Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
The name of your medicine is Metoclopramide Hydrochloride 5mg/5ml Oral Solution (known as Metoclopramide in this leaflet).This belongs to a group of medicines called antiemetics.
Metoclopramide works on a part of the brain that prevents you from feeling sick (nausea) and 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 treatment does not work or cannot be used to prevent delayed nausea and vomiting that may occur after chemotherapy.
Do not take Metoclopramide if: • you are allergic (hypersensitive) to metoclopramide, procaine or procainamide or any other ingredients in this liquid (listed in section 6 below).The signs of an allergic reaction can include a rash, itching or shortness of breath
• you have bleeding, blockage or a tear in your stomach or gut
• you have had an operation on your stomach or gut in the last three or four days
• you have or may have a rare tumour of the adrenal gland, which sits near the kidney (phaeochromocytoma)
• you have ever had involuntary muscle spasms (tardive dyskinesia), when you have been treated with a medicine
• you have epilepsy. Metoclopramide may increase the risk of you having a fit (seizure)
• 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 apply to you. If you are not sure, talk to your doctor or pharmacist before taking Metoclopramide.
Warnings and precautions Talk to your doctor or pharmacist 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 beats
• you have any neurological (brain) problems
• you have liver or kidney problems.The dose may be reduced (see section 3)
• you have an inherited blood disorder known as porphyria
• you have a history of allergies including asthma.
If vomiting persists, even when you are taking this medicine, you should talk to your doctor.
Tests whilst taking Metoclopramide • 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.
• Metoclopramide may interfere with a hormone test (Gonadorelin test).Tell your doctor you are taking Metoclopramide if you need to take this test.
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 months treatment because of the risk of involuntary muscle spasms.
Children and adolescents Uncontrollable movements (extrapyramidal disorders) may occur in children and young adults.This medicine 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").
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking metoclopramide.
Other medicines and Metoclopramide Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines.This includes medicines bought without a prescription, including herbal medicines.This is because metoclopramide can affect the way some other medicines work. Also, some medicines can affect the way metoclopramide works.
In particular tell your doctor if you are taking any of the following:
• medicines used to treat Parkinson's disease and other related conditions, such as apomorphine, levodopa, pergolide and bromocriptine (see above "Do not take Metoclopramide if")
• tetrabenazine, a medicine used to treat movement disorders
• anticholinergics, used to relieve stomach cramps or spasms
• painkillers such as paracetamol or aspirin or stronger painkillers containing 'opioids', such as codeine and other similar medicines.These may also be used for drug addiction
• medicines known as sedatives that have a calming effect on you and may make you feel drowsy or lethargic
• any medicines for mental health problems, such as schizophrenia and other related conditions, including medicines known as phenothiazines (for example promazines or trifluoperazine)
• fluoxetine and paroxetine, used to treat depression
• other medicines used to treat depression or anxiety including medicines known as serotonergic drugs (SSRIs, for example citalopram, sertraline) and benzodiazepines (e.g. diazepam, temazepam), especially if they have a sedative effect
• barbiturates, used to treat epilepsy, such as phenobarbital
• digoxin, used to treat heart failure
• mexiletine, or other medicines used to treat unusual heart rhythms
• clonidine, normally used to treat high blood pressure
• antihistamines such as chlorphenamine that have a sedative effect
• ciclosporin, a medicine used during organ transplant to avoid the organ rejection
• suxamethonium or mivacurium, used to relax the muscles when having anaesthetic
• atovaquone, used to treat pneumonia.
Taking Metoclopramide with alcohol Do not drink alcohol whilst taking metoclopramide.This is because alcohol will make you drowsy and taking metoclopramide with it may make you even more drowsy. Also, it may make your blood alcohol levels higher than normal.
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 being given 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.
Fertility
No data available.
Driving and using machines Metoclopramide may make you drowsy, feel dizzy and can cause movement disorders 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 Oral Solution contains methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sorbitol (E420) and propylene glycol (E1520): • parahydroxybenzoates.These may cause allergic reactions (possibly delayed).
• sorbitol (a type of sugar).This medicine contains 227.3mg sorbitol in each 5ml. Sorbitol is a source of fructose. If your doctor has told you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.
• propylene glycol.This medicine contains 259.3mg propylene glycol in each 5ml. If your child is less than 5 years old, talk to your doctor or pharmacist before giving them this medicine, in particular if they use other medicines that contain propylene glycol or alcohol. If you are pregnant, breast-feeding or suffer from a liver or kidney disease, do not take this medicine unless recommended by your doctor.Your doctor may carry out extra checks while you are taking this medicine
• sodium.This medicine contains less than 1mmol sodium in each 5ml, that is to say essentially 'sodium-free'.
