Ulipristal Acetate 30mg tablet

: -■ Ulipristal acetate

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

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your pharmacist, doctor or healthcare provider.
• If you get any side effects, talk to your pharmacist, doctor or healthcare provider. This includes any possible side effects not listed in this leaflet. See Section 4.

^A/hat is in this leaflet:

4. what ulipristal acetate 30mg tablet is and what it is used for

!2. What you need to know before you take Ulipristal Acetate 30mg tablet

B. How to take Ulipristal Acetate 30mg tablet

4. possible side effects

|5. How to store Ulipristal Acetate 30mg tablet

Contents of the pack and other information

• - Useful information about contraception

1. what ulipristal acetate 30mg tablet is and what it is used for

• Ulipristal Acetate 30mg tablet is an emergency contraceptive i |UIipristaI Acetate 30mg tablet 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;

ifyour or vour partner's condom tore, slipped or came off, or if you forgot to use one;1 I- if you did not take your contraceptive pill as recommended. I

You should take the tablet as soon as possible after sex, and within a maximum of 5 days (120 hours). ।

This is because the sperm can survive up to 5 days in your body after intercourse.! This medicine is suitable for any woman of childbearing age, including adolescents.! You can take the tablet at any time in the menstrual cycle. I

Ulipristal Acetate 30mg tablet does not work if you are already pregnant If your menstrual period is late, there is a possibility that you may be pregnant.1 When your period is late or when you have symptoms of pregnancy (heavy preasts, morning sickness) you should consult a doctor or other healthcarei professional before taking the tablet.

|lf you have unprotected sex after taking the tablet, it will not stop you frorri| becoming pregnant.

Unprotected sex at any time during your cycle can lead to pregnancy.

li pristaI Acetate 30mg tablet is not to be used for regular contraception ! A 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.

i How Ulipristal Acetate 30mg tablet works ।

.Ulipristal Acetate 30mg tablet contains the substance ulipristal acetate which, acts by modifying the activity of the natural hormone progesterone which is hecessary for ovulation to occur. As a result, this medicine works by postponing bvulation. Emergency contraception is not effective in every case. Of 100 womenl yvho 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 i infections i

Qnly condoms can protect you from sexually transmitted infections. This medicinq 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). !Aska healthcare professional for advice if you are worried about this.

h"here is more information about contraception at the end of this leaflet.

2. what you need to know before you take ulipristal

Acetate 30mg tablet________­__________________

E3 Do not take Ulipristal Acetate 30mg tablet i

C if you are allergic to ulipristal acetate or any of the other ingredients of this, Lmedicine (listed in section 6). _____________­_______,

A Warning and precautions ।

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

I- if your period is late or you have symptoms of pregnancy (heavy breasts,! I 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 possible1 bfter unprotected intercourse. There is some evidence that this medicine may1 Ibe less effective with increasing body weight or body mass index (BMI), but thesel pata were limited and inconclusive. Therefore, Ulipristal Acetate 30mg tablet is| ptill 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.

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

Other contraceptives and Ulipristal Acetate 30mg tablet

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

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

Other medicines and Ulipristal Acetate 30mg tablet ।

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

^ome medicines may prevent Ulipristal Acetate 30mg tablet from working Effectively. If you have used any of the medicines listed below during the last 4 Weeks, Ulipristal Acetate 30mg tablet may be less suitable for you. Your doctor! imay 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, I phenytoin, fosphenytoine, carbamazepine, oxcarbazepine and barbiturates) । I- medicines used to treat tuberculosis (for example, rifampicin, rifabutin) I p 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 pharmacist or doctor before using Ulipristal Acetate 30mg tablet1 'when you use (or have recently used) any of the medicines stated above.

'pregnancy, breast-feeding and fertility

Pregnancy

A. 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 lyou are not already pregnant (see section „Warning and precautions“). ।

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

A If you become pregnant despite taking this medicine, there is no evidence that lit 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 the1 Womb, tubal surgery or long term (chronic) genital infection. I

A If you become pregnant despite taking Ulipristal Acetate 30mg tablet, you arel pncouraged to ask your doctor to register your pregnancy in an official registry. Youi can also report this information on your own at.. Your information will remain anonymous – nobody will know it is information 'about you. Sharing your information may help women in the future understand1 the safety or risks of Ulipristal Acetate 30mg tablet during a pregnancy. I

Breast-feeding I

A If you take this medicine while you are breast-feeding a baby, do not breast-1 Ifeed 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 youq breast milk. The effect of breast-feeding your baby in the week after taking this, medicine is not known.

