FEMIN-9

Main information

  • Trade name:
  • FEMIN-9 Capsule
  • Pharmaceutical form:
  • Capsule
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FEMIN-9 Capsule
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0416/009/001
  • Authorization date:
  • 18-12-1992
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Femin-9 Capsules

2QUALITATIVEANDQUANTITATIVECOMPOSITION

3PHARMACEUTICALFORM

Capsules, soft

6 minimoval, opaqueblack,softgelatin capsulescontaining an oily, yellowliquid.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forusein themanagementofsymptomsassociatedwith thepremenstrualsyndrome.

4.2Posologyandmethodofadminstration

Adults:

Onecapsuledaily for6 dayspre-mensesand forthefirst2-3 daysofmenstruation.

Elderly:

Notapplicable.

Children:

Notapplicable.

Infantsand Neonates:

Notapplicable.

DONOTEXCEEDTHESTATEDDOSE.

Method ofAdministration

Each capsulecontains:

PyridoxineHydrochloridePh.Eur. 75mg

AscorbicAcid Ph. Eur 60mg

Alpha-TocopherylAcetatePh. Eur. 30IU

Iron (asdried ferroussulphatePh. Eur.) 12mg

Zinc(aszincsulphatemonohydratePh. Eur.) 4mg

Cyanocobalamin Ph. Eur. 2micrograms

FolicAcid Ph. Eur. 300micrograms

Iodine(aspotassiumiodidePh. Eur.) 140micrograms

Epanoil 100mg

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4.3Contraindications

Usein patientshypersensitiveto any ingredient.

Usein patientswith undiagnosed anaemia.

4.4Special warningsandspecialprecautionsforuse

Ifthereisno improvementthedoctorshould beconsulted.

Ifthepatientison any othermedication orhasanotherillness, thephysician should confirmthatuse

oftheproductissafe.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Pyridoxinereducestheeffectsoflevodopa.

Zincmay diminish theeffectofpenicillamine.

4.6Pregnancyandlactation

Theproductwillnotbeused during pregnancy.

Useduring lactation asforadultdose.

4.7Effectsonabilitytodriveandusemachines

None.

4.8Undesirableeffects

Notapplicable.

4.9Overdose

Symptomsofoverdosageareunlikely following an acuteintake. No dataavailable.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

AscorbicAcid:AscorbicAcid (Vitamin C)isan essentialvitamin.Severedeficiency producestheclassicalsyndrome

ofVitamin Cdeficiency.

D-L-Alpha-TocopherylAcetate:DL-alphaTocopherylacetate(vitamin E)isan essentialfat-solublevitamin forthe

prevention ofbody tissueoxidation (antioxidant), and isinvolved in metabolicreaction.

Iron:Iron isan essentialconstituentofthebody and isnecessary forhaemoglobin formation and fortheoxidative

processesofliving tissue.Iron isimportantin thereduction ofanaemia.

Zinc:Zincisan essentialnutritionalelementand isaconstituentofmany enzymesystemsand itisan integral

constituentofinsulin.

Cyanocobalamin:Cyanocobalamin (Vitamin B12)isan essentialvitamin, forwhich theaveragedaily human

requirementisbetween 2-3mcg, and which occursonly in animalproducts.Strictvegetarianscan beVitamin

B12 deficient.

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in severalimportantmetabolicpathways.Vitamin B12 deficiency can resultin anaemia.

FolicAcid:FolicAcid isavitamin.

Iodine:Iodinein theformofpotassiumiodideisutilised forthealleviation ofiodine-deficiency.

Epanoil:Epanoilisasourceofthepolyunsaturated fatty acidseicosapentaenoicacid and docosahexaenoicacid

which can actasprecursorsforeicosanoid bio-synthesis.

5.2Pharmacokineticproperties

Pyridoxine:Pyridoxineisreadily absorbed fromthegastrointestinaltractfollowing oraladministration and is

converted to pyridoxalphosphate.Thisisstored mainly in theliverwherethereisoxidation to 4-pyridoxicacid

which isexcreted in theurine.

