Trifeme

Levonorgestrel and Ethinyloestradiol Tablets
Consumer Medicine Information

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Trifeme. It does not contain all the information that is known about Trifeme. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What Trifeme is used for

Trifeme is an oral contraceptive, commonly known as a "birth control pill" or "the Pill". Trifeme tablets contain two hormones (levonorgestrel and ethinyloestradiol), which prevent you from becoming pregnant if taken correctly. They are similar to the hormones that your body normally produces.
Trifeme prevents pregnancy in several ways:
It inhibits the egg release by stopping it maturing
It changes the cervical mucus consistency making it difficult for the sperm to reach the egg
It changes the lining of the uterus making it less suitable for implantation.
Ask your doctor if you have any questions about why Trifeme has been prescribed for you.
Your doctor may have prescribed Trifeme for another reason.
This medicine is only available with a doctor's prescription.
Trifeme is not habit-forming.
This medicine is not expected to affect your ability to drive a car or operate machinery.

Before you take Trifeme

When you must not take Trifeme

Do not take Trifeme if you have an allergy to:
Any medicine containing ethinyloestradiol or levonorgestrel
Any of the ingredients listed at the end of this leaflet
Any other similar medicines (such as other oral contraceptives).
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
Do not take Trifeme if you have, or have had, any of the following medical conditions:
Blood clots in the legs (thrombophlebitis or deep vein thrombosis (DVT)), lungs (pulmonary embolism) or eyes
Heart valve or heart rhythm disorders that may be associated with the formation of blood clots
Heart attack or stroke
Chest pain (angina pectoris)
High blood pressure which is uncontrolled
Some severe types of headache or migraine, including migraine with partial paralysis
Diabetes with blood vessel damage
Breast cancer or cancer of the lining of the womb, cervix or vagina, or you think you have these conditions
Unexplained vaginal bleeding
Liver tumour or liver disease
Inflammation of the pancreas, which is associated with very high blood levels of triglycerides (fatty substances)
Yellowing of the whites of the eyes or the skin (jaundice) during pregnancy or during previous use of an oral contraceptive
High blood levels of cholesterol or triglycerides (a type of fat found in your blood)
Changes in vision, such as blurring.
If you are not certain whether these may apply to you, or you are worried by anything in this list, tell your doctor.
Do not take this medicine if you are pregnant or you think you are pregnant.
Pregnancy must be excluded before you start taking Trifeme.
Do not give this medicine to a child.
Do not take this medicine if you have already experienced menopause.
Do not take this medicine after the expiry date (EXP) printed on the pack or if the packaging is torn or shows signs of tampering.
If it is expired or damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take Trifeme

You must have a thorough medical check-up, including a Pap smear, breast check, blood pressure check and urine test.
Tell your doctor if you are allergic to any foods, dyes, preservatives or any other medicines.
Tell your doctor if you smoke.
Oral contraceptives increase your risk of having a stroke or heart attack. The risk of serious side effects on the heart and blood vessels is even greater if you smoke and take oral contraceptives. The risk increases with age and with heavy smoking (15 or more cigarettes per day), especially in women older than 35 years. If you take Trifeme, you should not smoke.
Tell your doctor if you have any other health problems, especially:
Breast lumps, abnormal breast X-ray or mammogram
Diabetes
Heart disease
High cholesterol or blood fats
High blood pressure, a history of high blood pressure, or high blood pressure during pregnancy
Migraine or other headaches
Epilepsy
Depression
Gallbladder disease
Fluid retention or kidney disease
Asthma
Fibroids
Yellowing of the whites of the eyes or skin (jaundice) during pregnancy or during previous oral contraceptive use
Hereditary angioedema (swelling of the face, lips, mouth, tongue or throat).
If you have any of these conditions, you should have regular check-ups with your doctor to make sure that taking Trifeme is not making the conditions worse.
Tell your doctor if anyone in your family has had blood clots in the deep veins of the legs, a stroke or heart attack or you have any of the following conditions:
Obesity
Recent surgery or trauma
Recently had a baby
Lost a baby in the second trimester
Confined to bed rest for long periods.
The risk of developing blood clots in the deep veins of your legs, which can break away and block a blood vessel elsewhere in your body, are increased if you have any of these conditions and use an oral contraceptive. Blood clots are a rare occurrence and can develop whether or not you are taking an oral contraceptive. They can also happen during pregnancy. The risk of having a blood clot is higher in oral contraceptive users than in non-users, but not as high as during pregnancy.
Tell your doctor if you plan to become pregnant or are breast feeding.
Your doctor can discuss the risks and benefits involved with you.
If you have not told your doctor about any of the above, tell him/her before you start taking Trifeme.

