DOPAGEN

Main information

  • Trade name:
  • DOPAGEN Tablets 125 Milligram
  • Dosage:
  • 125 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DOPAGEN Tablets 125 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0073/051/001
  • Authorization date:
  • 04-11-1981
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Dopagen Tablets125 mg.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each tabletcontainsMethyldopaequivalentto 125 mg anhydrousmethyldopa.

Forexcipients, see6.1.

3PHARMACEUTICALFORM

Yellow, film-coatedtabletsembossed‘a’on onefaceand‘M/125’on theother.

4CLINICALPARTICULARS

4.1TherapeuticIndications

In thetreatmentofhypertension.

4.2Posologyandmethodofadminstration

Dopagen tabletsarefororaladministration only.

Adults:

Theusualdoseis250-500mg daily with subsequentslowincrementsuntiloptimalcontrolisachieved.Maintenance

dosageisusually 0.5 to 2.0 gramsdaily in divided doses.Themaximumrecommended daily dosageis3 grams.

Children:

Theusualinitialdosageis10mg/kg body weightdaily in 2 to 4 divided doseswith gradualincrementsuntiloptimal

controlisachieved.Theusualmaintenancedoseis10 to 65mg/kg daily, butamaximumdoseof3g or65mg/kg,

whicheverisless, should notbeexceeded.

Elderly:

In olderpatients,syncopemayberelated to an increased sensitivity and to atherosclerosisand may beavoided by using

lowerdoses.

4.3Contraindications

Hypersensitivity to methyldopaorto any ofthecomponentsin thesetablets.

Activeliverdisease.

Depression.

Concurrentuseofmonoamineoxidaseinhibitors(MAOIs).

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4.4Special warningsandprecautionsforuse

Methyldopamay giveriseto haemolyticanaemia, theoccurrenceofwhich necessitatesstopping thedrug and the

initiation ofappropriatetherapy.Leucopeniaand thrombocytopeniamay also occurand regularmonitoring ofthe

haemopoieticstateisessentialduring long-termtherapy.

Methyldopamay giveriseto ahepaticreaction which may beacute(severehepatitiswith jaundice)orchronic(active

hepatitiswith clearprodromalsymptomsoffever, malaise, epigastricdiscomfortorpain, nausea, vomiting and colic,

with an eosinophilia).Rising transaminaselevelsherald ahepaticreaction and baselineliverfunction testsand white

blood cellcountsshould beestablished priorto commencementoftherapy.Thereafterthesetestsshould becarried out

atintervalsduring thefirst6-12 weeksoftreatmentand regularly (e.g. twiceyearly)during long termtreatmentor

wheneveran unexplained pyrexiaoccurs.

Theproductshould beintroduced with caution in thosewith pre-existing liverdysfunction.

Methyldopamay giveriseto apositiveCoomb'stestand may thusinterferewith thex-matching ofblood.

Thisproductmay giveriseto systemiclupuserythematosuswith apositiveANFtestand also to involuntary

choreoathetoticmovement, theoccurrenceofeitherofwhich isan indication fordrug withdrawal.

Methyldopamay causedarkening oftheurinein somepatients, and spuriously high amountsofcatecholaminesmay

giveriseto afalsepositivediagnosisofphaeochromocytoma.

Toleranceto thisproductmay occur.

Patientswith impairmentofrenalfunction may respond tosmallerdosesofthisagent.

Ifcerebralormyocardialinfarction occursduring therapy with thisagent, adjustmentofdosageortemporary cessation

may berequired during theacutephase.Therapy with thisagentshould notbeinitiated during theacutephaseof

cerebralormyocardialinfarction.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Thehypotensiveeffectsofthispreparation areenhanced by otheranti-hypertensivedrugs, diuretics, alcohol

and anaestheticagents, and aremodified bysympathomimetics, tricyclicantidepressants, phenothiazine

derivativesand monoamineoxidaseinhibitors.Thisshould bebornein mind when relevantconcomitant

therapy isbeing considered.Interactionswith haloperidolandlithiumhavebeen reported.

In theeventthatapatientrequiresanaesthesia, theanaesthetistshould beinformed oftheuseofthemedication

priorto theadministration ofageneralanaesthetic, to permithistaking thenecessary precautions.

Theanti-hypertensiveeffectsofmethyldopacan bereduced by theconcurrentuseofferroussulphateand

ferrousgluconate.

