MAALOX PLUS TABLETS

Active substance: SIMETICONE

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PACKAGE LEAFLET: INFORMATION FOR THE USER Take special care with Maalox Plus Tablets.
Check with your doctor or pharmacist before
taking this medicine if:
- You are on a low-phosphorous diet

89027585
89027333

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.

-

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

1

What Maalox Plus Tablets looks like and contents
of the pack

10pt su 10pt

-- 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)

-

What Maalox Plus Tablets contain

62C0005

167 x 304,8 s

Stop taking Maalox Plus Tablets and see a doctor
or go to a hospital straight away if:
Not know (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.

6. Further information

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

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 to protect the environment.

Verificare la corrispondenza delle pellicole
con l’artwork approvato - la nostra
responsabilità è limitata al rifacimento
delle eventuali pellicole errate.

4. Possible side effects

5. How to store Maalox Plus Tablets

Arkhé S.n.c.

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 (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
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.

By reporting side effects you can help provide more
information on the safety of this medicine
Tel. 0862.404140
fax 0862.404140

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Malta
ADR Reporting, The Medicines Authority, PostLicensing Directorate, 203 Level 3, Rue D’Argens,
GŻR-1368 Gżira
Website: www.medicinesauthorty.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt

89027585

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
In this leaflet:
1. What Maalox Plus Tablets are and what they are doctor that you cannot tolerate or digest some
sugars, talk to your doctor before taking this
used for
medicine.
2. Before you take Maalox Plus Tablets
3. How to take Maalox Plus Tablets
3. How to take Maalox Plus Tablets
4. Possible side effects
5. How to store Maalox Plus Tablets
Taking this medicine
6. Further information
-- Take this medicine by mouth
-- Chew the tablets well before swallowing
1. What Maalox Plus Tablets are
and what they are used for
Adults including the elderly
-- Take one or two tablets 4 times each day
Maalox Plus Tablets contain three different -- Take 20 minutes to one hour after meals and at
bedtime or as required
medicines:
-- The first two medicines are called dried aluminium
hydroxide gel and magnesium hydroxide. They Children
Maalox Plus Tablets are not recommended for
belong to a group of medicines called antacids.
-- The other medicine is called simeticone. It belongs children.
to a group of medicines called anti-foaming
If the symptoms do not go away, talk to your doctor.
agents.
Maalox Plus Tablets is used for:
If you take more Maalox Plus Tablets than you
-- The relief of indigestion (dyspepsia)
should
-- Heartburn
Talk to your doctor or go to a hospital straight away.
-- Wind (flatulence)
Maalox Plus Tablets work by lowering the amount of Remember to take any medicine that is left with
acid in your stomach. The anti-foaming agent in you so the doctor knows what you have taken.
Maalox Plus Tablets helps to remove gas from your The following effects may happen: diarrhoea,
stomach pain or you may get a bloated feeling and
stomach.
cramping pain in the abdomen (stomach), be sick
(vomit), have indigestion, heartburn, upset stomach,
2. Before you take Maalox Plus Tablets
constipation, loss of appetite, dry mouth. This could
be caused by an obstruction or blockage of the
bowel (ileus).

This leaflet was last revised in March 2014
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side © Sanofi, 1989 - 2014
effects not listed in this leaflet.
United Kingdom
You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard

1001000001

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

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.

31-03-2014
IST MAALOX PLUS 200MG
GB I01
Istruzione

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.

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

PACK. ITEM:

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 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 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.

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

GB: GREAT BRITAIN

Maalox Plus Tablets should not be taken at the same

Is this leaflet hard to see or read? time as other medicines. This is because Maalox
Phone 0845 372 7101 for help Plus Tablets can affect the way other medicines

Uncommon (may affect up to 1 in 100 people)
• Constipation
• Diarrhoea

and

 Reflex Blue

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.

Marketing
Authorisation
Holder
Manufacturer
Marketing Authorisation Holder
Sanofi,
One Onslow Street,
Guildford
Surrey, GU1 4YS, UK
Tel: 0845 372 7101
Email: uk-medicalinformation@sanofi.com

1 - Prima realizzazione

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

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:

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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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