Maalox Plus

PACKAGE LEAFLET: INFORMATION FOR THE USER

Maafoxpius Tablets

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

SANOFI O

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

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.

In this leaflet:

1. What Maalox Plus Tablets are and what they are used for

2. 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. Further information

1. What Maalox Plus Tablets are and what they are used for

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.

2. Before you take Maalox Plus Tablets

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.

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

US

USJ 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 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.

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 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.

3. How to take Maalox Plus Tablets

Taking this medicine

- Take this medicine by mouth

- Chew the tablets well before swallowing

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

Children

Maalox Plus Tablets are not recommended for children.

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

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).

4. Possible side effects

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

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.

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.

United Kingdom

You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

Malta

ADR Reporting, The Medicines Authority, PostLicensing Directorate, 203 Level 3, Rue D’Argens, GZR-1368 Gzira

Website: www.medicinesauthorty.gov.mt e-mail: postlicensing.medicinesauthority@gov.mt

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

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 to protect the environment.

6. Further information

What Maalox Plus Tablets contain

- 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 looks like and contents of the pack

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

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.

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 S.p.A.

Strada Statale 17, KM 22 67019 Scoppito (AQ)

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.

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