Taking other medicines

Tell your doctor if you are taking any other medicines, including:
All prescription medicines
All medicines, vitamins, herbal supplements or natural therapies you buy without a prescription from a pharmacy, supermarket, naturopath or health food shop.
Some medicines may be affected by Trifeme or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines. Your doctor will advise you.
Tell your doctor or pharmacist if you are taking any of the following:
Rifampicin and rifabutin for the treatment of tuberculosis
Antibiotics such as ampicillin, other penicillins and tetracyclines
Anti-fungal agents such as griseofulvin
Barbiturates (certain types of medicines prescribed for epilepsy, such as phenobarbitone)
Medicines for epilepsy (such as phenytoin, primidone, carbamazepine and topiramate)
Ritonavir for the treatment of HIV infection
Modafinil used to treat excessive daytime sleepiness
St. John's wort, an ingredient in many medicines you can buy without a prescription from a pharmacy, health food shop or supermarket
Corticosteroids such as dexamethasone.
While you are taking any of these medicines and for the next 7 days after stopping them, you must also use an additional non-hormonal method of contraception (such as condoms or a diaphragm, but not the rhythm or temperature methods). If you come to the end of the yellow tablets during this time, start the next pack straight away. Skip the 7 red tablets.
If you take rifampicin and some other medicines, you may need to use additional non-hormonal contraception for four weeks after finishing the course of treatment.
Ask your doctor or pharmacist about how long you need to use additional non-hormonal contraception.
Tell your doctor or pharmacist if you are taking any of the following:
Atorvastatin used to treat high cholesterol
Indinavir for the treatment of HIV infection
Anti-fungal agents such as itraconazole and fluconazole
Paracetamol
Ascorbic acid (Vitamin C)
Cyclosporin used to prevent organ rejection
Theophyllines used for asthma and other breathing difficulties
Corticosteroids
Lamotrigine for seizures.
If you have not told your doctor or pharmacist about any of the above, tell them before you start taking Trifeme.

How to take Trifeme

Follow the directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
Each blister pack of Trifeme contains 21 active tablets: 6 tablets are brown, 5 tablets are white and 10 tablets are yellow in colour; and 7 inactive tablets which are red. Each blister strip of Trifeme provides a month of tablets. It is important that you take the tablets in the correct order. Following the arrows on the blister strip will assist you.

When to take Trifeme

You must take Trifeme every day, regardless of how often you have sex.
Trifeme will work best if you do not miss any tablets and take it at the same time each day. Taking your tablet at the same time each day will also help you remember when to take the tablets.
It does not matter if you take Trifeme before or after food.
If you are concerned about this, please speak to your doctor or pharmacist.

How to take it

Swallow Trifeme with a full glass of water.

Starting a hormonal contraceptive for the first time

To start taking Trifeme follow these steps:

1. On the first day of your menstrual period, take a tablet that matches the day of the week from the shaded section of the blister pack. If your period starts between Monday and Friday, your first tablet is red. If your period starts on a Saturday or Sunday, your first tablet is brown.

You must also use an additional non-hormonal method of contraception (such as condoms or a diaphragm, but not the rhythm or temperature methods) until you have taken a brown or white tablet in the correct order every day for 7 days without a break.

2. Then take one tablet each day; following the arrows so that you are taking the correct tablet for the day of the week until all tablets have gone.

3. You will have a 'withdrawal' bleed, similar to having a period, during the week of the red tablets.

If you do not have a period while you are taking the red tablets, 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 blister packs

1. On the day after the last tablet in your previous blister pack, begin the next pack by taking a tablet from the shaded section of the blister pack. If the day of the week when you start your new pack is between Monday and Friday, your first tablet is red. If it is Saturday or Sunday, your first tablet is brown. Do this even if you are still bleeding.

2. Each new pack is started with a red or brown tablet on the same day as the first pack, so that you have 6 days on brown tablets, 5 days on white tablets, 10 days on yellow tablets and 7 days on red tablets. There is no break between packs.

If you start taking your new pack late, you must also use an additional non-hormonal method of contraception (such as condoms or a diaphragm, but not the rhythm or temperature methods) until you have taken a brown or white tablet in the correct order every day for 7 days without a break.

Switching from a different combined oral contraceptive

Follow these steps if your current oral contraceptive contains an oestrogen and a progestogen:

1. Stop taking your current oral contraceptive after you have taken the last active tablet. If your current oral contraceptive pack also contains inactive, or reminder tablets, do not take them.

