COntrella"30

; – Ulipristal acetate

1 Read all of this leaflet carefully before you start using this medicine 1 because it contains important information for you.

• I Keep this leaflet. You may need to read it again.
• I If you have any further questions, ask your pharmacist, doctor or healthcare

I 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.

I

What is in this leaflet:

|1. What Contrella is and what it is used for

j2.

What you need to know before you take Contrella

j3. How to take Contrella

4. Possible side effects

5. How to store Contrella

fe. Contents of the pack and other information

• 1 – Useful information about contraception

1. what contrella is and what it is used for

l’ if you had sex without protection;

• if your or your partner's condom tore, slipped or came off, or if you forgot to 1 use one;

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.! h'ou can take the tablet at any time in the menstrual cycle. 1

'contrella does not work if you are already pregnant

'if your menstrual period is late’, there is a possibility that you may be pregnant. Vvhen your period is late or when you have symptoms of pregnancy (heavy1 breasts, morning sickness) you should consult a doctor or other healthcard professional before taking the tablet. |

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

Contrella 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.

H"his medicine is a contraceptive used to prevent a pregnancy from starting. If* jyou 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 Vvill not protect you against HIV infection or any other sexually transmitted diseased (e.g. chlamydia, genital herpes, genital warts, gonorrhoea, hepatitis B and syphilis)) Ask a healthcare professional for advice if you are worried about this. I

There is more information about contraception at the end of this leaflet. I

2. what you need to know before you take contrella

R3 Do not take Contrella i

p 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 |data were limited and inconclusive. Therefore, Contrella is still recommended foq pll 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. I

bther contraceptives and Contrella

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 condomsi pvery time you have sex until your next period. ।

po 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.

Some medicines may prevent Contrella from working effectively. If you have! lused any of the medicines listed below during the last 4 weeks, Contrella may bel lless 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, 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).

^peak to your doctor or pharmacist before using Contrella when you use (or have1 '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 k/vomb, tubal surgery or long term (chronic) genital infection. I

A If you become pregnant despite taking Contrella, you are encouraged |to ask your doctor to register your pregnancy in an official registry. You cani 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 Contrella 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.

r 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 ‚is important you use condoms until your next period. ‘

Ilf you wish to start or continue with a regular method of contraception afterl 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. ।

Contrella contains lactose ।

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

3. how to take contrella

How to take the Contrella

• You can take the tablet at anytime in your cycle.
• You can take the tablet at any time of the day either before, during or after a

I- If you are using one of the medicines that may prevent Contrella from working । properly (see section 2 "What you need to know before you take Contrella'^. or if you have used one of these medicines in the past 4 weeks, Contrella may work less effectively for you. Speak to your doctor or pharmacist before

'if you vomit after taking Contrella

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

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

'if you take more Contrella than you should

'There have been no reports of harmful effects from taking a higher dose than1 recommended of this medicine. However, do ask your pharmacist or othen ihealthcare 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. I

f>ome 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 Contrella, you Should do a pregnancy test (see section 2 „Pregnancy, breast-feeding and1 fertility“). I

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

• . muscle pain, back pain, tiredness

• unusual or irregular vaginal bleeding, heavy/prolonged periods, premenstrual syndrome, vaginal irritation or discharge, lesser or greater sex drive

• influenza
• acne, skin lesions, itching

'Rare stele 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: 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 contrella

|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

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

.Contrella is a white to marble creamy, round curved tablet of 9 mm diameter, engraved with "e//a"on both sides.

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

LABORATOIRE HRA PHARMA

200 avenue de Paris

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 tontraceptive 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 typesi pf contraception available, and you should be able to find the right method for you.| [Examples of regular contraception methods: ।

'contraceptive pill '

5. how to store contrella

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 Contrella contains

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

What Contrella looks like and contents of the pack

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

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

Marketing Authorisation Holder

LABORATOIRE HRA PHARMA

200 avenue de Paris

92320 CHATILLON

France

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 March 2021

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

Contrella” 30 mg 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 Contrella is and what it is used for

2. What you need to know before you take Contrella

3. How to take Contrella

4. Possible side effects

5. How to store Contrella

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

1. what contrella is and what it is used for

Contrella is an emergency contraceptive

• Contrella 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.

Contrella 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.

Contrella is not to be used for regular contraception

Q 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 Contrella works

Contrella 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 contrella

E3 Do not take Contrella

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

Jk 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, Contrella 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 Contrella

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 Contrella

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 Contrella from working effectively. If you have used any of the medicines listed below during the last 4 weeks, Contrella 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 Contrella 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 Contrella, 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 Contrella 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 breast-feeding 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.

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.

Contrella 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 before taking this medicine.

3. how to take contrella

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 Contrella

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

If you vomit after taking Contrella

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 Contrella

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 comes, you should use condoms every time you have sex.

If your next period is late after taking Contrella

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, breastfeeding and fertility”)

If you take more Contrella 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 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. I

f>ome 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 Contrella, you Should do a pregnancy test (see section 2 „Pregnancy, breast-feeding and1 fertility“). I

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

• . muscle pain, back pain, tiredness

• unusual or irregular vaginal bleeding, heavy/prolonged periods, premenstrual syndrome, vaginal irritation or discharge, lesser or greater sex drive

• influenza
• acne, skin lesions, itching

'Rare stele 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: 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 contrella

|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

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

.Contrella is a white to marble creamy, round curved tablet of 9 mm diameter, engraved with "e//a"on both sides.

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

LABORATOIRE HRA PHARMA

200 avenue de Paris

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 tontraceptive 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 typesi pf contraception available, and you should be able to find the right method for you.| [Examples of regular contraception methods: ।

'contraceptive pill '

5. how to store contrella

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 Contrella contains

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

What Contrella looks like and contents of the pack

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

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

Marketing Authorisation Holder

LABORATOIRE HRA PHARMA

200 avenue de Paris

92320 CHATILLON

France

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 March 2021

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

Contrella” 30 mg 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 Contrella is and what it is used for

• 2. What you need to know before you take Contrella

• 3. How to take Contrella

• 4. Possible side effects

• 5. How to store Contrella

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

1. what contrella is and what it is used for

Contrella is an emergency contraceptive

• Contrella 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.

Contrella 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.

Contrella is not to be used for regular contraception

Q 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 Contrella works

Contrella 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 contrella

E3 Do not take Contrella

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

Jk 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, Contrella 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 Contrella

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 Contrella

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 Contrella from working effectively. If you have used any of the medicines listed below during the last 4 weeks, Contrella 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 Contrella 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 Contrella, 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 Contrella 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 breast-feeding 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.

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.

Contrella 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 before taking this medicine.

3. how to take contrella

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 Contrella

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

If you vomit after taking Contrella

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 Contrella

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 comes, you should use condoms every time you have sex.

If your next period is late after taking Contrella

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, breastfeeding and fertility”)

If you take more Contrella 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 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 Contrella, 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
• hives (itchy rash), feeling thirsty