Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using Minulet?
Minulet contains two active ingredients, gestodene and ethinylestradiol. Minulet is
used to prevent pregnancy.
2. What should I know before I use Minulet?
Do not use if you have ever had an allergic reaction to gestodene or ethinylestradiol
or any of the ingredients listed at the end of the CMI. 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.
3. What if I am taking other medicines?
4. How do I use Minulet?
Take one tablet at the same time every day, regardless of how often you have sex.
See the full CMI for instructions on how to start taking Minulet for the first time
or how to change to Minulet from a different contraceptive.
5. What should I know while using Minulet?
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Things you should do
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Remind any doctor or dentist and pharmacist you visit that you are using Minulet.
Tell your doctor immediately if you become pregnant while taking Minulet.
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
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Things you should not do
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Do not stop using this medicine or change the dosage, without checking with your doctor.
If you stop taking Minulet or do not take a tablet every day without using another
form of contraception, you may become pregnant.
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Driving or using machines
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Make sure you know how Minulet affects you before you drive or use machines. Minulet
may cause dizziness in some people.
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Looking after your medicine
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Keep Minulet in a cool, dry place where the temperate stays below 25°C, away from
moisture, heat or sunlight.
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6. Are there any side effects?
Common side effects include changes to your bleeding patterns, painful periods, breast
tenderness, changes in sex drive, 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),
increase in epileptic seizures or significant rise in blood pressure. 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):
gestodene and ethinylestradiol
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Minulet. 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 Minulet.
Where to find information in this leaflet:
1. Why am I using Minulet?
Minulet contains two active ingredients, gestodene and ethinylestradiol, which are
similar to the hormones that your body normally produces. Minulet is an oral contraceptive, commonly known as a "birth control pill" or "the
Pill".
Minulet is used to prevent you from becoming pregnant in several ways, if taken correctly:
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.
Your doctor may have prescribed Minulet for another reason.
Ask your doctor if you have any questions about why Minulet has been prescribed for
you.
2. What should I know before I use Minulet?
Warnings
Do not take Minulet if:
1. You are allergic to gestodene or ethinylestradiol, 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 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, a blood clot in the:
legs (deep vein thrombosis (DVT))
lungs (pulmonary embolism (PE))
heart (heart attack)
brain (stroke)
other parts of the body
3. You are at increased risk of a blood clot in the legs (DVT) or lungs (PE) due to any
of the following:
A family history of blood clots (DVT or PE) or you have been advised that you have
an increased risk of blood clots
Prolonged immobilisation, major surgery, any surgery to the legs or pelvis, neurosurgery,
or major trauma
Biochemical factors, such as Activated Protein C resistance (including Factor V Leiden),
antithrombin-III deficiency, protein C deficiency, protein S deficiency
Cancer, systemic lupus erythematosus, haemolytic uraemic syndrome, chronic inflammatory
bowel disease (e.g. Crohn's disease or ulcerative colitis)
Sickle cell disease
Obesity, age above 35 years, high cholesterol
Smoking, particularly if you are a heavy smoker (15 or more cigarettes per day) and
are aged over 35 years
4. You have, or have had, blood clots in the arteries (known as arterial thromboembolism
(ATE)).
Examples of these include:
Stroke
Angina
Transient ischaemic attack or "mini stroke"
5. You are at increased risk of arterial thromboembolism (ATE), including:
A family history of ATE or you have been advised that you have an increased risk of
ATE
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 (fatty materials) disease, such as cholesterol or triglyceride issues
History of migraine, accompanied by blurred vision, difficulty in speaking, muscle
weakness, or increased sensitivity to light, sound or noise.
Biochemical factors, such as hyperhomocysteinaemia and antiphospholipid antibodies
(e.g. anticardiolipin antibodies and lupus anticoagulant)
6. You have any of the following conditions
Disease in any blood vessel(s)
Inflammation of the pancreas, which is associated with very high blood levels of triglycerides
(fatty substances)
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
Yellowing of the whites of the eyes or of the skin (jaundice) during pregnancy or
during previous use of an oral contraceptive
Severe skin itchiness during pregnancy
A history of herpes in pregnancy, known as herpes gestationis
A history of a hearing problem known as otosclerosis, which is worse during pregnancy
7. You are pregnant or you think you are pregnant. Pregnancy must be excluded before
you start taking Minulet.
8. You are under 18 years of age or are post-menopausal.
9. You are taking anti-viral hepatitis C virus (HCV) medicinal products such as those
containing glecaprevir, pibrentasvir, ombitasvir, paritaprevir, ritonavir and dasabuvir
with or without ribavirin.
If you are not sure about your anti-HCV medication, tell your doctor.
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
Epilepsy
Depression
Gallbladder disease
Fluid retention or kidney disease
Asthma
Fibroids
Hereditary angioedema
If you have any of these conditions you should have regular check-ups with your doctor
to make sure that taking Minulet is not making the conditions worse. If you are not
certain whether any of the above may apply to you, check with your doctor.
