Levonorgestrel Sandoz 1,5 mg tablet EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Levonorgestrel Sandoz 1.5 mg tablet EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

Always follow exactly the instructions for use of this medicine as described in this leaflet or as given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not pass it on to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Levonorgestrel Sandoz is and what it is used for
2. What you need to know before taking Levonorgestrel Sandoz
3. How to take Levonorgestrel Sandoz
4. Possible side effects
5. How to store Levonorgestrel Sandoz
6. Contents of the pack and other information

1. What Levonorgestrel Sandoz is and what it is used for

Levonorgestrel Sandoz is an emergency contraceptive that can be used within 72 hours (3 days) after having unprotected sex or if your regular contraceptive method has failed.

When should emergency contraception be used?

• no contraceptive method was used during sexual intercourse,
• the contraceptive method was not used correctly, for example, a condom broke, slipped, or was used incorrectly; a vaginal ring or diaphragm has moved out of position, has been punctured, torn, or removed too early; or withdrawal during coitus interruptus failed (e.g., semen was ejaculated into the vagina or onto the external genitals).

This medicine contains a synthetic hormone called levonorgestrel. It prevents approximately 84% of unwanted pregnancies when taken within 72 hours after unprotected sex. It does not always protect against pregnancy every time it is taken, and it is much more effective if taken as soon as possible after unprotected sex. It is best to take it within the first 12 hours rather than waiting until the third day.

Levonorgestrel Sandoz is believed to work by:

• preventing the ovaries from releasing an egg,
• preventing sperm from fertilizing any egg that has already been released.

Levonorgestrel Sandoz can only prevent pregnancy if taken within 72 hours after unprotected sex. It does not work if you are already pregnant. If you have unprotected sex again after taking Levonorgestrel Sandoz (even if it is during the same menstrual cycle), the medicine will not provide contraceptive protection, and there is again a risk of pregnancy.

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

2. What you need to know before starting Levonorgestrel Sandoz

Do not take Levonorgestrel Sandoz:

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

Warnings and precautions

Consult your doctor or pharmacist before taking Levonorgestrel Sandoz. If any of the conditions described below apply to you, consult your doctor or pharmacist before taking levonorgestrel as emergency contraception, as it may not be suitable for you. Your doctor may prescribe you an alternative emergency contraceptive method.

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

You may already be pregnant if:

• your period is more than 5 days late, or you have experienced abnormal bleeding around the time your next menstrual period is expected;
• you had unprotected sex after your last menstrual period and more than 72 hours have passed.

The use of levonorgestrel is not recommended if:

• you have a small intestine disorder (such as Crohn's disease) that impairs absorption of the medicine,
• you have severe liver problems,
• you have a family history of ectopic pregnancy (a pregnancy in which the baby develops outside the uterus),
• you have a family history of salpingitis (inflammation of the fallopian tubes).

A previous ectopic pregnancy and a prior fallopian tube infection increase the risk of a new ectopic pregnancy.

In all women, emergency contraception should be taken as soon as possible after unprotected sex. There is some evidence that levonorgestrel may be less effective with increasing body weight or body mass index (BMI), but this data was limited and inconclusive. Therefore, levonorgestrel is recommended for all women, regardless of their weight or BMI.

You are advised to consult a healthcare professional if you have concerns about any issues related to emergency contraception.

Children

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

If you are concerned about sexually transmitted infections

If you did not use a condom (or if it broke or slipped off) during sexual intercourse, you may have contracted a sexually transmitted infection (STI) or HIV.

This medicine does not protect you against sexually transmitted infections, as only the use of condoms can provide such protection.

Consult your doctor, nurse, family planning clinic, or pharmacist if you are concerned about this.

Use of Levonorgestrel Sandoz with other medicines

Inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those obtained without a prescription or herbal medicines.

Some medicines may prevent levonorgestrel from working effectively. If you have taken any of the following medicines within the last 4 weeks, levonorgestrel may be less suitable for you. Your doctor may prescribe another type of emergency contraception (non-hormonal), that is, a copper intrauterine device (Cu-IUD). If this is not an option for you or if you cannot see your doctor quickly, a double dose of levonorgestrel may be taken:

• barbiturates and other medicines used to treat epilepsy (e.g., primidone, phenytoin, and carbamazepine),
• medicines used to treat tuberculosis (e.g., rifampicin and rifabutin),
• some medicines used to treat HIV (ritonavir, efavirenz),
• a medicine used to treat fungal infections (griseofulvin),
• a herbal medicine containing St. John’s wort (Hypericum perforatum).

