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

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
CALCIUM CARBONATE, MAGNESIUM CARBONATE LIGHT, SODIUM BICARBONATE
Available from:
Forest Laboratories UK Ltd
ATC code:
A02AC01
INN (International Name):
CALCIUM CARBONATE, MAGNESIUM CARBONATE LIGHT, SODIUM BICARBONATE
Dosage:
522/68/64 Milligram
Pharmaceutical form:
Tablets Chewable
Prescription type:
Product not subject to medical prescription
Therapeutic area:
Calcium compounds
Authorization status:
Authorised
Authorization number:
PA0100/046/001
Authorization date:
1999-08-23

dimensions:

pharmacode:

datesent: TechnicalApproval min pt size:

1. Profile

Bisodol Extra Strong Mint 522mg/68mg/64mg ChewableTablets x30 Back Label Leaflet - Ireland

awstudio@actavis.co.uk 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

09.04.15

08-09-15

55x204.5

PMS 286

PMS 288

PMS 354

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

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. Thisis 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

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 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

HPRA Pharmacovigilance,

Earlsfort Terrace,

IRL - Dublin 2;

Tel: +353 1 6764971;

Fax: +353 1 6762517.

Website: www.hpra.ie;

E-mail: medsafety@hpra.ie.

By reporting side effects you

information on the safety of

this medicine.

5.How to store Bisodol

Extra Strong Mint

Chewable Tablets

Keep this medicine out of the

sight and reach of children.

Keep the container tightly

closed.

Do not use this medicine

after the expiry date printed

on the pack after the

abbreviation ‘EXP’ . The expiry

date refers to the last day of

that month.

Do not store above 25°C.

Do not throw away any

medicine via wastewater or

household waste. Ask your

pharmacist how to throw

away medicines you no longer

use. These measures will help

6.Contents of the pack and

other information

What Bisodol Extra Strong

Mint Chewable Tablets

contain

The active ingredients are

calcium carbonate 522 mg,

magnesium carbonate, light

68 mg and sodium hydrogen

carbonate 64 mg.

The other ingredients are

saccharin sodium, maize starch,

sucrose, calcium stearate and

peppermint oil flavouring.

What Bisodol Extra Strong

Mint Chewable Tablets look

like and contents of the pack

Bisodol Extra Strong Mint are

Chewable Tablets. They are

round, white tablets with

Bisodol ESM imprinted on both

sides.

Bisodol Extra Strong Mint

in packs of 20, 30 and 100

tablets. Not all pack sizes may be

marketed.

Patients in the Republic of

Ireland with visual impairment

requiring this information in

other formats should telephone

Forest Laboratories UK Ltd

on +44 (0)1322 421800.

Marketing Authorisation

Holder

Forest Laboratories UK Ltd,

Whiddon Valley, Barnstaple,

North Devon, EX32 8NS,

United Kingdom.

Manufacturer

Brunel Healthcare

Manufacturing Ltd, Swadlincote,

Derbyshire, DE11 0BB, UK

PA 100/46/1

This leaflet was last revised in

June 2015

Package Leaflet:

Information for the user

BISODOL® EXTRA STRONG

MINT CHEWABLE TABLETS

Calcium Carbonate 522 mg,

Magnesium Carbonate, light

68 mg, Sodium Hydrogen

Carbonate 64 mg.

Read all of this leaflet carefully

before you start using this

medicine, because it contains

important information for you.

This medicine is available without

prescription. However, you still

need to take Bisodol Extra Strong

Mint Chewable Tablets carefully to

get the best results.

Always use this medicine

exactly as your doctor or

pharmacist has told you.

Keep this leaflet.You may need

Ask your pharmacist if you

need more information or

advice.

If you get any side effects, talk

to your doctor, pharmacist or

nurse. This includes any

possible side effects not listed

in this leaflet. See section 4.

You must contact a doctor if

your signs of illness worsen or

do not improve.

What is in this leaflet:

1. What Bisodol Extra

Strong Mint Chewable

Tablets are and what they are

used for

2. What you need to know

before you take Bisodol Extra

Strong Mint Chewable

Tablets

3. How to take Bisodol Extra

Strong Mint Chewable

Tablets

5. How to store Bisodol Extra

Strong Mint Chewable

Tablets

6. Contents of the pack and

other information.

1.What Bisodol Extra Stong

Mint Chewable Tablets are

and what they are used for

Bisodol Extra Strong Mint

Chewable Tablets are antacids.

They work by neutralising

excess stomach acid.

Bisodol Extra Strong Mint

Chewable Tablets treat the

pain and discomfort of acid

indigestion, heartburn and

trapped wind.

2. What you need to know

before you take Bisodol Extra

Strong Mint Chewable

Tablets

Do not take Bisodol Extra

Strong Mint Chewable

If you are allergic to any of

the ingredients of this

medicine (listed in

section 6).

