MAALOX PLUS

Active substance: SIMETICONE

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Maalox
Plus
#180 ml

4819331A

OPEN

Contents: 180ml suspension

Each 5ml contains: Dried aluminium hydroxide
gel 220mg, magnesium hydroxide 195mg and
simeticone 25mg.
For oral use.
Effective relief of
Trapped wind
Heartburn
Indigestion
Read the enclosed leaflet carefully before use.
SHAKE WELL BEFORE USE
Dosage: For details of dosage regimen refer to the
enclosed leaflet.
If symptoms persist, consult your doctor or pharmacist.
Also contains: Methylparaben (E218),
Propylparaben (E216) and Sorbitol (E420).
Consult your doctor: If you are pregnant,
breast-feeding or are taking any other medicines
before taking Maalox Plus.
Storage: Keep out of the sight and reach of children.
Do not freeze
MA Holder: Sanofi, One Onslow Street, Guildford,
Surrey, GU1 4YS, UK
PL 04425/0382

PACKAGE LEAFLET:
INFORMATION FOR
THE USER

Maalox Plus
Suspension
dried aluminium
hydroxide gel
220 mg/5 ml
magnesium hydroxide
195 mg/5 ml
simeticone 25 mg/5 ml

BN:
EXP:

Is this leaflet hard
to see or read?
Phone 0845 372 7101
for help
Read all of this leaflet
carefully because it
contains important
information for you
This medicine is available
without a prescription.
However, you still need to
use Maalox Plus carefully to
get the best results from it.
• Keep this leaflet. You may
need to read it again

• Ask your pharmacist if you
need more information
or advice
• You must contact a doctor
if your symptoms worsen
or do not improve
• If any of the side effects
gets serious, or if you
notice any side effects
not listed in this leaflet,
please tell your doctor or
pharmacist
In this leaflet:
1. What Maalox Plus is and
what it is used for
2. Before you take Maalox
Plus

3. How to take Maalox Plus
4. Possible side effects
5. How to store Maalox Plus
6. Further Information
1.  hat Maalox
W
Plus is and what
it is used for

i

Maalox Plus contains three
different medicines:
• The first two medicines are
called dried aluminium
hydroxide gel and
magnesium hydroxide.
They belong to a group of
medicines called antacids

• The other medicine is
called simeticone. It
belongs to a group of
medicines called antifoaming agents
Maalox Plus is used for:
• The relief of indigestion
(dyspepsia)
• Heartburn
• Wind (flatulence)
Maalox Plus works by
lowering the amount of acid
in your stomach. The antifoaming agent in Maalox
Plus helps to remove gas
from your stomach.

2.  efore you take
B
Maalox Plus
Do not take
Maalox Plus if:
You are allergic
(hypersensitive) to dried
aluminium hydroxide
gel, magnesium
hydroxide, simeticone
or any of the other
ingredients in Maalox
Plus (see Section 6:
Further Information)
Signs of an allergic
reaction include: a rash,
swallowing or breathing

problems, swelling of
your lips, face, throat or
tongue
You are feeling very weak
and have no energy
(debilitated)
You have kidney disease
You have low levels
of phosphate (called
‘hypophosphataemia’).
This is shown up in blood
tests.
Do not take this medicine
if any of the above apply
to you. If you are not sure,
talk to your doctor or
pharmacist before taking
Maalox Plus.

Take special care with
Maalox Plus. Check with
your doctor or pharmacist
before taking this
medicine if:
- You are on a lowphosphorous diet
Taking other
medicines
Please tell your doctor or
pharmacist if you are taking
or have recently taken
any other medicines. This
includes medicines you
buy without a prescription,
including herbal medicines.
Maalox Plus should not be

taken at the same time
as other medicines. This
is because Maalox Plus
can affect the way other
medicines work. If Maalox
Plus is taken within one
hour of any other medicine,
it can affect the uptake
of that medicine into the
blood.
Pregnancy and
breast-feeding
Talk to your doctor or
pharmacist before taking
this medicine if:
• You are pregnant, might
become pregnant,

or think you may be
pregnant.
• You are breast-feeding or
planning to breast-feed
Important information
about some of the
ingredients of Maalox Plus
• Maalox Plus contains
methylparaben (E218)
and propylparaben
(E216). These may cause
an allergic reaction. This
allergy may happen some
time after taking this
medicine. Signs of an
allergic reaction include:

breathing problems with
wheezing and tightness
in your chest (called
‘bronchospasm’)
• Maalox Plus contains
sorbitol (E420). If you
have been told by your
doctor that you cannot
tolerate or digest some
sugars, talk to your
doctor before taking this
medicine
3. How to take

