1. What this product is and what it is used for Navela is an emergency contraceptive that can be used within 72 hours (3 days) of unprotected sex or if your usual method of contraception has failed. It is about the following cases: • No contraception was used during the sexual intercourse • The contraception measure was used incorrectly, for example as if a condom was penetrated, slipped away or used in a wrong way, if vaginal pessary or diaphragm changed position, burst, was broken or taken out ahead of time, in the case of a failed interruption during coitus interruptus (e.g. sperm ejaculated in vagina or on external genitalia). • Navela contains a synthetic hormone-like substance called levonorgestrel. It prevents about 84% of expected pregnancies when you take it within 72 hours of having unprotected sex. It will not prevent a pregnancy every time and is more effective if you take it as soon as possible after unprotected sex. It is better to take it within 12 hours rather than delay until the third day . Navela is thought to work by: • preventing sperm from fertilising any egg that may have already released; Navela can only prevent you from becoming pregnant if you take it within 72 hours of having unprotected sex. It does not work if you are already pregnant. If another unprotected intercourse takes place after the use of Navela (also if this is during the same menstrual cycle), the tablet will not exert its contraceptive effect and there is again the risk of pregnancy. Navela is not indicated for use before the first menstrual bleeding (menarche). 2. What you need to know before you use this product 1. Do not take Navela -if you are allergic (hypersensitive) to levonorgestrel or any of the 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 Navela as emergency contraception may not be suitable for you. Your doctor may prescribe another type of emergency contraception for you. 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, Navela cannot terminate pregnancy, so Navela is not an “abortion tablet”. You may already be pregnant if: your period is more than 5 days late, or you have experienced unusual bleeding when your next period is due; you have had unprotected sex more than 72 hours ago and since your last period. The use of Navela is not advised if: you have a disease of your small bowel (such as Crohn’s disease) that inhibits the absorption of the drug ; -you have severe liver problems; -you have a history of ectopic pregnancy (where the baby develops somewhere outside the womb) -you have a history of salpingitis (inflammation of the Fallopian tubes). A previous ectopic pregnancy and a previous infection of the fallopian tubes increase the risk of a new ectopic pregnancy. In all women, emergency contraception should be taken as soon as possible after unprotected intercourse. There is some evidence that Navela may be less effective with increasing body weight or body mass index (BMI), but these data were limited and inconclusive. Therefore,Navela 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. Children and adolescents Navela is not indicated for use before the first menstrual bleeding (menarche). If you are worried about sexually transmitted diseases If you did not use a condom (or if it has been torn or slid down) during the intercourse, it might be possible that you have caught a sexually transmitted disease or the HIV virus. This medicine will not protect you against sexually transmitted diseases, only condoms can do this. Ask your doctor, nurse, family planning clinic or pharmacist for advice if you are worried about this. Other medicines and Navela Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. including medicines obtained without a prescription or herbal medicines. Some medicines may prevent Navela from working effectively. If you have used any of the medicines below during the last 4 weeks, Navela may be less suitable for you. Your doctor may prescribe another type of (nonhormonal) emergency contraceptive, i.e. a copper intrauterine device (Cu- IUD). If this is not an option for you or if you are unable to see your doctor promptly, you can take a double dose of Navela Some medicines may prevent Navela from working properly, these include: - Barbiturates and other medicines used to treat epilepsy (for example, primidone, phenytoin and carbamazepine). - Medicines used to treat tuberculosis (for example, rifampicin and rifabutin). - Some medicines used to treat HIV infection (ritonavir, efavirenz) - A medicine used to treat fungal infections (griseofulvin). - Herbal medicines containing St. John's Wort (Hypericum perforatum). Speak to your pharmacist or doctor if you need further advice on the correct dose for you. Consult a doctor as soon as possible after taking the tablets for further advice on a reliable form of regular contraception and to exclude a pregnancy. (See also section 3 “How to take Navela” for further advice). Navela may also affect how well other medicines work - a medicine called cyclosporin (suppresses the immune system). How often can Navela be used You should only use Navela in emergencies, and not as a