LEVONELLE 1500 MICROGRAM TABLET
Active substance: LEVONORGESTREL
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Levonelle
1500 microgram tablet levonorgestrel
Packaging Material Management pewi page U1 client: 0086 item-no.: 80835000 PZ: 2534A-4E name: LF-BRO-Levonelle 1500 TAB colors: Black / PANTONE 520 C version: 12.03.2012/02 approval:
Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
Anja Bernwald
Digitally signed by Anja Bernwald DN: o=Bayer Group, ou=SignCert, 0.9.2342.19200300.100.1.1=sgrf h, cn=Anja Bernwald Date: 2012.03.13 13:26:36 +01'00'
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Packaging Material Management pewi page U2 client: 0086 item-no.: 80835000 PZ: 2534A-4E name: LF-BRO-Levonelle 1500 TAB colors: Black / PANTONE 520 C version: 12.03.2012/02 approval:
Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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Packaging Material Management pewi page U3 client: 0086 item-no.: 80835000 PZ: 2534A-4E name: LF-BRO-Levonelle 1500 TAB colors: Black / PANTONE 520 C version: 12.03.2012/02 approval:
Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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United Kingdom 80835000
Packaging Material Management pewi page U4 client: 0086 item-no.: 80835000 PZ: 2534A-4E name: LF-BRO-Levonelle 1500 TAB colors: Black / PANTONE 520 C version: 12.03.2012/02 approval:
Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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Package leaflet: Information for the user
Levonelle
1500 microgram tablet Levonorgestrel
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Packaging Material Management pewi page 1 client: 0086 item-no.: 80835000 PZ: 2534A-4E name: LF-BRO-Levonelle 1500 TAB colors: Black / PANTONE 520 C version: 12.03.2012/02 approval:
Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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Read all of this leaflet carefully before you start using this medicine because it contains important information for you. 5 Keep this leaflet. You may need to read it again. 5 If you have any further questions, ask your doctor.
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Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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5 This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. 5 If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
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Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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What is in this leaflet: 1. What Levonelle 1500 microgram tablet (hereinafter Levonelle 1500) is and what it is used for 7
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Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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2. What you need to know before you take Levonelle 1500 3. How to take Levonelle 1500 4. Possible side effects 5. How to store Levonelle 1500 11 34 48 55
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Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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6. Contents of the pack and other information 57
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Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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1. What Levonelle 1500 is and what it is used for
Levonelle 1500 is an emergency contraceptive that can be used within 72 hours (3 days) of unprotected sex or if your usual contraceptive method has failed.
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Levonelle 1500 contains a synthetic hormone like active substance called levonorgestrel. It prevents about 85% of expected pregnancies when you take it within 72 hours of having unprotected sex. It will not prevent a pregnancy every time and is more effective if you take it as soon as possible after
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unprotected sex. It is better to take it within 12 hours rather than delay until the third day. Levonelle 1500 is thought to work by: 5 stopping your ovaries from releasing an egg; 5 preventing sperm from fertilising any egg you may have already released.
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Levonelle 1500 can only prevent you becoming pregnant if you take it within 72 hours of unprotected sex. It does not work if you are already pregnant. If you have unprotected sex after taking Levonelle 1500, it will not stop you from becoming pregnant after this second intercourse.
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Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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2. What you need to know before you take Levonelle 1500
Do not use Levonelle 1500 5 if you are allergic to levonorgestrel or any of the
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other ingredients of this medicine listed in section 6. Warnings and precautions If any of the following applies to you, talk to your doctor before taking Levonelle 1500 as emergency contraception may not be suitable for you. Your
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Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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doctor may prescribe another type of emergency contraception for you. 5 if you are pregnant or think that you may already be pregnant. This medicine will not work if you are already pregnant. If you are already pregnant,
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Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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Levonelle 1500 cannot terminate pregnancy, so Levonelle 1500 is not an abortion pill. You may already be pregnant if: 5 your period is more than 5 days late, or you have experienced unusual bleeding when your next period is due
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Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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5 you have had unprotected sex more than 72 hours ago, and since your last period The use of Levonelle 1500 is not advised if: 5 you have a disease of your small bowel (such as Crohns disease) that inhibits the absorption of the drug.
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Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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5 you have severe liver problems 5 you have a history of ectopic pregnancy (where the baby develops somewhere outside the womb) 5 you have a salpingitis (inflammation of the Fallopian tubes).
