Bisodol Indigestion Relief Tablets

Country: Малта

Језик: Енглески

Извор: Medicines Authority

Активни састојак:

CALCIUM CARBONATE, MAGNESIUM CARBONATE, LIGHT, SODIUM HYDROGEN

Доступно од:

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

АТЦ код:

A02AH

INN (Међународно име):

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

Фармацеутски облик:

CHEWABLE TABLET

Састав:

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

Тип рецептора:

OTC

Терапеутска област:

DRUGS FOR ACID RELATED DISORDERS

Статус ауторизације:

Withdrawn

Датум одобрења:

2007-04-09

Информативни летак

BISODOL INDIGESTION RELIEF TABLETS, PIL TEXT
Page 1 of 5
AAAH6725
Bisodol
®
INDIGESTION RELIEF TABLETS
BISODOL
®
INDIGESTION RELIEF 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
Indigestion Relief 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 Indigestion Relief Tablets are and what they are used for
2.
Before you take Bisodol Indigestion Relief Tablets
3.
How to take Bisodol Indigestion Relief Tablets
4.
Possible side effects
5.
How to store Bisodol Indigestion Relief Tablets
6.
Further information
Tablet graphic
1.
WHAT BISODOL INDIGESTION RELIEF TABLETS ARE AND WHAT THEY ARE
USED FOR
Bisodol Indigestion Relief Tablets are antacids. They work by
neutralising excess
stomach acid.
Bisodol Indigestion Relief Tablets treat the pain and discomfort of
acid indigestion,
heartburn and trapped wind.
X graphic
2.
BEFORE YOU TAKE BISODOL INDIGESTION RELIEF TABLETS
DO NOT TAKE BISODOL INDIGESTION RELIEF 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 INDIGESTION RELIEF TABLETS

If you have been told by your doctor that you are intolerant to some
sugars,
speak to your doctor before taking Bisodol Indigestion Relief Tablets.
BISODOL INDIGESTION RELIEF TABLETS, PIL TEXT
Page 2 of 5

If you are following a controlled sodium diet, you

Карактеристике производа

Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Bisodol Indigestion Relief Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients:
Sodium Bicarbonate Ph.Eur.
64mg/tablet
Calcium Carbonate Ph.Eur.
522mg/tablet
Magnesium Carbonate Light Ph.Eur.
68mg/tablet
3.
PHARMACEUTICAL FORM
Chewable tablet for oral administration.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For
relief
of
the
symptoms
of
gastric
hyperacidity,
variously
called
indigestion,
heartburn, dyspepsia and flatulence.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults, elderly and children over 12 years:
Suck slowly or chew one or two tablets as required.
Children under 12 years:
Not recommended.
4.3
CONTRA-INDICATIONS
Hypophosphataemia, and avoid in patients with heart failure or renal
failure.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If symptoms persist, consult your doctor.
Keep all medicines out of the reach of children.
Not to be taken during the first three months of pregnancy.
4.5
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Page 2 of 5
Antacids are known to reduce the absorption of certain medicines
including tetracyclines
and iron salts.
4.6
PREGNANCY AND LACTATION
Animal studies are insufficient with respect to effects on
pregnancy/embryonal/foetal
development/parturition and postnatal development.
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 specific 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 authorisation of the
medicinal product is
important. It allows continued moni