Emergency Contraception: Levonorgestrel

Package leaflet: Information for the user
ellaOne 30 mg tablet

Ulipristal acetate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your pharmacist, doctor or other healthcare professional has told you.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your pharmacist, doctor, or other healthcare professional.

This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What ellaOne is and what it is used for
2. What you need to know before you take ellaOne
3. How to take ellaOne
4. Possible side effects
5. How to store ellaOne
6. Contents of the pack and other information

- Useful information about contraception

1. What ellaOne is and what it is used for

ellaOne is an emergency contraceptive ellaOne is a contraceptive intended to prevent pregnancy after unprotected sex or if your contraceptive method has failed. For example:

• if you had sex without protection;
• if your or your partner’s condom tore, slipped or came off, or if you forgot to use one;
• if you did not take your contraceptive pill as recommended.

You should take the tablet as soon as possible after sex, and within a maximum of 5 days (120 hours). This is because it is more effective if you take it as soon as possible after unprotected sex.

This medicine is suitable for any woman of childbearing age, including adolescents. You can take the tablet at any time in the menstrual cycle.

ellaOne does not work if you are already pregnant If your menstrual period is late, there is a possibility that you may be pregnant. When your period is late or when you have symptoms of pregnancy (heavy breasts, morning sickness) you should consult a doctor or other healthcare professional before taking the tablet.

If you have unprotected sex after taking the tablet, it will not stop you from becoming pregnant. Unprotected sex at any time during your cycle can lead to pregnancy.

ellaOne is not to be used for regular contraception If you do not have a regular method of contraception, talk to your doctor or healthcare professional to choose one that is suitable for you.

How ellaOne works ellaOne contains the substance ulipristal acetate which acts by modifying the activity of the natural hormone progesterone which is necessary for ovulation to occur. As a result, this medicine works by postponing ovulation. Emergency contraception is not effective in every case. Of 100 women who take this medicine approximately 2 will become pregnant.

This medicine is a contraceptive used to prevent a pregnancy from starting. If you are already pregnant, it will not interrupt an existing pregnancy.

Emergency contraception does not protect against sexually transmitted infections Only condoms can protect you from sexually transmitted infections. This medicine will not protect you against HIV infection or any other sexually transmitted diseases (e.g. chlamydia, genital herpes, genital warts, gonorrhoea, hepatitis B and syphilis). Ask a healthcare professional for advice if you are worried about this. There is more information about contraception at the end of this leaflet.

2. What you need to know before you take ellaOne

Do not take ellaOne

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

Warning and precautions

Talk to your pharmacist, doctor or other healthcare professional before taking this medicine

• if your period is late or you have symptoms of pregnancy (heavy breasts, morning sickness), as you may already be pregnant (see section “Pregnancy, breast-feeding and fertility”);
• if you suffer from severe asthma;
• if you suffer from severe liver disease.

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

If you become pregnant despite taking the tablet, it is important that you see your doctor. See section “Pregnancy, breast-feeding and fertility” for more information.

Other contraceptives and ellaOne

This medicine may make regular hormonal contraceptives, like pills and patches, temporarily less effective. If you are currently taking hormonal contraception, continue to use it as usual after taking this medicine, but be sure to use condoms every time you have sex until your next period.

Do not take this medicine together with another emergency contraceptive pill that contains levonorgestrel. By taking them both together, you might make this medicine less effective.

Other medicines and ellaOne

Tell your pharmacist, doctor or other healthcare professional if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or herbal medicines.

Some medicines may prevent ellaOne from working effectively. If you have used any of the medicines listed below during the last 4 weeks, ellaOne 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):

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

Speak to your doctor or pharmacist before using ellaOne when you use (or have recently used) any of the medicines stated above.

Pregnancy, breast-feeding and fertility

Pregnancy Before taking this medicine, if your period is late, tell your pharmacist, doctor or other healthcare professional, or do a pregnancy test in order to make sure you are not already pregnant (see section “Warning and precautions”).

This medicine is a contraceptive used to prevent a pregnancy from starting. If you are already pregnant it will not interrupt an existing pregnancy.

If you become pregnant despite taking this medicine, there is no evidence that it will affect your pregnancy. However, it is important that you see your doctor. As for any pregnancy, your doctor may want to check that the pregnancy is not outside the womb. This is especially important if you have severe abdominal (stomach) pain or bleeding or if you have previously had a pregnancy outside the womb, tubal surgery or long term (chronic) genital infection.

