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Improvil

Ethinyloestradiol and Norethisterone
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 Improvil. It does not contain all the information that is known about Improvil. 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 Improvil is used for

Improvil is a birth control pill commonly known as a "Combined Oral Contraceptive". It contains both an oestrogen (ethinyloestradiol) and progestogen (norethisterone) hormone.
Oral contraceptives belonging to this group produce their birth control (or contraceptive) effect by preventing ovulation (the release of an egg from the ovary) during each menstrual cycle. Combined Oral Contraceptives also cause changes to the mucus of the cervix and the lining of the womb which contribute to the contraceptive action.
Ask your doctor if you have any questions about why Improvil has been prescribed for you.
Your doctor may have prescribed Improvil for another reason.
Improvil 28 Day is only available on a prescription from your doctor.
This medicine is not expected to affect your ability to drive a car or operate machinery.

Before you start to take Improvil

When you must not take it

Do not take Improvil if you have an allergy to:
any medicine containing ethinyloestradiol or norethisterone
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 it if:

you have had a stroke or heart attack
you have or have had inflammation, infection or clotting in any blood vessel(s), including a clot in the lung
you have or have had liver disease (including tumours of any type), a history of jaundice or cholestatic jaundice of pregnancy, or severe generalised itch in the body during pregnancy, Dubin-Johnson Syndrome or Rotor Syndrome
you have abnormal vaginal bleeding, the cause of which is unknown
you are pregnant or suspect that you may be pregnant
you have cancer or suspected cancer of the breast or sex organs (e.g. cervix, vagina, ovaries, endometrium, womb) and known or suspected oestrogen-dependent tumours
you have a family history of breast nodules, fibrocystic disease or have had an abnormal mammograph
you have sickle cell anaemia
you have a lipid metabolism disorder such as congenital hyperlipidaemia
you have diabetes with blood vessel damage
you have a history of herpes of pregnancy
you have otosclerosis (an ear disorder) which worsened in past pregnancies.
If you are not certain whether these may apply to you, or you are worried by anything in this list, tell your doctor.
Tell your doctor about any existing medical condition as this may be affected by taking the birth control pill.
Do not take Improvil if the packaging is torn or shows signs of tampering.
If it is expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should be taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you are allergic to any foods, dyes, preservatives or any other medicines.
You must tell your doctor if:
you are a heavy smoker (15 or more cigarettes per day), especially if you are aged over 35 years.
Oral contraceptives increase your risk of having a stroke or heart attack. Smoking, while taking oral contraceptives, further increases this risk.
Tell your doctor if you have any other health problems, especially:
uterine fibroids
gallbladder disease
liver, kidney or heart disease
high blood pressure
high cholesterol
diabetes
epilepsy
asthma
migraine or other headaches
depression.
If you have any of these conditions you should have regular check-ups with your doctor to make sure that taking Improvil is not making these worse.
Tell your doctor if you have any of the following:
recent surgery or trauma
recently had a baby
confined to bed rest for long periods.
The risk of developing blood clots in the deep veins of your body, which can break away and block a blood vessel elsewhere in your body, is increased if you take an oral contraceptive in the above situations.
Tell your doctor if you wear contact lenses and experience a change in vision or intolerance to your lenses.
Your doctor may refer you to an eye specialist.
Improvil contains lactose. If you know that you are intolerant to some sugars, or your doctor has told you so, speak to your doctor before taking it.
Tell your doctor if you plan to become pregnant or are breastfeeding.
Your doctor can discuss the risks and benefits with you.
If you have not told your doctor about any of the above, tell him/her before you start taking Improvil.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may interfere with the effectiveness of Improvil. These include medicines such as:
rifampicin for the treatment of tuberculosis
antibiotics such as ampicillin, oxacillin, tetracyclines, sulfamethoxazole and trimethoprim
anti-fungal agents such as griseofulvin
barbiturates
medicines for epilepsy such as carbamazepine and phenytoin
phenylbutazone, a medicine used to relieve symptoms of inflammation, including arthritis
St John's wort, an ingredient found in medicines you can purchase without a prescription from a pharmacy, supermarket or health food shop.
While you are taking these medicines, and for seven days after stopping them, you should use a non-hormonal method of contraception (such as condoms or a diaphragm, but not the rhythm or temperature methods). If the seven days extend into the inactive orange tablet section, then you should start a new pack on the next day after having taken the last blue or white active tablet from the current pack. Skip the 7 orange tablets.
This is particularly important if you need to take antibiotics or medicines for epilepsy.
Ask your doctor or pharmacist about how long you need to use additional non-hormonal contraception.
If you have not told your doctor or pharmacist about any of the above, tell them before you start taking Improvil.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while you are taking this medicine.

