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Setlers Antacid Chewable Tablets Spearmint Flavour

Document: leaflet MAH BRAND_PL 00240-0121 change

Setlers Antacid Chewable Tablets Spearmint Flavour

(calcium carbonate)

Important information about Setlers Antacid

Chewable Tablets

•    This medicine relieves symptoms of indigestion and heartburn.

•    It can be taken by adults and children over 6 years.

Do not take....

•    At exactly the same time as other medicines. See section 2.

Talk to your doctor..

•    If your symptoms keep occurring or last a long time.

Now read the rest of the leaflet before you use

this medicine. It includes other information

which might be especially important for you.

•    Keep this leaflet. You may need to read it again.

•    Ask your pharmacist if you need any more information or advice.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.


1.    What the medicine is for

Setlers Antacid Chewable Tablets contain calcium carbonate to neutralize excess stomach acid. They are used to relieve the symptoms of acid indigestion, heartburn, wind and nausea (feeling sick).

2.    Before you use this medicine

□ t use the medicine if you have..

•    An allergy to any of the ingredients listed in section 6.

•    Kidney or liver problems.

•    Kidney stones.

•    High calcium levels in your blood or urine.

   A low phosphate diet.

•    Or are taking cardiac glycosides (e.g. digoxin).

A Talk to your doctor or pharmacist if you have..

Ever had kidney stones.

Sarcoidosis (inflammation that produces lumps of cells in various organs in the body).

• Any other disease where your blood calcium levels are already high.


Talk to your doctor or pharmacist if you are taking ..

•    Digoxin for heart failure.

•    Tetracycline or Ciprofloxacin for infections.

•    Bisphosphonates for osteoporosis.

•    Medicines to remove fluids from the body (e.g. water tablets).

•    Eltrombopag to increase blood platelet levels.

•    Fluoride to prevent tooth decay.

•    Zinc or vitamin D (dietary supplements).

•    Oral iron for anaemia.

•    Levothyroxine for underactive thyroid gland.

•    Medicines with an enteric coating (prevents disintegration in the stomach).

Taking any other medicines - these tablets may affect some other medicines you may be taking, and they should not be taken at the same time as or within 3 hours of taking other medicines.

Pregnant or breastfeeding..

Ask your doctor or pharmacist for advice before using this medicine if you are pregnant, might be pregnant or are breastfeeding.


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MHRA Header Box

Product

Title

Setlers Antacid Chewable Tablets Spearmint Calcium Carbonate

Colours Used

Fonts Used

Process Black

Helvetica Neue

Component

Leaflet

Keyline (Does not print)

Pack Size

36's

IG Code

24795002

Dimensions

200 x 110mm

Proof No.

1 Date 24.06.2014


Important information about some of k the ingredients


•    This product contains 0.47g of sucrose per tablet. To be taken into account in people with diabetes.

If you have an intolerance to some sugars, contact your doctor before taking this medicine.

•    Spearmint Flavour (containing sulphur dioxide E220) may rarely cause severe hypersensitivity reactions and bronchospasm.


3. How to use this medicine

Suck or chew the tablets.

Adults, the elderly and children over 12

Take 1 or 2 tablets when required (maximum 16 per day).

Children 6-12 yrs: Take 1 tablet when required (maximum 4 per day).

□ Children under 6 years

Do not give to children under 6 unless your doctor tells you to.

If you take too many

If you accidentally take too many tablets, see a doctor straight away. Take the pack with you to show which medicine you have swallowed.


4.    Possible side effects

Like all medicines, Setlers Antacid Chewable Tablets can have side effects, although these don't affect everyone.

•    May cause stomach problems including wind and constipation.

•    May cause a return of acid indigestion after initial relief of symptoms.

•    May rarely cause severe hypersensitivity reactions and bronchospasm.

If you notice these or any other side effect not included above, stop use and tell your doctor or pharmacist. They will tell you what to do.

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.    Storing this medicine

•    Keep it out of the sight and reach of children.

•    Store in the original pack.

•    Do not use after the expiry date shown on the carton. The expiry date refers to the last day of that month.


• Medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicine. These measures will help to protect the environment.

6. Further information

What is in this medicine

The active ingredient per tablet is: calcium

carbonate 500mg.

The other ingredients are: sucrose, glucose, maize starch, maltodextrin, talc, magnesium stearate, spearmint flavour, adipic acid.

What the medicine looks like

Setlers Antacid Chewable Tablets are round white tablets with bevelled edges and ‘Setlers' engraved on both faces.

They are supplied in packs of 36 tablets.

Marketing authorisation holder

Thornton and Ross Ltd., Huddersfield, HD7 5QH, UK.

Manufacturer

Brunel Healthcare Manufacturing Ltd,

William Nadin Way, Swadlincote,

Derbyshire, DE11 0BB, UK.

This leaflet was revised in August 2014

24795002


MHRA Header Box

Product

Title

Setlers Antacid Chewable Tablets Spearmint Calcium Carbonate

Colours Used

Fonts Used

Process Black

Helvetica Neue

Component

Leaflet

Keyline (Does not print)

Pack Size

36's

IG Code

24795002

Dimensions

200 x 110mm

Proof No.

1 Date 24.06.2014