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Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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A previous ectopic pregnancy or previous infection of the fallopian tubes increase the risk of a new ectopic pregnancy. If you are worried about sexually transmitted diseases If you did not use a condom (or if it has been torn or
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slid down) during the intercourse, it might be possible that you have caught a sexually transmitted disease or the HIV virus. This medicine will not protect you against sexually transmitted diseases, only condoms can do this. Ask
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your doctor, nurse, family planning clinic or pharmacist for advice if you are worried about this. Other medicines and Levonelle 1500 Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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Some medicines may prevent Levonelle 1500 from working properly, these include: 5 barbiturates and other medicines used to treat epilepsy (for example, primidone, phenytoin, and carbamazepine)
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5 medicines used to treat tuberculosis (for example, rifampicin, rifabutin) 5 a treatment for HIV infection (ritonavir) 5 a medicine used to treat fungal infections (griseofulvin)
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5 herbal remedies containing St Johns wort (Hypericum perforatum) 5 a medicine called ciclosporin (suppresses the immune system) Consult a doctor or pharmacist before using
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Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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Levonelle 1500 if you use any of the above mentioned medicine. How often can you use Levonelle 1500 You should only use Levonelle 1500 in emergencies and not as a regular method of contraception. If Levonelle 1500 is used more than once in a
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menstrual cycle, it is less reliable and it is more likely to upset your menstrual cycle (period). Levonelle 1500 does not work as well as regular methods of contraception. Your doctor, practice nurse or family planning clinic can tell you about
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Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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long-term methods of contraception which are more effective in preventing you from getting pregnant. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your
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doctor or pharmacist for advice before taking any medicine Pregnancy You should not take this medicine if you are already pregnant. If you do become pregnant even after taking this medicine, it is important that you see
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your doctor. There is no evidence that Levonelle 1500 will harm a baby that develops in your uterus/ womb if you use Levonelle 1500 as described. Nevertheless, your doctor may want to check that the pregnancy is not ectopic (where the baby develops somewhere outside the womb). This is
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especially important if you develop severe abdominal pain after taking Levonelle 1500 or if you have previously had an ectopic pregnancy, Fallopian tube surgery or pelvic inflammatory disease. Breast-feeding Very small amounts of the active ingredient of this
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medicine may appear in your breast milk. This is not thought to be harmful to the baby, but if you are worried you can take your tablet immediately after a breast-feeding and avoid nursing at least 8 hours following tablet taking In this way you are taking your tablet well before the next feed and reducing
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Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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the amount of active ingredient your baby may take in with the breast milk. Fertility Levonelle 1500 increases the possibility of menstruation disturbances which can sometimes lead to earlier or later ovulation date. These changes
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can result in modified fertility date, however there are no fertility data in the long term. Driving and using machines Your Levonelle 1500 tablet is unlikely to affect your ability to drive a car or use machines. However, if
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you feel tired or dizzy do not drive or operate machinery. Levonelle 1500 contains lactose In case of milk sugar (lactose) intolerance it should be considered that each Levonelle 1500 tablet also contains 142.5 mg lactose monohydrate. If you have
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been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
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3. How to take Levonelle 1500
Always use this medicine exactly as described in the leaflet or as your pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
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Use in children and adolescents This medicine is not recommended for use in children 5 Take the tablet as soon as possible, preferably within 12 hours, and no later than 72 hours (3 days) after you have had unprotected sex.
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Levonelle 1500 can be taken at any time in your menstrual cycle assuming you are not already pregnant or think you may be pregnant. Do not chew but swallow the tablet whole with water. Do not delay taking the tablet. The tablet works
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better the sooner you take it after having unprotected sex. If you forget to use your regular method of contraception such as the contraceptive pill, you can continue to take this according to the
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recommendation described in the PIL of your contraceptive product. If another unprotected intercourse takes place after the use of Levonelle 1500 (also if this is during the same menstrual cycle), the tablet will not exert its
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contraceptive effect and there is again the risk of pregnancy. What to do if you are sick (vomit) If you are sick (vomit) within three hours of taking the tablet, you should take another tablet. You will need to contact your pharmacist, doctor, practice
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nurse or family planning clinic immediately for one more tablet. After you have taken Levonelle 1500 After you have taken Levonelle 1500, if you want to have sex, and are not using the contraceptive pill, you should use condoms or a cap plus spermicide
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until your next menstrual period. This is because Levonelle 1500 wont work if you have unprotected sex again, before your next period is due. After you have taken Levonelle 1500, you are advised to make an appointment to see your doctor about three weeks later, to make sure that Levonelle
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1500 has worked. If your period is more than 5 days late or is unusually light or unusually heavy, you should contact your doctor as soon as possible. If you do become pregnant even after taking this medicine, it is important that you see your doctor.
