BALMOSA CREAM

Main information

  • Trade name:
  • BALMOSA CREAM
  • Pharmaceutical form:
  • Cream
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BALMOSA CREAM
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1443/001/001
  • Authorization date:
  • 23-11-2007
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA1443/001/001

CaseNo:2043305

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

TransferredfromPA0100/015/001.

GalenConsumerLtd.

212-220AddingtonRoad,Selsdon,SouthCroydon,SurreyCR28LD,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

BalmosaCream

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom23/11/2007until31/03/2008.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 27/11/2007 CRN 2043305 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BalmosaCream

2QUALITATIVEANDQUANTITATIVECOMPOSITION

3PHARMACEUTICALFORM

Cream

Smoothhomogeneousoff-whitecreamwithcharacteristicodour.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthetopicalmanagementofthesymptomsofmusculofibroarticulardisorderssuchasrheumatism,fibrositis,

lumbago,sciaticaandunbrokenchilblains.

4.2Posologyandmethodofadministration

Gentlyrubintothepainfulareaandkeepcovered,ifpossible.

4.3Contraindications

Patientswithahistoryofhypersensitivitytoanyoftheactivesubstancesorexcipients.

4.4Specialwarningsandprecautionsforuse

Skinsensitivityreactionsarepossible,althoughrareinoccurrence.

Contactwitheyesandallmucousmembranesshouldbeavoidedandthehandsshouldbewashedthoroughlyafter

applyingthecream.Useshouldbediscontinuedifanyevidenceofirritationappears.Applyonlytounbrokenskin.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Nonestated.

4.6Pregnancyandlactation

Activesubstances:

Menthol,racemic 2.0 %w/w

Camphor,racemic 4.0 %w/w

MethylSalicylate 4.0 %w/w

CapsicumOleoresin 0.035%w/w

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 27/11/2007 CRN 2043305 page number: 2

4.7Effectsonabilitytodriveandusemachines

Nonestated.

4.8Undesirableeffects

Skinsensitivityreactionsarepossiblealthoughrare.

4.9Overdose

Overdosageisextremelyunlikelyfromtopicaluse.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Capsicumoleoresinisarubefacient.Camphorexhibitscounter-irritantandweaklocalanaestheticactivity.Mentholand

methylsalicylateimpartanalgesicpropertiestotheformulation.

5.2Pharmacokineticproperties

Notapplicable.

5.3Preclinicalsafetydata

Therearenopreclinicaldataofrelevancetotheprescriberwhichareadditionaltothatalreadyincludedinother

sectionsoftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Methylcellulose

Whitesoftparaffin

Emulsifyingwax

Liquidparaffin

Woolfat

Phenonipcontaining:

Phenoxyethanol

Methylparahydroxybenzoate

Propylparahydroxybenzoate

Purifiedwater

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 27/11/2007 CRN 2043305 page number: 3

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

Internallylacqueredaluminiumtubewithpolyethylenecapcontaining20gor40gofcream.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

GALENCONSUMERLTD

212-220

AddingtonRoad

Selsdon

SouthCroydon

Surrey

CR28LD

8MARKETINGAUTHORISATIONNUMBER

PA1443/1/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:01April1978

Dateoflastrenewal:01April2003

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 27/11/2007 CRN 2043305 page number: 4