Dozile

New Zealand - English - Medsafe (Medicines Safety Authority)

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Active ingredient:
Doxylamine succinate 25 mg;  
Available from:
Wilson Foods Limited
INN (International Name):
Doxylamine succinate 25 mg
Dosage:
25 mg
Pharmaceutical form:
Liquid filled capsule
Composition:
Active: Doxylamine succinate 25 mg   Excipient: Amaranth Butylated hydroxyanisole Gelatin Macrogol 400 Patent blue V Propylene glycol Purified water Sorbitol
Units in package:
Blister pack, 10 capsules
Class:
Restricted
Prescription type:
Restricted
Manufactured by:
Corden Pharma Bergamo SpA
Therapeutic indications:
Temporary use in the relief of insomnia
Product summary:
Package - Contents - Shelf Life: Blister pack, - 10 capsules - 24 months from date of manufacture stored at or below 25°C
Authorization number:
TT50-5595
Authorization date:
1994-06-15

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INFORMATIONFOR

CONSUMERS

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Information

DOZILE ®

Doxylaminesuccinate25mgcapsules

Whatisinthisleaflet

PleasereadthisleafletcarefullybeforeyoustarttakingDOZILE.Thisleafletanswerssomecommon

questionsaboutDOZILE.Itdoesnotcontainalltheavailableinformation.

Itdoesnottaketheplaceoftalkingtoyourpharmacistordoctor.

Allmedicineshaverisksandbenefits.Yourpharmacistordoctorhasweighedtherisksofyoutaking

DOZILEagainstthebenefitstheyexpectitwillhaveforyou.

UseDOZILEasinstructedandfollowtheadvicegiveninthisleaflet.

Ifyouhaveanyconcernsabouttakingthismedicine,askyourpharmacistordoctor.

Keepthisleafletwiththemedicine.Youmayneedtoreaditagain.

WhatDOZILEisusedfor

DOZILEisusedtohelpinthetemporaryreliefofsleeplessness.Ifyouhavetroublefallingasleep,your

doctororpharmacistwilladviseyouifDOZILEmayhelp.

AskyourdoctororpharmacistifyouhaveanyquestionsaboutwhyDOZILEhasbeenrecommended

foryou.

HowDOZILEworks

DOZILEcapsulescontaindoxylaminesuccinate.Doxylaminesuccinateisatypeofantihistaminecalled

anethanolaminederivativeantihistamine.Ithasasedatingeffect.

BeforetakingDOZILE

BeforetakingDOZILE

Whenyoumustnottakeit

DonottakeDOZILEif:

youhaveanallergytodoxylaminesuccinate,otherethanolaminederivativeantihistaminesorany

oftheingredientslistedattheendofthisleaflet.Ifyouarenotsureifyouhavesuchanallergyto

DOZILE,checkwithyourpharmacistordoctor.

theexpirydate(EXP)printedonthepackhaspassed.Ifyoutakethismedicineafterthe

expirydatehaspassed,itmaynotworkaswell.

thepackagingistornorshowssignsoftampering.

youarehavinganacuteasthmaattack.

DonottakeDOZILEtotreatanyothercomplaintunlessyourpharmacistordoctortellsyouto.

Beforeyoustarttotakeit

Tellyourpharmacistordoctorifyouhaveallergiesto:

anyothermedicines

anyothersubstances,suchasfoods,preservativesordyes.

Tellyourpharmacistordoctorifyouarepregnantorareplanningtobecomepregnant,oryou

arebreastfeedingorplantobreastfeed.DOZILEshouldbeavoidedduringpregnancyor

lactation.

Tellyourpharmacistordoctorifyouhaveorhavehadanymedicalconditions,especiallythe

following:

narrowangleglaucoma

difficultypassingurine

prostateproblems

ablockageinyourstomach(pyloroduodenalobstruction)

epilepsy

aproblemwithyourheartorbloodvessels.

Ifyouhavenottoldyourpharmacistordoctoraboutanyofthesethings,tellthembeforeyou

starttakingDOZILE.

Donotgivethismedicinetoanyoneelseeveniftheyhavethesameconditionasyou.

Takingothermedicines

Tellyourpharmacistordoctoraboutanyothermedicinesyouaretakingincludingmedicines

thatyoubuywithoutaprescription,inapharmacy,supermarketorhealthfoodshop.

