Metoclopramide 10mg Tablets
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Read all of this leaflet carefully before you start
taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
Index
What Metoclopramide tablets are and
what they are used for
Before you take
How to take
Possible side effects
How to store
Further information
T| What Metoclopramide tablets are and what they are used for
Metoclopramide tablets are an antiemetic. It works on a part of your brain that prevents you from feeling sick (nausea) or being sick (vomiting).
Adults
Metoclopramide tablets are used in adults:
• to prevent delayed nausea and vomiting that may occur after chemotherapy
• to prevent nausea and vomiting caused by radiotherapy
• to treat nausea and vomiting including nausea and vomiting which may occur with a migraine.
Metoclopramide can be taken with oral painkillers in case of migraine to help painkillers work more effectively.
Children and adolescents
Metoclopramide tablets are indicated in children (aged 15-18 years) if other treatment does not work or cannot be used to prevent delayed nausea and vomiting that may occur after chemotherapy
Before you take
Do not take Metoclopramide tablets if you:
• are allergic to metoclopramide or any of the other ingredients of this medicine (listed in section 6).
• have bleeding, obstruction or a tear in your stomach or gut.
• you have or may have a rare tumour of the adrenal gland, which sits near the kidney (pheochromocytoma).
• have ever had involuntary muscle spasms (tardive dyskinesia), when you have been treated with a medicine.
• have epilepsy
• have Parkinson's disease
• are taking levodopa (a medicine for Parkinson's disease) or dopaminergic agonists (see below"Other medicines and Metoclopramide tablets")
• have ever had an abnormal blood pigment levels
(methaemoglobinemia) or NADH cytochromeb5 Deficiency
Do not give Metoclopramide tablets to a child less than 1 years of age (see below"Children and adolescents").
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Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking
Metoclopramide tablets if you:
• have a history of abnormal heart beats (QT interval prolongation) or any other heart problems
• have problems with the levels of salts in your blood, such as potassium, sodium and magnesium.
• are using other medicines known to affect the way your heart beats
• have any neurological (brain) problems
• have liver or kidney problems. The dose may be reduced (see section 3).
Blood tests
Your doctor may perform blood tests to check your blood pigment
levels. In cases of abnormal levels (methaemoglobinemia), the
treatment should be immediately and permanently stopped.
Do not exceed 3-month treatment because of the risk of involuntary muscle spasms.
Children and adolescents
Uncontrollable movements (extrapyramidal disorders) may occur in children and young adults. This medicine must not be used in children below 1 years of age because of the increased risk of the uncontrollable movements (see above "Do not take Metoclopramide tablets if").
Other medicines and Metoclopramide tablets
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This is because some medicines can affect the way Metoclopramide tablets works or Metoclopramide tablets can affect how other medicines work.
These medicines include the following:
• levodopa or other medicines used to treat Parkinson's disease (see above"Do not take Metoclopramide tablets if")
• anticholinergics (medicines used to relieve stomach cramps or spasms)
• morphine derivatives (medicines used to treat severe pain)
• sedative medicines
• any medicines used to treat mental health problems
• digoxin (medicine used to treat heart failure)
• ciclosporin (medicine used to treat certain problems with the immune system)
• mivacurium and suxamethonium (medicines used to relax muscles)
• fluoxetine and paroxetine (medicine used to treat depression)
Metoclopramide tablets with alcohol
Alcohol should not be consumed during treatment with metoclopramide because it increases the sedative effect of Metoclopramide tablets.
Pregnancy, breast-feeding
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before being given this medicine. If necessary, Metoclopramide tablets may be taken during pregnancy. Your doctor will decide whether or not you should be given this medicine.
Metoclopramide tablets are not recommended if you are breastfeeding because metoclopramide passes into breast milk and may affect your baby.
Driving and using machines
You may feel drowsy, dizzy or have uncontrollable twitching, jerking or writhing movements and unusual muscle tone causing distortion of the body after taking Metoclopramide tablets. This may affect your vision and also interfere with your ability to drive and use machines. Continued over page
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Sugar intolerance
If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains a type of sugar called lactose.
How to take
Adults
The recommended single dose is 10mg, repeated up to three times daily.
The maximum recommended dose per day is 30mg or 0.5mg/kg body weight.
