1.5 mg tablet
levonorgestrel

What Levonorgestrel Apofri is and what it is used for

Levonorgestrel is the Apofri acute – the pill that can be used within 72 hours (3 days) after unprotected sexual intercourse or if used contraception failed.

It can be used on the following occasions:

  • 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) .

Levonorgestrel Apofri contains a synthetic hormone-like active substance called levonorgestrel. It prevents about 85% of expected pregnancies when the tablet is taken within 72 hours (3 days) after unprotected intercourse. Levonorgestrel Apofri does not prevent a pregnancy every time, but the tablet is more effective earlier after unprotected intercourse. It is better to take it within 12 hours than to wait until the third day.

Levonorgestrel Apofri is believed to work by:

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

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

Levonorgestrel Apofri is not for use before the first menstrual period.

Levonorgestrel contained in Levonorgestrel Apofri 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 use Levonorgestrel Apofri

Do not take levonorgestrel Apofri

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

Warnings and cautions

If any of the following apply to you, tell your doctor before taking Levonorgestrel Apofri 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. Levonorgestrel Apofri does not work if you are already pregnant. If you are already pregnant, Levonorgestrel Apofri can not terminate a pregnancy. Levonorgestrel Apofri is therefore not an “abortion pill”.

You may already be pregnant if:

  • your period is more than 5 days delayed or 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.

Levonorgestrel Apofri 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 Apofri may decrease with increasing body weight or body mass index ( BMI ), but these data are limited and incomplete. Therefore, Levonorgestrel Apofri 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 – pills.

Children and young people

Levonorgestrel Apofri 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.

Levonorgestrel Apofri 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.

Other medicines and Levonorgestrel Apofri

Tell your doctor

Some medicines may prevent Levonorgestrel Apofri from working effectively. If you have been taking any of the medicines below for the past 4 weeks, Levonorgestrel Apofri 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 Levonorgestrel April:

  • barbiturates and other medicines used to treat epilepsy (eg 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.

Check with your doctor as soon as possible after taking the tablets for further advice on reliable typ iga contraception and to exclude pregnancy. (See also section 3 “How to take Levonorgestrel Apofri” for further advice).

Levonorgestrel Apofri may also affect the effectiveness of the following medicines:

  • a drug called ciclosporin (suppresses the immune system).

How often Levonorgestrel Apofri can be taken

Levonorgestrel Apofri should only be used as an emergency measure and not as a regular method of contraception. If Levonorgestrel Apofri is used more than once during a menstrual cycle, it becomes less reliable and is likely to disrupt the menstrual cycle.

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

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 any medicine.

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 Apofri harms a fetus if Levonorgestrel Apofri 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 Levonorgestrel Apofri or if you have previously had an ectopic pregnancy, surgery on the fallopian tubes, or inflammatory conditions in the pelvis.

The active substance in this medicine passes into breast milk. Therefore, it is recommended that you take the tablet immediately after a breastfeeding session and then avoid breastfeeding for at least 8 hours thereafter. Pump out the milk with a breast pump for 8 hours after taking the tablet. In this way, you take the tablet well before the next breastfeeding session and reduce the amount of active substance that can be transferred to the baby via breast milk.

Levonorgestrel Apofri increases the risk of disorders in the menstrual cycle, which can sometimes lead to earlier or later ovulation dates and thus change the fertile days. There are no long-term data on fertility, but after treatment with Levonorgestrel Apofri, a rapid return to fertility is expected. Therefore, the usual method of contraception should be resumed or initiated as soon as possible after the use of Levonorgestrel April.

Driving and using machines

Levonorgestrel Apofri 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.

Levonorgestrel Apofri contains lactose

If you have an intolerance to lactose ( lactose ), you should know that each Levonorgestrel Apofri pill contains 43 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 medicine.

Levonorgestrel Apofri contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’. is next to “sodium-free”.

How to use Levonorgestrel Apofri

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.

  • Take the tablet as soon as possible, preferably within 12 hours and no later than 72 hours (3 days) after unprotected intercourse. Levonorgestrel Apofri can be taken at any time during the menstrual cycle, provided you are not already pregnant or think you may be pregnant. Do not chew the tablet but swallow it whole with water. 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.
  • If you are taking any medicine that may prevent Levonorgestrel Apofri from working properly (see section “Other medicines and Levonorgestrel Apofri” above) or if you have used any of these medicines in the last 4 weeks, Levonorgestrel Apofri 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 can not be able to see a doctor immediately, you can take a double dose of Levonorgestrel Apofri (ie 2 tablets at the same time).
  • If you already use a regular method of contraception, e.g. birth control pills , you can continue to take these at the usual time.

If you have had unprotected intercourse after taking Levonorgestrel Apofri (even if it happens during the same menstrual cycle), the tablet will not have the same preventive effect and you may be pregnant.

What to do if you vomit

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

After taking Levonorgestrel Apofri

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

After taking Levonorgestrel Apofri, you should make an appointment with a doctor about three weeks later to check that Levonorgestrel Apofri 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 contraceptive methods that prevent pregnancy more effectively.

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

Your next period after taking Levonorgestrel April

After taking Levonorgestrel Apofri, 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 pregnancy is suspected, you should have a pregnancy test.

If you use more Levonorgestrel Apofri 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 if you are worried, 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 side effects (may affect more than 1 user in 10):

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

Common side effects (may affect up to 1 to 10 users):

  • 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 menstruate later or earlier than normal. You may also experience 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 side effects (may affect up to 1 in 10,000 people):

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

How to store Levonorgestrel Apofri

Keep this medicine out of the sight and reach of children.

Use before the expiry date (EXP) indicated on the carton. 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.

Other ingredients are:

microcrystalline cellulose,

lactose monohydrate,

poloxamer 188,

croscarmellose sodium,

magnesium stearate.

What the medicine looks like and contents of the pack

Round white tablet, about 6 mm in diameter and marked with “C” on one side and “1” on the other.

Packaging: an aluminum blister tablet in a carton.

Marketing Authorization Holder and Manufacturer

April AB

Box 120

182 12 Danderyd

Manufacturer:

Laboratories León Farma SA

C / La Vallina s / n, Pol. Ind. Navatejera

24008- Leon, Spain

Muhammad Nadeem

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