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MAALOX PLUS TABLETS

Active substance(s): ALUMINIUM OXIDE HYDRATED / MAGNESIUM HYDROXIDE / SIMETICONE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Dried Aluminium Hydroxide Gel 200mg
Magnesium Hydroxide 200mg
Simeticone 25mg

Warnings and precautions
Talk to your doctor or pharmacist before taking Maalox
Plus Tablets if:
- You are on a low-phosphorous diet
Other medicines and Maalox Plus Tablets
Tell your doctor or pharmacist if you are taking or
have recently taken any other medicines.
This includes medicines you buy without prescription,
including herbal medicines.

04-12-2017
IST MAALOX PLUS 200MG
GB I01
Istruzione
89032380

62C0005

89028787
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Stop taking Maalox Plus Tablets and see a doctor
or go 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,
difficulty breathing or swallowing. This
could be an allergic reaction.

10 pt su 10 pt

Like all medicines, Maalox Plus Tablets can cause side
effects, although not everybody gets them.

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4. Possible side effects

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If you take more Maalox Plus Tablets 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).

Sanofi S.p.A.

If the symptoms do not go away, talk to your doctor.

PACK. ITEM:
01001000001
167 x 304,8 S

Children
Maalox Plus Tablets are not recommended for children.

GB: GREAT BRITAIN

 Reflex Blue

Adults including the elderly
-- Take one or two tablets 4 times each day
-- Take 20 minutes to one hour after meals and at
bedtime or as required

Verificare la corrispondenza dell’artwork
approvato - la nostra responsabilità è
limitata al rifacimento dei file forniti.

Do not take Maalox Plus Tablets if:
• You are allergic (hypersensitive) to dried aluminium
hydroxide gel, magnesium hydroxide, simeticone
or any of the other ingredients in Maalox Plus
Tablets (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)
• You have kidney problems
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 Tablets.

Taking this medicine
-- Take this medicine by mouth
-- Chew the tablets well before swallowing

Arkhé S.n.c.

2. What you need to know before you take
Maalox Plus Tablets

3. How to take Maalox Plus Tablets

Tel. 0862.404140
fax 0862.090006

Maalox Plus Tablets contain 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 Tablets is used for:
-- The relief of indigestion (dyspepsia)
-- Heartburn
-- Wind (flatulence)
Maalox Plus Tablets work by lowering the amount
of acid in your stomach. The anti-foaming agent in
Maalox Plus Tablets helps to remove gas from your
stomach.

Important information about some of the
ingredients of Maalox Plus Tablets
Maalox Plus Tablets contain anhydrous glucose, sucrose
and sorbitol (E420). This product may be harmful to
teeth. 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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1. What Maalox Plus Tablets are
and what they are used for

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

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What is in this leaflet
1. What Maalox Plus Tablets are and what they are
used for
2. What you need to know before you take Maalox
Plus Tablets
3. How to take Maalox Plus Tablets
4. Possible side effects
5. How to store Maalox Plus Tablets
6. Contents of the pack and other information

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

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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.
However, you still need to use Maalox Plus Tablets
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 you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.

Maalox Plus Tablets should not be taken at the same
time as other medicines. This is because Maalox Plus
Tablets can affect the way other medicines work. If
Maalox Plus Tablets are taken within one hour of
any other medicine, they can affect the uptake of
that medicine into the blood.

1 - Prima realizzazione

Is this leaflet hard to see or read?
Phone 0845 372 7101 for help

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.

Manufacturer
Sanofi S.p.A.
Strada Statale 17, KM 22
67019 Scoppito (AQ)
Italy

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.

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10 pt su 10 pt

Maalox Plus Tablets are made in blister packs
containing 10, 12, 20, 24, 30, 36, 40, 48, 50, 60, 70,
72, 80, 84, 90, 96, and 100 tablets or tubes containing
12, 24, 36, 48, 72 and 144 tablets. Not all pack sizes
may be available.

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Maalox® Plus Tablets are white and yellow with “Maalox”
embossed on one side. They taste of lemon/cream.

Sanofi S.p.A.

What Maalox Plus Tablets looks like and contents
of the pack

Verificare la corrispondenza dell’artwork
approvato - la nostra responsabilità è
limitata al rifacimento dei file forniti.

-- Each tablet contains: 200mg of dried aluminium
hydroxide gel, 200mg of magnesium hydroxide
and 25mg of simeticone
-- The other ingredients are: swiss cream flavour, lemon
flavour, magnesium stearate, talc, anhydrous citric
acid, anhydrous glucose, saccharin sodium, sorbitol
(E420), sorbitol liquid non-crystallising (E420), iron
oxide yellow (E172), pregelatinised starch (maize
starch), maize starch, sucrose and mannitol (E421)

Arkhé S.n.c.

What Maalox Plus Tablets contain

Tel. 0862.404140
fax 0862.090006

6. Contents of the pack and other information

89032380

5. How to store Maalox Plus Tablets
Keep this medicine in a safe place where children
cannot see or reach it.
Do not use Maalox Plus Tablets after the expiry date
which is stated on the carton and foil after EXP. The
expiry date refers to the last day of that month.
Store below 25°C
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 protect the environment.

62C0005

167 x 304,8 S

89032380

By reporting side effects you can help provide more
information on the safety of this medicine

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Malta
You can also report side effects directly via ADR
Reporting www.medicinesauthority.gov.mt/adrportal

01001000001

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United Kingdom
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.

04-12-2017
IST MAALOX PLUS 200MG
GB I01
Istruzione

2 - Modifica testo reg.

© Sanofi, 1989 - 2017

GB: GREAT BRITAIN

This leaflet was last revised in December 2017

PACK. ITEM:

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.

 Reflex Blue

1 - Prima realizzazione

Not known (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
-- Hyperaluminemia is an electrolyte disturbance
in which there is an abnormally elevated level of
aluminium in the body
-- Abdominal pain

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

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