NEBREMEL 1.5mg x 1 tabl
NEBREMEL 1.5 mg tablet
levonorgestrel/levonorgestrel
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- If you need further information or advice, ask your pharmacist.
- If you get any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What this leaflet contains
1. What NEBREMEL is and what it is used for
2. What you need to know before you take NEBREMEL
3. How to take NEBREMEL
4. Possible side effects
5. How to store NEBREMEL
6. Contents of the pack and other information
1. What NEBREMEL is and what it is used for
NEBREMEL is an emergency contraceptive that can be used up to 72 hours (3 days) after unprotected intercourse or if your usual method of contraception fails.
It applies in the following cases:
- contraception was not used during sexual intercourse,
- contraceptive measures have been used incorrectly, for example, if a condom is missed, slips off or used incorrectly, if the position is changed, a vaginal pessary or diaphragm ruptures or breaks, or if a vaginal pessary or diaphragm is removed prematurely, or if a so-called interrupted sexual intercourse fails (e.g. if semen is ejaculated into the vagina or on the external genitalia).
NEBREMEL contains a synthetic hormone-like substance called levonorgestrel. It prevents a suspected pregnancy in about 84% of cases when taken within 72 hours of unprotected sex. It will not prevent pregnancy every time and is more effective if taken as soon as possible after unprotected sex. It is better to take it within 12 hours than to delay taking it until the third day.
NEBREMEL is thought to act as:
- stops the release of an egg from the ovaries;
- prevents the fertilization of the already released egg by the sperm.
NEBREMEL can only prevent pregnancy if you take it within 72 hours of unprotected sex. It does not work if you are already pregnant. If you have another unprotected sexual intercourse after taking NEBREMEL (even if this happens during the same menstrual cycle), the tablet will not have its contraceptive effect and there is a risk of pregnancy again.
NEBREMEL is not indicated for use before the first menstrual bleeding (menarche).
2. What you need to know before you take NEBREMEL
Do not take NEBREMEL
- if you are allergic to levonorgestrel or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
If any of the above applies to you, talk to your doctor before taking NEBREMEL, as emergency contraception may not be suitable for you. Your doctor may prescribe another type of emergency contraception.
- If you are pregnant or think you may be pregnant. This medicine will not work if you are already pregnant. If you are already pregnant, NEBREMEL cannot terminate the pregnancy, so NEBREMEL is not an “abortion pill”.
You may already be pregnant if:
- Your period is more than 5 days late or you have unusual bleeding when it is time for your next period;
- you had unprotected sex more than 72 hours ago and after your last menstrual period.
The use of NEBREMEL is not recommended if:
- you have a disease of the small intestine (such as Crohn's disease) that inhibits the absorption of the medicine;
- you have severe liver problems;
- you have had an ectopic pregnancy in the past (when the baby develops outside the uterus);
- you have had salpingitis (inflammation of the fallopian tubes) in the past.
A previous ectopic pregnancy and a previous fallopian tube infection increase the risk of a new ectopic pregnancy.
In all cases, emergency contraception should be taken as soon as possible after unprotected intercourse. There is some evidence that NEBREMEL may be less effective with increasing body weight or body mass index (BMI), but these data are limited and inconclusive. Therefore, NEBREMEL is considered suitable regardless of the woman's weight or BMI.
We advise you to speak to a healthcare professional if you are concerned about any problems associated with using emergency contraception.
Children and adolescents
NEBREMEL is not indicated for use before the first menstrual period (menarche). Data are limited in girls under 16 years of age.
If you are worried about sexually transmitted diseases
If you did not use a condom (or if it broke or slipped off) during sexual intercourse, you could get a sexually transmitted disease or become infected with HIV.
This medicine will not protect you from sexually transmitted diseases, only condoms can do that. Talk to your doctor, nurse, family planning clinic or pharmacist if you are worried about this.
