2. What should I know before I use MONOFEME?
Do not use if you have ever had an allergic reaction to ethinylestradiol or levonorgestrel,
or any other similar oral contraceptives, or any of the ingredients listed in Section
7. Product Details in the full CMI. Do not use MONOFEME if you have or have had thromboembolism/disease
in any blood vessels or liver disease. Talk to your doctor if you have any other medical
conditions, take any other medicines, or are pregnant or plan to become pregnant or
are breastfeeding.
For more information, see Section
2. What should I know before I use MONOFEME? in the full CMI.
3. What if I am taking other medicines?
4. How do I use MONOFEME?
Take one tablet at the same time every day, regardless of how often you have sex.
It is very important to follow the instructions provided in the full CMI for the medicine
to work.
See the full CMI Section
4. How do I use MONOFEME? for instructions on how to start taking MONOFEME for the first time or how to change
to MONOFEME from a different contraceptive and other additional instructions.
5. What should I know while using MONOFEME?
|
Things you should do
|
Remind any doctor, dentist, or pharmacist you visit that you are using MONOFEME.
Tell your doctor immediately if you become pregnant while taking MONOFEME.
See your doctor if you have not taken your tablets correctly and have missed a period.
Have regular check ups from your doctor, including a Pap smear.
Perform regular breast self-examination
|
|
Things you should not do
|
Do not stop using this medicine or change the dosage, without checking with your doctor.
If you stop taking MONOFEME or do not take a tablet every day without using another
form of contraception, you may become pregnant.
|
|
Driving or using machines
|
Make sure you know how MONOFEME affects you before you drive or use machines.
|
|
Looking after your medicine
|
Keep MONOFEME in a cool, dry place where the temperature stays below 25°C.
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.
|
6. Are there any side effects?
Common side effects include changes to your bleeding patterns, painful periods, breast
tenderness, changes in sex drive, nausea or vomiting, abdominal pain, cramps or bloating,
changes to your mood, headaches, weight changes, swelling of the hands, ankles or
feet, acne, loss of scalp hair, increase in body hair. More serious side effects include
blood clots, worsening or new onset of migraines/headaches, jaundice (yellowing of
skin or eyes), significant rise in blood pressure, worsening of existing conditions,
e.g. epileptic seizures.
For full list of side effects and further information, including what to do if you
have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s):
ethinylestradiol and levonorgestrel
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using MONOFEME. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using MONOFEME.
Where to find information in this leaflet:
1. Why am I using MONOFEME?
MONOFEME contains the active ingredients ethinylestradiol and levonorgestrel. MONOFEME is a combined oral contraceptive, commonly known as a "birth control pill"
or "the Pill".
MONOFEME is used to prevent you from becoming pregnant in several ways, if taken correctly:
By preventing ovulation (the release of an egg from the ovary) during each menstrual
cycle.
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.
Your doctor may have prescribed MONOFEME for another reason.
Ask your doctor if you have any questions about why MONOFEME has been prescribed for
you.
2. What should I know before I use MONOFEME?
Warnings
Do not use MONOFEME if:
1. You are allergic to ethinylestradiol or levonorgestrel, or any other similar medicines
(such as other oral contraceptives) or any of the ingredients listed at the end of
this leaflet.
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.
Always check the ingredients to make sure you can use this medicine.
2. You have, or have had any of the following medical conditions:
Venous thromboembolism (VTE) and are on medicines called anticoagulants which are
used to "thin the blood"
Hereditary or acquired disposition of VTE
Multiple risk factors for VTE including obesity, age above 35 years, smoking, high
cholesterol
Blood clots or a history of blood clots in legs (deep vein thrombosis (DVT)), or lungs
(pulmonary embolism (PE)) or eyes and you are currently taking an anticoagulant medicine
Major surgery and have been confined to bed for long periods of time
Arterial thromboembolism (ATE) or past history of these that include:
Stroke
Angina
Transient ischaemic attack or "mini stroke"
Hereditary or acquired disposition for ATE
History of migraine, accompanied by blurred vision, difficulty in speaking, muscle
weakness, or increased sensitivity to light, sound, or noise
Multiple risk factors for ATE or a serious risk factor for ATE that include:
Uncontrolled high blood pressure
Diabetes with blood vessel damage
Severe lipid disease (high levels of fatty substances in the blood)
Sickle cell anaemia
Disease in any blood vessel(s)
Inflammation of the pancreas which is associated with very high blood levels of triglycerides
(fatty substances).