ThesemedicinesmayaffectthewayDOZILEworks.

SomemedicinesandDOZILEmayinterferewitheachother.Theseinclude:

SomemedicinesandDOZILEmayinterferewitheachother.Theseinclude:

Somemedicinesfortreatingdepression

Somemedicinesthattreatlossofbladdercontrol

Tranquillisersormedicinesusedtotreatanxiety

Alcohol

Sleepingtablets

Someantihistamines.

OthermedicinesthatmayaffectthewayDOZILEworksincludemedicinesforstomachspasmsor

cramps.

Askyourpharmacistordoctorifyouarenotsureifyouaretakinganyofthesemedicines.

Yourpharmacistordoctormayhavemoreinformationonmedicinestobecarefulwithortoavoidwhile

takingDOZILE.

UsingDOZILE

Howtotakeit

Followalldirectionsgiventoyoubyyourpharmacistordoctorcarefully.

Theymaydifferfromtheinformationcontainedinthisleaflet.

Ifyoudonotunderstandtheinstructionsonthecarton,askyourpharmacistordoctorforhelp.

Swallow1capsulewholewithaglassofwater30minutesbeforebedtime.

Donotexceedtherecommendeddosage.

ElderlypeoplemaybemoresensitivetotheeffectsofDOZILE.Ifyouhaveanydoubtsaboutthedose

youshouldtake,discussthiswithyourpharmacistordoctor.

DOZILEisnotrecommendedforchildrenunder12yearsofage.

Ifyouforgettotakeit

IfyouforgettotakeDOZILEbeforeyougotobedandyouwakeuplateinthenightorearlyin

themorning,donottakeadosethenasyoumayhavetroublewakinginthemorning.

Ifyouhaveanyquestionsaboutthis,askyourpharmacistordoctor.

Donottrytomakeupformisseddosesbytakingmorethanonedoseatatimebecausethismay

increasethechanceofyougettinganunwantedsideeffect.

Ifyouhavetroublerememberingwhentotakeyourmedicine,askyourpharmacistforsomehints.

Ifyoutaketoomuch(overdose)

ImmediatelytelephoneyourdoctorortheNationalPoisonsInformationCentre(telephone0800

ImmediatelytelephoneyourdoctorortheNationalPoisonsInformationCentre(telephone0800

POISONor0800764766)orgotoAccident&Emergencyatyournearesthospitalifyouthink

youoranyoneelsehastakentoomuchDOZILE,eveniftherearenosignsofdiscomfortor

poisoning.Youmayneedurgentmedicalattention.

Keeptelephonenumbersfortheseplaceshandy.

IfyoutaketoomuchDOZILEyoumayhavethefollowingsymptoms:

drymouth

dilatedandfixedpupils

flushing

stomachupsets

sleeplessness

nervousness

overexcitement

irritability

tremors

nightmares

hallucinations

fits

fastheartbeat

coma

heartattack

stoppingbreathing.

WhileyouaretakingDOZILE

Thingsyoumustdo

Tellanyotherdoctors,dentistsandpharmacistswhoaretreatingyouthatyouaretaking

DOZILE.

Ifyouareabouttostartonanynewmedicine,tellyourdoctor,dentistorpharmacistthatyou

aretakingDOZILE.

SeeyourdoctorifyouarestillsufferingfromsleeplessnessaftertakingDOZILEfor2weeks.

Youmayhaveamoreseriousproblemthatneedsmedicalattention.

Thingsyoumustnotdo

Ifyoufeeltired,drowsy,dizzyorlight-headed,donotdriveoroperatemachinery.Aswithsome

otherantihistaminemedicines,DOZILEmaycausetiredness,drowsiness,dizzinessorlight-headedness

insomepeople.Ifyoudrinkalcohol,thedrowsiness,dizzinessorlight-headednessmaybeworse.

Thingstobecarefulof

BecarefuldrinkingalcoholwhiletakingDOZILE.Theeffectsofalcoholcanbeincreasedbysome

antihistaminemedicines,includingDOZILE.

antihistaminemedicines,includingDOZILE.

