Norlevo

levonorgestrel 750µg tablets
Consumer Medicine Information
 
 

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Norlevo. It does not contain all the information that is known about Norlevo. 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 Norlevo is used for and how it works

NorLevo is an oral emergency contraceptive indicated for use within 72 hours of unprotected intercourse. It is not intended as a regular method of contraception.
It contains the active ingredient levonorgestrel.
NorLevo must be taken as soon as possible, preferably within 12 hours and no later than within 72 hours of unprotected intercourse. It has been estimated that NorLevo will prevent 85% of expected pregnancies if taken within 72 hours. The sooner you take NorLevo, the more likely it is that it will work.
NorLevo is thought to work by:
stopping your ovaries from releasing an egg
preventing sperm from fertilising any eggs you may have already released
stopping a fertilised egg from attaching itself to your womb lining.
Therefore, NorLevo stops a pregnancy before it is established. It does not work if you are already pregnant.
NorLevo does not protect against sexually transmitted diseases.

Before you take NorLevo

When you must not take it

Do not take this medicine if:
you are allergic to the active ingredient or any of the other ingredients listed at the end of this leaflet under Product Description
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 have unexplained vaginal bleeding
you have breast cancer.
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.

Before you start to take NorLevo

Tell your doctor, pharmacist or nurse if you have allergies to any other medicines, foods, preservatives or dyes.
You should consult your doctor, pharmacist or nurse before taking NorLevo if:
you have any severe digestive diseases (e.g. Crohn's disease) which impair the absorption of medications
you suffer from diabetes mellitus
you suffer from high blood pressure or ischaemic heart disease (a reduced blood flow in the vessels that provide your heart muscle with blood)
you have ever suffered a stroke
you had breast cancer in the past
you suffer from severe liver disease.
If any of these conditions apply to you, NorLevo may not be suitable for you, or other types of emergency contraception may be better for you.
You should not take this medicine if you are already pregnant.
If you have had unprotected sex which was more than 72 hours ago in the same menstrual cycle, you may already be pregnant and the treatment won't work. If your period was more than 5 days late or was unusually light or unusually heavy, you should check with your doctor that you are not already pregnant.
Tell your doctor, pharmacist or nurse, if you are breastfeeding.
Small amounts of levonorgestrel may appear in your breast milk. Therefore, you should breastfeed immediately before taking the NorLevo tablet and avoid nursing for at least 8 hours afterwards. The milk should be expressed and discarded the first 8 hours after dosing.

Taking other medicines

Tell your doctor, pharmacist or nurse if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop, in particular the following:
medicines used to treat epilepsy (e.g. barbiturates, primidone, phenytoin and carbamazepine)
medicines used to treat tuberculosis (e.g. rifampicin and rifabutin)
ritonavir, a medicine used to treat HIV infection
griseofulvin, a medicine used to treat fungal infections
herbal remedies containing St John's wort (Hypericum perforatum).
These medicines may be affected by NorLevo, or may affect how well it works. Your doctor, pharmacist or nurse can advise you on what to do if you are taking any of these medicines.

How to take NorLevo

Take 2 tablets at the same time as a single dose as soon as possible, preferably within 12 hours, after the unprotected intercourse and not later than 72 hours (3 days) after the intercourse.
The sooner you take the tablets, the more effective the treatment will be and the more likely an unexpected pregnancy will be prevented. It is best to take the tablets immediately after you receive it.
Swallow the tablets whole with a full glass of water.
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.
NorLevo is not recommended for use in children. There is only limited information available on this medicine when taken by women aged 14-16 years and no information on its use in younger women or children.

How often can you take NorLevo?

You should only take NorLevo in emergencies and not as a regular method of contraception.
If NorLevo is used more than once in a menstrual cycle it is more likely to upset your menstrual cycle.

If you take too much (overdose)

Immediately telephone your doctor, or the Poisons Information Centre (telephone Australia 131 126 or New Zealand 0800 POISON or 0800 764766) or go to Accident and Emergency at your nearest hospital, if you think you or anyone else has taken too much NorLevo, or if a child has taken this medicine. 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 or have vaginal bleeding.

While you are taking NorLevo

If you vomit within two hours of taking this medicine, you should return to your doctor, pharmacy, nurse or family planning clinic.
You may need another dose as the first one may not have been absorbed completely.

Things you must do

Tell any doctors and pharmacists who treat you that you are taking this medicine.

Things you must not do

Do not give this medicine to anyone else.

Things to be careful of

Be careful driving or operating machinery until you know how NorLevo affects you.
It may cause dizziness or light-headedness in some people.

Side effects

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by the following list of side effects. You may not experience any of them.
Tell your doctor, pharmacist or nurse if you notice any of the following and they worry you:
nausea and vomiting
diarrhoea
dizziness, fatigue, headache
lower abdominal pain
tender breasts
increased vaginal bleeding, irregular bleeding or spotting. Most women will have a normal period at the expected time, but some may have their period later or earlier than normal. If your period is more than 5 days late or is unusually light or unusually heavy, or especially painful, you should contact your doctor or pharmacist as soon as possible.
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing.
These are very serious side effects. You may need urgent medical attention or hospitalisation. All of these side effects are very rare.
Tell your doctor or pharmacist if you notice anything else that is making you feel unwell.
Other side effects not listed above may also occur in some people.

After taking NorLevo

After you have taken this medicine, if you want to have sex, you should use other contraceptive methods, because NorLevo won't stop pregnancy from further unprotected sex. Your doctor or pharmacist should advise you to use a barrier contraception method until your next period.
After you have taken this medicine, you are advised to make an appointment to see your doctor about three weeks later, to make sure that NorLevo has worked. If your period is more than 5 days late or is unusually light or unusually heavy, you should contact your doctor as soon as possible.
Your doctor can also tell you about long-term methods of contraception which are more effective in preventing you from getting pregnant.
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, see your doctor to make sure you are not pregnant.
If you do become pregnant even after taking this medicine, it is important to see your doctor.
There is no evidence that NorLevo will harm a baby that develops in your uterus/womb, but 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 NorLevo or if you previously had an ectopic pregnancy, fallopian tube surgery or pelvic inflammatory disease. You should tell your doctor if you have had any unusual pain or vaginal bleeding. If abdominal pain is severe you should see your doctor immediately.

Storage

Keep NorLevo in the original packaging to protect from light until you need to take it.
Keep NorLevo in a cool dry place where the temperature stays below 30°C.
Do not store NorLevo or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
The expiry date of your medicine is printed on the pack. Do not use the tablet after this date.

Disposal

Return any unused or out of date medicine to your pharmacist.

Product description

What it looks like

NorLevo 750 microgram tablets - round, white tablets.
Available in blister packs of 2 tablets.

Ingredients

Active ingredient:
Each NorLevo tablet contains 750 microgram levonorgestrel.
Inactive ingredients:
lactose
maize starch
povidone
colloidal anhydrous silica
magnesium stearate.
This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.

Where to go for further information

If you have any questions on the use of NorLevo, you should discuss these with your doctor, pharmacist, nurse or family planning clinic.

Supplier

NorLevo is supplied in Australia by:
Sandoz Pty Ltd
ABN 60 075 449 553
19 Harris St
Pyrmont NSW 2009
Tel: 1800 634 500
NorLevo is supplied in New Zealand by:
Novartis New Zealand Limited
Private Bag 65904 Mairangi Bay
Auckland 0754
Tel: 0800 354 335
This leaflet was revised in December 2011.
Australian Register Number
NorLevo 750 microgram tablets: AUST R 119794 (blisters)