Liver disease (including tumours of any type), yellowing of the whites of the eyes
or of the skin (jaundice) or a history of jaundice or cholestatic jaundice of pregnancy,
or severe generalised itch in the body during pregnancy, Dubin-Johnson Syndrome or
Rotor Syndrome.
Unexplained vaginal bleeding
Cancer or suspected cancer of the breast or sex organs (e.g. cervix, vagina, ovaries,
endometrium, womb) and known or suspected estrogen-dependent tumours.
A family history of breast nodules, fibrocystic disease or have had an abnormal mammograph.
3. You are pregnant or you think you are pregnant. Pregnancy must be excluded before
you start taking MONOFEME.
4. You are taking anti-viral hepatitis C virus (HCV) medicinal products such as those
containing ombitasvir, paritaprevir, ritonavir and dasabuvir with or without ribavirin.
If you are not sure about your anti-HCV medication, tell your doctor.
5. You have already experienced menopause.
If you are not certain whether these may apply to you, or you are worried by anything
in this list, tell your doctor.
Medical Check-ups
Before you start to take MONOFEME, you must have a thorough medical check-up, including
a Pap smear, breast check, blood pressure check and urine test.
Check with your doctor if you:
Take any medicines for any other condition
Have any other medical conditions or health problems, such as:
Heart disease including heart valve disorders or certain heart rhythm disorders
High blood pressure, a history of high blood pressure or high blood pressure during
pregnancy
High cholesterol
Hepatitis C
Diabetes
Migraine or other headaches
Hyperhomocysteinemia
Breast lumps, abnormal breast X-ray or mammogram
Gallbladder disease
Fluid retention or kidney disease
Yellowing of the whites of the eyes or skin (jaundice) during pregnancy or during
previous oral contraceptive use
Multiple sclerosis
Epilepsy
Depression
Asthma
Fibroids
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 MONOFEME is not making the conditions worse.
Are older than 35 years of age or are overweight.
Are intolerant to some sugars, or your doctor has told you so. MONOFEME contains lactose.
Are allergic to any foods, dyes, preservatives or any other medicines.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Your doctor will advise you how to take MONOFEME after a miscarriage or abortion.
If you have just had a baby, talk to your doctor before you start taking MONOFEME.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Your doctor can discuss the risks and benefits involved with you.
Blood clots
You must tell your doctor if you or anyone in your immediate family has or has had
blood clots in the legs or lungs.
Blood clots are a rare occurrence when taking an oral contraceptive.
The risk of a blood clot is highest during the first year of taking an oral contraceptive
for the first time or if you are re-starting the "pill" after a break of 4 weeks or
more.
The risk of having a blood clot is higher in oral contraceptive users than in non-users
but is not as high as during pregnancy.
Tell your doctor about any of the following conditions as these are risk factors for
developing blood clots:
Cancer
Systemic lupus erythematosus (SLE)
Haemolytic uraemic syndrome (HUS) - a disorder of blood coagulation causing failure
of the kidneys)
Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease)
Sickle cell disease
Smoking particularly if you are heavy smoker (15 or more cigarettes per day) and are
aged over 35 years
Have had any recent surgery or trauma
Recently had a baby
Lost a baby in the second trimester
Are pregnant
Had major surgery and have been confined to bed for long periods of time
Also tell your doctor if you are planning a long haul plane flight (greater than 4
hours).
Stroke
You must tell your doctor if you or anyone in your immediate family has or has had
a stroke or heart attack.
Taking oral contraceptives is linked with an increased risk of having a heart attack,
angina, stroke or a "mini stroke".
If you have not told your doctor about any of the above, tell him/her before you start
taking MONOFEME.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including all
prescription medicines and any medicines, vitamins or supplements that you buy without
a prescription from your pharmacy, supermarket or health food shop.