BecarefuldrivingoroperatingmachineryifyouhavetakenDOZILEthenightbefore.Youmaystillbe

drowsythenextmorning.

Thingsyoushoulddotohelpyousleep

Gotobedandariseatthesametimedaily

Engageinrelaxingactivitiesbeforebedtime

Exerciseregularlybutnotinthelateevening

Avoideatingmealsorlargesnacksjustbeforebedtime

Eliminatedaytimenaps

Avoidcaffeine-containingdrinksaftermidday

Avoidalcoholortheuseofnicotinelateintheevening

Minimiseexternaldisruption(eglightandnoise)

Ifyouareunabletosleep,donotbecomeanxious.Leavethebedroomandparticipateinrelaxing

activitiessuchasreadingorlisteningtomusicuntilyouaretired.

Sideeffects

Allmedicinescanhavesideeffects.Sometimestheyareserious,mostofthetimetheyarenot.

Youmayneedmedicaltreatmentifyougetsomeofthesideeffects.Askyourpharmacistor

doctortoansweranyquestionsyoumayhave.

Tellyourpharmacistordoctorifyounoticeanyofthefollowingandtheyworryyou:

dizziness

clumsiness

over-excitement.

ThesearethemostcommonsideeffectsofDOZILE.Mostlythesesideeffectsaremildandshort-lived.

LesscommonsideeffectsofDOZILEare:

nausea

vomiting

diarrhoea

stomachproblems

headache

drymouth

difficultypassingurine

blurredvision

thickmucousfromyourlungs.

Tellyourpharmacistordoctorimmediatelyifyounoticethefollowing:

fastorirregularheartbeats.

Thisisaserioussideeffect.Serioussideeffectsarerare.

Othersideeffectsnotlistedabovemayoccurinsomepatients.

Othersideeffectsnotlistedabovemayoccurinsomepatients.

Tellyourpharmacistordoctorassoonaspossibleifyoudonotfeelwellwhileyouaretaking

DOZILEorareconcernedaboutanysideeffects.

Donotbealarmedbythislistofpossiblesideeffects.Youmaynotexperienceanyofthem.

AfterusingDOZILE

Storage

Keepyourmedicineinacooldryplacewherethetemperaturestaysbelow25°C.

DonotstoreDOZILEoranyothermedicineinthebathroomornearasink.

Donotleavethemedicineinthecaronhotdaysoronawindowsill.Heatanddampnesscan

destroysomemedicines.

KeepDOZILEwherechildrencannotreachit.Alockedcupboardatleastoneandahalfmetres

abovethegroundisagoodplacetostoremedicines.

Disposal

IfyourpharmacistordoctortellsyoutostoptakingDOZILEorthemedicinehaspassedthe

expirydate,askyourpharmacistwhattodowithanymedicinethatisleftover.

ProductDescription

Whatitlookslike

DOZILEisapurple,oval,softgelcapsule.

Ingredients

TheactiveingredientinDOZILEisdoxylaminesuccinate.Eachcapsulecontains25mgofdoxylamine

succinate.

Theinactiveingredientsare:

butylatedhydroxyanisole

propyleneglycol

macrogol400

gelatin

amaranth

patentblueV

sorbitolspecial-glycerinblend

water-purified.

Packsizes

Packsizes

DOZILEisavailableinblisterpacksof10capsules.

Supplier

DOZILEissuppliedinNewZealandby:

WilsonConsumerProducts

AUCKLAND

Ph:093795390

Fax:093795356

ThisleafletwasupdatedinJuly2008

New Zealand Datasheet

1 PRODUCT NAME

DOZILE 25 mg capsules

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Doxylamine Succinate 25 mg Capsules

3 PHARMACEUTICAL FORM

Liquid filled soft gel capsules, purple, containing 25 mg doxylamine succinate.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Temporary use in the relief of insomnia.

4.2 Dose and method of administration

Adults: 1 capsule 30 minutes before retiring, or as directed by a pharmacist or physician.

Maximum stated dose should not be exceeded.

Dozile is recommended for occasional use only i.e. for periods of no longer than a week at a

time. If sleeplessness persists, consult your doctor.

Note: Dozile is not recommended for children under 12 years of age.

4.3 Contraindications

Hypersensitivity to doxylamine, other ethanolamine derivative antihistamines or to any other

ingredient in the product.

