Consumer Medicine Information
LEVONELLE
Levonorgestrel 750 mcg tablets
Read this leaflet before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor, nurse, pharmacist or family planning clinic.
- This medicine has been prescribed for you personally and you should not pass it on to others.
What is LEVONELLE used for and how does it work
LEVONELLE is an emergency contraceptive that can be used after unprotected sex or where a contraceptive method has failed. This type of contraception is often called "the morning-after pill".
Each pack contains two round, white tablets. Each tablet contains 750 micrograms of levonorgestrel, which is the active ingredient.
LEVONELLE also contains the inactive ingredients: potato starch, maize starch, colloidal silica anhydrous, magnesium stearate, talc and lactose monohydrate.
How does LEVONELLE work?
LEVONELLE is an emergency contraceptive which is taken after unprotected sex. It is estimated that LEVONELLE prevents about 85% of expected pregnancies and so will not prevent a pregnancy in every instance. It is thought to work by:
- Stopping your ovaries from releasing an egg;
- Preventing sperm from fertilising any egg you may have already released; or
- Stopping a fertilised egg from attaching itself to your womb lining.
LEVONELLE helps to stop a pregnancy before it is established. It does not work if you are already pregnant.
LEVONELLE can help to prevent you from getting pregnant, but you must take the first tablet within 72 hours (three days) of having unprotected sex. The tablets are more effective if they are taken as soon as possible after unprotected sex. You need to take the second tablet 12 hours (but no more than 16 hours) after the first.
Before you use LEVONELLE
If any of these apply to you, tell your doctor, nurse, or pharmacist before you take LEVONELLE, as emergency contraception may not be suitable for you.
Do not take LEVONELLE if:
- you are pregnant or think you may be pregnant
- your period is late, or your last period was unusual at all
- since your last period you have already had unprotected sex more than 72 hours ago (a pregnancy may have already occurred and the treatment won't work)
- you know you have an allergy to any of the ingredients of LEVONELLE.
Tell your doctor, nurse or pharmacist if you have:
- a disease of your small bowel (such as Crohn's disease) that interferes with the digestion of your food
- severe liver problems
- high blood pressure
- diabetes mellitus
- heart disease or have had a stroke
- you have had breast cancer in the past
If any of these apply to you, LEVONELLE may not be suitable for you, or other types of emergency contraception may be better for you.
What else you need to know
If you are taking any other medicines
Tell your doctor, nurse or pharmacist if you are taking any of the following medicines, as they may prevent LEVONELLE from working properly
- barbiturates and other medicines used to treat epilepsy (for example, primidone, phenytoin and carbamazepine)
- medicines used to treat tuberculosis (for example, rifampicin, rifabutin)
- a treatment for HIV infection (ritonavir)
- a medicine used to treat fungal infections (griseofulvin)
- herbal remedies containing St John's wort (Hypericum perforatum)
- you are taking cyclosporin (a medicine used to help the immune system).
If any of these apply to you LEVONELLE may not be suitable for you, or other types of emergency contraception may be better for you.
If you are pregnant
You should not take this medicine if you are already pregnant. If you have had unprotected sex which was more than 72 hours ago and since your last period, 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.
What if I become pregnant after taking LEVONELLE ?
If you do become pregnant even after taking this medicine, it is important to see your doctor. There is no evidence that LEVONELLE will harm the developing baby but your doctor may want to check that the pregnancy is not ectopic (where the baby develops somewhere other than the womb). You should report to your doctor any unusual cramping pain or vaginal bleeding.
How often can you use LEVONELLE?
You should only use LEVONELLE in emergencies and not as a regular method of contraception. If LEVONELLE is used more than once in a menstrual cycle it is more likely to upset your menstrual cycle.
LEVONELLE does not work as well as regular methods of contraception. Your doctor, nurse, pharmacist or family planning clinic can tell you about long-term methods of contraception that are more effective in preventing you from getting pregnant.
If you are worried about sexually transmitted diseases
This medicine will not protect you against sexually transmitted disease, only condoms can do this. Ask your doctor, nurse, pharmacist or family planning clinic for advice if you are worried about this.
