MAXOLON INJECTION 5MG/ML

Active substance: METOCLOPRAMIDE HYDROCHLORIDE

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PATIENT INFORMATION LEAFLET - 102886/LF/2
8081020-01

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. What you need to know 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 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).
Adult population
Maxolon Injection is used in adults:
- 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
Maxolon Injection is used in children (aged 1-18
years) only if other treatment does not work or
cannot be used:
- to prevent delayed nausea and vomiting that
may occur after chemotherapy
- to treat nausea and vomiting that has occurred
after surgery.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE
GIVEN MAXOLON INJECTION
Do not take Maxolon Injection if:
- you are allergic to metoclopramide or any of the
other ingredients of this medicine (listed in
section 6)
- you have bleeding, obstruction or a tear in your
stomach or gut
- you have or may have a rare tumour of the
adrenal gland, which sits near the kidney
(pheochromocytoma)
- you have ever had involuntary muscle spasms
(tardive dyskinesia), when you have been
treated with a medicine
- you have epilepsy
- you have Parkinson’s disease
- you are taking levodopa (a medicine for
Parkinson’s disease) or dopaminergic agonists
(see below “Other medicines and Maxolon
Injection”)
- you have ever had an abnormal blood pigment
levels (methaemoglobinemia) or NADH
cytochrome-b5 deficiency.
Do not give Maxolon Injection to a child less than 1
year of age (see below “Children and adolescents”).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before
taking Maxolon Injection if:
- you have a history of abnormal heart beats (QT
interval prolongation) or any other heart
problems
- you have problems with the levels of salts in
your blood, such as potassium, sodium and
magnesium
- you are using other medicines known to affect
the way your heart beats
- you have any neurological (brain) problems
- you have liver or kidney problems. The dose
may be reduced (see section 3).

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 “Do not take
Maxolon Injection if”).
Other medicines and Maxolon Injection
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 Maxolon Injection works or Maxolon
Injection 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
Maxolon Injection if”)
- 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)
- cyclosporine (medicine used to treat certain
problems with the immune system)
- mivacurium and suxamethonium (medicines
used to relax muscles)
- fluoxetine and paroxetine (medicine used to
treat depression).
Maxolon Injection with alcohol
Alcohol should not be consumed during treatment
with metoclopramide because it increases the
sedative effect of Maxolon Injection.
Pregnancy, breast-feeding and fertility
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, Maxolon Injection may be
taken during pregnancy. Your doctor will decide
whether or not you should be given this medicine.
Maxolon Injection 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 Maxolon Injection. This may affect your
vision and also interfere with your ability to drive
and use machines.
3. HOW TO TAKE MAXOLON INJECTION
The medicine will normally be given to you by a
doctor or a nurse. It will be given as a slow
injection into a vein (over at least 3 minutes) or by
injection into a muscle.
In adults 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 10 mg, repeated up to
3 times daily.
The maximum recommended dose per day is
30 mg or 0.5 mg/kg body weight.
For the prevention of nausea and vomiting that may
occur after surgery prevention: a single dose of
10 mg is recommended.
Paediatric patients (aged 1-18 years)
The recommended dose is 0.1 to 0.15 mg/kg body
weight, repeated up to 3 times daily, given by slow
injection into a vein.
The maximum dose in 24 hours is 0.5 mg/kg body
weight.

PRODUCT NAME:
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Maxolon Injection 5mg/ml
102886/LF/2
Leaflet
155 x 390
folded 155 x 32.5 mm
P019-1
Great Britain
8081020-01
TBC
100%
Black & Cutters
13/06/2014
8.5 pt
2
AMCo
CAC
463

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APPROVAL CONFIRMATION
Confirmation that this artwork has been approved by
the appropriate market authority (if applicable, e.g.
MHRA, IMB, etc and that Amdipharm have license
approval to distribute this component for sale in the
relevent market.
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PAGE 1 OF 2

