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 . It does not contain all the information that is known about . 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 Nordette is used for
Nordette is an oral contraceptive, commonly known as a "birth control pill" or "the Pill". Nordette 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.
Nordette 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 Nordette has been prescribed for you.
Your doctor may have prescribed Nordette for another reason.
This medicine is available only with a doctor's prescription.
Nordette is not habit-forming.
This medicine is not expected to affect your ability to drive a car or operate machinery.
Before you take Nordette
When you must not take Nordette
Do not take Nordette 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 Nordette 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 of the skin (jaundice) during pregnancy or during previous use of an oral contraceptive
High blood levels of cholesterol or triglycerides
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 Nordette.
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 Nordette
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 Nordette, 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 or you have a history of high blood pressure, including 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 Nordette 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 breastfeeding
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 Nordette.
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 Nordette 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 white tablets during these 7 days, 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 and ascorbic acid (Vitamin C).
Cyclosporin used to prevent organ rejection
Theophyllines used for asthma and other breathing difficulties
Corticosteroids
Lamotrigine used for seizures.
If you have not told your doctor or pharmacist about any of the above, tell them before you start taking Nordette.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while you are taking this medicine.
How to take Nordette
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist for help.
How to take it
Swallow tablets whole with a full glass of water.
When to take Nordette
You must take Nordette every day, regardless of how often you have sex.
Nordette will work best if you do not miss any tablets and take it at the same time each day. Taking Nordette at the same time each day will also help you remember when to take the tablets.
It does not matter if you take Nordette before or after food.
If you are concerned about this, please speak to your doctor or pharmacist.
Starting a hormonal contraceptive for the first time
To start taking Nordette follow these steps:
1. On the first day of your menstrual bleed, take a white tablet that matches the day of the week from the green shaded section of the blister pack.
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 a white tablet has been taken daily for 7 days without a break.
2. Then take one white tablet each day, following the arrows so that you are taking the correct tablet for the day of the week until all 21 white tablets have gone.
3. Then take one red tablet each day for the next 7 days.
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 the instructions in this leaflet, contact your doctor to check if you are pregnant.
Going on to further blister packs:
On the day after your last red tablet, begin the next pack with a white tablet from the green shaded section of the blister pack that matches the day of the week. Do this even if you are still bleeding.
Each new pack is started with a white tablet on the same day as the first pack, so that you have 21 days on white tablets, then 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 a white tablet has been taken daily for 7 days without a break.
Switching from a different combined oral contraceptive
When changing from a different combined oral contraceptive to Nordette, it is important to follow the instructions below carefully.
Nordette works best if you do not miss any tablets and take it at the same time each day.
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 reminder tablets, do not take them.
2. The next day, take the first white Nordette tablet from the green 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 a white tablet has been taken daily for 7 days without a break.
3. Then take one white tablet each day following the direction of the arrows until all 21 white tablets have gone.
4. Then take one red tablet each day for the next 7 days.
5. 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 the instructions 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 Nordette the next day, at the same time.
If you have been using a progestogen-only implant, start taking Nordette on the day the implant is removed.
If you have been using a progestogen-only injection, start taking Nordette on the day the next injection would be due.
In all cases start Nordette by taking a white tablet from the green 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 a white tablet has been taken daily 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 Nordette.
After a miscarriage or abortion
Your doctor will advise you how to take Nordette after a miscarriage or abortion.
How long to take Nordette
Continue taking your medicine for as long s your doctor tells you.
Your doctor may prescribe Nordette for long periods, until you no longer need or want contraception.
If you are not sure how long you should be taking Nordette, ask your doctor.
If you forget to take your tablets
If you forget to take Nordette 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 white tablet:
If you forget one white 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 white tablets in one day.
If you do not take the missed tablet within 12 hours, Nordette may not work as well in protecting you from becoming pregnant.
If one white tablet is missed and is remembered more than 12 hours late, take the last tablet as soon as you remember and the next tablet at the usual time.
