METOCLOPRAMIDE PIL:00070216/03 .......210 X 297mm 2/6/16 5		.4 PM Page 1
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Patient Information Leaflet

METOCLOPRAMIDE 10 MG TABLETS

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

•    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 you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

See section-4.

In this leaflet:

1.    What Metoclopramide is and what it is used for

2.    What you need to know before you take Metoclopramide

3.    How to take Metoclopramide Tablets

4.    Possible side effects

5.    How to store Metoclopramide Tablets

6.    Contents of the pack and other information

Metoclopramide is an antiemetic. It contains a medicine called

“metoclopramide”. It works on a part of your brain that prevents you

from feeling sick (nausea) or being sick (vomiting).

Adult Population

Metoclopramide is 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.

Paediatric population

Metoclopramide is indicated in children (aged 1-18 years) if other treatment does not work or cannot be used to prevent delayed nausea and vomiting that may occur after chemotherapy.

2. What you need to know before you take Metoclopramide

Do not take Metoclopramide tablets if you:

•    are allergic to metoclopramide, or any of the other ingredients of this medicine (see section 6)

•    have bleeding, obstruction or a tear in your stomach or gut

•    have or may have a tumour of the adrenal gland, which sits near the kidney (phaeochromocytoma)

•    have ever had involuntary muscle spasms (tardive dyskinesia), when you have 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”)

•    have ever had an abnormal blood pigment levels (methaemoglobinemia) or NADH cytochrome-b5 deficiency

Do not give Metoclopramide to a child less than 1 year of age (see below “Children and adolescents”).

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) 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.

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. 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 year of age because of the increased risk of the uncontrollable movements (see above “Do not take Metoclopramide if”).

Other medicines and MetoclopramideTell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This is because some medicine can affect the way Metoclopramide works or Metoclopramide 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 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)

•    cyclosporine (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 with alcohol

Alcohol should not be consumed during treatment with metoclopramide because it increases the sedative effect of Metoclopramide.

Pregnancy and 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 may be taken during pregnancy. Your doctor will decide whether or not you should be given this medicine.

Metoclopramide is not recommended if you are breast-feeding 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.

This may affect your vision and also interfere with your ability to drive and use machines.

Metoclopramide tablet contains lactose

If you have been told you have 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 that you are taking this medicine.

Always take Metoclopramide tablets exactly as your doctor has told you. The pharmacist’s label should tell you how much to take and how often. Check with your doctor or pharmacist if you are not sure.

Adult patients (All indications)

The recommended single dose is 10 mg, repeated up to three times daily.

The maximum recommended dose per day is 30 mg or 0.5 mg/kg body weight.

The maximum recommended treatment duration is 5 days.

To prevent delayed nausea and vomiting that may occur after chemotherapy (children aged 1-18 years):

The recommended dose is 0.1 to 0.15 mg/kg body weight, repeated up to 3 times daily, taken by mouth (oral route).

The maximum dose in 24 hours is 0.5 mg/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

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 year (see section 2).

If you take more Metoclopramide 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. Your doctor may prescribe you a treatment for these signs if necessary.

If you forget to take Metoclopramide

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.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Metoclopramide tablets 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

•    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

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

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 breastfeeding

•    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

•    high fever, high blood pressure, convulsions, sweating, production of saliva. These may be signs of a condition called neuroleptic malignant syndrome

•    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)

•    allergic reaction which may be severe (particularly with intravenous route)

•    very high blood pressure

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet.

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.

Keep all the medicines out of the sight and reach of children

•    Do not use the Tablets after the expiry date stated on the label after ‘EXP’. The expiry date refers to the last day of that month

•    Store in dry cool condition protected from bright sun light

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Metoclopramide tablets contain

•    The active substance is 10mg of anhydrous Metoclopramide hydrochloride BP

•    The other ingredients are lactose, maize starch, magnesium stearate, colloidal silicon dioxide and sodium starch glycollate

See end of section 2 for further information on lactose

What Metoclopramide tablets looks like and contents of the pack

•    White, circular, biconvex uncoated tablets. Embossed M/10 on one face and ‘PV’ on the other

•    Metoclopramide tablets are available in 28, 50, 56, 100, 200, 500 and 1000’s pack sizes. Pharmvit Metoclopramide tablets are only available from pharmacies. Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer:

Pharmvit Ltd, 177 Bilton Road, Perivale,

Greenford, Middlesex UB6 7HQ.

Telephone: 0208 997 5444

Fax:_0208 997 5433_

To request a copy of this leaflet in large print or audio format or

additional copies, please contact the licence holder at the address (or

telephone, fax) above.

PL 04556 / 0007    PoM

Reference: 00070216/03

Date leaflet last revised: February 2016