BREVINOR-1* 21 and BREVINOR-1* 28 Day Tablets - Discount ...

BREVINOR-1* 21 andBREVINOR-1* 28 DayTabletsEthinyloestradiol and NorethisteroneConsumer Medicine InformationWhat is in this leafletThis leaflet answers some commonquestions about BREVINOR-1 21and BREVINOR-1 28 Day tablets.It does not contain all the availableinformation.It does not take the place of talkingto your doctor or pharmacist.All medicines have risks andbenefits. Your doctor has weighedthe risks of you takingBREVINOR-1 against the benefits itis expected to have for you.Use BREVINOR-1 as directed byyour doctor and follow advicegiven in this leaflet.If you have any concerns abouttaking this medicine, ask yourdoctor or pharmacist.Keep this leaflet with the medicine.You may need to read it again.Remember: This medicine isprescribed for you and should notbe given to others.What BREVINOR-1 isused forBREVINOR-1 is a birth control pillcommonly known as a "CombinedOral Contraceptive", that is itcontains both an oestrogen(ethinyloestradiol) and progestogen(norethisterone) hormone.Oral contraceptives belonging to thisgroup produce their birth control (orcontraceptive) effect by preventingovulation (or the release of an eggfrom the ovary) during eachmenstrual cycle. Combined OralContraceptives also cause changes tothe mucus of the cervix and thelining of the womb which contributeto the contraceptive action.If taken according to directions thecombined oral contraceptives arevery effective in preventingpregnancy. The failure rate of thistype of contraceptive is such that forevery 1,000 women using the pill forone year, two will become pregnant.BREVINOR-1 (like all oralcontraceptives) is intended to preventpregnancy. It does not protectagainst HIV infection (AIDS) andother sexually transmitted diseases.BREVINOR-1 21 and 28 Day areonly available on a prescription fromyour doctor.Before you start to takeBREVINOR-1When you must not take itBREVINOR-1 tablets are notsuitable for some women.If you have or have had any ofthese problems, do not takeBREVINOR-1 until you havetalked to your doctor.Do not take it if:* you have or have had high bloodpressure, stroke, heart attack or aclot in the lung.* you have or have hadinflammation, infection orclotting in any blood vessel(s).* you have liver disease (includingtumours of any type), a history ofjaundice or cholestatic jaundiceof pregnancy, or severegeneralised itch in the bodyduring pregnancy;Dubin-Johnson Syndrome orRotor Syndrome.* you have abnormal vaginalbleeding, the cause of which isunknown.* you are pregnant or suspect thatyou may be pregnant.* you have cancer or suspectedcancer of the breast or sex organs(e.g. cervix, ovaries,endometrium, womb) and knownor suspected oestrogen-dependenttumours.* you have a family history ofbreast nodules, fibrocysticdisease or have had an abnormalmammograph.* you have sickle cell anaemia.* you have lipid or carbohydratemetabolism disorders, includingdiabetes.* you have a history of herpes ofpregnancy.* you have otosclerosis (an eardisorder) which worsened in pastpregnancies.BREVINOR-1* 21 AND BREVINOR-1* 28 DAY TABLETS 1

* you have an allergy toethinyloestradiol, norethisteroneor any of the ingredients listed atthe end of this leaflet.Symptoms of an allergic reactionmay include:* asthma, wheezing or shortness ofbreath* swelling of the face, lips ortongue which may causedifficulty in swallowing orbreathing* hives, itching or skin rash* faintingTell your doctor about any existingmedical condition as this may beaffected by taking the birth controlpill.Do not take BREVINOR-1 if thepackaging is torn or shows signs oftampering.Before you start to take itYou must tell your doctor if:* you are breast feeding.* you have gallbladder disease.* you are a heavy smoker,especially if you are aged over 35years (See "While you are takingBREVINOR-1").* you have diabetes.* you have or have had depression.* you are lactose intolerant. Thismedicine contains lactose.Taking other medicinesTell your doctor or pharmacist ifyou are taking any othermedicines, including any that youbuy without a prescription fromyour pharmacy, supermarket orhealth food shop.Some medicines may interfere withthe effectiveness of BREVINOR-1.This is particularly important ifyou need to take antibiotics ormedicines for epilepsy.Your doctor will advise you if youneed to take extra contraceptiveprecautions for the time that you aretaking the other medicine.How to takeBREVINOR-1BREVINOR-1 21 DayEach strip of BREVINOR-1 21 DayTablets contains 21 white activetablets.* To begin BREVINOR-1 21 Day,take your first tablet on the firstday of your next period, that is,the day your bleeding starts.