BISODOL EXTRA STRONG MINT 522/68/64 Milligram Tablets Chewable

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

CALCIUM CARBONATE, MAGNESIUM CARBONATE LIGHT, SODIUM BICARBONATE

Disponible desde:

Forest Laboratories UK Ltd

Código ATC:

A02AC01

Designación común internacional (DCI):

CALCIUM CARBONATE, MAGNESIUM CARBONATE LIGHT, SODIUM BICARBONATE

Dosis:

522/68/64 Milligram

formulario farmacéutico:

Tablets Chewable

tipo de receta:

Product not subject to medical prescription

Área terapéutica:

Calcium compounds

Estado de Autorización:

Authorised

Fecha de autorización:

1999-08-23

Información para el usuario

dimensions: 
pharmacode: 
date sent:
TECHNICAL APPROVAL
min pt size:
1. Profile
2. Silicone   
Bisodol Extra Strong Mint 522mg/68mg/64mg Chewable Tablets x30 Back
Label Leaflet - Ireland
[e-mail]
print proof no: 
item no: 
origination date: 
originated by: 
revision date: 
supplier:
technically app. date*: 
Non Printing Colours
colours/plates
3.  
revised by: 
approved for print/date
AAAH7852
11
09.04.15
DR
08-09-15
SA
IL/Brunel Healthcare
55x204.5
5pt
09.04.15
1.
2.
3.
4.
5.
6.
PMS 286
PMS 288
PMS 354
 2
3
6
5
4
7
8
9
10
2
1
1
1
13
1
4
1
PA 100/46/1
AAAH7852
PHARM
ACODE
3.  HOW TO TAKE BISODOL EXTRA 
STRONG MINT CHEWABLE 
TABLETS
Always take this medicine 
exactly as your doctor or 
pharmacist has told you. Check 
with your doctor or pharmacist 
if you are not sure.
THE RECOMMENDED DOSE IS:  
•  ADULTS, THE ELDERLY AND 
CHILDREN OVER 12 YEARS
Suck or chew one or two 
tablets, as required.
•  CHILDREN UNDER 12 YEARS 
NOT RECOMMENDED. 
Do not take more than 12 
tablets in 24 hours.
Prolonged use should be 
avoided. If symptoms persist 
medical advice should be 
sought.
IF YOU TAKE MORE BISODOL EXTRA 
STRONG MINT CHEWABLE TABLETS 
THAN YOU SHOULD
It is unlikely that they will cause 
you any harm.
However, you may experience 
constipation, diarrhoea or feel 
bloated. Consult your doctor if 
these symptoms do not go 
away.
IF YOU STOP TAKING BISODOL EXTRA 
STRONG MINT CHEWABLE TABLETS
If you stop taking this medicine 
after you have been taking it for 
a long time, you may suffer a 
temporary 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 medicine, ask 
your pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this 
medicine can cause side 
effects, although not 
everybody gets them. 
Some patients may experience 
side effects such as 
constipation or diarrhoea.
REPORTING OF SIDE EFFECTS
If you get any side effe

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bisodol Extra Strong Mint Chewable Tablets
Calcium carbonate 522mg
Magnesium carbonate light 68mg
Sodium hydrogen carbonate 64mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Chewable tablet
Circular, smooth, chewable tablet with bevelled edges and impressed ‘Bisodol ESM’ on both sides.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the relief of symptoms of indigestion, dyspepsia, heartburn, acidity and flatulence.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Adults_
One or two tablets as required.
_Paediatric population_
Children under 12 years: not recommended
Do not take more than 12 tablets in 24 hours.
Method of administration
Bisodol Chewable Tablets are to be administered orally.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Hypophosphataemia. Avoid in patients with renal failure.
Hypercalcaemia and hypercalciuria.
Each chewable tablet contains:
Calcium carbonate
522
mg
Magnesium carbonate light
68
mg
Sodium hydrogen carbonate
64
mg
Excipients with known effect:
Each chewable tablet also contains sucrose 538.1mg
Each chewable tablet also contains sodium 18mg
For the full list of excipients, see section 6.1.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 12/07/2016_
_CRN 2177284_
_page number: 1_
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Magnesium salts may cause central nervous depression in the presence of renal insufficiency.
Persons with kidney disease or receiving medical treatment should consult their doctor before using.
Prolonged use should be avoided. If symptoms persist, medical advice should be sought.
Do not excee