MAALOX SUSPENSION

Active substance: MAGNESIUM HYDROXIDE

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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

cod. 152461
FIX-A-FORM Format
LABEL Format

Technical Data

For sanofi-aventis use only

4819321A

Code :
Update :
V03 - 15-01-2014
000/000000-00000
Local code :
Current item code : 4819320A
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

Fonts : Ocean Sans Pro SAN Light / Bold
Gill Sans Regular / Bold

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

sanofi-aventis S.p.A.

BN:
EXP:

5 012877 344137

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

SIGNATURE:

Vietata la manomissione - Rendere dopo la stampa

Contents: 500 ml Suspension

3. How to take Maalox Suspension

PRINT

DATE:

REJECTED

Maalox
Suspension

4819321A

62 x 82,5 mm

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

APPROVAL

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

OPEN

8 + 51 + 50 x 82,5 mm

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 0845 372 7101
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

straight away. Remember 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 cause by an
obstruction or blockage of the bowel
(ileus).
4. Possible side effects
Like all medicines, Maalox
Suspension can cause side effects,
although not everybody gets them.
Stop taking Maalox Suspension
and see a doctor or go to a
hospital straight away if:
Not known (frequency cannot be
estimated from the available data)

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

- 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

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.

• 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 Suspension
Keep this medicine in a safe place

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

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.

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.
Take special care with Maalox
Suspension. 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 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

Marketing Authorisation Holder
and Manufacturer
Marketing Authorisation Holder
Sanofi, One Onslow Street, Guildford,
Surrey, GU1 4YS, UK
Tel: 0845 372 7101
email:
uk-medicalinformation@sanofi.com
What Maalox Suspension looks like
Manufacturer
and contents of the pack
sanofi-aventis S.p.A.
Maalox® Suspension is a white, mint
Viale Europa, 11 - Origgio (VA), Italy
flavoured suspension and is available
This leaflet does not contain all the
in 100 ml, 180 ml, 200 ml, 250 ml,
information about your medicine.
300 ml and 500 ml plastic bottles or
If you have any questions or are not
180 ml and 300 ml glass bottles or
10 ml sachets. Not all pack sizes may sure about anything, ask your doctor
or pharmacist.
be marketed.
• 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.

This leaflet was last revised in
January 2014
© Sanofi, 1990 - 2014

• 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

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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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