8/13/2019 Maxolon* Injection 5 mg / ml

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PATIENT INFORMATION LEAFLET - UKGB 726-8758-APIL8093545-04

Read all of this leaflet carefully before you starttaking 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 ifyou notice any side effects not listed in thisleaflet, please tell your doctor or pharmacist.

In this leaflet1. What Maxolon Injectionis and what it is used for2. Before you are givenMaxolon Injection3. How you will be givenMaxolon Injection4. Possible side effects5. How to store Maxolon Injection6. Further Information

1. WHAT MAXOLON INJECTIONIS AND WHAT ITIS USED FOR

The name of your medicine is Maxolon Injection.Maxolon Injection contains the active ingredientMetoclopramide Hydrochloride BP which belongs toa group of medicines called antiemetics.

Maxolon Injection is used to treat problems in adultssuch as: Feeling sick (nausea) and being sick (vomiting)

caused by, amongst other things, diseases of thedigestive system, heart problems and bytreatments such as radiotherapy andantitumour drugs.

Pain anddiscomfortof problems such asindigestion, heartburn, wind, sickness andbringing up bile. These problems canbe causedby acid rising from the stomach, hiatus hernia,inflammation or ulcer of the upper part of yourdigestivesystem, gallstones or after an operationto remove gallstones.

Migrainesto stop nausea and vomiting and tohelp painkillers work moreeffectively.

Maxolon Injection is used to treat severevomiting oris given before surgery in children and adolescents(aged 1-20 years).

2. BEFORE YOU TAKE MAXOLON INJECTIONDo not take Maxolon Injection if you: are allergic tometoclopramidehydrochlorideor

any of the other ingredients of Maxolon Injection; have a tumour in your adrenal gland

(phaeochromocytoma);

have had surgery on your digestive system inthe last 3-4 days;

have been told by your doctor that you have ablockage, bleeding or a tear in your digestivesystem;

are in early stages of pregnancy or arebreast-feeding;

have epilepsy; Maxolon Injection should not be given to children

under the age of 1 year.

Takespecialcarewith MaxolonInjectionifyouhave: 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 yourdoctor before being treated with Maxolon.

Maxolon when given intravenously in patientswith any heart problems can cause irregularheart beats, palpitations, fainting or dizziness.Please inform your doctor if you have any heartproblems.

If vomiting persists, even when you are takingthis medicine, you should talk to your doctor.

Taking other medicinesTell your doctor or pharmacist if you are taking,or have recently taken, any other medicines,including those obtained without a pres cription.

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 usedto treat Parkinson's Disease;

ciclosporin, an immunosuppressantmedicine;

any medicines for mental health problems; a medicine used to control movement

disorders in conditions such asHuntington's Chorea called tetrabenazine;

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

any other medicine taken by mouth, as thedose may be affected by Maxolon;

atovaquone, used to treat pneumonia.

Taking Maxolon with food and drinkAlcohol should be avoided when you are takingMaxolon.

Pregnancy and breast-feedingIf you are pregnant, think you may be pregnantor are trying to become pregnant, please tellyour doctor before taking Maxolon. Maxolon isnot recommended for use in the early stages ofpregnancy.

Maxolon passes into the breast milk, thereforebreast-feeding is not recommended while takingMaxolon.

Driving and using machinesYou can drive while being treated with Maxolon,

but do not drive until you know how it affectsyou. It may make you feel drowsy or dizzy andcould cause movement disorders, if it affects youin this way, do not drive or operate machinery.

3. HOW TO TAKE MAXOLON INJECTIONMaxolon Injection will be given to you as injectioninto a muscle, or as a slow injection into a vein(taking 1-2 minutes). Your doctor will work out thecorrect dose for you based on your weight.

The usual doses taken to treat a condition are:

Adults 21 years and over:10 mg given three times a day.

Paediatric population including adolescents(aged 1-20 years):0.15 mg/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 atleast 6 hours, even if vomiting continues, to avoidan overdose.

For diagnostic purposes a single dose of Maxolonmay be given 5-10 minutes before investigations ofthe upper digestive system:

Adults 21 years and over:10-20 mg.

Paediatric population including adolescents(aged 1-20 years):0.15 mg/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 atleast 6 hours, even if vomiting continues, to avoidan overdose.

If you are given more Maxolon Injection than youshouldIt is unlikely that you will be given more Maxolon thanyoushould,howevera doctorwouldtreatanysymptomsthat follow.

4. POSSIBLE SIDE EFFECTSLike all medicines, Maxolon can cause side effectsalthough 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 besigns of an allergic reaction.

If you notice: a very high fever; loss of consciousness; sti ff muscles; slurred speech; odd tongue or eye movements; body spasms; unnatural position of the head

and shoulders;

slow repeated movements, such as headnodding (only in the elderly who are on longterm treatment),

Seek medical advice immediately.

Other side effects may include:

raised prolactin levels in the blood. Symptomsinclude; milk production in men, and womenwho are not breast-feeding; irregular periods;breast tissue growth in men;

repetitive muscle contractions, leading to jerkyand twisted movements;

disturbances in your vision; increase or decrease in blood pressure; t remo rs ; dizziness.

Rare: drowsiness; confusion; anx ie ty ; d iarrho ea ; heart problems such as a very low heart rate; agi tation.

Extremely rare: depression; Maxolon 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 Maxolon Injectionand get in touch with your doctor.

If any of the side effects becomes severe, or if younotice a side effect not listed in the leaflet, please tellyour doctor or pharmacist immediately.

5. HOW TO STORE MAXOLON INJECTION

KEEPOUTOFTHE REACHANDSIGHTOFCHILDREN

Do not use Maxolon Injection after the expiry datewhich is printed on the pack.Protect from light.Do not store above 25oC

6. FURTHER INFORMATIONWhat Maxolon Injection containsMaxolon Injection contains 10 mg of the activeingredient metoclopramide hydrochloride BP.Other inactive ingredients are: sodium chloride,sodium metabisulphite and water for injection.

What Maxolon Injection looks like and content ofthe packMaxolon Injectionis a clear, colourless solutionavailable in clear glass 2 ml ampoules, in packs of1or 12 ampoules or 1 ampoule and 12 tablets inan aluminium canister as a home visit pack.

Marketing Authorisation HolderAmdipharm plc,Regency House,Miles Gray Road,Basildon,Essex,SS14 3AF.

Manufacturer responsible for release:Kern Pharma SL,Poligono Ind. Colon II,C/Venus 72, 08228 Terrassa,Barcelona, Spain.

Date of last revision: June 2011

* Trade mark

Maxolon* Injection 5 mg / ml(Metoclopramide Hydrochloride BP)