Maalox® Plus Tablets

cod. 233261 Format : 157 x 210 mm Plant barcode : 697 Colours : 1 - Blu Reflex - XXXX Code : 4805211A - XXXX - XXXX Update : V03 - 15-01-2014 - XXXX - XXXX Local code : 000/000000-00000 Fonts : Ocean Sans Pro SAN Light / Bold y Current item code : 4805210A echnical Data T Minimum point size of text : 9,5 pt Product/Item type : Istruzione in bobina - Fronte Assembly Card : 360/03 Maalox Plus Tablets Layout of Cutting : 000 Country : UK Technical Card : 0000000 Technical Constraint : 0000000 For sanofi-aventis use onl Artwork by : Origgio Plant : Origgio APPROVAL DATE: Supplier code : XXXX REJECTED SIGNATURE:

Impianti di proprietà sanofi-aventis S.p.A. Vietata la manomissione - Rendere dopo la stampa

PACKAGE LEAFLET: aluminium hydroxide gel, magnesium hydroxide, INFORMATION FOR THE USER simeticone or any of the other ingredients in Maalox Plus Tablets Maalox® Plus Tablets (see Section 6: Further information) Dried Aluminium Hydroxide Gel 200mg Signs of an allergic reaction include: a rash, Magnesium Hydroxide 200mg swallowing or breathing problems, swelling of Simeticone 25mg your lips, face, throat or tongue 75 mm You are feeling very weak and have no energy Is this leaflet hard to see or read? (debilitated) You have kidney problems Phone 0845 372 7101 for help Do not take this medicine if any of the above apply Read all of this leaflet carefully because it to you. If you are not sure, talk to your doctor or contains important information for you pharmacist before taking Maalox Plus Tablets. This medicine is available without prescription. Take special care with Maalox Plus Tablets. However, you still need to use Maalox Plus Tablets Check with your doctor or pharmacist before carefully to get the best results from it. taking this medicine if: • Keep this leaflet. You may need to read it again - You are on a low-phosphorous diet • Ask your pharmacist if you need more information or advice • You must contact a doctor if your symptoms Taking other medicines worsen or do not improve Please tell your doctor or pharmacist if you are • If any of the side effects get serious, or if you taking or have recently taken any other medicines. notice any side effects not listed in this leaflet, This includes medicines you buy without a please tell your doctor or pharmacist prescription, including herbal medicines. In this leaflet: Maalox Plus Tablets should not be taken at the same 1. What Maalox Plus Tablets are and what they are time as other medicines. This is because Maalox Plus used for Tablets can affect the way other medicines work. If 2. Before you take Maalox Plus Tablets Maalox Plus Tablets are taken within one hour of 3. How to take Maalox Plus Tablets any other medicine, they can affect the uptake of 4. Possible side effects that medicine into the blood. 5. How to store Maalox Plus Tablets 6. Further information Pregnancy and breast-feeding 1. What Maalox Plus Tablets are Talk to your doctor or pharmacist before taking this and what they are used for medicine if: i • You are pregnant, might become pregnant, or Maalox Plus Tablets contain three different think you may be pregnant medicines: • You are breast-feeding or planning to breast-feed • The first two medicines are called dried aluminium hydroxide gel and magnesium hydroxide. They Important information about some of the belong to a group of medicines called antacids. ingredients of Maalox Plus Tablets • The other medicine is called simeticone. It belongs Maalox Plus Tablets contain anhydrous glucose, to a group of medicines called anti-foaming agents. sucrose and sorbitol (E420). This product may be Maalox Plus Tablets is used for: harmful to teeth. If you have been told by your • The relief of indigestion (dyspepsia) doctor that you cannot tolerate or digest some • Heartburn sugars, talk to your doctor before taking this • Wind (flatulence) medicine. Maalox Plus Tablets work by lowering the amount 3. How to take Maalox Plus Tablets of acid in your stomach. The anti-foaming agent in Maalox Plus Tablets helps to remove gas from your Taking this medicine stomach. • Take this medicine by mouth • Chew the tablets well before swallowing 2. Before you take Maalox Plus Tablets Adults including the elderly • Take one or two tablets 4 times each day Do not take Maalox Plus Tablets if: • Take 20 minutes to one hour after meals You are allergic (hypersensitive) to dried and at bedtime or as required cod. 233261 Format : 157 x 210 mm Plant barcode : 697 Colours : 1 - Blu Reflex - XXXX Code : 4805211A - XXXX - XXXX Update : V03 - 15-01-2014 - XXXX - XXXX Local code : 000/000000-00000 Fonts : Ocean Sans Pro SAN Light / Bold y Current item code : 4805210A echnical Data T Minimum point size of text : 9,5 pt Product/Item type : Istruzione in bobina - Retro Assembly Card : 360/03 Maalox Plus Tablets Layout of Cutting : 000 Country : UK Technical Card : 0000000 Technical Constraint : 0000000 For sanofi-aventis use onl Artwork by : Origgio Plant : Origgio APPROVAL DATE: Supplier code : XXXX REJECTED SIGNATURE:

