BRADOSOL PLUS

Main information

  • Trade name:
  • BRADOSOL PLUS
  • Dosage:
  • 0.5mg/5mg Per Cent
  • Pharmaceutical form:
  • Lozenges
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BRADOSOL PLUS
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0030/037/001
  • Authorization date:
  • 08-03-1994
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BradosolPlusLozenges

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each lozengecontains:

Domiphen Bromide0.5 mg

LidocaineHydrochloride5.0 mg

Forexcipients, see6.1.

3PHARMACEUTICALFORM

Abrightgreen, flat-biconvex cylindricallozenge.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Asan adjunctin themanagementofsuperficialinfectionsofthemouth and oropharynx.

4.2Posologyandmethodofadminstration

Adultsand Children over12 yearsonly:

Onelozengeto besucked every 2-3 hoursasrequired

Amaximumnumberof8 lozengesperday should notbeexceeded

Method ofadministration: Oromucosaluse

4.3Contraindications

Usein patientshypersensitiveto theactiveingredients.

4.4Special warningsandspecialprecautionsforuse

Thelocalanaestheticmay affectswallowing reflexes.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

None.

4.6Pregnancyandlactation

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Issued 30/08/2005 CRN 2014252 page number: 1

4.7Effectsonabilitytodriveandusemachines

None.

4.8Undesirableeffects

Thisproductmay giveriseto allergicreactions,sensitisation may also develop.

4.9Overdose

No information given.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Antiseptic/localanaestheticcombination lozenge.

5.2Pharmacokineticproperties

No information given.

5.3Preclinical safetydata

No information given.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Citricacid monohydrate

Menthol

Eucalyptusoil

Quinolineyellow(E104)

Indigo carmine(E132)

AcesulfamePotassium

Isomalt

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

1 year.

6.4Special precautionsforstorage

Do notstoreabove25 o

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Issued 30/08/2005 CRN 2014252 page number: 2

6.5Natureandcontentsofcontainer

PVC/PVDCblisterpacks.

Pack size:20, 24 lozenges.

Notallpack sizesmay bemarketed.

6.6Instructionsforuseandhandling

No specialrequirements.

7MARKETINGAUTHORISATIONHOLDER

NovartisConsumerHealth UKLimited,

Trading asNovartisConsumerHealth,

WimblehurstRoad,

Horsham,

WestSussex,

RH125AB,

England.

8MARKETINGAUTHORISATIONNUMBER

PA30/37/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:3 rd

March1989

Dateoflastrenewal:3 rd

March2004

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Issued 30/08/2005 CRN 2014252 page number: 3