PATIENT INFORMATION LEAFLET - UK GB727-1513LF-AM02 8093548-04

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Metoclopramide 5mg/ml Solution for Infusion

(Metoclopramide Hydrochloride)

AMDIPHARM

Read all of this leaflet carefully before you start taking this medicine.

-    Please 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 becomes severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

The name of your medicine is Metoclopramide 5mg/ml Solution for Infusion; it will be called Metoclopramide Infusion for ease here after.

In this leaflet

1.    What Metoclopramide Infusion is and what it is used tor

2.    Before you take Metoclopramide Infusion

3.    How to take Metoclopramide Infusion

4.    Possible side effects

5.    How to store Metoclopramide Infusion

6.    Further Information

1.    WHAT METOCLOPRAMIDE INFUSION IS AND WHAT IT IS USED FOR

The name of your medicine is Metoclopramide Infusion. Metoclopramide Infusion contains the active ingredient Metoclopramide Hydrochloride which belongs to a group of medicines called antiemetics.

Metoclopramide Infusion is used to help adults to stop feeling sick (nausea) and adults or children being sick (vomiting) caused by treatments such as radiotherapy and antitumour drugs.

2.    BEFORE YOU TAKE METOCLOPRAMIDE INFUSION Do not take Metoclopramide Infusion If you:

•    are allergic to metociopramlde hydrochloride or any of the

other ingredients of Metoclopramide Infusion;

•    have a tumour in your adrenat gland (phaeochromocytoma);

•    have had surgery on your digestive system in the last 3-4 days;

•    have been told by your doctor that you have a blockage bleeding or a tear in your digestive system;

•    are in early stages of pregnancy or are breast-feeding;

•    have epilepsy;

•    Metoclopramide Infusion should not be given to children under the age of 1 year.

Take special care with Metoclopramide Infusion If you have:

•    severe liver or kidney problems;

•    a history of allergic asthma or other allergic type reactions;

•    an uncommon Inherited blood disorder called porphyria.

If any of these apply to you, please see your doctor before being treated with Metoclopramide Infusion, Metoclopramide Infusion when given intravenously in patients with any heart problems can cause irregular heart beats, palpitations, fainting or dizziness.

Please inform your doctor if you have any heart problems.

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, including those obtained without a prescription.

This is especially important if you are taking:

•    painkillers, such as aspirin and paracetamol;

•    any medicine belonging to a group called anticholinergic medicines, such as atropine, scopolamine or suxamethonium;

•    levodopa, bromocriptine and pergolide used to treat Parkinson's Disease;

•    ciclosporin, an immunosuppressant medicine;

•    any medicines for mental health problems;

•    a medicine used to control movement disorders in conditions such as Huntington's Chorea called tetrabenazine;

•    any medicine used to treat depression: Selective Serotonin Reuptake Inhibitors (SSRls) such as fluoxetine or citalopram; Monoamine Oxidase Inhibitors (MAOls) such as procarbazine;

•    any other medicine taken by mouth, as the dose may be affected by Metoclopramide Infusion;

•    atovaquone, used to treat pneumonia

Taking Metoclopramide Infusion with food and drink Alcohol should be avoided when you are taking Metoclopramide Infusion. Pregnancy and breast-feeding If you are pregnant, think you may be pregnant or are trying to become pregnant, please tell your doctor before taking Metoclopramide Infusion. Metoclopramide Infusion is not recommended for use in the early stages of pregnancy. Metoclopramide Infusion passes into the breast milk, therefore breastfeeding is not recommended while taking Metoclopramide Infusion.

Driving and using machines

You can drive while being treated with Metoclopramide Infusion, but do not drive until you know how it affects you. It may make you feel drowsy or dizzy and could cause movement disorders, if it affects you in this way, do not drive or operate machinery.

3. HOW TO TAKE METOCLOPRAMIDE INFUSION

Metoclopramide Infusion will be given to you as a drip, usually over a few hours. Your doctor will work out the correct dose for you based on your weight.

Dose:

The usual dose given to adults is 2-4 mg/kg of body weight for the first 15-20 minutes before you receive your radiotherapy or other antitumour medicine. The dose will then change to 3-5 mg/Kg of body weight either over the course of a few hours or repeated every 2 hours for 15 minutes.

Paediatric population including adolescents (aged 1-20 years)

0.15mg/kg as a slow infusion (at least 3 minutes) per dose. The maximum daily dose is 0.5 mg/kg over 24 hours.

Each dose of 0.15 mg/kg should be separated by at least 6 hours, even if vomiting continues, to avoid an overdose.

If you feel unwell at the end of your treatment, or continue to be sick please tell your doctor.

If you are given more Metoclopramide Infusion than you should

It is unlikely that you will be given more Metoclopramide Infusion than you should, however a doctor would treat any symptoms that follow.

4. POSSIBLE SIDE EFFECTS

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

If you notice:

•    itching or skin rashes;

•    swelling of the face, lips or throat;

•    difficulty in breathing or wheeziness,

Seek medical advice immediately. These may be signs of an allergic reaction.

If you notice:

a very high fever; loss of consciousness; stiff muscles; slurred speech;

odd tongue or eye movements; body spasms;

unnatural position of the head and shoulders; slow repeated movements, such as head nodding (only in the elderly who are on long term treatment),

Stop taking the medicine and seek medical advice immediately. Other side effects may include:

•    raised prolactin levels in the blood. Symptoms include; milk production in men, and women who are not breast-feeding; irregular periods; breast tissue growth in men;

•    repetitive muscle contractions. leading to jerky and twisted movements;

•    disturbances in your vision;

•    drowsiness;

•    confusion;

•    anxiety;

•    increase or decrease in blood pressure;

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•    agitation;

•    tremors;

•    dizziness;

•    diarrhoea.

Very rare:

•    heart problems such as a very low hear rate.

Extremely rare:

•    depression;

•    Metoclopramide Infusion may affect the blood and cause breathing problems, headache and tiredness. The lips, nail beds and ears may look blue. If this happens stop taking Metoclopramide Infusion and get in touch with your doctor.

If any of the side effects becomes severe, or if you notice aside effect not listed in the leaflet, please tell your doctor or pharmacist immediately.

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.

5.    HOW TO STORE METOCLOPRAMIDE INFUSION KEEP OUT OF THE REACH AND SIGHT OF CHILDREN

Do not use Metoclopramide Infusion after the expiry date which is printed on the pack.

Protect from light.

6.    FURTHER INFORMATION

What Metoclopramide Infusion contain

Metoclopramide Infusion contains 100 mg of the active ingredient metoclopramide hydrochloride.

Other inactive ingredients are: sodium chloride and water for injections. What Metoclopramide Infusion looks like and content of the pack

Metoclopramide Infusion is a clear, colourless solution available in clear glass 20 ml ampoules, packed in boxes of 10.

Marketing Authorisation Holder and Manufacturer

Amdipharm UK Limited,

Capital House,

85 King William Street,

London EC4N 7BL,

UK

Manufacturer responsible for release:

Kern Pharma SL,

Poligono Ind. Colon II,

C/Venus 72,

08228 Terrassa,

Barcelona, Spain.

Date of last revision: December 2013.

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