2. The next day, take the first tablet from the shaded section that matches the day of the week. If the day of the week is between Monday and Friday, your first tablet is red. If the day of the week is Saturday or Sunday, your first tablet is brown.

You must also use an additional non-hormonal method of contraception (such as condoms or a diaphragm, but not the rhythm or temperature methods) until you have taken a brown or white tablet in the correct order every day for 7 days without a break.

3. Then take one tablet each day, following the arrows so that you are taking the correct tablet for the day of the week until all of the tablets have gone.

4. You will have a 'withdrawal' bleed, similar to having a period, during the week of red tablets.

If you do not have a period while you are taking the red tablets, and there is any chance that you have not followed all of the advice in this leaflet, contact your doctor to check if you are pregnant.

Switching from a progestogen-only contraceptive

You can stop taking a progestogen-only contraceptive tablet any day and start taking Trifeme the next day, at the same time.
If you have been using a progestogen-only implant, start taking Trifeme on the day the implant is removed.
If you have been using a progestogen-only injection, start taking Trifeme on the day the next injection would be due.
In all cases start Trifeme by taking a red or brown tablet from the shaded section that matches the day of the week.
You must also use an additional non-hormonal method of contraception (such as condoms or a diaphragm, but not the rhythm or temperature methods) until you have taken a brown or white tablet in the correct order every day for 7 days without a break.

After having a baby

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

After a miscarriage or abortion

Your doctor will advise you how to take Trifeme after a miscarriage or abortion.

How long to take Trifeme

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

If you forget to take your tablets

If you forget to take Trifeme every day, it may not work as well in protecting you from becoming pregnant.
Do not try to make up for missed doses by taking more than one tablet at a time.

Forgetting one or more active tablets

If you forget to take one active tablet (brown, white or yellow tablet) but it is less than 12 hours late, take the missed tablet immediately. Take the next tablet at your usual time, even if this means taking two active tablets in one day.
If you do not take the missed tablet within 12 hours, Trifeme may not work as well in protecting you from becoming pregnant.
If you forget to take one active tablet (brown, white or yellow tablet) and you remember more than 12 hours late, take the last missed tablet as soon as you remember and the next tablet at the usual time.
Continue to take your tablets at the usual time but you must also use an additional non-hormonal method of contraception (such as condoms or a diaphragm but not the rhythm or temperature methods) until you have taken an active tablet in the correct order every day for 7 days without a break. If you come to the end of the yellow tablets during this time, start the next pack straight away. Skip the 7 red tablets.

Forgetting two active tablets

If you forget two active tablets (brown, white or yellow tablets), take the last missed tablet as soon as you remember and then the next tablet at the usual time.
Continue to take your tablets at the usual time but you must also use an additional non-hormonal method of contraception (such as condoms or a diaphragm but not the rhythm or temperature methods) until you have taken an active tablet in the correct order every day for 7 days without a break. If you come to the end of the yellow tablets during this time, start the next pack straight away. Skip the 7 red tablets.
You may not have a withdrawal bleed until the end of this new pack, but you may have spotting or breakthrough bleeding when taking the active tablets. If you don't have a withdrawal bleed at the end of the new pack, contact your doctor, who must make sure that you are not pregnant before you start the next pack.

Forgetting three or more active tablets

Contact your doctor for advice on what to do.

Forgetting a red tablet

If you miss one or more inactive, red tablets, leave them in the pack and do not worry.
However, if you miss red tablets and then forget to start the next pack on time, start as soon as you remember by taking a brown tablet that matches the day of the week. You must also use an additional non-hormonal method of contraception (such as condoms or a diaphragm but not the rhythm or temperature methods) until you have taken a brown or white tablet in the correct order every day for 7 days without a break.
If you are not sure what to do, ask your doctor or pharmacist.
If you are having trouble remembering to take Trifeme, ask your pharmacist for some hints.

If you vomit or have diarrhoea after taking Trifeme

If you have vomiting or diarrhoea within 4 hours of taking an active tablet (brown, white or yellow tablet), you must use an additional non-hormonal method of contraception (such as condoms or a diaphragm, but not the rhythm or temperature methods) until you have taken an active tablet in the correct order every day for 7 days without a break. If you come to the end of the yellow tablets during this time, start the next pack straight away. Skip the 7 red tablets.
The tablet may not have time to be absorbed properly and may not protect you from becoming pregnant.
If you have vomiting or diarrhoea after taking a red tablet, do not worry.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital if you think you or anyone else may have taken too much Trifeme.
Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
Symptoms of an overdose may include:
Feeling sick or vomiting
Dizziness
Feeling sleepy or tired
Women may also experience menstrual bleeding.

