Metoclopramide 10mg Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Metoclopramide 10 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains metoclopramide hydrochloride 10 mg.
Also contains lactose, for a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet
White, normal, bi-convex tablets. Engraved MP34 on one side.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Adults (20 years and over)
Digestive disorders:
Metoclopramide restores normal co-ordination and tone to the upper digestive tract.
Metoclopramide relieves the symptoms of gastro-duodenal dysfunction including:
Dyspepsia, Heartburn,
Flatulence, Sickness,
Regurgitation of bile, Pain
These symptoms are associated with such conditions as:
Peptic ulcer, Duodenitis,
Reflux oesophagitis, Hiatus hernia,
Gastritis, dyspepsia, Cholelithiasis and
Post-cholecystectomy dyspepsia
Nausea and vomiting:
Metoclopramide is indicated for the treatment of the nausea and vomiting associated with:
Gastro-intestinal disorders,
Cyclical vomiting,
Intolerance to cytotoxic drugs,
Congestive heart failure,
Deep X-ray or cobalt therapy,
Post-anaesthetic vomiting
Migraine:
Metoclopramide relieves symptoms of nausea and vomiting, and overcomes gastric stasis associated with attacks of migraine. This improvement in gastric emptying assists the absorption of concurrently administered oral anti-migraine therapy (e.g. paracetamol) which may otherwise be impaired in such patients.
Post-operative conditions:
Post-operative gastric hypotonia Post-vagotomy syndrome
Metoclopramide promotes normal gastric emptying and restores motility in vagotomised patients, and where post-operative symptoms suggest gastroduodenal dysfunction.
Diagnostic procedures:
Radiology,
Duodenal intubation
Metoclopramide speeds up the passage of a barium meal by increasing gastric emptying time, co-ordinating peristalsis and dilating the duodenal bulb. Metoclopramide also facilitates duodenal intubation procedures.
Young adults and children
The use of Metoclopramide in patients under 20 years should be restricted to the following:
Severe intractable vomiting of known cause, vomiting associated with radiotherapy and intolerance to cytotoxic drugs, as an aid to gastro-intestinal intubation, and as part of the premedication before surgical procedures.
4.2 Posology and method of administration
The dosage recommendations given below should be strictly adhered to if side effects of the dystonic type are to be avoided. It should be noted that total daily dosage of Metoclopramide, especially for children and young adults, should not normally exceed 0.5 mg/kg body weight.
In patients with clinically significant degrees of renal or hepatic impairment, therapy should be at reduced dosage. Metoclopramide is metabolized in the liver and the predominant route of elimination of Metoclopramide and its metabolites is via the kidney.
Medical indications:
Adults 20 years and over:
10 mg three times daily
For patients of less than 60 kg see below.
Elderly patients:
As for adults; to avoid adverse reactions adhere strictly to dosage recommendations and where prolonged therapy is considered necessary, patients should be regularly reviewed.
Young adults and children:
Metoclopramide should only be used after careful examination to avoid masking an underlying disorder, e.g. cerebral irritation. In the treatment of this group attention should be given to body weight and treatment should commence at the lower dosage where stated.
Young adults: 15-19 years 60 kg and over 10 mg three times daily
30-59 kg 5 mg three times daily
Tablets should not be used in children under the age of 15. A liquid presentation should be used in the younger age groups; more accurate dosage is facilitated by the use of the Paediatric Liquid.
Diagnostic indications:
A single dose of Metoclopramide may be given 5-10 minutes before the examination, subject to body weight consideration, (see above), the following dosages are recommended.
Adults: 20 years and over 10-20 mg
Young adults: 15-19 years 10 mg
A liquid presentation should be used in the younger age groups; more accurate dosage is facilitated by the use of the Paediatric liquid
4.3
Contraindications
Metoclopramide is contraindicated in neonates.
Metoclopramide should not be used in patients with phaeochromocytoma as it may induce an acute hypertensive response
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
Metoclopramide should not be administered to patients with gastrointestinal obstruction, perforation or haemorrhage
Metoclopramide is contra-indicated in patients who have previously shown hypersensitivity to metoclopramide or any of its components
4.4 Special warnings and precautions for use
Precautions:
If vomiting persists the patient should be re-assessed to exclude the possibility of an underlying disorder, e.g. cerebral irritation.
Care should be exercised in epileptic patients and patients being treated with other centrally acting drugs.
Extrapyramidal disorders may occur, particularly in children and young adults and/or when high doses are used (see section 4.8 Undesirable effects).
Since extrapyramidal symptoms may occur with both metoclopramide and neuroleptics such as phenothiazines, particular care should be exercised in the event of these drugs being prescribed concurrently.
The neuroleptic malignant syndrome has been reported with metoclopramide in combination with neuroleptics as well as with metoclopramide monotherapy (see section 4.8 Undesirable effects).
Metoclopramide should be used with care in combination with other serotonergic drugs including SSRIs.
Special care should be taken in cases of severe renal and hepatic insufficiency (see also section 4.2 Posology and method of administration).
Care should be exercised when using Metoclopramide in patients with a history of atopy (including asthma) or porphyria.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
4.5 Interaction with other medicinal products and other forms of interaction
The action of Metoclopramide on the gastro-intestinal tract is antagonized by Anticholinergics and opioid analgesics. The absorption of a concurrently administered oral medication may be modified by the effect of Metoclopramide on gastric motility. Drugs known to be affected in this way include aspirin and paracetamol.