Maalox Plus
Taking this medicine
• Shake well before use

• Take this medicine by
mouth
Adults including the
elderly
• Take one to two 5ml
spoonfuls 4 times each
day
• Take 20 minutes to
1 hour after meals and
at bedtime
• Alternatively, take as
directed by your doctor
Children aged 12 to 18
years
• Give your child one to two
5ml spoonfuls
4 times each day

Each 5ml contains:
Dried aluminium hydroxide gel
220mg, magnesium hydroxide
195mg and simeticone 25mg.
For oral use.
Effective relief of Trapped wind
Heartburn
Indigestion
Read the enclosed leaflet
carefully before use.
SHAKE WELL BEFORE USE
Dosage: For details of dosage
regimen refer to the enclosed leaflet.
If symptoms persist, consult your
doctor or pharmacist.
Also contains: Methylparaben
(E218), Propylparaben (E216) and
Sorbitol (E420).
Consult your doctor: If you are
pregnant, breast-feeding or are
taking any other medicines before
taking Maalox Plus.
Storage: Keep out of the sight and
reach of children. Do not freeze.
MA Holder: Sanofi,
One Onslow Street, Guildford,
Surrey, GU1 4YS, UK
PL 04425/0382

BACK LABEL 46 x 63 mm
BRAILLE TEXT

medicine that is left with
you so the doctor knows
what you have taken.
The following effects
may happen: diarrhoea,
stomach pain or you may
get a bloated feeling and
cramping pain in the
abdomen (stomach), be sick
(vomit), have indigestion,
heartburn, upset stomach,
constipation, loss of
appetite, dry mouth. This
could be caused by an
obstruction or blockage of
the bowel (ileus).

4. Possible side effects
Like all medicines, Maalox
Plus can cause side effects,
although not everybody
gets them.
Stop taking Maalox Plus
and see a doctor or go
to a hospital straight
away if:
Not known (frequency
cannot be estimated from
the available data)
- You have a red and lumpy
skin rash, swollen eyelids,

face, lips, mouth or tongue,
itching, difficulty breathing
or swallowing. This could
be an allergic reaction.
Tell your doctor or
pharmacist if any of the
following side effects get
serious or lasts longer
than a few days. Also tell
them if you notice any
side effects not listed in
this leaflet:
Uncommon (may affect up
to 1 in 100 people)
• Constipation
• Diarrhoea

Not know (frequency
cannot be estimated from
the available data)
• Hypophosphatemia, this
may occur at high doses
of the product or even at
normal doses especially
in patients with low
phosphorus diets
• Hypermagnesemia is an
electrolyte disturbance
in which there is an
abnormally elevated level
of magnesium in the body
• Hyperaluminemia is an
electrolyte disturbance
in which there is an

abnormally elevated level
of aluminium in the body
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

Maalox Plus
Keep this medicine in a
safe place where children
cannot see or reach it.
Do not use Maalox Plus
after the expiry date which
is stated on this leaflet after
EXP. The expiry date refers to
the last day of that month.
Do not freeze.
Medicines should not be
disposed of via wastewater
or household waste. Ask
your pharmacist how to
dispose of medicines no
longer required. These

measures will help to
protect the environment.
6. Further Information
What Maalox Plus
contains
• Each bottle contains
the following active
substances in each 5ml
of suspension: 220mg
of dried aluminium
hydroxide gel, 195mg of
magnesium hydroxide
and 25mg of simeticone
• The other ingredients
are: methylparaben