Some medicines may interact with MONOFEME and affect how well it or the other medicine
works. This may lead to unwanted side effects, reduce the effect of MONOFEME and/or
the other medicine.
These medicines include:
Atorvastatin used to treat high cholesterol
Indinavir for the treatment of HIV infection
Anti-fungal medicines 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 MONOFEME.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while you are taking this medicine.
Medicines that may
reduce
the effect of MONOFEME include:
Anti-viral hepatitis C virus (HCV) medicines such as ombitasvir, paritaprevir, ritonavir
and dasabuvir
Rifampicin and rifabutin for the treatment of infections such as tuberculosis
Antibiotics such as ampicillin, other penicillins and tetracyclines
Anti-fungal agents such as griseofulvin
Barbiturates (medicines prescribed for epilepsy, such as phenobarbital)
Medicines for epilepsy such as phenytoin, primidone, carbamazepine and topiramate
Ritonavir for the treatment of HIV infection
Modafinil used to treat excessive daytime sleepiness
Corticosteroids such as dexamethasone
St John's wort, an ingredient found in medicines you can purchase without a prescription
from a pharmacy, supermarket or health food shop
Corticosteroids such as dexamethasone.
While you are taking these medicines, and for seven days after stopping them, you
must 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 red tablet section, then you should start
a new pack on the next day after having taken the last white active tablet from the
current pack. Skip the 7 red tablets.
This is particularly important if you need to take antibiotics or medicines for epilepsy.
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.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect MONOFEME.
4. How do I use MONOFEME?
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 much to take
Take one tablet every day.
Follow the instructions provided and use MONOFEME until your doctor tells you to stop.
When to take MONOFEME
MONOFEME should be taken at the same time every day regardless of how often you have
sex.
MONOFEME will work best if you do not miss any tablets and take it at the same time
each day. Taking MONOFEME at the same time each day will also help you remember when
to take your tablets.
It does not matter if you take MONOFEME before or after food.
If you are concerned about this, please speak to your doctor or pharmacist.
How to take MONOFEME
Swallow the tablet whole with a full glass of water.
How long to take it
Continue taking your medicine for as long as your doctor tells you. Your doctor may
prescribe MONOFEME for long periods, until you no longer need or want contraception.
If you are not sure how long you should be taking MONOFEME, ask your doctor.
How to start taking hormonal contraceptive for the first time
To begin MONOFEME, take your first white tablet on the first day of your next period,
that is, the day your bleeding starts.
Take a white tablet that matches the day of the week from the green shaded section
of the blister pack. For example if your period commences on a Friday, then take a
white tablet marked Friday.
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.
Continue to take one white tablet every day, following the arrows around the strip,
until you finish all 21 white tablets.
Then take one red 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 red tablets helps
you to remember to take a tablet every day.
You can expect your period during the week that you are taking these red inactive
tablets. Your protection continues during this week.
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 to MONOFEME from a different combined oral contraceptive
When changing from a different combined oral contraceptive to MONOFEME, it is important
to follow the instructions below carefully.
MONOFEME 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 estrogen and a progestogen:
Stop taking your current oral contraceptive after you have taken the last active tablet
in the strip. If your current oral contraceptive pack also contains inactive or reminder
tablets, do not take them.
Start the new MONOFEME pack on the next day by taking a white active tablet from the
top row which corresponds to the day of the week.
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.
Continue to take one white tablet every day, following the arrows around the strip
until you finish all 21 white tablets in the green shaded section of the strip.
Then take one red tablet daily for the next 7 days, before starting your new strip.
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
MONOFEME the next day, at the same time.
If you have been using a progestogen implant, start taking MONOFEME on the day the
implant is removed.
If you have been using a progestogen injection, start taking MONOFEME when your next
injection would be due.
In all cases start MONOFEME 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.
If you forget to use MONOFEME
MONOFEME should be used regularly at the same time each day. If you miss your dose
at the usual time, it may not work as well in protecting you from becoming pregnant.
Do not take a double dose to make up for the dose you missed.
If you miss a white active tablet:
If you are less than 12 hours late in taking your tablet, you should take that tablet
immediately and then take the next one at your usual time, even if this means taking
two tablets in one day.
