This leaflet tells you about oral contraceptives in general and about Triadene in detail. Please read it carefully to get the best from Triadene. If you are in any doubt about these instructions contact your doctor, pharmacist or Family Planning clinic.

You can usually become pregnant (conceive) from when you start to have periods, up until you are in your late 40s. Every menstrual cycle takes about 28 days. About halfway through this cycle an egg is released from one of your ovaries into a fallopian tube. This is called ovulation.

The egg travels down the fallopian tube towards your womb. When you make love, your partner's penis releases millions of sperm into your vagina. Some of these sperm travel up through your womb into your fallopian tubes. If there is an egg in one of these tubes, and a sperm reaches it, you can become pregnant. This is called 'conception'.

A fertilised egg gets embedded in the lining of your womb and takes 9 months to grow into a baby. As an egg can live for up to 2 days, and sperm for up to 5 days, you can become pregnant if you have made love up to 5 days before ovulation and for some time afterwards. If a sperm does not fertilise an egg, the egg is lost at the end of the menstrual cycle with the lining of your womb. This is called a 'period'.

Your menstrual cycle is controlled by two sex hormones made by your ovaries: one called oestrogen, the other progesterone (a progestogen). Oestrogen increases during the first half of your menstrual cycle, and makes your womb develop a thick lining, ready to receive the egg if conception happens. Progesterone comes later in the cycle and changes the lining of the womb still further to prepare it for pregnancy.

If you do not become pregnant, you make less of these hormones and this causes the lining of your womb to break down and the lining leaves your body as a period. But during pregnancy, your ovaries, and then the placenta (this attaches the growing baby to the womb and gives it food), carry on making progesterone and oestrogen to stop any more eggs being released.

A pill such as Triadene contains hormones which are like those your body produces (oestrogen and progestogen). These help stop you from getting pregnant, just as your natural hormones would stop you conceiving again when you are already pregnant.

The combined contraceptive pill protects you against getting pregnant in 3 ways:

• No egg is released to be fertilised by sperm.
• The fluid in the neck of your womb thickens so it is more difficult for sperm to enter it.
• The lining of your womb does not thicken enough for an egg to grow in it.

The pill is one of the most effective contraceptives apart from sterilisation. But this can only be true when it is taken correctly. So you must follow your doctor's instructions and take the tablets exactly as it says in the next section of this leaflet.

The name of your medicine is: Triadene.

(ethinylestradiol), 5 dark brown tablets

containing 70 micrograms gestodene and 40 micrograms ethinyloestradiol, 10 white tablets containing 100 micrograms gestodene and 30 micrograms ethinyloestradiol. All tablets are sugar-coated. Gestodene is a progestogen and ethinyloestradiol is an oestrogen. Progestogen and oestrogen are both female types of hormone.

Triadene also contains the following inactive ingredients: lactose, maize starch, povidone, magnesium stearate (E572), sucrose, macrogol 6000, sodium calcium edetate, calcium carbonate (E170), talc, montan glycol wax, titanium dioxide (E171), ferric oxide pigment brown and yellow (E172), glycerin (E422).

Each pack of Triadene contains 3 memo strips of 21

tablets.

Triadene is a combined oral contraceptive pill. Combined oral contraceptives contain two female types of hormone, oestrogen and progestogen.

The product licence is held by Schering Health Care Ltd, The Brow, Burgess Hill, West Sussex RH15 9NE.

Product licence number 0053/0205.

Triadene is manufactured by: Schering AG, Berlin, Germany.

Triadene is a low dose combined oral contraceptive. When used as instructed you are very unlikely to become pregnant.

Before taking Triadene, tell your doctor if you have any of these:

• you are pregnant or think you may be pregnant.
• blood clots in the legs, lungs, eyes, or anywhere
• else or have ever had these. If you have had a heart attack or if you have any medical condition which makes you more at risk of developing blood clots.
• abnormal red blood cells (sickle-cell anaemia).
• disorders of blood fat (lipid) metabolism.
• cancer of the breast or of the lining of the womb
• (mammary or endometrial carcinoma) or have ever had either of these conditions.
• abnormal bleeding from your vagina of unknown
• cause.
• certain types of jaundice (Dubin-Johnson or Rotor
• syndromes).
• severe diabetes with changes to the blood vessels.
• liver tumours or have ever had these.
• any other long or short term liver disease.
• allergy to any of the ingredients of Triadene.

Do not take Triadene if you have had any of these conditions when you were pregnant:

• itching of your whole body (pruritus of pregnancy).
• the rash known as herpes gestationis.
• worsening of inherited deafness (otosclerosis).
• yellowing of the skin (jaundice).

Before you start taking Triadene your pelvic organs, breasts and blood pressure should be checked by your doctor and these checks should be repeated regularly. The doctor will also make sure you are not pregnant.

