Bisodol Extra Strong Mint Tablets

Riik: Malta

keel: inglise

Allikas: Medicines Authority

Toimeaine:

CALCIUM CARBONATE, MAGNESIUM CARBONATE, LIGHT, SODIUM HYDROGEN

Saadav alates:

Forest Laboratories UK Limited Whiddon Valley, Barnstaple North Devon, EX32 8NS, United Kingdom

ATC kood:

A02AH

INN (Rahvusvaheline Nimetus):

CALCIUM CARBONATE 522 mg MAGNESIUM CARBONATE, LIGHT 68 mg SODIUM HYDROGEN CARBONATE 64 mg

Ravimvorm:

CHEWABLE TABLET

Koostis:

CALCIUM CARBONATE 522 mg MAGNESIUM CARBONATE, LIGHT 68 mg SODIUM HYDROGEN CARBONATE 64 mg

Retsepti tüüp:

OTC

Terapeutiline ala:

DRUGS FOR ACID RELATED DISORDERS

Volitamisolek:

Withdrawn

Loa andmise kuupäev:

2007-04-09

Infovoldik

1 of 3
Bisodol
®
Extra Strong Mint Tablets
BISODOL
®
EXTRA STRONG MINT TABLETS
Calcium Carbonate 522 mg, Light Magnesium Carbonate 68 mg, Sodium
Bicarbonate 64 mg.
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to take Bisodol Extra
Strong Mint Tablets carefully to get the best results from it.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

You must contact a doctor if your symptoms worsen or do not improve.

If any of the side effects get serious, or if you notice any side
effect not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Bisodol Extra Strong Mint Tablets are and what they are used for
2.
Before you take Bisodol Extra Strong Mint Tablets
3.
How to take Bisodol Extra Strong Mint Tablets
4.
Possible side effects
5.
How to store Bisodol Extra Strong Mint Tablets
6.
Further information
Diagram scored tablet
1. WHAT BISODOL EXTRA STRONG MINT TABLETS ARE AND WHAT THEY ARE USED
FOR
Bisodol Extra Strong Mint Tablets are antacids. They work by
neutralising excess stomach acid.
Bisodol Extra Strong Mint Tablets treat the pain and discomfort of
acid indigestion, heartburn and
trapped wind.
Diagram X
2. BEFORE YOU TAKE BISODOL EXTRA STRONG MINT TABLETS
DO NOT TAKE BISODOL EXTRA STRONG MINT TABLETS:

If you are allergic to any of the ingredients (see Section 6 for
ingredients),

If you have been told the level of phosphate in your blood is low
(hypophosphataemia),

If you have heart or kidney problems.
TAKE SPECIAL CARE WITH BISODOL EXTRA STRONG MINT TABLETS

If you have been told by your doctor that you are intolerant to some
sugars, speak to your doctor
before taking Bisodol Extra Strong Mint Tablets.

If you are following a controlled sodium diet, you should take into
consideration that each tablet
contains 18mg of sodium.
TAKING OTHER MEDICINES
If you are taking tetracy

Toote omadused

Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Bisodol Extra Strong Mint Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients per tablet:
Calcium Carbonate Ph.Eur.
522m g
Magnesium Carbonate Light Ph.Eur.
68mg
Sodium Bicarbonate Ph.Eur.
64mg
3.
PHARMACEUTICAL FORM
Chewable tablet
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For relief from indigestion, dyspepsia, heartburn, acidity and
flatulence.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults, elderly and children over 12 years:
Take one or two tablets as required. Suck slowly or chew as preferred.
Children below 12 years: Not recommended.
4.3
CONTRA-INDICATIONS
Hypophosphataemia, and avoid in patients with heart or renal failure.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The label will contain the following statements:
1. If symptoms persist, consult your doctor.
2. Keep all medicines out of the reach of children.
3. Not to be taken during the first three months of pregnancy.
4.5
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Antacids
are
known
to
reduce
the
absorption
of
certain
medicines
including
Page 2 of 4
tetracyclines and iron salts.
4.6
PREGNANCY AND LACTATION
No clinical data on exposed pregnancies are available.
Animal studies do not indicate direct or indirect harmful effects with
respect to
pregnancy, embryonal/foetal development, parturition or postnatal
development (see
section 5.3).
Caution should be exercised when prescribing to pregnant
women.
4.7
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None stated
4.8
UNDESIRABLE EFFECTS
Calcium
salts
can
have
a
constipating
effect
and
magnesium
salts
can
have
a
laxative
effect.
The
mixture
of
antacids
is
intended
to
avoid
the
lower
gastrointestinal
effects
seen
with
single
antacid
preparations.
No
side
effects
associated with sodium bicarbonate except when taken in excess.
Rebound hyperacidity may occur with prolonged dosage.
REPORTING OF SUSPECTED ADVERSE REACTIONS
Reporting suspected adverse reactions after