Other medicines and NEBREMEL
You should tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines may prevent NEBREMEL from working effectively. If you have used any of the medicines listed below in the last 4 weeks, NEBREMEL may not be suitable for you. Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, i.e. a copper intrauterine device. If this is not an option for you or if you cannot see your doctor immediately, you can take a double dose of NEBREMEL:
- barbiturates and other medicines used to treat epilepsy (e.g. primidone, phenytoin and carbamazepine);
- medicines used to treat tuberculosis (e.g. rifampicin and rifabutin);
- medicines to treat HIV (ritonavir, efavirenz);
- a medicine used to treat fungal infections (griseofulvin);
- herbal medicines containing St. John's wort (Hypericum perforatum).
Talk to your pharmacist or doctor if you need further advice on the right dose for you.
Consult your doctor as soon as possible after taking the tablet to get further advice on a reliable form of regular contraception and to rule out pregnancy (see also section 3 “How to take NEBREMEL” for further advice).
NEBREMEL may also affect the way other medicines work.
- a medicine called ciclosporin (suppresses the immune system).
How often can NEBREMEL be taken?
You should only use NEBREMEL in emergencies and not as a regular method of contraception. If you use NEBREMEL more than once in a menstrual cycle, it will not be as reliable and is more likely to disrupt your menstrual cycle (period). NEBREMEL does not work as well as regular methods of contraception. Your doctor, nurse or family planning clinic can tell you which long-term methods of contraception are more effective at preventing pregnancy.
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
You should not take this medicine if you are already pregnant. If you become pregnant despite taking this medicine, it is important to consult your doctor. There is no evidence that NEBREMEL can harm a baby developing in your womb/womb if you use NEBREMEL as described.
However, your doctor may want to check that the pregnancy is not ectopic (when the baby develops outside the uterus). This is especially important if you get severe abdominal pain after taking Nebremel or if you have had an ectopic pregnancy, tubal surgery or pelvic inflammatory disease in the past.
Breastfeeding
The active ingredient of this medicine is excreted in breast milk. It is therefore recommended that you take the tablet immediately after breastfeeding and avoid breastfeeding for at least 8 hours after taking levonorgestrel, so express and discard the breast milk with a breast pump for 8 hours after taking the tablet. This way you take the tablet well before the next feeding and reduce the amount of active ingredient that your baby can take in with the breast milk.
Fertility
NEBREMEL increases the possibility of menstrual irregularities, which can sometimes lead to an earlier or later ovulation date and, as a result, to a change in the day when you are most likely to become pregnant. Although there are no data on fertility over a long period of time, a rapid return to fertility is expected after treatment with NEBREMEL.
Driving and using machines
NEBREMEL is unlikely to affect your ability to drive or use machines. However, if you feel tired or dizzy, do not drive or use machines.
NEBREMEL contains lactose
In case of intolerance to milk sugar (lactose), it should be noted that NEBREMEL 1.5 mg tablet contains 43.3 mg of lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. essentially 'sodium-free'.
3. How to take NEBREMEL
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. Do not delay taking the tablet. The tablet works best when taken as soon as possible after unprotected sex. The tablet can only protect you from pregnancy if taken within 72 hours of unprotected sex.
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
- NEBREMEL can be taken at any time during your menstrual cycle, provided you are not already pregnant or do not think you may be pregnant. Do not chew the tablet, but swallow it whole with water.
- If you are using any of the medicines that may prevent NEBREMEL from working properly (see section “Other medicines and NEBREMEL” above), or if you have used one of these medicines in the last 4 weeks, NEBREMEL may work less effectively for you. Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, i.e. a copper intrauterine device. If this is not an option for you or if you cannot see your doctor immediately, you can take a double dose of NEBREMEL (i.e. 2 tablets at once).
- If you are already using a regular contraceptive method such as the contraceptive pill, you can continue taking it at your usual time.