4.4 Special warnings and precautions for use

Caution should be used if taken with alcohol. Due to the anticholinergic properties of

antihistamines,

caution

should be

used when Dozile is

taken concurrently

with other

medications. (See section 4.5)

Caution should be taken by those with narrow angle or open-angle glaucoma, urinary

retention,

prostate

enlargement,

pyloroduodenal

obstruction,

epilepsy

severe

cardiovascular disorders.

Doxylamine may suppress positive skin test results.

Use in Children

Dozile is not recommended for children under 12 years of age. The safety and efficacy of

doxylamine as a night time sleep aid in children younger than 12 years of age have not been

established. In addition, children may be more prone than adults to experience paradoxical

CNS stimulation rather than sedation when antihistamines are used as night time sleep aids.

Use in the Elderly

The elderly may be more sensitive to the effects of the usual adult dose.

4.5 Interaction with other medicines and other forms of interaction

Dozile produces an additive effect when administered with other CNS depressants such as

opioid analgesics, neuroleptics, alcohol, hypnotics and psychotherapeutic drugs.

MAOIs may enhance the antimuscarinic effects of doxylamine.

Doxylamine has additive antimuscarinic action with other antimuscarinic drugs such as

atropine and tricyclic antidepressants.

Dozile may decrease the emetic response to apomorphine.

Concurrent use of oral contraceptives does not appear to affect the pharmacokinetics of

doxylamine.

4.6 Fertility, pregnancy and lactation

Pregnancy

Category A

Drugs that

have been

taken

large

number

pregnant

women and

women of

childbearing age without any proven increase in the frequency of malformations or other

direct or indirect harmful effects on the fetus having been observed. Use of Dozile should be

avoided during pregnancy.

Breast feeding

Use of Dozile should be avoided during lactation. First generation antihistamines may inhibit

lactation because of their anticholinergic actions. Small amounts of antihistamines are

distributed in human breast milk. Use is not recommended in nursing mothers because of

the risk of adverse effects, such as unusual excitement or irritability in infants.

Because of the potential for serious adverse reactions to antihistamines in nursing infants, a

decision should be made as to whether to discontinue nursing or doxylamine taking into

account the importance of the drug to the woman.

Fertility

No data available.

4.7 Effects on ability to drive and use machines

Doxylamine causes drowsiness. Patients should not drive or operate machinery if affected.

4.8 Undesirable effects

CNS: CNS depression, stimulation (insomnia, nervousness, euphoria, irritability, tremors,

nightmares,

hallucinations,

convulsions),

headache,

lack

coordination,

dizziness,

psychomotor impairment.

Gastrointestinal:

Constipation,

nausea,

vomiting,

diarrhoea,

increased

gastric

reflux,

epigastric pain.

Respiratory: Thickened respiratory tract secretions.

Local: Dry mouth.

Cardiovascular: Palpitations, arrhythmias.

Ophthalmic: Blurred vision.

Renal: Urinary difficulty or retention.

Other: Hypersensitivity reactions, blood disorders, hypotension, tinnitus and paraesthesia.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It

allows

continued

monitoring of the

benefit/risk

balance

of the

medicine.

Healthcare

professionals

asked

report

suspected

adverse

reactions

https://nzphvc.otago.ac.nz/reporting/.

4.9 Overdose

Overdose produces signs and symptoms of anticholinergic toxicity. Acute overdose may

cause

various

reactions

including

mouth,

fixed

dilated

pupils,

flushing,

gastrointestinal symptoms, insomnia, nervousness, euphoria, irritability, tremors, nightmares,

hallucinations,

depression

stimulation,

impaired

consciousness,

seizures,

tachycardia, mydriasis and a psychosis similar to that in catatonic stupor. Rhabdomyolysis

with impairment of renal function and acute renal failure has been observed. However, in

one series of cases of overdose, 39% of patients studied had no symptoms. Stimulation is

particularly likely in children.

Fatalities have been reported from doxylamine overdose. These have been characterized by

coma, grand mal seizures and cardiorespiratory arrest. Children appear to be at a high risk

for cardiorespiratory arrest. A toxic dose for children of more than 1.8 mg/kg has been

reported. A 3 year old child died 18 hours after ingesting 1,000 mg doxylamine succinate.

