Mygdalon/Metoclopramide 10mg
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
MYGDALON/Metoclopramide 10 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Metoclopramide Hydrochloride BP 10.00 mg equivalent to the anhydrous form
3 PHARMACEUTICAL FORM
Tablet
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Adults (20 years and over)
1. The symptomatic relief of:
Dyspepsia Heartburn
Flatulence Sickness
Regurgitation of bile Pain
associated with such conditions as:
Peptic ulcer Hiatus Hernia
Reflux oesophagitis Cholelithiasis and post-cholecystectomy
Gastritis Dyspepsia
Duodenitis
2. The treatment of nausea and vomiting associated with:
Gastro-intestinal disorders
Cyclical vomiting
Intolerance to essential drugs including digitalis, antibacterial and cytotoxic drugs
Congestive heart failure Deep X-ray or cobalt therapy Post-anaesthetic vomiting
3. To overcome gastric stasis associated with attacks of migraine.
4. To promote normal gastric emptying and restore motility in vagotomised patients, and where post-operative symptoms suggest gastroduodenal dysfunction.
5. Post-operative gastric hypotonia.
6. Post-vagotomy syndrome.
Young adults (15 - 19 years):
The use of mygdalon in patients under 20 years should be restricted to the following:
1. Severe intractable vomiting of known cause
2. vomiting associated with radiotherapy and intolerance to cytotoxic drugs
3. as an aid to gastro-intestinal intubation
4. as part of the premedication before surgical procedures.
4.2 Posology and method of administration
Adults over 20 years old:
10 mg three times daily, commencing at the lower dosage Young Adults:
(15-19 years): 5-10 mg three times daily, commencing at lower dosage.
Children:
Use in the paediatric population is not recommended
Elderly: Commence with half adult dose and increase if necessary
Method of administration: Oral
4.3 Contraindications
Metoclopramide is contraindicated in neonates.
Gastro-intestinal obstruction, perforation or haemorrhage, 3-4 days after gastrointestinal surgery, phaeochromocytoma, breast-feeding.
Metoclopramide is also contra-indicated in patients who have previously shown hypersensitivity to metoclopramide or any of its components.
4.4 Special warnings and precautions for use
Following operations such as pyloroplasty or gut anastomosis metoclopramide therapy should be withheld for three or four days as vigorous muscular contractions may not help healing.
If vomiting persists the patient should be re-assessed to exclude the possibility of an underlying disorder, e.g. cerebral irritation.
Special care should be taken in cases of severe hepatic or renal impairment.
Care should be exercised in epileptic patients.
Care should be exercised when using Metoclopramide in patients with a history of atopy (including asthma) or porphyria.
Hypertensive crises have occurred in patients with phaeochromocytomas. Galactorrhoea and gynaecomastia have been reported.
Metoclopramide may affect the absorption of other drugs either by diminishing absorption from the stomach or by enhancing absorption from the small intestine. The effects of CNS depressants may be enhanced.
The elderly and young adults should be treated with care.
Extrapyramidal disorders may occur, particularly in children and young adults and/or when high doses are used (see 4.8 undesirable effects).
Patients with rare hereditary problems of lactose 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
Extrapyramidal symptoms may occur with metoclopramide, phenothiazines and tetrabenazine, care should be exercised in the event of these drugs being prescribed concurrently.
Opioid analgesics antagonise the effect of metoclopramide on gastro-intestinal activity. The action of aspirin and paracetamol is enhanced by metoclopramide.
Anticholinergics antagonise metoclopramide’s action on the gastro-intestinal tract.
Metoclopramide may reduce the plasma concentration of atovaquone and increase the plasma concentration of ciclosporin.
Metoclopramide should be used with care in association with dopaminergics such as bromocriptine and pergolide.
4.6 Pregnancy and lactation
Treatment with Metoclopramide is not advised during the first trimester of pregnancy or during lactation.
4.7 Effects on ability to drive and use machines
None stated.
4.8 Undesirable effects
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).
Reactions include: spasm of the facial muscles, trisumus, 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 episthotonos. 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. The incidence of these reactions in young adults may be increased if daily dosages higher than 0.5 mg/kg bodyweight are administered.
Raised serum prolactin levels have been observed during metoclopramide therapy. This may result in galactorrhoea, irregular periods and gynaecomastia.
Cardiac function abnormalities have also been reported following intravenous administration.
Rare cases of confusion have been reported during metoclopramide therapy.
Hyperprolactinaemia, occasionally tardive dyskinesia on prolonged administration, also reported, drowsiness, restlessness, diarrhoea, depression, neuroleptic malignant syndrome, rashes, pruritus, oedema, rarely methaemoglobinaemia (more severe in G6PD deficiency). Methaemoglobinaemia could be related to NADH cytochrome b5 reductase deficiency particularly in neonates.
Very rarely hypersensitivity, including anaphylaxis, has been reported.
4.9 Overdose
Gastric lavage and intensive supportive therapy should be initiated immediately. Treatment with atropine, benztropine or other anticholinergic agents to counteract dystonic symptoms. Treatment for extrapyramidal disorders is only symptomatic (e.g. benzodiazepines in children). Control electrolyte balance.
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
Not applicable
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Anhydrous Lactose Lactose
Pre-gelatinised Starch Colloidal Silicon Dioxide Magnesium Stearate
6.2 Incompatibilities
None Stated.
Shelf life
6.3
48 months all sizes.
6.4 Special precautions for storage
Store below 25°C in a dry place.
6.5 Nature and contents of container
High density polystyrene with polythene lids and/or polypropylene containers with polythene lids and polyurethane or polythene inserts.
Pack sizes: 28, 30, 50, 56, 60, 84, 100, 250, 500 and 1000 tablets.
6.6 Special precautions for disposal
No special instructions
7 MARKETING AUTHORISATION HOLDER
Chelonia Healthcare Limited
Boumpoulinas 11, 3 rd Floor
NICOSIA
CYPRUS
PC. 1060
CYPRUS
8 MARKETING AUTHORISATION NUMBER(S)
PL 33414/0063
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
14/01/1983 24/02/1999
10
DATE OF REVISION OF THE TEXT
30/01/2012