Tuesday, October 18, 2016

Metoclopramide Tablets 10mg (Actavis UK Ltd)





Metoclopramide 10mg tablets




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



  • 1 What Metoclopramide tablets are and what they are used for


  • 2 Before you take


  • 3 How to take


  • 4 Possible side effects


  • 5 How to store


  • 6 Further information





What Metoclopramide tablets are and what they are used for



Metoclopramide tablets belong to a group of medicines which speed up stomach emptying and also prevent vomiting (being sick) and may be used to:



  • relieve symptoms of digestive disorders including heartburn, feeling or being sick caused by indigestion
    with wind, stomach upset, acid reflux in the gullet, hiatus hernia (causing heartburn which may be worse when bending, lying flat or after food), gallstones, stomach ulcers or after stomach operations


  • treat nausea and vomiting caused by certain drugs (such as digoxin, antibiotics, rifabutin, rifampicin and methotrexate), heart failure, following operations or radiotherapy. Metoclopramide tablets may also be used to treat regular episodes of vomiting


  • relieve nausea and vomiting associated with migraine


  • help restore normal gut movements after operations


  • help during diagnostic procedures. Metoclopramide tablets increase the passage of a barium meal in radiology treatment and makes it easier for the introduction of a tube into the stomach and intestine.


If you are under 20 years of age Metoclopramide tablets will only be used:



  • for severe unmanageable vomiting of a known cause


  • for sickness caused by radiotherapy or chemotherapy


  • to help in passing a tube into the stomach and intestine


  • before operations.





Before you take




Do not take Metoclopramide tablets and tell your doctor if you:



  • are allergic (hypersensitive) to Metoclopramide tablets, procaine, procainamide or any of the other ingredients (see section 6)


  • have a history of muscle disorders when using drugs with a similar action to Metoclopramide tablets


  • have or have had bleeding, perforation or blockage of the stomach or intestines


  • have high blood pressure due to a tumour near the kidney (phaeochromocytoma)


  • have had an operation on your stomach or intestines within the last 3-4 days.




Check with your doctor or pharmacist before taking Metoclopramide tablets if you:



  • have epilepsy (Metoclopramide tablets may increase the risk of having a seizure)


  • have liver impairment or severe kidney disease


  • suffer with allergies or asthma


  • have Parkinson’s disease (Metoclopramide tablets may make your symptoms worse)


  • suffer from the metabolic condition porphyria.




Taking other medicines



Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially:



  • painkillers such as aspirin or paracetamol


  • ciclosporin (to prevent transplant rejection)


  • medicines used to treat Parkinson’s disease such as levodopa or pergolide


  • anticholinergics (eg atropine sulphate)


  • lithium (to treat depression)


  • medicines which can cause liver damage


  • mexiletine (for irregular heart beats)


  • atovaquone (to treat pneumonia)


  • digoxin (to treat heart condition)


  • bromocriptine (for infertility or to stop breast milk production)


  • cimetidine (to treat ulcers)


  • medicines that act on the brain (CNS depressants, antiepileptics, apomorphine, antipsychotics, medicines containing opioids, tetrabenazine)


  • medicines to treat depression (Monoamine Oxidase Inhibitors [MAOI]) and furazolidine and procarbazine.




Pregnancy and breast-feeding



If you are pregnant especially in the first 3 months, planning to become pregnant or are breast-feeding ask your doctor or pharmacist for advice before taking this medicine.





Driving and using machines



Metoclopramide tablets may cause dizziness and confusion or movement disorders. Make sure you are not affected before you drive or operate machinery.





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.





Surgery and tests



If you need to have an operation including having your teeth removed or blood and urine tests, tell your doctor or dentist you are taking this medicine.






How to take



Always take Metoclopramide tablets exactly as your doctor has told you. If you are not sure, check with your doctor or
pharmacist.



Avoid alcohol whilst taking this medicine.



Swallow the tablets with water.




Doses:



  • Adults over 20 years (including elderly):
    10mg three times a day.

  • Young adults 15-19 years:
    60kg of body weight and over: 10mg three times a day.
    30-59kg of body weight: 5mg three times a day.

  • Children under 15 years:
    not recommended.

  • Diagnostic procedures:
    a single dose of metoclopramide should be given 5-10 minutes before the examination.
    Adults over 20 years: 10-20mg.
    Young adults 15-19 years: 10mg.


If you have kidney or liver disease, you may be given a smaller dose.





If you take more than you should



If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately.





If you forget to take the tablets



Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time.





If you stop taking the tablets



Talk to your doctor before you stop taking the tablets and follow their advice.






Possible side effects



Like all medicines, Metoclopramide tablets can cause side effects, although not everybody gets them.




Stop taking Metoclopramide tablets and contact your doctor at once if the following effects occur:



  • Neuroleptic Malignant Syndrome: excessive temperature, drowsiness, rigid muscles, rapid breathing, restlessness and uncontrolled movements. This is more likely to occur if you are taking ‘neuroleptic’ medicines such as chlorpromazine or haloperidol.


  • Blood: your medicine may alter the numbers and types of your blood cells, you may notice increased bruising, nosebleeds, sore throats or infections. Your doctor may want to give you a blood test.




Tell your doctor if you notice any of the following side effects or notice any other effects not listed:



  • Severe allergic reactions such as swelling of the face, lips, throat or tongue, difficulty breathing, very fast heart beat or even loss of consciousness


  • Central Nervous System (CNS):

    • extrapyramidal or Parkinsonian effects (difficulty in speaking or swallowing, loss of balance control, mask-like face, shuffling walk, stiffness of arms or legs, trembling and shaking of hands and fingers)


    • tardive dyskinesia (lip smacking or puckering; puffing of cheeks, rapid or worm-like movements of tongue, uncontrolled chewing movements, uncontrolled movements of arms and legs)


    • dystonic effects (spasms of facial muscles and jaw muscles which prevent the jaw from opening, rhythmic protrusion of the tongue, difficulty speaking, spasm of muscles around the eyes causing rolling movements of the eyes, unnatural positioning of the head and neck, involuntary arching of the head, neck and back)


    • others: dizziness, weakness, trouble in sleeping, headache, firm muscles, drowsiness, confusion, restlessness, depression. The following are more common at high doses: agitation, panic or panic-like sensation, sensation of crawling in legs (restless leg syndrome)



  • Heart: low or high blood pressure, racing heart beat


  • Stomach and gut: diarrhoea (with high doses), constipation, feeling sick, unusual dryness of mouth


  • Genital and urine system: raised blood levels of the hormone prolactin which can cause breast milk production, breast tenderness and swelling or changes in periods


  • Skin: skin rashes, which may be itchy or water retention.



If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or pharmacist.





How to store



Keep out of the reach and sight of children.



Store below 25ÂșC 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.





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 colloidal silica, lactose, 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:



November 2007








Actavis

Barnstaple

EX32 8NS

UK


50136070





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