There is no correlation between the amount of doxylamine ingested, the doxylamine plasma

level and clinical symptomatology.

Treatment

As overdosage may produce potentially fatal cardiovascular or CNS reactions, patients

should be monitored for any abnormalities of vital signs. Adequacy of ventilation and blood

pressure should be assessed and full supportive care, including oxygen and assisted

ventilation,

provided

required.

patient

should

observed

evidence

rhabdomyolysis. Laboratory tests on admission should include a determination of creatine

kinase. If this is elevated, a test for myoglobin in the urine should be done and, if present, is

a contraindication to acid diuresis. Adequate fluid replacement must be provided and good

urine output maintained.

Most patients recover with symptomatic and supportive care. Gastric lavage should be

considered if it can be performed soon after ingestion, generally within 60 minutes. Another

method of preventing absorption is charcoal administration, which again is most effective

when administered within 60 minutes of ingestion. Whole bowel irrigation with polyethylene

glycol

electrolyte lavage solution may

considered

in patients

with extremely

large

ingestions.

Haemodialysis,

haemofiltration

peritoneal

dialysis

have

been

studied

treatment of doxylamine overdose but are unlikely to be effective in view of the high volume

of distribution. The efficacy of forced diuresis has not been established.

case

accidental

overdosage,

symptomatic

treatments

supportive

care

suggested. For information on the management of overdose, contact the National Poisons

Centre on 0800 764 766.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic

group:

Systemic

antihistamines-

aminoalkyl

ethers,

code:

R06AA59.

Doxylamine succinate is a white or creamy white powder with a characteristic odour and has

solubilities of approximately 1 g/mL in water and 500 mg/mL in alcohol at 25°C. It has a pKa

of 5.8 and 9.3. A 1% aqueous solution has a pH of 4.8 - 5.2.

Doxylamine succinate is an ethanolamine derivative antihistamine. Because of its sedative

effect, it is used for the temporary relief of sleeplessness. The drug is also used in

combination with antitussives and decongestants for the temporary relief of cold and cough

symptoms. It is not structurally related to the cyclic antidepressants.

It is an antihistamine with hypnotic, anticholinergic, antimuscarinic and local anaesthetic

effects.

Duration of action is 6-8 hours.

5.2 Pharmacokinetic properties

Following oral administration of a single 25 mg dose of doxylamine succinate in healthy

adults, mean peak plasma concentrations of about 100 ng/mL occur within 2-3 hours after

administration. The drug has an elimination half-life of about 10 hours in healthy adults.

Absorption

It is easily absorbed from the gastrointestinal tract. Following an oral dose of 25 mg the

mean peak plasma level is 99 ng/mL 2.4 hours after ingestion. This level declines to 28

ng/mL at 24 hours and 10 ng/mL at 36 hours.

Distribution

The apparent volume of distribution is 2.5 L/kg.

Metabolism

major

metabolic

pathways

N-demethylation,

N-oxidation,

hydroxylation,

acetylation, N-desalkylation and ether cleavage.

Elimination

The elimination half life is 10.1 hours. Oral plasma clearance is 217 mL/min the drug is

excreted in the urine as unchanged doxylamine (60%), nordoxylamine and dinordoxylamine.

5.3 Preclinical safety data

No data available.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

The capsules also contain the following inactive ingredients: butylated hydroxyanisole,

propylene glycol, macrogol 400, gelatin, amaranth, patent blue V, sorbitol special - glycerin

blend, and purified water.

6.2 Incompatibilities

None are known.

6.3 Shelf life

2 years (24 months).

6.4 Special precautions for storage

Store at or below 25°C.

6.5 Nature and contents of container

Dozile is available in a blister pack of 10 capsules.

7 MEDICINE SCHEDULE

Pharmacist-only-medicine.

8 SPONSOR

Wilson Consumer Products

AUCKLAND

Ph: 09 379 5390

Fax: 09 379 5356

9 DATE OF FIRST APPROVAL

27 March 1997

10 DATE OF REVISION OF THE TEXT

13 May 2019

SUMMARY TABLE OF CHANGES

Section changed

Summary of new information

Update to SPC format

Reporting of adverse events added

Poison centre details added

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