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Maalox Suspension

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Document: leaflet MAH BRAND_PLPI 15184-1341 change

Maalox Suspension

(aluminium hydroxide / magnesium hydroxide)

Patient Information Leaflet

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 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:

0 What Maalox Suspension is and what it is used for Q Before you take Maalox Suspension 0 How to take Maalox Suspension 0 Possible side effects 0 How to store Maalox Suspension 0 Further information

Q 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 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.

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.

*    You are breast-feeding or planning to breast-feed

Important information about some of the ingredients of Maalox Suspension

*    Maalox Suspension contains methyl hydroxybenzoate (E218) and propyl hydroxybenzoate (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 liquid crystallising (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

0 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

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.

0 How to take Maalox Suspension

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.

Maalox Suspension

Ref: 1341/060814/1/F


(aluminium hydroxide / magnesium hydroxide)

Patient Information Leaflet (continued)

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 cause by an obstruction or blockage of the bowel (ileus).

Q 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, 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

If your medicine becomes discoloured or shows any signs of deterioration, ask your pharmacist who will advise you what to do.

Medicines should not be disposed of via water waste or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Q Further information

What Maalox Suspension contains

Each 5 ml of suspension contains 225 mg of aluminium hydroxide and 200 mg of magnesium hydroxide, as the active ingredients.

The other ingredients are: methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), citric acid anhydrous, saccharin sodium, sorbitol liquid crystallising (E420), hydrogen peroxide, mannitol, hydrochloric acid concentrated, peppermint oil 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 500ml plastic bottle.

Manufacturer and Licence Holder

This medicine is manufactured by Sanofi-Aventis S.p.A., Viale Europa,

11 Origgio (VA), Italy and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

PL 15184/1341

Maalox is a registered trademark of Aventisub II Inc.

Leaflet revision date: 06/08/14

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited,

Tel: 01527 505414 for help.

0 How to store Maalox Suspension

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Do not store above 25°C.

Do not freeze.

Protect from sunlight.

Discard any medicine remaining 28 days after opening the bottle.

Do not take this medicine after the expiry date shown on the carton or bottle label.