66 mm

Information for the user

27 mm

Emergency Contraceptive 1.5 mg Tablet (Levonorgestrel)

Patient Information Booklet J

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Information for the user

Emergency Contraceptive    I

1.5 mg Tablet (Levonorgestrel)    J

_____________Patient Information-Booklet J

27 mm

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27 mm

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27 mm

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£4250589.

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Read all oT thisleaflet carefully because It contains important information for you.

This medicine is available without prescription for emergency contraception. However, you still need to take it carefully to get the best results from it.

i

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•    Keep this leaflet, you may need" to read" if again

•    Ask your pharmacist if you need more information or advice

e_

a

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WhatlFiTs medicine is for

This medicine contains Levonorgestrel, which is a ' progestogen-based emergency hormonal contraceptive.. It can be used to help prevent a pregnancy when taken' within 72 hours (3 days) of having had unprotected sex | or if your usual method of contraception has failed , [e.g. a split condom)^________________4

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What this medicine is for

This medicine contains Levonorgestrel, which is a Drogestogen-based emergency hormonal contraceptive, t can be used to help prevent a pregnancy when taken within 72 hours (3 days) of having had unprotected sex or if your usual method of contraception has failed [e.g._a_spNt condom)^________________₅

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] It Fs more effective the sooner you take ft affer i unprotected sex or failure of your usual contraception, i This medicine is intended for occasional use only. It | should not be used on a regular basis, or as a i substitute tor long-term contraception.

¹ This medicine will not stop a pregnancy if you are e_ already pregnant.___________________

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] It Fs more effective ffie sooner you take It affer i unprotected sex or failure of your usual contraception, i This medicine is intended for occasional use only. It | should not be used on a regular basis, or as a i substitute for long-term contraception.

¹ This medicine will not stop a pregnancy if you are e_ already pregnant.__________________

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Before you fake this medicine

This medicine can be taken by women aged 16    |

years and over. However, some women should not i take this medicine or should seek the advice of their¹ pharmacist or doctor first.    |

___________________________±

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Before you fake this medicine    i

This medicine can be taken by women aged 16    ]

years and over. However, some women should not i take this medicine or should seek the advice of their¹ pharmacist or doctor first.    |

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A Do not take:    i

i • If you are allergic to any of the ingredients in this | | medicine (see “What is in this medicine”)    i

i • If you have an intolerance to some sugars, unless ¹ your doctor tells you to (this medicine contains ! | lactose)    '

6_____________________________¹

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| XDo not take:

i • If you are allergic to any of the ingredients in this | medicine (see “What is in this medicine”) i • If you have an intolerance to some sugars, unless ¹ your doctor tells you to (this medicine contains | lactose)

6_____________________________

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• If you are pregnant    i

You may already be pregnant if:    ¹

-    you have had unprotected sex or a failure of

contraception more than 72 hours ago and since i your last period    ¹

-    your last period was later, heavier or lighter than normal

_ T your current periqdislate____________^

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• IT you are pregnant    i

You may already be pregnant if:    ¹

-    you have had unprotected sex or a failure of |

contraception more than 72 hours ago and since i your last period    ¹

-    your last period was later, heavier or lighter than normal

_ - your current periqd is late____________^

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11 Talk to your doctor:

i • If you have severe liver problems ¹ • If you have severe digestive problems (e.g. Crohn’s | disease)

i • If you have ever had an ectopic pregnancy (where a ¹ baby develops outside the womb), fallopian tube !io su_rgery_or pelvic Inflammatory disease,______

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f Talk to your pharmacist or doctor:

•    If you are under 16 years of age (your local family planning clinic may also be able to help)

•    If you are breastfeeding

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f

Talk to your pharmacist or doctor:

If you are under 16 years of age (your local family Dlanning clinic may also be able to help) f you are breastfeeding

u

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| Tfyou fake other medicines

i Before you take this tablet, make sure that you tell ¹ your doctor or pharmacist about ANY other | medicines you might be using at the same time, i particularly the following:

• Barbiturates, primidone, phenytoin or carbamazepine ii2 [normally used to treat epilepsy)___________

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Tf you take other medicines

Before you take this tablet, make sure that you tell your doctor or pharmacist about ANY other medicines you might be using at the same time, particularly the following:

• Barbiturates, primidone, phenytoin or carbamazepine 12 [normally used to treat epilepsy)___________

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•    Rifampicin or rifabutin (normally usedlor tuberculosis}

•    Ritonavir (for HIV infection)    ¹

•    Griseofulvin (for fungal infections)

•    Ciclosporin (given after transplant surgery, or for i

psoriasis or rheumatism)    |

•    Herbal remedies containing St John’s Wort

[Hypericum perforatum}______________^

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Rifampicin or rifabutin (normally usedlor Tuberculosis) Ritonavir (for HIV infection)

Griseofulvin (for fungal infections)

Ciclosporin (given after transplant surgery, or for jsoriasis or rheumatism)

Herbal remedies containing St John’s Wort (Hypericumperforatum)______________₁₃i

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TF you are unsure abouflriteracfions with any cither medicines, talk to your doctor or pharmacist.

This includes medicines prescribed by your doctor or medicines you have bought lor yourself including herbal and homeopathic remedies.

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IT you are unsure aboufiriteracfions wiTh any other medicines, talk to your doctor or pharmacist.

This includes medicines prescribed by your doctor or medicines you have bought for yourself including herbal and homeopathic remedies.

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Other important information

In all women, emergency contraception should be | taken as soon as possible after unprotected , Intercourse. There is some evidence that Boots ' Emergency Contraceptive may be less effective withj Increasing body weight or body mass index (BMI), i but these data were limited_a_nd inconclusive,___^

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Other important information    i

In all women, emergency contraception should be | taken as soon as possible after unprotected i intercourse. There is some evidence that Boots ' Emergency Contraceptive may be less effective with ] increasing body weight or body mass index (BMI), i but these data were imjted_and inconclusive.,___1^

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| Therefore, Boots Emergency Contraceptive is sliH i recommended for all women regardless of their i weight or BMI.

| You are advised to speak to a healthcare i professional if you are concerned about any ¹ problems related to taking emergency lie contraception.

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This medicine can sometimes disturb your normal^- i monthly cycle (period). Your next period may start a ¹ few days earlier or later than expected. If your next | period is more than 5 days late, or is unusually light i or heavy, or there is any other reason to suspect you¹ might be pregnant, you should talk to your doctor as| soon as possible and have a pregnancy test.____₁₂i

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This medicine can sometimes disturb your normal i monthly cycle (period). Your next period may start a ¹ few days earlier or later than expected. If your next | period is more than 5 days late, or is unusually light i or heavy, or there is any other reason to suspect you¹ might be pregnant, you should talk to your doctor as| soon as possible and have a pregnancy test.____₁₂i

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TF youTiave any questTons about this medicine, or need any further help and advice, talk to your pharmacist, doctor, nurse or family planning clinic. Driving and using machines: This medicine may make you feel dizzy or tired. Do not drive or use machines until you are sure you are not affected.

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Effectiveness ofltiis medTcTneflftaken correctly i this medicine can prevent about 84% of expected | pregnancies when taken as directed within 72 hours, (3 days) of having had unprotected sex or if usual ¹ methods of contraception have failed. However, this | medicine will not prevent a pregnancy every time, i ___________________________id

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Effectiveness oflfiis medicine: Iftaken correctly i this medicine can prevent about 84% of expected ] pregnancies when taken as directed within 72 hours! (3 days) of having had unprotected sex or if usual ' methods of contraception have failed. However, this | medicine will not prevent a pregnancy every time, i

___________________________ia!

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Tt Fs more effective Fofake the FaBlet as soon as possible (preferably within 12 hours) after unprotected sex or when contraception has failed. Do not wait until the 72 hours are almost up. If you need advice, your pharmacist, doctor, nurse or family planning clinic will be able to help.

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It Fs more effective tolake the FaBlet as soon as possible (preferably within 12 hours) after unprotected sex or when contraception has failed. Do not wait until the 72 hours are almost up. If you need advice, your pharmacist, doctor, nurse or family planning clinic will be able to help.