While you are taking Trifeme

Things you must do

Tell any other doctors, dentists and pharmacists who are treating you that you are taking Trifeme.
If you are about to start taking any new medicines, tell the doctor or pharmacist that you are taking Trifeme.
If you become pregnant while taking Trifeme, see your doctor immediately.
If you are about to have any blood tests, tell your doctor you are taking Trifeme.
It may interfere with the results of some tests.
If you miss a period and you have taken your tablets correctly, continue taking your tablets as you would normally.
Sometimes you might not have a menstrual period while taking Trifeme.
If you miss a period and you have not taken your tablets correctly, keep taking your tablets and see your doctor immediately.
Not taking your tablets correctly includes missing one or more tablets or starting a new pack later than you should have.
If you miss two menstrual periods, stop taking your tablets and see your doctor, even if you have taken the tablets correctly. You must use a non-hormonal method of contraception, (such as condoms or a diaphragm) during this time.
Your doctor should make sure you are not pregnant before you start taking Trifeme again.
Have regular check-ups from your doctor, including a Pap smear.
Oral contraceptives should not be prescribed for longer than one year without your doctor carrying out a check-up. Your doctor will advise you how often you need a Pap smear. A Pap smear can detect abnormal cells lining the cervix. Sometimes abnormal cells can progress to cervical cancer. The most important risk factor for cervical cancer is persistent human papillomavirus (HPV) infection. However, cervical cancer has been reported to occur more often in women using an oral contraceptive for a long time. This finding may not be caused by the oral contraceptive, but may be related to sexual behaviour and other reasons.
Perform regular breast self-examination.
Risk factors for the development of breast cancer include increasing age, family history, obesity, never having had a baby, and late age for first full-term pregnancy. Breast cancer has also been found slightly more often in women who take oral contraceptives than in women of the same age who do not. This slight increase in the number of breast cancer cases gradually disappears during the course of the 10 years after stopping use of oral contraceptives. It is not known whether the oral contraceptive causes the difference. It may be that the women were examined more often, so that the breast cancer was noticed earlier.
If you are concerned about contracting a sexually transmitted disease (STD), ask your partner to wear a condom when having sexual intercourse with you.
Trifeme will not protect you from HIV-AIDS or any other sexually transmitted diseases (STDs) such as chlamydia, genital herpes, genital warts, gonorrhoea, hepatitis B, human papilloma virus and syphilis. To help protect yourself from STDs, you need to use a barrier contraceptive such as a condom.
Tell your doctor you are taking Trifeme at least 4 weeks before any planned hospitalisation or surgery.
Your doctor may tell you to stop taking Trifeme several weeks before surgery or at the time of immobilisation. Your doctor will tell you when you can start taking Trifeme after you are back on your feet.
To avoid pregnancy during this time you must use a non-hormonal method of contraception such as condoms or a diaphragm.

Things you must not do

Do not take Trifeme to treat any other complaints unless your doctor tells you to.
Do not give Trifeme to anyone else.
Do not stop taking Trifeme, or change the dosage, without checking with your doctor.
If you stop taking Trifeme or do not take a tablet every day, without using another form of contraception, you may become pregnant.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while taking Trifeme.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get certain side effects.
It can be difficult to tell whether side effects are the result of taking Trifeme or are side effects of another medicine you are taking.
Do not be alarmed by the list of side effects.
You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you have.

Tell your doctor if...

Tell your doctor if you notice any of the following.
Changes in bleeding patterns, including breakthrough bleeding/spotting
Painful periods
Missed periods, but if you have not taken Trifeme as directed you should check whether you are pregnant
Changes in mucus from the vagina
Changes in the cervix
Vaginal thrush (candida)
Breast pain, tenderness, enlargement, possible milk secretion
Changes in sex drive.
Nausea or vomiting
Abdominal pain, cramps or bloating
Mood changes, including depression
Headache, including migraines
Nervousness
Dizziness
Contact lenses becoming uncomfortable to wear
Weight change (increase or decrease)
Changes in appetite
Swelling of the hands, ankles or feet
Acne
Rash
Darkening of the skin, which may persist after stopping Trifeme
Loss of scalp hair
Increase in body hair.

Tell your doctor as soon as possible if...

