CALAMINE

Main information

  • Trade name:
  • CALAMINE Cutaneous Suspension
  • Pharmaceutical form:
  • Cutaneous Suspension
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CALAMINE Cutaneous Suspension
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0074/047/001
  • Authorization date:
  • 12-12-1994
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CalamineLotion BP15%w/v CutaneousSuspension

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Calamine15%w/v

Forexcipientssee6.1.

3PHARMACEUTICALFORM

CutaneousSuspension

Apalepink liquid withafaintsmellofphenol.

4CLINICALPARTICULARS

4.1TherapeuticIndications

CalamineLotionisindicatedforthesymptomaticreliefofskinirritationduetosunburn,heatrashandallergic

reactions.

4.2Posologyandmethodofadminstration

RouteofAdministration:cutaneoususe

RecommendedDosageSchedule:

Apply to theaffected areas3-4 timesdaily orasdirected by thephysician.

4.3Contraindications

Thereareno contra-indicationsto theuseofCalamineLotion.

4.4Special warningsandspecialprecautionsforuse

Ifsymptomspersistconsultyourdoctor.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.6Pregnancyandlactation

Irish Medicines Board

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Date Issued 20/09/2005 CRN 2014882 page number: 1

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Noneknown.

4.9Overdose

Notapplicable

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Notapplicable.

5.2Pharmacokineticproperties

Notapplicable.

5.3Preclinical safetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

ZincOxide

Bentonite

SodiumCitrate

Phenol

Glycerol

Purified Water

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3 years.

6.4Special precautionsforstorage

Do notstoreabove25 o

Irish Medicines Board

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Date Issued 20/09/2005 CRN 2014882 page number: 2

6.5Natureandcontentsofcontainer

CalamineLotion isfilled into 500mland 200mlpolypropylenebottlesthatarefitted with polypropylenecircular

unwadded caps.

Notallpack sizesmay bemarketed.

6.6Instructionsforuseandhandling

Do notswallow, forcutaneoususeonly.

Shakewellbeforeuse.

7MARKETINGAUTHORISATIONHOLDER

RowaPharmaceuticalsLtd

Bantry

Co. Cork

8MARKETINGAUTHORISATIONNUMBER

PA74/47/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:12 th

December1994

Dateoflastrenewal:12 th

December2004

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Issued 20/09/2005 CRN 2014882 page number: 3