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How tfie medicine worts: If is unclear exactly howlhese i tablets help prevent pregnancy, but it is thought to work by:¹

•    Stopping you from releasing an egg (ovulating)

•    Preventing sperm from meeting an egg that has been or i

is about to be released (fertilisation)    |

• Stopping a fertilised egg from attaching itself to your    i

_ womb________________________2i

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How tfie medicine works: I! is unclear exactly fiowlhese" tablets help prevent pregnancy, but it is thought to work by:

•    Stopping you from releasing an egg (ovulating)

•    Preventing sperm from meeting an egg that has been or is about to be released (fertilisation)

•    Stopping a fertilised egg from attaching itself to your

womb    21

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Thelablefwiirnot worklf you are already pregnant, on have had unprotected sex or a failure of contraception¹ more than 72 hours ago and since your last period. | You MUST NOT take the tablet but should speak to i your doctor as soon as possible.    ¹

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Thelablet wiirnot worklf you are already pregnant, or have had unprotected sex or a failure of contraception¹ more than 72 hours ago and since your last period. | You MUST NOT take the tablet but should speak to i your doctor as soon as possible.    ¹

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Profection againsf sexually transmitted^-    i

diseases: This medicine will not protect you against' sexually transmitted diseases, only condoms can , help do this. If you are worried about any sexually ¹ transmitted disease, talk to your pharmacist, doctor, | nurse or family planning clinic for advice.    i

___________________________2d

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Profection againsf sexually transmitted    i

diseases: This medicine will not protect you againstj sexually transmitted diseases, only condoms can ! help do this. If you are worried about any sexually ¹ transmitted disease, talk to your pharmacist, doctor, ] nurse or family planning clinic for advice.    i

___________________________2i

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| How often fo takeltiis medicTnefThis medicine i i should only be used for emergencies and not as a ¹ i regular method of contraception, because it is not a^ | reliable as regular methods of contraception and i i offers no protection against sexually transmitted ¹ diseases. It is also not recommended to take this medicjne more dian once in a monthjy cycle as theyj

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| How often To takelffis medIcme:TFiis medicine i i should only be used for emergencies and not as a ¹ i regular method of contraception, because it is not a^ | reliable as regular methods of contraception and i i offers no protection against sexually transmitted | ¹ diseases. It is also not recommended to take this ! ai medjcjne more than once in a mqnth]y_cyc]e_as theyj

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can disturb your period?    i

To discuss long-term methods of contraception, ¹ which may be more effective, talk to your doctor, nurse or family planning clinic.    i

Your pharmacist may also be able to help answer | any questions you have about long-term methods of, contraception.___________________₂d

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can disturb your period.

To discuss long-term methods of contraception, which may be more effective, talk to your doctor, nurse or family planning clinic.

Your pharmacist may also be able to help answer any questions you have about long-term methods of contraception.    ₂,

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Sale sex lor (he resfoflhe monthly cycre: TaRing i this medicine does not provide you with ongoing ¹ contraception for the rest of your monthly cycle. ! Once you have taken the tablet, you should use ¹ condoms or other barrier methods of contraception | until your next period starts.    i

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Safe sex Tor the resf of The monflily cycre: TaRing i this medicine does not provide you with ongoing ' contraception for the rest of your monthly cycle. ! Once you have taken the tablet, you should use ¹ condoms or other barrier methods of contraception ] until your next period starts.    1

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TF youTiave unprofectecTsex or a method of    i

contraception fails again in the same monthly cycle, | you should speak to a pharmacist, doctor, nurse or , family planning clinic for a further supply of    ¹

emergency contraception.    |

___________________________22!

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IT youTiave unprotected"sex or a metliod of    i

contraception fails again in the same monthly cycle, ] you should speak to a pharmacist, doctor, nurse or ! family planning clinic for a further supply of    '

emergency contraception.    |

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Effecfonlfie monfhry cycle: Once youTiave Men this medicine, your next period will normally be around the expected date. However, this medicine can sometimes make your period start earlier or later than normal by a few days.

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Effecf onlhe monfhry cycle: Once you have taken this medicine, your next period will normally be around the expected date. However, this medicine can sometimes make your period start earlier or later than normal by a few days.

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TF your next period is more than 5~ dayslate or Ts    i

unusually light or heavy, you should contact your ¹ doctor as soon as possible to make sure you are not| pregnant.    i

If you have continued to use your regular method of' hormonal contraception (such as the contraceptive , piN) and not had a bleed in your piH-free break_±

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IT your next period is more Than 5 dayslate or Ts i unusually light or heavy, you should contact your ¹ doctor as soon as possible to make sure you are not| iregnant.    i

T you have continued to use your regular method oT | hormonal contraception (such as the contraceptive ! pill) and not had a bleed in ^our pil[-Tree breaks _ _₂^

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you sFToulS contact your doctor as soon as possible to make sure you are not pregnant.

