Navela 1,5 mg Tabletten

Navela is an emergency contraceptive that can be taken within 72 hours (3 days) of unprotected sex or contraceptive failure.

How to use

1. What is Navela and what is it used for?

Navela is an emergency contraceptive that can be taken within 72 hours (3 days) of unprotected sex or contraceptive failure.

It is intended for use in the following situations:
- if no contraception was used during sex
- if the contraceptive method was used incorrectly, for example if the condom broke or slipped off, if the position of your cap or diaphragm changed, if the cap or diaphragm broke/tore or was removed too early, or if sperm (semen) got into the vagina or onto the woman's external genitals during the so-called "withdrawal method" (pulling the penis out of the vagina before ejaculation).

Navela contains a synthetic hormone-like active ingredient called levonorgestrel. When taken within 72 hours of unprotected sex, it prevents unwanted pregnancy in approximately 85% of cases. It does not always prevent pregnancy and the effectiveness is greater the sooner it is taken after unprotected sex. It is better to take the medicine within 12 hours than to wait until the third day.

Navela is thought to work by:
- stopping an egg from being released from your ovaries.
- preventing sperm from fertilising an egg that has already been released, or
- stopping a fertilised egg from attaching to the lining of your womb.

Navela can only prevent pregnancy if you take it within 72 hours of unprotected sex. It will not work if you are already pregnant. If you have unprotected sex again after taking Navela (even if this is during the same menstrual cycle), the tablet you have taken will not provide further protection against pregnancy. You are therefore at risk of becoming pregnant again.

This medicine is not as effective as regular, ongoing contraceptive methods and is only intended for use as an emergency measure.

How to take it

What is Navela and what is it used for?

Navela is an emergency contraceptive that can be taken within 72 hours (3 days) of unprotected sex or contraceptive failure.

It is intended for use in the following situations:

• if no contraception was used during sex
• if the contraceptive method was used incorrectly, for example if the condom broke or slipped off, if the position of your
  cap or diaphragm changed, if the cap or diaphragm broke/tore or was removed too early, or if sperm
  (semen) got into the vagina or onto the woman's external genitals during the so-called “withdrawal method" (pulling the penis out of the vagina before ejaculation).

Navela contains a synthetic hormone-like active ingredient called levonorgestrel. When taken within 72 hours of unprotected sex, it prevents unwanted pregnancy in approximately 84% of cases. It does not always prevent pregnancy and the effectiveness is greater the sooner it is taken after unprotected sex. It is better to take the medicine within 12 hours than to wait until the third day.

Navela is thought to work by:

• stopping an egg from being released from your ovaries
• preventing sperm from fertilising an egg that has already been released

Navela can only prevent pregnancy if you take it within 72 hours of unprotected sex. It will not work if you are already pregnant. If you have unprotected sex again after taking Navela (even if this is during the same menstrual cycle), the tablet you have taken will not provide further protection against pregnancy. You are therefore at risk of becoming pregnant again.

What you need to know before you take it

What you need to know before taking Navela

Do not take Navela

• 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 apply to you, talk to your doctor before taking Navela, as an emergency contraceptive (morning after pill) may not be suitable for you. Your doctor may prescribe a different type of emergency contraceptive.

If you are pregnant or think you might already be pregnant
This medicine will not work if you are already pregnant. If you are already pregnant, Navela will not terminate the pregnancy, Navela is therefore not an “abortion pill”.

You may already be pregnant if

• your period is more than 5 days late or you have unusual bleeding when your next period is due.
• you had unprotected sex more than 72 hours ago and since the start of your last period.

Navela is not recommended if:

• you have a disease of the small intestine (such as Crohn's disease) that prevents the medicine from being absorbed,
• you have severe liver problems,
• you have ever had an ectopic pregnancy (a pregnancy that develops outside the womb),
• you have ever had salpingitis (inflammation of the fallopian tubes).

A previous ectopic pregnancy or previous infection of the fallopian tubes increases the risk of a new ectopic pregnancy.

All women should take emergency contraception as soon as possible after unprotected sex. There is some evidence that Navela may be less effective in women who are overweight or have a high body mass index (BMI). However, these data are limited and not conclusive. Therefore, Navela is recommended for all women regardless of their weight or BMI.
If you have any concerns about possible problems that may occur when taking emergency contraception, you should contact a doctor.

Children and adolescents
Navela is not indicated before the first menstrual period (menarche).

If you are worried about sexually transmitted infections
If you did not use a condom during sex (or if it broke or slipped off), there is a possibility of catching a sexually transmitted infection or HIV. This medicine will not protect you from sexually transmitted infections – only condoms can do that. If you are concerned, talk to your doctor, family planning clinic or pharmacist.

Taking Navela with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Some medicines may interfere with the action of Navela. These include:

• barbiturates and other medicines for epilepsy (such as primidone, phenytoin and carbamazepine)
• medicines to treat tuberculosis (such as rifampicin, rifabutin)
• treatment for HIV infection (ritonavir)
• medicines to treat fungal infections (griseofulvin)
• herbal preparations containing St John's Wort (Hypericum perforatum)
• a medicine called ciclosporin (used to suppress the immune system)

Tell your doctor or pharmacist if you are taking or using any of the above before taking Navela.

