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 POSTRELLE-1?
POSTRELLE-1 contains the active ingredient levonorgestrel. POSTRELLE-1 is an emergency
contraceptive used to prevent pregnancy when taken within 72 hours of unprotected
intercourse.
2. What should I know before I use POSTRELLE-1?
Do not use if you have ever had an allergic reaction to POSTRELLE-1 or any of the
ingredients listed at the end of the CMI.
Talk to your doctor or pharmacist 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?
Some medicines may interfere with POSTRELLE-1 and affect how it works.
4. How do I use POSTRELLE-1?
Take 1 tablet as a single dose as soon as possible after unprotected intercourse and
no later than 72 hours (3 days) after intercourse.
Swallow the tablet whole with a full glass of water. Do not chew.
5. What should I know while using POSTRELLE-1?
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are using POSTRELLE-1.
|
Things you should not do
|
Do not take this medicine if you had unprotected intercourse more than 72 hours earlier
in the same menstrual cycle.
Do not take this medicine if you are pregnant.
|
Driving or using machines
|
Be careful driving or operating machinery until you know how POSTRELLE-1 affects you.
POSTRELLE-1 may cause dizziness or light-headedness in some people.
|
Drinking alcohol
|
Tell your doctor or pharmacist if you drink alcohol.
|
Looking after your medicine
|
Store the medicine in a cool, dry place where the temperature is below 25°C.
|
6. Are there any side effects?
The most common side effects are tiredness, nausea and vomiting. Other side effects
include stomach pain, diarrhoea, dizziness, headache, tender breasts, increased vaginal
bleeding and skin reactions.
Active ingredient(s):
levonorgestrel
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using POSTRELLE-1. 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 POSTRELLE-1.
Where to find information in this leaflet:
1. Why am I using POSTRELLE-1?
POSTRELLE-1 contains the active ingredient levonorgestrel.
POSTRELLE-1
is an emergency contraceptive only. POSTRELLE-1 is not intended as a regular method
of contraception.
It is used to prevent pregnancy when taken within 72 hours of unprotected intercourse
(sex).
It is estimated that POSTRELLE-1 will prevent 85% of expected pregnancies when you
take it within 72 hours of having unprotected sex. It will not prevent a pregnancy
every time and is more effective if you take it as soon as possible after unprotected
sex.
POSTRELLE-1 is most effective if taken within 72 hours of unprotected sex. The sooner
that you take POSTRELLE-1 after unprotected intercourse, the more likely it is that
the medicine will work.
POSTRELLE-1 is thought to work by:
stopping your ovaries from releasing an egg
preventing sperm from fertilising any eggs you may have already released
Therefore, POSTRELLE-1 stops a pregnancy before it is established. It does not work
if you are already pregnant. If another unprotected intercourse takes place after
the use of POSTRELLE-1 (also if this is during the same menstrual cycle), the tablet
will not be effective and there is again the risk of pregnancy.
POSTRELLE-1 will not prevent you from catching sexually transmitted diseases.
2. What should I know before I use POSTRELLE-1?
Warnings
Do not use POSTRELLE-1 if:
you are allergic to levonorgestrel, or any of the ingredients listed at the end of
this leaflet.
Always check the ingredients to make sure you can use this medicine.
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.
you are pregnant or think you may be pregnant.
you have previously had unprotected intercourse more than 72 hours earlier in the
same menstrual cycle, as you may already be pregnant.
you are experiencing vaginal bleeding for which the reason is not known.
you have breast cancer.
the tablets do not look quite right.
Do not take this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering.
If it has expired or is 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 treatment with POSTRELLE-1, your doctor or pharmacist should:
discuss if you have allergies to any other medicines, foods, preservatives or dyes.
check you are not already pregnant if they suspect you may already have been pregnant
before this occurrence of unprotected intercourse.
ask you if you are breast feeding.
ask you if you are taking any other medicines.
ask if you suffer from high blood pressure.
advise you of the need for careful use of a barrier method of contraception until
you have your next period.
advise you to see your doctor in three weeks' time, especially if you have not had
a period by then.
discuss the need for regular contraception.
You should consult with your doctor before you take POSTRELLE-1 if:
you have diabetes mellitus (with kidney, eye or nerve damage, or vascular disease).