If anyone in your family has had any illness caused by blood clots, or a heart attack, or a stroke at a young age, tell your doctor.

The following conditions need watching carefully

while you are taking the pill:

If you have:

• severe depressive states, past or present.
• varicose veins.
• diabetes (diabetes mellitus) or a tendency towards diabetes.
• high blood pressure (hypertension).
• fits (epilepsy).
• the inherited form of deafness known as otosclerosis.
• the disease of the nervous system called multiple sclerosis.
• the inherited disease called porphyria.

or, if:

• you have had inflamed veins (phlebitis).
• anyone in your family has had breast cancer.
• anyone in your family has had any illness caused by blood clots, or a heart attack or stroke at a young age.

If any of these conditions gets worse or you have them for the first time, this may be a sign that you should stop taking Triadene.

When you stop taking Triadene it may take some time for your regular periods to return.

Some medicines may stop Triadene from working properly,

If you are taking any other medicine while you are taking Triadene, be sure to tell your doctor (or dentist). Your doctor (or dentist) can tell you whether you should use extra contraceptive precautions and for how long.

Medicines which can sometimes stop Triadene from working properly are antibiotics (such as ampicillin and rifampicin); griseofulvin (which is used to treat fungal infections); phenylbutazone (which is used as an anti-inflammatory drug to treat some types of joint diseases), phenytoin primidone, phenobarbitone and some other medicines used in people with epilepsy, and carbamazepine (which can be used to treat epilepsy or other illnesses).

If you are taking any of these medicines you might still be able to use Triadene, but you will also need to use an extra contraceptive method (condoms or cap plus spermicide) while you are taking the other medicine and for 7 days after you stop taking it. If your present pack ends before these 7 days, start the next pack the next day without a break. This means taking a pill every day during your normal 7 pill-free days.

If you run two packs together you may not have a period until the end of two packs, but this is not harmful. If you do not have a period after the second pack, you must talk to your doctor before you start the next pack.

If you are taking rifampicin you will need to use another method of contraception as well as Triadene. You should do this while you are taking the rifampicin and for 4 weeks after you stop.

If you are diabetic your doctor may alter the dose of medicine required to treat your diabetes.

If you are in doubt check with your doctor, pharmacist or Family Planning clinic.

Being sick or having very bad diarrhoea may stop Triadene from working properly and make it less effective. Carry on taking Triadene as usual, and also use another method of contraception, (condom or cap plus spermicide) until 7 days after you have recovered from the stomach upset. If you finish your pack before these 7 days, start the next pack the next day without a break. This means taking a pill every day during your normal 7 pill-free days. If you run two packs together you may not have a period until the end oftwo packs, but this is not harmful. If you do not have

a period after the second pack, you must talk to your

doctor before starting the next pack. If your stomach

upset continues for some time, consult your doctor

who may consider another form of contraception.

It has been suggested, on the basis of statistical

evidence, that the risk of developing various disorders

of the circulation of the blood is slightly greater in

women who take the combined pill than in those who

do not. This can lead to, for example, deep vein

thrombosis (blood clot in the leg), strokes (blood clots

and haemorrhages from the blood vessels of the

brain), heart attacks or pulmonary embolism (blood

clots blocking the arteries of the lungs). People do not

always fully recover from these disorders, and, very

rarely, they are fatal. Studies suggest that these

disorders occur less often with modern low-dose oral

contraceptives then with older pills.

Certain conditions increase the risk of thrombosis.

They include:

• smoking.
• obesity.
• some diseases of the heart and blood vessels.
• diabetes.
• migraine.
• a major operation or period of immobilisation (e.g.
• you are in bed after an accident or operation or you
• have a plaster cast on a broken leg).
• if any members of your family have suffered from thromboembolic diseases (e.g. deep vein thrombosis, stroke or heart attack) at a young age.
• varicose veins.

If any of these conditions apply to you before you decide to take Triadene or while you are taking Triadene you must discuss them with your doctor.

The risk of arterial thrombosis (e.g. heart attack and stroke) associated with the pill increases with age, and this risk is increased by cigarette smoking. For this reason, the use of combined pills by women in the older age-group, especially those who also smoke, is discouraged.

Signs and symptoms of blood clots are given in the section "Reasons for stopping Triadene immediately"

The pill does give a substantial degree of protection against cancers of the ovary and the lining of the womb. An increased risk of cervical cancer in long-term users of the pill has been reported in some; studies. It is uncertain whether this increased risk is caused by the pill as it could be due to the effects of sexual behaviour and other factors.

The evidence linking use of the pill and breast cancer is unclear. Some studies suggest an increased risk of breast cancer in women below the age of 35, the risk increasing the longer the pill is used. Any possible increased risk of breast cancer with combined pills is, however, likely to be small.