L I

Fertility

A 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 (s important you use condoms until your next period. 1

Ilf you wish to start or continue with a regular method of contraception after! psi ng this medicine, you can do so but you should also use condoms until youq pext.period.

Driving and using madunes

lAfter taking this medicine, some women experience dizziness, drowsiness,1 blu­rred vision and/or loss of concentration (see section 4). If you experience thesel pymptoms, do not drive or use machines ।

lUlipristal Acetate 30mg tablet contains lactose ।

Ilf you have been told by your doctor or other healthcare professional that youl ihave an intolerance to some sugars, tell your pharmacist or doctor before taking |this medicine.

3. how to take ulipristal acetate 30mg tablet

you can take the tablet at any time of the day either before, during or after a meal. i- if you are using one of the medicines that may prevent ulipristal acetate 30mg i tablet from working properly (see section 2 "what you need to know before youl i take ulipristal acetate 30mg tablet") or if you have used one of these medicine^. in the past 4 weeks, ulipristal acetate 30mg tablet may work less effectively for.

you. Speak to your doctor or pharmacist before using Ulipristal Acetate 30mg 1 tablet. Your doctor may prescribe another type of (non-hormonal) emergency I contraceptive, i.e. a Cu-IUD. I

’if you vomit after taking Ulipristal Acetate 30mg tablet

If you vomit (be sick, throw up) within 3 hours of taking the tablet, you should tonsuit your doctor or healthcare provider in order to take another tablet asl poon as possible. ।

i|f you have sex again after taking Ulipristal Acetate 30mg tablet I O 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 comesj you should use condoms every time you have sex. ।

ilf your next period is late after taking Ulipristal Acetate 30mg tablet i ft After taking the tablet, it is normal for your next period to be a few days late.I However, if your period is more than 7 days late; if it is unusually light oq pnusually 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 you1 bee your doctor. (See section „Pregnancy, breast-feeding and fertility“) I

i|f you take more Ulipristal Acetate 30mg tablet than you should h’here have been no reports of harmful effects from taking a higher dose than1 Irecommended of this medicine. However, do ask your pharmacist, doctor or other! ihealthcare professional for advice. ।

|lf 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 everybody1 gets them. I

f>ome symptoms such as breast tenderness and abdominal (stomach) painj ithrowing up (vomiting), feeling sick (nausea) are also possible signs of pregnancy 1 If you miss your period and experience such symptoms after taking Ulipristal Acetate 30mg tablet, you should do a pregnancy test (see section 2 „Pregnancy,1 breast-feeding and fertility“). I

Common side effects (may affect up to 1 in 10 people) nausea, abdominal (stomach) pain or discomfort, vomiting

l’ muscle pain, back pain, tiredness

• |- influenza acne, skin lesions, itching ' fever, chills, malaise

[Rare side effects (may affect up to 1 in 1,000 people)

• , dry throat, disturbance in taste hives (itchy rash), feeling thirsty

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 the Yellow Card Scheme Website :' yvww.mhra.gov­.uk/yellowcard or search for MHRA Yellow Card in the Google Playl pr Apple App Store. ।

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

5. how to store ulipristal acetate 30mg tablet

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

6. contents of the pack and other information

What Ulipristal Acetate 30mg tablet contains '

I- The active substance is ulipristal acetate. Each tablet contains 30 milligrams ofl I ulipristal acetate. I

• .The other ingredients are lactose monohydrate, povidone, croscarmellose, । sodium, magnesium stearate.

iWhat Ulipristal Acetate 30mg tablet looks like and contents of the । pack

Ulipristal Acetate 30mg tablet is a white to marble creamy, round curved tablet of '9 mm diameter engraved with „ella“ on both sides.