* Take your first tablet from thetop row of the strip. Take thetablet which corresponds to theappropriate day of the week. Forexample, if your first day ofbleeding is on TUESDAY, take awhite tablet marked "TUE".* Continue to take one tablet everyday, following the arrows aroundthe strip coinciding with the daysof the week, until you finish all21 white tablets.* Once all 21 white tablets havebeen taken, leave 7 tablet-freedays before starting your newstrip.* Start your tablets the same day ofthe week every four weeks.For each new strip take your firsttablet from the top row of the strip.Take the tablet which corresponds tothe appropriate day of the week. Forexample, if your first day of bleedingis on TUESDAY, take a tabletmarked "TUE" from the top row ofthe strip. Then repeat the sequenceof tablet taking for as long as birthcontrol is required.You can expect your period duringthe tablet-free week. Your protectioncontinues during the week you arewithout tablets. This product iseffective from the first day if taken asdirected above.Although spotting and break-throughbleeding may occur in some women,these tend to disappear in themajority of patients after the firstthree to four cycles.If you are switching toBREVINOR-1 21 Day fromanother 21 or 28 Day oralcontraceptive, please talk to yourdoctor or pharmacist.During any period of vomiting ordiarrhoea, continue takingBREVINOR-1 tablets. Also use anon-hormonal method ofcontraception (other than therhythm or temperature method),and continue for seven daysfollowing the episode of vomitingor diarrhoea.If these seven days extend into the 7tablet-free days, you should start anew pack on the next day afterhaving taken the last tablet from thecurrent pack.If you suffer from a stomach upsetwhich results in vomiting ordiarrhoea, the effectiveness ofBREVINOR-1 may be reduced.BREVINOR-1 28 DayEach strip of BREVINOR-1 28 DayTablets contains 21 white activetablets and 7 orange inactive tablets.* To begin BREVINOR-1 28 Day,take your first tablet on the firstday of your next period, that is,the day your bleeding starts.* Take your first tablet from thetop row of the green section ofthe strip (ie the section whichcontains all the white tablets).Take the tablet whichcorresponds to the appropriateday of the week. For example, ifyour first day of bleeding is onTUESDAY, take the white tabletmarked "TUE" from the top rowof the green section of the strip.* Continue to take one tablet everyday, following the arrows aroundthe strip, until you finish all 21white tablets in the green sectionof the strip.* Then take one orange tablet dailyfor the next 7 days, following thearrows. Taking these orangetablets helps you to remember totake a tablet every day.When you have finished your firststrip of tablets start the next strip thefollowing day and continue takingthe tablets even when you are havinga period.BREVINOR-1* 21 AND BREVINOR-1* 28 DAY TABLETS 2

For each new strip take your firsttablet from the top row of the greensection of the strip. Take the tabletwhich corresponds to the appropriateday of the week. For example, ifyour first day of bleeding is onTUESDAY, take the white tabletmarked "TUE" from the top row ofthe green section of the strip. Thenrepeat the sequence of tablet takingfor as long as birth control isrequired. This product is effectivefrom the first day if taken as directedabove.Although spotting and break-throughbleeding may occur in some women,these tend to disappear in themajority of patients after the firstthree to four cycles.Make sure you always have a newstrip of tablets available, so thatyou can continue to take the tabletswithout interruption.If you are switching toBREVINOR-1 28 Day fromanother 21 or 28 Day oralcontraceptive, please talk to yourdoctor or pharmacist.During any period of vomiting ordiarrhoea, continue takingBREVINOR-1 tablets. Also use anon-hormonal method ofcontraception (other than therhythm or temperature method),and continue for seven daysfollowing the episode of vomitingor diarrhoea.If these seven days extend into theinactive orange tablet section youshould start a new pack on the nextday after having taken the last activewhite tablet from the green section ofthe current pack (i.e. skip the orangeinactive tablets).If you suffer from a stomach upsetwhich results in vomiting ordiarrhoea, the effectiveness ofBREVINOR-1 may be reduced.When to take itTake your tablet at approximately thesame time each day.If you forget to take a tabletTake the tablets at about the sametime each day.If you miss a white active tablet:If you are less than 12 hours late intaking your tablet, you should takethat tablet at once and then takethe next one at your usual time.If you are more than 12 hours latein taking your tablet, do not takeit.Take the next day's tablet at the