How to use LEVONELLE properly
- Take one tablet as soon as possible (but no later than 72 hours) after you have had unprotected sex. Swallow the tablet whole, with water if necessary. Do not delay taking the first tablet. The tablets work better the sooner you take them after having unprotected sex.
- It is important to take the second tablet 12 hours (and no longer than 16 hours) after the first tablet. This may mean that you need to set your alarm clock for the second tablet. If you are unsure about the timing of the tablets, ask your doctor, nurse, family planning clinic or pharmacist to advise 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.
What to do if you are sick (vomit)
- If you are sick (vomit) within three hours of taking the first tablet, you should take the second tablet in the pack at once and contact your doctor, nurse, pharmacist, or family planning clinic immediately for another tablet.
- If you are sick (vomit) within three hours of taking the second tablet you should contact your doctor, nurse, pharmacist, or family planning clinic for advice as soon as possible.
What to do if you miss a tablet
You must take both tablets in the pack (as described above) and leave no longer than 16 hours (preferably 12 hours) between taking the tablets.
If you are late taking the second tablet, (more than a 16 hour gap), take it as soon as you remember and contact your doctor, nurse, pharmacist or family planning clinic for advice as soon as possible.
Overdosage
Although there have been no reports of serious harmful effects from taking too many tablets at once, you may feel sick, actually be sick (vomit), or have vaginal bleeding. You should ask your doctor, nurse, pharmacist, or family planning clinic for advice, especially if you have been sick, as the tablets may not have worked properly.
When using LEVONELLE
Tell your doctor, nurse or pharmacist immediately:
If you are sick (vomit) within 3 hours after taking this medicine, or if you have a disease of the small bowel (such as Crohn's disease) that interferes with the absorption of your food as the active ingredient of LEVONELLE may not have been completely absorbed. You should contact your doctor, nurse or pharmacist who may need to give you another course of treatment.
Tell your doctor, nurse or pharmacist:
- If you are breast-feeding; Very small amounts of the active ingredient of this medicine may appear in your breast milk. This is not thought to be harmful to the baby, but if you are worried you can take your tablets immediately after breast feeding. In this way you are taking your tablets well before the next feed and reducing the amount of active ingredient your baby may take in with the breast milk.
- If you are taking other medicines; some medicines may stop LEVONELLE from working properly. These are described in the section "Before you use LEVONELLE".
- After you have taken LEVONELLE, if you want to have sex, and are not using the contraceptive pill, you should use condoms or a cap plus spermicide. This is because LEVONELLE won't work if you have unprotected sex again, before your next period is due.
- After you have taken LEVONELLE, you are advised to make an appointment to see your doctor or nurse practitioner about three weeks later, to make sure that LEVONELLE 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.
- 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 that you see your doctor.
Side effects
Like all medicines LEVONELLE can have side effects:
- You might feel sick for a short time after taking this medicine. About one in four women who take this medicine will feel sick.
- You might actually be sick (vomit) after taking this medicine. This is not usual, but if it happens to you make sure you read the section "What to do if you are sick".
- Your period might be different. Most women will have a normal period at the expected time, but some may have their period later or earlier than normal. You might also have some irregular bleeding or spotting until your next period. If your period is more than 5 days late or is unusually light or unusually heavy, or especially painful, you should contact your doctor, nurse or pharmacist as soon as possible.
- You might have tender breasts, headaches, lower abdominal (tummy) pain, diarrhoea, feel dizzy or feel tired after taking this medicine. These symptoms should get better within a few days. If the symptoms do not go away or get worse, you should contact your doctor, nurse or pharmacist without delay.
- If you think that this medicine has affected you in any other way that is not mentioned above, tell your doctor, nurse, pharmacist, or family planning clinic.
Storage
Store LEVONELLE below 25°C.
Keep LEVONELLE out of the reach and sight of children.
Use by date: The use by or expiry date is printed on the pack. Do not use the tablets after this date.
Where to go for further information
If you have any questions on the use of LEVONELLE, you should discuss these with your doctor, nurse, pharmacist or family planning clinic.
Name and Address
LEVONELLE is distributed in New Zealand by:
Bayer New Zealand Limited
3 Argus Place
Hillcrest
North Shore
AUCKLAND 0627
Free phone: 0800 233 988
Date of Preparation
28 June 2007