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Your doctor can also tell you about longer-term methods of contraception which are more effective in preventing you from getting pregnant. If you continue to use regular hormonal contraception such as the contraceptive pill and you
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do not have a bleed in your pill-free period, see your doctor to make sure you are not pregnant. Your next period after you took Levonelle 1500 After the use of Levonelle 1500, your period is usually normal and will start at the usual day; however sometimes, this will be a few days later or
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Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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earlier. If your period starts more than 5 days later than expected, an abnormal bleeding occurs at that time or if you think that you might be pregnant, you should check whether you are pregnant by a pregnancy test.
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If you take more Levonelle 1500 than you should Although there have been no reports of serious harmful effects from taking too many tablets at once, you may feel sick, actually be sick (vomit), or have vaginal bleeding. You should ask your pharmacist, doctor, practice nurse or family
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planning clinic for advice, especially if you have been sick, as the tablet may not have worked properly. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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Very common (may affect more than 1 in 10 people): 5 Feeling sick (nausea) 5 You might have some irregular bleeding until your next period 5 You might have lower abdominal pain
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Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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5 Tiredness 5 Headache Common (may affect up to 1 in 10 people): 5 Being sick (vomiting). If you are sick, read the section What to do if you are sick (vomit)
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Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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5 Your period might be different. Most women will have a normal period at the expected time, but some may have their period later or earlier than normal. You might also have some irregular bleeding or spotting until your next period. If your period is more than 5 days late or is
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Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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unusually light or unusually heavy, you should contact your doctor as soon as possible. 5 You might have tender breasts, diarrhoea, feel dizzy after taking this medicine.
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Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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Very rare effects (may affect up to 1 in 10000 people): 5 rash, urticaria, pruritus, swelling of the face, pelvic pain, painful period If you get any side effects, talk to your doctor or
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pharmacist. This includes any possible side effects not listed in this leaflet.
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Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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5. How to store Levonelle 1500
Keep out of the reach and sight of children. Do not use Levonelle 1500 after the expiry date which is stated on the package after EXP. The expiry date refers to the last day of the month
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Store in the original packaging in order to protect from light. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
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Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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6. Contents of the pack and other information
What Levonelle 1500 contains The active substance is levonorgestrel. Each tablet contains 1500 micrograms of levonorgestrel.
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Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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The other ingredients are Potato starch, Maize starch, Colloidal silica anhydrous, Magnesium stearate
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Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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Talc Lactose monohydrate. What Levonelle 1500 looks like and contents of the pack Tablet: almost white, flat, rimmed tablet of about
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Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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8 mm diameter with an impressed mark of G00 on one side. Packaging: one tablet in PVC//aluminium blister and cardboard cartons.
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Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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Marketing Authorisation Holder Medimpex UK Limited 127 Shirland Road, London, W9 2EP, UK
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Manufacturer Bayer Pharma AG Mullerstrasse 178., D-13353 Berlin, Germany or Bayer Weimar GmBH und Co.KG Dbereinerstrasse 20, D-99427 Weimar, Germany
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or Gedeon Richter Plc. Gymroi t 19-21., H-1103 Budapest, Hungary
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Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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Levonelle 1500 is distributed in the UK by Bayer plc Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA. UK
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Levonelle is a registered trademark of Bayer Pharma AG. This leaflet was last revised in 02/2012.
