Triphasil 28 Consumer Medicine Information

Levonorgestrel and Ethinyloestradiol Tablets

What is in this leaflet

This leaflet answers some common questions about TRIPHASIL.

It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking TRIPHASIL against the benefits this medicine is expected to have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What TRIPHASIL is used for

TRIPHASIL is an oral contraceptive. Oral contraceptives are commonly known as 'the Pill'. TRIPHASIL pills contain two active ingredients (levonorgestrel and ethinyloestradiol) that can stop you from becoming pregnant if taken correctly. They are similar to hormones your body normally produces.

Levonorgestrel is a progestogen. It changes the mucus in the vaginal passages, making it difficult for sperm to reach the egg. Levonorgestrel may also change the lining of the womb, making it less likely for a fertilised egg to implant.

Ethinyloestradiol is an estrogen, similar to the estrogen produced in your body in varying amounts during each monthly cycle. Taking a small amount of ethinyloestradiol every day prevents eggs from growing and being released ready for pregnancy.

Your doctor may have prescribed TRIPHASIL for another reason. In some women, irregular, very painful or heavy periods may lead to iron loss and anaemia. TRIPHASIL can normalise these periods. There are other benefits from long-term use.

Ask your doctor if you have any questions about why TRIPHASIL has been prescribed for you.

This medicine is available only with a doctor's prescription.

TRIPHASIL is not addictive.

TRIPHASIL will not protect you from HIV-AIDS or any other sexually transmitted diseases.

Before you take TRIPHASIL

When you must not take it

Do not take TRIPHASIL if:

  1. you have an allergy to
    • TRIPHASIL
    • levonorgestrel or ethinyloestradiol or any other oral contraceptives
    • any medicine known as estrogens or progestogens, or
    • any of the ingredients listed at the end of this leaflet
    Some of the symptoms of an allergic reaction may include rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or troubled breathing.
  2. you are pregnant or think you are pregnant.
    TRIPHASIL may affect your developing baby if you take it during pregnancy.
  3. you have or have had any of the medical conditions including:
    • heart attack or stroke
    • blood clots in the legs, including the deep veins of your legs
    • blood clots in the lungs, heart or eyes or other blood clotting disorders
    • breast cancer or cancer of the lining of the womb, cervix or vagina, or you think you have these conditions
    • chest pain (angina pectoris)
      Taking oral contraceptives may increase the risk of developing these conditions.
    • unexplained abnormal vaginal bleeding
      You should not take TRIPHASIL until your doctor has worked out why this bleeding is happening.
    • liver tumour or liver disease
    • diabetes
    • high blood pressure, which is not controlled
    • hemiplegic migraine
    • disturbances of blood fat metabolism

If you are not sure whether any of these apply to you, or you are worried by anything in this list, tell your doctor.

TRIPHASIL is not for use in children.

Do not use TRIPHASIL if the packaging is torn or shows signs of tampering.

Do not use TRIPHASIL after the expiry date (EXP) printed on the pack.
If you take TRIPHASIL after the expiry date has passed; it may have no effect at all, or worse, have an entirely unexpected effect.

If you are not sure whether you should start using TRIPHASIL, contact your doctor.

Before you take it

You must have a thorough medical check-up, including a Pap smear and urine test.

Tell your doctor if:

  1. you have any allergies to:
    • any other medicines
    • any other substances, such as foods, preservatives or dyes
  2. you smoke
    Cigarette smoking increases the risk of serious side effects on the heart and blood vessels when taking oral contraceptives. The risk increases with age and with heavy smoking (15 or more cigarettes per day), especially in women more than 35 years old. If you take TRIPHASIL, you should not smoke. If you smoke you are advised to choose another method of contraception.
  3. you have any other health problems, especially:
    • breast lumps, abnormal breast X-ray or mammogram
    • high cholesterol or blood fats
    • migraine or other headaches
    • epilepsy
    • gallbladder or heart disease
    • diabetes
    • high blood pressure
    • varicose veins
    • depression
    • fluid retention or kidney disease
    • asthma
    • fibroids
    Some studies show that using oral contraceptives increases the risk of heart attack and stroke. The risk of developing heart disease increase if you also have one or more of the following conditions:
    • you smoke
    • high blood pressure
    • high blood cholesterol levels
    • obesity
    • diabetes
    • history of high blood pressure during pregnancy
  4. yellowing of the whites of the eyes or skin (jaundice) during pregnancy or during previous use of oral contraceptives.
    Taking oral contraceptives may be associated with liver disease.
  5. anyone in your family has had blood clots in the deep veins of the legs, a stroke or heart attack.
    Your doctor will need to check that TRIPHASIL is not likely to cause these illnesses in you.
  6. you plan to become pregnant or think you are pregnant.
    Like most medicines, TRIPHASIL is not recommended for use during pregnancy.
  7. you are breast-feeding or plan to breast-feed.
    Like most medicines, TRIPHASIL is not recommended while you are breast-feeding. Small amounts of oral contraceptives have been found in breast milk. It is not known what effect this may have on the baby. A decrease in milk supply may also occur.