How to take Improvil

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 one Improvil tablet with a glass of water.

When to take it

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

Starting a hormonal contraceptive for the first time

To begin Improvil 28 Day, take your first tablet on the first day of your next period, that is, the day your bleeding starts.
Take your first tablet from the top row of the silver section of the strip (i.e. the section which contains all the blue and white tablets). Take the tablet which corresponds to the appropriate day of the week. For example, if your first day of bleeding is on TUESDAY, take the blue tablet marked "TUE" from the top row of the silver section of the strip.
Continue to take one tablet every day, following the arrows around the strip, until you finish all 21 blue and white tablets in the silver section of the strip.
You should then take one orange tablet daily for the next 7 days, following the arrows so that you are taking the correct tablet for the day of the week. Taking these orange tablets helps you to remember to take a tablet every day.
You can expect your period during the week that you are taking these orange inactive tablets. Your protection continues during this week.
On the day after your last orange tablet, begin the next strip with a blue tablet from the top row of the silver section that matches the day of the week. Do this even if you are still bleeding.
You should start your tablets the same day of the week every 4 weeks.
Repeat this sequence of tablet taking for as long as birth control is required.
This product is effective from the first day if taken as directed above.
Although spotting and break-through bleeding may occur in some women, these tend to disappear in the majority of patients after the first three to four cycles.
Make sure you always have a new strip of tablets available, so that you can continue to take the tablets without interruption.

Changing from a different oral contraceptive

If you are switching to Improvil 28 Day from another 21 or 28 Day oral contraceptive, follow the instructions below carefully.
If switching from a 21 day oral contraceptive:
Stop taking your current oral contraceptive after you have taken the last active tablet.
Leave 7 tablet-free days.
Start the new Improvil 28 Day pack on the eighth day by taking a blue active tablet from the top row of the silver section which corresponds to the day of the week.
Continue to take one tablet every day, following the arrows around the strip until you finish all 21 blue and white tablets in the silver section of the strip.
Then take one orange tablet daily for the next 7 days, before starting your new strip.
You must use an additional, non-hormonal method of contraception (such as condoms or a diaphragm, but not the rhythm or temperature methods) until an active tablet has been taken daily for 7 days without a break.
If switching from a 28 day oral contraceptive:
Stop taking your current oral contraceptive after you have taken the last inactive tablet in the strip.
Start the new Improvil 28 Day pack on the next day by taking a blue active tablet from the top row of the silver section which corresponds to the day of the week.
Continue to take one tablet every day, following the arrows around the strip until you finish all 21 blue and white tablets in the silver section of the strip.
Then take one orange tablet daily for the next 7 days, before starting your new strip.
You must use an additional, non-hormonal method of contraception (such as condoms or a diaphragm, but not the rhythm or temperature methods) until an active tablet has been taken daily for 7 days without a break.

