PACKAGE LEAFLET: INFORMATION FOR THE USER

Metoclopramide 5mg/ml Injection

(metoclopramide hydrochloride)

Read all of this leaflet carefully before you start

using 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

What is in this leaflet:

1.    What Metoclopramide 5mg/ml Injection is and what it is used for

2.    What you need to know before you are given Metoclopramide 5mg/ml Injection

3.    How to use Metoclopramide 5mg/ml Injection

4.    Possible side effects

5.    How to store Metoclopramide 5mg/ml Injection

6.    Contents of pack and other information

1. WHAT METOCLOPRAMIDE 5MG/ML

INJECTION IS AND WHAT IT IS USED FOR

Metoclopramide belongs to a group of medicines called 'antiematics'. It works on a part of your brain that prevents you from feeling sick (nausea) or being sick (vomiting).

It is used to treat the following:

•    To prevent nausea and vomiting that may occur after surgery

•    To treat nausea and vomiting including nausea and vomiting which may occur with a migraine

•    To prevent nausea and vomiting caused by radiotherapy.

Paediatric population (aged 1 - 18 years):

This product can be used to treat nausea and vomiting after surgery or to prevent delayed nausea and vomiting that may occur after chemotherapy, in children from the age of 1 year. It should only be used if other treatment does not work or cannot be used.

It is not recommended for use in children for any other indication.

2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN METOCLOPRAMIDE 5MG/ML INJECTION

You should not be given Metoclopramide

Injection if you:

•    Are allergic to metoclopramide, or any other ingredients contained in the injection (see section 6)

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

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

•    Have epilepsy

•    Have ever had involuntary muscle spasms (tardive dyskinesia), when you have been treated with a medicine

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

Metoclopramide Injection should not be used in

neonates.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you

are given metoclopramide if:

•    You have liver or kidney problems. The dose may be reduced (see section 3)

•    You have a history of abnormal heart beats (QT interval prolongation) or any other heart problems

•    You are using other medicines known to affect the way your heart beats

•    You have problems with the levels of salts in your blood, such as potassium, sodium and magnesium

•    You have any neurological (brain) problems.

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 year of age because of the increased risk of the uncontrollable movements (see above You should not be given Metoclopramide Injection if you).

Other medicines and Metoclopramide Injection:

Please tell your doctor or nurse if you are taking or have recently taken or might take any other medicines. This is because some medicines can affect the way metoclopramide works or metoclopramide can affect how other medicines work. These medicines include the following:

•    Fluoxetine and paroxetine (medicines to treat depression)

•    Medicines to treat Parkinson's disease e.g. levodopa (see above "You should not be given metoclopramide injection if")

•    Anticholinergics (medicines used to relieve stomach cramps or spasms)

•    Morphine derivatives (medicines used to treat severe pain)

•    Cyclosporine (medicine used to treat certain problems with the immune system)

•    Suxamethonium and mivacurium (medicines used to relax muscles)

•    Digoxin (medicine used to treat heart failure)

•    Sedative medicines

•    Any medicines used to treat mental health problems

•    Atovaquone (to treat pneumonia)

•    Pain killers such as aspirin or paracetamol or stronger pain killers called opioids.

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, you should ask your doctor or pharmacist for advice before you are 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 Injection contains sodium metabisulphite

This may rarely cause severe hypersensitivity reactions and bronchospasm.

3. HOW TO USE METOCLOPRAMIDE 5MG/ML INJECTION

The medicine will normally be given to you by a doctor or nurse. It will be given as a slow injection into a vein (over at least 3 minutes) or by injection into a muscle.

In adult patients

For the treatment of nausea and vomiting including nausea and vomiting which may occur with a migraine and for the prevention of nausea and vomiting caused by radiotherapy: the recommended single dose is 10mg, repeated up to 3 times daily.

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

For the prevention of nausea and vomiting that may occur after surgery prevention: a single dose of 10mg is recommended.

Metoclopramide Injection may be mixed with the following substances for intravenous infusion: Sodium chloride intravenous infusion BP 0.9% w/v,

INFORMATION FOR HEALTHCARE PROFESSIONALS

PLEASE DETACH BEFORE HANDING ABOVE SECTION TO THE PATIENT

Metoclopramide 5mg/ml Injection

Below is a summary of information to assist in the administration of Metoclopramide Injection.

• Please refer to SPC for complete prescribing information.

Presentation

Metoclopramide Injection is a clear and colourless sterile aqueous solution in an amber glass ampoule containing 5mg of anhydrous metoclopramide hydrochloride per ml. Each 2ml ampoule contains 10mg of metoclopramide hydrochloride.

Preparation of infusion

Intravenous solutions should be prepared as near as possible to the time of infusion. However Metoclopramide Injection has been shown to be stable in the solutions listed below for at least 24 hours at room temperature.

Metoclopramide Injection can be mixed with the following substances for intravenous infusion: Sodium Chloride intravenous infusion BP (0.9% w/v)

Glucose intravenous infusion BP (5%w/v)

Sodium chloride and glucose intravenous infusion BP (sodium chloride 0.18%w/v; glucose 4%w/v) Potassium chloride (0.15% or 0.3%)

Posology and method of administration

Administration: by intramuscular or intravenous injection.

Intravenous doses should be administered as a slow bolus (at least over 3 minutes).

Adults

For prevention of Post operative nausea and vomiting (PONV) a single dose of 10mg is recommended.