If you become pregnant despite taking ellaOne, you are encouraged to ask your doctor to register your pregnancy in an official registry. You can also report this information on your own at www.hra-pregnancy-registry.com.Your information will remain anonymous – nobody will know it is information about you. Sharing your information may help women in the future understand the safety or risks of ellaOne during a pregnancy.

Breast-feeding If you take this medicine while you are breast-feeding a baby, do not breast-feed for one week after taking this medicine. During this time, it is recommended to use a breast pump in order to maintain milk production, but throw away your breast milk. The effect of breast-feeding your baby in the week after taking this medicine is not known.

Fertility This medicine will not affect your future fertility. If you have unprotected sex after taking the tablet, it will not stop you from becoming pregnant. Therefore it is important you use condoms until your next period. If you wish to start or continue with a regular method of contraception after using this medicine, you can do so but you should also use condoms until your next period.

Driving and using machines

After taking this medicine, some women experience dizziness, drowsiness, blurred vision and/or loss of concentration (see section 4). If you experience these symptoms, do not drive or use machines

ellaOne contains lactose

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

ellaOne contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. How to take ellaOne

Always take this medicine exactly as described in this leaflet or as your pharmacist, doctor or other healthcare professional has told you. Check with your pharmacist or doctor if you are not sure. How to take the ellaOne tablet

• Take one tablet by mouth as soon as possible and no later than 5 days (120 hours) after unprotected sex or contraceptive failure. Take the tablet without delay.
• You can take the tablet at any time in your cycle.
• You can take the tablet at any time of the day either before, during or after a meal.
• If you are using one of the medicines that may prevent ellaOne from working properly (see section 2 “What you need to know before you take ellaOne”) or if you have used one of these medicines in the past 4 weeks, ellaOne may work less effectively for you. Speak to your doctor or pharmacist before using ellaOne. Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, i.e. a Cu-IUD.

If you vomit after taking ellaOne If you vomit (be sick, throw up) within 3 hours of taking the tablet, take another tablet as soon as possible.

If you have sex again after taking ellaOne If you have unprotected sex after taking the tablet, it will not stop you from becoming pregnant. After you take the tablet and until your next period comes, you should use condoms every time you have sex.

If your next period is late after taking ellaOne After taking the tablet, it is normal for your next period to be a few days late.

However, if your period is more than 7 days late; if it is unusually light or unusually heavy; or if you experience symptoms such as abdominal (stomach) pain, breast tenderness, vomiting or nausea, you may be pregnant. You should do a pregnancy test right away. If you are pregnant, it is important that you see your doctor. (See section “Pregnancy, breast-feeding and fertility”)

If you take more ellaOne than you should There have been no reports of harmful effects from taking a higher dose than recommended of this medicine However do ask your pharmacist, doctor or other healthcare professional for advice. If you have any further questions on the use of this medicine, ask your pharmacist, doctor or other healthcare professional.

4. Possible side effects

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

Some symptoms such as breast tenderness and abdominal (stomach) pain, throwing up (vomiting), feeling sick (nausea) are also possible signs of pregnancy. If you miss your period and experience such symptoms after taking ellaOne, you should do a pregnancy test (see section 2 “Pregnancy, breast- feeding and fertility”).

Common side effects (may affect up to 1 in 10 people)

• nausea, abdominal (stomach) pain or discomfort, vomiting - painful periods, pelvic pain, breast tenderness
• headache, dizziness, mood swings
• muscle pain, back pain, tiredness

Uncommon side effects (may affect up to 1 in 100 people)

• diarrhoea, heartburn, wind, dry mouth
• unusual or irregular vaginal bleeding, heavy/prolonged periods premenstrual syndrome, vaginal irritation or discharge, lesser or greater sex drive
• hot flushes
• appetite changes, emotional disorders, anxiety, agitation, trouble sleeping, sleepiness, migraine visual disturbances
• influenza
• acne, skin lesions, itching
• fever, chills, malaise Rare side effects (may affect up to 1 in 1,000 people)
• genital pain or itching, pain during sex, rupture of an ovarian cyst, unusually light period
• loss of concentration, vertigo, shaking, disorientation, fainting
• unusual sensation in eye, red eye, sensitivity to light
• dry throat, disturbance in taste
• allergic reactions such as rash, hives or swelling of the face
• feeling thirsty

Reporting of side effects

If you get any side effects, talk to your pharmacist, doctor or other healthcare professional. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via: Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

By reporting side effects you can provide more information on the safety of this medicine.

