Patient leaflet - Levonorgestrel 1.5 mg tablets

1. What Levonorgestrel tablets are and what they are used for

Levonorgestrel tablets are an emergency contraceptive that can be used within 72 hours (3 days) of unprotected sex or if your usual contraceptive method has failed.

It is about the following cases:

No contraception was used during the sexual intercourse. - The contraception measure was used incorrectly, for
example as if a condom was penetrated, slipped away or used in a wrong way, if vaginal pessary or diaphragm changed position, burst, was broken or taken out ahead of time, in the case of a failed interruption during coitus interruptus (e.g. sperm ejaculated in vagina or on external genitalia).

Levonorgestrel tablets contain a synthetic hormone like substance called levonorgestrel. It prevents about 84% 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. It is better to take it within 12 hours rather than delay until the third day.

Levonorgestrel tablets are thought to work by: • stopping your ovaries from releasing an egg; • preventing sperm from fertilising any egg you may have

already released.

Levonorgestrel tablets can only prevent you becoming pregnant if you take it within 72 hours of unprotected sex. It does not work if you are already pregnant. If another unprotected intercourse takes place after the use of Levonorgestrel tablets (also if this is during the same menstrual cycle), the tablet will not exert its contraceptive effect and there is again the risk of pregnancy.

Levonorgestrel tablets are not indicated for use before the first menstrual bleeding (menarche).

2. What you need to know before you take Levonorgestrel tablets

Do not use Levonorgestrel tablets

if you are allergic to levonorgestrel or any of the other
ingredients of this medicine (listed in section 6).

Warnings and precautions

If any of the following applies to you, talk to your doctor before taking Levonorgestrel tablets as emergency contraception may not be suitable for you. Your doctor may prescribe another type of emergency contraception for you. • If you 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, Levonorgestrel tablets cannot terminate pregnancy, so Levonorgestrel tablets are not “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.

The use of Levonorgestrel tablets are not advised if: • you have a disease of your small bowel (such as Crohn’s

disease) that inhibits the absorption of the drug • you have severe liver problems

you have a history of ectopic pregnancy (where the baby
develops somewhere outside the womb)
you 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.

In all women, emergency contraception should be taken as soon as possible after unprotected intercourse. There is some evidence that Levonorgestrel tablets may be less effective with increasing body weight or body mass index (BMI), but these data were limited and inconclusive. Therefore, Levonorgestrel tablets are still recommended for all women

regardless of their weight or BMI.

You are advised to speak to a healthcare professional if you are concerned about any problems related to taking emergency contraception.

Children and adolescents

Levonorgestrel tablets are not indicated for use before the first menstrual bleeding (menarche).

If you are worried about sexually transmitted diseases

If you did not use a condom (or if it has been torn or slid down) during the intercourse, it might be possible that you have caught a sexually transmitted disease or the HIV virus.

This medicine will not protect you against sexually transmitted diseases, only condoms can do this. Ask your doctor, nurse, family planning clinic or pharmacist for advice if you are worried about this.

Other medicines and Levonorgestrel tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Some medicines may prevent Levonorgestrel tablets from working effectively. If you have used any of the medicines below during the last 4 weeks, Levonorgestrel tablets may be less suitable for you. Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, i.e. a copper intrauterine device (Cu-IUD). If this is not an option for you or if you are unable to see your doctor promptly, you can take a double dose of Levonorgestrel tablets:

barbiturates and other medicines used to treat epilepsy (for example, primidone, phenytoin, and carbamazepine) - medicines used to treat tuberculosis (for example, rifampicin, rifabutin)
treatment for HIV (ritonavir, efavirenz)
a medicine used to treat fungal infections (griseofulvin) - herbal remedies containing St John’s wort (Hypericum perforatum).

Talk to your pharmacist or doctor if you need further advice on the correct dose for you.

Consult a doctor as soon as possible after taking the tablets for further advice on a reliable form of regular contraception and to exclude a pregnancy. (See also section 3 “How to take Levonorgestrel tablets” for further advice).

Levonorgestrel tablets may also affect how well other medicines work

a medicine called ciclosporin (suppresses the immune system).

How often can you use Levonorgestrel tablets

You should only use Levonorgestrel tablets in emergencies and not as a regular method of contraception. If Levonorgestrel tablets are used more than once in a menstrual cycle, it is less reliable and it is more likely to upset your menstrual cycle (period).

Levonorgestrel tablets do 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.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

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. There is no evidence that Levonorgestrel tablets will harm a baby that develops in your uterus/womb if you use Levonorgestrel tablets as described. Nevertheless, 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 Levonorgestrel tablets or if you have previously had an ectopic pregnancy, Fallopian tube surgery or pelvic inflammatory disease.

Breast-feeding

The active ingredient of this medicine is excreted into your breast milk. Therefore, it is suggested that you take your tablet immediately after a breast-feeding and avoid nursing at least 8 hours following levonorgestrel administration then drain your milk with a breast pump for 8 hours following tablet taking. In this way you are taking your tablet well before the next feed and reducing the amount of active ingredient your baby may take in with the breast milk.

