Maxolon^® SR

Each capsule contains Metoclopramide Hydrochloride BP equivalent to 15 mg of the anhydrous substance.

Colourless, transparent capsules, overprinted 'Maxolon SR 15', containing white sustained release microgranules.

Digestive disorders:

Maxolon SR restores normal co-ordination and tone to the upper digestive tract. Maxolon SR relieves symptoms of gastro-duodenal dysfunction.

Including: dyspepsia, heartburn, flatulence, sickness, pain, regurgitation of bile. These symptoms may be associated with such conditions as: reflux oesophagitis, hiatus hernia, gastritis, duodenitis, peptic ulcer, cholelithiasis and post-cholecystectomy dyspepsia.

Nausea and vomiting:

Maxolon SR is indicated for the treatment of the nausea and vomiting associated with gastro-intestinal disorders and intolerance to cytotoxic drugs.

Adults

In adults 20 years and over: 1 capsule (15 mg) twice daily, swallowed whole. Total daily dosage of Maxolon SR should not normally exceed 0.5 mg/kg body weight.

Elderly:

As for adults. To avoid adverse reactions adhere strictly to dosage recommendations and where prolonged therapy is considered necessary, patients should be regularly reviewed.

The interval between doses may need to be extended in patients with clinically significant degrees of renal or hepatic impairment. The predominant route of elimination is via the kidney.

Children and young adults:

A presentation of Maxolon SR suitable for patients under 20 years of age is not available.

'Maxolon' SR is contraindicated in patients under 20 years since the dose level cannot be reduced.

'Maxolon' should not be used in patients with phaeochromocytoma as it may induce an acute hypertensive response.

'Maxolon' should not be used in patients suffering from epilepsy, since the frequency and severity of seizures may be increased.

'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.

'Maxolon' should not be administered to patients with gastrointestinal obstruction, perforation or haemorrhage.

'Maxolon' is contraindicated in patients who have previously shown hypersensitivity to metoclopramide or any of its components.

Precautions:

If vomiting persists the patient should be reassessed to exclude the possibility of an underlying disorder e.g. cerebral irritation.

Care should be exercised patients being treated with other centrally acting drugs.

Risk-benefit should be carefully considered in patients with significant hepatic or renal impairment (loss of conjugation and increased risk of extrapyramidal effects) or with Parkinson's disease (symptoms may be exacerbated).

The neuroleptic malignant syndrome has been reported with metoclopramide in combination with neuroleptics as well as with metoclopramide monotherapy (see adverse reactions).

Maxolon should be used with care in combination with other serotonergic drugs including SSRIs.

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.

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.

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 Maxolon intravenously to patients with “sick sinus syndrome” or other cardiac conduction disturbances.

There have been very rare reports of abnormalities of cardiac conduction with intravenous metoclopramide. Maxolon should be used with care with other drugs affecting cardiac conduction.

The action of 'Maxolon' on the gastrointestinal tract is antagonised by anticholinergics and opioid analgesics. The absorption of any concurrently administered oral medication may be modified by the effect of 'Maxolon' on gastric motility. Drugs known to be affected in this way include aspirin and paracetamol.

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

Concomitant use of anticholinergic drugs may inhibit the favourable effects on gastrointestinal motility.

Since metoclopramide influences gastrointestinal motility and absorption, the dosage of other drugs used concomitantly may possibly need adjustment.

'Maxolon' may potentiate the effects of alcohol.

Concomitant use of 'Maxolon' with ciclosporin or suxamethonium may increase plasma levels of either ciclosporin or suxamethonium.

Since extrapyramidal reactions may occur with 'Maxolon', Phenothiazines and Tetrabenazine, care should be exercised in the event of co-administration of these drugs.

The effects of certain other drugs with potential central stimulant effects, e.g. monoamine oxidase inhibitors and sympathomimetics, may be modified when prescribed with metoclopramide and their dosage may need to be adjusted accordingly.

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

'Maxolon' may reduce plasma concentrations of atovaquone.

Animal tests in several mammalian species and clinical experience have not indicated a teratogenic effect. Nevertheless 'Maxolon' SR 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.

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

Blood and lymphatic system 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.

Immune system disorders

Very rarely hypersensitivity, including anaphylactic/anaphylactoid reactions, have been reported (including symptoms such as tongue swelling/oedema).

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 'Maxolon', 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.

Tardive dyskinesia, which may be persistent, has been reported as a side effect in elderly patients undergoing long-term 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, dizziness and tremor may occur.

Eye disorders

Visual disturbances have been reported.

Cardiac disorders

Very rare reports of abnormalities of cardiac conduction (bradycardia, asystole, heart block, sinus arrest and cardiac arrest) have been reported following intravenous administration.

Vascular disorders

Acute hypertension may occur in patients with phaeochromocytoma (see section 4.3 Contraindications). Hypotension has also been reported.

Respiratory, thoracic and mediastinal disorders

Dyspnoea may occur.

Gastrointestinal disorders

Diarrhoea

Skin and subcutaneous tissue disorders

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

General disorders and administration site conditions

Oedema

In cases of overdosage, acute dystonic reactions have occurred. Should treatment of a dystonic reaction be required, an anticholinergic anti-Parkinsonian drug or a benzodiazepine may be used.

The action of metoclopramide is closely associated with parasympathetic nervous control of the upper gastro-intestinal tract, where it has the effect of encouraging normal peristaltic action. This provides for a fundamental approach to the control of those conditions where disturbed gastro-intestinal motility is a common underlying factor.

The following pharmacokinetic parameters for MAXOLON SR after a single administration have been established.

No relevant information available.

Sucrose

Maize starch

Dibutyl phthalate

Talc

Polymethacrylates

Gelatin

Black iron oxide

Not applicable.

See under 6.5.

Protect from direct light.

All pack sizes (8, 14 or 56 capsules) are available in the following packs:

PVC blister (300 microns) backed with aluminium foil (20 microns). The underside of the foil is coated with vinyl based lacquer. Shelf life 24 months.

PVC (200 microns)/PVDC (60gsm) blister. Shelf life 24 months.

Polypropylene containers with polyethylene caps. Shelf life 36 months.

None.

Amdipharm PLC

Regency House

Miles Gray Road

Basildon

Essex

SS14 3AF

United Kingdom

PL 20072/0047

16 June 1995

January 2011