(E218), propylparaben
(E216), microcrystalline
cellulose, sodium
carboxymethylcellulose,
methylcellulose,
hydroxypropylcellulose,
hydrogen peroxide, citric
acid, sodium saccharin,
sorbitol (E420), natural
lemon concentrate, swiss
cream flavour and water
What Maalox Plus looks
like and contents of the
pack
Maalox Plus is a white
suspension with the odour

and taste of lemon and is
available in a plastic bottle.
Each bottle contains 100,
180, 200, 250, 300, 355 or
500mls with security caps or
alternative polypropylene
closure or in 10 ml sachets.
Not all pack sizes may be
available.
Marketing Authorisation
Holder
Sanofi,
One Onslow Street,
Guildford, Surrey,
GU1 4YS UK
Tel: 0845 372 7101

email:
uk-medicalinformation@
sanofi.com
Manufacturer
Sanofi-aventis S.p.A.
Viale Europa, 11
Origgio (VA), Italy
This leaflet does not contain
all the information about
your medicine. If you have
any questions or are not
sure about anything, ask
your doctor or pharmacist.
This leaflet was last
revised in January 2014
© Sanofi, 1989 - 2014

TEXT

cod. 283661
FIX-A-FORM Format :
LABEL Format :

4819331A

Code :
Update :
V06 - 15-01-2014
000/000000-00000
Local code :
Current item code : 4819330A
Product/Item type : Etichetta FIX-A-FORM
Maalox Plus Sosp. 180 ml
Country :

UK

Artwork by :
Plant :
Supplier code :

Origgio
Origgio
XXXX

Impianti di proprietà

sanofi-aventis S.p.A.

8 + 35 + 34 x 63 mm
46 x 63 mm

Colours :
Technical Data

Children aged 5 to 12
years
• Give your child a
maximum of one 5 ml
spoonful 3 to 4 times
each day
• Give this medicine 20
minutes to 1 hour after
meals and at bedtime
• Alternatively give as
directed by your doctor

Children 2 to 5 years old
• Do not give your child
more than one 5 ml
spoonful three times
each day
• Give this medicine 20
minutes to 1 hour after
meals or at bedtime
• Alternatively give as
directed by your doctor
If the symptoms do not go
away, talk to your doctor.
If you take more Maalox
Plus than you should
Talk to your doctor or go
to a hospital straight away.
Remember to take any

For sanofi-aventis use only

• Give this medicine 20
minutes to 1 hour after
meals and at bedtime
• Alternatively give as
directed by your doctor

Maalox
Plus
#180 ml
5

- Nero -
Giallo
- Cyan
-
Blu Reflex
- Magenta -
Braille
Fonts : Cosmos - Ocean Sans Pro SAN - Verdana
Minimum point size of text : 9 pt
Assembly Card :
Layout of Cutting :
Technical Card :
Technical Constraint :

360/03
000
0000000
0000000

APPROVAL

DATE:

REJECTED

SIGNATURE:

Vietata la manomissione - Rendere dopo la stampa

Maalox plus
Contents: 500 ml Suspension

dried aluminium hydroxide gel
220 mg/5 ml
magnesium hydroxide 195 mg/5 ml
simeticone 25 mg/5 ml
Fast relief of indigestion, heartburn and
trapped wind
For oral use
For details of dosage regimen refer to
enclosed leaflet
SHAKE WELL BEFORE USE
Also contains: methylparaben (E218),
propylparaben (E216) and sorbitol (E420).
See enclosed leaflet for further
information.
Keep out of the sight and reach of
children.
Do not freeze
Always read the leaflet before taking
this medicine.
MA Holder: Sanofi, One Onslow Street,
Guildford, Surrey, GU1 4YS, UK
PL 04425/0382

cod. 230461
FIX-A-FORM Format
LABEL Format

Technical Data

For sanofi-aventis use only

4819301A

Code :
Update :
V03 - 15-01-2014
000/000000-00000
Local code :
Current item code : 4819300A

Maalox Plus sospensione 500 ml

UK

Artwork by :
Plant :
Supplier code :

Origgio
XXXX
Origgio
N.A.

OPEN

BRAILLE TEXT

maalox
plus
suspension

PRINT

DATE:
SIGNATURE:

Vietata la manomissione - Rendere dopo la stampa

Maalox plus
Contents: 500 ml Suspension

dried aluminium hydroxide gel 220 mg/5 ml
magnesium hydroxide 195 mg/5 ml
simeticone 25 mg/5 ml
Fast relief of indigestion, heartburn and trapped
wind
For oral use
For details of dosage regimen refer to enclosed
leaflet.
SHAKE WELL BEFORE USE
Also contains: methylparaben (E218),
propylparaben (E216) and sorbitol (E420).
See enclosed leaflet for further information.
Keep out of the sight and reach of children.
Do not freeze
Always read the leaflet before taking this
medicine.
MA Holder: Sanofi, One Onslow Street,
Guildford, Surrey, GU1 4YS, UK
PL 04425/0382
BN:
EXP:

5 012877 343635

Children aged 5 to 12 years
• Give your child a maximum of one
5 ml spoonful 3 to 4 times each
day
• Give this medicine 20 minutes to
1 hour after meals and at bedtime
• Alternatively give as directed
by your doctor
Children 2 to 5 years old
• Do not give your child more than
one 5 ml spoonful three times each
day
• Give this medicine 20 minutes to
1 hour after meals or at bedtime
• Alternatively give as directed by
your doctor
If the symptoms do not go away, talk
to your doctor.
If you take more Maalox Plus than
you should
Talk to your doctor or go to a
hospital straight away. Remember

Minimum point size of text : 9 pt
Assembly Card :
Layout of Cutting :
0000000
Technical Card :
0000000
Technical Constraint :

REJECTED

sanofi-aventis S.p.A.

- Braille

Fonts : Ocean Sans AV Light / Light Italic / Bold

APPROVAL

maalox
plus
suspension

4819301A

Impianti di proprietà

62 x 82,5 mm

Colours :
5
- Nero - Yellow
- Cyan - Blu Reflex
- Magenta -

Product/Item type : Istruzione FIX-A-FORM
Country :

8 + 51 + 50 x 82,5 mm

PACKAGE LEAFLET:
INFORMATION FOR THE USER

However, you still need to use
Maalox plus carefully to get the best
results from it.
Maalox Plus
• Keep this leaflet. You may need to
Suspension
read it again
dried aluminium hydroxide • Ask your pharmacist if you need
gel 220 mg/5 ml
more information or advice
magnesium hydroxide
• You must contact a doctor if your
195 mg/5 ml
symptoms worsen or do not
simeticone 25 mg/5 ml
improve
• If any of the side effects get serious,
or if you notice any side effects not
listed in this leaflet, please tell your
Is this leaflet hard doctor or pharmacist

to see or read?
Phone 0845 372 7101
for help

In this leaflet:
1. What Maalox plus is and what it is
used for
2. Before you take Maalox plus
Read all of this leaflet
3. How to take Maalox plus
carefully because it contains
important information for you 4. Possible side effects
5. How to store Maalox plus
This medicine is available
6. Further information
without prescription.

to take any medicine that is left with
you so the doctor knows what you
have taken.
The following effects may happen:
diarrhoea, stomach pain or you may
get a bloated feeling and cramping
pain in the abdomen (stomach), be sick
(vomit), have indigestion, heartburn,
upset stomach, constipation, loss of
appetite, dry mouth. This could be
caused by an obstruction or blockage
of the bowel (ileus).
4. Possible side effects
Like all medicines, Maalox Plus can
cause side effects, although not
everybody gets them.
Stop taking Maalox Plus and see a
doctor or go to a hospital straight
away if:
Not known (frequency cannot be
estimated from the available data)

- You have a red and lumpy skin
rash, swollen eyelids, face, lips,
mouth or tongue, itching, difficulty
breathing or swallowing. This could
be an allergic reaction.
Tell your doctor or pharmacist if
any of the following side effects
get serious or lasts longer than
a few days. Also tell them if you
notice any side effects not listed in
this leaflet:
Uncommon (may affect up to 1 in
100 people)
• Constipation
• Diarrhoea
Not know (frequency cannot be
estimated from the available data)
• Hypophosphatemia, this may occur
at high doses of the product or
even at normal doses especially in
patients with low phosphorus diets

i

1. What Maalox Plus is and
what it is used for
Maalox Plus contains three different
medicines:
• The first two medicines are called
dried aluminium hydroxide gel and
magnesium hydroxide. They belong
to a group of medicines called
antacids
• The other medicine is called
simeticone. It belongs to a group
of medicines called anti-foaming
agents
Maalox Plus is used for:
• The relief of indigestion (dyspepsia)
• Heartburn
• Wind (flatulence)
Maalox Plus works by lowering the
amount of acid in your stomach.
The anti-foaming agent in Maalox
Plus helps to remove gas from your
stomach.

• Hypermagnesemia is an electrolyte
disturbance in which there is
an abnormally elevated level of
magnesium in the body
• Hyperaluminemia is an electrolyte
disturbance in which there is
an abnormally elevated level of
aluminium in the body
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 Maalox Plus
Keep this medicine in a safe place
where children cannot see or reach it.

