Metoclopramide 10mg Tablets

Active constituents: metoclopramide hydrochloride BP 10.55* mg.

*10.55 mg equivalent to 10mg anhydrous metoclopramide hydrochloride BP.

White uncoated tablet. Side one embossed “a” and “M/10” on either side of breakline, intended for oral administration to human beings.

In patients above 20 years:

Anti-emetic and accelerator of gastric emptying.

In patients below 20 years:

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 gastrointestinal intubation, and as part of the premedication before surgical procedures.

For use as directed by the physician.

Route of Administration

Oral

Adults 20 years and over: 10 mg three times daily

For patients of less than 60 kg see below

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.

Young adults

Tablets should not be used in children under the age of 15.

In patients with clinically significant degrees of renal or hepatic impairment, therapy should be at a reduced dosage. Metoclopramide is metabolised in the liver and the predominant route of elimination of metoclopramide and its metabolites is via the kidney.

Metoclopramide should not be used in patients with pheochromocytoma as it may induce an acute hypertensive response.

Metoclopramide should not be used in patients with gastro-intestinal obstruction, perforation or haemorrhage; Metoclopramide should not be used during the first 3-4 days following operations such as pyloroplasty or gut anastomosis as vigorous muscular contractions may not help healing.

Metoclopramide is contra-indicated in patients who have previously shown hypersensitivity to Metoclopramide or any of its components.

Metoclopramide is contraindicated in neonates.

If vomiting persists the patient should be reassessed 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

Care should be exercised when using Metoclopramide in patients with a history of atopy (including asthma) or porphyria.

Since extrapyramidal symptoms may occur with both metoclopramide and neuroleptics such as the phenothiazines, particular care should be exercised in the event of these drugs being prescribed concurrently.

Extrapyramidal disorders may occur, particularly in children and young adults and/or when high doses are used (see 4.8. undesirable effects).

The 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 used with care in combination with other serotonergic drugs including SSRIs. (See section 4.5)

Special care should be taken in cases of severe renal and hepatic insufficiency. (See section 4.2)

Patients with rare hereditary problems of lactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Actions of metoclopramide on the gastrointestinal tract are antagonized by anticholinergics and opioid analgesics.

The effect of metoclopramide on gastric motility may modify the absorption of other drugs from the gastrointestinal tract. Drugs known to be affected in this way include aspirin and paracetamol.

Metoclopramide moderately increases the absorption of ciclosporin and raises its blood levels.

Metoclopramide may enhance and prolong the neuromuscular blocking effects of Suxamethonium and Mivacurium.

Since extrapyramidal reactions may occur with metoclopramide, Phenothiazines and Tetrabenazine, care should be exercised in the event of coadministration of these drugs.

Metoclopramide should be used with care in association with other drugs acting at central dopamine receptors, such as levodopa, bromocriptine pergolide.

The use of Metoclopramide with serotonergic drugs may increase the risk of serotonin syndrome.

Metoclopramide may reduce plasma concentrations of atovaquone.

Neither clinical experience nor animal tests in several mammalian species have indicated a teratogenic effect.

Not to be used in pregnancy unless there are compelling reasons and should not be used in the first trimester.

During lactation metoclopramide is found in breast milk, therefore it should not be used during lactation.

Metoclopramide may cause side effects including drowsiness, dizziness, dyskinesia and dystonias which could affect the vision and also interfere with the ability to drive and operate machinery.

Blood and lymphatic disorders:

Extremely rarely cases of red cell disorders such as methaemoglobinaemia and sulphaemoglobinaemia have been reported, particularly at high doses of Metoclopramide. If this occurs the drug should be withdrawn. Methaemoglobinaemia may be treated using methylene blue.

Methaemoglobinaemia which could be related to NADH cytochrome b5 reductase deficiency particularly in neonates.

Immune system disorders:

Very rarely hypersensitivity, including anaphylaxis has been reported.

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, agitation and anxiety have been reported in patients receiving metoclopramide therapy.

Depression has been reported extremely rarely.

Nervous system disorders:

Various extrapyramidal reactions to metoclopramide, usually of the dystonic type, have been reported. The incidence of dystonic reactions, particularly in children and young adults, is increased if daily dosages higher than 0.5mg 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 the head and shoulders and opisthotonos. There may be a 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.

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.).

Tardive dyskinesia, which may be persistent, has been reported as a side effect in elderly patients undergoing longterm therapy with metoclopramide. Prolonged therapy in such patients should be carefully reviewed. The likelihood of the occurrence of this serious effect is increased when neuroleptic agents are used concurrently.

Very rare occurrences of the neuroleptic malignant syndrome have been reported. This syndrome is potentially fatal and comprises hyperpyrexia, altered consciousness, 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.

Drowsiness, lassitude, dizziness and tremor may occur.

Eye disorders:

Visual disturbances have been reported.

Vascular disorders:

Acute hypertension may occur in patients with phaeochromocytoma (see section 4.3).

Hypotension has been reported.

Respiratory, thoracic and mediastinal disorders:

Dyspnoea.

Gastrointestinal disorders:

Diarrhoea, oedema of the tongue.

Skin and subcutaneous tissue disorders:

A small number of skin reactions such as rashes, urticaria, pruritus and oedema have been reported.

General disorders and administration site conditions:

Oedema.

Possible symptoms of overdosage include drowsiness, disorientation and extrapyramidal reactions. In cases of overdosage, acute dystonic reactions have occurred. An anticholinergic, anti-parkinsonian drug may be used to control extrapyramidal reactions, a benzodiazepine may also be effective. General supportive measure should be instituted. Treatment for extrapyramidal disorders is only symptomatic (benzodiazepines in children).

None stated.

None stated.

None stated.

*Aerosil/Moisture

Colloidal Silicon Dioxide BP/Ph.Eur.

Purified water BP

None stated.

48 months (securitainers).

24 months (blister packs).

Protect from light.

Store in a cool dry place.

Tablets are contained in polypropylene securitainers with tamper evident polypropylene caps. Packs sizes of 21, 28, 56, 84, 100, 112 and 500.

Tablets are packed in blister of 28.

None stated.

Goldshield Pharmaceuticals Limited

12-16 Addiscombe Road

Croydon

Surrey

CR0 0XT

United Kingdom

PL 12762/0123

25 July 2001

20 July 2011