4.6Pregnancyandlactation

Methyldopacrossestheplacentalbarrierand appearsin cord blood and breastmilk.Although noobviousteratogenic

effectshavebeen reported, thepossibility offoetaldamagecannotbeexcluded and thedrug should notbeused during

pregnancy andlactation unlessconsidered essentialby thephysician.

4.7Effectsonabilitytodriveandusemachines

Sedation usually transientmay occurduringtheinitialperiod oftherapy, orwheneverdosageisincreased.Ifaffected,

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4.8Undesirableeffects

Sedation,usuallytransientmayoccurduringtheinitialperiodoftherapyorwheneverdosageisincreased.The

followingreactionshavebeen reported:

CentralNervoussystem:

Sedation(usuallytransient),headache,weakness,fatigue,paraesthesia,Parkinsonism,involuntarychoreoathetotic

movements, Bells’palsy.

Dizzinessandlightheadedness,whichmaybeassociatedwithreductioninbloodpressure.Nightmares,impaired

mentalactivity, mild psychosisordepression.

Cardiovascularsystem:

Bradycardia,prolongedcarotidsinushypersensitivity,orthostatichypotension,aggravationofanginapectoris.

Oedema(discontinuemethyldopaifoedemaprogressesorifsignsofheartfailuredevelop).

Gastrointestinalsystem:

Nausea,vomiting,diarrhoeaorconstipation.Colitis,pancreatitis,drymouth,sialadenitis,sorenessofblacknessofthe

tongue.

Hepatic:

Liverdisorders, including hepatitis, jaundice,abnormalliverfunction tests.

Haematological:

Haemolyticanaemia,bonemarrowdepression,leucopenia,granulocytopenia,thrombocytopenia,eosinophilia.A

positiveCoombstestand positivetestsforantinuclearantibody, LEcellsand rheumatoid factor.

Dermatological:

Skin rashes, including eczemaorlichenoid eruption, toxicepidermalnecrolysis

Immunological:

Allergicreactions, including drug-related feverand lupuslikesyndrome, pericarditis, myocarditis.

Musculoskeletal:

Arthralgia,myalgia.

Endocrine:

Hyperprolactinaemia, gynaecomastia, breastenlargement, lactation.

Genitourinary:

Amenorrhoea, impotence, decreased libido, failureofejaculation, risein blood urea.

Other:

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4.9Overdose

Possiblesymptomsofacuteoverdosageincludeacutehypotension, bradycardia, weakness, nausea, vomiting and

coma.Thereisno antidoteto methyldopaand treatmentissymptomaticand supportive.

In acuteoverdosage, thestomach should beemptied by aspiration and lavage.Ifnecessary, intravenousinfusionsmay

begiven to promoteurinary excretion and pressoragentsmay beadministered cautiously whereindicated.Methyldopa

isdialysable.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Methyldopaisan antihypertensiveagent.Itactscentrally by stimulating alpha2-adrenoceptors, resulting in areduction

in sympathetictoneand afallin blood pressure.

5.2Pharmacokineticproperties

Methyldopaisincompletely absorbed fromthegut, reachespeak concentrationsin plasmain 2 hoursand iseliminated

viathekidney asunchanged drug and conjugates:half-liferangesfrom8 to 65 hours.

5.3Preclinical safetydata

No furtherrelevantinformation otherthan that, which isincluded in othersectionsoftheSummary ofProduct

Characteristics.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate

Colloidalanhydroussilica

Povidone

Magnesiumstearate

Sodiumstarch glycollateTypeA

Methylcellulose

Ethylcellulose

Diethylphthalate

Opaspray K-I-2119 (ContainsHydroxypropylcellulose, TitaniumDioxideE171, TartrazineLakeE102).

6.2Incompatibilities

Noneknown.

6.3ShelfLife

5 years.

6.4Special precautionsforstorage

Do notstoreabove25°C.

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6.5Natureandcontentsofcontainer

Polypropylenesecuritainerswith tamperevidentpolypropylenecaps.

Pack sizes:100, 500 and 1,000 tablets.

6.6Instructionsforuseandhandling

None.

7MARKETINGAUTHORISATIONHOLDER

Antigen PharmaceuticalsLimited

Roscrea

Co. Tipperary

8MARKETINGAUTHORISATIONNUMBER

PA73/51/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 14 th

November1981.

Dateoflastrenewal: 14 th

November2001.

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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