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MAALOX 175MG/200MG ORAL SUSPENSION

Active substance(s): ALUMINIUM HYDROXIDE / MAGNESIUM HYDROXIDE

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GDO - Graphic Department Origgio

Code:
Update:
Local code:
Current item code:

4831181A

V03 - 01-12-2017
4831180A

Product/Item type:

Istruzione - Fronte
Maalox - 250 ml

Country:

UK

Artwork by:
Plant:
Supplier code:

Origgio
Origgio

Impianti di proprietà

Sanofi S.p.A.

Format:
Plant barcode:
Colours:

Technical Data

For Sanofi use only

Sanofi
PAC K AG I N G T E A M

- P Reflex Blue C
- XXXX
- XXXX

Stesa 157 x 315 mm.

1301

1

- XXXX
- XXXX
- XXXX

Fonts: Ocean Sans Pro SAN Light / Light Italic / Bold
Minimum point size of text:
Assembly Card:
Layout of Cutting:
Technical Card:
Technical Constraint:

10 pt

APPROVAL DATE:
REJECTED

SIGNATURE:

Vietata la manomissione - Rendere dopo la stampa

PACKAGE LEAFLET: INFORMATION FOR THE USER

MAALOX® 175mg/200mg
Oral Suspension
Aluminium hydroxide 175mg/5 ml
Magnesium hydroxide 200mg/5 ml

• You have kidney problems. Long term exposure
to high doses of Maalox Suspension can lead to
dementia.
• 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.
Warnings and precautions

Is this leaflet hard to see or read?
Phone 0845 372 7101 for help
Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
This medicine is available without prescription.
Always take this medicine exactly as described in
this leaflet or as your doctor or pharmacist has
told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information
or advice
- If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet (see section 4).
- You must talk to a doctor if you do not feel better
or if you feel worse
What is in this leaflet:
1. What Maalox Suspension is and what it is used for
2. What you need to know before you take Maalox
Suspension
3. How to take Maalox Suspension
4. Possible side effects
5. How to store Maalox Suspension
6. Contents of the pack and other information
1. What Maalox Suspension is
and what it is used for

i

Maalox Suspension contains two different
medicines. They are called aluminium hydroxide
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 it 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. What you need to know before you take
Maalox Suspension
Do not take Maalox Suspension if:
• You are allergic to aluminium hydroxide or
magnesium hydroxide or any of the other
ingredients in Maalox Suspension (listed in
section 6).
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)

Take special care with Maalox Suspension.
Check with your doctor or pharmacist before
taking this medicine if:
You are on a low-phosphorous diet
Other medicines and Maalox Suspension
Tell your doctor or pharmacist if you are taking,
have recently taken or might take 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.
Some medicines may be affected by magnesium
hydroxide or they may affect how well magnesium hydroxide will work. Tell your doctor or pharmacist if you are already taking: - salicylates.
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
• Polystyrene sulphonate – used to treat high
levels of potassium in 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 should not
take Maalox Suspension during the first three
months of pregnancy
• You are breast-feeding or planning to breastfeed
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
Maalox Suspension contains less than 1 mmol
sodium (23 mg) per 5 ml dose, i.e. essentially
‘sodium free’.
3. How to take Maalox Suspension

Always take this medicine exactly as described in
this leaflet or as your doctor or pharmacist has
told you. Check with your doctor or
pharmacist if you are not sure.

GDO - Graphic Department Origgio

Code:
Update:
Local code:
Current item code:

4831181A

V03 - 01-12-2017
4831180A

Product/Item type:

Istruzione - Retro
Maalox - 250 ml

Country:

UK

Artwork by:
Plant:
Supplier code:

Origgio
Origgio

Impianti di proprietà

Sanofi S.p.A.

Format:
Plant barcode:
Colours:

Technical Data

For Sanofi use only

Sanofi
PAC K AG I N G T E A M

- P Reflex Blue C
- XXXX

Stesa 157 x 315 mm.

1301

1

- XXXX
- XXXX
- XXXX

Fonts: Ocean Sans Pro SAN Light / Light Italic / Bold
Minimum point size of text:
Assembly Card:
Layout of Cutting:
Technical Card:
Technical Constraint:

APPROVAL DATE:
REJECTED

Taking this medicine
• Shake well before use to ensure the product is
mixed properly
• 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 5ml teaspoonfuls
• 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.
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 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)
• You have a red and lumpy skin rash, swollen
eyelids, face, lips, mouth or tongue, itching and
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
Very rare (may affect up to 1 in 10,000 people)
• Hypermagnesemia, including observations after prolonged administration to patients with
renal impairment.
Not known (frequency cannot be estimated from
the available data)
• Hypophosphatemia is an electrolyte disturbance
in which there is an abnormally low level of
phosphate in the body. This may occur at high
doses of the product or even at normal doses
especially in patients with low phosphorous
diets
• Abdominal pain
• Hyperaluminemia is an electrolyte disturbance
in which there is an abnormally elevated level
of aluminium in the body

10 pt

SIGNATURE:

Vietata la manomissione - Rendere dopo la stampa

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 or
search for MHRA Yellow Card in the Google Play
or Apple App Store.
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 out of the sight and reach of
children.
Do not use Maalox Suspension after the expiry
date which is stated on the carton and the bottle
after EXP. The expiry date refers to the last day of
that month.
Discard any medicine remaining 6 months after
opening the bottle.
Store below 25°C.
Do not throw away medicines 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. Contents of the pack and other information

