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Rennie'.

Orange Flavour

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CAD Ref No:    PIL 135x 197 (SB712)    |

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Calcium carbonate

plead all of this leaflet carefully because it

Contains important information for you.

This medicine is available without prescription. However, you still need to take Rennie Orange Flavour tablets carefully to get the best results from (hem. Keep this leaflet, you may need to read it hgain. 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 have any unusual effects after taking Rennie Orange Flavour, tell your doctor or pharmacist.

IN THIS LEAFLET

1.    What is Rennie Orange Flavour and what is it used for?

2.    Before you take Rennie Orange Flavour

3.    How to take Rennie Orange Flavour

4.    Possible side effects

5.    How to store Rennie Orange Flavour

6.    Further information

1.    WHAT IS RENNIE⁸ ORANGE FLAVOUR AND WHAT IS IT USED FOR?

Rennie Orange Flavour is an antacid tablet which Quickly neutralises excess stomach acid and provides relief from indigestion, heartburn, acid indigestion, dyspepsia, hyperacidity, nervous Indigestion, flatulence, upset stomach, indigestion during pregnancy and biliousness.

2.    BEFORE YOU TAKE RENNIE* ORANGE FLAVOUR Po not take Rennie Orange Flavour: r If you have severe kidney disease, r If you have high calcium in the urine or

kidney stones.

r If you have high calcium or low phosphate levels in the blood.

r If you are allergic (hypersensitive) to any of the ingredients (listedin Section 6. Further Information).

Special precautions:

Do not exceed the stated dose.

Rennie Orange Flavour should not be used for more than 14 days without consulting a doctor. Please consult your doctor or pharmacist if you have mild or moderate kidney problems as regular blood tests should be carried out.

This product contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This product also contains ponceau 4R (El 24) which may cause allergic reactions.

Taking Rennie Orange Flavour with food and ^ drink    20mm

Avoid taking Rennie Orange Flavour with large amounts of milk or dairy products.

Taking other medicines:

•    Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

•    If you are taking any of the following medicines speak to your doctor or pharmacist before taking Rennie Orange Flavour because it can affect how these medicines work.

-    Tetracyclines and quinolones (antibiotics)

-    Levothyroxine (a thyroid hormone)

-    Eltrombopag (used to increase the number of platelets)

-    Digoxin (used for some heart conditions)

-    Thiazide diuretics (water tablets to treat fluid retention and high blood pressure)

-    Fluorides (for preventing dental caries)

-    Phosphates (for clearing the bowel before a surgical procedure)

-    Iron supplements

•    To maximise the benefit of all medicines being used, take Rennie Orange Flavour at least

4 hours before or after taking eltrombopag and 1 to 2 hours after taking any other medicines.

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3.    HOW TO TAKE RENNIE* ORANGE FLAVOUR Adults and children over 12 years:

2 tablets to be sucked or chewed, as required, preferably 1 hour after meals and before bedtime. For heartburn an extra 2 tablets may be taken between these times. Do not take more than 16 tablets a day.

Children under 12 years: Not recommended.

|f symptoms persist after 14 days consult your pharmacist or doctor. Prolonged use should be pvoided.

pregnancy and breast-feeding:

Rennie Orange Flavour can be used during pregnancy and breast-feeding if taken as Instructed.

If you take more Rennie Orange Flavour than Vou should:

Drink plenty of water and consult your doctor or pharmacist. Symptoms of an overdose include pausea and vomiting, tiredness, constipation and piuscular weakness.

If you have any questions on the use of this product, ask your doctor or pharmacist.

4.    POSSIBLE SIDE EFFECTS

|.ike all medicines, Rennie Orange Flavour can cause side effects, although not everybody gets them.

^ide effects are unlikely at the recommended dose. |f you experience the following side effects stop Treatment immediately and seek medical advice. Rarely allergic reactions to ingredients have been Reported, e.g. rashes, itching, difficulty in breathing and swelling of the face, mouth or throat and Anaphylactic shock (anaphylactic shock is a severe sudden allergic reaction, symptoms of which are low blood pressure, shock, palpitations, difficulty in breathing, bronchospasm, skin reactions,

Abdominal pain or cramps, vomiting and diarrhoea).

Long term use of high doses can cause high blood levels of calcium, especially in people with kidney Conditions. Symptoms of this may include nausea, Vomiting, upset stomach, diarrhoea, tiredness, piuscular weakness, headache, kidney problems and impaired sense of taste. In exceptional cases, long term use of high doses can lead to milk alkali Ayndrome, which can cause high blood levels of Calcium._________________________

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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine. 5. HOW TO STORE RENNIE* ORANGE FLAVOUR

Keep out of the reach and sight of children.

Do not store above 25°C and keep in the original pack.

Do not use Rennie Orange Flavour after the expiry date which is stated on the carton and blister.

The expiry date refers to the last day of that month. Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required, t i These measures will help to protect the _20mm environment.

6. FURTHER INFORMATION

What Rennie Orange Flavour contains:

Each tablet contains the active ingredient: calcium carbonate 500mg.

The other ingredients are sucrose, potato starch, pregelatinised maize starch, magnesium stearate, talc, citric acid, saccharin, orange flavour, ponceau 4R (E124) and quinoline yellow (E104). What Rennie Orange Flavour looks like and the contents of the pack:

Rennie Orange Flavour are orange-coloured square tablets with rounded edges and are occasionally spotted.

Rennie Orange Flavour are available in packs of 8, 12,24,32,48,64,72,96,120 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder: Bayer pic, Consumer Care Division, Bayer House,

Strawberry Hill, Newbury, Berkshire, RG141JA, UK.

consumer.careiabayer.co.uk

Manufacturer: Delpharm Gaillard,

74240 Gaillard, France.

This leaflet was last revised in: June 2015

101871/0515GB Bayer

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