CALENDOLON 20 %v/w Ointment

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
CALENDULA OFFICINALIS
Available from:
Weleda (UK) Limited
ATC code:
D03
INN (International Name):
CALENDULA OFFICINALIS
Dosage:
20 %v/w
Pharmaceutical form:
Ointment
Prescription type:
Product not subject to medical prescription
Therapeutic area:
PREPARATIONS FOR TREATMENT OF WOUNDS & ULCERS
Authorization status:
Authorised
Authorization number:
PA0407/005/001
Authorization date:
1991-10-11

IRISHMEDICINESBOARDACT1995

MEDICINALPRODUCTS(LICENSINGANDSALE)REGULATIONS,1998

(S.I.No.142of1998)

PA0407/005/001

CaseNo:2021991

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

Weleda(UK)Limited

HeanorRoad,Ilkeston,DerbyshireDE78DR,England

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

CalendolonOintment20%v/vCalendulaofficinalisointment

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom11/10/2006.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 24/10/2006 CRN 2021991 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CalendolonOintment20%v/wCalendulaOfficinalisOintment

2QUALITATIVEANDQUANTITATIVECOMPOSITION

20mltinctureofCalendulaofficinalisLfreshplant(1=2)in43%w/wethanolper100gointment.

Excipient:Contains32%w/wwoolfat

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Ointment.

Asmooth,homogeneous,paleyellowcutaneousointment,withafaintodourcharacteristicofwoolfat.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthetreatmentofcuts,minorwoundsandabrasions.

Fortopicalapplicationonly.

4.2Posologyandmethodofadministration

Cleansetheaffectedareaandapplytotheaffectedpartdirectoronadrydressingtwoorthreetimesdailyuntilthe

conditionclears.

Childrenandtheelderly:Fortheaboveconditionswhereapplicabletothesegroups,thereisnodifferenceinthe

dosagebetweenchildren,adultsandtheelderly.

4.3Contraindications

HypersensivitytotheactivesubstanceCalendulaofficinalistincture,ortotheexcipientslanolinorbeeswax.

4.4Specialwarningsandprecautionsforuse

Noneknown.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 24/10/2006 CRN 2021991 page number: 2

4.6Pregnancyandlactation

Pregnancy:ForCalendulaofficinalistincturenoclinicaldataonexposedpregnanciesisavailable.Animalstudies

donotindicatedirectorindirectharmfuleffectswithrespecttopregnancy,embryonal/foetaldevelopment,postuntion

orpostnataldevelopment(see5.3.)Cautionshouldbeusedwhenprescribingtopregnantwemen.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Contactsensitisationhasbeenreported.

MeDRAclass021:Frequencey005.

4.9Overdose

Thereisnoknowndataonoverdose.Therearenogroundsforsupposingthatanyadverseeffectswouldresultfrom

singleorrepeatedexcessivetopicalapplicationofthisproduct.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Phamacotherapeuticgroup:Preparationsforthetreatmentofwoundsandulcers.

ATCcode:D03

Noinformationinthisareaispresentlyavailable.

5.2Pharmacokineticproperties

Noinformationinthisareaispresentlyavailable.

5.3Preclinicalsafetydata

Thisproducthasbeenmarketedforover30years.Thissectionisthereforenotapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Ointmentbasecontains:

Woolalcohols

YellowBeeswax

WoolFat(Anhydrouslanolin)

Oliveoil,virgin

Sunfloweroil,refined

6.2Incompatibilities

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 24/10/2006 CRN 2021991 page number: 3

6.3ShelfLife

Fouryears.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

25gand6gcollapsiblealuminiumtubesinternallylacquered,withplasticscrewcapclosure.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

Weleda(UK)Ltd

HeanorRoad

Ilkeston

Derbys.DE78DR

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA407/5/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:11 th

October1991

Dateoflastrenewal:11 th

October2006

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 24/10/2006 CRN 2021991 page number: 4

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