All indications (adult patients) The recommended single dose is 10 mg (10 ml), repeated up to three times daily.
The maximum recommended dose per day is 30 mg (30 ml) 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 1-18 years) The recommended dose is 0.1 to 0.15 mg/kg body weight, repeated up to 3 times daily, taken by mouth (oral route).
The maximum dose in 24 hours is 0.5 mg/kg body weight.
Dosing table Age: 1-3 years, Body Weight: 10-14 kg, Dose: 1 mg (1 ml), Frequency: Up to 3 times daily
Age: 3-5 years, Body Weight: 15-19 kg, Dose: 2 mg (2 ml), Frequency: Up to 3 times daily
Age: 5-9 years, Body Weight: 20-29 kg, Dose: 2.5 mg (2.5 ml), Frequency: Up to 3 times daily
Age: 9-18 years, Body Weight: 30-60 kg, Dose: 5 mg (5 ml), Frequency: Up to 3 times daily
Age: 15-18 years, Body Weight: over 60 kg, Dose: 10 mg (10 ml), Frequency: 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.
Taking this medicine • This medicine contains 5 milligram (mg) of metoclopramide hydrochloride in each 5 millilitre (ml) of solution.This is equivalent to 1mg in each ml of solution.
• Take this medicine by mouth.
• Always use the syringe supplied with the pack.
• This medicine can also be administered via nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes.
• 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.
Measuring your dose using the oral syringe provided Instructions for use of the oral syringe.
• Open the bottle: press the cap and turn it anticlockwise (Figure 1).
• Insert the syringe adaptor into the bottle neck (Figure 2).
• Take the syringe and put it in the adaptor opening (Figure 3).
• Turn the bottle upside down (Figure 4).
• Fill the syringe with a small amount of solution by pulling the piston down (Figure 4A).Then push the piston upward in order to remove any possible bubbles (Figure 4B). Finally, pull the piston down to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor (Figure 4C).
• Turn the bottle the right way up (Figure 5A).
• Remove the syringe from the adaptor (Figure 5B). Put the end of the syringe into your mouth and push the plunger slowly back in to take the medicine.
• Wash the syringe with water and let it dry before you use it again (Figure 6).
• Close the bottle with the plastic screw cap - leave the syringe adaptor in the bottle.
Taking this medicine via NG or PEG tubes 1. Ensure the tube is clear before taking the medicine.
2. Flush the tube with 5mL of water.
3. Administer the medicine into the tube with a suitable measuring device, which will be provided by your doctor, pharmacist or nurse. Do not use the oral syringe provided in the pack.
4. Flush the tube again with 5mL of water.
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).
If you take more Metoclopramide Oral Solution than you should • If you take more of this medicine than you should, talk to a doctor or go to your nearest hospital straight away.Take the medicine pack with you.
• The signs of an overdose are feeling confused, feeling drowsy, muscle spasms, shuffling walk, jerky movements of your head and face and trembling of your hands (extrapyramidal disorders), loss of consciousness, hallucinations and heart problems.Your doctor may prescribe you a treatment for these signs if necessary.
If you forget to take Metoclopramide Oral Solution • Always leave at least 6 hours between doses, even if you are sick.
• If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose.
• Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
If you stop taking Metoclopramide Oral Solution Do not stop taking the medicine unless your doctor tells you to.The symptoms may come back if treatment is stopped too early.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, Metoclopramide Oral Solution can cause side effects although not everybody gets them.
Stop taking Metoclopramide Oral Solution and see a doctor straight away if you have: • an allergic reaction .The signs of an allergic reaction may include swelling of your face, lips, tongue or throat or difficulty breathing or swallowing, severe itching of your skin with raised lumps
• symptoms of 'Neuroleptic Malignant Syndrome'. The early warning signs are unusually fast heart beats and sweating. Other signs include high fever, high blood pressure, muscle stiffness, convulsions, production of saliva and unconsciousness leading to a coma
• 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
• blood disorders .The signs of these may include breathing problems, headache and tiredness.Your lips, nail beds and ears may look blue
• heart disorders .This includes slow heart beats, heart attack, stopping of the heart.
Other side effects reported with metoclopramide: Very common (may affect more than 1 in 10 people)
• feeling drowsy.