If you are more than 12 hours late in taking your tablet or if two active white tablets
are missed, MONOFEME may not work as well in protecting you from becoming pregnant.
You should take the missed tablet immediately and then take the next one at your usual
time, even if this means taking two tablets in one day.
Continue to take tablets 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 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.
If you miss three or more white tablets, contact your doctor for advice on what to
do.
If you miss a red inactive tablet, leave them in the pack and do not worry. Additional
birth control method is not necessary in this case.
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 your doctor told you to take MONOFEME differently, or you are unclear about the
above directions, discuss this with them.
If you have trouble remembering to take MONOFEME, ask your pharmacist for some hints.
If you vomit or have diarrhoea while taking MONOFEME
If you suffer from a stomach upset which results in vomiting or diarrhoea, the effectiveness
of MONOFEME may be reduced. The white tablets may not have time to be absorbed properly
and may not protect you from becoming pregnant. If vomiting or diarrhoea occurs within
4 hours after taking a pink tablet, you must take an extra pink tablet from a back-up
pack.
During any period of vomiting or diarrhoea, continue taking MONOFEME 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 red tablet
section, you should start a new pack on the next day after having taken the last active
white tablet from the current pack (i.e. skip the 7 red inactive tablets).
You may not have a period until you finish the second pack.
If you have vomiting or diarrhoea after taking a red tablet, do not worry.
If you take too much MONOFEME
If you think that you have taken too much MONOFEME, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
Symptoms of an overdose may include:
Feeling sick or vomiting,
Dizziness
Feeling sleepy or tired
Women may also experience menstrual bleeding.
Serious ill effects have not been reported in young children who have taken large
doses of birth control pills.
5. What should I know while using MONOFEME?
Things you should do
Tell all doctors, dentists and pharmacists who are treating you that you are taking
MONOFEME.
Tell the hospital doctor that you are taking MONOFEME 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 MONOFEME.
If you become pregnant while taking MONOFEME, see your doctor immediately.
If you are about to have any blood tests, tell your doctor you are taking MONOFEME.
It may interfere with the results of some tests.
Tell your doctor you are taking MONOFEME at least 4 weeks before any planned hospitalisation
or surgery.
Your doctor may tell you to stop taking MONOFEME several weeks before surgery or at
the time of immobilisation. Your doctor will tell you when you can start taking MONOFEME
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.
Missed periods
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 MONOFEME.
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 MONOFEME
again.
Medical Check Up
Visit your doctor regularly for check-ups and physical examinations, including Pap
smears, blood pressure checks and breast, abdomen and pelvic organ examinations. Oral
contraceptives should not be prescribed for longer than one year without your doctor
carrying out a check-up.
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 for a long time.
Your doctor will advise you of the type and frequency of any tests required.
Breast cancer risk
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 slightly 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.
Sexually transmitted disease (STD)
If you are worried about contracting a sexually transmitted disease (STD) use a barrier
contraceptive method such as a condom.
MONOFEME does not protect against the transmission of STDs such as HIV-AIDS, chlamydia,
genital herpes and warts, gonorrhoea, hepatitis B, human papilloma virus or syphilis.
To protect against STDs ask your partner to wear a condom when having sexual intercourse
with you.
Things you should not do
Do not take MONOFEME if the packaging is torn or shows signs of tampering.
If it is expired or is damaged, return it to your pharmacist for disposal.
MONOFEME may have no effect at all, or worse, have an entirely unexpected effect,
if you take it after the expiry date.
Do not take MONOFEME 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 MONOFEME, or change the dosage, without checking with your doctor.
If you stop taking MONOFEME or do not take a tablet every day, without using another
form of contraception, you may become pregnant.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how MONOFEME
affects you.
MONOFEME is not expected to affect your ability to drive a car or operate machinery.
Drinking alcohol
No information available.
Looking after your medicine
Keep your MONOFEME tablets in a dry place, at a temperature below 25°C.
Do not keep your tablets in the refrigerator.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Do not use this medicine after the expiry date.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
After stopping MONOFEME
If your periods do not return within 2 to 3 months of stopping MONOFEME tell your
doctor.
