Mygdalon/Metoclopramide 10mg
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MYGDALON
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE
What is in your medicine?
The name of this medicine is MYGDALON. Each tablet contains 10 mg of Metoclopramide Hydrochloride together with the following ingredients: Anhydrous lactose, pregelatinised starch, colloidal silicone dioxide, magnesium stearate.
MYGDALON tablets are round, bi-convex tablets scored on one side and embossed MH108 on the other side. They are available in packs of 28, 30, 50, 56, 60, 84, 100, 250, 500 and 1000 tablets.
What are MYGDALON tablets for?
MYGDALON belongs to a group of medicines known as anti-spasmodics, and is used in the treatment of nausea and vomiting in association with stomach disorders, and in patients who cannot tolerate drugs such as digitalis, antibacterial and anti-cancer drugs. It is also used for the treatment of nausea and vomiting associated with congestive heart failure, deep x-ray treatment and vomiting after anaesthetics.
MYGDALON is also used in the symptomatic relief of:
• Dyspepsia and flatulence
• Heartburn
• Sickness and pain associated with:
• Peptic ulcer
• Inflammation of the stomach, oesophagus and duodenum
• Hiatus hernia
• Gall stones
• Operations for the removal of the gall bladder
• Attacks of migraine associated with absence of contractions of the stomach.
If you are under 20 years old this medicine may only be used:
• In severe and prolonged vomiting where the cause is known
• For vomiting which has been caused by cancer treatment
• As a premedication before an operation
• As an aid to investigative procedures in hospital.
Before taking this medicine
Before taking this medicine, tell your doctor if you have or ever had any unusual or allergic reactions to this medicine or to any of the ingredients of these tablets. Also tell your doctor or pharmacist if you are allergic to any other substances such as foods, preservatives or dyes.
Because the presence of other medical problems may affect the use of MYGDALON make sure to tell your doctor if you have any other medical problems, especially if you have a blockage in the intestines or if it is punctured or bleeding, if you have conditions known as phaeochromocytoma or porphyria, or if you suffer from kidney or liver disorders.
Also tell your doctor or pharmacist if you have a rare intolerance to some sugars, including lactose.
Metoclopramide should not be taken for 2 or 3 days after some types of operation, as it may not help healing.
Care is also needed if you are taking any drugs known as Central Nervous System (CNS) depressants or tranquillisers such as phenothiazines.
Precautions while using this medicine
If you develop any new medical problems while using this medicine, check with your doctor or pharmacist.
It is important for your doctor and pharmacist to know if you are taking any of the following:
• Any medicine for depression, particularly medicines from a group known as the phenothiazines
• Tetrabenazine used for movement disorders
• Anti-cholinergic drugs and opioid pain killers
• Bromocriptine and pergolide used for Parkinson's disease
• Atovaquone for pneumonia
• Ciclosporin
• MYGDALON may affect the absorption of other drugs so be sure to tell your Doctor of any other medicines you are taking especially aspirin or paracetamol
Use in pregnancy and breast feeding
Treatment with MYGDALON is not advised during the first trimester of pregnancy or during breast feeding.
Proper use of this medicine
Take this medicine by mouth and only in the doses prescribed by your doctor. Do not take more of it, and do not take it more often or for a longer time than your doctor ordered.
The Manufacturer of MYGDALON is: Meridian Healthcare Dosages:
(UK) Ltd., 208-214 York Road, Battersea, London SW11
3SD Adults: 10 mg three times daily.
The Product Licence holder of MYGDALON is: Chelonia Young Adults (15 - 19 years): 5 - 10 mg three times daily,
Healthcare Ltd., 310 Old Brompton Road, London SW5 commencing at the lower dosage.
9JQ
Children: Not recommended
Elderly: Commence with half adult dose and increase if necessary.
If you miss a dose, skip the missed dose and go back to your regular dosage schedule. Do not double the dose.
If you feel that this medicine is not working as well after you have taken it for a short time (1-2 weeks) do not increase the dose, instead check with your doctor.
Overdose
If you think you may have taken an overdose of this medicine, you must obtain emergency help at once. Go to your doctor or nearest hospital casualty department straight away. Take with you any remaining tablets in their container so that the medicine may be identified.
Undesirable effects that may occur with the use of this medicine
Metoclopramide can affect muscles. This is more common in children and young adults taking large doses of the drug. Facial and eye spasms, difficulty chewing, slurred speech, protrusion of the tongue or general increases in muscle tension are due to affected muscles of the face, jaw, tongue and body. These reactions usually occur after 36 hours of the start of treatment and usually disappear within 24 hours after treatment with metoclopramide is discontinued.
A combination of high temperature, pale complexion, muscle stiffness and changes in levels of alertness are symptoms of a serious condition called 'neuroleptic malignant syndrome'. If these develop, you should inform your doctor immediately.
If you are taking metoclopramide for a long time your doctor may want to see you for regular check-ups to reduce the risk of a condition known as 'tardive dyskinesia' which affects all the muscles of your body and is characterised by uncontrolled shaking of the hands or limbs and muscle stiffness.
Extremely rare cases of blood disorders have been reported with metoclopramide therapy, particularly at high doses. If these occur metoclopramide treatment must be discontinued.
Rare cases of drowsiness, restlessness, confusion and diarrhoea have been reported during metoclopramide therapy. Skin reactions such as rashes, hives, itching and swelling due to fluid retention have also been reported.
Severe allergic reactions can occur very rarely and usually happen soon after taking Metoclopramide Tablets. These can involve difficulty breathing, tightness in the throat, rapidly spreading rashes, dizziness, very fast heart beat or even loss of consciousness.
Other side effects include increased blood levels of prolactin (a milk-releasing hormone) which may cause irregular periods, unusual breast milk production and rarely swollen breasts.
Other side effects not listed above may also occur in some patients. If you notice any other effects check with your doctor.
Storing your medicine
You must keep the medicine in a safe place where children cannot get it. Your medicine could harm them.
Keep your medicine in a dry place and store below 25°C. Keep the tablets in the container in which they were given to you.
On the label you will find the words "Expiry Date" followed by numbers indicating the day, month and year. This is the date when the medicine is no longer fit for use. Do not use the medicine after this date, but return it to your doctor or pharmacist.
This leaflet does not contain the complete information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist who have access to additional information.
A reminder
REMEMBER this medicine is for you. Never give it to someone else, even if their symptoms are the same as yours.
This leaflet was revised in November 2011
Depression has been reported extremely rarely.