Metoclopramide 10mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
METOCLOPRAMIDE 10 mg 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.
- If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
THIS LEAFLET CONTAINS
1. What Metoclopramide is for
2. Before you take Metoclopramide
3. How to take Metoclopramide
4. Possible side effects
5. How to store Metoclopramide
6. Further information
1. WHAT METOCLOPRAMIDE IS FOR
Metoclopramide belongs to a group of medicines called 'dopaminergic' blockers.
It acts on the muscles in the digestive system, helping to stop problems such as feeling sick (nausea) and being sick (vomiting).
Metoclopramide can be used:
• to treat stomach upset including heartburn, wind, pain, indigestion, sickness and bile regurgitation. These symptoms may be due to conditions such as acid reflux in the gullet, stomach ulcers, inflammation of the stomach or intestines, hiatus hernia, gallstones or after an operation to remove the gall bladder
• to stop nausea and vomiting caused by disorders of the stomach or intestines, certain drugs (such as antibiotics or anti-cancer drugs), heart failure or after an operation or radiotherapy
• to treat regular episodes of nausea and vomiting
• to relieve the symptoms of nausea and vomiting when you have a migraine
• to help restore normal stomach emptying after an operation
• during hospital tests such as a barium meal (a type of examination of the stomach and intestines).
If you are under 20 years of age Metoclopramide will only be given:
• for severe and long-lasting vomiting if the cause is known
• to stop vomiting caused by cancer treatment such as radiotherapy and chemotherapy
• to help in passing a tube into the stomach and intestines
• to help stop nausea and vomiting before having an operation.
2. BEFORE YOU TAKE METOCLOPRAMIDE
Do not take Metoclopramide and tell your
doctor if:
• you are allergic to Metoclopramide or any of the other ingredients in the tablets (listed in section 6 of this leaflet). The signs of an allergic reaction can include a rash, itching or shortness of breath
• you have had an operation on your stomach or intestines in the last three or four days
• you have or have had bleeding, perforation or blockage of your stomach or intestines
• you have phaeochromocytoma, a tumour of the adrenal gland that causes high blood pressure
• you are breast-feeding.
Take special care with Metoclopramide
Tell your doctor before you take this medicine if:
• you have liver or kidney problems
• you have epilepsy
• you have an inherited blood disorder known as porphyria
• you suffer from allergies or asthma
• you are taking medicines called Phenothiazines, such as Chlorpromazine. Special care should be taken, as Phenothiazines and Metoclopramide can cause similar side effects such as jerky movements
• you have hospital tests.
Your doctor will monitor you closely, especially if you are elderly, a young adult or a child.
If vomiting persists, even when you are taking this medicine, you should talk to your doctor.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken, any other medicines, even medicines bought without a prescription. This is because Metoclopramide can affect the way some other medicines work. Also, some medicines can affect the way Metoclopramide works.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
• Medicines called 'Antimuscarinics' such as Atropine, used for lots of different types of illness such as eye, kidney, breathing or bowel problems
• Medicines to treat mental health problems and other related conditions, such as Chlorpromazine or Prochlorperazine
• Medicines that increase the levels of Serotonin in your central nervous system, such as antidepressants or medicines to calm you down or to help you sleep
• Painkillers such as Paracetamol or Aspirin or stronger painkillers containing 'opoids', such as Codeine and other similar medicines.
These may be used to treat drug addiction
• Medicines to treat Parkinson's disease and other related conditions, such as Levodopa, Bromocriptine, Cabergoline, Rotigotine, Ropinirole, Pergolide, Amantadine or Tetrabenazine
• Suxamethonium for muscle relaxation
• Ciclosporin to stop the rejection of organs after transplants
• Atovaquone to treat pneumonia.
Taking Metoclopramide with food and drink
Do not drink alcohol whilst taking Metoclopramide. This is because alcohol will make you drowsy and taking Metoclopramide with it may make you even more drowsy.
Pregnancy and breast-feeding
If you are pregnant especially in the first 3 months or you are planning a pregnancy, ask your doctor for advice before taking Metoclopramide.
Do not take Metoclopramide if you are breastfeeding.
Driving and using machines
Metoclopramide may make you drowsy. If affected do not drive or operate machinery.