If you have not told your doctor about any of the above, tell them before you start taking TRIPHASIL.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Many other medicines may be affected by TRIPHASIL or they may affect how well TRIPHASIL works. This includes a wide range of prescription medicines including:

  • antibiotics such as rifampicin, ampicillin and tetracyclines
  • barbiturates (phenobarbitone)
  • medicines for epilepsy (such as phenytoin and primidone)
  • St. John's wort, an ingredient in many medicines that you can buy without a prescription from a pharmacy, health food shop or supermarket
  • Non-prescription medicines such as paracetamol and Vitamin C

You may need to use an additional method of non-hormonal contraception (such as condoms or a diaphragm) while you are taking the other medicine and for 14 days following. Your doctor may also advise you to skip the 7 red reminder pills.

If you take rifampicin, you may need to use additional contraception for four weeks after finishing the course of rifampicin.

If you have not told your doctor or pharmacist about any of the above, tell them before you start taking TRIPHASIL.

If you are scheduled for any laboratory tests, tell your doctor you are taking TRIPHASIL.
Some blood tests may be affected by taking TRIPHASIL.

How to use TRIPHASIL

How much to take

It is very important to take TRIPHASIL exactly as your doctor tells you. TRIPHASIL works best if you do not miss any pills and if you take the pills at the same time every day.
You may find it easier to remember to take them if you take TRIPHASIL after the evening meal or at bedtime.

If you are concerned about this, speak to your doctor or pharmacist.

If your doctor has prescribed TRIPHASIL for some other purpose other than contraception, follow their directions closely, even if they are not the same as on the pack.

For contraception, follow the directions on the blister pack.
If you do not understand the instructions on the blister pack, ask your doctor or pharmacist for help.

When starting your first pack

For complete protection during the first month of taking TRIPHASIL, use a non-hormonal contraceptive method, (such as condoms or a diaphragm) in addition to the first 14 TRIPHASIL pills. Do not use the rhythm or temperature methods as your additional contraception.

Each blister pack of TRIPHASIL contains 6 brown hormone pills, 5 white hormone pills, 10 yellow hormone pills and 7 red inactive or reminder pills. To start using TRIPHASIL follow these steps:

  1. Wait for your next period to start. On the first day of menstrual bleeding, take the pill from the shaded section of the blister pack that has the day of the week on which you are taking the pill written above it. If your period starts between Monday and Friday your first pill is red. If your period starts on a Saturday or Sunday your first pill is brown.
  2. After that, take one pill each day, following the arrows so that you are taking the correct pill for the day of the week until all 6 brown pills, 5 white pills and 10 yellow pills have gone.
  3. Carry straight on with the red reminder pills taking one pill each day for the next 7 days.
  4. You will usually get your period during the week you are taking the red pills.

If you do not bleed and there is any chance that you have not followed all the instructions in this leaflet, contact your doctor to check if you are pregnant.

Going on to further packs

  1. Begin the next pack on the day after you take the last red pill. Take the pill from the shaded section that has the day of the week on which you are taking the pill written above it. Do this even if you are still bleeding.
  2. If you start the new pack later than the day after your last red pill, you may have started a normal fertile cycle.

If you start your new pack late, you must use an additional method of non-hormonal contraception (such as condoms or a diaphragm) until you have taken TRIPHASIL pills for 14 days in a row without a break.

Changing from a different oral contraceptive

  1. Stop taking your current oral contraceptive after you have taken the last active pill. If your current oral contraceptive pack also contains reminder pills, do not take them.
  2. The next day take the first TRIPHASIL pill from the silver section with the day of the week you are taking it written above it.

If you are not sure which pill this is, ask your doctor or pharmacist.

You must use an additional method of non-hormonal contraception (such as condoms or a diaphragm) until you have taken TRIPHASIL pills for 14 days in a row without a break. Do not use the rhythm or temperature methods as your additional contraception.

  1. Take one TRIPHASIL pill each day following the direction of the arrows until the pack is finished.
  2. Carry straight on with red reminder pills for the next 7 days.
  3. You will have a 'withdrawal' bleed, similar to a period, during the week of red pills.

If you do not bleed and there is any chance that you have not followed all the instructions in this leaflet, see your doctor to check if you are pregnant.

After having a baby

If you have just had a baby, talk to your doctor before you start taking TRIPHASIL.

If you are breastfeeding

If you are breastfeeding and want to take TRIPHASIL, talk to your doctor first.

After a miscarriage or abortion

Your doctor will tell you how to take TRIPHASIL after a miscarriage or abortion.