Common (may affect up to 1 in 10 people)
• feeling depressed
• muscle spasms of your face and jaw, speech problems, unnatural tongue and eye movements (including rolling eyes), unnatural positioning of your head, shoulders and spine, difficulty with movement, tremors or restlessness. These side effects may be seen more when high doses are given to children or young adults
• symptoms similar to Parkinson disease (rigidity, tremor)
• feel restless
• low blood pressure (particularly when given by injection), this may show as dizziness or light-headedness
• 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
• irregular or absent monthly periods
• hallucination
• decreased level of consciousness
• slow heartbeat (particularly when metoclopramide is given by injection)
• allergy
• visual disturbances and involuntary deviation of the eye ball.
Rare (may affect up to 1 in 1,000 people)
• feeling irritable and confused
• fits (especially in patients with epilepsy)
• constipation
• feeling sick (nausea)
• dry mouth
• headache or dizziness
• difficulty sleeping
• skin rash, itching and swelling (including swelling of your face).
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 in males (gynaecomastia)
• involuntary muscle spasms after prolonged use, particularly in elderly patients
• 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
• fainting, shock (severe decrease of heart pressure) or cardiac arrest (particularly when metoclopramide is given by injection)
• allergic reaction which may be severe (particularly when metoclopramide is given by injection)
• a sudden rise in blood pressure in patients with a tumour of the adrenal gland (phaeochromocytoma)
• shortness of breath
• very high blood pressure.
If you get any side effects, talk to your doctor or pharmacist.This includes any side effects not listed in this leaflet.
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse.This includes any possible side effects not listed in this leaflet.You can also report side effects directly via theYellow Card Scheme.Website: www.mhra.gov.uk/yellowcard or search for MHRAYellow 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.
• Keep out of the sight and reach of children.
• Do not store above 25°C.
• Keep in the original outer carton.
• Use within 1 month of opening the bottle.
• Do not use after the expiry date (month, year) stated on the label and carton.The expiry date refers to the last day of that month.
• Do not use Metoclopramide Oral Solution if you notice anything wrong with the medicine.Talk to your pharmacist.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.These measures will help protect the environment.
What Metoclopramide Oral Solution contains • The active ingredient is metoclopramide hydrochloride.This medicine contains 5 mg of metoclopramide hydrochloride monohydrate in each 5 ml of solution.
• The other ingredients are methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), propylene glycol (E1520), sorbitol solution (non-crystallising) (E420), glycerol (E422), citric acid (E330), sodium citrate (E331), lime and lemon flavours and purified water.
What Metoclopramide Oral Solution looks like and contents of the pack A colourless solution with a lime and lemon odour.
It comes in a brown glass bottle holding 150ml of solution.
A 10ml oral syringe with markings at every 1ml and intermediate marks at every 0.5ml is provided to help measure your dose.
Marketing Authorisation Holder and Manufacturer Rosemont Pharmaceuticals Ltd
Yorkdale Industrial Park
Braithwaite Street
Leeds
LS11 9XE
UK
This leaflet was last revised in 04/2024
Rosemont Pharmaceuticals Limited
Address
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+44 (0)113 244 1400
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http://www.rosemontpharma.com
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+44 (0)800 919 312
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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.
The active substance in Metoclopramide Hydrochloride 5mg/5ml Oral Solution is metoclopramide hydrochloride.
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.
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.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
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.
Method of Administration.
For oral use.Suitable for administration via nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes. For further instructions see section 6.6. Posology.
All indications (adult patients)
The recommended single dose is 10 mg, repeated up to three times daily.The maximum recommended daily dose is 30 mg or 0.5 mg/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 (1ml) Up to 3 times daily
3-5 years 15-19 kg 2 mg (2ml) Up to 3 times daily
5-9 years 20-29 kg 2.5 mg (2.5ml) Up to 3 times daily
9-18 years 30-60 kg 5 mg (5ml) Up to 3 times daily
15-18 years Over 60 kg 10 mg (10ml) Up to 3 times daily
The maximum treatment duration is 5 days for prevention of delayed chemotherapy induced nausea and vomiting (CINV). Method of administration:
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). 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).
- Hypersensitivity to metoclopramide hydrochloride or any of the excipients listed in section 6.1- Patients hypersensitive to procaine and procainamide may show cross-sensitivity - Metoclopramide should not be used during the first three to four days following operations such as pyloroplasty or gut anastomosis as vigorous muscular contractions may not help healing- Gastrointestinal haemorrhage, mechanical obstruction or gastro-intestinal perforation for which the stimulation of gastrointestinal motility constitutes a risk- Confirmed or suspected pheochromocytoma, due to the risk of severe hypertension episodes- History of neuroleptic or metoclopramide-induced tardive dyskinesia - Epilepsy (increased crises frequency and intensity)- Parkinson's disease- 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).