'ulipristal Acetate 30mg tablet is available in a carton containing one blister of 11 tablet. I

'Marketing Authorisation Holder lJensonR+ Ltd

IFishleigh Court, Fishleigh Road, Barnstaple, Devon, EX31 3UD, United Kingdom I 'Manufacturer

USEFUL INFORMATION ABOUT CONTRACEPTION

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 everytime 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‘ Ito your doctor or family planning clinic for advice. There are many different typesl pf contraception available, and you should be able to find the right method for you.| [Examples of regular contraception methods: ।

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
• hives (itchy rash), feeling thirsty

Re porting 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 the Yellow Card Scheme Website :

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 ulipristal acetate 30mg tablet

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 Ulipristal Acetate 30mg tablet 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 Ulipristal Acetate 30mg tablet looks like and contents of the pack

Ulipristal Acetate 30mg tablet

Ulipristal acetate

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

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your pharmacist, doctor or healthcare provider.
• If you get any side effects, talk to your pharmacist, doctor or healthcare provider. This includes any possible side effects not listed in this leaflet. See Section 4.

What is in this leaflet:

1. What Ulipristal Acetate 30mg tablet is and what it is used for

2. What you need to know before you take Ulipristal Acetate 30mg tablet

3. How to take Ulipristal Acetate 30mg tablet

4. Possible side effects

5. How to store Ulipristal Acetate 30mg tablet

6. Contents of the pack and other information - Useful information about contraception

1. what ulipristal acetate 30mg tablet is and what it is used for

Uli pristal Acetate 30mg tablet is an emergency contraceptive Ulipristal Acetate 30mg tablet 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 the sperm can survive up to 5 days in your body after intercourse.

This medicine is suitable for any woman of childbearing age, including adolescents.

You can take the tablet at any time in the menstrual cycle.

Ulipristal Acetate 30mg tablet 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.

Uli pristal Acetate 30mg tablet is not to be used for regular contraception

O 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 Ulipristal Acetate 30mg tablet works

Ulipristal Acetate 30mg tablet 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 ulipristal acetate 30mg tablet

H Do not take Ulipristal Acetate 30mg tablet

• 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, Ulipristal Acetate 30mg tablet 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.

A 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 Ulipristal Acetate 30mg tablet

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 Ulipristal Acetate 30mg tablet

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 Ulipristal Acetate 30mg tablet from working effectively. If you have used any of the medicines listed below during the last 4 weeks, Ulipristal Acetate 30mg tablet 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 pharmacist, doctor before using Ulipristal Acetate 30mg tablet when you use (or have recently used) any of the medicines stated above.

Pregnancy, breast-feeding and fertility

Pregnancy

A 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.

A 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.

A If you become pregnant despite taking Ulipristal Acetate 30mg tablet, 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. 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 Ulipristal Acetate 30mg tablet during a pregnancy.

Breast-feeding

A 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 breastfeeding your baby in the week after taking this medicine is not known.

Fertility

A 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.

2

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

Ulipristal Acetate 30mg tablet contains lactose

If you have been told by your doctor or other healthcare professional that you have an intolerance to some sugars, tell your pharmacist or doctor before taking this medicine.

3. how to take ulipristal acetate 30mg tablet

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 Ulipristal Acetate 30mg 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 Ulipristal Acetate 30mg tablet from working properly (see section 2 “What you need to know before you take Ulipristal Acetate 30mg tablet”) or if you have used one of these medicines in the past 4 weeks, Ulipristal Acetate 30mg tablet may work less effectively for you. Speak to your doctor or pharmacist before using Ulipristal Acetate 30mg tablet. Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, i.e. a Cu-IUD.

If you vomit after taking Ulipristal Acetate 30mg tablet

If you vomit (be sick, throw up) within 3 hours of taking the tablet, you should consult your doctor or healthcare provider in order to take another tablet as soon as possible.