If you vomit or have diarrhoea after taking Improvil

If you suffer from a stomach upset which results in vomiting or diarrhoea, the effectiveness of Improvil may be reduced.
During any period of vomiting or diarrhoea, continue taking Improvil tablets. Also use a non-hormonal method of contraception (such as condoms or a diaphragm, but not the rhythm or temperature methods), and continue for seven days following the episode of vomiting or diarrhoea. If these seven days extend into the inactive orange tablet section you should start a new pack on the next day after having taken the last active blue or white tablet from the silver section of the current pack (i.e. skip the orange inactive tablets).
You may not have a period until you finish the second pack.
If you have vomiting or diarrhoea after taking an orange tablet, do not worry.

If you forget to take a tablet

If you forget to take Improvil 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.
If you miss a blue or white active tablet:
If you are less than 12 hours late in taking your tablet, take that tablet at once and then take the next one at your usual time.
If you are more than 12 hours late in taking your tablet, do not take it.
Take the next day's tablet at the usual time and use an additional, non-hormonal method of contraception for the next seven days (such as condoms or a diaphragm, but not the rhythm or temperature methods).
If the seven days extend into the inactive orange tablet section, do not take the orange tablets. Start a new pack on the day after taking the last blue or white tablet from the current pack. Take your first tablet from the top row of the silver section of the strip, then repeat the sequence of tablet taking for as long as birth control is required. This will mean that you will not have a period until you finish the second pack.
If you miss more than one active (blue or white) tablet, contact your doctor for advice on what to do.
If you miss an orange (inactive) tablet, take it as soon as you remember and continue on as before.
Additional birth control is not necessary in this case.
If your doctor told you to take Improvil differently, or you are unclear about the above directions, discuss this with him or her.
If you have trouble remembering to take Improvil, ask your pharmacist for some hints.

If you miss a period

If you have missed a period you may be pregnant.
Contact your doctor to check if you are pregnant.

If you take too much (overdose)

Immediately telephone your doctor or pharmacist 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 Improvil. Do this even if there are no signs of discomfort or poisoning.
Serious ill effects have not been reported in young children who have taken large doses of birth control pills.
Overdosage may cause nausea. This may be followed by vaginal bleeding in some women.

While you are taking Improvil

Things you must do

Tell all doctors, dentists and pharmacists who are treating you that you are taking Improvil.
Tell the hospital doctor that you are taking Improvil birth control pills if you need to have an operation, or go to hospital in an emergency.
If you are about to be started on any new medicine, tell your doctor or dentist and your pharmacist that you are taking Improvil.
If you become pregnant while taking Improvil, see your doctor immediately.
If you are about to have any blood tests, tell your doctor you are taking Improvil.
It may interfere with the results of some tests.
Visit your doctor regularly for check-ups, including a Pap smear.
A Pap smear can detect any abnormal cells from the cervix, which may develop into cancer. Cervical cancer has been reported to occur more frequently in women who use oral contraceptives.
Your doctor will advise you of the type and frequency of any tests required.
Perform regular breast self-examination.
Examining your breasts for lumps or any changes in size or shape can help you find a breast cancer early. Breast cancer has been found more frequently in women who use oral contraceptives. It is not known whether this increase is caused by the use of oral contraceptives, or if it is due to the fact that users were examined more often, and therefore the breast cancer was detected earlier.
If you are unsure, ask your doctor about breast self-examination.
If you are worried about contracting a sexually transmitted disease (STD) use a condom during sexual intercourse.
Improvil does not protect against the transmission of STDs such as HIV-AIDS, chlamydia, genital herpes and warts, gonorrhoea, hepatitis B or human papilloma virus. To protect against STDs ask your partner to wear a condom when having sexual intercourse with you.
Tell your doctor if you feel depressed, think you are retaining water, experience headaches, experience persistent or recurrent irregular bleeding, or your eyes are uncomfortable whilst wearing contact lenses.
Your doctor will make an assessment of your condition and advise whether or not you should continue to take Improvil.

Things you must not do

Do not take Improvil 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 Improvil, or change the dosage, without checking with your doctor.
If you stop taking Improvil or do not take a tablet every day, without using another form of contraception, you may become pregnant.