Important information about some of the ingredients of Metoclopramide tablets
This medicine contains lactose (a type of sugar). If you know you have an intolerance to some sugars contact your doctor before taking this medicine.
3. HOW TO TAKE METOCLOPRAMIDE
Always take Metoclopramide tablets exactly as your doctor has told you. Swallow the tablets with a glass of water.
The usual doses are given below. These may be changed by your doctor:
Dosage for adults 20 years and above (including elderly)
To treat a medical condition:
• 10 mg three times a day. If you weigh less than 60 kg see below
• If you are elderly and are taking Metoclopramide for long-term treatment, your doctor may wish to see you regularly.
For investigative procedures:
• A single dose of 10-20 mg will be given 5 to 10 minutes before the procedure.
Dosages for young adults between 15 and 19 years
The dose will be worked out by your doctor. The total daily dosage should not be more than 0.5 mg per kg of bodyweight.
To treat a medical condition:
• If you weigh over 60 kg, you should take 10 mg three times a day
• If you weigh between 30 to 59 kg, you should take 5 mg three times a day.
For investigative procedures:
• A single dose of 10 mg will be given 5 to 10 minutes before the procedure.
Dosages for children
Metoclopramide tablets are not recommended for children under 15 years of age. A liquid form of the medicine should be used instead.
Your doctor will decide the dose for your child, as it depends on your child's age and bodyweight.
People with liver or kidney problems
Your doctor will start you on a lower dose and gradually increase it as you may be more sensitive to the medicine.
If you take more Metoclopramide than you should
Contact your doctor or go to a hospital immediately. Take the container and any remaining tablets with you. Symptoms of an overdose may include muscle cramps of your face and jaw or unnatural tongue and eye movements.
If you forget to take Metoclopramide
Don't worry, just take your next scheduled dose at the correct time. Do not take a double dose to make up for the one you have missed.
If you stop taking Metoclopramide
DO NOT STOP taking this medicine unless your doctor tells you to. The symptoms may come back if treatment is stopped too early.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Metoclopramide can cause side effects, although not everybody gets them.
STOP TAKING Metoclopramide and see a doctor straight away if you have:
• an allergic reaction. The signs of an allergic reaction may include swelling of your face, lips, tongue or throat, difficulty breathing or swallowing or severe itching of your skin with raised lumps
• symptoms of 'Neuroleptic Malignant Syndrome'. The early warning signs are unusually fast heart beats and sweating. Other
signs include over heating, muscle stiffness or unconsciousness leading to a coma
• blood disorders. The signs of these may include breathing problems, headache and tiredness. Your lips, nail beds and ears may turn blue.
If you get any of these side effects, carry on taking the medicine but tell your doctor straight away:
• muscle cramps of your face and jaw, speech problems, unnatural tongue and eye movements (including rolling eyes), unnatural positioning of your head, shoulders and spine or difficulty with movement
• feeling depressed
• skin rash, itching or swelling due to a build-up of excess fluid in your body
• feeling confused.
Tell your doctor if you get any of these side effects:
• feeling drowsy
• feeling restless or anxious
• breast swelling, tenderness and sometimes production of breast milk
• irregular periods
• diarrhoea.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE METOCLOPRAMID
Keep out of the reach and sight of children.
Do not store above 25°C. Store in the original container and keep the container tightly closed.
Do not use these tablets after the expiry date, which is stated on the container. 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 ingredient in Metoclopramide 10 mg tablets is metoclopramide hydrochloride. The other ingredients are lactose, anhydrous lactose, pregelatinised starch, colloidal anhydrous silica and magnesium stearate.
What Metoclopramide tablets look like and contents of the pack
Metoclopramide 10 mg tablets are round white tablets with the marking MP34 on one side and a break line engraved on the other.
The tablets come in containers of 28, 30, 50, 56, 60, 84, 100, 250, 500 and 1000 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Metwest Pharmaceuticals Limited,
15 Runnelfield, Harrow on the Hill,
Middlesex HA1 3NY
Manufacturer
DDSA Pharmaceuticals Limited,
310 Old Brompton Road,
London SW5 9jQ
For more information about this product, please contact the Marketing Authorisation Holder.
This leaflet was last approved in 07/2011