1.5 mg tablet of
levonorgestrel

What Levodonna is and what it is used for

Levodonna is an acute – pill that can be used within 72 hours (3 days) after unprotected sexual intercourse or a contraceptive used not worked. 

When should acute – pill be used?

  • No contraceptive was used during intercourse.
  • The contraceptive was used incorrectly, e.g. if a condom broke, slipped off or was used incorrectly, if a diaphragm changed position, ruptured, broke or was removed prematurely, if concerns about failure of interrupted intercourse (eg ejaculation in the vagina or on external genitalia) .

Levodonna contains a synthetic hormone-like active substance called levonorgestrel. It prevents about 84% of expected pregnancies when the tablet is taken within 72 hours (3 days) after unprotected intercourse. Levodonna does not prevent pregnancy at any time, but the tablet is more effective the earlier after unprotected intercourse it is taken. It is better to take it within 12 hours than to wait until the third day.

Levonorgestrel is believed to work by: 

  • prevent ovulation
  • prevent the sperm from fertilizing an egg that has already been released.

Levodonna can only prevent you from getting pregnant if you take it within 72 hours of unprotected intercourse. It does not work if you are already pregnant. If you have unprotected intercourse after taking Levodonna (even if it takes place during the same menstrual cycle), the tablet does not have a preventive effect and there is again a risk that you may become pregnant.

Levodonna is not for use before the first menstrual period.

Levonorgestrel contained in Levodonna may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you take Levodonna

Do not take Levodonna

  • if you are allergic to levonorgestrel or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor or pharmacist before taking Levodonna.

If any of the following apply to you, tell your doctor before taking Levodonna as emergency contraceptive pills may not be suitable for you. Your doctor may prescribe another type of emergency contraceptive.

  • If you are pregnant or think you may be pregnant, ask your doctor. Levodonna does not work if you are already pregnant. If you are already pregnant, levonorgestrel can not terminate an ongoing pregnancy. Levodonna is thus not an “abortion pill”.

You may already be pregnant if:

  • your period is more than 5 days late or if abnormal bleeding occurs at the expected time of the next period
  • you have had unprotected intercourse more than 72 hours before and since your last menstrual period.

Levodonna should not be used if:

  • you have an intestinal disease (eg Crohn’s disease ) that inhibits the absorption of the drug
  • you have severe liver problems
  • you have previously had an ectopic pregnancy (where the fetus develops outside the womb)
  • you have had ovarian inflammation (salpingitis).

Previous ectopic pregnancy or fallopian tube inflammation increases the risk of a new ectopic pregnancy.

Acute – birth control pills should be taken as soon as possible after unprotected intercourse. This applies to all women. There is some evidence that the effect of levonorgestrel may decrease with increasing body weight or body mass index ( BMI ), but these data are limited and incomplete. Therefore, levonorgestrel is still recommended for all women regardless of weight and BMI.

Talk to your healthcare professional if you have any questions about any issues relating to the use of the emergency – pill.

Children

Levodonna is not for use before the first menstrual period.

If you are worried about sexually transmitted diseases

If you did not use a condom (or if it broke or slipped off) during intercourse, you may have contracted a sexually transmitted disease or HIV – the virus.

This medicine does not protect you against sexually transmitted diseases, only condoms can. If you have any further questions, ask your doctor, nurse, contraceptive clinic, or pharmacist.

How often Levodonna can be taken

Levodonna should only be used as an emergency measure and not as a regular contraceptive. If levonorgestrel is used more than once during a menstrual cycle, it becomes less reliable and is likely to disrupt the menstrual cycle.

Levonorgestrel does not work as well as regular contraceptives. You can get information from a doctor, reception nurse, or contraceptive clinic about long-term contraceptives that prevent pregnancy in a more effective way

Other medicines and Levodonna

Tell your pharmacist or doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and (traditional) herbal medicines.

Some medicines may prevent Levodonna from working effectively. If you have been taking any of the medicines below for the past 4 weeks, Levodonna may be less suitable for you. Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, ie copper coil. If this is not an option for you or if you do not have the opportunity to see a doctor immediately, you can take a double dose of Levodonna:

  • barbiturate s and other anti- epilepsy (e.g., primidone, phenytoin and carbamazepine)
  • drugs against tuberculosis (eg rifampicin, rifabutin)
  • treatment of HIV (ritonavir, efavirenz)
  • medicines for fungal infections (griseofulvin)
  • (traditional) 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 tablets for further advice on reliable common contraceptives and to rule out pregnancy. (See also section 3 “How to take Levodonna” for further advice.)

Levodonna may also affect the way some other medicines work

– a drug called cyclosporin (suppresses the immune system).

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, 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 become pregnant even though you have taken this medicine, you must consult a doctor. There is no evidence that levonorgestrel harms a fetus if Levodonna is used as directed.

