MAXOLON INJECTION 5MG/ML

Active substance: METOCLOPRAMIDE HYDROCHLORIDE

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PATIENT INFORMATION LEAFLET - UK
GB 726-8758-APIL
8093545-04

Maxolon* Injection 5 mg / ml
(Metoclopramide Hydrochloride BP)
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.
In this leaflet
1. What Maxolon Injection is and what it is used for
2. Before you are given Maxolon Injection
3. How you will be given Maxolon Injection
4. Possible side effects
5. How to store Maxolon Injection
6. Further Information
1. WHAT MAXOLON INJECTION IS AND WHAT IT
IS USED FOR
The name of your medicine is Maxolon Injection.
Maxolon Injection contains the active ingredient
Metoclopramide Hydrochloride BP which belongs to
a group of medicines called antiemetics.
Maxolon Injection is used to treat problems in adults
such as:
• Feeling sick (nausea) and being sick (vomiting)
caused by, amongst other things, diseases of the
digestive system, heart problems and by
treatments such as radiotherapy and
antitumour drugs.
• Pain and discomfort of problems such as
indigestion, heartburn, wind, sickness and
bringing up bile. These problems can be caused
by acid rising from the stomach, hiatus hernia,
inflammation or ulcer of the upper part of your
digestive system, gallstones or after an operation
to remove gallstones.
• Migraines to stop nausea and vomiting and to
help painkillers work more effectively.
Maxolon Injection is used to treat severe vomiting or
is given before surgery in children and adolescents
(aged 1-20 years).
2. BEFORE YOU TAKE MAXOLON INJECTION
Do not take Maxolon Injection if you:
• are allergic to metoclopramide hydrochloride or
any of the other ingredients of Maxolon Injection;
• have a tumour in your adrenal gland
(phaeochromocytoma);



Maxolon passes into the breast milk, therefore
breast-feeding is not recommended while taking
Maxolon.
Driving and using machines
You can drive while being treated with Maxolon,
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.

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;
Maxolon Injection should not be given to children
under the age of 1 year.

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

Take special care with Maxolon Injection 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.

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 at
least 6 hours, even if vomiting continues, to avoid
an overdose.






If any of these apply to you, please see your
doctor before being treated with Maxolon.
Maxolon 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
(SSRIs) such as fluoxetine or citalopram;
Monoamine Oxidase Inhibitors (MAOIs)
such as procarbazine;
• any other medicine taken by mouth, as the
dose may be affected by Maxolon;
• atovaquone, used to treat pneumonia.
Taking Maxolon with food and drink
Alcohol should be avoided when you are taking
Maxolon.
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 Maxolon. Maxolon is
not recommended for use in the early stages of
pregnancy.

The usual doses taken to treat a condition are:
Adults 21 years and over:
10 mg given three times a day.

For diagnostic purposes a single dose of Maxolon
may be given 5-10 minutes before investigations of
the upper digestive system:
Adults 21 years and over: 10-20 mg.



slow repeated movements, such as head
nodding (only in the elderly who are on long
term treatment),
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;
• increase or decrease in blood pressure;
• tremors;
• dizziness.
Rare:
• drowsiness;
• confusion;
• anxiety;
• diarrhoea;
• heart problems such as a very low heart rate;
• agitation.
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 Injection
and get in touch with your doctor.
If any of the side effects becomes severe, or if you
notice a side effect not listed in the leaflet, please tell
your doctor or pharmacist immediately.

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 at
least 6 hours, even if vomiting continues, to avoid
an overdose.

5. HOW TO STORE MAXOLON INJECTION

If you are given more Maxolon Injection than you
should
It is unlikely that you will be given more Maxolon than
you should, however a doctor would treat any symptoms
that follow.

6. FURTHER INFORMATION
What Maxolon Injection contains
Maxolon Injection contains 10 mg of the active
ingredient metoclopramide hydrochloride BP.
Other inactive ingredients are: sodium chloride,
sodium metabisulphite and water for injection.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Maxolon 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;

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN
Do not use Maxolon Injection after the expiry date
which is printed on the pack.
Protect from light. o
Do not store above 25 C

What Maxolon Injection looks like and content of
the pack
Maxolon Injection is a clear, colourless solution
available in clear glass 2 ml ampoules, in packs of
1 or 12 ampoules or 1 ampoule and 12 tablets in
an aluminium canister as a home visit pack.
Marketing Authorisation Holder
Amdipharm 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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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