COMBUDORON

Main information

  • Trade name:
  • COMBUDORON Cutaneous Solution
  • Pharmaceutical form:
  • Cutaneous Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • COMBUDORON Cutaneous Solution
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0407/007/001
  • Authorization date:
  • 18-02-1994
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Combudoron Lotion.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Ingredientsper100 ml:

2.5 gArnica montanaLwholeplant(tincture(1=2)in 30%w/wethanol)and

47.5 gUrtica urensLherb (tincture(1=2)in 30%w/wethanol)

Forexcipients, see6.1.

3PHARMACEUTICALFORM

Cutaneoussolution.

Aclearto slightly turbid, olivegreen to brown mobileliquid, with acharacteristicodourofnettles.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Traditionally used forthereliefofsunburn, insectbites, minorburnsandminorrashesincluding nettlerash.

4.2Posologyandmethodofadminstration

Dilute1 teaspoonful(5 ml)in aglassful(200ml)ofcooled boiled water.

Soak apieceoflintin thesolution and apply asacompress.Keepmoist.

Apply thesolution undiluted to insectbites.

Children and theelderly:

Theadultdoseisappropriate

4.3Contraindications

Do notusein patientsknown to besensitivetoArnica montana L

4.4Special warningsandspecialprecautionsforuse

In therarecaseofsensitivity toArnica montana Llocalirritation and rednessmayoccur.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Issued 03/08/2005 CRN 2013274 page number: 1

4.6Pregnancyandlactation

Pregnancy:Thereisno evidenceofthesafety oftheproductin human pregnancy, noristhereany evidencefrom

animalstudies.Although noadversereactionshavebeen observed, theuseoftheproductduring pregnancy should be

avoided unlessundertheguidanceofamedicalpractitioner.

Lactation:thereisno evidenceto suggestthattheproductshould notbeused during lactation.

4.7Effectsonabilitytodriveandusemachines

Noneknown

4.8Undesirableeffects

Noneknown

4.9Overdose

Thereareno known dataon overdose.Thereareno groundsforsupposing thatany adverseeffectswould resultfrom

singleorrepeated excessivetopicalapplication ofthisproduct.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

No information in thisareaispresently available

5.2Pharmacokineticproperties

No information in thisareaispresently available

5.3Preclinical safetydata

Thisproducthasbeen marketed in theUKforover50 years.Thissection isthereforenotapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Ethanol90 %

Purified Water

6.2Incompatibilities

Notapplicable

6.3ShelfLife

3 years.

6.4Special precautionsforstorage

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Issued 03/08/2005 CRN 2013274 page number: 2

6.5Natureandcontentsofcontainer

50 and 100 mlamberglassbottlesfitted with aHDPEdropperinsertand atamperevidentHDPEscrewcap closure.

Notallpack sizesmay bemarketed.

6.6Instructionsforuseandhandling

No specialrequirements.

7MARKETINGAUTHORISATIONHOLDER

Weleda(UK)Ltd,

HeanorRoad,

Ilkeston,

Derbyshire,

DE7 8DR,

United Kingdom.

8MARKETINGAUTHORISATIONNUMBER

PA407/7/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 18 February 1994

Dateoflastrenewal: 18 February 2004

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Issued 03/08/2005 CRN 2013274 page number: 3