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MAALOX® Plus Suspension

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MAALOX® Plus Suspension PACKAGE LEAFLET: INFORMATION FOR THE USER Warnings and precautions Talk to your doctor or pharmacist before taking Maalox Plus if: MAALOX® Plus - You are on a low-phosphorous diet - You are suffering from porphyria and are under- Suspension going haemodialysis. Dried aluminium hydroxide gel 230mg/5 ml Children Magnesium hydroxide 200 mg/5 ml In small children use of magnesium hydroxide may Simeticone 25 mg/5 ml cause hypermagnesemia particularly if they have renal impairment or dehydration. Other medicines and Maalox Plus Is this leaflet hard to see or read? Tell your doctor or pharmacist if you are taking or Phone 0800 035 2525 for help have recently taken any other medicines. Read all of this leaflet carefully before This includes medicines you buy without a prescrip- you start taking this medicine because it tion including herbal medicines. contains important information for you. This medicine is available without prescription. Maalox Plus should not be taken at the same time as However, you still need to use Maalox Plus carefully other medicines. This is because Maalox Plus can af- to get the best results from it. fect the way other medicines work. If Maalox Plus is - Keep this leaflet. You may need to read it again. taken within one hour of any other medicine, it can - Ask your pharmacist if you need more informa- affect the uptake of that medicine into the blood. tion or advice - You must contact a doctor if your symptoms Some medicines may be affected by magnesium worsen or do not improve hydroxide or they may affect how well magnesium - If you get any side effects, talk to your doctor or hydroxide will work. pharmacist. This includes any possible side ef- Tell your doctor or pharmacist if you are taking, fects not listed in this leaflet. See section 4. have recently taken or might take any of the med- icines listed below, as some medicines may be af- What is in this leaflet fected by Maalox Plus or they may affect how well 1. What Maalox Plus is and what it is used for Maalox Plus will work. In particular: 2. What you need to know before you take Maalox • Medicines used to treat the heart such as quini- Plus dine, metoprolol, atenolol and propranolol 3. How to take Maalox Plus • Medicines used to treat anemia such as iron salts 4. Possible side effects • Medicines used to treat stomach ulcers and acidity 5. How to store Maalox Plus such as ranitidine or cimetidine (H2 antagonists) 6. Contents of the pack and other information • Medicines used to treat malaria such as chloro- quine 1. What Maalox Plus is • Medicines used to treat some bone disorders and what it is used for i such as bisphosphonates Maalox Plus contains three different medicines: • Medicines used to treat some allergic, inflam- • The first two medicines are called dried alumin- matory or abnormal immune reactions such as ium hydroxide gel and magnesium hydroxide. glucocorticoids They belong to a group of medicines called ant- • Medicines used to treat tuberculosis such as acids ethambutol, isoniazid • The other medicine is called simeticone. It be- • Medicines used to treat infections such as fluro- longs to a group of medicines called anti-foam- quinolones, lincosamides, ketoconazole, cyclines ing agents including tetracylines, cephalosporins (cefpodox- Maalox Plus is used for: ime & cefdinir) • The relief of indigestion (dyspepsia) • Medicines used to treat mental illness (psychosis) • Heartburn such as phenothiazine neuroleptics • Wind (flatulence) • Medicines used to treat increased amounts of po- Maalox Plus works by lowering the amount of acid tassium in the body such as polystyrene sulfonate in your stomach. The anti-foaming agent in Maalox • Medicines used to treat pain such as diflunisal Plus helps to remove gas from your stomach. and indomethacin • Medicines used in dental care such as sodium 2. What you need to know before you take fluoride Maalox Plus • Medicines used to treat an underactive thyroid gland such as levothyroxine Do not take Maalox Plus if: • Medicines used to treat joint pains and abnormal chemical reactions in the body such as penicillamine X You are allergic (hypersensitive) to dried alumin- • Medicines used to reduce cholesterol such as ium hydroxide gel, magnesium hydroxide, sime- rosuvastatin ticone or any of the other ingredients in Maalox • Salicylates including aspirin Plus (listed in section 6). Signs of an allergic reaction include: a rash, swal- Pregnancy and breast-feeding lowing or breathing problems, swelling of your Talk to your doctor or pharmacist before taking this lips, face, throat or tongue medicine if: X You are feeling very weak and have no energy • You are pregnant, might become pregnant, or (debilitated) think you may be pregnant. X You have kidney disease / kidney failure • You are breast-feeding or planning to