If you have sex again after taking Ulipristal Acetate 30mg tablet

Q 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 Ulipristal Acetate 30mg tablet

O 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 Ulipristal Acetate 30mg tablet 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

|5. How to store Ulipristal Acetate 30mg tablet

Contents of the pack and other information

• - Useful information about contraception

1. what ulipristal acetate 30mg tablet is and what it is used for

• Ulipristal Acetate 30mg tablet is an emergency contraceptive i |UIipristaI Acetate 30mg tablet 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;

ifyour or vour partner's condom tore, slipped or came off, or if you forgot to use one;1 I- if you did not take your contraceptive pill as recommended. I

You should take the tablet as soon as possible after sex, and within a maximum of 5 days (120 hours). ।

This is because the sperm can survive up to 5 days in your body after intercourse.! This medicine is suitable for any woman of childbearing age, including adolescents.! You can take the tablet at any time in the menstrual cycle. I

Ulipristal Acetate 30mg tablet does not work if you are already pregnant If your menstrual period is late, there is a possibility that you may be pregnant.1 When your period is late or when you have symptoms of pregnancy (heavy preasts, morning sickness) you should consult a doctor or other healthcarei professional before taking the tablet.

|lf you have unprotected sex after taking the tablet, it will not stop you frorri| becoming pregnant.

Unprotected sex at any time during your cycle can lead to pregnancy.

li pristaI Acetate 30mg tablet is not to be used for regular contraception ! A 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.

i How Ulipristal Acetate 30mg tablet works ।

.Ulipristal Acetate 30mg tablet contains the substance ulipristal acetate which, acts by modifying the activity of the natural hormone progesterone which is hecessary for ovulation to occur. As a result, this medicine works by postponing bvulation. Emergency contraception is not effective in every case. Of 100 womenl yvho 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 i infections i

Qnly condoms can protect you from sexually transmitted infections. This medicinq 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). !Aska healthcare professional for advice if you are worried about this.

h"here is more information about contraception at the end of this leaflet.

2. what you need to know before you take ulipristal

Acetate 30mg tablet________­__________________

E3 Do not take Ulipristal Acetate 30mg tablet i

C if you are allergic to ulipristal acetate or any of the other ingredients of this, Lmedicine (listed in section 6). _____________­_______,

A Warning and precautions ।

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

I- if your period is late or you have symptoms of pregnancy (heavy breasts,! I 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 possible1 bfter unprotected intercourse. There is some evidence that this medicine may1 Ibe less effective with increasing body weight or body mass index (BMI), but thesel pata were limited and inconclusive. Therefore, Ulipristal Acetate 30mg tablet is| ptill 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.

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

Other contraceptives and Ulipristal Acetate 30mg tablet

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

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

Other medicines and Ulipristal Acetate 30mg tablet ।

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

^ome medicines may prevent Ulipristal Acetate 30mg tablet from working Effectively. If you have used any of the medicines listed below during the last 4 Weeks, Ulipristal Acetate 30mg tablet may be less suitable for you. Your doctor! imay 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, I phenytoin, fosphenytoine, carbamazepine, oxcarbazepine and barbiturates) । I- medicines used to treat tuberculosis (for example, rifampicin, rifabutin) I p 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 pharmacist or doctor before using Ulipristal Acetate 30mg tablet1 'when you use (or have recently used) any of the medicines stated above.

'pregnancy, breast-feeding and fertility

Pregnancy

A. 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 lyou are not already pregnant (see section „Warning and precautions“). ।

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

A If you become pregnant despite taking this medicine, there is no evidence that lit 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 the1 Womb, tubal surgery or long term (chronic) genital infection. I

A If you become pregnant despite taking Ulipristal Acetate 30mg tablet, you arel pncouraged to ask your doctor to register your pregnancy in an official registry. Youi can also report this information on your own at.. Your information will remain anonymous – nobody will know it is information 'about you. Sharing your information may help women in the future understand1 the safety or risks of Ulipristal Acetate 30mg tablet during a pregnancy. I

Breast-feeding I

A If you take this medicine while you are breast-feeding a baby, do not breast-1 Ifeed 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 youq breast milk. The effect of breast-feeding your baby in the week after taking this, medicine is not known.

L I

Fertility

A 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 (s important you use condoms until your next period. 1

Ilf you wish to start or continue with a regular method of contraception after! psi ng this medicine, you can do so but you should also use condoms until youq pext.period.