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Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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United Kingdom 80835000
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1500 microgram tablet levonorgestrel
Packaging Material Management pewi page U1 client: 0086 item-no.: 80835000 PZ: 2534A-4E name: LF-BRO-Levonelle 1500 TAB colors: Black / PANTONE 520 C version: 12.03.2012/02 approval:
Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
Anja Bernwald
Digitally signed by Anja Bernwald DN: o=Bayer Group, ou=SignCert, 0.9.2342.19200300.100.1.1=sgrf h, cn=Anja Bernwald Date: 2012.03.13 13:26:36 +01'00'
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Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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Packaging Material Management pewi page U3 client: 0086 item-no.: 80835000 PZ: 2534A-4E name: LF-BRO-Levonelle 1500 TAB colors: Black / PANTONE 520 C version: 12.03.2012/02 approval:
Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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United Kingdom 80835000
Packaging Material Management pewi page U4 client: 0086 item-no.: 80835000 PZ: 2534A-4E name: LF-BRO-Levonelle 1500 TAB colors: Black / PANTONE 520 C version: 12.03.2012/02 approval:
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Package leaflet: Information for the user
Levonelle
1500 microgram tablet Levonorgestrel
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Read all of this leaflet carefully before you start using this medicine because it contains important information for you. 5 Keep this leaflet. You may need to read it again. 5 If you have any further questions, ask your doctor.
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5 This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. 5 If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
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Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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What is in this leaflet: 1. What Levonelle 1500 microgram tablet (hereinafter Levonelle 1500) is and what it is used for 7
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2. What you need to know before you take Levonelle 1500 3. How to take Levonelle 1500 4. Possible side effects 5. How to store Levonelle 1500 11 34 48 55
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6. Contents of the pack and other information 57
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Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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1. What Levonelle 1500 is and what it is used for
Levonelle 1500 is an emergency contraceptive that can be used within 72 hours (3 days) of unprotected sex or if your usual contraceptive method has failed.
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Packaging Material Management pewi page 7 client: 0086 item-no.: 80835000 PZ: 2534A-4E name: LF-BRO-Levonelle 1500 TAB colors: Black / PANTONE 520 C version: 12.03.2012/02 approval:
Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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Levonelle 1500 contains a synthetic hormone like active substance called levonorgestrel. It prevents about 85% of expected pregnancies when you take it within 72 hours of having unprotected sex. It will not prevent a pregnancy every time and is more effective if you take it as soon as possible after
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Packaging Material Management pewi page 8 client: 0086 item-no.: 80835000 PZ: 2534A-4E name: LF-BRO-Levonelle 1500 TAB colors: Black / PANTONE 520 C version: 12.03.2012/02 approval:
Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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unprotected sex. It is better to take it within 12 hours rather than delay until the third day. Levonelle 1500 is thought to work by: 5 stopping your ovaries from releasing an egg; 5 preventing sperm from fertilising any egg you may have already released.
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Packaging Material Management pewi page 9 client: 0086 item-no.: 80835000 PZ: 2534A-4E name: LF-BRO-Levonelle 1500 TAB colors: Black / PANTONE 520 C version: 12.03.2012/02 approval:
Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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Levonelle 1500 can only prevent you becoming pregnant if you take it within 72 hours of unprotected sex. It does not work if you are already pregnant. If you have unprotected sex after taking Levonelle 1500, it will not stop you from becoming pregnant after this second intercourse.
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Packaging Material Management pewi page 10 client: 0086 item-no.: 80835000 PZ: 2534A-4E name: LF-BRO-Levonelle 1500 TAB colors: Black / PANTONE 520 C version: 12.03.2012/02 approval:
Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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2. What you need to know before you take Levonelle 1500
Do not use Levonelle 1500 5 if you are allergic to levonorgestrel or any of the
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other ingredients of this medicine listed in section 6. Warnings and precautions If any of the following applies to you, talk to your doctor before taking Levonelle 1500 as emergency contraception may not be suitable for you. Your
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Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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doctor may prescribe another type of emergency contraception for you. 5 if you are pregnant or think that you may already be pregnant. This medicine will not work if you are already pregnant. If you are already pregnant,
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Packaging Material Management pewi page 13 client: 0086 item-no.: 80835000 PZ: 2534A-4E name: LF-BRO-Levonelle 1500 TAB colors: Black / PANTONE 520 C version: 12.03.2012/02 approval:
Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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Levonelle 1500 cannot terminate pregnancy, so Levonelle 1500 is not an abortion pill. You may already be pregnant if: 5 your period is more than 5 days late, or you have experienced unusual bleeding when your next period is due
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Packaging Material Management pewi page 14 client: 0086 item-no.: 80835000 PZ: 2534A-4E name: LF-BRO-Levonelle 1500 TAB colors: Black / PANTONE 520 C version: 12.03.2012/02 approval:
Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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5 you have had unprotected sex more than 72 hours ago, and since your last period The use of Levonelle 1500 is not advised if: 5 you have a disease of your small bowel (such as Crohns disease) that inhibits the absorption of the drug.