The combination of ethinyloestradiol and gestodene, like other contraceptives, has been linked with an increased incidence of abnormal growths in the rat liver, but it is unclear whether this could happen in humans. On rare occasions, the use of the pill has led to liver diseases such as jaundice and benign liver tumours, and, very rarely, it has been associated with some forms of malignant liver tumours (cancer) in long-term users. Liver tumours may lead to life-threatening intra-abdominal haemorrhage (bleeding in the abdomen). Therefore, if you have pain in the upper abdomen that does not soon clear up, tell your doctor. Also, if your skin becomes yellow (jaundice) you must tell your doctor.

If you think you might be pregnant, stop taking Triadene and consult your doctor immediately. Use another method of contraception such as a condom until you see your doctor.

Certain conditions may sometimes get worse during use of the pill. The diseases are those listed under "What you should know before taking Triadene".

no further tablets of Triadene and consult your doctor

immediately. In the meantime use another method of

contraception such as a condom.

• migraine for the first time, or if existing migraine occurs more often than before.
• unusually bad headaches or if you have headaches more often than before.
• sudden changes to your eyesight, hearing, speech, sense of smell, taste or touch.
• Unusual pains in your leg or unusual swelling of your arms or legs, sharp pains in your chest or sudden shortness of breath, crushing pains or feelings of heaviness in your chest coughing for no apparent reason, dizziness or fainting or if one side of your body suddenly becomes very weak or numb. These may be symptoms of blood clot formation or symptoms of an inflammation of veins combined with the formation of blood clots(thrombophlebitis).
• your skin becomes yellow (jaundice), you develop hepatitis (inflammation of the liver) or if your whole body starts itching.
• an increase in the number of fits (epileptic seizures).
• a large increase in your blood pressure.
• severe depression.
• severe upper abdominal pains or unusual swelling of your abdomen.
• definite worsening of conditions which had got worse during a previous pregnancy or while taking the pill in the past.
• pregnancy.
• surgery or immobilisation. You must stop Triadene six weeks before a planned major operation (e.g. stomach surgery), if you are having any surgery to the legs, or medical treatment for varicose veins. Also if you are immobilised for a long time (e.g. you are in bed after an accident or operation or you have a plaster cast on a broken leg). Your doctor will advise you when to start taking Triadene again.

This pack is designed to help you remember to take

your pills.

In addition to the pills, the Triadene box contains 3 self-adhesive stickers marked with the days of the week.

Peel off one of the stickers and place it onto the pill pack so that the first day of pill taking is directly under the red section marked "start".

For instance, if you start the pills on a Monday, the "start" section should be lined up with a day marked "Mon".

You can now see on which day you have to take each pill.

After taking your first pill which is marked "start" take one pill each day, following the direction of the arrows, until you have finished all 21 pills in the pack.

You should try to take the pill at the same time every day, for example, after breakfast.

Swallow each pill whole, with water if necessary.

By starting in this way you will have contraceptive protection at once.Your seven pill-free days

After you have taken all 21 tablets, you have 7 days when you take no tablets. A few days after you have taken the last pill from each pack you will have a period. Your periods will be regular, probably lighter than before and almost always painless. The feelings that often make the last days before a period unpleasant (called premenstrual syndrome) usually disappear. You will not have to take extra contraceptive precautions during the 7 day break from taking the pill as long as you have taken your pills correctly and start the next pack on time.

Start taking your next pack of Triadene after 7 pill-free days. Each new pack will begin on the same day of the week as the one before, so it is easy to remember when to start again. You should start taking your next pack of Triadene after 7 days, even if you are still bleeding. The table "How to take Triadene" should help you to take the pills properly.

If you are taking a 21 day contraceptive pill, finish that pack and then start taking Triadene the next day. Do not leave a gap between packs. Start with a pill from a blister which you have marked with the correct day of the week. Then follow the instructions as described before. (see "Taking your first pack of Triadene"). By starting in this way you will have contraceptive protection at once. You may not have a period until the end of the first Triadene pack but this is not harmful. You may have some bleeding on pill-taking days, but do not worry.

Triadene should be started after taking the last active tablet from the Every Day pill pack. If you are not sure which tablets are the active ones, ask your doctor or pharmacist. The first Triadene tablet is taken the next day which means that you do not leave a gap between packs. Start with a pill from a blister which you have marked with the correct day of the week. Return to your pharmacist any remaining inactive tablets from your old Every Day pack. Then follow the instructions as before (see "Taking your first pack of Triadene"). By starting in this way you will have contraceptive protection at once. You may not have a period until the end of the first Triadene pack, but this is not harmful. You may have some bleeding on pill-taking days, but do not worry.