Driving and using madunes

lAfter taking this medicine, some women experience dizziness, drowsiness,1 blu­rred vision and/or loss of concentration (see section 4). If you experience thesel pymptoms, do not drive or use machines ।

lUlipristal Acetate 30mg tablet contains lactose ।

Ilf you have been told by your doctor or other healthcare professional that youl ihave an intolerance to some sugars, tell your pharmacist or doctor before taking |this medicine.

3. how to take ulipristal acetate 30mg tablet

• . 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. i- if you are using one of the medicines that may prevent ulipristal acetate 30mg i tablet from working properly (see section 2 „what you need to know before youl i take ulipristal acetate 30mg tablet“) or if you have used one of these medicine^. in the past 4 weeks, ulipristal acetate 30mg tablet may work less effectively for.

you. Speak to your doctor or pharmacist before using Ulipristal Acetate 30mg 1 tablet. Your doctor may prescribe another type of (non-hormonal) emergency I contraceptive, i.e. a Cu-IUD. I

’if you vomit after taking Ulipristal Acetate 30mg tablet

If you vomit (be sick, throw up) within 3 hours of taking the tablet, you should tonsuit your doctor or healthcare provider in order to take another tablet asl poon as possible. ।

i|f you have sex again after taking Ulipristal Acetate 30mg tablet I O 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 comesj you should use condoms every time you have sex. ।

ilf your next period is late after taking Ulipristal Acetate 30mg tablet i ft After taking the tablet, it is normal for your next period to be a few days late.I However, if your period is more than 7 days late; if it is unusually light oq pnusually 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 you1 bee your doctor. (See section „Pregnancy, breast-feeding and fertility“) I

i|f you take more Ulipristal Acetate 30mg tablet than you should h’here have been no reports of harmful effects from taking a higher dose than1 Irecommended of this medicine. However, do ask your pharmacist, doctor or other! ihealthcare professional for advice. ।

|lf 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 everybody1 gets them. I

f>ome symptoms such as breast tenderness and abdominal (stomach) painj ithrowing up (vomiting), feeling sick (nausea) are also possible signs of pregnancy 1 If you miss your period and experience such symptoms after taking Ulipristal Acetate 30mg tablet, you should do a pregnancy test (see section 2 „Pregnancy,1 breast-feeding and fertility“). I

Common side effects (may affect up to 1 in 10 people) nausea, abdominal (stomach) pain or discomfort, vomiting

l’ muscle pain, back pain, tiredness

• |- influenza acne, skin lesions, itching ' fever, chills, malaise

[Rare side effects (may affect up to 1 in 1,000 people)

• , dry throat, disturbance in taste hives (itchy rash), feeling thirsty

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 the Yellow Card Scheme Website :' yvww.mhra.gov­.uk/yellowcard or search for MHRA Yellow Card in the Google Playl pr Apple App Store. ।

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

5. how to store ulipristal acetate 30mg tablet

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

6. contents of the pack and other information

What Ulipristal Acetate 30mg tablet contains '

I- The active substance is ulipristal acetate. Each tablet contains 30 milligrams ofl I ulipristal acetate. I

• .The other ingredients are lactose monohydrate, povidone, croscarmellose, । sodium, magnesium stearate.

iWhat Ulipristal Acetate 30mg tablet looks like and contents of the । pack

Ulipristal Acetate 30mg tablet is a white to marble creamy, round curved tablet of '9 mm diameter engraved with „ella“ on both sides.

'ulipristal Acetate 30mg tablet is available in a carton containing one blister of 11 tablet. I

'Marketing Authorisation Holder lJensonR+ Ltd

IFishleigh Court, Fishleigh Road, Barnstaple, Devon, EX31 3UD, United Kingdom I 'Manufacturer

USEFUL INFORMATION ABOUT CONTRACEPTION

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 everytime 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‘ Ito your doctor or family planning clinic for advice. There are many different typesl pf contraception available, and you should be able to find the right method for you.| [Examples of regular contraception methods: ।

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
• hives (itchy rash), feeling thirsty

Re porting 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 the Yellow Card Scheme Website :

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 ulipristal acetate 30mg tablet

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 Ulipristal Acetate 30mg tablet 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 Ulipristal Acetate 30mg tablet looks like and contents of the pack

Ulipristal Acetate 30mg tablet is a white to marble creamy, round curved tablet of 9 mm diameter engraved with „ella“ on both sides.