Consult your doctor or pharmacist if you need further information on the correct dosage for you.

Contact your doctor as soon as possible after taking the tablets to receive advice on reliable methods of regular contraception to prevent pregnancy (see also section 3 “How to take Levonorgestrel Sandoz” for more information).

Levonorgestrel may also affect the proper functioning of other medicines:

• A medicine called cyclosporine (which suppresses the immune system).

How often can Levonorgestrel Sandoz be used

Levonorgestrel Sandoz should only be used in emergency situations and never as a regular method of contraception. If you use levonorgestrel more than once during the same menstrual cycle, its effectiveness decreases and menstrual cycle disturbances (period) may occur.

Levonorgestrel is not as effective as conventional contraceptive methods. Your doctor, nurse, or family planning clinic can advise you on longer-acting contraceptive methods that are more effective in preventing pregnancy.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

You should not take this medicine if you are pregnant. If you become pregnant despite taking this medicine, it is important that you see your doctor. Available data do not indicate that levonorgestrel causes harm to the embryo when used as directed.

However, your doctor may wish to confirm that your pregnancy is not ectopic (when the fertilized egg implants outside the uterus). This is especially important if you experience severe abdominal pain after taking Levonorgestrel Sandoz or if you have previously had an ectopic pregnancy, tubal surgery, or pelvic inflammatory disease.

Breastfeeding

The active ingredient in this medicine is excreted in breast milk. Therefore, it is recommended that you take the tablet immediately after breastfeeding and avoid breastfeeding for at least 8 hours after taking levonorgestrel. During the 8 hours following tablet intake, express milk with a breast pump and discard it. This way, you take the tablet well before the next feeding, minimizing the amount of active ingredient that your child might ingest through breast milk.

Fertility

Levonorgestrel may increase the likelihood of menstrual disturbances, which can sometimes lead to earlier or delayed ovulation, thereby altering the timing of fertility. Although there are no long-term fertility data available, rapid return to fertility is expected after treatment with levonorgestrel. Therefore, regular contraceptive methods should be continued or initiated as soon as possible after using levonorgestrel.

Driving and use of machines

It is unlikely that levonorgestrel will affect your ability to drive or operate machinery.

However, if you feel tired or dizzy, do not drive or operate machinery.

Levonorgestrel Sandoz contains lactose and sodium

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take Levonorgestrel Sandoz

Follow exactly the instructions for taking this medicine as described in this leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Take the tablet as soon as possible, preferably within 12 hours, and no later than 72 hours (3 days) after having had unprotected sexual intercourse. Do not delay taking the tablet. This medicine is most effective the sooner you take it after unprotected sex. It can only prevent pregnancy if taken within 72 hours after unprotected sexual intercourse.

• You may take levonorgestrel at any time during your menstrual cycle, except if you are already pregnant or think you may be pregnant. Swallow the tablet whole with a little water; do not chew it.
• If you are taking any of the medicines that may reduce the effectiveness of levonorgestrel (see section “Use of Levonorgestrel Sandoz with other medicines”) or if you have taken any of these medicines in the past 4 weeks, levonorgestrel may be less effective for you. Your doctor may prescribe another type of emergency contraception (non-hormonal), namely a copper intrauterine device (Cu-IUD). If this is not an option for you or if you cannot see your doctor quickly, you may take a double dose of levonorgestrel (i.e. 2 tablets taken at the same time).
• If you are already using a regular contraceptive method such as the oral contraceptive pill, you may continue taking it as usual.

If you have another episode of unprotected sexual intercourse after taking Levonorgestrel Sandoz (even if this occurs during the same menstrual cycle), the medicine will not provide contraceptive protection, and there is again a risk of pregnancy.

Use in girls

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

What to do if you have nausea (vomiting)

If you experience nausea and vomit within 3 hours of taking the tablet, you should take another tablet immediately.