usualtime and take extra contraceptiveprecautions for the next seven days.The rhythm or temperature methodsare not suitable for this.If the seven days extend into theinactive orange tablet section (ifusing a 28 day pack) or the 7tablet-free days (if using a 21 daypack), do not take the orange tablets(if using a 28 day pack). Start a newpack on the day after taking the lastwhite active tablet from the greensection of the current pack. Takeyour first tablet from the top row ofthe green section of the strip, thenrepeat the sequence of tablet takingfor as long as birth control isrequired. This will mean that youwill not have a period until youfinish the second pack.If you miss an orange inactivetablet (if using a 28 day pack), takeit as soon as you remember andcontinue on as before. Additionalbirth control method is notnecessary in this case.If your doctor told you to takeBREVINOR-1 differently, or you areunclear about the above directions,discuss this with him or her.If you have trouble rememberingto take BREVINOR-1, ask yourpharmacist for some hints.If you miss a periodIf you have missed a period you maybe pregnant.Contact your doctor immediately.If you take too much(overdose)Immediately telephone your doctoror pharmacist or the PoisonsInformation Centre (telephone 1311 26) or go to Accident andEmergency at your nearesthospital. Do this even if there areno signs of discomfort orpoisoning.Serious ill effects have not beenreported in young children who havetaken large doses of birth controlpills. Overdosage may cause nausea.This may be followed by vaginalbleeding in some women.While you are takingBREVINOR-1Things you must doStop taking the tablets and seeyour doctor if you developunexplained or persistent pains inthe head, chest, stomach or legs. Inthe meantime, use another methodof birth control. See your doctorimmediately.Stop taking BREVINOR-1 Tabletsif you develop gradual or sudden,partial or complete loss of vision;double vision or symptoms ofsevere vision impairment, eyeprotrusion, swelling of the eye oreye lesions, aggravation ofmigraine or development of severeheadache of a new pattern. Seeyour doctor immediately and useanother birth control method inthe meantime.Tell the hospital doctor that youare taking BREVINOR-1 birthcontrol pills if you need to have anoperation, or go to hospital in anemergency.Delays in becoming pregnant mayoccur after BREVINOR-1 therapy isstopped. This is more likely to occurin women whose periods wereirregular before using birth controlpills.BREVINOR-1* 21 AND BREVINOR-1* 28 DAY TABLETS 3

See your doctor if you continue toexperience difficulties in fallingpregnant.Tell your doctor if you feeldepressed, think you are retainingwater or your eyes areuncomfortable whilst wearingcontact lenses.Your doctor will make an assessmentof your condition and advise whetheror not you should continue to takeBREVINOR-1.See your doctor if you notice anyunusual physical changes ordiscomfort while using oralcontraceptives.Women who use oral contraceptivesshould visit their doctor regularly formedical check-ups, which mayinclude blood tests and a cervicalsmear. Your doctor will advise youof the type and frequency of any testsrequired.Tell any other doctors, dentists,and pharmacists who are treatingyou that you are takingBREVINOR-1.Tell your doctor, dentist orpharmacist that you are takingBREVINOR-1 if you are about tobe started on any new medicine.Things you must not doDo not smoke while you are takingoral contraceptives.Cigarette smoking increases the riskof blood clotting and damage to theheart and blood vessels from birthcontrol pills. The risk increases withage and with heavy smoking (15 ormore cigarettes per day) and is quitemarked in women over 35 years ofage.Do not stop taking your tablets if afull monthly period or slightspotting starts before all tabletshave been taken.Slight spotting during tablet taking isnormally of no significance.See your doctor if such bleedingpersists, or if heavier bleedingoccurs.Things to be careful ofSlight breast tenderness or a feelingof sickness may occur in the first fewmonths of use. This usuallyimproves or stops with continueduse.If vaginal irritation or dischargeoccurs, it may be an indication ofyeast infection for which treatment isavailable from your doctor.Talk to your doctor if you arebreast feeding.BREVINOR-1 may affect theamount and quality of breast milk asthe components of BREVINOR-1 arefound in breast milk.Side effectsTell your doctor or pharmacist assoon as possible if you do not feelwell while you are takingBREVINOR-1.All medicines can have side effects.Sometimes they are serious, most ofthe time they are not. You may needmedical treatment if you get some ofthe side effects.Ask