Amdipharm Limited

Maxolon 10 mg Tablets

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

Excipients: Contains Lactose Monohydrate to 125.0mg

For a full list of excipients, see section 6.1.

Tablet

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'.

Adults 20 years and over:

1) Disorders of the gastrointestinal tract associated with delayed gastric emptying e.g. reflux oesophagitis, hiatus hernia, post-vagotomy syndrome.

2) Nausea and vomiting associated with gastrointestinal disorders, administration of some cytotoxic drugs, congestive heart failure and radiotherapy.

3) Diagnostic procedures e.g. barium studies and duodenal intubations.

4) To counteract gastric stasis associated with attacks of migraine and assist absorption of orally administered analgesics for that condition.

Young adults and children:

The use of Maxolon 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 pre-medication before surgical procedures.

Route:

Oral

Dosage and 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 Maxolon, 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 metabolised in the liver and the predominant route of elimination of metoclopramide and its metabolites is via the kidney.

Medical indications:

Oral

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: Maxolon 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 primarily to body weight and treatment should commence at the lower dosage where stated.

Young adults:

Tablets should not be used in children under the age of 15 years. 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 Maxolon may be given 5-10 minutes before the examination. Subject to body weight consideration (see above), the following dosages are recommended.

'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.

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 patients being treated with other centrally active 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).

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.

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.

Various extrapyramidal reactions to metoclopramide, usually of the dystonic type, can occur. The incidence of these reactions in children and young adults may increase if a daily dosage higher than 0.5 mg/kg is administered.

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 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.

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 metoclopramide and phenothiazines and tetrabenazine, care should be exercised when both are used concurrently.

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.

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

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.

No additional data available.

Maize starch (dried)

Colloidal anhydrous silica

Magnesium stearate

Pregelatinised maize starch

Lactose monohydrate

Not applicable.

5 years.

Do not store above 30°C.

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

Not all pack sizes may be marketed.

No special requirements

Amdipharm Limited

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

PA 1142/011/003

Date of first authorisation: 1^st April 1979

Date of last renewal: 1^st April 2009

April 2009