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Amdipharm Mercury Company Limited

No. 1 Croydon, 12 - 16 Addiscombe Road, Croyden, Surrey, CR0 0XT, UK
Telephone: +44 (0)208 588 9100
Fax: +44 (0)208 588 9200
WWW: http://www.amcolimited.com
Medical Information Direct Line: 08700 70 30 33
Medical Information e-mail: medicalinformation@amcolimited.com
Customer Care direct line: +44 (0)020 8588 9200
Medical Information Facsimile: +44 (0)20 8588 9200

Summary of Product Characteristics last updated on medicines.ie: 27/01/2015
SPC Maxolon 10 mg tablets

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Maxolon 10 mg Tablets

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Each tablet contains metoclopramide hydrochloride equivalent to 10 mg of the anhydrous substance.

1Excipients: Contains Lactose Monohydrate to 125.0mg

For a full list of excipients, see section 6.1.

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White to off-white, round, convex, tablets with a breakline on one side enabling the tablet to be divided into equal halves. The other side is engraved 'Maxolon'.

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4.1 Therapeutic indications

Adult population:

Maxolon 10 mg tablets are 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

Maxolon 10mg tablets are indicated in adolescents aged 15-18 years and weighing more than 60kg for:

- Prevention of delayed chemotherapy induced nausea and vomiting (CINV) as a second line option.

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4.2 Posology and method of administration

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 0.5mg/kg body weight. The maximum recommended treatment duration is 5 days.

Paediatric population

Adolescents aged 15-18 years and weighing > 60kg.

Prevention of delayed chemotherapy induced nausea and vomiting (CINV)

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.


Body Weight



Adolescents 15-18 years

Over 60kg

10 mg

Up to 3 times daily

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

Maxolon 10 mg Tablets are not suitable for use in adolescents weighing less than 60 kg or in adolescents/children aged 15 years of age or under.

Metoclopramide is contraindicated in children aged less than 1 year (see section 4.3).

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


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).

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4.3 Contraindications

- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

- 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 of Metoclopramide in children less than 1 year of age due to an increased risk of extrapyramidal disorders (see section 4.4)

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4.4 Special warnings and precautions for use

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. Maxolon 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.

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.


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 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).

Metoclopramide should not be used in the immediate post-operative period (up to 3-4 days) following pyloroplasty or gut anastomosis, as vigorous gastrointestinal contractions may adversely affect healing.

Metoclopramide may cause elevation of serum prolactin levels.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency of glucose-galactose malabsorption should not take this medicine. Care should be exercised when using Maxolon in patients with a history of atopy (including asthma) or porphyria.

Special care should be taken when administering to patients with “sick sinus syndrome” or other cardiac conduction disturbances.

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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.


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.


Metoclopramide may decrease digoxin bioavailability. Careful monitoring of digoxin plasma concentration is required.


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.

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4.6 Fertility, pregnancy and lactation


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.


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.

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4.7 Effects on ability to drive and use machines

'Maxolon' may cause drowsiness, dizziness, dyskinesia and dystonias which could affect the vision and also interfere with the ability to drive and operate machinery.

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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, <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).

Systeme Organ Class


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



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;

Respiratory, thoracic and mediastinal disorders


Not known


Endocrine disorders*



Amenorrhoea, Hyperprolactinaemia,





Not known


Gastrointestinal disorders




Eye disorders


Not known

Visual disturbance

General disorders and administration site conditions








Not known


Immune system disorders





Not known

Anaphylactic reaction (including anaphylactic shock Skin reactions such as rashes, urticaria, pruritus and angioedema.)

Nervous system disorders


Very 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



Dystonia, Dyskinesia, Depressed level of consciousness



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









Confusional state, restlessness, agitation

Vascular disorder



Hypotension, particularly with intravenous formulation


Not known

Shock, syncope after injectable use Acute hypertension in patients with phaeochromocytoma (see section 4.3)

* 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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

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4.9 Overdose


Extrapyramidal disorders, drowsiness, decreased level of consciousness, confusion, hallucination, and cardio-respiratory arrest may occur.


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.

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5.1 Pharmacodynamic properties

The action of metoclopramide is closely associated with parasympathetic nervous control of the upper gastrointestinal tract, where it has the effect of encouraging normal peristaltic action. Metoclopramide is a benzamide derivative which acts peripherally to enhance cholinergic action at muscarinic synapses and in the central nervous system to antagonise dopamine. This provides for a fundamental approach to the control of those conditions where disturbed gastrointestinal motility is a common underlying factor.

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5.2 Pharmacokinetic properties

Absorption from the gastrointestinal tract is rapid. The drug undergoes significant first-pass hepatic metabolism. It is excreted in the urine as unchanged drug and metabolites in both free and conjugated form. The drug is also excreted in breast milk.

Renal impairment

The clearance of metoclopramide is reduced 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

In patients with cirrhosis of the liver, accumulation of metoclopramide has been observed, associated with a 50% reduction in plasma clearance.

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5.3 Preclinical safety data

No additional data available.

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6.1 List of excipient(s)

Maize starch (dried)

Colloidal anhydrous silica

Magnesium stearate

Pregelatinised maize starch

Lactose monohydrate

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6.2 Incompatibilities

Not applicable.

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6.3 Shelf life

5 years.

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6.4 Special precautions for storage

Do not store above 30°C.

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6.5 Nature and contents of container

Packs of 20, 21 and 84 tablets in PVC aluminium blister strip.

Not all pack sizes may be marketed.

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6.6 Special precautions for disposal and other handling

No special requirements

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Amdipharm Limited

Temple Chambers

3 Burlington Road

Dublin 4


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PA 1142/011/003

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Date of first authorisation: 1st April 1979

Date of last renewal: 1st April 2009

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January 2015

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Active Ingredients

   Metoclopramide Hydrochloride