Levonorgestrel 1.5 Mg Tablet
Package leaflet: Information for the user
Levonorgestrel 1.5 mg tablet
Levonorgestrel
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, or pharmacist.
- 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.
- If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Levonorgestrel 1.5 mg tablet (hereinafter Levonorgestrel) is and what it is used for
2. What you need to know before you take Levonorgestrel
3. How to take Levonorgestrel
4. Possible side effects
5. How to store Levonorgestrel
6. Contents of the pack and other information
1. What Levonorgestrel is and what it is used for
Levonorgestrel is an emergency contraceptive that can be used within 72 hours (3 days) of unprotected sex or if your usual contraceptive method has failed.
Levonorgestrel contains a synthetic hormone-like active 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.
Levonorgestrel is thought to work by:
• stopping your ovaries from releasing an egg;
• preventing sperm from fertilising any egg you may have already released.
Levonorgestrel 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 Levonorgestrel, it will not stop you from becoming pregnant.
2. What you need to know before you take Levonorgestrel Do not use Levonorgestrel
- 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 following applies to you, talk to your doctor before taking Levonorgestrel 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, Levonorgestrel cannot terminate pregnancy, so Levonorgestrel is not an “abortion pill”.
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 Levonorgestrel is not advised if:
• you have a disease of your small bowel (such as Crohn’s disease) that inhibits the absorption of the medicine
• you have severe liver problems
• you have a history of ectopic pregnancy (where the baby develops somewhere outside the womb)
• you have ever had a disease called salpingitis (inflammation of the Fallopian tubes).
In all women, emergency contraception should be taken as soon as possible after unprotected intercourse. There is some evidence that Levonorgestrel may be less effective with increasing body weight or body mass index (BMI), but these data were limited and inconclusive. Therefore, Levonorgestrel 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
Levonorgestrel not recommended for young women under 16 years of age without medical supervision.
Other medicines and Levonorgestrel
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines may prevent Levonorgestrel 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, rifabutin)
- a treatment for HIV infection (ritonavir, efavirenz)
- a medicine used to treat fungal infections (griseofulvin)
- herbal remedies containing St John’s wort (Hypericum perforatum)
- a medicine called ciclosporin (suppresses the immune system).
How often can you use Levonorgestrel
You should only use Levonorgestrel in emergencies and not as a regular method of contraception. If Levonorgestrel is used more than once in a menstrual cycle it is more likely to upset your menstrual cycle (period).
Levonorgestrel 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, 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 this medicine.
Pregnancy
You should not take this medicine if you are already pregnant. If you have had unprotected sex which was more than 72 hours ago, and since your last period, you may already be pregnant and the
treatment won’t work. If your last period was more than 5 days late or was unusually light or unusually heavy, you should check with your doctor that you are not 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 Levonorgestrel will harm a baby that develops in your uterus/womb but your doctor may want to check that the pregnancy is not ectopic This is especially important if you develop severe abdominal pain after taking Levonorgestrel 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, but if you are worried you can take your tablet immediately after a breast-feed. In this way you are taking your tablet well before the next feed and reducing the amount of active ingredient your baby may take in with the breast milk.
Driving and using machines
Your Levonorgestrel tablet 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 machinery.
Levonorgestrel tablet contains lactose
In case of milk sugar (lactose) intolerance it should be considered that each Levonorgestrel tablet also contains 142.5 mg lactose monohydrate.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Levonorgestrel
Always use this medicine exactly 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 you have had unprotected sex. Levonorgestrel 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 better the sooner you take it after having unprotected sex.
• If you are already using a regular method of contraception such as the contraceptive pill, you can continue to take this at your regular times.
If another unprotected intercourse takes place after the use of Levonorgestrel (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. If you are under 16, you must visit your doctor or family planning clinic to get emergency contraception.
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 nurse or family planning clinic immediately for one more tablet.
After you have taken Levonorgestrel
After you have taken Levonorgestrel, if you want to have sex, and are not using the contraceptive pill, you should use condoms or a cap plus spermicide until your next menstrual period. This is because Levonorgestrel won’t work if you have unprotected sex again, before your next period is due.
After you have taken Levonorgestrel, you are advised to make an appointment to see your doctor about three weeks later, to make sure that Levonorgestrel 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.
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 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 Levonorgestrel
After the use of Levonorgestrel, your period is usually normal and will start at the usual day; however sometimes, this will be a few days later or 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.
If you take more Levonorgestrel 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 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, this medicine can cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 people):
• Feeling sick (nausea)
• You might have some irregular bleeding until your next period
• You might have lower abdominal pain
• Tiredness
• Headache
Common (may affect up to 1 in 10 people):
• Being sick (vomiting). If you are sick, read the section ‘What to do if you are sick (vomit)’.
• 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 unusually light or unusually heavy, you should contact your doctor as soon as possible.
• You might have tender breasts, diarrhoea, feel dizzy after taking this medicine.
Very rare effects (may affect up to 1 in 10000 people):
• Rash, urticaria, pruritus, swelling of the face, pelvic pain, painful period, abdominal pain. Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone
0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.
5. How to store Levonorgestrel
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Store in the original package 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 protect the environment.
6. Contents of the pack and other information What Levonorgestrel contains
The active substance is levonorgestrel. Each tablet contains 1.5 mg of levonorgestrel.
The other ingredients are:
Potato starch,
Maize starch,
Silica, colloidal anhydrous,
Magnesium stearate,
Talc,
Lactose monohydrate.
What Levonorgestrel looks like and contents of the pack
Tablet: almost white, flat, rimmed tablet of about 8 mm diameter with an impressed mark of “G00” on one side.
Packaging: one tablet in PVC//aluminium blister and cardboard carton.
Marketing Authorisation Holder and Manufacturer
Gedeon Richter Plc.
1103 Budapest,
Gyomroi ut 19-21.
Hungary
This medicinal product is authorised in the Member States of the EEA under the following names:
Finland: Postinor 1500
United Kingdom: Levonorgestrel 1.5 mg tablets This leaflet was last revised in 06/2015.