Maalox Plus suspension

This medicine is available without 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 you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

• You are allergic (hypersensitive) to aluminium hydroxide, magnesium hydroxide, simeticone or any of the other ingredients in Maalox Plus (listed in section 6).
  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 / kidney failure
• 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.

Talk to your doctor or pharmacist before taking Maalox Plus if:

• You are on a low-phosphorous diet
• You are suffering from porphyria and are undergoing haemodialysis.

In small children use of magnesium hydroxide may cause hypermagnesemia particularly if they have renal impairment or dehydration.

Tell your doctor or pharmacist if you are taking, have recently taken or might take 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 some medicines may be affected by Maalox Plus or they may affect how well Maalox Plus will work.

In particular:

• Medicines used to treat the heart such as digoxin quinidine, metoprolol, atenolol and propranolol
• Medicines used to treat anemia such as iron salts
• Medicines used to treat stomach ulcers and acidity such as ranitidine or cimetidine (H₂ antagonists)
• Medicines used to treat malaria such as chloroquine
• Medicines used to treat some bone disorders such as bisphosphonates
• Medicines used to treat some allergic, inflammatory or abnormal immune reactions such as glucocorticoids
• Medicines used to treat kidney disorders such as citrates
• Medicines used to treat tuberculosis such as ethambutol, isoniazid
• Medicines used to treat infections such as fluroquinolones, lincosamides, ketoconazole, cyclines including tetracylines, cephalosporins (cefpodoxime & cefdinir), dolutegravir, elvitegravir, raltegravir potassium and antiviral treatment combination of tenofovir alafenamide fumarate/emtricitabine/bictegravir sodium, rilpivirine
• Medicines used to treat mental illness (psychosis)such as phenothiazine neuroleptics
• Medicines used to treat increased amounts of potassium in the body such as polystyrene sulfonate
• Medicines used to treat pain such as diflunisal and indomethacin
• Medicines used in dental care such as sodium fluorure
• Medicines used to treat an underactive thyroid gland such as levothyroxine
• Medicines used to treat joint pains and abnormal chemical reactions in the body such as penicillamine
• Medicines used to reduce cholesterol such as rosuvastatin
• Medicines used to treat cancer such as nilotinib, dasatinib monohydrate
• Medicines used to treat blood disorders such as eltrombopag olamine
• Medicines used to treat high blood pressure in the lungs (pulmonary hypertension) such as riociguat
• Salicylates including aspirin

As a precaution, staggering the administration times of any orally administered drug and the antacid by at least 2 hours (4 hours for the fluoroquinolones).

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

This medicine contains 224 mg sorbitol in each 5ml unit which is equivalent to 44.8mg/ml.

Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.

Maalox Suspension contains less than 1 mmol sodium (23mg) per 5ml dose, that is to say essentially ‘sodium free’.

• Shake well before use
• Take this medicine by mouth

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

• Give your child one to two 5 ml 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

• 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 or at bedtime
• Alternatively, give as directed by your doctor

• 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 and at bedtime
• Alternatively, give as directed by your doctor

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

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.

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.

Uncommon (may affect up to 1 in 100 people)

• Constipation
• Diarrhoea

Very rare (may affect up to 1 in 10,000 people)

• Hypermagnesemia, including observations after prolonged administration to patients with renal impairment.

Not known (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
• Hyperaluminemia is an electrolyte disturbance in which there is an abnormally elevated level of aluminium in the body
• Abdominal pain

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

• Each bottle contains the following active substances in each 5ml of suspension: 175mg of aluminium hydroxide, 200mg of magnesium hydroxide and 25mg of simeticone
• The other ingredients are: domiphen bromide, microcrystalline cellulose, methylcellulose, hydroxypropylcellulose, hydrogen peroxide, citric acid monohydrate, sodium saccharin, sorbitol(E420), carmellose sodium, lemon flavour, swiss cream flavour and water

Maalox Plus is a white suspension, homogenous after shaking and is available in a plastic bottle. Each bottle contains 250ml or 355ml with polypropylene closure.

Not all pack sizes may be available.

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