Dosing table
Age

Body
Weight

Dose

Frequency

1-3
years

10-14 kg

1 mg

Up to 3
times daily

3-5
years

15-19 kg

2 mg

Up to 3
times daily

5-9
years

20-29 kg

2.5 mg

Up to 3
times daily

9-18
years

30-60 kg

5 mg

Up to 3
times daily

15-18
years

Over 60 kg

10 mg

Up to 3
times daily

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 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
The treatment should not exceed 48 hours for
change the colour of your skin
treatment of nausea and vomiting that has occurred
• abnormal development of breasts
after surgery.
(gynaecomastia)
The treatment should not exceed 5 days for
• involuntary muscle spasms after prolonged use,
prevention of delayed nausea and vomiting that may
particularly in elderly patients
occur after chemotherapy.
• high fever, high blood pressure, convulsions,
Method of administration
sweating, production of saliva. These may be
You must wait at least 6 hours between each
signs of a condition called neuroleptic malignant
metoclopramide dose, even in case of vomiting and
syndrome
rejection of the dose, in order to avoid overdose.
• changes in heart beat, which may be shown on
an ECG test
Older people
• cardiac arrest (particularly with injection route)
The dose may need to be reduced depending on
kidney problems, liver problems and overall health. • shock (severe decrease of heart pressure)
(particularly with injection route)
Adults with kidney problems
• fainting (particularly with intravenous route)
Talk to your doctor if you have kidney problems. The • allergic reaction which may be severe
dose should be reduced if you have moderate or
(particularly with intravenous route)
severe kidney problems.
• very high blood pressure.
If you get any side effects talk to your doctor,
Adults with liver problems
pharmacist or nurse. This includes any side effects
Talk to your doctor if you have liver problems. The
not listed in this leaflet.
dose should be reduced if you have severe liver
problems.
5. HOW TO STORE MAXOLON INJECTION
Children and adolescents
KEEP OUT OF THE REACH AND SIGHT OF
Metoclopramide must not be used in children aged
CHILDREN
less than 1 year (see section 2).
Do not use Maxolon injection after the expiry date
If you take more Maxolon Injection than you should:
which is printed on the pack.
Contact your doctor or pharmacist straight away.
Protect from light.
You may experience uncontrollable movements
o
Do not store above 25 C
(extrapyramidal disorders), feel drowsy, have some
troubles of consciousness, be confused, have
6. FURTHER INFORMATION
hallucination and heart problems. Your doctor may
What Maxolon Injection contains
prescribe you a treatment for these signs if
Maxolon injection contains 10mg of the active
necessary.
ingredient metoclopramide hydrochloride BP
If you forget to take Maxolon Injection
Other inactive ingredients are: sodium chloride,
Do not take a double dose to make up for a
sodium metabisulphite and water for injection.
forgotten dose.
What Maxolon Injection looks like and content of
If you have any further questions on the use of this
the pack
medicine, ask your doctor, nurse or pharmacist.
Maxolon injection is a clear, colourless solution
4. POSSIBLE SlDE EFFECTS
available in clear glass 2ml ampoules in packs of 1
Like all medicines, this medicine can cause side
or 12 ampoules or 1 ampoule and 12 tablets in an
effects, although not everybody gets them.
aluminium canister as a home visit pack.
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.

Marketing Authorisation Holder
Amdipharm UK Limited,
Capital House,
85 King William Street,
London EC4N 7BL,
UK
Manufacturer responsible for release:
Kern Pharms SL
Poligono Ind. Colon II,
C/Venus 72, 08228 Terrassa,
Barcelona, Spain.
Date of last revision: June 2014
Maxolon is a registered trademark of Amdipharm
Mercury International Limited

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)
• symptoms similar to Parkinson disease (rigidity,
tremor)
• feel restless
• blood pressure decrease (particularly with
intravenous route)
• diarrhoea
• feeling weak.

8081020-01

PRODUCT NAME:
PIP CODE:
COMPONENT:
SIZE:
MARKET:
COMMODITY NO.:
PRODUCT SITE:
SCALE:
COLOURS:
DATE:
FONT SIZE:
VERSION NO:
AMENDED BY:
PROJECT:
PHARMA CODE:

Maxolon Injection 5mg/ml
102886/LF/2
Leaflet
155 x 390
folded 155 x 32.5 mm
P019-1
Great Britain
8081020-01
TBC
100%
Black & Cutters
13/06/2014
8.5 pt
2
AMCo
CAC
463

REGULATORY AUTHORITY
APPROVAL CONFIRMATION
Confirmation that this artwork has been approved by
the appropriate market authority (if applicable, e.g.
MHRA, IMB, etc and that Amdipharm have license
approval to distribute this component for sale in the
relevent market.
Accept Artwork ................................................................
Reject Artwork .................................................................
Signature ..........................................................................
Name ................................................................................
Date ...................................................................................

PAGE 2 OF 2

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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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