regular method of contraception. If you use Navela more than once in a menstrual cycle, it is less reliable and it is more likely to upset your menstrual cycle (period). Navela does not work as well as regular methods of contraception. Your doctor, practice nurse or family planning clinic can tell you about long-term methods of contraception which are more effective in preventing you from getting pregnant. Pregnancy and breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.Navela increases the possibility of menstruation disturbances which can sometimes lead to earlier or later ovulation date resulting in modified fertility date. Although there are no fertility data in the long term, after treatment with Navela a rapid return to fertility is expected and therefore, regular contraception should be continued or initiated as soon as possible after Navela use. Pregnancy You should not take this medicine if you are already pregnant. If you do become pregnant even after taking this medicine, it is important that you see your doctor. There is no evidence that Navela will harm a baby that develops in your uterus/womb if you use Navela as described. Nevertheless, your doctor may want to check that the pregnancy is not ectopic (where the baby develops somewhere outside the womb). This is especially important if you develop severe abdominal pain after taking Navela or if you have previously had an ectopic pregnancy, Fallopian tube surgery or pelvic inflammatory disease. Breast-feeding Very small amounts of the active ingredient of this medicine may appear in your breast milk. This is not thought to be harmful to the baby. However, if you are worried you can take the tablet immediately after a breast-feed and avoid nursing following levonorgestrel administration then drain your milk with a breast pump for 8 hours after taking Navela and throw away this milk. In this way you can reduce the amount of active ingredient your baby may take in with the breast milk. Driving and using machines Navela is unlikely to affect your ability to drive a car or use machines. However, if you feel tired or dizzy, do not drive or operate machines. Navela contains lactose In case of milk sugar (lactose) intolerance it should be considered that each Navela tablet contains 43.3 mg of lactose. If your doctor has told you that you have intolerance to certain sugars, contact your doctor before taking this medicine. 3. How to use this product. Always use this medicine exactly as described in the leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. •Take the tablet as soon as possible, preferably within 12 hours and no later than 72 hours (3 days) after having unprotected sex. You can take Navela at any time during your menstrual cycle assuming you are not already pregnant or think you may be pregnant. Do not chew but swallow the tablet whole withwater. Do not delay taking the tablet. The tablet works better the sooner you take it after having unprotected sex. • If you are using one of the medicines that may prevent Navela from working properly(see section above „Other medicines and Navela”) or if you have used one of these medicines in the past 4 weeks, Navela may work less effectively for you. Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, i.e. a copper intrauterine device (Cu-IUD). If this is not an option for you or if you are unable to see your doctor promptly, you can take a double dose of Navela (i.e. 2 tablets taken together at the same time). •If you are already using a regular method of contraception, such as the contraceptive tablet, you can continue to take this at your regular times. If another unprotected intercourse takes place after the use of Navela (also if this is during the same menstrual cycle), the tablet will not exert its contraceptive effect and there is again the risk of pregnancy. Use in children and adolescents This medicine is not recommended for use in children and only intended for use in women who had a first menstrual bleeding. Limited data are available in women under 16 years of age. What to do if you are sick (vomit) If you are sick (vomit) within three hours of taking the tablet, you should immediately take another tablet. After you have taken Navela After you have taken Navela , if you want to have sex, , and are not using the contraceptive tablet, you should use condoms or a cap plus spermicide until your next menstrual period. This is because Navela will not work if you have unprotected sex again, before your next period is due. After taking Navela you are advised to make an appointment to see your doctor about three weeks later to make sure that Navela has worked. If your period is more than 5 days late or is unusually light or heavy, you should contact your doctor as soon as possible. If you do become pregnant even after taking this medicine, it is important that you see your doctor. Your doctor can also tell you about long-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 tablet and you do not have a bleed in your tablet-free period, , see your doctor to make sure you are not pregnant. Your next period after you took Navela After the use of Navela your period is usually normal and will start at the usual day; however sometimes, it will start a few days earlier or later. If your period starts more than 5 days later than expected, an "abnormal" bleeding occurs at that time or if you think you might be pregnant, you should check whether you are pregnant by pregnancy test. If you take more Navela than you should Although there have been no reports of serious harmful effects after taking too many tablets at once, you may feel sick, actually be sick (vomit) or have vaginal bleeding. You should ask your doctor, pharmacist, practice nurse or family planning clinic for advice, especially if you have been sick, as the tablet may not have worked properly. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, Navela can cause side effects, although not everybody gets them. Possible side effects are listed below according to how common they are: Very common side effects (may affect more than 1 in every 10 users): • Feeling sick (Nausea) • You might have some irregular bleeding until your next period • You might have lower abdominal pain • Tiredness • Headache Common side effects (may affect up to 1 in 10 users): • Being sick (vomiting). If you are sick, read the section "What to do if you are sick (vomit). • Your period may 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 may also have irregular bleeding or spotting until your next period. If your period is more than 5 days late or is unusually light or heavy, you should contact your doctor as soon as possible. • You might have tender breasts, diarrhoea or feel dizzy after taking this medicine. Very rare side effects (may affect up to 1 in 10,000 users): •Rash, urticaria, pruritus, swelling of the face, pelvic pain, painful period . To report any side effect(s): If you get any side effects talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. To report any side effect(s): If you get any side effects talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. To report any side effect(s): Saudi Arabia: -The National Pharmacovigilance and Drug Safety Centre (NPC) Fax: +966-11-205-766 Call NPC at +966-11-2038222 Exts: 2317-2356-2353-2354-2334-2340. Toll free phone: 800249000 E-mail: [email protected] Website: www.sfda.gov.sa/np 5. How to store this product Keep this medicine out of the sight and reach of children. Do not use Navela after the expiry date which is stated on the pack and blister. The expiry date refers to the last day of the month. Do not store above 30°C Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 1. What this product is and what it is used for Navela is an emergency contraceptive that can be used within 72 hours (3 days) of unprotected sex or if your usual method of contraception has failed. It is about the following cases: • No contraception was used during the sexual intercourse • The contraception measure was used incorrectly, for example as if a condom was penetrated, slipped away or used in a wrong way, if vaginal pessary or diaphragm changed position, burst, was broken or taken out ahead of time, in the case of a failed interruption during coitus interruptus (e.g. sperm ejaculated in vagina or on external genitalia). • Navela contains a synthetic hormone-like substance called levonorgestrel. It prevents about 84% of expected pregnancies when you take it within 72 hours of having unprotected sex. It will not prevent a pregnancy every time and is more effective if you take it as soon as possible after unprotected sex. It is better to take it within 12 hours rather than delay until the third day . Navela is thought to work by: • preventing sperm from fertilising any egg that may have already released; Navela can only prevent you from becoming pregnant if you take it within 72 hours of having unprotected sex. It does not work if you are already pregnant. If another unprotected intercourse takes place after the use of Navela (also if this is during the same menstrual cycle), the tablet will not exert its contraceptive effect and there is again the risk of pregnancy. Navela is not indicated for use before the first menstrual bleeding (menarche). 2. What you need to know before you use this product 1. Do not take Navela -if you are allergic (hypersensitive) to levonorgestrel or any of the 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 Navela as emergency contraception may not be suitable for you. Your doctor may prescribe another type of emergency contraception for you. 