Things to be careful of

Slight breast tenderness or a feeling of sickness may occur in the first few months of use. This usually improves or stops with continued use.
If vaginal irritation or discharge occurs, it may be an indication of yeast infection for which treatment is available from your doctor.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Improvil.
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.
It can be difficult to tell whether side effects are the result of taking Improvil 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 may have.

Tell your doctor if...

Tell your doctor if you notice any of the following and they worry you:
break-through bleeding
spotting
gastric or stomach discomforts including nausea, vomiting and diarrhoea
change in appetite
change in menstrual flow
absence of periods
change in weight
retention of fluids
dark discolouration of the skin
blotchy discolouration on the face or arms or legs (which may persist after the tablets have been stopped)
breast changes (tenderness, enlargement and secretion)
headache, dizziness
mental depression
fatigue or tiredness
hair growth or loss of scalp hair
acne, rashes, itching
leg cramps
back ache
change in sexual drive
vaginal thrush, vaginal irritation, bladder irritation or urinary tract infection
pre-menstrual-like symptoms
change in cervical secretions
suppression of milk production
contact lenses becoming difficult to wear.
The above list contains the more common side effects of your medicine.

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:
porphyria
gallbladder disease
kidney disease
hereditary angioedema (swelling of the face, lips, mouth, tongue or throat.
Oral contraceptives are associated with inflammatory bowel diseases (ulcerative colitis, Crohn's disease). See your doctor as soon as possible if you develop bloody diarrhoea, abdominal pain, fever, rectal bleeding, feeling tired, lose your appetite or lose weight. These are some of the symptoms of inflammatory bowel diseases.
The above list includes serious side effects that may require medical attention. Serious side effects are rare.

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:
unexplained or persistent pains in the head, chest, stomach or legs
gradual or sudden, partial or complete loss of vision
double vision, or symptoms of severe vision impairment
eye protrusion, swelling of the eye or eye lesions
migraine headaches for the first time
more frequent or severe migraines if you already suffer from them
breast lumps
jaundice or yellowing of the skin or eyes, often with fever, fatigue, loss of appetite, dark coloured urine, nausea and vomiting
Taking oral contraceptives may be associated with liver disease including liver cancer.
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 of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing.
Whilst these side effects are rare, they are serious. You may need urgent medical attention or hospitalisation.
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 Improvil

Delays in becoming pregnant may occur after Improvil therapy is stopped. This is more likely to occur in women whose periods were irregular before using birth control pills.
See your doctor if you continue to experience difficulties in falling pregnant.

After taking Improvil

Storage

Keep your tablets in a safe place away from the sight and reach of children.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Keep your Improvil tablets in a dry place, at a temperature below 25°C.
Do not keep your tablets in the refrigerator.
Do not store Improvil or any other medicine in the bathroom or near a sink. Do not leave it in the car on hot days or on window sills.
Heat and dampness can destroy some medicines.

Disposal

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

Product description

What it looks like

Improvil 28 Day is available in calendar packs consisting of four strips of tablets (4 months' supply) each with 12 blue active tablets marked "SEARLE" on one side and "BX" on the other, and 9 white active tablets marked "SEARLE" on one side and "BX" on the other and 7 orange inactive tablets.

Ingredients

Each blue tablet contains:
norethisterone 500 micrograms
ethinyloestradiol 35 micrograms
magnesium stearate
povidone
maize starch
lactose
indigo carmine CI 73015.
Each white tablet contains:
norethisterone 1 milligram
ethinyloestradiol 35 micrograms
magnesium stearate
povidone
maize starch
lactose.
The orange inactive tablets contain:
magnesium stearate
cellulose microcrystalline
lactose
sunset yellow FCF (CI No. 15985).
Improvil contains lactose.
Improvil does not contain sucrose, gluten or tartrazine.

Supplier

Improvil 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 number

AUST R 62139

Date of preparation

This leaflet was prepared in April 2015.
© Pfizer Australia Pty Ltd 2015
®Registered trademark