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The product code for this leaflet is: PL04425/0382

 

Maalox Plus Suspension

Company Details

SANOFI


1 Onslow StreetGuildfordSurreyGU1 4YS
Telephone:
Fax:
Medical Information Direct Line:
Medical Information e-mail:uk-medicalinformation@sanofi.com
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PACKAGE LEAFLET: INFORMATION FOR THE USER

Maalox Plus Suspension

dried aluminium hydroxide gel 220 mg/5 ml

magnesium hydroxide 195 mg/5 ml

simeticone 25 mg/5 ml

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Read all of this leaflet carefully because it contains important information for you

This medicine is available without a prescription. However, you still need to use Maalox Plus 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 gets 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 Plus is and what it is used for
2. Before you take Maalox Plus
3. How to take Maalox Plus
4. Possible side effects
5. How to store Maalox Plus
6. Further Information

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

Maalox Plus contains 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 is used for:

  • The relief of indigestion (dyspepsia)
  • Heartburn
  • Wind (flatulence)

Maalox Plus works by lowering the amount of acid in your stomach. The anti-foaming agent in Maalox Plus helps to remove gas from your stomach.

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2. Before you take Maalox Plus

Do not take Maalox Plus if:

  • You are allergic (hypersensitive) to dried aluminium hydroxide gel, magnesium hydroxide, simeticone or any of the other ingredients in Maalox Plus (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 disease
  • You have low levels of phosphate (called ‘hypophosphataemia’). This is shown up in blood tests.

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.

Take special care with Maalox Plus. 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 Plus should not be taken at the same time as other medicines. This is because Maalox Plus can affect the way other medicines work. If Maalox Plus is taken within one hour of any other medicine, it can affect the uptake of that medicine into 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 are breast-feeding or planning to breast-feed

Important information about some of the ingredients of Maalox Plus

  • Maalox Plus 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 Plus 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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3. How to take Maalox Plus

Taking this medicine

  • Shake well before use
  • Take this medicine by mouth

Adults including the elderly

  • Take one to two 5ml spoonfuls 4 times each day
  • Take 20 minutes to 1 hour after meals and at bedtime
  • Alternatively, take as directed by your doctor

Children aged 12 to 18 years

  • Give your child one to two 5ml spoonfuls 4 times each day
  • Give this medicine 20 minutes to 1 hour after meals and at bedtime
  • Alternatively give as directed by your doctor

Children aged 5 to 12 years

  • Give your child a maximum of one 5 ml spoonful 3 to 4 times each day
  • Give this medicine 20 minutes to 1 hour after meals and at bedtime
  • Alternatively give as directed by your doctor

Children 2 to 5 years old

  • Do not give your child more than one 5 ml spoonful three times each day
  • Give this medicine 20 minutes to 1 hour after meals or at bedtime
  • Alternatively give as directed by your doctor

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

If you take more Maalox Plus 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).

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4. Possible side effects

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

Stop taking Maalox Plus 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, 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
  • 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.

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5. How to store Maalox Plus

Keep this medicine in a safe place where children cannot see or reach it.

Do not use Maalox Plus after the expiry date which is stated on this leaflet after EXP. The expiry date refers to the last day of that month.

Do not freeze.

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.

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6. Further Information

What Maalox Plus contains

  • Each bottle contains the following active substances in each 5ml of suspension: 220mg of dried aluminium hydroxide gel, 195mg of magnesium hydroxide and 25mg of simeticone
  • The other ingredients are: methylparaben (E218), propylparaben (E216), microcrystalline cellulose, sodium carboxymethylcellulose, methylcellulose, hydroxypropylcellulose, hydrogen peroxide, citric acid, sodium saccharin, sorbitol (E420), natural lemon concentrate, swiss cream flavour and water

What Maalox Plus looks like and contents of the pack

Maalox Plus is a white suspension with the odour and taste of lemon and is available in a plastic bottle.

Each bottle contains 100, 180, 200, 250, 300, 355 or 500mls with security caps or alternative polypropylene closure or in 10 ml sachets.

Not all pack sizes may be available.

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 Origgio (VA)
Italy
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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 January 2014

© Sanofi, 1989 - 2014


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