The maximum recommended treatment duration is 5 days.
Children and Adolescents
To prevent delayed nausea and vomiting that may occur after chemotherapy (children aged 15-18 years)
The recommended dose is 0.1 to 0.15mg/kg body weight, repeated up to 3 times daily, taken by mouth (oral route).
The maximum dose in 24 hours is 0.5mg/kg body weight.
You should not take this medicine for more than 5 days to prevent delayed nausea and vomiting that may occur after chemotherapy.
Metoclopramide tablets is not suitable for use in children weighing less than 61 kg.
Other pharmaceutical forms/strengths may be more appropriate for administration.
Method of administration
The score line is only there to help you break the tablet if you have difficulty swallowing it whole. You must wait at least 6 hours between each metoclopramide dose, even in case of vomiting and rejection of the dose, in order to avoid overdose.
Older people
The dose may need to be reduced depending on kidney problems, liver problems and overall health.
Adults with kidney problems
Talk to your doctor if you have kidney problems. The dose should be reduced if you have moderate or severe kidney problems.
Adults with liver problems
Talk to your doctor if you have liver problems. The dose should be reduced if you have severe liver problems.
Children and adolescents
Metoclopramide must not be used in children aged less than 1 years (see section 2).
If you take more Metoclopramide tablets than you should
Contact your doctor or pharmacist straight away. You may experience uncontrollable movements (extrapyramidal disorders), feel drowsy, have some troubles of consciousness, be confused, have hallucination and heart problems. You doctor may prescribe you a treatment for these signs if necessary.
If you forget to take Metoclopramide tablets
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.
"4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop the treatment and talk straight away to your doctor, pharmacist or nurse if you experience one of the following signs while having this medicine:
• uncontrollable movements (often involving head or neck). These may occur in children or young adults and particularly when high doses are used. These signs usually occur at the beginning of treatment and may even occur after one single administration. These movements will stop when when treated appropriately.
• high fever, high blood pressure, convulsions, sweating, production of saliva. These may be signs of a condition called neuroleptic malignant syndrome.
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• itching or skin rashes, swelling of the face, lips or throat, difficulty in breathing. These may be signs of an allergic reaction, which may be severe.
Very common (may affect more than 1 in 10 people)
• feeling drowsy
Common (may affect up to 1 in 10 people)
• depression
• uncontrollable movements such as tics, shaking, twisting movements or muscle contracture (stiffness, rigidity)
• symptoms similar to Parkinson disease (rigidity, tremor)
• feel restless
• blood pressure decrease (particularly with intravenous route)
• diarrhoea
• feeling weak
Uncommon (may affect up to 1 in 100 people)
• raised levels of a hormone called prolactin in the blood which may cause milk production in men, and women who are not breast-feeding
• irregular periods
• hallucination
• decreased level of consciousness
• slow heartbeat (particularly with intravenous route)
• allergy
Rare (may affect up to 1 in 1,000 people)
• confusional state
• convulsion (especially in patients with epilepsy)
Not known (frequency cannot be estimated from the available data)
• abnormal blood pigment levels which may change the colour of your skin
• abnormal development of breasts (gynaecomastia)
• involuntary muscle spasms after prolonged use, particularly in elderly patients
• changes in heart beat, which may be shown on an ECG test
• cardiac arrest (particularly with injection route)
• shock (severe decrease of heart pressure) (particularly with injection route)
• fainting (particularly with intravenous route)
• very high blood pressure
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
T| How to store
Keep out of the reach and sight of children.
Store below 25°C in a dry place and protected from light. Do not use Metoclopramide tablets after the expiry date stated on the label/carton/bottle. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
"6 Further information
What Metoclopramide tablets contain
• The active substance (the ingredient that makes the tablet work) is 10.54mg of metoclopramide hydrochloride.
• The other ingredients are colloidal silica, lactose monohydrate, magnesium stearate, maize starch, microcrystalline cellulose (E460).
What Metoclopramide tablets look like and contents of the pack
Metoclopramide tablets are white uncoated tablets.
Pack sizes are 28 tablets.
Marketing Authorisation Holder and manufacturer
Actavis, Barnstaple, EX32 8NS, UK
Date of last revision: March 2016
Actavis, Barnstaple, EX32 8NS, UK
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