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, Navela cannot terminate pregnancy, so Navela is not an “abortion tablet”. You may already be pregnant if: your period is more than 5 days late, or you have experienced unusual bleeding when your next period is due; you have had unprotected sex more than 72 hours ago and since your last period. The use of Navela is not advised if: you have a disease of your small bowel (such as Crohn’s disease) that inhibits the absorption of the drug ; -you have severe liver problems; -you have a history of ectopic pregnancy (where the baby develops somewhere outside the womb) -you have a history of salpingitis (inflammation of the Fallopian tubes). A previous ectopic pregnancy and a previous infection of the fallopian tubes increase the risk of a new ectopic pregnancy. In all women, emergency contraception should be taken as soon as possible after unprotected intercourse. There is some evidence that Navela may be less effective with increasing body weight or body mass index (BMI), but these data were limited and inconclusive. Therefore,Navela 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. Children and adolescents Navela is not indicated for use before the first menstrual bleeding (menarche). If you are worried about sexually transmitted diseases If you did not use a condom (or if it has been torn or slid down) during the intercourse, it might be possible that you have caught a sexually transmitted disease or the HIV virus. This medicine will not protect you against sexually transmitted diseases, only condoms can do this. Ask your doctor, nurse, family planning clinic or pharmacist for advice if you are worried about this. Other medicines and Navela Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. including medicines obtained without a prescription or herbal medicines. Some medicines may prevent Navela from working effectively. If you have used any of the medicines below during the last 4 weeks, Navela may be less suitable for you. Your doctor may prescribe another type of (nonhormonal) emergency contraceptive, i.e. a copper intrauterine device (Cu- IUD). If this is not an option for you or if you are unable to see your doctor promptly, you can take a double dose of Navela Some medicines may prevent Navela from working properly, these include: - Barbiturates and other medicines used to treat epilepsy (for example, primidone, phenytoin and carbamazepine). - Medicines used to treat tuberculosis (for example, rifampicin and rifabutin). - Some medicines used to treat HIV infection (ritonavir, efavirenz) - A medicine used to treat fungal infections (griseofulvin). - Herbal medicines containing St. John's Wort (Hypericum perforatum). Speak to your pharmacist or doctor if you need further advice on the correct dose for you. Consult a doctor as soon as possible after taking the tablets for further advice on a reliable form of regular contraception and to exclude a pregnancy. (See also section 3 “How to take Navela” for further advice). Navela may also affect how well other medicines work - a medicine called cyclosporin (suppresses the immune system). How often can Navela be used You should only use Navela in emergencies, and not as a regular method of contraception. If you use Navela more than once in a menstrual cycle, it is less reliable and it is more likely to upset your menstrual cycle (period). Navela does not work as well as regular methods of contraception. Your doctor, practice nurse or family planning clinic can tell you about long-term methods of contraception which are more effective in preventing you from getting pregnant. Pregnancy and breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.Navela increases the possibility of menstruation disturbances which can sometimes lead to earlier or later ovulation date resulting in modified fertility date. Although there are no fertility data in the long term, after treatment with Navela a rapid return to fertility is expected and therefore, regular contraception should be continued or initiated as soon as possible after Navela use. Pregnancy You should not take this medicine if you are already pregnant. If you do become pregnant even after taking this medicine, it is important that you see your doctor. There is no evidence that Navela will harm a baby that develops in your uterus/womb if you use Navela as described. Nevertheless, your doctor may want to check that the pregnancy is not ectopic (where the baby develops somewhere outside the womb). This is especially important if you develop severe abdominal pain after taking Navela or if you have previously had an ectopic pregnancy, Fallopian tube surgery or pelvic inflammatory disease. Breast-feeding Very small amounts of the active ingredient of this medicine may appear in your breast milk. This is not thought to be harmful to the baby. However, if you are worried you can take the tablet immediately after a breast-feed and avoid nursing following levonorgestrel administration then drain your milk with a breast pump for 8 hours after taking Navela and throw away this milk. In this way you can reduce the amount of active ingredient your baby may take in with the breast milk. Driving and using machines Navela is unlikely to affect your ability to drive a car or use machines. However, if you feel tired or dizzy, do not drive or operate machines. Navela contains lactose In case of milk sugar (lactose) intolerance it should be considered that each Navela tablet contains 43.3 mg of lactose. If your doctor has told you that you have intolerance to certain sugars, contact your doctor before taking this medicine. 