The first Triadene tablet should be taken on the first day of the period, even if you have already taken a mini pill on that day. Return to your pharmacist any mini pills left in your old pack. Start with a pill from a blister which you have marked with the correct day of the week. Follow the instructions as before (see "Taking your first pack of Triadene"). By starting in this way you will have contraceptive protection at once.

If you have just had a baby, your doctor may advise you to start taking Triadene 21 days after delivery provided that you are fully mobile. You do not have to wait for a period. You will need to use another method of contraception, such as a condom, until you start Triadene and for the first 7 days of pill-taking. Follow the instructions as before (see "Taking your first pack of Triadene").

The use of Triadene during breast feeding may reduce the amount of milk that you produce.

Very small amounts of the active ingredients of Triadene are found in breast milk. If you are breast feeding and want to take Triadene you should discuss this with your doctor. Your doctor may decide to give you the mini pill instead.

If you have just had a miscarriage or an abortion your doctor may advise you to start using Triadene

immediately. Follow the instructions as before (see "Taking your first pack of Triadene").

Occasionally, you may miss a period. While this can mean you are pregnant, it is most unlikely if you have taken your pills correctly. Take your next pack as normal. If you think that you might have put yourself at risk (e.g. missed pills, taking other medicines} or if you miss a second period, see your doctor at once.

If you forget to take a pill please follow these instructions:

1. If you are more than 12 hours late in taking a pill, or have missed more than one pill

Contraceptive protection may be lower, so you must use extra protection. Follow the instructions for the 7-day rule.

• take the most recent 'late' pill and continue to take your next pills at your normal times and
• use an extra contraceptive method (condoms or cap plus spermicide) for the next 7 days and
• if your present pack ends before the 7 days do, start the next pack the next day, without a break. Do not leave a gap between packs. You will not have a period until you have finished the next pack, but this is not harmful. You may see some bleeding on pill-taking days, but do not worry. If you do not have a period after the second pack, you must talk to you r doctor before you start the next pack.

2. If one pill is 12 hours late or less

Don't worry. Contraceptive protection should not be affected if you take the late pill at once, and keep taking your next pills at the usual time. This may mean taking two pills in one day.

If you lose a pill, the easiest thing to do is to take the last pill of the pack in place of the lost pill. Then take all the other pills on their proper days. Your cycle will one day shorter than normal, but contraceptive protection is not affected. After your 7 pill-free days you will have a new starting-day, one day earlier than before. Should you lose a pack of pills halfway through, ask your doctor or pharmacist what to do.

A small number of women may have a little breakthrough bleeding or spotting while taking Triadene especially during the first few months. Normally, this bleeding is nothing to worry about, and will stop in a day or two. Keep taking the pills as usual, and the problem should disappear after the first few packs.

If the bleeding keeps on returning, is annoying or long-lasting, talk to your doctor. Also, if you start to have breakthrough bleeding for the first time after being on Triadene for a long time, you should see your doctor.

Unexpected bleeding may also be a sign of irregular pill-taking, so try to take your pill at the same time every day.

Your periods may become shorter, more regular and less painful. Heavy periods may become lighter. The symptoms that often make the last few days before a period so unpleasant (known as premenstrual syndrome) usually disappear. Long-term use of the pill reduces your risk of cancers of the ovaries and of the lining of the womb.

Overdosage may cause nausea, vomiting and, in females, withdrawal bleeding. You should consult your doctor who will be able to advise you what action, If any, ~s necessary.

Sometimes unwanted effects occur with Triadene. These can be mild or serious.

Sometimes mild unwanted effects can occur in the first few months after starting Triadene.

• bleeding and spotting between your periods can
• sometimes occur for the first few months but this usually stops once your body has adjusted to Triadene. If it continues, becomes heavy or starts again, contact your doctor.
• headaches.
• feeling sick, being sick and stomach upsets.
• sore breasts.
• depressive moods, loss of interest in sex.
• changes in weight.
• chloasma (yellow brown patches on the skin). This
• may happen even if you have been using Triadene for a number of months. Chloasma may be reduced by avoiding too much sunlight.
• poor tolerance of contact lenses.

More serious reactions have sometimes been associated with contraceptive pills that contain oestrogen and progestogen, for example thrombosis (the formation of a clot in blood vessels) or liver disease. These are explained more fully in the "Warnings" section.

If you think that you have a serious adverse reaction to Triadene, stop taking your tablets and consult your doctor as soon as possible.

If you think you have an unwanted effect due to Triadene even if it is not included in this leaflet, tell your doctor or a pharmacist about it.

Effect on blood tests: The use of oral contraceptives may affect the results of certain laboratory tests. Always tell your doctor or the laboratory staff that you are using an oral contraceptive.

Expiry date: The expiry date is printed on the pack. Do not use after this date.

Storage: Store all medicines out of the reach of children.

Date of last revision of this leaflet: 22 March 1996.