DHC CONTINUS

Main information

  • Trade name:
  • DHC CONTINUS
  • Dosage:
  • 90 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DHC CONTINUS
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0913/008/002
  • Authorization date:
  • 19-04-1995
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

DHCContinusProlonged-releaseTablets90mg

2QUALITATIVEANDQUANTITATIVECOMPOSITION

DihydrocodeineTartrate90 mg

Forexcipients, see6.1

3PHARMACEUTICALFORM

Prolonged releasetablets.

Whiteto off-white, capsule-shaped, biconvex tabletwith‘DHC90’on oneside.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Asan analgesicin thereliefofmoderateto severepain.

4.2Posologyandmethodofadminstration

Adultsonly

Onetablet12 hourly.

Elderly

Reduced dosageorincreased intervalsbetween dosesmay berequired.

RouteofAdministration

Oral.

4.3Contraindications

DHCCONTINUStabletsshould notbeused in patientshypersensitivetotheactiveingredientorany oftheother

constituentsoftheproductorin patientswith respiratory depression orobstructiveairwaysdisease. Asdihydrocodeine

may causethereleaseofhistamineitshould notbegiven during an attack ofasthma. Patientswith rarehereditary

problemsofgalactoseintolerance,theLapp lactasedeficiency orglucose-galactosemalabsorption should nottakethis

medicine.

4.4Special warningsandspecialprecautionsforuse

Prolonged useofhigh dosagemay inducedependencewith awithdrawalsyndromeon discontinuation.Repeated use

may resultin thedevelopmentoftolerance.DHCCONTINUStabletsshould beused with greatcaution in patients

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injury.

Reduced dosageorincreased intervalsbetween dosesmay berequired in patientswith hypothyroidismand in those

with renalorhepaticdysfunction.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Dihydrocodeineshould beused with caution in patientswho arecurrently receiving, orhavewithin theprevioustwo

weeksreceived, monoamineoxidaseinhibitors.

Othercentralnervoussystemdepressants, including alcohol, willaccentuatethesedativeeffectsofthisproduct.

4.6Pregnancyandlactation

Allthenarcoticanalgesicsareableto traversetheplacentaandarealso excreted in milk.They should notbeused

during pregnancy orlactation unlessconsidered essentialby thephysician.

4.7Effectsonabilitytodriveandusemachines

Thisproductmay inducedrowsiness.Patientsreceiving itshould notdriveoroperatemachinery unlessithasbeen

shown notto affectphysicalormentalability.

4.8Undesirableeffects

Themostcommon adversedrug reactionsseen during therapy areconstipation, nausea, vomiting, headacheand

vertigo.Occasionaladversereactionsareurinary retention, abdominalpain, hypotension, paraesthesia, confusion,

hallucinationsand rash with orwithoutpruritus.Toleranceand dependencemay occur.

4.9Overdose

Administernaloxone0.8 mg intravenously.Repeatat2-3 minuteintervalsasnecessary, orby an infusion of2 mg in

500 mlofnormalsalineor5%dextrose(0.004 mg/ml).Theinfusion should berunataraterelated to theprevious

bolusdosesadministered and shouldbein accordancewith thepatient’sresponse.Empty thestomach.Assist

respiration ifnecessary. Maintain fluid and electrolytelevels.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Naturalopiumalkaloids

ATCcode:N02AA08

Dihydrocodeineisasemisyntheticnarcoticanalgesicwith apotency between morphineand codeine.Itactson opioid

receptorsin thebrain to reducethepatients’perception ofpain and improvethepsychologicalreaction to pain by

reducing theassociated anxiety.

5.2Pharmacokineticproperties

Dihydrocodeineiswellabsorbed fromthegastrointestinaltractfollowing administration ofDHCCONTINUStablets

and plasmalevelsaremaintained throughoutthetwelvehourdosing interval.

Likeotherphenanthrenederivatives, dihydrocodeineismainly metabolised in theliverwith theresultantmetabolites

being excreted mainly in theurine.Metabolismofdihydrocodeineincludes0-demethylation, N-demethylation and 6-

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5.3Preclinical safetydata

Thereareno pre-clinicaldataofrelevanceto theprescriberwhich areadditionalto thatalready included in other

sectionsoftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactose(anhydrous)

Hydroxyethylcellulose

Cetostearylalcohol

Magnesiumstearate

Purified talc

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3 years.

6.4Special precautionsforstorage

Do notstoreabove25°C.

6.5Natureandcontentsofcontainer

20µmhard tempered aluminiumfoilbacked PVdC/PVCblisterpacks(56 tablets).

Polypropylenecontainerswith polyethylenelids(56 tablets).

6.6Instructionsforuseandhandling

No specialrequirements.

7MARKETINGAUTHORISATIONHOLDER

Napp PharmaceuticalsLimited

CambridgeSciencePark

Milton Road

CambridgeCB4 0GW

United Kingdom

8MARKETINGAUTHORISATIONNUMBER

PA913/8/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 19 th

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Dateoflastrenewal: 19 th

April2005

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Issued 01/09/2005 CRN 2014432 page number: 4