What to do if pregnancy occurs: A pregnancy will not normally be affected by this medicine, however there is a risk that a pregnancy may continue outside of the womb (ectopic pregnancy).

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you should contact your doctor as soon as possible to make sure you are not pregnant.

What to do if pregnancy occurs: A pregnancy will not normally be affected by this medicine, however there is a risk that a pregnancy may continue outside of the womb (ectopic pregnancy).

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Tt rsTmpoftanftfiaf you talklo your doctor it you i become pregnant despite taking this medicine, as | they will need to check it is not ectopic.    ,

This is especially important if you have previously ¹ had an ectopic pregnancy, fallopian tube surgery or | pelvic inflammatory disease.    i

___________________________

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It rslmportanftfiat you talklo your doctor it you i become pregnant despite taking this medicine, as | they will need to check it is not ectopic.    !

This is especially important if you have previously ¹ had an ectopic pregnancy, fallopian tube surgery or | pelvic inflammatory disease.    i

___________________________31¹

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/ How to take this medicine

Check the foil is not broken before use. If it is, do not take the tablet.

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Swallow the table! wfioTe witfi water.

Do not take more than the amount recommended In the table.

If you are sick within 3 hours of taking the tablet, you will need to take another tablet. Talk to our pharmacist, doctor, nurse or family planning

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Swallow the tablet whole with water.

Do not take more than the amount recommended in the table.

If you are sick within 3 hours of taking the tablet, you will need to take another tablet. Talk to our pharmacist, doctor, nurse or family planning

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clinic Immediately for advice ancfto obtain another i tablet.    |

Once you have taken this medicine, it is    ,

recommended that you use barrier methods of    ¹

contraception (such as condoms) until your next    |

period starts.    i

___________________________3d

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clinic Immediately for advice ancTto obtain another i tablet.    ]

Once you have taken this medicine, it is    !

recommended that you use barrier methods of    ¹

contraception (such as condoms) until your next    ]

period starts.    i

___________________________3d

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TF you are already using a regular method of hormonal contraception (such as the contraceptive pill), continue using these as normal at your regular times, as well as using barrier methods of contraception until your next period.

Once you have taken this medicine, talk to a pharmacist ordoctor jf your next period is more

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] IT you are already using a regular meThod of i hormonal contraception (such as the contraceptive i pill), continue using these as normal at your regular ] times, as well as using barrier methods of i contraception until your next period.

¹ Once you have taken this medicine, talk to a ee pharmacist or doctorjf your nextperipd is more _

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5 Says late or you suspect you may be pregnant, i f If you get any lower stomach pain or discomfort, talk to a doctor straight away.    ,

If you take too many tablets: Although there have ¹ been no reports of serious effects of taking too    |

many tablets at once, you may feel sick or    i

____________________________3±

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5 clays (ate or you suspect you may be pregnant, i ? If you get any lower stomach pain or discomfort, talk] to a doctor straight away.    !

If you take too many tablets: Although there have ¹ been no reports of serious effects of taking too    ]

many tablets at once, you may feel sick or    i

____________________________3

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notice vaginarbleeding.

Talk to your pharmacist or doctor for advice. Possible side effects Most people will not have problems, but some may get some.

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notice vaginarbleeding.

Talk to your pharmacist or doctor for advice.

Possible side effects

Most people will not have problems, but some may get some.