breast-feed X You have low levels of phosphate (called ‘hy- pophosphataemia’). This is shown up in blood Important information about some of the ingre- tests. dients of Maalox Plus Do not take this medicine if any of the above apply This medicine contains 22 mg sorbitol to you. If you are not sure, talk to your doctor or in each 5ml unit which is equivalent to pharmacist before taking Maalox Plus. 0.32 mg/kg. Sorbitol is a source of fructose. If your doctor has - Hypophosphatemia, this may occur at high doses told you that you (or your child) have an intolerance of the product or even at normal doses especially to some sugars or if you have been diag nosed with in patients with low phosphorus diets hereditary fructose intolerance (HFI), a rare genetic - Hyperaluminemia is an electrolyte disturbance disorder in which a person cannot break down fruc- in which there is an abnormally elevated level of tose, talk to your doctor before you (or your child) aluminium in the body take or receive this medicine. - Abdominal pain Maalox Suspension contains less than 1 mmol sodi- Reporting of side effects um (23mg) per 5ml dose i.e. essentially ‘so dium free’. If you get any side effects, talk to your doctor, phar- macist or nurse. This includes any possible side ef- 3. How to take Maalox Plus fects not listed in this leaflet. Taking this medicine You can also report side effects directly via the Yel- • Shake well before use low Card Scheme at: www.mhra.gov.uk/yellowcard • Take this medicine by mouth or search for MHRA Yellow Card in the Google Play Adults including the elderly or Apple App Store. • Take one to two 5 ml spoonfuls 4 times each day By reporting side effects you can help provide more • Take 20 minutes to 1 hour after meals and at information on the safety of this medicine. bedtime 5. How to store Maalox Plus • Alternatively, take as directed by your doctor Children aged 12 to 18 years Keep this medicine in a safe place where children • Give your child one to two 5 ml spoonfuls 4 times cannot see or reach it. each day • Give this medicine 20 minutes to 1 hour after Do not use Maalox Plus after the expiry date which meals and at bedtime is stated on the bottle and carton after EXP. The ex- • Alternatively, give as directed by your doctor piry date refers to the last day of that month. Children aged 5 to 12 years Do not refrigerate or freeze. Store below 30°C. • Give your child a maximum of one 5 ml spoonful 3 to 4 times each day Maalox Plus should be disposed of 6 months after • Give this medicine 20 minutes to 1 hour after opening the bottle. meals or at bedtime • Alternatively, give as directed by your doctor Medicines should not be disposed of via wastewa- Children 2 to 5 years old ter or household waste. Ask your pharmacist how • Do not give your child more than one 5 ml to dispose of medicines no longer required. These spoonful three times each day measures will help protect the environment. • Give this medicine 20 minutes to 1 hour after meals and at bedtime 6. Contents of the pack and other information • Alternatively, give as directed by your doctor What Maalox Plus contains If the symptoms do not go away, talk to your doctor. • Each bottle contains the following active sub- stances in each 5ml of suspension: 230mg of If you take more Maalox Plus than you should dried aluminium hydroxide gel, 200mg of mag- Talk to your doctor or go to a hospital straight away. nesium hydroxide and 25mg of simeticone Remember to take any medicine that is left with • The other ingredients are: domiphen bromide, you so the doctor knows what you have taken. microcrystalline cellulose, methylcellulose, hy- 4. Possible side effects droxypropylcellulose, hydrogen peroxide, citric acid monohydrate, sodium saccharin, sorbitol The following effects may happen; diarrhoea, (E420), carmellose sodium, lemon flavour, swiss stomach pain or you may get a bloated feeling and cream flavour and water cramping pain in the abdomen (stomach), be sick (vomit), have indigestion, heartburn, upset stom- What Maalox Plus looks like and contents of the ach, constipation, loss of appetite, dry mouth. This pack could be caused by an obstruction or blockage of Maalox Plus is a white suspension, homogenous af- the bowel (ileus). ter shaking and is available in a plastic bottle. Each bottle contains 250ml or 355ml with polypropylene Like all medicines, Maalox Plus can cause side ef- closure. fects, although not everybody gets them. Not all pack sizes may be available. Stop taking Maalox Plus and see a doctor or go Marketing Authorisation Holder and Manufacturer to a hospital straight away if: Not known (frequency cannot be estimated from Marketing Authorisation Holder the available data) Sanofi, - You have a red and lumpy skin rash, swollen 410 Thames Valley Park Drive eyelids, face, lips, mouth or tongue, itching, dif- Reading, Berkshire, RG6 1PT, UK ficulty breathing or swallowing.
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