Are over 35 years of age or are overweight
Are intolerant to some sugars, or your doctor has told you so, speak to your doctor
before taking it.
Minulet 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.
Minulet is not recommended during pregnancy. Pregnancy must be excluded before you
start taking Minulet.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Minulet is not recommended while you are breastfeeding. Small amounts of oral contraceptives
have been found in breast milk. It is not known what effect this may have on the baby.
A decrease in milk supply may also occur.
Children
Do not give this medicine to a child under 18 years.
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 if you have, or have had, any of the following conditions as these
are risk factors for developing blood clots:
Cancer
Systemic lupus erythematosus (SLE) - a type of inflammatory disease caused when the
immune system attacks its own tissues
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 a 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".
Medical check-ups
Before you start to take Minulet, you must have a thorough medical check-up, including
a Pap smear, breast check, blood pressure check and urine test.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with Minulet and affect how it or the other medicine
works.
Some medicines may
increase
the levels of Minulet in your blood, which may lead to unwanted side effects. These
medicines include:
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)
Medicines that may
reduce
the effect of Minulet include:
Rifampicin and rifabutin for the treatment of infections, including tuberculosis
Antibiotics such as ampicillin, other penicillins and tetracyclines
Anti-fungal agents such as griseofulvin
Barbiturates (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.
Minulet may also affect how well some other medicines work.
These medicines include:
Anti-viral hepatitis C virus (HCV) medicines such as glecaprevir, pibrentasvir, ombitasvir,
paritaprevir, ritonavir and dasabuvir
Ciclosporin, used to prevent organ rejection
Theophylline, 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 Minulet.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Minulet.
4. How do I use Minulet?
How much to take
Take one tablet every day.
Follow the instructions provided and use Minulet until your doctor tells you to stop.
When to take Minulet
Minulet should be taken at the same time every day, regardless of whether you have
sex.
Minulet 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 Minulet before or after food.
If you are concerned about this, please speak to your doctor or pharmacist.
How to take Minulet
Swallow Minulet with a glass of water.
How to start taking Minulet for the first time
1. On the first day of your menstrual bleed, take a white tablet that matches the day
of the week from the purple shaded section of the blister pack.
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.
Minulet is effective from the first day of use if begun as instructed. Your first
cycle is likely to be shorter than usual, approximately 23 to 24 days long. Thereafter,
your cycles should be about 28 days long.
If you do not bleed and there is any chance that you have not followed all the instructions
in this leaflet, contact your doctor to check if you are pregnant.
Going on to further blister packs
On the day after your last red tablet, begin the next pack with a white tablet from
the purple 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 the new pack later than the day after your last red tablet, you may have
started a normal fertile cycle.
If you start 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.
How to change to Minulet from a different combined oral contraceptive
Follow these steps if your current oral contraceptive contains an estrogen and a progestogen:
1. Stop taking your current oral contraceptive after you have taken the last tablet in
the pack.
2. If your current oral contraceptive is a 28 day pack, start Minulet the next day by
taking take the first white tablet from the purple shaded section that matches the
day of the week. If your current oral contraceptive is a 21 day pack, wait 7 days
from when the last tablet was taken. On the 8th day, start Minulet by taking take
the first white tablet from the purple 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 bleed and there is any chance that you have not followed all the instructions
in this leaflet, contact your doctor to check if you are pregnant.
How to change to Minulet from a progesterone-only contraceptive
You can stop taking a progestogen-only contraceptive tablet any day and start taking
Minulet the next day, at the same time.
If you have been using a progestogen-only implant, start taking Minulet on the day
the implant is removed.
If you have been using a progestogen-only injection, start taking Minulet on the day
the next injection would be due.
In all cases start Minulet by taking a white tablet from the purple 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 Minulet.
After a miscarriage or abortion
Your doctor will advise you how to take Minulet after a miscarriage or abortion.
How long to take Minulet
Your doctor may prescribe Minulet for long periods, until you no longer need or want
contraception.
If you are not sure how long you should be taking Minulet, ask your doctor.
If you forget to use Minulet
Minulet 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.
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 tablets in one day.
If you do not take the missed tablet within 12 hours, Minulet may not work as well
in protecting you from becoming pregnant.
If one white tablet is missed and is more than 12 hours late, skip the missed white
tablet and take the next white 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 more than one white tablet
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 purple 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 Minulet, ask your pharmacist for some
hints.
If you vomit or have diarrhoea after taking Minulet
If you have vomiting or diarrhoea within 4 hours of 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 use too much Minulet
If you think that you have used too much Minulet, 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.
If you take too much Minulet, some of the symptoms you may have include:
Feeling sick or vomiting
Dizziness
Feeling sleepy or tired.
Women may also experience menstrual bleeding.
5. What should I know while using Minulet?
Things you should do
Tell all doctors, dentists and pharmacists who are treating you that you are taking
Minulet.