After taking Levonorgestrel Sandoz

After taking Levonorgestrel Sandoz, if you wish to have sexual intercourse and are not using the oral contraceptive pill, you must use a condom or a diaphragm with spermicide until your next menstrual period. This is because levonorgestrel will not be effective if you have unprotected sex again before your next period.

After taking Levonorgestrel Sandoz, it is advisable to make an appointment with your doctor approximately three weeks later to confirm that you are not pregnant. If your menstrual period is delayed by more than 5 days, or is unusually light or heavy, you should consult your doctor as soon as possible. If you become pregnant despite having taken this medicine, it is important that you see your doctor.

Your doctor will also advise you on long-acting contraceptive methods that are more effective in preventing pregnancy.

If you continue using hormonal contraceptives regularly, such as the oral contraceptive pill, and do not have your expected withdrawal bleeding, consult your doctor to confirm that you are not pregnant.

What to expect for your next period after taking Levonorgestrel Sandoz

After taking Levonorgestrel Sandoz, your period will usually come at the expected time and be normal. However, in some cases, it may start a few days earlier or later than expected. If your period is delayed by more than 5 days, if you experience any abnormal vaginal bleeding, or if you suspect you might be pregnant, a pregnancy test should be performed to rule out pregnancy.

If you take more Levonorgestrel Sandoz than you should

Although no serious harmful effects have been observed after taking several tablets at once, you may feel dizzy, nauseous (vomiting), or experience vaginal bleeding. Consult your doctor, nurse, family planning clinic, or pharmacist for advice, especially if you have vomited, as the medicine may not have worked properly.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following adverse effects may occur with the following frequencies:

Very common adverse effects (may affect more than 1 in 10 people)

• dizziness (nausea),
• you may experience irregular bleeding until your next menstruation,
• you may have pain in the lower abdomen,
• fatigue,
• headache.

Common adverse effects (may affect up to 1 in 10 people)

• feeling dizzy (vomiting). If you feel dizzy, read the section “What to do if you have nausea (vomiting)”,
• your menstruation may be different. Many women have their period normally and on the expected date, but others may have their period earlier or later than expected. You may also experience irregular bleeding or spotting until your next menstruation. If your period is delayed by more than 5 days, or is unusually light or unusually heavy, contact your doctor as soon as possible,
• breast tenderness, diarrhea, or dizziness after taking this medicine.

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

• rash, urticaria, pruritus (itching), facial swelling, pelvic pain, painful menstruation.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines (Website: www.notificaram.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levonorgestrel Sandoz

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

Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levonorgestrel Sandoz

• The active substance is levonorgestrel. Each tablet contains 1.5 mg of levonorgestrel.
• The other components are: microcrystalline cellulose, lactose monohydrate, poloxamer 188, sodium croscarmellose, and magnesium stearate.

Appearance of Levonorgestrel Sandoz and contents of the pack

Each pack contains a complete treatment with one tablet, round, white, approximately 6 mm in diameter, marked with the letter "C" on one side and the letter "l" on the other.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Centre

Roble Building

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d.

Verovskova 57,

1526, Ljubljana,

Slovenia

or

Salutas Pharma GmBH

Otto-von-Guericke-Allee 1,

39179, Barleben,

Germany

or

Laboratorios León Farma S.A.

C/La Vallina s/n

Polígono Industrial de Navatejera

24193 Navatejera, León,

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria: Levodonna 1500 Microgram Tablets

Germany: unofem HEXAL 1.5 mg Tablet

Belgium: Levodonna® 1.5 mg tabletten

Bulgaria: ??????? 1.5 MG ????????

Denmark: Levodonna

Estonia: Levodonna

Netherlands: Isteranda 1.5 mg Tabletten

Italy: Stromalidan

Norway: ISTERANDA 1.5 mg tablet

Czech Republic: Nulsora 1.5 mg

Sweden: Levodonna 1.5 mg tablett

Finland: Levodonna 1.5 mg tabletti

Ireland: Levonorgestrel Rowex 1.5 mg Tablets

Lithuania: Lenostella 1.5 mg tabletė

Latvia: Lenostella 1.5 mg tabletes

Portugal: Levodonna Levonorgestrel 1.5 mg Comprimido

Romania: Nulsora 1.5 mg comprimate

This leaflet has been reviewed in October 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es.