Ulipristal Acetate 30mg tablet is available in a carton containing one blister of 1 tablet.

Marketing Authorisation Holder

JensonR+ Ltd

Fishleigh Court, Fishleigh Road,

Barnstaple,

Devon, Ex31 3UD, United Kingdom

Manufacturer

Delpharm Lille S.A.S.

Parc d’activites Roubaix-Est

• 22, rue de Toufflers

CS 50070

59452 Lys-Lez-Lannoy

France

This leaflet was last revised in December 2020

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)

Package leaflet: Information for the user

Ulipristal Acetate 30mg tablet

Ulipristal acetate

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

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your pharmacist, doctor or healthcare provider.
• If you get any side effects, talk to your pharmacist, doctor or healthcare provider. This includes any possible side effects not listed in this leaflet. See Section 4.

What is in this leaflet:

• 1. What Ulipristal Acetate 30mg tablet is and what it is used for

• 2. What you need to know before you take Ulipristal Acetate 30mg tablet

• 3. How to take Ulipristal Acetate 30mg tablet

• 4. Possible side effects

• 5. How to store Ulipristal Acetate 30mg tablet

• 6. Contents of the pack and other information – Useful information about contraception

1. what ulipristal acetate 30mg tablet is and what it is used for

Uli pristal Acetate 30mg tablet is an emergency contraceptive Ulipristal Acetate 30mg tablet 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 the sperm can survive up to 5 days in your body after intercourse.

This medicine is suitable for any woman of childbearing age, including adolescents.

You can take the tablet at any time in the menstrual cycle.

Ulipristal Acetate 30mg tablet 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.

Uli pristal Acetate 30mg tablet is not to be used for regular contraception

O 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 Ulipristal Acetate 30mg tablet works

Ulipristal Acetate 30mg tablet 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 ulipristal acetate 30mg tablet

H Do not take Ulipristal Acetate 30mg tablet

• 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, Ulipristal Acetate 30mg tablet 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.

A 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 Ulipristal Acetate 30mg tablet

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 Ulipristal Acetate 30mg tablet

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 Ulipristal Acetate 30mg tablet from working effectively. If you have used any of the medicines listed below during the last 4 weeks, Ulipristal Acetate 30mg tablet 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 pharmacist, doctor before using Ulipristal Acetate 30mg tablet when you use (or have recently used) any of the medicines stated above.

Pregnancy, breast-feeding and fertility

Pregnancy

A 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.

A 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.

A If you become pregnant despite taking Ulipristal Acetate 30mg tablet, 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. 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 Ulipristal Acetate 30mg tablet during a pregnancy.

Breast-feeding

A 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 breastfeeding your baby in the week after taking this medicine is not known.

Fertility

A 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.

2

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

Ulipristal Acetate 30mg tablet contains lactose

If you have been told by your doctor or other healthcare professional that you have an intolerance to some sugars, tell your pharmacist or doctor before taking this medicine.

3. how to take ulipristal acetate 30mg tablet

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 Ulipristal Acetate 30mg 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 Ulipristal Acetate 30mg tablet from working properly (see section 2 “What you need to know before you take Ulipristal Acetate 30mg tablet”) or if you have used one of these medicines in the past 4 weeks, Ulipristal Acetate 30mg tablet may work less effectively for you. Speak to your doctor or pharmacist before using Ulipristal Acetate 30mg tablet. Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, i.e. a Cu-IUD.

If you vomit after taking Ulipristal Acetate 30mg tablet

If you vomit (be sick, throw up) within 3 hours of taking the tablet, you should consult your doctor or healthcare provider in order to take another tablet as soon as possible.

If you have sex again after taking Ulipristal Acetate 30mg tablet

Q 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 Ulipristal Acetate 30mg tablet

O 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 Ulipristal Acetate 30mg tablet 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 Ulipristal Acetate 30mg tablet, 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