Diabetes mellitus is a condition in which the body does not produce enough insulin
or else the body tissues are not able to use the insulin present. This leads to hyperglycaemia
(too much sugar in the blood).
you have ischaemic heart disease (heart disease caused by reduced blood flow in the
blood vessels of the heart muscle).
you have suffered a stroke.
you have had breast cancer.
are pregnant or think that you may already be pregnant. This medicine will not work
if you are already pregnant. If you are already pregnant, POSTRELLE-1 cannot terminate
pregnancy. POSTRELLE-1 is not an “abortion pill”. You may already be pregnant if:
your period is more than 5 days late, or you have experienced unusual bleeding when
your next period is due.
you have had unprotected sex more than 72 hours ago and since your last period.
If any of these conditions apply to you, it may not be suitable for you to take POSTRELLE-1.
The use of POSTRELLE-1 is not advised if you:
have a disease of your gastrointestinal tract (such as Crohn's disease) that interferes
with the digestion and absorption of your food and medicines.
have severe liver disease.
have a history of ectopic pregnancy (where the baby develops somewhere outside the
womb).
have a history of salpingitis (inflammation of the fallopian tubes).
A previous ectopic pregnancy or previous infection of the fallopian tubes increases
the risk of a new ectopic pregnancy.
are vomiting or have severe diarrhoea.
Emergency contraception should be taken as soon as possible after unprotected intercourse.
You should only use POSTRELE-1 in emergencies and not as a regular method of contraception.
If POSTRELLE-1 is used more than once in a menstrual cycle, it is less reliable and
it is more likely to upset your menstrual cycle (period).
POSTRELLE-1 does not work as well as regular methods of contraception. Your doctor,
practice nurse or family planning clinic can tell you about long-term methods of contraception
which are more effective in preventing you from getting pregnant.
If you have not told your doctor or pharmacist about any of the above, tell them before
you start taking POSTRELLE-1.
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 or pharmacist if you are pregnant or intend to become pregnant.
You should not take this medicine if you are already pregnant. If you do become pregnant
even after taking this medicine, it is important that you see your doctor. Your doctor
may want to check that the pregnancy is not ectopic (where the baby develops somewhere
outside the womb). This is especially important if you develop severe abdominal pain
after taking POSTRELLE-1, or if you have previously had an ectopic pregnancy, fallopian
tube surgery, or pelvic inflammatory disease.
Talk to your doctor or pharmacist if you are breastfeeding or intend to breastfeed.
The active ingredient of this medicine is excreted into your breast milk. Therefore,
it is suggested that you take your tablet immediately after breastfeeding and avoid
nursing at least 3 days after taking this medicine.
Fertility
POSTRELLE-1 increases the possibility of menstruation disturbances which can sometimes
lead to an earlier or later ovulation date resulting in a modified fertility date.
Although there are no fertility data in the long term, after treatment with POSTRELLE-1,
a rapid return to fertility is expected and therefore, regular contraception should
be continued or initiated as soon as possible after POSTRELLE-1 use.
Children and adolescents
POSTRELLE-1 is not recommended for children. There is only limited information available
on levonorgestrel when taken by women aged 14-16 years and no information on its use
in younger women or children.
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 POSTRELLE-1 and affect how it works.
These include:
medicines used to treat epilepsy (for example, barbiturates, primidone, phenytoin,
and carbamazepine).
medicines used to treat tuberculosis (for example, rifampicin, rifabutin).
medicines used to treat HIV infection (ritonavir, efavirenz).
a medicine used to treat fungal infections (griseofulvin).
herbal remedies containing St John's Wort (Hypericum perforatum).
POSTRELLE-1 may affect the way other medicines work. These include:
medicines used to prevent organ transplant rejection (ciclosporin).
These medicines may be affected by POSTRELLE-1 or may affect how well it works.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking this medicine.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect POSTRELLE-1.
4. How do I use POSTRELLE-1?
How much to take
Take 1 tablet as a single dose.
Swallow the tablet whole with a full glass of water. Do not chew.
If you are already using a regular method of contraception such as the contraceptive
pill, you can continue to take this at your regular time.
Your doctor or pharmacist should advise you to use a barrier contraception method
until your next period.
If you vomit within 2 hours of taking the tablet you should return to your pharmacy,
doctor or clinic.
You will need to take an additional tablet as the first one may not have been absorbed
completely.
When to take POSTRELLE-1
POSTRELLE-1 should be used as soon as possible after unprotected intercourse and no
later than 72 hours (3 days) after intercourse.
The sooner that you take the tablet, the more effective the treatment is likely to
be and the more likely that an unexpected pregnancy will be prevented. It is best
to take it immediately after you receive it.
You should only take POSTRELLE-1 in emergencies and not as a regular method of contraception.
If POSTRELLE-1 is used more than once in a menstrual cycle it is more likely to upset
your menstrual cycle.