Tell your doctor as soon as possible if you notice any worsening of conditions that you may already have such as:
Chorea (involuntary muscle spasm)
Porphyria
Systemic lupus erythematosus (Lupus)
Varicose veins
Gallbladder disease
Hereditary angioedema (swelling of the face, lips, mouth tongue or throat).

Go to hospital if...

Tell your doctor immediately, or go to accident and emergency at your nearest hospital if you notice any of the following:
Sharp chest pain, coughing of blood, or sudden shortness of breath
Pain in the calf muscle area
Crushing chest pain or heaviness in the chest
Sudden severe headache or vomiting, dizziness or fainting, disturbances of vision or speech, weakness, or numbness in an arm or leg
Sudden changes or loss of vision
Breast lumps
Severe pain or tenderness in the stomach area
Jaundice or a yellowing of the skin or eyeballs, often with fever, fatigue, loss of appetite, dark coloured urine or light coloured bowel movements. Taking oral contraceptives has been associated with an increased risk of having a benign liver tumour, and in very rare cases, liver cancer. The risk appears to increase the longer oral contraceptives are taken
Migraine headaches for the first time
More frequent migraines if you already suffer from them
Itchy rash
You are an epileptic and your fits become more frequent
Rise in blood pressure. You may experience headache, blurred vision or palpitations. Sometimes your blood pressure may rise without you experiencing any of these symptoms. It is important to keep your routine doctor's appointments so that your blood pressure can be checked
Swelling around eyes or mouth
Bloody diarrhoea, abdominal pain or tenderness, fever, nausea or vomiting.
Whilst these side effects are rare, they are serious. You may need urgent medical attention or hospitalisation.
Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.
Other side effects not listed above may also occur in some patients.

After stopping Trifeme

If your periods do not return within 2 to 3 months of stopping Trifeme, tell your doctor.
Some women have short-term problems getting pregnant after stopping Trifeme, especially if they had irregular menstrual cycles before starting to use an oral contraceptive.
If you are planning to become pregnant after stopping Trifeme, use a non-hormonal method of contraception such as condoms or a diaphragm for 3 months before trying to get pregnant.
Ask your doctor or pharmacist for advice about taking folate if you plan to become pregnant.

After taking Trifeme

Storage

Keep your tablets in the blister pack until it is time to take them.
If you take the tablets out of the blister pack they may not keep well.
Keep your tablets in a cool, dry place where the temperature stays below 25°C and is away from light.
Do not store Trifeme or any other medicine, in a bathroom or near a sink. Do not leave Trifeme in the car on hot days or on window sills.
Heat and dampness can destroy some medicines.
Keep Trifeme where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

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

Product description

What it looks like

Trifeme comes in a 16 week box containing 4 blister packs. Each blister pack contains 4 different types of tablet:
6 brown active tablets
5 white active tablets
10 yellow active tablets
7 red inactive tablets.
The blister pack is marked with days of the week next to each tablet to ensure they are taken in the correct order.

Ingredients

Each brown tablet contains 50 micrograms of levonorgestrel and 30 micrograms of ethinyloestradiol as the active ingredients.
Each white tablet contains 75 micrograms of levonorgestrel and 40 micrograms of ethinyloestradiol as the active ingredients.
Each yellow tablet contains 125 micrograms of levonorgestrel and 30 micrograms of ethinyloestradiol as the active ingredients.
Each red tablet contains no active ingredients.
The brown, white, yellow and red tablets also contain the following inactive ingredients:
Lactose
Maize starch
Povidone
Talc
Magnesium stearate
Sucrose
Macrogol 6000
Calcium carbonate
Glycerol (brown and yellow tablets only)
Glycol montanate.
The brown tablets also contain the following colouring agents:
Iron Oxide Yellow CI 77492
Iron Oxide Red CI 77491
Titanium dioxide.
The yellow tablets also contain the colouring agents:
Iron Oxide Yellow CI 77492
Titanium dioxide.
The red tablets also contain the colouring agents:
Brilliant scarlet 4R CI 16255
Erythrosine CI 45430.
Trifeme does not contain gluten, tartrazine or any other azo dyes.

Supplier

Trifeme is supplied in Australia by:
Pfizer Australia Pty Ltd
ABN 50 008 422 348
38-42 Wharf Road
West Ryde NSW 2114
Australia.
Toll Free Number 1800 675 229

Australian registration numbers

Australian Registration Number: AUST R 40133

Date of preparation

This leaflet was prepared in March 2014.
© Pfizer Australia Pty Ltd 2014.
® = Registered Trademark.