How to take TRIPHASIL

Swallow TRIPHASIL with a glass of water.

When to take it

You must take TRIPHASIL every day, even if you do not have sex very often. Take TRIPHASIL at about the same time each day.
Taking your pill at the same time each day will have the best effect. It will also help you remember when to take the pills.

It does not matter if you take TRIPHASIL before or after food.

How long to take it

Your doctor may prescribe TRIPHASIL for long periods, until you no longer need or want contraception.
If you are not sure how long you should be taking TRIPHASIL, ask your doctor.

If you forget to take it

If you forget to take TRIPHASIL every day, it may not work as well in protecting you from becoming pregnant.

If you forget one pill

If one of the brown, white or yellow pills is missed, take the missed pill immediately and the next pill at the usual time.
You must also use additional contraception (such as condoms or diaphragm) for the next 14 days. Do not use the rhythm or temperature methods as your additional contraception.

If you forget two pills

If two brown, white or yellow pills are missed in a row, take both missed pills immediately. Take the next pill at the usual time.
You must also use additional contraception (such as condoms or diaphragm) for the next 14 days. Do not use the rhythm or temperature methods as your additional contraception.

If you forget three or more pills

If you forget to take three or more brown, white or yellow pills, do not take them. Throw away the remaining pills in the pack and start a new pack on the 8th day after the last pill was taken.
You must use a non-hormonal method of contraception (such as condoms or a diaphragm) during this time and until 14 daily pills have been taken from the new pack. Do not use the rhythm or temperature methods as your additional contraception.

If one of the red reminder pills is forgotten, do not worry as you are still protected from pregnancy as long as the next pack is started on the correct day.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take TRIPHASIL, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 0800 764 766), or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much TRIPHASIL. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.

If you take too much TRIPHASIL, you may feel sick or vomit.

While you are taking TRIPHASIL

Things you must do

Tell all other doctors, dentists, and pharmacists who are treating you that you are using TRIPHASIL.

If you become pregnant while taking TRIPHASIL, tell your doctor immediately

If you miss a period and you have taken your pills correctly, continue taking your pills as you would normally.
Sometimes you might not have a menstrual period while taking TRIPHASIL.

If you miss a period and you have not taken your pills correctly stop taking your pills and see your doctor. Use a non-hormonal method of contraception, such as condoms or a diaphragm during this time.
Not taking your pills correctly includes missing one or more pills or starting a new pack later than you should have.
Your doctor should make sure you are not pregnant before you start taking TRIPHASIL again.

If you miss two menstrual periods stop taking your pills and see your doctor, even if you have taken the pills correctly.
You must use a non-hormonal method of contraception, such as condoms or a diaphragm during this time. Do not use the rhythm or temperature methods as your additional contraception.

Your doctor should make sure you are not pregnant before you start taking TRIPHASIL again.

Have regular check ups from your doctor
Oral contraceptives should not be prescribed for longer than one year without your doctor carrying out a check-up.

Things you must not do

Do not give TRIPHASIL to anyone else even if they have the same condition as you.

Do not use TRIPHASIL to treat any other complaints unless your doctor tells you to.
Do not stop taking TRIPHASIL, or change the dosage, without checking with your doctor.

If you stop taking TRIPHASIL or do not take a pill every day, without using another form of contraception, you may become pregnant.

Things to be careful of

If you have vomiting or diarrhoea shortly after taking TRIPHASIL, you must use additional non-hormonal contraception (such as condoms or a diaphragm) for the next 14 days. Do not use the rhythm or temperature methods as your additional contraception.
TRIPHASIL may not have had time to be absorbed properly and may not protect you from becoming pregnant.

If these 14 days go over into the section containing the 7 red reminder pills, do not take the red pills. Start a new pack on the day after you have taken the last active yellow pill.
This will mean that you may not have a period until the end of two packs.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking TRIPHASIL.
TRIPHASIL helps prevent pregnancy in most women, but it may have unwanted side effects in a few people.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

  • feeling sick
  • vomiting

These are the more common side effects of TRIPHASIL.

Less common side effects of oral contraceptives include:

  • bloating, stomach cramps or stomach pain
  • painful periods
  • changes in mucus from the vagina
  • vaginal inflammation
  • changes in sex drive
  • rash
  • vaginal thrush (vaginal candidiasis)
  • changes to the shape of the cornea of the eye
  • contact lenses become uncomfortable to wear
  • blurred vision
  • darkening of the skin
  • increase or decrease in appetite
  • weight gain or loss
  • mood changes
  • nervousness
  • dizziness
  • loss of scalp hair
  • increase in body hair
  • headache, including migraine
  • acne
  • fluid retention
  • changes in blood fat levels
  • worsening of the following pre-existing conditions
    • chorea
    • porphyria
    • systemic lupus erythematosus (SLE)
    • varicose veins
    • some blood disorders
  • breast pain or tenderness, enlargement or secretion
  • changes in menstrual blood flow
  • missed periods
    However, if you have not taken TRIPHASIL as directed, check with your doctor to see if you are pregnant.
  • spotting or breakthrough bleeding
    Slight "spotting" of blood between your menstrual periods usually stops by itself within a few days.
    If this bleeding keeps going or is heavy, see your doctor.