Pyridoxalcrossestheplacentaand appearsin breastmilk.

AscorbicAcid:Ascorbicacid isreadily absorbed fromthegastrointestinaltractand iswidely distributedin the

body tissues.

Ascorbicacid isreversibly oxidised to dehydroascorbicacid;someofwhich ismetabolised to ascorbate-2-

sulphate, which isinactiveand oxalicacid, which issecreted in theurine.

Ascorbicacid in excessofthebody’sneedsisalso rapidly eliminated in theurine.

D-L-Alpha-TocopherylAcetate:D-L-alpha-tocopherylacetateabsorption fromthegastrointestinaltractis

dependentupon thepresenceofbile.Itentersthebloodstreamviathelymph and iswidely distributedin all

tissues, and isstored in adiposetissue.

SomeVitamin Eismetabolised in theliverto glucuronidesand tocopheronicacid and itsgamma-lactoneand is

excreted in theurine.Mostvitamin Eisslowly excreted in bile.Vitamin Eappearsin breastmilk, butispoorly

transported acrosstheplacenta.

Iron:Iron isirregularly and incompletely absorbed fromthegastrointestinaltract, themain sitesofabsorption

being theduodenumand jejunum.

Iron absorption isusually increased in conditionsofiron-deficiency orwhen given in afasting state.

Theabsorption ofiron may bereduced in certain diseasestates.

Zinc:Zincispoorly absorbed fromthegastrointestinaltract, and only asmallproportion ofdietary zincis

absorbed.

Zincisdistributed widely throughoutthebody andisexcreted in thefaeceswith only tracesappearing in the

urine.

Cyanocobalamin:Vitamin B12 bindsto intrinsicfactorand isthen actively absorbed fromthegastrointestinal

tract. Vitamin B12 isextensively bound to transcobalaminsin theplasma, and istransported to alltissues.

Vitamin B12 isstored in theliver, excreted in thebileand undergoesenterohepaticrecycling.Someisexcreted

in theurine, mostin thefirst8 hoursfollowing intake.Vitamin B12 diffusesacrosstheplacentaand appearsin

thebreastmilk.

FolicAcid:Folicacid isabsorbed mainly fromtheproximalpartofthesmallintestine, and iswidely distributed

in thebody tissues.Theprincipalfolicacid storagesiteistheliver.Thereisan enterohepaticcirculation of

folate, and about4 to 5 microgramsareexcreted in theurinedaily.Folateisdistributed into breastmilk.

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Iodineisexcreted mainly in theurine, with smalleramountsappearing in thefaeces, salivaand sweat.Iodides

readily crosstheplacentaand appearin breastmilk.

Epanoil:Epanoilisasourceofpolyunsaturated fatty acids, eicosapentaenoicacid and docosahexaenoicacid.

Polyunsaturated fatty acidsarereadily absorbed in thesmallintestinalsection ofthegastrointestinaltract, and

arewidely distributed throughoutthebody in membranephospholipids.

5.3Preclinical safetydata

Thereareno preclinicalsafety dataofrelevancewhich areadditionalto thosealready included in othersections

oftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

a)FillIngredients

Hydrogenated vegetableoil

Soyalecithin (E322)

Beeswax (E901)

b)ShellIngredients

Gelatine

Glycerol

Black iron oxide(E172)

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Threeyears.

6.4Special precautionsforstorage

Do notstoreabove25°C.

6.5Natureandcontentsofcontainer

Whitepolypropylenetubswith bluepolypropylenecaps, with boresealsand containing 30 capsules.

6.6Instructionsforuseandhandling

No specialrequirements.

7MARKETINGAUTHORISATIONHOLDER

Seven SeasLimited

Hedon Road

Marfleet

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HU9 5NJ

United Kingdom

8MARKETINGAUTHORISATIONNUMBER

PA416/9/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 18 th

December1992

Dateoflastrenewal: 18 th

December2002

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Issued 03/11/2005 CRN 2016337 page number: 5