AVENA SATIVA COMP. 100 Millilitre Oral Drops Solution

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
HUMULUS LUPULUS, AVENA SATIVA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, COFFEE PREPARED
Available from:
Weleda (UK) Limited
INN (International Name):
HUMULUS LUPULUS, AVENA SATIVA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, COFFEE PREPARED
Dosage:
100 Millilitre
Pharmaceutical form:
Oral Drops Solution
Prescription type:
Product not subject to medical prescription
Authorization status:
Authorised
Authorization number:
PA0407/003/001
Authorization date:
1991-10-11

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Avenasativacomporaldropssolution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Totalcontentofethanol:45%v/v

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Oraldrops,solution.

Acleartoslightlyturbidamber-brownliquid,finesuspendedparticlesmaybepresent.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Traditionallyusedforreliefofsymptomsofrestlessness,promotingrelaxationandnaturalsleepatnight.

4.2Posologyandmethodofadministration

Over12years: Daytimeuse:15-20dropstobetakeninwaterthreetimesdaily.Night-timeuse:20-40dropstobe

takeninwaterhalfanhourbeforeretiring.

Elderly: Theadultdoseisappropriate.

Children: Nottobeusedinchildrenunder12yearsunlessundertheguidanceofamedicalpractitioner.

4.3Contraindications

Noneknown.

4.4Specialwarningsandprecautionsforuse

100mlcontainstheethanolictincturesof:

AvenasativaL.,Herba(1=2in30%w/walcohol) 25.0ml

HumuluslupulusL.,Fruct.(1=10in86%w/walcohol) 4.0ml

PassifloraincarnataL.,Herba(1=3in62%w/walcohol) 7.5ml

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 27/04/2011 CRN 2098605 page number: 1

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.6Fertility,pregnancyandlactation

Pregnancy:Thereisnoevidenceofthesafetyoftheproductinhumanpregnancy,noristhereanyevidencefrom

animalstudies.Althoughnoadversereactionshavebeenobserved,theuseoftheproductduringpregnancyshouldbe

avoidedunlessundertheguidanceofamedicalpractitioner.

Lactation:Thereisnoevidencetosuggestthattheproductshouldnotbeusedduringlactation.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Noneknown.

4.9Overdose

Noknowndataonoverdose.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Herbalhypnoticsandsedatives.ATCcode:N5B5

5.2Pharmacokineticproperties

Noinformationinthisareaispresentlyavailable.

5.3Preclinicalsafetydata

Thisproducthasbeenmarketedforover50years.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

CoffeaarabicaL.,Sementostadecoct.60Xhomeopathicpotency. 15.0ml

Ethanol90%

PurifiedWater

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 27/04/2011 CRN 2098605 page number: 2

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

25mlamberglassbottlefittedwithaplasticdropperwhichdispensesapproximately0.021mlperdrop,andsealed

withawhitetamper-evidentplasticscrewcapclosure.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

Weleda(UK)Ltd

HeanorRoad

Ilkeston

DerbyshireDE78DR

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA407/3/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:11 th

October1991

Dateoflastrenewal:11 th

October2006

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 27/04/2011 CRN 2098605 page number: 3

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