5. How to store ellaOne

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

Do not use this medicine after the expiry date which is on the carton and on the blister after EXP. The expiry date refers to the last day of that month.

Store below 25°C. Store in the original package in order to protect from moisture. Keep the blister in the outer carton in order to protect from light.

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

6. Contents of the pack and other information What ellaOne contains

• The active substance is ulipristal acetate. Each tablet contains 30 milligrams of ulipristal acetate. - The other ingredients are lactose monohydrate, povidone, croscarmellose sodium, magnesium stearate.

What ellaOne looks like and contents of the pack

ellaOne is a white to marble creamy, round curved tablet of 9 mm diameter engraved with “еllа” on both sides.

ellaOne is available in a carton containing one blister of 1 tablet.

Marketing Authorisation Holder

LABORATOIRE HRA PHARMA 200 avenue de Paris
92320 CHATILLON
France
E-mail: info-ella@hra-pharma.com

Manufacturer

17, rue de Pontoise
95520 Osny
France

Laboratorios León Farma S.A.
C/ La Vallina, s/n Pol. Ind. Navatejera
24008 Navatejera, León
Spain

Delpharm Lille S.A.S.
Parc d’activités Roubaix-Est
22, rue de Toufflers
CS 50070
59452 Lys-Lez-Lannoy
France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder

HRA Pharma UK & Ireland Limited Tel: 0800 917 9548

This leaflet was last revised in October 2022

Package leaflet: Information for the user Levonorgestrel 1.5 mg tablet

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Always take this medicine exactly as described in this leaflet or as your pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Levonorgestrel is and what it is used for
2. What you need to know before you take Levonorgestrel
3. How to take Levonorgestrel
4. Possible side effects
5. How to store Levonorgestrel
6. Contents of the pack and other information

1. What Levonorgestrel is and what it is used for

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

Levonorgestrel contains 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 is thought to work by:

• stopping your ovaries from releasing an egg;
• preventing sperm from fertilising any egg you may have already released.

Levonorgestrel 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 you have unprotected sex after taking this medicine, it will not stop you from becoming pregnant.

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

2. What you need to know before you take Levonorgestrel

Do not take Levonorgestrel:

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Levonorgestrel.

If any of the following applies to you, talk to your doctor before taking Levonorgestrel as emergency contraception may not be suitable for you. Your doctor may prescribe another type of emergency contraception for you.

• 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 cannot terminate pregnancy, so Levonorgestrel 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

Children and adolescents

Levonorgestrel is not recommended for young women under 16 years of age without medical supervision.

The use of Levonorgestrel is 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 ever had a disease called salpingitis (inflammation of the fallopian tubes)

A previous ectopic pregnancy or a previous infection of the fallopian tubes increases the risk of a new ectopic pregnancy.

Your doctor may decide that Levonorgestrel is not suitable for you, or that another type of emergency contraception would be better for you.

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

Psychiatric disorders

Some women using hormonal contraceptives including Levonorgestrel have reported depression or depressed mood. Depression can be serious and may sometimes lead to suicidal thoughts. If you experience mood changes and depressive symptoms contact your doctor for further medical advice as soon as possible.

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

Tell your pharmacist or doctor if you are taking or have recently taken any other medicines including medicines obtained without a prescription or herbal medicines.

Some medicines may prevent Levonorgestrel from working effectively. If you have used any of the medicines below during the last 4 weeks, Levonorgestrel 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:

• barbiturates and other medicines used to treat epilepsy (for example, primidone, phenytoin, and carbamazepine)
• medicines used to treat tuberculosis (for example, rifampicin, rifabutin) 2
• medicines used to treat HIV (for example, ritonavir, efavirenz)
• a medicine used to treat fungal infections (griseofulvin)
• herbal remedies containing St John’s wort (Hypericum perforatum)

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

Consult your 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 section 3 “How to take Levonorgestrel for further advice).

Levonorgestrel may also affect how well other medicines work:

• a medicine called ciclosporin (suppresses the immune system).

How often can you use Levonorgestrel

You should only use Levonorgestrel in emergencies and not as a regular method of contraception.