How to take the medicine

How often can you take Navela?

Navela should only be used as an emergency and not as a regular method of contraception. If Navela is taken more than once in a menstrual cycle, it is less likely to be effective and is more likely to disrupt your menstrual cycle (period).
Navela is less effective than regular contraceptive methods. Your doctor or family planning clinic can advise you about long-term methods of contraception that are more effective at preventing pregnancy.

Pregnancy and breast-feeding and fertility
If you are pregnant or breast-feeding, or if you think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
This medicine must not be taken if you are already pregnant. If you do become pregnant despite taking this medicine, you must see your doctor. There is no evidence that Navela will harm a baby that is developing in your womb if you use Navela as directed. But your doctor will still check that you do not have an ectopic pregnancy (a pregnancy that develops somewhere outside the
womb). This is especially important if you get severe abdominal pain after taking Navela or if you have had an ectopic pregnancy, an operation on your fallopian tubes or pelvic inflammatory disease in the past.

Breast-feeding
The active ingredient in this medicine passes into breast milk. You should therefore take your tablet immediately after breast-feeding and if possible avoid breast-feeding for 8 hours after taking the tablet. Express your breast milk with a breast pump for 8 hours after taking the tablet and discard the milk. This will ensure that you take the tablet well before your next breast-feed and reduce the amount of medicine that your baby may get in their breast milk.

Fertility
Navela may cause changes in your menstrual cycle, sometimes leading to earlier or later ovulation and thus to a shift in your fertile period. Although no long-term fertility data are available, it can be assumed that fertility is restored rapidly after treatment with levonorgestrel. Therefore regular contraception should be continued or started as soon as possible after emergency contraception with levonorgestrel.

Driving and using machines


Take care: this medicine may impair your ability to drive or operate machines.

Navela is unlikely to affect your ability to drive or operate machines. However, if you feel tired or dizzy, you should not drive or operate machines.

Navela contains lactose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. How to take Navela

Always take 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 unprotected sex. Do not delay taking the tablet. The tablet is most effective the sooner you take it after unprotected sex. It can only prevent pregnancy if you take the tablet within 72 hours of unprotected sex.

Navela can be taken at any time during your menstrual cycle, provided you are not already pregnant or think you might be pregnant. Swallow the tablet whole with water.
If you are taking any of the medicines that may stop Navela from working properly (see section “Taking Navela with other medicines” above) or if you have taken any of these medicines in the past 4 weeks, Navela may be less effective for you. Your doctor may prescribe a different (non-hormonal) type of emergency contraception, i.e. a copper IUD. If this is not suitable for you or if it is not possible for you to see your doctor promptly, you can take a double dose of Navela (i.e. two tablets, taken together at the same time).

If you are already using a regular method of contraception, such as the Pill, you can continue to take it as usual.

If you have unprotected sex again after taking Navela (even if this is during the same menstrual cycle), the tablet you have taken will not provide further protection against pregnancy and you are at risk of becoming pregnant again.

What to do if you vomit
If you vomit within three hours of taking the tablet, you should take another tablet straight away.

After taking Navela
If you want to have sex after taking Navela but are not using the contraceptive pill, you should use condoms or a cap plus spermicide (sperm-killing medicine) until your next period. Navela will not work if you have unprotected sex again before your next period.

It is advisable to make an appointment with your doctor about three weeks after taking Navela so that they can check that Navela has worked. If your period is more than 5 days late or is unusually light or unusually heavy, you should see your doctor as soon as possible. If you become pregnant despite taking this medicine, you must see your doctor.

Your doctor can also advise you about longer-term methods of contraception that are more effective at preventing pregnancy.

If you continue with your regular hormonal contraceptive method, such as the contraceptive pill, but do not have a bleed during the pill-free break, you should see your doctor to rule out pregnancy.

Your next period after taking Navela
After taking Navela, your period will usually be normal and start on the day expected, but sometimes it may start a few days earlier or later. If your period is more than
5 days late, if you have an “abnormal” bleed at this time or if you think you might be pregnant, you should do a pregnancy test to check if you are pregnant.

If you take more Navela than you should
Although there have been no reports of serious harmful effects from taking too many tablets at once, you may feel sick, vomit or have a vaginal bleed. Ask your doctor, pharmacist or family planning clinic for advice, especially if you have been vomiting, 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.

Possible side effects

How to store Navela

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 and blister after
“EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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.

Special precautions for storage

5. How to store Navela?

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 and blister after,,EXP"/,,Use by" The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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 theenvironment.

Special precautions for disposal and other information

Contents of the pack and other information

What Navela contains

• The active substance is levonorgestrel. One tablet contains 1.5 mg levonorgestrel.
• The other ingredients are: Microcrystalline cellulose, lactose monohydrate, poloxamer 188, croscarmellose sodium, magnesium stearate.

What Navela looks like and contents of the pack
Each carton contains one complete treatment with one round, white tablet, with a diameter of approximately 6 mm and with the imprint “C” on one side and “1” on the other side.