Delays in becoming pregnant may occur after MONOFEME therapy is stopped. This is more
likely to occur in women whose periods were irregular before using birth control pills.
If you are planning to become pregnant after stopping MONOFEME, 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 folic acid if you plan to become
pregnant.
See your doctor if you continue to experience difficulties in falling pregnant.
When to discard your medicine
If your doctor tells you to stop taking MONOFEME or if the tablets have passed their
expiry date, ask your pharmacist what to do with any that are left over.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Side effects
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Side effects
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What to do
|
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Reproductive or breast problems:
changes in bleeding patterns, including break-through bleeding/spotting
painful periods
missed periods, but if you have not taken MONOFEME as directed you should check whether
you are pregnant
change in menstrual flow
change in cervical secretions (mucus from the vagina)
vaginal thrush (Candida), vaginal irritation
breast pain, tenderness, enlargement, possible milk secretion
change in sexual drive
Stomach problems such as:
gastric or stomach discomforts including abdominal pain, cramps, bloating, nausea,
vomiting and diarrhoea
change in appetite.
Difficulties thinking or working because:
headache, including migraines
nervousness, dizziness
mood change, including depression
contact lenses becoming uncomfortable to wear
Changes to your appearance such as:
change in weight
swelling of the hands, ankles or feet
dark discolouration of the skin (which may persist after the tablets have been stopped)
loss of scalp hair
increase in body hair
acne, rashes
|
Speak to your doctor if you have any of these side effects and they worry you.
|
Serious side effects
|
Serious side effects
|
What to do
|
|
Worsening of your existing conditions such as:
chorea (involuntary muscle spasm)
porphyria (a group of disorders than can cause skin or nerve problems)
systemic lupus erythematosus (Lupus)
varicose veins
gallbladder disease
kidney disease
hereditary angioedema (swelling of the face lips, mouth tongue or throat)
You are an epileptic and your fits become more frequent
Pain or discomfort:
fever
unexplained or persistent pains in the head, chest, arm or below the breastbone
severe pain, swelling or discolouration in either of your legs
discomfort radiating to the back, jaw, throat or stomach
abdominal pain
weakness or numbness in any part of your body
Digestive system problems:
bloody diarrhoea
feeling of indigestion or choking
rectal bleeding
loss of appetite or weight loss
Problems with your eyes or eyesight:
blurred or double vision
partial or complete loss of sight
eye protrusion, swelling of the eye or eye lesions
Migraines:
migraine headaches for the first time
more frequent or severe migraines if you already suffer from them
General feelings of unwellness, including:
feeling tired
shortness of breath
rapid or irregular heartbeat
dizziness or fainting, sometimes with loss of balance
sweating, nausea or vomiting
an unusual cough
Changes to your body:
confusion, trouble speaking or understanding
breast lumps
jaundice or a 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
itchy rash
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.
|
Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
You may need urgent medical attention or hospitalisation.
|
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What MONOFEME contains
|
Active ingredient
(main ingredient)
|
Each white active tablet contains:
levonorgestrel 100 micrograms (mcg)
ethinylestradiol 20 micrograms (mcg)
The red tablets do not contain active ingredients.
|
|
Other ingredients
(inactive ingredients)
|
The white active tablets also contain:
Lactose monohydrate
Maize starch
Povidone
Purified talc
Magnesium stearate
Sucrose
Macrogol 6000
Calcium carbonate
White beeswax
Carnauba wax
The red inactive tablets contain:
Lactose monohydrate
Maize starch
Povidone
Purified talc
Magnesium stearate
Sucrose
Macrogol 6000
Calcium carbonate
Glycol montanite
Brilliant scarlet 4R
Erythrosine
|
Do not take this medicine if you are allergic to any of these ingredients.
MONOFEME contains lactose.
MONOFEME does not contain gluten, tartrazine or any other azo dyes.
What MONOFEME looks like
MONOFEME is available in a 16-week box containing 4 blister packs. Each blister pack
contains 21 white hormone tablets and 7 red nonhormonal tablets. The blister pack
is marked with days of the week next to each tablet.
(AUST R 296399)
Who distributes MONOFEME
Pfizer Australia Pty Ltd
Sydney NSW
This leaflet was prepared in July 2025.