Continue to take tablets at your 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 a white tablet has been taken daily for 7 days without a break. If you come to the end of the white tablets during the 7 days after a missed tablet, start the next pack straight away. Skip the 7 red tablets.
Forgetting two white tablets:
If you forget two white tablets, take the last missed tablet as soon as you remember and the next tablet at the usual time.
Continue to take tablets at your 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 a white tablet has been taken daily for 7 days without a break. If you come to the end of the white tablets during the 7 days after the missed tablets, 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 white 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 white tablets:
Contact your doctor for advice on what to do.
Forgetting a red tablet:
If you miss one or more 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 white tablet that matches the day of the week from the green shaded section. 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 a white tablet has been taken daily 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 Nordette, ask your pharmacist for some hints.
If you vomit or have diarrhoea after taking Nordette
If you have vomiting or diarrhoea within 3 to 4 hours after taking a white 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 a white tablet has been taken daily for 7 days without a break. If you come to the end of the white tablets during these 7 days, 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 Nordette.
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 Nordette
Things you must do
Tell any other doctors, dentists and pharmacists who are treating you that you are taking Nordette.
If you are about to start taking any new medicines, tell the doctor or pharmacist that you are taking Nordette.
If you become pregnant while taking Nordette, see your doctor immediately.
If you are about to have any blood tests, tell your doctor you are taking Nordette.
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 Nordette.
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 Nordette 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 use oral contraceptives than in women of the same age who do not use them. 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.
Nordette 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 using Nordette at least 4 weeks before any planned hospitalisation or surgery.
Your doctor may tell you to stop taking Nordette several weeks before surgery or at the time of immobilisation. Your doctor will tell you when you can start taking Nordette 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 Nordette to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else even if they have the same condition as you.
Do not stop taking Nordette, or change the dosage, without checking with your doctor.
If you stop taking Nordette 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 Nordette.
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 Nordette 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 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
Swelling around the 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 any of the following and they worry you:
Changes in bleeding patterns, including breakthrough bleeding/spotting
Painful periods
Missed periods, but if you have not taken Nordette 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 Nordette
Loss of scalp hair
Increase in body hair.
Any worsening of conditions 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).
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, even if it is not on this list.
After stopping Nordette
If your periods do not return within 2 to 3 months of stopping Nordette tell your doctor.
Some women have short-term problems getting pregnant after stopping Nordette, especially if they had irregular menstrual cycles before starting to use an oral contraceptive.
If you are planning to become pregnant after stopping Nordette, 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 Nordette
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 Nordette or any other medicine, in a bathroom or near a sink. Do not leave Nordette in the car on hot days or on window sills.
Heat and dampness can destroy some medicines.
Keep it 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 Nordette, or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.
Product description
What it looks like
Nordette comes in a 16-week box containing 4 blister packs. Each blister pack contains 21 white hormone tablets and 7 red non-hormonal tablets. The blister pack is marked with days of the week next to each tablet.
Ingredients
Each white tablet contains 150 micrograms of levonorgestrel and 30 micrograms of ethinyloestradiol as the active ingredients.
Each red tablet contains no active ingredients.
The white and red tablets also contain the following inactive ingredients:
Lactose
Maize starch
Povidone
Talc
Magnesium stearate
Sucrose
Macrogol 6000
Calcium carbonate
Glycol montanate (red tablets only)
White beeswax (white tablets only)
Carnauba Wax (white tablets only)
The red tablets also contain the colouring agents:
Brilliant scarlet 4R
Erythrosine
Nordette does not contain gluten, tartrazine or any other azo dyes.
Supplier
Nordette is supplied in Australia by:
Pfizer Australia Pty Ltd.
ABN 50 008 422 348
38-42 Wharf Road
West Ryde NSW 2114
Toll Free Number: 1800 675 229.
Australian Registration Number: AUST R 153763.
This leaflet was prepared in July 2011.
® Registered Trade Mark
