Norlevo

Consumer Medicine Information NorLevo®-1 Published by MIMS November 2021 1 What is in this leaflet This leaflet answers some common questions about NorLevo-1.

It does not contain all the available information. It does not take the place of talking to your doctor, pharmacist, nurse or family planning clinic. All medicines have risks and benefits. Your doctor, pharmacist, nurse or family planning clinic have weighed the risk of you taking this medicine against the benefits they expect it will have for you. If you have any concerns about taking this medicine, ask your doctor, pharmacist, nurse or family planning clinic. Keep this leaflet with the medicine. You may want to read it again.

What NorLevo-1 is used for and how it works NorLevo-1 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-1 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-1 will prevent 85% of expected pregnancies if taken within 72 hours. The sooner you take NorLevo-1, the more likely it is that it will work. NorLevo-1 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-1 stops a pregnancy before it is established. It does not work if you are already pregnant. NorLevo-1 does not protect against sexually transmitted diseases. Before you take NorLevo-1 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-1 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-1 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-1 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-1 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)

• medicines used to treat HIV infection (e.g. ritonavir, efavirenz)

• griseofulvin, a medicine used to treat fungal infections

• herbal remedies containing St John's wort (Hypericum perforatum)

• medicines used to prevent organ transplant rejection (cyclosporin).

These medicines may be affected by NorLevo-1, 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, including using another non-hormonal emergency contraceptive such as copper-IUD, or doubling the dose of NorLevo-1.

How to take NorLevo-1 Take 1 tablet 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 tablet, the more effective the treatment will be and the more likely an unexpected pregnancy will be prevented. It is best to take the tablet immediately after you receive it. Swallow the tablet 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-1 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-1? You should only take NorLevo-1 in emergencies and not as a regular method of contraception. If NorLevo-1 is used more than once in a menstrual cycle it is more likely to upset your menstrual cycle.