Since extrapyramidal reactions may occur with Metoclopramide, Phenothiazines and Tetrabenazine, care should be exercised in the event of co-administration of these drugs.
Metoclopramide should be used with care in association with other drugs acting at central dopamine receptors, such as levodopa, bromocriptine, and pergolide.
The use of Metoclopramide with serotonergic drugs may increase the risk of serotonin syndrome.
Metoclopramide may reduce plasma concentrations of atovaquone.
4.6. Pregnancy and lactation
Animal tests in several mammalian species and clinical experiences have not indicated a teratogenic effect. Nevertheless Metoclopramide should only be used when there are compelling reasons and is not advised during the first trimester.
During lactation metoclopramide is found in breast milk, therefore it should not be used during lactation.
4.7. Effects on ability to drive and use machines
None but see 4.8.
4.8 Undesirable effects
Blood and the lymphatic system disorders
Extremely rarely cases of red cell disorders such as methaemoglobinaemia and sulphaemoglobinaemia have been reported, particularly at high doses of metoclopramide. Methaemoglobinaemia could be related to NADH cytochrome b5 reductase deficiency particularly in neonates.
If this occurs the drug should be withdrawn. Methaemoglobinaemia may be treated using methylene blue.
Immune system disorders
Very rarely hypersensitivity, including anaphylaxis, has been reported. (Also see; Skin and subcutaneous tissue disorders)
Endocrine disorders
Raised serum prolactin levels have been observed during Metoclopramide therapy: this may result in galactorrhoea, irregular periods and gynaecomastia.
Psychiatric disorders
Rarely, restlessness, confusion, and anxiety have been reported in patients receiving Metoclopramide therapy. Depression has been reported extremely rarely.
Extrapyramidal symptoms: acute dystonia and dyskinesia, parkinsonian syndrome, akathisia, even following administration of a single dose of the drug, particularly in children and young adults (see section 4.4 Special warnings and precautions for use).
The incidence of dystonic reactions, particularly in children and young adults, is increased if daily dosages higher than 0.5 mg per kg body weight are administered. Dystonic reactions include: spasm of the facial muscles, trismus, rhythmic protrusion of the tongue, a bulbar type of speech, spasm of extra-ocular muscles including oculogyric crises, unnatural positioning of head and shoulders and opisthotonos. There may be generalised increase in muscle tone. The majority of reactions occur within 36 hours of starting treatment and the effects usually disappear within 24 hours of withdrawal of the drug. Should treatment of a dystonic reaction be required an anticholinergic anti-Parkinsonian drug, or a benzodiazepine may be used.
Very rarely occurrences of the neuroleptic malignant syndrome have been reported. This syndrome is potentially fatal and comprises hyperpyrexia, altered consiousness, muscle rigidity, autonomic instability and elevated levels of creatine phosphokinase (CPK) and must be treated urgently (recognised treatments include dantrolene and bromocriptine). Metoclopramide should be stopped immediately if this syndrome occurs.
Tardive dyskinesia has been reported during prolonged treatment in a small number of mainly elderly patients. Patients on prolonged treatment should be regularly reviewed.
Rarely, drowsiness has been reported in patients receiving Metoclopramide therapy.
Gastrointestinal disorders
Rarely, diarrhoea has been reported in patients receiving Metoclopramide therapy.
Skin and subcutaneous tissue disorders
A small number of skin reactions such as rashes, urticaria, pruritus and oedema have also been reported.
4.9 Overdose
In cases of overdosage, acute dystonic reactions have occurred. Overdosage should be treated by gastric lavage with appropriate supportive measures.
Should treatment of a dystonic reaction be required, an anticholinergic, antiParkinsonian drug or a benzodiazepine may be used.
Treatment for extrapyramidal disorders is only symptomatic (e.g. benzodiazepines in children).
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Metoclopramide acts by a blockade of dopamine receptors and an increase in prolactin secretion.
Gastric peristalsis is increased leading to an increase in the gastric-emptying rate. Duodenal peristalsis may be increased which increases intestinal transit. The resting tone of the gastro-oesophageal sphincter is also increased.
5.2. Pharmacokinetic properties
Metoclopramide is rapidly absorbed from the gastro-intestinal tract and undergoes a high degree of first-pass hepatic metabolism. It is excreted in the urine as free and as conjugated Metoclopramide and as metabolites. It is excreted in breast milk.
5.3. Preclinical safety data
No relevant information additional to that contained elsewhere in the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Anhydrous lactose Lactose
Starch, pregelatinised Silica, colloidal anhydrous Magnesium stearate
6.2. Incompatibilities
Not applicable
6.3. Shelf life
48 months
6.4.
Special precautions for storage
Do not store above 25°C. Keep the container tightly closed.
6.5. Nature and contents of container
High density polystyrene with polythene lids and/or polypropylene containers with polypropylene or polythene lids and polyurethane or polythene inserts.
Packs of 28, 30, 50, 56, 60, 84, 100, 250, 500 and 1000 tablets.
6.6. Instructions for use/handling
Not Applicable
7 MARKETING AUTHORISATION HOLDER
Metwest Pharmaceuticals Limited 15 Runnelfield Harrow on the Hill Middlesex HA1 3NY United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 17521/0034
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
13/03/2009
10 DATE OF REVISION OF THE TEXT
27/07/2011