1.5 mg tablets
levonorgestrel

1. What Frivelle is and what it is used for

Frivelle is an emergency pill that can be used within 72 hours (3 days) after unprotected intercourse or if a used contraceptive method has 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 the failure of interrupted intercourse (eg ejaculation in the vagina or on the external genitalia ).

Frivelle 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. The drug does not prevent pregnancy at every opportunity, but the tablet is more effective the earlier after unprotected intercourse it is taken. It is better to take the tablet within 12 hours than to wait until the third day.

Frivelle is assumed to work by:

  • prevent ovulation
  • prevent the sperm from fertilizing an egg that has already been released or
  • prevent a fertilized egg from attaching to the uterine wall.

Frivelle 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 unprotected intercourse after taking Frivelle (even if it takes place within the same menstrual cycle), the tablet does not have a preventive effect and there is again a risk that you will become pregnant.

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

Frivelle is not intended for use before the first menstrual period has occurred ( menarche ).

2. What you need to know before taking Frivelle

Do not take Frivelle:

– 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 Frivelle as emergency contraception 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, tell your doctor. The medicine does not work if you are already pregnant. If you are already pregnant, Frivelle can not terminate an ongoing pregnancy. Frivelle is thus 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 or after your last period.

Frivelle 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 uterus)
  • 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 Frivelle may decrease with increasing body weight or body mass index ( BMI ), but these data are limited and incomplete. Therefore, Frivelle 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 emergency – the pill.

Children and young people

This medicine is not recommended for children. There are only limited data for women younger than 16 years.

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.

The drug does not protect you from sexually transmitted diseases, only condoms can do that.

If you have any further questions, ask your doctor or pharmacist.

Other medicines and Frivelle

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

Some medicines can prevent Frivelle from working effectively. If you have been taking any of the medicines below for the past 4 weeks, Frivelle 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 Frivelle:

  • 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 contraceptives and to rule out pregnancy (See also section 3 “How to take Frivelle” for further advice).

Frivelle may also affect the effectiveness of other medicines

  • a drug called cyclosporin (suppresses the immune system)

How often Frivelle can be taken

Frivelle should only be used as an emergency measure and not used as a regular method of contraception.

If Frivelle is used more than once during a menstrual cycle, it becomes less reliable and is likely to disrupt the menstrual cycle.

Frivelle 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 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 become pregnant even though you have taken this medicine, you must consult a doctor. There is no evidence that Frivelle harms a fetus if Frivelle is used according to the instructions. 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 Frivelle or if you have previously had an ectopic pregnancy, surgery on the fallopian tubes, or inflammatory conditions in the pelvis.

Breast-feeding

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 breast-feeding 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 in advance of the next breastfeeding session and reduce the amount of active substance that can be transferred to the baby via breast milk.

Fertility

Frivelle 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 Frivelle, a rapid return to fertility is expected. Therefore, the usual method of contraception should be resumed or started as soon as possible after using Frivelle.

Driving and using machines

It is unlikely that Frivelle will 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 increased vigilance. 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.

Frivelle contains lactose

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

How to take Frivelle

Always use this medicine exactly as described in this leaflet or as directed by your pharmacist. 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. Frivelle 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. 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 Frivelle from working properly (see section “Other medicines and Frivelle” above) or if you have used any of these medicines in the last 4 weeks, Frivelle 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 Frivelle (ie 2 tablets at the same time).
  • If you are already using a regular contraceptive such as birth control pills, you can continue to take this at the usual times.

If you have unprotected intercourse after taking Frivelle (even if it takes place within the same menstrual cycle), the tablet does not give the same preventive effect and you risk becoming pregnant.

Use for children and adolescents

This medicine is not recommended for children. There are only limited data for women younger than 16 years.

What to do if you vomit

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

After you have taken Frivelle

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

After taking Frivelle, you should make an appointment with a doctor about three weeks later to check that Frivelle has worked. Contact a doctor as soon as possible if your period is more than 5 days late, or if it is unusually light or unusually abundant. 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 Frivelle

After taking Frivelle, menstruation is usually normal and begins when it should, but sometimes it can come a few days too late or too early. Perform a pregnancy test if menstruation is more than 5 days late, if abnormal bleeding occurs at the expected time of menstruation or if pregnancy is suspected.

If you take more Frivelle 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 doctor, especially if you have vomited, as the tablet may not have worked properly.

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse

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 user in 10):

  • Nausea
  • Irregular bleeding before the next menstruation
  • 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 get 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. Contact a doctor as soon as possible if your period is more than 5 days late, or if it is unusually light or unusually abundant.
  • You may get chest tightness, diarrhea, or dizziness after taking this medicine.

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

  • Rash, hivesitching, swelling of the face, pelvic pain, and painful menstruation.

5. How Frivelle should be stored

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 after EXP. dat / EXP.
The expiration date is the last day of the specified month.

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.

6. Contents of the packaging 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, croscarmellose sodium, poloxamer, and magnesium stearate.

What Frivelle looks like and the contents of the package

Round, biconvex, white tablet, 6 mm large and embossed with the text “C” on one side and “1” on the other side.

Blister with 1 tablet.

Marketing Authorisation Holder

Orifarm Generics A / S

Energizer 15

5260 Odense S

Denmark

Local representative:

Orifarm Generics AB,

Box 56048

102 17 Stockholm

info@orifarm.com

Muhammad Nadeem

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