Bisodol Extra tablets

Země: Velká Británie

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivní složka:

Magaldrate; Alginic acid; Sodium bicarbonate

Dostupné s:

Forest Laboratories UK Ltd

ATC kód:

n/a

INN (Mezinárodní Name):

Magaldrate; Alginic acid; Sodium bicarbonate

Dávkování:

400mg ; 200mg ; 100mg

Léková forma:

Oral tablet

Podání:

Oral

Třída:

No Controlled Drug Status

Druh předpisu:

Never Valid To Prescribe As A VMP

Přehled produktů:

BNF:

Informace pro uživatele

Page 1 of 4
BISODOL EXTRA STRONG MINT TABLETS
LABEL-LEAFLET TEXT (USED ON 30 TABLETS PACK)
AS THIS IS TEXT, PLEASE NOTE THAT IF AN ARTWORK IS PRODUCED THAT THE
ACTUAL TEXT ON EACH
PAGE MAY VARY DEPENDING ON HOW THE TEXT FITS.
CARRIER:
Bisodol
®
Extra Strong Mint
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN
Forest logo
Forest Laboratories UK Limited,
Whiddon Valley, Barnstaple, North Devon, EX32 8NS, United Kingdom.
Barcode
PL 0108/0125
Malta MA 003/01402
Component code number
CARRIER SIDE:
BN:
EXP:
Pharmacode
LEAFLET FACE:
Page 1
BISODOL EXTRA STRONG MINT TABLETS – a unique triple action formula
to provide
effective, rapid relief from acid indigestion, heartburn and trapped
wind.
DOSAGE: Suck or chew one or two tablets as required. Not recommended
for children under
12 years. If symptoms persist, please consult your doctor. If you are
pregnant talk to your
doctor before using this medicine.
READ INSIDE THIS LABEL BEFORE FIRST USE.
REMOVE DISC UNDER CAP - IF MISSING DO NOT USE.
Each tablet contains: calcium carb. 522mg, light mag. carb. 68mg, sod.
bicarbonate 64mg.
Sodium content 18mg per tablet.
Also contains: saccharin, sugar.
Do not store above 25°C
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN
Forest logo
Forest Laboratories UK Limited, Whiddon Valley, Barnstaple, North
Devon, EX32 8NS,
United Kingdom.
PL 0108/0125
Malta MA 003/01402 Component code number 1
Barcode
Braille reads: mint tablets
Page 2 of 4
Page 9
worsening of symptoms. This is called rebound hyperacidity. Consult
your doctor if this
symptom does not go away.
If you have any further questions on the use of this product, ask your
pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Bisodol Extra Strong Mint Tablets can cause side
effects, although not
everybody gets them.
Some patients may experience side effects such as constipation or
diarrhoea.
9
Page 10
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
sid

Charakteristika produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Bisodol Extra Strong Mint Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredients per tablet:
Calcium Carbonate PhEur 522mg
Magnesium Carbonate Light PhEur 68mg
Sodium Bicarbonate PhEur 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, the 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
CONTRAINDICATIONS
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
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Antacids are known to reduce the absorption of certain medicines
including
tetracyclines and iron salts.
4.6
FERTILITY, 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 authorisation of the
medici