MAXOLON TABLETS 10MG

Active substance: METOCLOPRAMIDE HYDROCHLORIDE

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PATIENT INFORMATION LEAFLET - 102887/LF/2
8081019-01

Maxolon® Tablets 10mg
(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 Tablets is and what it is used for
2. What you need to know before you are given
Maxolon Tablets
3. How to take Maxolon Tablets
4. Possible side effects
5. How to store Maxolon Tablets
6. Further Information
1. WHAT MAXOLON TABLET IS AND WHAT IT IS
USED FOR
The name of your medicine is Maxolon Tablets 10 mg.
Maxolon Tablets contain the active ingredient
Metoclopramide Hydrochloride BP 10 mg which
belongs to a group of medicines called antiemetics.
It works on a part of your brain that prevents you
from feeling sick (nausea) or being sick (vomiting).
Adult population
Maxolon Tablets is used in adults:
- to prevent delayed nausea and vomiting that
may occur after chemotherapy
- to prevent nausea and vomiting caused by
radiotherapy
- to treat nausea and vomiting including nausea
and vomiting which may occur with a migraine.
Metoclopramide can be taken with oral painkillers in
case of migraine to help painkillers work more
effectively.
Paediatric population
Maxolon Tablets is indicated in children (aged 1-18
years) if other treatment does not work or cannot
be used to prevent delayed nausea and vomiting
that may occur after chemotherapy.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE
GIVEN MAXOLON TABLETS
Do not take Maxolon Tablets 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
Tablets”)
- you have ever had an abnormal blood pigment
levels (methaemoglobinemia) or NADH
cytochrome-b5 deficiency.
Do not give Maxolon Tablets 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 Tablets 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.
You must wait at least 6 hours between each
metoclopramide dose, even in case of vomiting and
rejection of the dose, in order to avoid overdose.
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 Tablets if”).
Other medicines and Maxolon Tablets
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 Tablets works or Maxolon
Tablets 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 Tablets 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 Tablets with alcohol
Alcohol should not be consumed during treatment
with metoclopramide because it increases the
sedative effect of Maxolon Tablets.
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 Tablets may be
taken during pregnancy. Your doctor will decide
whether or not you should be given this medicine.
Maxolon Tablets 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 Tablets. This may affect your
vision and also interfere with your ability to drive
and use machines.
Important information about some of the
ingredients of Maxolon tablets
Tell your doctor before taking this medicine if you
have been told that you have an intolerance to
some sugars. This is because Maxolon Tablets
contains Lactose, a type of sugar.
3. How to take Maxolon Tablets
Adult patients
The recommended single dose is 10 mg, repeated
up to three times daily.
The maximum recommended dose per day is 30
mg or 0.5 mg/kg body weight.
The maximum recommended treatment duration is
5 days.
To prevent delayed nausea and vomiting that may
occur after chemotherapy (children aged 1-18
years).
The recommended dose is 0.1 to 0.15 mg/kg body
weight, repeated up to 3 times daily, taken by
mouth (oral route).
The maximum dose in 24 hours is 0.5 mg/kg body
weight.

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Maxolon Tablets 10mg Tabs
102887/LF/2
Leaflet
155 x 390
folded 155 x 195
P019
Great Britain
8081019-01
TBC
100%
Black & Cutters
13/06/2014
8.5 pt
2
AMCo
CAC

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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

You should not take this medicine for more than 5
days to prevent delayed nausea and vomiting that
may occur after chemotherapy.
Maxolon Tablets is not suitable for use in children
weighing less than 61 kg.
Other pharmaceutical forms/strengths may be more
appropriate for administration.
Method of administration
You must wait at least 6 hours between each
metoclopramide dose, even in case of vomiting and
rejection of the dose, in order to avoid overdose.
Older people
The dose may need to be reduced depending on
kidney problems, liver problems and overall health.
Adults with liver problems
Talk to your doctor if you have liver problems. The
dose should be reduced if you have severe liver
problems.
Children and adolescents
Metoclopramide must not be used in children aged
less than 1 year (see section 2).
If you take more Maxolon Tablets than you should
Contact your doctor or pharmacist straight away.
You may experience uncontrollable movements
(extrapyramidal disorders), feel drowsy, have some
troubles of consciousness, be confused, have
hallucination and heart problems. Your doctor may
prescribe you a treatment for these signs if
necessary.
If you forget to take Maxolon Tablets
Do not take a double dose to make up for a
forgotten dose.
If you have any further questions on the use of this
medicine, ask your doctor, nurse or pharmacist.
4. POSSIBLE SlDE EFFECTS
Like all medicines, this medicine 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)
• symptoms similar to Parkinson 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 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
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.
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any side effects
not listed in this leaflet.

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

Maxolon Tablets 10mg Tabs
102887/LF/2
Leaflet
155 x 390
folded 155 x 195
P019
Great Britain
8081019-01
TBC
100%
Black & Cutters
13/06/2014
8.5 pt
2
AMCo
CAC

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 ...................................................................................

5. HOW TO STORE MAXOLON TABLETS
KEEP OUT OF THE REACH AND SIGHT OF
CHILDREN
Do not use Maxolon Tablets after the expiry date
which is printed on the pack.
Do not store above 30°C.
Medicines should not be disposed of via waste. Ask
your pharmacist how to dispose of medicines no
longer required. These measures will help to protect
the environment.
6. FURTHER INFORMATION
What Maxolon Tablets contains
Maxolon Tablets contains 10mg of the active
ingredient metoclopramide hydrochloride BP
Other inactive ingredients are: maize starch (dried),
colloidal silicon dioxide, magnesium stearate,
pregelatinised maize starch and lactose.
What Maxolon Tablets looks like and content of
the pack.
Maxolon Tablets are white and engraved with
‘Maxolon’
Maxolon Tablets is available in aluminium canisters
of 3,6,9,12,100 or 500 tablets; plastic recloseable
containers packed into a carton of 42,84,100 or 500
tablets; amber glass bottles of 100 or 500 tablets;
blister packs of 20,21,42 or 84 tablets.
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: June 2014
Maxolon Tablets is a registered trademark of
Amdipharm Mercury International Limited

8081019-01

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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