Maalox Plus Chewable Tablets 200mg/200mg/25mg

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 Chewable 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 Chewable Tablets are and what they are used for
2. What you need to know before you take Maalox Plus Chewable Tablets
3. How to take Maalox Plus Chewable Tablets
4. Possible side effects
5. How to store Maalox Plus Chewable Tablets
6. Contents of the pack and other information

Do not take Maalox Plus Chewable Tablets if:

• You are allergic (hypersensitive) to hydrated aluminium oxide, magnesium hydroxide, dimeticone (as simeticone) or any of the other ingredients in Maalox Plus Chewable 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
• 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 Chewable Tablets.

Warnings and precautions

Take special care with Maalox Plus Chewable Tablets

Check with your doctor or pharmacist before taking your medicine if:

• You suffer from porphyria
• You suffer from diabetes

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Maalox.

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 Chewable Tablets should not be taken at the same time as other medicines. This is because Maalox Plus Chewable Tablets can affect the way other medicines work. If Maalox Plus Chewable Tablets are taken within one hour of any other medicine, they can affect the uptake of that medicine into the blood.

Other medicines and magnesium hydroxide:

Some medicines may be affected by magnesium hydroxide or they may affect how well magnesium hydroxide will work. Tell your doctor or pharmacist if you are already taking: - salicylates

In particular, Maalox Plus Chewable Tablets can affect the following medicines:

• Medicines used to treat the heart such as digoxin, quinidine, metoprolol, atenolol or propranolol.
• Medicines used to treat anaemia such as iron salts.
• Medicines used to treat dyspepsia such as ranitidine or cimetidine.
• Medicines used to treat malaria such as chloroquine.
• Medicines used to treat some bone disorders such as diphosphonates.
• Medicines used to treat some allergic, inflammatory or autoimmune disorders such as glucocorticoids.
• Medicines used to treat kidney disorders such as citrates.
• Medicines used to treat tuberculosis such as ethambutol or isoniazid.
• Medicines used to treat bacterial infections such as fluroquinolones or lincosamides.
• Medicines used to treat infections such as ketoconazole, tetracyclines, Cephalosporins such as cefpodoxime & Cefdinir.
• Medicines used to treat mental illness (psychosis) such as phenothiazines, neuroleptics.
• Medicines used to treat increased amounts of potassium in the body such as polystyrene sulfonate.
• Non-steroidal anti-inflammatories such as diflunisal or indometacine.
• 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 are breast-feeding or planning to breast-feed

Important information about some of the ingredients of Maalox Plus Chewable Tablets

Maalox Plus Chewable Tablets contain glucose, sucrose and 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.

Care should be observed if used by diabetics because of the sugar content in the tablet.

Maalox Plus Chewable Tablets also contain sulphur dioxide (E220), which may rarely cause hypersensitivity reactions and bronchospasm.

Maalox Plus Chewable Tablets contain small amounts of ethanol (alcohol), less than 100mg per dose.

Taking this medicine

• Take this medicine by mouth
• Chew the tablets well before swallowing

Adults

• Take one or two tablets 4 times each day
• Take 20 minutes to one hour after meals and at bedtime or as required

Do not take this medicine for prolonged periods as it may mask more serious diseases such as stomach ulcers or stomach cancer.

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

Children

Not recommended in children.

If you take more Maalox Plus Chewable Tablets than you should

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).

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.

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:

• Constipation
• Diarrhoea

Very rare:

• Hypermagnesemia, inlcuding observations after prolonged administration of magnesium hydroxide to patients with renal impairment.

Not Known:

• Allergic or anaphylactic reactions, signs include; red and lumpy skin rash, swollen eyelids, face, lips, mouth or tongue, itching, difficulty breathing or swallowing.
• Abdominal pain
• Hypophosphatemia, this may occur at high doses of the product or even at normal doses especially in patients with low phosphorus diets or in infants less than 2 years.
• 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

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

What Maalox Plus Chewable Tablets contain

• Each tablet contains: 200mg of hydrated aluminium oxide, 200mg of magnesium hydroxide and 25mg of dimeticone (as simeticone)
• The other ingredients are: sucrose, mannitol, sorbitol liquid non crystallising, sorbitol, saccharin sodium, magnesium stearate, talc, pregelatinised maize starch, maize starch, citric acid anhydrous, glucose anhydrous, lemon flavour (contains sulphur dioxide (E220)), swiss cream flavour (contains sulphur dioxide (E220) and ethanol) and iron oxide yellow (E172).

What Maalox Plus Chewable Tablets looks like and contents of the pack

Maalox Plus Chewable Tablets have a white and yellow layer with “Maalox” embossed on the white side. They taste of lemon/cream.

Maalox Plus Chewable Tablets are made in blister packs containing 10, 12, 20, 24, 30, 36, 40, 48, 50, 60, 70, 80, 84, 90, 96, and 100 tablets. Not all pack sizes may be available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Manufacturer

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.