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Document: label-leaflet MAH BRAND_PL 04425-0378 change

• label-leaflet MAH BRAND_PL 04425-0378
• leaflet MAH BRAND_PLPI 15184-1341

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Maalox

Suspension

Contents: 500 ml Suspension

dried aluminium hydroxide gel 220 mg/5 ml magnesium hydroxide 195 mg/5 ml A direct answer to the problems of indigestion, heartburn and acidity For oral use

For details of dosage regimen refer to enclosed leaflet. SHAKE WELL BEFORE USE Also contains: methylparaben (E218), propylparaben (E216) and sorbitol (E420). See enclosed leaflet for further information.

Keep out of the sight and reach of children.

Do not freeze. Store away from direct sunlight. Use within 28 days of opening. Always read the leaflet before taking this medicine.

MA Holder: Sanofi, One Onslow Street,

Guildford, Surrey, GU1 4YS, UK PL 04425/0378

dried aluminium hydroxide gel 220 mg/5 ml magnesium hydroxide 195 mg/5 ml A direct answer to the problems of indigestion, heartburn and acidity For oral use

For details of dosage regimen refer to enclosed leaflet. SHAKE WELL BEFORE USE Also contains: methylparaben (E218), propylparaben (E216) and sorbitol (E420).

See enclosed leaflet for further information. Keep out of the sight and reach of children.

Do not freeze. Store away from direct sunlight. Use within 28 days of opening.

Always read the leaflet before taking this medicine.

MA Holder: Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK ^pl 04425/0378

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:

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

2.    Before you take Maalox Suspension

3.    How to take Maalox Suspension

4.    Possible side effects

5.    How to store Maalox Suspension

6.    Further information

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

Maalox Suspension contains two different medicines. They are called dried aluminium hydroxide gel 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.

2. Before you take Maalox Suspension

Do not take

CAJ Maalox Suspension if:

X 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 X You are feeling very weak and have no energy (debilitated)

X You have kidney problems 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.

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 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 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

3. 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.

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).

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, 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

5. How to store Maalox Suspension

Keep this medicine in a safe place

where children cannot see or reach it. Do not use Maalox Suspension after the expiry date which is stated on this leaflet and the bottle after EXP. The expiry date refers to the last day of that month.

Discard any medicine remaining 28 days after opening the bottle.

Do not freeze. Store away from direct sunlight.

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.

6. Further Information

What Maalox Suspension contains

• Each 5 ml of suspension contains 220 mg of dried aluminium hydroxide gel and 195 mg of magnesium hydroxide, as the active ingredients.

• The other ingredients are: methylparaben (E218), propylparaben (E216), citric acid (anhydrous), sodium saccharin, sorbitol (E420), mannitol powder, hydrogen peroxide, hydrochloric acid, 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 100 ml, 180 ml, 200 ml, 250 ml, 300 ml and 500 ml plastic bottles or 180 ml and 300 ml glass bottles or 10 ml sachets. Not all pack sizes may be marketed.

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 - 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 January 2014

©Sanofi, 1990 - 2014