Impianti di proprietà sanofi-aventis S.p.A. Vietata la manomissione - Rendere dopo la stampa

Children Website: www.medicinesauthorty.gov.mt Maalox Plus Tablets are not recommended for e-mail: [email protected] children. By reporting side effects you can help provide more If the symptoms do not go away, talk to your doctor. information on the safety of this medicine. If you take more Maalox Plus Tablets than you should 5. How to store Maalox Plus Tablets Talk to your doctor or go to a hospital straight away. Keep this medicine in a safe place where children Remember to take any medicine that is left with you cannot see or reach it. 83,6 mm so the doctor knows what you have taken. Do not use Maalox Plus Tablets after the expiry date The following effects may happen: diarrhoea, stomach which is stated on the carton and foil after EXP. The pain or you may get a bloated feeling and cramping expiry date refers to the last day of that month. pain in the abdomen (stomach), be sick (vomit), have Store below 30°C. indigestion, heartburn, upset stomach, constipation, Medicines should not be disposed of via wastewater or loss of appetite, dry mouth. This could be caused by household waste. Ask your pharmacist how to dispose an obstruction or blockage of the bowel (ileus). of medicines no longer required. These measures will help to protect the environment. 4. Possible side effects Like all medicines, Maalox Plus Tablets can cause 6. Further information side effects, although not everybody gets them. What Maalox Plus Tablets contain Stop taking Maalox Plus Tablets and see a doctor • Each tablet contains: 200mg of dried aluminium or go to a hospital straight away if: hydroxide gel, 200mg of magnesium hydroxide Not know (frequency cannot be estimated from the and 25 mg of simeticone available data) • The other ingredients are: swiss cream flavour, - You have a red and lumpy skin rash, swollen lemon flavour, magnesium stearate, talc, eyelids, face, lips, mouth or tongue, itching, anhydrous citric acid, anhydrous glucose, difficulty breathing or swallowing. This could be an saccharin sodium, sorbitol (E420), sorbitol liquid allergic reaction. non-crystallising (E420), iron oxide yellow (E172), Tell your doctor or pharmacist if any of the pregelatinised starch (maize starch), maize starch, following side effects get serious or lasts longer sucrose and mannitol (E421) than a few days. Also tell them if you notice any What Maalox Plus Tablets looks like and contents side effects not listed in this leaflet: of the pack Uncommon (may affect up to 1 in 100 people) Maalox® Plus Tablets are white and yellow with • Constipation “Maalox” embossed on one side. They taste of • Diarrhoea lemon/cream. Not know (frequency cannot be estimated from the Maalox Plus Tablets are made in blister packs available data) containing 10, 12, 20, 24, 30, 36, 40, 48, 50, 60, • Hypophosphatemia, this may occur at high doses 70, 72, 80, 84, 90, 96, and 100 tablets or tubes of the product or even at normal doses especially containing 12, 24, 36, 48, 72 and 144 tablets. Not all in patients with low phosphorus diets pack sizes may be available. • Hypermagnesemia is an electrolyte disturbance in which there is an abnormally elevated level of Marketing Authorisation Holder and magnesium in the body Manufacturer • Hyperaluminemia is an electrolyte disturbance Marketing Authorisation Holder in which there is an abnormally elevated level of Sanofi, aluminium in the body One Onslow Street, Guildford, Surrey, GU1 4YS, UK Reporting of side effects Tel: 0845 372 7101 If you get any side effects, talk to your doctor, email: [email protected] pharmacist or nurse. This includes any possible side Manufacturer effects not listed in this leaflet. Sanofi-aventis S.p.A. United Kingdom Viale Europa, 11 - Origgio (VA), Italy You can also report side effects directly via the Yellow This leaflet does not contain all the information about Card Scheme at: www.mhra.gov.uk/yellowcard your medicine. If you have any questions or are not Malta sure about anything, ask your doctor or pharmacist. ADR Reporting, The Medicines Authority, This leaflet was last revised in January 2014 Post-Licensing Directorate, 203 Level