Levonelle One Step 1.5mg Tablet

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.

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).

Levonelle 1500 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.

Levonelle 1500 is thought to work by:

• stopping your ovaries from releasing an egg;
• preventing sperm from fertilising any egg you may have already released

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 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 contraceptive effect and there is again the risk of pregnancy.

Levonelle 1500 is not indicated for use before the first menstrual bleeding (menarche).

Do not use Levonelle 1500 if: you are allergic to levonorgestrel or any of the other ingredients of this medicine listed

• How effective is the morning after pill?

  If EllaOne is taken when you are not ovulating and within the 120 hour timeframe after unprotected sex, there is a 98-99% chance of the pregnancy being terminated. 

  If Levonelle is taken when you are not ovulating and within the 72 hour timeframe after unprotected sex, there is a 97-99% chance of the pregnancy being terminated. 

  If you are close to ovulation, EllaOne is the better choice to Levonelle. During ovulation neither pill will work. 

  Levonelle does not hinder the ability of contraceptive pills, so contraceptive pills are still able to be used as normal.

  EllaOne can hinder the ability of contraceptive pills by your body building tolerance to them. Due to this, you must use a different type of contraception 7 days after using EllaOne for full protection against pregnancy. 

• How long after sex can you take the morning after pill?

  There are two different morning after pills, Levonelle and Ellaone. When you can take it depends on which brand you take.

  Levonelle needs to be taken within 72 hours of unprotected sex, whereas EllaOne can be taken until up to 120 hours after unprotected sex. The sooner after sex you take the morning after pill, the better - this goes for both Levonelle and Ellaone.

• How Does the Morning After Pill Work?

  Levonelle and EllaOne contain chemicals that mimic the female sex hormone progesterone. They are thought to prevent ovulation, fertilisation and change the lining of the womb. 

  Levonelle and EllaOne trick the body into thinking that it has already ovulated, which prevents eggs being released from the ovaries. They also thickens the mucus in the cervix (the neck of the womb) which makes it harder for sperm to cross from the vagina into the womb to fertilise any eggs that might be there. Finally, Levonelle and EllaOne change the lining of the womb so that any fertilised eggs cannot implant into it.

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):

• 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.
• Being sick (vomiting). If you are sick, read the section ‘What to do if you are sick (vomit)’.
• 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

Reporting of side effects:

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

Before taking any medication, it is important to read the Patient Information Leaflet. You can find information leaflets for your medicines by typing them into the search bar at medicines.org, or by contacting us.

Patient Information Leaflet Levonelle 1500 microgram tablet

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 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 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 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 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 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

The active ingredient of this medicine is excreted into your breast milk.Therefore, it is suggested that
you take your tablet immediately after a breast-feeding and avoid nursing at least 8 hours following levonorgestrel administration then drain your milk with a breast pump for 8 hours following tablet taking.

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.

Fertility
Levonelle 1500 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 Levonelle 1500 a rapid return to fertility is expected and therefore, regular contraception should be continued or initiated as soon as possible after Levonelle 1500 use.

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 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, Levonelle 1500 cannot terminate pregnancy, so Levonelle 1500 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 Levonelle 1500 is not advised if:

• you have a history of ectopic pregnancy (where the baby develops somewhere outside the
  womb).
• 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 salpingitis(inflammation of the Fallopian tubes).

A previous ectopic pregnancy or 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 Levonelle 1500 may be less effective with increasing body weight or body mass index (BMI), but these data were limited and inconclusive. Therefore, Levonelle 1500 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.

The active substance is levonorgestrel. Each tablet contains 1500 micrograms of levonorgestrel.

• The other ingredients are:
• Potato starch,
• Maize starch,
• Colloidal silica anhydrous,
• Magnesium stearate,
• Talc,
• Lactose monohydrate.