CALAMINE B.P.

Main information

  • Trade name:
  • CALAMINE B.P.
  • Dosage:
  • 15, 5 %w/v
  • Pharmaceutical form:
  • Cutaneous Suspension
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CALAMINE B.P.
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0095/021/001
  • Authorization date:
  • 27-04-1993
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CalamineLotionBP

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Calamine15%w/vandZincOxide5%w/v.

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Cutaneoussuspension

Pinkcutaneoussuspension.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Calaminelotionhasmildastringentandsoothingproperties.Itisindicatedforthemanagementofminorpruritic

conditions.

4.2Posologyandmethodofadministration

Fortopicaluse.Shakebottlebeforeuse.

Applytoaffectedareathreetimesdailyasrequired.

4.3Contraindications

None.

4.4Specialwarningsandprecautionsforuse

Thisproductisforexternaluseonly.

Ifsymptomspersistorworsenconsultyourdoctor.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

None.

4.6Pregnancyandlactation

Safetyinpregnancyhasnotbeenestablished.

4.7Effectsonabilitytodriveandusemachines

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 11/07/2006 CRN 2025353 page number: 1

4.8Undesirableeffects

Noneknown.

4.9Overdose

NotApplicable.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

CalamineLotionactslocallyontheskinandhasmildastringentandsoothingproperties.

5.2Pharmacokineticproperties

Noinformationavailable.

5.3Preclinicalsafetydata

CalamineandZincOxidearewellestablisheddrugsubstancesandhavebeenwidelyusedformanyyears.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Bentonite

SodiumCitrate

Phenol

Glycerol

PurifiedWater

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

2years.

6.4Specialprecautionsforstorage

Donotstoreabove25ºC.

6.5Natureandcontentsofcontainer

AmberTypeIIIsodaglassbottleswithLDPEliner,unlinedPPorPPscrewcapswithawoodpulpwaddingand

aluminiumfoilcontactlayercontaining125ml,250mlor500mlofsuspension.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 11/07/2006 CRN 2025353 page number: 2

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Shakebottlebeforeuse.

7MARKETINGAUTHORISATIONHOLDER

RiceSteeleManufacturingLimited

CookstownIndustrialEstate

Tallaght

Dublin24

8MARKETINGAUTHORISATIONNUMBER

PA95/21/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:27April1993

Dateoflastrenewal:27April2003

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 11/07/2006 CRN 2025353 page number: 3