your doctor or pharmacist toanswer any questions you mayhave.Tell your doctor if you notice anyof the following and they worryyou:* break-through bleeding* spotting* gastric or stomach discomfortsincluding nausea and vomiting* change in menstrual flow* change in weight* retention of fluids* dark discolouration of the skin* blotchy discolouration on theface (which may persist after thetablets have been stopped)* absence of periods* breast changes (tenderness,enlargement and secretion)* headache, dizziness* nervousness* mental depression* fatigue or tiredness* hair growth or loss of scalp hair* acne, rashes, itching* eye lesions* leg cramps* back ache, change in libido* vaginal thrush, vaginal irritation,bladder irritation or urinary tractinfection* pre-menstrual-like symptoms* change in cervical secretions* suppression of milk production* vitamin B6 (pyridoxine)deficiencyThe most serious known side effectwith Combined Oral Contraceptiveuse is abnormal blood clotting whichmay have serious consequences.Deaths have occurred in somewomen as a result of blood clotscarried by the blood stream causingobstruction of blood vessels in thelungs or in the brain. The risk ofdeveloping blood clotting disordersand other blood vessel diseases inoral contraceptive users increaseswith age from 30 years onwards.Cigarette smoking also increases therisk. These problems may persistafter a woman has stopped taking thebirth control pill.The use of a Combined OralContraceptive can increase the risk ofa woman having a heart attack.Other risk factors for a heart attackinclude cigarette smoking; highblood pressure; high cholesterol;obesity; diabetes; a history ofpre-eclamptic toxaemia in pregnancyand age over 40 years.Some women may experience a risein blood pressure following the useof oral contraceptives.The association between the use ofCombined Oral Contraceptives andthe development of breast cancer andcervical cancer has not been firmlyestablished to date.Rarer side effects associated with theuse of combined oral contraceptivesare not listed here. You may wish todiscuss these, or any of the sideBREVINOR-1* 21 AND BREVINOR-1* 28 DAY TABLETS 4

effects listed above, with your doctorif you are concerned.Side effects not previously reportedwith BREVINOR-1 may also occur.If you notice anything unusualwhile you are takingBREVINOR-1, see your doctor.Do not be alarmed by this list ofpossible side effects.You may not experience any of them.After takingBREVINOR-1StorageKeep your BREVINOR-1 Tabletsin a safe place away from the sightand reach of children.A locked cupboard at leastone-and-a-half metres above theground is a good place to storemedicines.Do not take BREVINOR-1 past theexpiry date shown on the label.If you take the tablets after the expirydate has passed, they may not workas well.Keep your BREVINOR-1 tablets ina dry place, at a temperature below25 degrees C.Do not keep your tablets in therefrigerator.Do not store BREVINOR-1 or anyother medicine in the bathroom ornear a sink. Do not leave it in thecar on hot days or on window sills.Heat and dampness can destroy somemedicines.DisposalIf your doctor tells you to stop takingBREVINOR-1 or if the tablets havepassed their expiry date, ask yourpharmacist what to do with any thatare left over.Product descriptionWhat it looks likeBREVINOR-1 21 DayBREVINOR-1 21 Day is available incalendar packs consisting of fourstrips of tablets (4 months' supply)each with 21 white active tabletsmarked "SEARLE" on one side and"BX" on the other.BREVINOR-1 28 DayBREVINOR-1 28 Day is available incalendar packs consisting of fourstrips of tablets (4 months' supply)each with 21 white active tabletsmarked "SEARLE" on one side and"BX" on the other, and 7 orangeinactive tablets.IngredientsBREVINOR-1 21 DayEach white tablet contains* norethisterone 1 milligram (mg)* ethinyloestradiol 35 micrograms(mcg)* magnesium stearate* povidone* maize starch* lactose.BREVINOR-1 28 DayEach white tablet contains* norethisterone 1 milligram (mg)* ethinyloestradiol 35 micrograms(mcg)* magnesium stearate* povidone* maize starch* lactose.The orange inactive tablets contain* magnesium stearate* cellulose microcrystalline* lactose* sunset yellow FCF (CI No.15985).BREVINOR-1 does not containsucrose, gluten or tartrazine.IdentificationBREVINOR-1 can be identified bythe Australian Register Number onthe carton labels.BREVINOR-1 21 Day Tablets -AUST R 10045BREVINOR-1 28 Day Tablets -AUST R 62134SupplierPharmacia Australia Pty LimitedACN 000 185 52659 Kirby StreetRydalmere NSW 2116AustraliaToll Free number: 1800 675 229This leaflet was prepared inDecember 1997, revised on 20February 2004.*Registered Trademark(C)Copyright 2004BREVINOR-1* 21 AND BREVINOR-1* 28 DAY TABLETS 5