If you are about to start taking any new medicines, tell the doctor or pharmacist
that you are taking Minulet.
If you become pregnant while taking Minulet, see your doctor immediately.
Tell your doctor you are using Minulet at least 4 weeks before any planned hospitalisation
or surgery.
Your doctor may tell you to stop taking Minulet several weeks before surgery or at
the time of immobilisation. Your doctor will tell you when you can start taking Minulet
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.
If you are scheduled for any laboratory tests, tell your doctor you are taking Minulet.
Some blood tests may be affected by taking Minulet.
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 Minulet.
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 Minulet
again.
Pap smear
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.
Breast cancer risk
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.
Sexually transmitted disease (STD)
If you are concerned about contracting a sexually transmitted disease (STD), ask your
partner to wear a condom when having sexual intercourse with you.
Minulet will not protect you from HIV-AIDS or any other sexually transmitted diseases
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.
Things you should not do
Do not take this medicine if the expiry date (EXP) printed on the pack has passed.
Minulet may have no effect at all, or worse, an entirely unexpected effect, if you
take it after the expiry date.
Do not take this medicine if the packaging is torn or shows signs of tampering.
If this is the case, take the tablets back to your pharmacist.
Do not give Minulet to anyone else.
Do not use Minulet to treat any other complaints unless your doctor tells you to.
Do not stop taking Minulet, or change the dosage, without checking with your doctor.
If you stop taking Minulet 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 Minulet
affects you.
Minulet may cause dizziness in some people.
Drinking alcohol
No information available.
Looking after your medicine
Keep your tablets in the blister pack until it is time to take them. If you take the
tablets out of the pack they may not keep well.
Keep Minulet where the temperature stays below 25°C and is away from light.
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.
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 Minulet
If your periods do not return within 2 to 3 months of stopping Minulet, tell your
doctor.
Some women have short-term problems getting pregnant after stopping Minulet, especially
if they had irregular menstrual cycles before starting to use an oral contraceptive.
If you are planning to become pregnant after stopping Minulet, 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.
When to discard your medicine
If your doctor tells you to stop taking Minulet, or the tablets have passed their
expiry date, ask your pharmacist what to do with any 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.
Do not use this medicine after the expiry date.
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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Common side effects
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What to do
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Reproductive or breast problems:
Changes in bleeding patterns, including breakthrough bleeding/spotting
Painful periods
Missed periods, but if you have not taken Minulet 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
Stomach problems such as:
Nausea or vomiting
Abdominal pain, cramps or bloating.
Difficulties
thinking or working because of:
Mood changes, including depression
Headache, including migraines
Nervousness
Dizziness
Contact lenses becoming uncomfortable to wear
Changes to your appearance such as:
Weight change (increase or decrease) or changes in appetite
Swelling of the hands, ankles or feet
Acne
Rash
Darkening of the skin, which may persist after stopping your medicine
Loss of scalp hair
Increase in body hair
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Speak to your doctor if you have any of these common side effects and they worry you.
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Serious side effects
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Serious side effects
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What to do
|
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Worsening of your existing conditions, such as:
Chorea
Porphyria
Systemic lupus erythematosus
Varicose veins
Gallbladder disease
Hereditary angioedema
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
Weakness or numbness in any part of your body
Discomfort radiating to the back, jaw, throat or stomach
Abdominal pain
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
Swelling around eyes or mouth
Migraines:
Migraine headaches for the first time
More frequent 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 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.
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.
If you have epilepsy and your fits become more frequent
Itchy rash
Digestive system problems:
Feeling of indigestion or choking
Rectal bleeding, or blood on your underwear or when going to the bathroom.
Bloody diarrhoea
Loss of appetite or weight loss
|
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 Minulet contains
|
Active ingredient
(main ingredient)
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Each white active tablet contains:
75 micrograms of gestodene
30 micrograms of ethinylestradiol
The red tablets do not contain active ingredients.
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Other ingredients
(inactive ingredients)
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Lactose monohydrate
Maize starch
Povidone
Magnesium stearate
Sucrose
Calcium carbonate
Purified talc
Macrogol 6000
Glycol montanate
The white active tablets also contain:
Sodium calcium edetate
The red inactive tablets also contain:
Brilliant scarlet 4R CI 16255
Erythrosine CI 45430
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Do not take this medicine if you are allergic to any of these ingredients.
Minulet does not contain gluten, tartrazine or any other azo dyes.
What Minulet looks like
Minulet comes in a 12 week box containing 3 blister packs. Each blister pack contains
21 white active tablets and 7 red inactive tablets. The white active tablets are round,
biconvex tablets, approximately 6 mm in diameter. The red inactive tablets are round,
biconvex coated tablets. The blister pack is marked with days of the week next to
each tablet.
(AUST R 296803)
Who distributes Minulet
Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
® = Registered Trademark
This leaflet was prepared in June 2023.