Despite this, the doctor may want to rule out an ectopic pregnancy (where the fetus develops outside the uterus). It is especially important if you get severe stomach pain after taking Levodonna or if you have previously had an ectopic pregnancy, surgery on the fallopian tubes, or inflammatory conditions in the pelvis.

Breast-feeding

The active ingredient passes into breast milk. You should therefore take the pill immediately after breastfeeding and avoid breastfeeding for at least 8 hours after taking levonorgestrel. Then pump out the breast milk for 8 hours after taking the tablet. In this way, you take the tablet well before the next breastfeeding and reduce the number of active ingredients that your baby can ingest with breast milk.

Fertility

Levonorgestrel increases the risk of menstrual disorders which can sometimes lead to earlier or later ovulation and change the days you are fertile. Even if there are no long-term data on fertility, you are expected to become fertile again quickly after treatment with Levodonna. You should therefore continue or start using a regular contraceptive as soon as possible after using Levodonna.

Driving and using machines

Levonorgestrel is unlikely to affect your ability to drive or use machines. However, avoid driving or using machines if you feel tired or dizzy.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Levodonna 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 23 mg sodium per tablet, it is essential ‘sodium-free’.

How to take Levodonna

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure. Show larger

Take the tablet as soon as possible, preferably within 12 hours and no later than 72 hours (3 days) after unprotected intercourse. Do not delay ingestion of the tablet. The tablet works better the faster you take it after unprotected intercourse. It can only prevent a pregnancy if you take it within 72 hours after unprotected intercourse.
  • Levodonna can be taken at any time during the menstrual cycle if you are not already pregnant or think you may be pregnant. Do not chew the tablet but swallow it whole with water.
  • If you are taking any medicine that may prevent Levodonna from working properly (see section “Other medicines and Levodonna” above) or if you have used any of these medicines in the last 4 weeks, Levodonna may be less effective. Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, ie copper coil. If this is not an option for you or if you do not have the opportunity to see a doctor immediately, you can take a double dose of Levodonna (ie 2 tablets at the same time).
  • If you are already taking a regular contraceptive such as on pills , you can continue to take this at the usual times.

If you have unprotected intercourse after taking Levodonna (even if it takes place during the same menstrual cycle), the tablet will not have the same preventive effect and you may become pregnant.

Use for children

Levodonna is not for use before the first menstrual period.

What to do if you vomit

If you vomit within 3 hours of taking the tablet, take a new tablet immediately.

After taking Levodonna

If you want to have intercourse after taking Levodonna and do not use pills, you should use condoms or pessaries combined with spermicides until your next period. The reason for this is that levonorgestrel does not work if you have unprotected intercourse again before you have your next period.

After taking Levodonna, you should make an appointment with a doctor about three weeks later to check that Levodonna has worked. If your period is more than 5 days late, or if it is unusually light or unusually abundant, you should contact your doctor as soon as possible. If you become pregnant even though you have taken this medicine, you must consult a doctor.

You can get information from your doctor about long-term contraceptives that prevent pregnancy more effectively. 

If you continue to use a regular hormonal contraceptive such as pills and you do not get any bleeding during the tablet-free period, you should see a doctor to check that you are not pregnant. 

Your next period after taking Levodonna

After taking Levodonna, menstruation is usually normal and starts when it should, but sometimes it can come a few days too late or too early. If your period is more than 5 days late, if abnormal bleeding occurs at the expected time of your period, or if you suspect you are pregnant, you should have a pregnancy test.

If you use more Levodonna than you should 

There are no reports of serious side effects in women who have taken too many pills at one time. If you have taken several tablets at once, you may experience nausea and vomiting, or vaginal bleeding. Ask your pharmacist, doctor, receptionist, or contraceptive clinic for advice, especially if you vomit because the pill may not have worked properly.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common (may affect more than 1 user in 10):

  • Nausea
  • Irregular bleeding before the next period
  • Pain in the lower abdomen
  • Fatigue
  • Headache

Common (may affect up to 1 in 10 people):

  • Vomiting. If you vomit, read the section “What to do if you vomit”
  • Menstruation may be different. Most women have a normal menstrual period at the expected time, but some may menstruate later or earlier than normal. You may also have irregular bleeding or spotting before the next period. If your period is more than 5 days late, or if it is unusually light or unusually abundant, you should contact your doctor as soon as possible.
  • You may get chest tightness, diarrhea or dizziness after taking this medicine.

Very rare (may affect up to 1 in 10,000 people):

  • Rash, hives, itching and swelling of the face, pelvic pain, painful menstruation

How to store Levodonna

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 or blister after EXP. The expiration date is the last day of the specified month.

No special storage instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the package and other information

Content declaration

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 the medicine looks like and contents of the pack

Each pack contains a complete treatment. The tablet is round and white, about 6 mm in diameter, and embossed with “C” on one side and “1” on the other side.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark

Manufacturer

Lek Pharmaceuticals dd, Verovskova 57, 1526 Ljubljana, Slovenia

or

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

Muhammad Nadeem

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