If you have another unprotected sexual intercourse after using NEBREMEL (even if this happens during the same menstrual cycle), the tablet will not have its contraceptive effect and there is a risk of pregnancy again.
What to do if you are vomiting
If you vomit within three hours of taking the tablet, you should take another tablet immediately.
After taking NEBREMEL
If you want to have sex after taking NEBREMEL and are not using a contraceptive pill, you should use condoms or a cervical cap plus spermicide until your next period. This is because NEBREMEL will not work if you have had unprotected sex again before your next period.
It is recommended that you consult your doctor about three weeks after taking NEBREMEL to make sure that NEBREMEL 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 become pregnant despite taking this medicine, it is important to consult your doctor.
Your doctor can also inform you about long-term contraception methods that are more effective at preventing pregnancy.
If you continue to use regular hormonal contraception, such as the contraceptive pill, and do not experience bleeding during your tablet-free period, consult your doctor to make sure you are not pregnant.
Your next period after taking NEBREMEL
After using NEBREMEL your period is usually normal and will start on the usual day. However, sometimes it starts a few days earlier or later. If your period is more than 5 days late than expected, you experience unusual bleeding at this time or if you think you may be pregnant, you should check that you are not pregnant with a pregnancy test.
If you take more NEBREMEL than you should
Although there are no reports of serious harmful effects after taking too many tablets at once, you may experience nausea, vomiting or vaginal bleeding. You should consult your doctor, pharmacist, nurse or family planning clinic, especially if you have had nausea, 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, this medicine can cause side effects, although not everybody gets them.
Very common side effects (may affect more than 1 in 10 users)
- Feeling sick (nausea)
- You may have some irregular bleeding until your next period.
- You may have pain in your lower abdomen
- Fatigue
- Headache
Common side effects (may affect up to 1 in 10 people)
- Vomiting. If you vomit, read the section “What to do if you vomit”.
- Your period may be different. Most women will have a normal period at the expected time, but for some it may come later or earlier than usual. 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 may have chest pain, diarrhea, or feel dizzy after taking this medicine.
Very rare side effects (may affect up to 1 in 10,000 users)
- Rash, hives, itching, facial swelling, pelvic pain, painful menstruation
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Reporting side effects
If you get any side effects, please tell your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via:
Executive Agency for Medicines
8 Damyan Gruev Street
1303 Sofia
tel.: +359 2 8903417
website: www.bda.bg
By reporting side effects, you can help provide more information about the safety of this medicine.
5. How to store NEBREMEL
Keep out of the reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help to protect the environment.
6. Contents of the pack and other information
What NEBREMEL contains
The active substance is levonorgestrel. Each tablet contains 1.5 mg of levonorgestrel.
The other ingredients are microcrystalline cellulose, lactose monohydrate, poloxamer 188, croscarmellose sodium and magnesium stearate.
What NEBREMEL looks like and contents of the pack
Each pack contains one round, biconvex, white tablet with a diameter of approximately 6 mm and engraved with “C” on one side and “1” on the other, for one complete treatment.
NEBREMEL 1.5 mg tablet is packaged in a PVC/PVDC/aluminium blister containing one tablet.
Each carton contains one blister with one tablet.
Marketing Authorisation Holder
ALKALOID-INT doo,
Slandrova Street 4,
1231 Ljubljana-Črnuče,
Slovenia
tel.: 386 1 300 42 90
fax: 386 1 300 42 91
email: info@alkaloid.si
Manufacturer
Laboratorios Leon Farma SA
C/La Vallina, s/n
Polígono Industrial Navatejera
Leon, 24008
Spain
This medicinal product is authorised in the Member States of the EEA under the following names:
Bulgaria NEBREMEL 1.5 mg tablet/ NEBREMEL 1.5 mg tablet
Croatia NEBREMEL 1.5 mg tablet
Slovenia NEBREMEL 1.5 mg tablet
Date the leaflet was last revised
04/2021