If, despite treatment, vomiting persists, the patient must be re-assessed to exclude the possibility of an underlying disorder, i.e. cerebral irritation.Care should be exercised when using metoclopramide in patients with a history of atopy (including asthma) or porphyria.Patients receiving this drug for the disorders associated with delayed gastric emptying should be reviewed at an early stage for response to treatment. Metoclopramide may cause elevation of serum prolactin levels. 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 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
Methaemoglobinemia 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 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 prolongation), patients with uncorrected electrolyte imbalance, bradycardia and those taking other drugs known to prolong QT interval.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 Warnings
• Methyl and propyl parahydroxybenzoates are contained in this product which may cause allergic reactions (possibly delayed).
• Sorbitol. This medicine contains 227.3mg sorbitol (E420) in each 5ml.
The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account. The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly.
Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product.
• Propylene glycol. This medicine contains 259mg propylene glycol (E1520) in each 5ml.
Co-administration with any substrate for alcohol dehydrogenase such as ethanol may induce adverse effects in children less than 5 years old.
While propylene glycol has not been shown to cause reproductive or development toxicity in animals or humans, it may reach the foetus and was found in milk. As a consequence, administration of propylene glycol to pregnant or lactating patients should be considered on a case by case basis.
Medical monitoring is required in patients with impaired renal or hepatic functions because various adverse events attributed to propylene glycol have been reported such as renal dysfunction (acute tubular necrosis), acute renal failure and liver dysfunction.
Contraindicated combination
Levodopa or dopaminergic agonists (including apomorphine, bromocriptine and pergolide) and metoclopramide have a mutual antagonism (see section 4.3). Combination to be avoided
Alcohol potentiates the sedative effect of metoclopramide; concurrent use may also accelerate gastric emptying of alcohol and thus may promote the rate and extent of absorption from the small intestine. 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. Ciclosporin
Metoclopramide increases ciclosporin bioavailability (Cmax by 46% and exposure by 22%). Careful monitoring of ciclosporin plasma concentration is required. The clinical consequence is uncertain.Mivacurium and suxamethoniumMetoclopramide 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.Extrapyramidal reaction causing drugs (such as phenothiazines and tetrabenazine) Concurrent use with metoclopramide may increase the frequency and severity of extrapyramidal side effects. Care should be exercised in the event of co-administration of these drugs. Mexiletine
Concurrent use with metoclopramide may accelerate absorption of mexiletine. Diagnostic interference
With Gonadorelin test, concurrent use with metoclopramide may blunt the response to gonaderelin by increasing serum prolactin concentrations. Concurrent metoclopramide therapy may increase aldosterone and serum prolactin levels. Aspirin and paracetamol
The absorption of any concurrently administered oral drug may be modified by the effect of metoclopramide on gastric motility. Drugs known to be affected in this way include aspirin and paracetamol. Atovaquone
Metoclopramide may reduce plasma concentrations of atovaquone.
Pregnancy
A large amount of data on pregnant women (more than 1000 exposed outcomes) indicates neither malformative toxicity nor foetotoxicity. Metoclopramide can be used during pregnancy if clinically needed. Due to pharmacological properties (as with 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. Breastfeeding
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. Fertility
No data available.
Metoclopramide may cause drowsiness, dizziness, dyskinesia and dystonias which can affect the vision and also interfere with the ability to drive and operate machinery.
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). 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 sulfur-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); Asystole; 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
Rare Constipation; Nausea; Unusual dryness of mouth
General disorders and administration site conditions
Common Asthenia
Rare Oedema (including face oedema)
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 young adults 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; Dizziness ; Headache
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; Restlessness
Uncommon Hallucination
Rare Confusional state; Trouble sleeping; Unusual irritability
Respiratory, thoracic and mediastinal disorders
Not known Dyspnoea may occur
Skin and subcutaneous tissue disorders
Rare Skin rash; A small number of skin reactions such as urticaria and pruritus
Vascular disorder
Common: Hypotension; particularly with intravenous formulation
Not known
Shock, Syncope 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).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 at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Symptoms
Extrapyramidal Disorder (muscle spasms, especially of jaw, neck, back, shuffling walk, tic like (jerky) movements of head and face, trembling and shaking of hands), 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 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.
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