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SETLERS ANTACID CHEWABLE TABLETS PEPPERMINT FLAVOUR

Active substance(s): CALCIUM CARBONATE

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Transcript
(calcium carbonate)

are used to relieve the symptoms of acid indigestion,
heartburn, wind and nausea (feeling sick).

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.

2. Before you use this medicine

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.

Do not 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).

Talk to your doctor or pharmacist if
you have….

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.

• 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).

P12462

What the medicine is for
Setlers Antacid Chewable 1.
Setlers Antacid Chewable Tablets contain calcium
Tablets Peppermint Flavour carbonate to neutralize excess stomach acid. They

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.

Turn over

Continued..

24796902

TEXT
FREE
AREA
18mm

5mm

36's and 96's

IG Code

24796902

Dimensions

200 x 110mm

Proof No.

1

Date

Process Black

Helvetica

Keyline (Does not print)

Helvetica Neue

24.06.2014

PCP Header Box
Operator

Approved by
Date

gill.kennedy

Artwork No 523014
Suf fix

CRN

11256

Reason for
Change

Update to reporting of side effects
statement

A

Issued by
Date

MHRA/IMB
submission Yes
required

fold

Pack Size

Fonts Used

1st bar

Leaflet

last bar

Component

Colours Used

fold

Setlers Antacid Chewable Tablets
Peppermint Calcium Carbonate

fold central

Product
Title

front of leaflet

Leaflet Size:
200 x 110mm
height x width

fold

fold

MHRA Header Box

Direction of Travel

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.
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.

• 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.

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).
(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

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.

Children 6-12 yrs: Take 1 tablet when required

5. Storing this medicine

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

• 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.

MHRA Header Box
Product
Title

Setlers Antacid Chewable Tablets
Peppermint Calcium Carbonate

Component

Leaflet

Pack Size

36's and 96's

IG Code

24796902

Dimensions

200 x 110mm

Proof No.

1

Date

Colours Used

Process Black

Helvetica

Keyline (Does not print)

Helvetica Neue

24.06.2014

PCP Header Box
Operator

Approved by
Date

gill.kennedy

Artwork No 523014
Suf fix

CRN

11256

Reason for
Change

Update to reporting of side effects
statement

A

Issued by
Date

MHRA/IMB
submission Yes
required

Fonts Used

•M
 edicine 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.

P12462

4. Possible side effects

Important information about some of
the ingredients

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,
peppermint 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 and
96 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

24796902

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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