LEVONORGESTREL SANDOZ 1.5 mg TABLETS

Introduction

Leaflet: information for the user

Levonorgestrel Sandoz 1.5 mg EFG tablet

Read the leaflet carefully before starting to take this medicine, as it contains important information for you.

Follow the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Levonorgestrel Sandoz and what is it used for
2. What you need to know before taking Levonorgestrel Sandoz
3. How to take Levonorgestrel Sandoz
4. Possible side effects
5. Storage of Levonorgestrel Sandoz
6. Package contents and additional information

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

Levonorgestrel Sandoz is an emergency contraceptive that can be used within 72 hours (3 days) after 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, the condom broke, slipped, or was used incorrectly, if the vaginal ring or diaphragm changed position, was punctured, broken, or removed too early, or in the case of failed interruption during coitus interruptus(e.g., sperm was ejaculated into the vagina or external genitals).

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

It is believed that Levonorgestrel Sandoz works 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 have a contraceptive effect, and there is a risk of pregnancy.

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

2. What you need to know before taking Levonorgestrel Sandoz

Do not takeLevonorgestrel Sandoz:

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

Warnings and precautions

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

• If you are pregnant or think you may be pregnant. This medicine does not work if you are already pregnant. If you are already pregnant, levonorgestrel will not interrupt the pregnancy, so levonorgestrel is not an "abortion pill".

You may already be pregnant if:

• your period is more than 5 days late or you have had abnormal bleeding when you should have had your next menstruation;
• you have had unprotected sex since your last menstruation and more than 72 hours have passed.

The use of levonorgestrel is not recommended if:

• you have a disease in the small intestine (such as Crohn's disease) that inhibits the absorption of the medicine,
• you have severe liver problems,
• you have a family history of ectopic pregnancy (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 previous infection of the fallopian tubes 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 weight or body mass index (BMI), but these data were limited and not conclusive. Therefore, levonorgestrel is recommended for all women, regardless of their weight or BMI.

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

Girls

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

If you are concerned about sexually transmitted diseases

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

This medicine does not protect you from sexually transmitted diseases, as only the use of condoms can do so.

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

Using Levonorgestrel Sandoz with other medicines

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

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

• 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 more information about the correct dose for you.

Consult your doctor as soon as possible after taking the tablets, so that they can inform you about reliable methods of regular contraception and avoid 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 cyclosporin (which inhibits the immune system).

How often can Levonorgestrel Sandoz be used

You should only use Levonorgestrel Sandoz in emergency situations and never as a regular contraceptive method. If you use levonorgestrel more than once during the same menstrual cycle, its effectiveness is lower, and you may experience changes in your menstrual cycle (period).

Levonorgestrel does not work as well as conventional contraceptive methods. Your doctor, nurse, or family planning center can advise you on long-term contraceptive methods that are more effective in preventing pregnancy.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or 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 consult your doctor. The available data do not indicate that levonorgestrel can cause harm to the embryo if used as advised.

However, your doctor may want 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 had a previous ectopic pregnancy, surgery on the fallopian tubes, or pelvic inflammatory disease.

Breastfeeding

The active ingredient of 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 administration of levonorgestrel; then express milk with a breast pump during the 8 hours after taking the tablet and discard it. This way, you will be taking your tablet well before the next feeding and reducing the amount of active ingredient that your child could ingest with breast milk.

Fertility

Levonorgestrel increases the possibility of changes in menstruation, which can sometimes lead to advancing or delaying the date of ovulation, modifying fertility accordingly. Although there is no long-term fertility data after treatment with levonorgestrel, it is expected that fertility will return quickly, and you should continue with your regular contraceptive methods or start them as soon as possible after using levonorgestrel.

Driving and using machines

Levonorgestrel is unlikely to affect your ability to drive or use machines.

However, if you feel dizzy or nauseous, do not drive or use machines.

Levonorgestrel Sandoz contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult them 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 the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

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. This medicine works best when taken as soon as possible after unprotected sex. It can only prevent pregnancy if taken within 72 hours after unprotected sex.

• You can take levonorgestrel at any time during your menstrual cycle, except if you are already pregnant or think you may be pregnant. Take the tablet whole with a little water, do not chew it.
• If you are using one of the medicines that may prevent levonorgestrel from working correctly (see section "Using Levonorgestrel Sandoz with other medicines") or if you have used one of these medicines in the last 4 weeks, levonorgestrel may be less effective for you. Your doctor may prescribe another type of emergency contraception (non-hormonal), i.e., a copper intrauterine device (IUD). If this is not an option for you or if you cannot see your doctor quickly, you can 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 pill, you can continue taking it with the same regularity.

If you have unprotected sex again after taking Levonorgestrel Sandoz (even if it is during the same menstrual cycle), the medicine will not have a contraceptive effect, and there is a risk of pregnancy.

Use in girls

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

What to do if you feel nauseous (vomit)

If you feel nauseous 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 want to have sex, and you are not using the pill, you should use a condom or a diaphragm with spermicide until your next menstrual period. This is because levonorgestrel will not work if you have unprotected sex again before your next period.

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

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

If you continue to use hormonal contraceptive methods regularly, such as the pill, and you do not have bleeding when you should, consult your doctor to confirm that you are not pregnant.

How your next period will be after taking Levonorgestrel Sandoz

After taking Levonorgestrel Sandoz, your period will be normal and will start on the expected date, however, in some cases, it may start a few days earlier or later than this date. If your period is more than 5 days late, you experience abnormal bleeding, or you think you may be pregnant, a pregnancy test should be done 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 (vomit), or experience vaginal bleeding. Consult your doctor, nurse, family planning center, or pharmacist for advice, especially if you have vomited, as the medicine may not have worked correctly.

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

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

4. Possible side effects

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

The following side effects may occur with the following frequencies:

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

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

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

• feeling nauseous (vomiting). If you feel nauseous, read the section "What to do if you feel nauseous (vomit)",
• 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 usual. You may also have irregular bleeding or spotting until your next menstruation. If your period is more than 5 days late or is unusually light or heavy, contact your doctor as soon as possible,
• breast tenderness, diarrhea, or dizziness after taking this medicine.

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

• rash, urticaria, itching, swelling of the face, pelvic pain, painful menstruation.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines (Website: www.notificaram.es). By reporting side 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 expiration date stated on the packaging and blister after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Levonorgestrel Sandoz

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

Appearance of Levonorgestrel Sandoz and package contents

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

Marketing Authorization Holder and manufacturer

Marketing Authorization Holder

Sandoz Pharmaceutical, S.A.

Business Center Parque Norte

Roble Building

Serrano Galvache Street, 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

León Farma Laboratories S.A.

La Vallina Street, s/n

Navatejera Industrial Estate

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 Micrograms Tablets

Germany: unofem HEXAL 1.5 mg Tablets

Belgium: Levodonna® 1.5 mg tablets

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

Denmark: Levodonna

Estonia: Levodonna

Netherlands: Isteranda 1.5 mg Tablets

Italy: Stromalidan

Norway: ISTERANDA 1.5 mg tablet

Czech Republic: Nulsora 1.5 mg

Sweden: Levodonna 1.5 mg tablet

Finland: Levodonna 1.5 mg tablets

Ireland: Levonorgestrel Rowex 1.5 mg Tablets

Lithuania: Lenostella 1.5 mg tablets

Latvia: Lenostella 1.5 mg tablets

Portugal: Levodonna Levonorgestrel 1.5 mg Tablet

Romania: Nulsora 1.5 mg tablets

This leaflethas been revisedinOctober 2024

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