2. Before you take Maalox Plus

Do not take Maalox Plus if:
You are allergic (hypersensitive) to
dried aluminium hydroxide gel,
magnesium hydroxide, simeticone
or any of the other ingredients in
Maalox Plus (see Section 6: Further
Information)
Signs of an allergic reaction
include: a rash, swallowing or
breathing problems, swelling of
your lips, face, throat or tongue
You are feeling very weak and
have no energy (debilitated)
You have kidney disease
You have low levels of phosphate
(called ‘hypophosphataemia’). This
is shown up in blood tests
Do not take this medicine if any
of the above apply to you. If you
are not sure, talk to your doctor or

Do not use Maalox Plus after the
expiry date which is stated on this
leaflet after EXP. The expiry date
refers to the last day of that month.
Do not freeze.
Medicines should not be disposed of
via wastewater or household waste.
Ask your pharmacist how to dispose
of medicines no longer required.
These measures will help to protect
the environment.
6. Further Information
What Maalox Plus contains
• Each bottle contains the following
active substances in each 5 ml
of suspension: 220 mg of dried
aluminium hydroxide gel, 195 mg
of magnesium hydroxide and
25 mg of simeticone
• The other ingredients are:
methylparaben (E218), propylparaben

pharmacist before taking Maalox
Plus.
Take special care with Maalox
Plus. Check with your doctor or
pharmacist before taking this
medicine if:
- You are on a low-phosphorous diet

Taking other medicines
Please tell your doctor or pharmacist
if you are taking or have recently
taken any other medicines. This
includes medicines you buy without
a prescription, including herbal
medicines.
Maalox Plus should not be taken at
the same time as other medicines.
This is because Maalox Plus can
affect the way other medicines work.
If Maalox Plus is taken within one
hour of any other medicine, it can
affect the uptake of that medicine
into the blood.

(E216), microcrystalline cellulose,
sodium carboxymethylcellulose,
methylcellulose,
hydroxypropylcellulose,
hydrogen peroxide, citric acid,
sodium saccharin, sorbitol (E420),
natural lemon concentrate,
swiss creme flavour and water.
What Maalox Plus looks like and
contents of the pack
Maalox Plus is a white suspension
with the odour and taste of lemon
and is available in a plastic bottle.
Each bottle contains 100, 180, 200,
250, 300, 355 or 500mls with security
caps or alternative polypropylene
closure or in 10 ml sachets.
Not all pack sizes may be marketed.

Pregnancy and breast-feeding
Talk to your doctor or pharmacist
before taking this medicine if:
• You are pregnant, might become
pregnant, or think you may be
pregnant
• You are breast-feeding or planning
to breast-feed
Important information about
some of the ingredients of Maalox
Plus
• Maalox Plus contains
methylparaben (E218) and
propylparaben (E216) These may
cause an allergic reaction. This
allergy may happen some time
after taking this medicine. Signs
of an allergic reaction include:
breathing problems with wheezing
and tightness in your chest (called
‘bronchospasm’)
• Maalox plus contains sorbitol
(E420). If you have been told

Marketing Authorisation Holder
Sanofi, One Onslow Street
Guildford, Surrey, GU1 4YS, UK
Tel: 0845 372 7101
email:
uk-medicalinformation@sanofi.com
Manufacturer
sanofi-aventis S.p.A.
Viale Europa, 11
Origgio (VA), Italy
This leaflet does not contain all the
information about your medicine.
If you have any questions or are
not sure about anything, ask your
doctor or pharmacist.
This leaflet was last revised in
January 2014
© Sanofi, 1990 - 2014

by your doctor that you cannot
tolerate or digest some sugars, talk
to your doctor before taking this
medicine
3. How to take Maalox Plus
Taking this medicine
• Shake well before use
• Take this medicine by mouth
Adults including the elderly
• Take one to two 5ml spoonfuls
4 times each day
• Take 20 minutes to 1 hour after
meals and at bedtime
• Alternatively, take as directed by
your doctor
Children aged 12 to 18 years
• Give your child one to two 5 ml
spoonfuls 4 times each day
• Give this medicine 20 minutes to
1 hour after meals and at bedtime
• Alternatively give as directed
by your doctor

Expand view ⇕

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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