What Maalox Suspension contains
• Each 5ml of suspension contains 175mg of
aluminium hydroxide and 200mg of magnesium
hydroxide as the active ingredients.
• The other ingredients are: hydrochloric acid,
citric acid monohydrate, peppermint oil,
mannitol (E421), domiphen bromide, saccharin
sodium, sorbitol liquid (E420), hydrogen peroxide
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 a 250ml
polyethylene terephthalate (PET) bottle, with
a polypropylene (PP) closure and polyethylene
(PE/LDPE) liner.
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
Manufacturer:
sanofi-aventis S.p.A
viale Europa, 11 – 21040 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 December 2017
© Sanofi, 2017

4831181A

419677 (alt 417868) GMID 691045
Code 192
Andrea Schmitz

PB Maalox 250ml GB
min. 9pt Version 5

PACKAGE LEAFLET: INFORMATION FOR THE USER

Maalox 175mg/200mg
Oral Suspension
Aluminium hydroxide 175mg/5ml
Magnesium hydroxide 200mg/5ml
Is this leaflet hard to see or read?
Phone 0845 372 7101 for help

Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
This medicine is available without prescription.
Always take this medicine exactly as described in this
leaflet or as your doctor or pharmacist has told you.
-- Keep this leaflet. You may need to read it again.
-- Ask your pharmacist if you need more
information or advice
-- If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet (see section 4).
-- You must talk to a doctor if you do not feel
better or if you feel worse
What is in this leaflet:
1. What Maalox Suspension is and what it is used for
2. What you need to know before you take Maalox
Suspension
3. How to take Maalox Suspension
4. Possible side effects
5. How to store Maalox Suspension
6. Contents of the pack and other information
1. What Maalox Suspension is and what it
is used for
Maalox Suspension contains two different
medicines. They are called aluminium hydroxide
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 it 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. What you need to know before you take
Maalox Suspension
Do not take Maalox Suspension if:
X You are allergic to aluminium hydroxide or

magnesium hydroxide or any of the other ingredients
in Maalox Suspension (listed in section 6).
X Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of
your lips, face, throat or tongue
X You are feeling very weak and have no energy
(debilitated)
X You have kidney problems. Long term exposure

419677 PB Maalox 250ml GB.indd 2

Seite 1

157 x 210 mm

Pantone reflex blue

to high doses of Maalox Suspension can lead to
dementia.
X You have severe stomach pain
X 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.
Warnings and precautions
Take special care with Maalox Suspension.
Check with your doctor or pharmacist before
taking this medicine if:
You are on a low-phosphorous diet
Other medicines and Maalox Suspension
Tell your doctor or pharmacist if you are taking,
have recently taken or might take 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.
Some medicines may be affected by magnesium
hydroxide or they may affect how well magnesium
hydroxide will work. Tell your doctor or pharmacist
if you are already taking: salicylates
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
•• Polystyrene sulphonate – used to treat high
levels of potassium in 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 should not take
Maalox Suspension during the first three months
of pregnancy
•• You are breast-feeding or planning to breast-feed
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
Maalox Suspension contains less than 1 mmol
sodium (23 mg) per 5 ml dose, i.e. essentially
‘sodium free’.
3. How to take Maalox Suspension
Always take this medicine exactly as described in
this leaflet or as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you
are not sure.
Taking this medicine
•• Shake well before use to ensure the product is
mixed properly
•• Take this medicine by mouth

04.12.2017 16:11:47

•• 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 5ml teaspoonfuls
•• 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.
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 Suspension can cause
side effects, although not everybody gets them.
Stop taking Maalox Suspension and see a doctor
or got to a hospital straight away if:
Not known (frequency cannot be estimated form
the available data)
•• You have a red and lumpy skin rash, swollen
eyelids, face, lips, mouth or tongue, itching and
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
Very rare (may affect up to 1 in 10,000 people)
•• Hypermagnesemia, including observations after
prolonged administration to patients with renal
impairment.
Not known (frequency cannot be estimated from
the available data)
•• Hypophosphatemia is an electrolyte disturbance
in which there is an abnormally low level of
phosphate in the body. This may occur at high
doses of the product or even at normal doses
especially in patients with low phosphorous diets
•• Hyperaluminemia is an electrolyte disturbance
in which there is an abnormally elevated level of
aluminium in the body
•• Abdominal pain

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 or
search for MHRA Yellow Card in the Google Play or
Apple App Store.
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 out of the sight and reach of
children.
Do not use Maalox Suspension after the expiry date
which is stated on the carton and the bottle after
EXP. The expiry date refers to the last day of that
month.
Discard any medicine remaining 6 months after
opening the bottle.
Store below 25°C.
Do not throw away medicines 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. Contents of the pack and other information
What Maalox Suspension contains
•• Each 5ml of suspension contains 175mg of
aluminium hydroxide and 200mg of magnesium
hydroxide as the active ingredients.
•• The other ingredients are: hydrochloric acid,
citric acid monohydrate, peppermint oil,
mannitol (E421), domiphen bromide, saccharin
sodium, sorbitol liquid (E420), hydrogen
peroxide 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 a 250ml polyethylene
terephthalate (PET) bottle, with a polypropylene (PP)
closure and polyethylene (PE/LDPE) liner.
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
Manufacturers:
A.Nattermann & Cie. GmbH, Nattermannallee 1,
D-50829 Cologne, Germany
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 December 2017
© Sanofi, 2016 - 2017
419677/691045-12.17-GB

419677 PB Maalox 250ml GB.indd 3

Seite 2

04.12.2017 16:11:48

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