PACKAGE LEAFLET: INFORMATION FOR THE USER

Metoclopramide Tablets 10mg

(metoclopramide hydrochloride)

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 or nurse.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Metoclopramide Tablets are and what they are used for

2.    What you need to know before you are given Metoclopramide Tablets

3.    How to take Metoclopramide Tablets

4.    Possible side effects

5.    How to store Metoclopramide Tablets

6.    Contents of the pack and other Information

1. WHAT METOCLOPRAMIDE TABLETS ARE AND WHAT THEY ARE USED FOR

Metoclopramide Tablets 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). Metoclopramide Tablets 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 Tablets are 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.

Do not take Metoclopramide Tablets if you:

•    Are allergic to metoclopramide, or any of the other ingredients contained in the tablets (listed in section 6)

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

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

•    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 level (methaemoglobinemia) or NADH cytochrome-b5 deficiency.

Do not give Metoclopramide Tablets to a child less then 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 body, 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).

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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 Tablets if you”).

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 you')

•    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 immune system)

•    Fluoxetine and paroxetine (medicine to treat depression)

•    Mivacurium and suxamethonium (medicines used to relax muscles)

•    Atovaquone (to treat pneumonia).

Metoclopramide Tablets with alcohol Alcohol should not be consumed during treatment with Metoclopramide because It increases the sedative effect of Metoclopramide Tablets.

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

Metoclopramide Tablets contain lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Always take Metoclopramide Tablets exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

All Indications:

Adults

The recommended single dose is 10mg three times a day. The maximum recommended dose per day is 30mg or 0.5mg/kg body weight.

The maximum recommend treatment duration is 5 days.

To prevent delayed nausea and vomiting that may occur after chemotherapy (children aoed 1- 18 vearst

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 0.5mg/kg body weight.

Dosing table

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.

Instructions for use

You should not take this medicine for more than 5 days to prevent delayed nausea and vomiting that may occur after chemotherapy.

Metoclopramide Tablets are not suitable for use In children weighing less than 61kg. 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. Other pharmaceutical forms/strength may be more appropriate for administration.

Adults with kidney problems

Talk to your doctor if you have kidney problems. The dose should be reduced if you have moderate to severe kidney problems.

Other pharmaceutical forms/strength may be more appropriate for administration.

Adults with liver problems

Talk to your doctor if you have liver problems. The dose should be reduced if you have severe liver problems.

Other pharmaceutical forms/strength may be more appropriate for administration.

Children and adolescents

Metoclopramide Tablets must not be used in children aged less than 1 year (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, decreased levels of consciousness, be confused, have hallucination and heart problems. Your doctor may prescribe you a treatment for these signs if necessary.

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 1000 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.

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.

Check the expiry date printed on the label or side of the box. Do not use after the expiry date stated on the label.

Store the product in a cool, dry place and protect from light.

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.

bike all medicines, this medicine can cause side effects, although not everyone gets them.

In case of any visible signs of deterioration, you should discard the package.

Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help to protect the environment

Keep out of the sight and reach of children

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 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.

Very common (may affect more than 1 in 10 people)

•    Feeling drowsy.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Metoclopramide Tablets contain:

Metoclopramide Tablets 10mg contain the active substance Metoclopramide.

The other Ingredients are:

Microcrystalline cellulose, anhydrous lactose, maize starch, sodium lauryl sulphate and magnesium stearate.

What Metoclopramide Tablets look like and contents of the pack

Metoclopramide 10mg Tablets are white, bi-convex tablets plain on one side, with a breakline on reverse.

Metoclopramide 10mg Tablets are packed into packs of 500.

Marketing Authorisation Holder and Manufacturer

Ennogen Pharma Limited

Unit G4, Riverside Industrial Estate,

Riverside Way, Dartford, DA1 5BS, UK.

This leaflet was last revised in February 2016.