For the symptomatic treatment of nausea and vomiting, including acute migraine induced nausea and vomiting and for the prevention of radiotherapy induced nausea and vomiting (RINV): the recommended single dose is 10mg, repeated up to three times daily.

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

Treatment duration should be as short as possible and transfer to oral or rectal treatment should be made as soon as possible.

Children

The recommended dose is 0.1 to 0.15mg/kg body weight, repeated up to three times daily by intravenous route. The maximum dose in 24 hours is 0.5mg/kg body weight.

Glucose intravenous infusion BP (5%w/v) Sodium chloride and glucose intravenous infusion BP (sodium chloride 0.18%w/v; glucose 4%w/v) Potassium chloride (0.15% or 0.3%)

Metoclopramide Injection will be prepared just before use.

Paediatric population (aged 1-18 years):

The recommended dose is 0.1 to 0.15mg/kg body weight, repeated up to 3 times daily, given by slow injection into a vein.

The maximum dose in 24 hours is 0.5mg/kg body weight.

The treatment should not exceed 48 hours for treatment of nausea and vomiting that has occurred after surgery.

The treatment should not exceed 5 days for the prevention of delayed nausea and vomiting that may occur after chemotherapy.

Older people

The dose may need to be reduced depending on kidney problems, liver problems and overall health. Other pharmaceutical forms/strengths 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 or severe kidney problems.

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

Children and adolescents

Metoclopramide must not be used in children aged less than 1 year (see section 2).

If you are given too much Metoclopramide Injection

Since the injection will be given to you by a doctor or nurse, it is unlikely that you will be given too much. However, if you think that you have been given too much, you should tell the person giving you the injection immediately. You may experience uncontrollable movements (extrapyramidal disorders), feel drowsy, decreased levels of consciousness, be confused, have hallucinations and heart problems. Your doctor may prescribe you a treatment for these signs if necessary.

If you stop taking Metoclopramide Injection

Your doctor will decide when you need to stop taking this medicine.

If you forget to take Metoclopramide Injection

As this medicine is given by a doctor or nurse it is unlikely that a dose will be missed. If however, you think a dose has been missed you should talk to the doctor or nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Metoclopramide Injection 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 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.

Common (may affect up to 1 in 10 people)

•    Depression

•    Uncontrollable movements such as tics, shaking, twisting movements or muscle contracture (stiffness, rigidity)

The maximum treatment duration is 48 hours for treatment of established post operative nausea and vomiting (PONV).

The maximum treatment duration is 5 days for prevention of delayed chemotherapy induced nausea and vomiting (CINV).

Metoclopramide injection should not be used in children aged less than 1 year.

Elderly

In elderly patients a dose reduction should be considered, based on renal and hepatic function and overall frailty.

Renal impairment

In patients with end stage renal disease (Creatinine clearance = 15ml/min), the daily dose should be reduced by 75%.

In patients with moderate to severe renal impairment (Creatinine clearance 15 60ml/min), the dose should be reduced by 50% .

Hepatic impairment:

In patients with severe hepatic impairment, the dose should be reduced by 50%.

•    Symptoms similar to Parkinson's 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 heart beat (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.

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/yellow card By reporting side effects you can help provide more information on the safety of this medicine.

^r5. HOW TO STORE METOCLOPRAMIDE _L 5MG/ML INJECTION_

Your injection will be stored in a cool place and need to protected from light. The nurse or doctor will check that the injection is not past its expiry date before giving you the injection.

The expiry date refers to the last day of that month.

Keep out of the sight and reach of children.

^r6. CONTENTS OF PACK AND OTHER _L INFORMATION_

What Metoclopramide Injection contains:

The injection contains an active ingredient called metoclopramide hydrochloride.

Each 1 ml of solution contains metoclopramide hydrochloride equivalent to 5 mg anhydrous metoclopramide hydrochloride in a sterile solution for injection.

The injection contains the following inactive ingredients:

E223 - Sodium metabisulphite Sodium chloride Water for injection.

What Metoclopramide Injection looks like and the content of the pack:

The injection is supplied in 2ml and 20ml amber glass ampoules.

The 2ml product is available as a pack size of 5 and/or 10 ampoules.

The 20ml product is available as a pack size of 10 ampoules.

Marketing Authorisation Holder:

Ennogen Pharma Limited

Unit G4, Riverside Industrial Estate,

Riverside Way, Dartford, DA1 5BS, UK.

Manufacturer:

SALF SpA Laboratorio Farmacologico

Via Marconi 2, 24069 Cenate Sotto (Bergamo),

Italy.

This leaflet was last revised January 2016.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

Toxicity and treatment of overdose

Symptoms

Extrapyramidal disorders, drowsiness, decreased level of consciousness, confusion, hallucination and cardio-respiratory arrest may occur.

Management

In case of extrapyramidal symptoms related or not to overdose, the treatment is only symptomatic (benzodiazepines in children and/or anticholinergic anti-parkinsonian medicinal products in adults).

A symptomatic treatment and a continuous monitoring of the cardiovascular and respiratory functions should be carried out according to clinical status.

Special precautions for storage

Store in a cool dry place. Protect from light. If only part of the ampoule is used, discard the remaining solution. For single use only.

An expiry date is given on the outer carton and ampoule label of the product. It should not be used after this date.

Nature and contents of the container

10mg/2ml injection: box of 5 ampoules

Product licence number

PL 40147/0059