POSTRELLE-1 can be taken at any time in your menstrual cycle, assuming you are not
already pregnant or think you may be pregnant.
If you are using one of the medicines that may prevent POSTRELLE-1 from working properly
or if you have used one of these medicines in the past 4 weeks, POSTRELLE-1 may not
work as well for you.
If you are already using a regular method of contraception, such as the contraceptive
pill, you can continue to take this at your regular times.
If another unprotected intercourse takes place after the use of POSTRELLE-1 (also
if this is during the same menstrual cycle), the tablet will not be effective and
there is again the risk of pregnancy.
Follow all directions given to you by your doctor and pharmacist carefully.
They may differ for the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist
for help.
After taking POSTRELLE-1
After taking POSTRELLE-1, you should use other contraceptive methods if you want to
have sex.
POSTRELLE-1 won't prevent pregnancy from further unprotected sex. Your doctor or pharmacist
should advise you to use a barrier contraception method until your next period.
You should see your doctor within 3 weeks of taking POSTRELLE-1.
You may experience spotting or vaginal bleeding earlier than expected.
You must see your doctor if you do not get your period, it is more than 5 days late
or your period is unusually light or unusually heavy.
If POSTRELLE-1 does not work, you could be pregnant. Your doctor will order a pregnancy
test.
If you continue to use the contraceptive pill and you do not have a bleed in your
pill-free week or while you are taking the non-hormonal tablets, you could be pregnant.
Your doctor will order a pregnancy test.
You should see your doctor if you do become pregnant even after taking this medicine.
There is no evidence that POSTRELLE-1 will harm a baby that develops in your uterus/womb,
but your doctor may want to check for an ectopic pregnancy (where the baby develops
somewhere outside the womb).
You must see your doctor immediately if you experience severe stomach pain.
On rare occasions an ectopic or tubal pregnancy could occur. This is especially important
if you have previously had an ectopic pregnancy, fallopian tube surgery or pelvic
inflammatory disease.
You should discuss with your doctor other methods of long-term contraception.
POSTRELLE-1 is only intended as an emergency measure. Discuss with your doctor other
methods of long-term contraception which are more effective in preventing you from
getting pregnant.
You should not breast feed within three days after taking POSTRELLE-1.
Small amounts of levonorgestrel may appear in your breast milk.
If you use too much POSTRELLE-1
If you think that you have used too much POSTRELLE-1, you may need urgent medical
attention.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, 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.
Although there have been no reports of serious harmful effects from taking too many
tablets at once, you may feel sick (vomit) or have vaginal bleeding. You should ask your pharmacist, doctor, practice
nurse or family planning clinic for advice, especially if you have been sick, as the
tablet may not have worked properly.
5. What should I know while using POSTRELLE-1?
Things you should do
Always follow your doctor's or pharmacist's instructions carefully.
Your doctor will be happy to discuss any questions you may have with your medication.
Remind any doctor, dentist or pharmacist you visit that you are using POSTRELLE-1.
Things you should not do
Do not give POSTRELLE-1 to anyone else.
Where to go for further information
If you require further information, you should contact your pharmacist, doctor or
clinic.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how POSTRELLE-1
affects you.
POSTRELLE-1 may cause dizziness or light-headedness in some people. Make sure you
know how you react to POSTRELLE-1 before you drive a car, operate machinery or do
anything else that could be dangerous.
Drinking alcohol
Tell your doctor or pharmacist if you drink alcohol.
Looking after your medicine
Keep your tablet in the original pack until you need to take it.
If you take the tablet out of the pack it will not keep well.
Keep your tablet in a cool dry place where the temperature stays below 25°C.
Do not take POSTRELLE-1 after the expiry date.
The expiry date is printed on the pack and the blister foil.
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.
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.
Less serious side effects
Serious side effects
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.
7. Product details
This medicine is available over-the-counter without a doctor's prescription.
What POSTRELLE-1 contains
Active ingredient
(main ingredient)
|
Levonorgestrel
|
Other ingredients
(inactive ingredients)
|
Povidone
Lactose monohydrate
Maize starch
Magnesium stearate
Silicon dioxide
|
Potential allergens
|
Contains sugars as lactose.
|
Do not take this medicine if you are allergic to any of these ingredients.
What POSTRELLE-1 looks like
POSTRELLE-1 is a round, white to off-white, uncoated flat tablet debossed '145' on
one side and other side plain (AUST R 221973).
Who distributes POSTRELLE-1
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in August 2024.
POSTRELLE®-1 is a Viatris company trade mark
POSTRELLE-1_cmi\Aug24/00