3. How to use this product. Always use this medicine exactly as described in the leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. •Take the tablet as soon as possible, preferably within 12 hours and no later than 72 hours (3 days) after having unprotected sex. You can take Navela at any time during your menstrual cycle assuming you are not already pregnant or think you may be pregnant. Do not chew but swallow the tablet whole withwater. Do not delay taking the tablet. The tablet works better the sooner you take it after having unprotected sex. • If you are using one of the medicines that may prevent Navela from working properly(see section above „Other medicines and Navela”) or if you have used one of these medicines in the past 4 weeks, Navela may work less effectively for you. Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, i.e. a copper intrauterine device (Cu-IUD). If this is not an option for you or if you are unable to see your doctor promptly, you can take a double dose of Navela (i.e. 2 tablets taken together at the same time). •If you are already using a regular method of contraception, such as the contraceptive tablet, you can continue to take this at your regular times. If another unprotected intercourse takes place after the use of Navela (also if this is during the same menstrual cycle), the tablet will not exert its contraceptive effect and there is again the risk of pregnancy. Use in children and adolescents This medicine is not recommended for use in children and only intended for use in women who had a first menstrual bleeding. Limited data are available in women under 16 years of age. What to do if you are sick (vomit) If you are sick (vomit) within three hours of taking the tablet, you should immediately take another tablet. After you have taken Navela After you have taken Navela , if you want to have sex, , and are not using the contraceptive tablet, you should use condoms or a cap plus spermicide until your next menstrual period. This is because Navela will not work if you have unprotected sex again, before your next period is due. After taking Navela you are advised to make an appointment to see your doctor about three weeks later to make sure that Navela has worked. If your period is more than 5 days late or is unusually light or heavy, you should contact your doctor as soon as possible. If you do become pregnant even after taking this medicine, it is important that you see your doctor. Your doctor can also tell you about long-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 tablet and you do not have a bleed in your tablet-free period, , see your doctor to make sure you are not pregnant. Your next period after you took Navela After the use of Navela your period is usually normal and will start at the usual day; however sometimes, it will start a few days earlier or later. If your period starts more than 5 days later than expected, an "abnormal" bleeding occurs at that time or if you think you might be pregnant, you should check whether you are pregnant by pregnancy test. If you take more Navela than you should Although there have been no reports of serious harmful effects after taking too many tablets at once, you may feel sick, actually be sick (vomit) or have vaginal bleeding. You should ask your doctor, pharmacist, practice nurse or family planning clinic for advice, especially if you have been sick, as the tablet may not have worked properly. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, Navela can cause side effects, although not everybody gets them. Possible side effects are listed below according to how common they are: Very common side effects (may affect more than 1 in every 10 users): • Feeling sick (Nausea) • You might have some irregular bleeding until your next period • You might have lower abdominal pain • Tiredness • Headache Common side effects (may affect up to 1 in 10 users): • Being sick (vomiting). If you are sick, read the section "What to do if you are sick (vomit). • Your period may 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 may also have irregular bleeding or spotting until your next period. If your period is more than 5 days late or is unusually light or heavy, you should contact your doctor as soon as possible. • You might have tender breasts, diarrhoea or feel dizzy after taking this medicine. Very rare side effects (may affect up to 1 in 10,000 users): •Rash, urticaria, pruritus, swelling of the face, pelvic pain, painful period . To report any side effect(s): If you get any side effects talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. To report any side effect(s): If you get any side effects talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. To report any side effect(s): Saudi Arabia: -The National Pharmacovigilance and Drug Safety Centre (NPC) Fax: +966-11-205-766 Call NPC at +966-11-2038222 Exts: 2317-2356-2353-2354-2334-2340. Toll free phone: 800249000 E-mail: [email protected] Website: www.sfda.gov.sa/np 5. How to store this product Keep this medicine out of the sight and reach of children. Do not use Navela after the expiry date which is stated on the pack and blister. The expiry date refers to the last day of the month. Do not store above 30°C Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.