Tell your doctor immediately if you notice any of the following:

  • sharp or crushing chest pain, coughing of blood or sudden shortness of breath
  • weakness, numbness in an arm or leg
  • a sharp pain or swelling in the calf muscle
  • breast lumps
  • sudden severe headache or vomiting, dizziness or fainting
  • migraine headaches for the first time
  • more frequent migraines if you are a migraine sufferer
  • problems with your hearing or speech
  • sudden changes or loss of sight
  • more frequent fits if you suffer from epilepsy
  • severe pain or tenderness in the stomach
  • severe depression
  • jaundice or yellowing of the skin or eyeballs, especially if it occurs with fever, tiredness, loss of appetite, dark coloured urine or light coloured bowel motions
  • itchy rash
  • rise in blood pressure

These are very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell.
Do not be alarmed by this list of possible side effects. You may not experience any of them.

Stop taking TRIPHASIL and visit your doctor:

  • At least 4 weeks before you plan to have an operation. Do not start taking TRIPHASIL again until 2 weeks after the operation
  • At least 4 weeks before any prolonged period of bed rest
  • If you fall pregnant or think you may be pregnant

After stopping TRIPHASIL

If your periods do not return within 2 to 3 months of stopping TRIPHASIL tell your doctor.
Some women have short-term problems getting pregnant after stopping TRIPHASIL, especially if they had irregular menstrual cycles before starting to use an oral contraceptive.

Ask your doctor or pharmacist for advice about taking folate if you plan to become pregnant.

After taking TRIPHASIL

Storage

Keep your pills in the pack until it is time to take them.
If you take the pills out of the pack they will not keep well.

Keep the pills in a cool dry place where the temperature stays below 30C. Do not store TRIPHASIL or any other medicine in the bathroom or near a sink. Do not leave it in the car or on windowsills.
Heat and dampness can destroy some medicines.

Keep it where children cannot reach it.
A locked cupboard at least one-and-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking TRIPHASIL or the pills have passed their expiry date, ask your pharmacist what to do with any that are left over.

Product description

What it looks like

Each blister pack of TRIPHASIL contains 4 different pills

  • 6 brown pills
  • 5 white pills
  • 10 yellow pills
  • 7 red pills.

The pack is marked with days of the week next to each pill.

TRIPHASIL comes in a box containing 3 blister packs. Each blister pack contains 28 pills.

Ingredients

The active ingredients in TRIPHASIL are levonorgestrel and ethinyloestradiol.

Each brown pill contains 50 micrograms levonorgestrel and 30 micrograms of ethinyloestradiol

Each white pill contains 75 micrograms of levonorgestrel and 40 micrograms of ethinyloestradiol.

Each yellow pill contains 125 micrograms levonorgestrel and 30 micrograms ethinyloestradiol.

Each red pill contains no active ingredients.

The brown pills also contain the following inactive ingredients:

  • lactose
  • maize starch
  • povidone
  • talc
  • magnesium stearate
  • sucrose
  • macrogol 6000
  • calcium carbonate
  • iron oxide yellow CI 77492
  • iron oxide red CI 77491
  • glycerol
  • titanium dioxide (171)
  • glycol/butylene glycol montanate.

 The white pills also contain the following inactive ingredients:

  • lactose
  • maize starch
  • povidone
  • talc
  • magnesium stearate
  • sucrose
  • macrogol 6000
  • calcium carbonate
  • montan wax.

The yellow pills also contain the following inactive ingredients:

  • lactose
  • maize starch
  • povidone
  • talc
  • magnesium stearate
  • sucrose
  • macrogol 6000
  • calcium carbonate
  • iron oxide yellow CI 77492
  • glycerol
  • titanium dioxide (171)
  • glycol/butylene glycol montanate.

TRIPHASIL red reminder pills contain the following inactive ingredients:

  • lactose
  • maize starch
  • povidone
  • talc
  • magnesium stearate
  • sucrose
  • macrogol 6000
  • calcium carbonate
  • brilliant scarlet 4R CI 16255
  • erythrosine CI 45430 (127)
  • glycol/butylene glycol montanate.

TRIPHASIL does not contain gluten, tartrazine or any other azo dyes.

The number in brackets following the colouring agent is the Australian/New Zealand Food Standard code.

This leaflet was prepared on 21 April 2002.

Registered Trade Mark

Triphasil-CMI-NZ-21Apr02D