If you have been told the

level of phosphate in your

blood is low (hypophos-

phataemia).

If you have kidney

problems.

If you have been told the

level of calcium in your

blood is high (hypercalcae-

mia) or the level of calcium

in your urine is high (hyper-

calciuria).

Warnings and Precautions

Talk to your Doctor or

Pharmacist before taking

Bisodol

Bisodol contains sodium and

This medicinal product also

contains sucrose. If you

have been told by your

doctor that you have an

intolerance to some sugars,

contact your doctor before

taking this medicinal

product.

May be harmful to the

teeth.

This medicinal product

contains 18 mg sodium per

tablet. To be taken into

consideration by patients

on a controlled sodium

diet.

Other medicines and Bisodol

Extra Strong Mint Chewable

Tablets

Tell your doctor or pharmacist

if you are taking, have

recently taken or might take

medicines obtained without a

prescription.

As with other antacids, Bisodol

Extra Strong Mint Chewable

Tablets may form complexes

with certain medicines, e.g.

tetracyclines, digoxin and

vitamins, resulting in their

decreased absorption.

Therefore this medicine should

not be administered within two

hours oftaking such medicines.

Bisodol Extra Strong Mint

Chewable Tablets may also

impede the absorption of

phosphates. If you are taking

iron tablets, speak to your

doctor or pharmacist before

taking Bisodol Extra Strong

Pregnancy and breast-feeding

Ask your doctor or pharmacist

for advice before taking any

medicine.

You should see your doctor if:

You are aged over 55 years

and experiencing heartburn

for the first time.

You have pain radiating to

your chest and arms.

You feel unwell.

You have unintentional

weight loss or loss of

appetite.

You have difficulty or pain

swallowing.

You are passing blood or

have dark bowel motions.

Information continues on

BISODOL EXTRA STRONG MINT

CHEWABLE 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.

For oral use.

READ INSIDE THIS LABEL BEFORE FIRST

USE. REMOVE DISC UNDER CAP –

IF MISSING DO NOT USE.

Each tablet contains:

Calcium Carbonate 522 mg,

Magnesium Carbonate, light

68 mg, Sodium Hydrogen

Carbonate 64 mg.

Sodium content 18 mg per tablet.

Also contains: saccharin sodium,

sucrose, see leaflet for further

information.

Do not store above 25°C

Keep the container tightly closed

KEEP OUT OF THE SIGHT

AND REACH OF CHILDREN

PA 100/46/1

Forest Laboratories UKLtd.,

Whiddon Valley, Barnstaple,

Forest Laboratories UKLtd.,

Whiddon Valley, Barnstaple,

North Devon, EX32 8NS, United Kingdom.

1439 8 00151 3

1439 8 00151 3

AAAH7852

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BisodolExtraStrongMintChewableTablets

Calciumcarbonate522mg

Magnesiumcarbonatelight68mg

Sodiumhydrogencarbonate64mg

2QUALITATIVEANDQUANTITATIVECOMPOSITION

3PHARMACEUTICALFORM

Chewabletablet

Circular,smooth,chewabletabletwithbevellededgesandimpressed‘BisodolESM’onbothsides.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Inthereliefofsymptomsofindigestion,dyspepsia,heartburn,acidityandflatulence.

4.2Posologyandmethodofadministration

Posology

Adults

Oneortwotabletsasrequired.

Paediatricpopulation

Childrenunder12years:notrecommended

Donottakemorethan12tabletsin24hours.

Methodofadministration

BisodolChewableTabletsaretobeadministeredorally.

4.3Contraindications

Hypersensitivitytotheactivesubstancesortoanyoftheexcipientslistedinsection6.1.

Hypophosphataemia.Avoidinpatientswithrenalfailure.

Eachchewabletabletcontains:

Calciumcarbonate 522 mg

Magnesiumcarbonatelight 68 mg

Sodiumhydrogencarbonate 64 mg

Excipientswithknowneffect:

Eachchewabletabletalsocontainssucrose538.1mg

Eachchewabletabletalsocontainssodium18mg

Health Products Regulatory Authority

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Date Printed 12/07/2016 CRN 2177284 page number: 1

4.4Specialwarningsandprecautionsforuse

Magnesiumsaltsmaycausecentralnervousdepressioninthepresenceofrenalinsufficiency.

Personswithkidneydiseaseorreceivingmedicaltreatmentshouldconsulttheirdoctorbeforeusing.

Prolongeduseshouldbeavoided.Ifsymptomspersist,medicaladviceshouldbesought.

Donotexceedthestateddoseexceptonmedicaladvice.

Ingestionoflargeamountsofantacidtabletsmaycausemilk-alkalisyndrome.