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Packaging Material Management pewi page 15 client: 0086 item-no.: 80835000 PZ: 2534A-4E name: LF-BRO-Levonelle 1500 TAB colors: Black / PANTONE 520 C version: 12.03.2012/02 approval:
Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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5 you have severe liver problems 5 you have a history of ectopic pregnancy (where the baby develops somewhere outside the womb) 5 you have a salpingitis (inflammation of the Fallopian tubes).
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Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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A previous ectopic pregnancy or previous infection of the fallopian tubes increase the risk of a new ectopic pregnancy. If you are worried about sexually transmitted diseases If you did not use a condom (or if it has been torn or
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slid down) during the intercourse, it might be possible that you have caught a sexually transmitted disease or the HIV virus. This medicine will not protect you against sexually transmitted diseases, only condoms can do this. Ask
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Bayer Pharma AG code-no.: 97 country: GB BPH replaces: 80357819
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your doctor, nurse, family planning clinic or pharmacist for advice if you are worried about this. Other medicines and Levonelle 1500 Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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Some medicines may prevent Levonelle 1500 from working properly, these include: 5 barbiturates and other medicines used to treat epilepsy (for example, primidone, phenytoin, and carbamazepine)
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5 medicines used to treat tuberculosis (for example, rifampicin, rifabutin) 5 a treatment for HIV infection (ritonavir) 5 a medicine used to treat fungal infections (griseofulvin)
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5 herbal remedies containing St Johns wort (Hypericum perforatum) 5 a medicine called ciclosporin (suppresses the immune system) Consult a doctor or pharmacist before using
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Levonelle 1500 if you use any of the above mentioned medicine. How often can you use Levonelle 1500 You should only use Levonelle 1500 in emergencies and not as a regular method of contraception. If Levonelle 1500 is used more than once in a
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menstrual cycle, it is less reliable and it is more likely to upset your menstrual cycle (period). Levonelle 1500 does not work as well as regular methods of contraception. Your doctor, practice nurse or family planning clinic can tell you about
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long-term methods of contraception which are more effective in preventing you from getting pregnant. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your
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doctor or pharmacist for advice before taking any medicine Pregnancy You should not take this medicine if you are already pregnant. If you do become pregnant even after taking this medicine, it is important that you see
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your doctor. There is no evidence that Levonelle 1500 will harm a baby that develops in your uterus/ womb if you use Levonelle 1500 as described. Nevertheless, your doctor may want to check that the pregnancy is not ectopic (where the baby develops somewhere outside the womb). This is
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especially important if you develop severe abdominal pain after taking Levonelle 1500 or if you have previously had an ectopic pregnancy, Fallopian tube surgery or pelvic inflammatory disease. Breast-feeding Very small amounts of the active ingredient of this
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medicine may appear in your breast milk. This is not thought to be harmful to the baby, but if you are worried you can take your tablet immediately after a breast-feeding and avoid nursing at least 8 hours following tablet taking In this way you are taking your tablet well before the next feed and reducing
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the amount of active ingredient your baby may take in with the breast milk. Fertility Levonelle 1500 increases the possibility of menstruation disturbances which can sometimes lead to earlier or later ovulation date. These changes
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can result in modified fertility date, however there are no fertility data in the long term. Driving and using machines Your Levonelle 1500 tablet is unlikely to affect your ability to drive a car or use machines. However, if
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you feel tired or dizzy do not drive or operate machinery. Levonelle 1500 contains lactose In case of milk sugar (lactose) intolerance it should be considered that each Levonelle 1500 tablet also contains 142.5 mg lactose monohydrate. If you have
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been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
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3. How to take Levonelle 1500
Always use this medicine exactly as described in the leaflet or as your pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
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Use in children and adolescents This medicine is not recommended for use in children 5 Take the tablet as soon as possible, preferably within 12 hours, and no later than 72 hours (3 days) after you have had unprotected sex.