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IT you gefany oflhese serious side effects, slop i taking the tablets. See a doctor at once:    ¹

• Difficulty in breathing, swelling of the lace, neck, tongue or throat (severe allergic reactions) i If you get any of the following side effects see ¹ your pharmacist or doctor:    |

Very common (more than 1 in ^0 women)_____^

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IT you gef any oflfTese serious side effects, slop i taking the tablets. See a doctor at once:    ¹

• Difficulty in breathing, swelling of the face, neck, | tongue or throat (severe allergic reactions)    i

If you get any of the following side effects see ¹ your pharmacist or doctor:    I

_ Very commonjmore t_han_1_in 1_0_women_)_____

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| • Feeling sick, lower stomacFi pain i • Headache, tiredness

i • Unexpected bleeding not related to your period I Common (more than 1 in 100 women, but less than , 1 in 10)

¹ • Being sick - if you are sick within 3 hours of taking *o tabletjou will need to take another tablet

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] • Feeling sick, lower stomacFi pain i* Headache, tiredness

i • Unexpected bleeding not related to your period | Common (more than 1 in 100 women, but less than i 1 in 10)

¹ • Being sick - if you are sick within 3 hours of taking 4Q the tablet_Lyou wil] need to take another tablet

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Talklo your pharmacist,    doctor, nurse orlamlly    i

planning clinic immediately for advice and to obtain ¹ another tablet.

•    Diarrhoea, dizziness    i

•    Breast tenderness    '

•    Irregular bleeding or spotting

•    Jempqrary djsturtiance of yournormalmonthly cycles

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Talklo your pharmacist, doctor, nurse or family i planning clinic immediately for advice and to obtain ¹ another tablet.    i

•    Diarrhoea, dizziness    i

•    Breast tenderness    |

•    Irregular bleeding or spotting    I

•    Temporary djstujtance of your normal monthly cycle ₄₁i

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Very rare {less ffian 1 in TD{DUG women)

• Allergic reaction (e.g. skin rash, raised, red, itchy skin)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

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Very rare {less than 1 in TO.ODCT women)

• Allergic reaction (e.g. skin rash, raised, red, itchy skin)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

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You can aTso report side effects directly via tlie    i

Yellow Card Scheme at:    ]

www.mhra.gov.uk/yellowcard. By reporting    side    !

effects you can help provide more information on ' the safety of this medicine.    ]

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| How fo store tHis medicine

i Store in the original package, in order to protect from ' ' light.    i

, Keep this medicine in a safe place out of the sight and¹ i reach of children, preferably in a locked cupboard.

| Use by the date on the end flap of the carton or on i 44 toe foil.________________________¹

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| How to store this medicine

i Store in the original package, in order to protect from ¹ light.

| Keep this medicine in a safe place out of the sight and i reach of children, preferably in a locked cupboard.

| Use by the date on the end flap of the carton or on 44 the foil.________________________

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After this Sate return any unused^-product to your i nearest pharmacy ter safe disposal.    |

What is in this medicine The tablet contains Levonorgestrel 1.5 mg, which is | the active ingredient.    i

___________________________4d

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After this elate return any unuseef product to your i nearest pharmacy for safe disposal.    |

What is in this medicine    i

The tablet contains Levonorgestrel 1.5 mg, which is ] the active ingredient.    i

___________________________4ij

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As well as tfie active Ingredient; the faBlet also contains lactose monohydrate, maize starch, talc (E533b), magnesium stearate (E572), colloidal silica anhydrous, potato starch.

This pack contains one round, white tablet marked GOO on one side.

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Who makes Ihis medicine

Manufactured for and distributed by The Boots Company PLC Nottingham NG2 3AA by Gedeon Richter Pic Gyomroi ut 19-21 H-1103 Budapest i Hungary. Marketing Authorisation held by Medimpex UK Limited London W9 2EP    ,

___________________________42I

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Who maltes this medicine    i

Manufactured for and distributed by The Boots | Company PLC Nottingham NG2 3AA by Gedeon , Richter Pic Gyomroi ut 19-21 H-1103 Budapest ' Hungary. Marketing Authorisation held    !

by Medimpex UK Limited London W9 2EP    i

___________________________4z!

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Leaflet prepared November 20T4^

If you would like any further information about this product, please contact The Boots Company PLC Nottingham NG2 3AA.

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Other formats

To request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800198 5000 (UK only)

Please be ready to give the following information: Product name: Boots Emergency Contraceptive i 1.5 mg Tablet.___________________₄d

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Other formats    i

To request a copy of this leaflet in Braille, large print] or audio please call, free of charge:    ,

0800198 5000 (UK only)

Please be ready to give the following information: ] Product name: Boots Emergency Contraceptive i 1.5 mgJabLet___________________4^

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Reference number:"D5276/002D

This is a service provided by the Royal National

Institute of Blind People.

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84250589