If Levonorgestrel is used more than once in a menstrual cycle, it is more likely to upset your menstrual cycle (period).

Levonorgestrel 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.

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 this 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 will harm a baby that develops in your uterus/womb if you use Levonorgestrel 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 or if you have previously had an ectopic pregnancy, Fallopian tube surgery or pelvic inflammatory disease.

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 tablet immediately after a breast- feeding and avoid nursing at least 8 hours following tablet taking. In this way you are taking the tablet well before the next feed and reducing the amount of active ingredient your baby may take in with the breast milk.

Fertility

Levonorgestrel increases the possibility of menstruation disturbances which can sometimes lead to earlier or later ovulation date. These changes can result in modified fertility date, however there are no fertility data in the long term. After treatment with levonorgestrel a rapid return to fertility is expected and therefore, regular contraception should be continued or initiated as soon as possible after levonorgestrel emergency contraceptive use.

Driving and using machines

Your Levonorgestrel tablet is 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.

Levonorgestrel contains lactose

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

3. How to take Levonorgestrel

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

Use in children and adolescents

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.

This medicine is not recommended for use in children. If you are under 16, you must visit your doctor or family planning clinic to get emergency contraception.

• Levonorgestrel 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. Do not delay taking the tablet. The tablet works best the sooner you take it after having unprotected sex.
• If you are using one of the medicines that may prevent Levonorgestrel from working properly (see section above “Other medicines and Levonorgestrel) or if you have used one of these medicines in the past 4 weeks, Levonorgestrel 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 (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 (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.

What to do if you are sick (vomit)

If you are sick (vomit) within three hours of taking the tablet, you should take another tablet. You will need to contact your pharmacist, doctor, practice nurse or family planning clinic immediately for one more tablet.

After you have taken Levonorgestrel

After you have taken Levonorgestrel, 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 won’t work if you have unprotected sex again, before your next period is due.

After you have taken Levonorgestrel, you are advised to make an appointment to see your doctor about three weeks later, to make sure that Levonorgestrel 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 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

After the use of Levonorgestrel, 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 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)
• Lower abdominal pain
• Tiredness (fatigue)
• Headache
• Irregular bleeding until your next period

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)’ (see section 3)
• 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 (may affect up to 1 in 10,000 people):

• Abdominal pain
• Rash
• Hives (urticaria)
• Itching (pruritus)
• Swelling of the face (facial oedema)
• Pain in the hips (pelvic pain)
• Painful periods

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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 effects you can help provide more information on the safety of this medicine.

5. How to store Levonorgestrel

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

Do not use this medicine after the expiry date which is stated on the carton 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 contains

• The active substance is levonorgestrel. Each tablet contains 1.5 mg of levonorgestrel.
• The other ingredients are povidone K-25, lactose monohydrate (see section 2, “Levonorgestrel contains lactose”), maize starch, colloidal anhydrous silica and magnesium stearate.

What Levonorgestrel looks like and contents of the pack

Your medicine comes as a round, white to off-white, uncoated flat tablet marked ‘145’ on one side and plain on the other side.

Levonorgestrel is available in a blister pack containing 1 tablet.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.

Manufacturers

Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom. Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.
Mylan Hungary Kft., Mylan Utca 1., Komarom 2900, Hungary.
Mylan UK Healthcare Limited, Building 20, Station Close, Potters Bar, EN6 1TL, United Kingdom.

This leaflet was last revised in April 2022.

USEFUL INFORMATION ABOUT CONTRACEPTION MORE ABOUT EMERGENCY CONTRACEPTION

The sooner you take emergency contraception, the better the chance of avoiding pregnancy. Emergency contraception will not affect your fertility.

Emergency contraception can delay ovulation within a given menstrual cycle, but it will not stop you from becoming pregnant if you have unprotected sex again. After you take emergency contraception and until your next period comes, you should use a condom every time you have sex.

MORE ABOUT REGULAR CONTRACEPTION If you have taken emergency contraception and you do not use a regular contraceptive method (or do not have a contraceptive method that suits you), talk to your doctor or family planning clinic for advice.

There are many different types of contraception available, and you should be able to find the right method for you. Examples of regular contraception methods: Daily methods: Contraceptive pill Weekly or monthly methods: Contraceptive patch, Vaginal Ring Long lasting methods: Contraceptive implant, IUD (intrauterine device)