Fertility

Levonorgestrel tablets increase the possibility of menstruation disturbances which can sometimes lead to earlier or later ovulation date resulting in modified fertility date. Although there are no fertility data in the long term, after treatment with Levonorgestrel tablets a rapid return to fertility is expected and therefore, regular contraception should be continued or initiated as soon as possible after Levonorgestrel tablets use.

Driving and using machines

Your Levonorgestrel tablets are unlikely to affect your ability to drive a car or use machines. However, if you feel tired or dizzy do not drive or operate machinery.

QR Code

85 mm

170 mm

PIL of Levonorgestrel tablets mg tablets for UK (170 mm x 430 mm)

Levonorgestrel tablets contain lactose

In case of milk sugar (lactose) intolerance it should be considered that each Levonorgestrel tablets also contains 129.10 mg lactose monohydrate.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Levonorgestrel tablets

Always use this medicine exactly as described in the leaflet or as your pharmacist or doctor has told you. Check with your doctor or pharmacist if you are not sure.

Take the tablet as soon as possible, preferably within 12 hours, and no later than 72 hours (3 days) after you have had unprotected sex. Do not delay taking the tablet. The tablet works best the sooner you take it after having unprotected sex. It can only prevent you becoming pregnant, if you take it within 72 hours of unprotected sex.

Levonorgestrel tablets can be taken at any time in your
menstrual cycle assuming you are not already pregnant or think you may be pregnant. Do not chew but swallow the tablet whole with water.
If you are using one of the medicines that may prevent
Levonorgestrel tablets from working properly (see section above “Other medicines and Levonorgestrel tablets”) or if you have used one of these medicines in the past 4 weeks, Levonorgestrel tablets may work less effectively for you. Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, i.e. a copper intrauterine device (Cu-IUD). If this is not an option for you or if you are unable to see your doctor promptly, you can take a double dose of Levonorgestrel tablets (i.e. 2 tablets taken together at the same time).
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 Levonorgestrel tablets (also if this is during the same menstrual cycle), the tablet will not exert its contraceptive effect and there is again the risk of pregnancy.

You are advised to speak to a healthcare professional if you are concerned about any problems related to taking emergency contraception.

What to do if you are sick (vomit)

If you are sick (vomit) within three hours of taking the tablet, you should immediately take another tablet.

After you have taken Levonorgestrel tablets

After you have taken Levonorgestrel tablets, if you want to have sex, and are not using the contraceptive pill, you should use condoms or a cap plus spermicide until your next menstrual period. This is because Levonorgestrel tablets will not work if you have unprotected sex again, before your next period is due.

After you have taken Levonorgestrel tablets, you are advised to make an appointment to see your doctor about three weeks later, to make sure that Levonorgestrel tablets have 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 do become pregnant even after taking this medicine, it is important that you see your doctor.

Your doctor can also tell you about longer-term methods of contraception which are more effective in preventing you from getting pregnant.

If you continue to use regular hormonal contraception such as the contraceptive pill and you do not have a bleed in your pill-free period, see your doctor to make sure you are not pregnant.

Your next period after you took Levonorgestrel tablets

After the use of Levonorgestrel tablets, your period is usually normal and will start at the usual day; however sometimes, this will be a few days later or earlier. If your period starts more than 5 days later than expected, an ‘abnormal’ bleeding occurs at that time or if you think that you might be pregnant, you should check whether you are pregnant by a pregnancy test.

If you take more Levonorgestrel tablets than you should

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 pharmacist, doctor, practice nurse or family planning clinic for advice, especially if you have been sick, as the tablet may not have worked properly.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common (may affect more than 1 in 10 people):

Feeling sick (nausea)
You might have some irregular bleeding until your next
period
- You might have lower abdominal pain
- Tiredness
- Headache.

Common (may affect up to 1 in 10 people):

Being sick (vomiting). If you are sick, read the section
‘What to do if you are sick’ (vomit).
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, you should contact your doctor as soon as possible.
You might have tender breasts, diarrhoea, feel dizzy after taking this medicine.

Very rare effects (may affect up to 1 in 10,000 people):

Rash, urticaria, pruritus, swelling of the face, pelvic pain, painful period.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side affects you can help provide more information on the safety of this medicine.

5. How to store Levonorgestrel tablets

Keep this medicine out of the sight and reach of children.

Do not use Levonorgestrel tablets after the expiry date which is stated on the package after “Exp”. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Levonorgestrel tablets contain

The active substance is levonorgestrel. Each tablet contains 1.5 mg of levonorgestrel.

The other ingredients are:

colloidal anhydrous silica, lactose monohydrate, magnesium stearate, maize starch, pregelatinized starch, povidone (K-30).

What Levonorgestrel tablets look like and contents of the pack

Each pack of Levonorgestrel tablets contains a complete treatment which is one white, round flat face bevel edge tablet of about 7.0 mm in diameter, with one side having logo “E 1.5” and other side is plain.

Packaging: Aluminium-PVDC foil blister sheet containing one tablet.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Renata (UK) Limited

Greenway Business Centre

Harlow Business Park

Harlow, CM19 5QE

United Kingdom

Manufacturer

Crescent Pharma Limited

Key house, Sarum Hill

Basingstoke, RG21 8SR