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Levonelle 1500 can be taken at any time in your menstrual cycle assuming you are not already pregnant or think you may be pregnant. Do not chew but swallow the tablet whole with water. Do not delay taking the tablet. The tablet works
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better the sooner you take it after having unprotected sex. If you forget to use your regular method of contraception such as the contraceptive pill, you can continue to take this according to the
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recommendation described in the PIL of your contraceptive product. If another unprotected intercourse takes place after the use of Levonelle 1500 (also if this is during the same menstrual cycle), the tablet will not exert its
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contraceptive effect and there is again the risk of pregnancy. What to do if you are sick (vomit) If you are sick (vomit) within three hours of taking the tablet, you should take another tablet. You will need to contact your pharmacist, doctor, practice
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nurse or family planning clinic immediately for one more tablet. After you have taken Levonelle 1500 After you have taken Levonelle 1500, if you want to have sex, and are not using the contraceptive pill, you should use condoms or a cap plus spermicide
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until your next menstrual period. This is because Levonelle 1500 wont work if you have unprotected sex again, before your next period is due. After you have taken Levonelle 1500, you are advised to make an appointment to see your doctor about three weeks later, to make sure that Levonelle
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1500 has worked. If your period is more than 5 days late or is unusually light or unusually heavy, you should contact your doctor as soon as possible. If you do become pregnant even after taking this medicine, it is important that you see your doctor.
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Your doctor can also tell you about longer-term methods of contraception which are more effective in preventing you from getting pregnant. If you continue to use regular hormonal contraception such as the contraceptive pill and you
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do not have a bleed in your pill-free period, see your doctor to make sure you are not pregnant. Your next period after you took Levonelle 1500 After the use of Levonelle 1500, your period is usually normal and will start at the usual day; however sometimes, this will be a few days later or
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earlier. If your period starts more than 5 days later than expected, an abnormal bleeding occurs at that time or if you think that you might be pregnant, you should check whether you are pregnant by a pregnancy test.
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If you take more Levonelle 1500 than you should Although there have been no reports of serious harmful effects from taking too many tablets at once, you may feel sick, actually be sick (vomit), or have vaginal bleeding. You should ask your pharmacist, doctor, practice nurse or family
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planning clinic for advice, especially if you have been sick, as the tablet may not have worked properly. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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Very common (may affect more than 1 in 10 people): 5 Feeling sick (nausea) 5 You might have some irregular bleeding until your next period 5 You might have lower abdominal pain
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5 Tiredness 5 Headache Common (may affect up to 1 in 10 people): 5 Being sick (vomiting). If you are sick, read the section What to do if you are sick (vomit)
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5 Your period might be different. Most women will have a normal period at the expected time, but some may have their period later or earlier than normal. You might also have some irregular bleeding or spotting until your next period. If your period is more than 5 days late or is
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unusually light or unusually heavy, you should contact your doctor as soon as possible. 5 You might have tender breasts, diarrhoea, feel dizzy after taking this medicine.
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Very rare effects (may affect up to 1 in 10000 people): 5 rash, urticaria, pruritus, swelling of the face, pelvic pain, painful period If you get any side effects, talk to your doctor or
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pharmacist. This includes any possible side effects not listed in this leaflet.
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5. How to store Levonelle 1500
Keep out of the reach and sight of children. Do not use Levonelle 1500 after the expiry date which is stated on the package after EXP. The expiry date refers to the last day of the month
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Store in the original packaging in order to protect from light. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
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6. Contents of the pack and other information
What Levonelle 1500 contains The active substance is levonorgestrel. Each tablet contains 1500 micrograms of levonorgestrel.
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The other ingredients are Potato starch, Maize starch, Colloidal silica anhydrous, Magnesium stearate
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Talc Lactose monohydrate. What Levonelle 1500 looks like and contents of the pack Tablet: almost white, flat, rimmed tablet of about
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8 mm diameter with an impressed mark of G00 on one side. Packaging: one tablet in PVC//aluminium blister and cardboard cartons.
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Marketing Authorisation Holder Medimpex UK Limited 127 Shirland Road, London, W9 2EP, UK
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Manufacturer Bayer Pharma AG Mullerstrasse 178., D-13353 Berlin, Germany or Bayer Weimar GmBH und Co.KG Dbereinerstrasse 20, D-99427 Weimar, Germany
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or Gedeon Richter Plc. Gymroi t 19-21., H-1103 Budapest, Hungary
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Levonelle 1500 is distributed in the UK by Bayer plc Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA. UK
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Levonelle is a registered trademark of Bayer Pharma AG. This leaflet was last revised in 02/2012.
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United Kingdom 80835000
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Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
