MAALOX SUSPENSION

Active substance: MAGNESIUM HYDROXIDE

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Technical Data

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Maalox 500 ml sosp. menta
UK

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- Cyan
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Origgio
Origgio
N.A.

maalox
suspension

6 pt
000
0000000
0000000

APPROVAL

DATE:

REJECTED

SIGNATURE:

sanofi-aventis S.p.A.

Vietata la manomissione - Rendere dopo la stampa

maalox
suspension

Maalox
A

N

T

A

C

*

I

D

A DIRECT ANSWER TO THE
PROBLEMS OF INDIGESTION,
HEARTBURN AND ACIDITY

598479

MINT FLAVOURED
500 ml SUSPENSION

MAX 310 m/m
4818400A

For sanofi-aventis use only

4818400A

Code :
Update :
V02 - 17-09-2012
42741-E
Local code :
Current item code : RP481840/01

226761

62 x 90 mm
173

MAX 75 m/m

4819320A

Maalox
Suspension
Contents: 500 ml Suspension

OPEN

dried aluminium hydroxide gel 220 mg/5 ml
magnesium hydroxide 195 mg/5 ml
A direct answer to the problems of indigestion,
heartburn and acidity
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. Store away from direct sunlight.
Use within 28 days of opening.
Always read the leaflet before taking this
medicine.
MA Holder: Sanofi, One Onslow Street,
Guildford, Surrey, GU1 4YS, UK
PL 04425/0378
BN:
EXP:

PACKAGE LEAFLET:
INFORMATION FOR THE USER

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

Is this leaflet hard
to see or read?
Phone 01483 505515
for help
Read all of this leaflet carefully
because it contains important
information for you
This medicine is available without
prescription. However, you still

need to use Maalox Suspension
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 get 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 Suspension is and
what it is used for
2. Before you take Maalox Suspension
3. How to take Maalox Suspension
4. Possible side effects
5. How to store Maalox Suspension
6. Further information

1. What Maalox Suspension is
and what it is used for

i

Maalox Suspension contains two
different medicines. They are called
dried aluminium hydroxide gel and
magnesium hydroxide. They belong
to a group of medicines called
antacids.
Maalox Suspension is used for:
• Heartburn or when your stomach
has too much acid (indigestion)
• Inflammation of the stomach
(gastritis), and
• When prescribed by a doctor may
also be used for lowering the
amount of acid in your stomach
or gut (intestine) when you have
an ulcer
Maalox Suspension works by lowering
the amount of acid in your stomach.

2. Before you take Maalox
Suspension
Do not take
Maalox Suspension if:
You are allergic (hypersensitive)
to dried aluminium hydroxide gel
or magnesium hydroxide or any
of the other ingredients in Maalox
Suspension (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 problems
You have severe stomach pain
Your bowel is partially or fully
blocked

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
Suspension.

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 Suspension should not be
taken at the same time as other
medicines. This is because Maalox
Suspension can affect the way other
medicines work.

In particular, Maalox Suspension
can affect the following
medicines:
• Some medicines used to treat
infections such as tetracycline,
ciprofloxacin, rifampicin and
ketoconazole
• Medicines for malaria such as
chloroquine and hydroxychloroquine
• Chlorpromazine - used for mental
illness (psychosis)
• Vitamins
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 should not take
Maalox Suspension during
the first three months
of pregnancy

Maalox
Suspension
Contents: 500 ml Suspension

dried aluminium hydroxide gel 220 mg/5 ml
magnesium hydroxide 195 mg/5 ml
A direct answer to the problems of indigestion,
heartburn and acidity
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. Store away from direct sunlight.
Use within 28 days of opening.
Always read the leaflet before taking this
medicine.
MA Holder: Sanofi, One Onslow Street,
Guildford, Surrey, GU1 4YS, UK
PL 04425/0378

5 012877 344137

LABEL 62 x 82,5 mm

Taking this medicine
• Shake well before use
• Take this medicine by mouth
• If necessary, Maalox Suspension
may be taken with water or milk
Adults, the elderly and children
aged 14 years or older
• Take two to four 5 ml spoonfuls
• Take 20 minutes to 1 hour after
meals and at bedtime
• Alternatively, take as directed by
your doctor
If the symptoms do not go away,
talk to your doctor.
Children less than 14 years old
• Maalox Suspension is not
recommended for children less
than 14 years of age.

If you take more Maalox
Suspension than you should
Talk to your doctor or go to a hospital
straight away. Remember to take any
medicine that is left with you so the
doctor knows what you have taken.
4. Possible side effects
Like all medicines, Maalox
Suspension can cause side effects,
although not everybody gets them.
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:
• Constipation
• Diarrhoea
These side effects can happen, but
are not common.

5. How to store Maalox Suspension
Keep this medicine in a safe place
where children cannot see or reach
it.
Do not use Maalox Suspension after
the expiry date which is stated on
this leaflet and the bottle after EXP.
The expiry date refers to the last day
of that month.
Discard any medicine remaining 28
days after opening the bottle.
Do not freeze. Store away from
direct sunlight.
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 Suspension contains
• Each 5 ml of suspension contains
220 mg of dried aluminium
hydroxide gel and 195 mg of
magnesium hydroxide, as the
active ingredients.
• The other ingredients are:
methylparaben (E218),
propylparaben (E216), citric acid
(anhydrous), sodium saccharin,
sorbitol (E420), mannitol powder,
hydrogen peroxide, hydrochloric
acid, peppermint oil and purified
water

What Maalox Suspension looks
like and contents of the pack
Maalox® Suspension is a white,
mint flavoured suspension and is
available in 100 ml, 180 ml, 200 ml,
250 ml, 300 ml and 500 ml plastic
bottles or 180 ml and 300 ml glass
bottles or 10 ml sachets. Not all
pack sizes may be marketed.
Marketing Authorisation Holder
and Manufacturer
Marketing Authorisation Holder
Sanofi, One Onslow Street,
Guildford, Surrey, GU1 4YS, UK
Tel: 01483 505515
Fax: 01483 535432
email:
uk-medicalinformation@sanofi.com
Manufacturer
sanofi-aventis S.p.A.
Viale Europa, 11 - Origgio (VA), Italy

PRINT

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.

Cod.

This leaflet was last revised in
09/2012
© Sanofi, 1990 - 2012

FIX-A-FORM Format

4819320A

Code :
Update :
V02 - 01-10-2012
000/000000-00000
Local code :
Current item code : RP481932C
Product/Item type : Istruzione FIX-A-FORM
Maalox Sospensione 500 ml

Country :

UK

Artwork by :
Plant :
Supplier code :

Origgio
XXXX
Origgio
N.A.

Impianti di proprietà

sanofi-aventis S.p.A.

152461

8 + 51 + 50 x 82,5 mm

LABEL Format

Technical Data

3. How to take Maalox Suspension

For sanofi-aventis use only

• You are breast-feeding or planning
to breast-feed
Important information about
some of the ingredients of Maalox
Suspension
• Maalox Suspension 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 Suspension 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

62 x 82,5 mm

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- Cyan
- Magenta

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Gill Sans Regular / Bold

Minimum point size of text : 9 pt
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0000000
Technical Card :
0000000
Technical Constraint :
APPROVAL

DATE:

REJECTED

SIGNATURE:

Vietata la manomissione - Rendere dopo la stampa

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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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