoided at the end of pregnancy. If metoclopramide is used, neonatal monitoring should be undertaken.
Breast-feeding
Metoclopramide is excreted in breast milk at low level. Adverse reactions in the breast-fed baby cannot be excluded. Therefore metoclopramide is not recommended during breastfeeding. Discontinuation of metoclopramide in breastfeeding women should be considered.
4.7. Effects on ability to drive and use machines
Metoclopramide may cause drowsiness, dizziness, dyskinesia and dystonias which could affect the vision and also interfere with the ability to drive and operate machinery.
4.8. Undesirable effects
Adverse reactions listed by System Organ Class. Frequencies are defined using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to<1/100), rare (≥1/10,000 to<1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
System Organ Class
Frequency
Adverse reactions
Blood and lymphatic system disorders
Not known
Methaemoglobinaemia, which could be related to NADH cytochrome b5 reductase deficiency, particularly in neonates (see section 4.4);
Sulfhaemoglobinaemia, mainly with concomitant administration of high doses of sulphur-releasing medicinal products
Cardiac disorders
Uncommon
Bradycardia, particularly with intravenous formulation
Not known
Cardiac arrest, occurring shortly after injectable use, and which can be subsequent to bradycardia (see section 4.4);
Atrioventricular block, Sinus arrest particularly with intravenous formulation;
Electrocardiogram QT prolonged; Torsade de Pointes.
Endocrine disorders*
Uncommon
Amenorrhoea, Hyperprolactinaemia
Rare
Galactorrhoea
Not known
Gynaecomastia
Gastrointestinal disorders
Common
Diarrhoea
General disorders and administration site conditions
Common
Asthenia
Immune system disorders
Uncommon
Hypersensitivity
Not known
Anaphylactic reaction (including anaphylactic shock particularly with intravenous formulation)
Nervous system disorders
Very Common
Somnolence
Common
Extrapyramidal disorders$ (particularly in children and adolescents and/or when the recommended dose is exceeded, even following administration of a single dose of the drug) (see section 4.4), Parkinsonism, Akathisia
Uncommon
Dystonia (including visual disturbances and oculogyric crisis), Dyskinesia, Depressed level of consciousness
Rare
Convulsion especially in epileptic patients
Not known
Tardive dyskinesia which may be persistent, during or after prolonged treatment, particularly in elderly patients (see section 4.4), Neuroleptic malignant syndrome (see section 4.4)
Psychiatric disorders
Common
Depression
Uncommon
Hallucination
Rare
Confusional state
Not known
Suicide Ideation
Vascular disorder
Common
Hypotension, particularly with intravenous formulation
Not known
Shock, syncope (fainting) after injectable use, Acute hypertension in patients with phaeochromocytoma (see section 4.3), Transient increase in blood pressure
* Endocrine disorders during prolonged treatment in relation with hyperprolactinaemia (amenorrhoea, galactorrhoea, gynaecomastia).
$ Patients with poor CYP2D6 metabolisers may be at increased risk of extrapyramidal disorders (see 5.2 Pharmacokinetic properties).
The following reactions, sometimes associated, occur more frequently when high doses are used:
• Extrapyramidal symptoms: acute dystonia and dyskinesia, parkinsonian syndrome, akathisia, even following administration of a single dose of the medicinal product, particularly in children and young adults (see section 4.4).
• 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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Symptoms
Extrapyramidal disorders, drowsiness, decreased level of consciousness, confusion, hallucination, and cardio-respiratory arrest may occur.
Management
In case of extrapyramidal symptoms related or not to overdose, the treatment is only symptomatic (benzodiazepines in children and/or anticholinergic anti-parkinsonian medicinal products in adults).
A symptomatic treatment and a continuous monitoring of the cardiovascular and respiratory functions should be carried out according to clinical status.
💬 Ask about this leaflet
Ask anything about Metoclopramide hydrochloride 5mg/5ml Oral Solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.