Thismedicinalproductcontainssucrose:Patientswithrarehereditaryproblemsoffructoseintolerance,

glucose-galactosemalabsorptionorsucrose-isomaltaseinsufficiencyshouldnottakethismedicine.

Thismedicinalproductcontains18mgsodiumpertablet.Tobetakenintoconsiderationbypatientsonacontrolled

sodiumdiet.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Aswithotherantacids,BisodolExtraStrongMintChewableTabletsmayformcomplexeswithcertaindrugse.g.

tetracyclines,ironsalts,vitaminsanddigoxin,resultingindecreasedabsorption.BisodolExtraStrongMintChewable

Tabletsshouldnotbeadministeredwithintwohoursoftakingsuchdrugs.BisodolExtraStrongMintChewableTablets

canalsoimpedetheabsorptionofphosphates.

4.6Fertility,pregnancyandlactation

Animalstudiesareinsufficientwithrespecttoeffectsonpregnancy/embryonal/foetaldevelopment/parturitionand

postnataldevelopment.

Cautionshouldbeexercisedwhenprescribingtopregnantwomen.

4.7Effectsonabilitytodriveandusemachines

Notapplicable.

4.8Undesirableeffects

Calciumsaltscanhaveaconstipatingeffectandmagnesiumsaltscanhavealaxativeeffect.Thespecificmixtureof

antacidsisintendedtoavoidthelowergastrointestinaleffectsseenwithsingleantacidpreparations.Nosideeffectsare

associatedwithsodiumbicarbonateexceptwhentakeninexcess.

Reboundhyperaciditymayoccurwithprolongedusage.

Magnesiumsaltsmaycausecentralnervousdepressioninthepresenceofrenalinsufficiency.

Reportingofsuspectedadversereactions

Reportingsuspectedadversereactionsafterauthorisationofthemedicinalproductisimportant.Itallowscontinued

monitoringofthebenefit/riskbalanceofthemedicinalproduct.Healthcareprofessionalsareaskedtoreportany

suspectedadversereactionsviaHPRAPharmacovigilance,EarlsfortTerrace,IRL–Dublin2;Tel:+35316764971;

Fax:+35316762517.Website: www.hpra.ie ;E-mail: medsafety@hpra.ie .

4.9Overdose

Chronicintakecanleadtohypercalcaemia,hypercalciuria,nephrolithiasis,metabolicalkalosisandrenalinsufficiency.

Health Products Regulatory Authority

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Date Printed 12/07/2016 CRN 2177284 page number: 2

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Sodiumbicarbonate,calciumcarbonateandmagnesiumcarbonateareantacids.Theyactbyneutralisingthehydrochloric

acidproducedbythestomachandthusreducinggastricandduodenalirritation.

5.2Pharmacokineticproperties

Calciumcarbonate:Calciumcarbonateisconvertedtocalciumchloridebygastricacid.Someofthecalciumis

absorbedfromtheintestinesbutabout85%isreconvertedtoinsolublecalciumsalts,suchasthecarbonateandis

excretedinthefaeces.

Magnesiumcarbonate:Magnesiumcarbonatereactswithgastricacidtoformsolublemagnesiumchlorideandcarbon

dioxideinthestomach.Somemagnesiumisabsorbedbutisusuallyexcretedrapidlyintheurine.

Sodiumbicarbonate:Administrationofsodiumbicarbonatebymouthcausesneutralisationofgastricacidwiththe

productionofcarbondioxide.Bicarbonatenotinvolvedinthatreactionisabsorbed.Intheabsenceofadeficitof

bicarbonateintheplasma,bicarbonateionsareexcretedintheurine,whichisrenderedalkalinewithanaccompanying

diuresis.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

SaccharinSodium

MaizeStarch

Sucrose

CalciumStearate

Peppermintessentialoil

6.2Incompatibilities

Notapplicable.

6.3Shelflife

5years

6.4Specialprecautionsforstorage

Donotstoreabove25 o

Keepthecontainertightlyclosed.

6.5Natureandcontentsofcontainer

Polypropylenecontainerswithapolypropylenelid,containing30tablets.

Health Products Regulatory Authority

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Date Printed 12/07/2016 CRN 2177284 page number: 3

Waxlaminatedfoilrollswithpaperlabelinacardboardoutercarton,containing5rollsof20tablets.

6.6Specialprecautionsfordisposalandotherhandling

Nospecialrequirementsfordisposal.Anyunusedmedicinalproductorwastematerialshouldbedisposedofin

accordancewithlocalrequirements.

7MARKETINGAUTHORISATIONHOLDER

ForestLaboratoriesUKLimited

WhiddonValley

Barnstaple

NorthDevon

EX328NS

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA0100/046/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:23August1999

Dateoflastrenewal:23August2009

10DATEOFREVISIONOFTHETEXT

Health Products Regulatory Authority

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Date Printed 12/07/2016 CRN 2177284 page number: 4

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