Label: information for the user

Levonorgestrel Sandoz 1.5 mg tablet EFG

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

Follow exactly the administration instructions for the medication contained in this label or those indicated by your doctor or pharmacist.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribedonlyto you, and you should not give it to other people even if they have the same symptomsas you,as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist even if they do not appear in this label. See section 4.

1.What isLevonorgestrel Sandozand for what it is used

2.What you need to know before starting to takeLevonorgestrel Sandoz

3.How to takeLevonorgestrel Sandoz

4.Possible adverse effects

5.Storage ofLevonorgestrel Sandoz

6.Contents of the package and additional information

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 the act of sex,

• the contraceptive method was not used correctly, for example, the condom broke, slipped off, or was used incorrectly, if the vaginal diaphragm or cervical cap changed position, was perforated, broke, or was removed too early, or in the case of failure of withdrawal during coitus interruptus (i.e., semen was ejaculated into the vagina or external genitalia).

This medication contains a synthetic hormone called levonorgestrel. It prevents approximately 84% of unwanted pregnancies when taken within 72 hours after having unprotected sex. It does not always prevent pregnancy each time it is taken and is much more effective if taken as soon as possible after having unprotected sex. It is better to take it within the first 12 hours than to delay it until the third day.

It is believed that Levonorgestrel Sandoz acts:

• 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 having 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 medication will not exercise its contraceptive effect and the risk of pregnancy will return.

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

Do not takeLevonorgestrel Sandoz:

• if you areallergicto levonorgestrel or any of the other ingredients of this medication (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 takelevonorgestrel as an emergency contraceptive, as it may not be suitable for you. Your doctor may prescribe another emergency contraceptive method.

• You are pregnant or think you may be pregnant. This medication does not work if you are already pregnant. If you are already pregnant,levonorgestrel does not interrupt the pregnancy, so levonorgestrel is not an “abortive pill”.

You may already be pregnant if:

• your period has been delayed by more than 5 days or if you have had abnormal bleeding when you would normally have your next period;
• after your last period, you have had unprotected sex 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 medication,
• you have severe liver problems,
• you have a family history of ectopic pregnancy (pregnancy in which the fetus develops in a location 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 increased weight or body mass index (BMI), but these data were 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 are concerned about any problem related to emergency contraception.

Girls

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

If you are concerned about sexually transmitted diseases

If you did not use a condom (or if it broke or came off) during sex, you are likely to have acquired a sexually transmitted disease or HIV.

This medication does not protect against 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.

Use of Levonorgestrel Sandoz with other medications

Inform your doctor or pharmacist if you are taking, have taken recently any other medication, including over-the-counter medications or herbal medications.

Some medications may prevent levonorgestrel from working effectively. If you have used any of the medications listed below in the last 4 weeks, levonorgestrel may be less suitable for you. Your doctor may prescribe another type of emergency contraceptive (non-hormonal), i.e., a copper intrauterine device (IUD-Cu). 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 medications used to treat epilepsy (e.g., primidone, phenytoin, and carbamazepine),
• medications used to treat tuberculosis (e.g., rifampicin and rifabutin),
• some medications used to treat HIV (ritonavir, efavirenz),
• a medication used to treat fungal infections (griseofulvin),
• a herbal medication containing St. John's Wort (Hypericumperforatum).

Consult your doctor or pharmacist if you need additional 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 medications:

• a medication called cyclosporine (inhibits the immune system).

How often Levonorgestrel Sandoz can 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 is not as effective as conventional contraceptive methods. Your doctor, nurse, or family planning center may advise you about long-term 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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

You should not take this medication if you are pregnant. If you become pregnant despite taking this medication, it is essential to see your doctor. The available data do not indicate that levonorgestrel can cause harm to the embryo if used as recommended.

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, fallopian tube surgery, or pelvic inflammatory disease.

Breastfeeding

The active ingredient of this medication is excreted in breast milk. Therefore, take the tablet immediately after feeding your baby and avoid breastfeeding for at least 8 hours after administering levonorgestrel; after that, express and discard the milk for 8 hours after taking the tablet, and then take the next tablet. This way, you take your tablet well before the next feeding and reduce the amount of active ingredient that your baby may ingest with the breast milk.

Fertility

Levonorgestrel increases the likelihood of changes in menstruation that may cause the ovulation date to be advanced or delayed, thereby affecting the fertility date. Although there are no long-term fertility data, it is expected that fertility will return quickly after treatment with levonorgestrel, and therefore, you should continue with your usual contraceptive methods or start them as soon as possible after using levonorgestrel.

Driving and operating machinery

Levonorgestrel is unlikely to affect your ability to drive and 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 told you that you have an intolerance to certain sugars, consult them before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; that is, it is essentially “sodium-free”.

Follow exactly the administration instructions of themedicationcontained in this leaflet or those 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 medication works best as soon as possible after unprotected sex. You can only prevent pregnancy if you take it within 72 hours after unprotected sex.

• You can take levonorgestrel at any time of your menstrual cycle except if you are already pregnant or think you may be pregnant. Take the entire tablet with a little water, do not chew it.
• If you are taking one of the medications that may prevent levonorgestrel from working correctly (see section “Use of Levonorgestrel Sandoz with other medications”) or if you have taken one of these medications in the last 4 weeks, levonorgestrel may be less effective for you. Your doctor may prescribe another type of emergency contraception (non-hormonal), that is a copper intrauterine device (IUD-Cu). If this is not an option for you or if you cannot see your doctor quickly, you can take a double dose of levonorgestrel (that is, 2 tablets taken at the same time),

-Ifyouare already using a regular contraceptive method such as the contraceptive pill, you can continue taking it with the same regularity.

If you have another unprotected sex after taking Levonorgestrel Sandoz (also if this occurs during the same menstrual cycle), the medication will not exert its contraceptive effect and again there is 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 have nausea and vomit before 3 hours have passed since taking the tablet, you must take another tablet immediately.

After taking Levonorgestrel Sandoz

After taking Levonorgestrel Sandoz, if you want to have sex, and you are not using the contraceptive pill, you must 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 you have had your next period.

It is recommended that you see your doctor about three weeks after taking Levonorgestrel Sandoz to confirm that you are not pregnant. If your menstrual period is delayed more than 5 days or is abnormally light or heavy, you must see your doctor as soon as possible. If you become pregnant despite taking this medication, it is essential that you see your doctor.

Your doctor will also advise you about long-term contraceptive methods that are more effective to prevent pregnancy.

If you continue using regular hormonal contraceptives such as the contraceptive pill, and you do not have bleeding when it is due, 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 your due date, however, in some cases, it may start a few days earlier or later than this date. If your period is delayed more than 5 days, you experience any abnormal bleeding or think you may be pregnant, a pregnancy test should be performed to rule out pregnancy.

If you take more Levonorgestrel Sandoz than you should

Although no serious adverse 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 center or pharmacist for advice, especially if you have vomited, as it is possible that the medication 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 medication and the amount ingested.

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

Like all medications, this medication may produce adverse effects, although not all people may 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 lower abdominal pain,
• 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 normal. You may also experience irregular or spotting bleeding until your next menstruation. If your period is delayed by more than 5 days or is unusually light or heavy, contact your doctor as soon as possible,
• breast tenderness, diarrhea, or dizziness after taking this medication.

Very Rare Adverse Effects (may affect up to 1 in 10,000 people)

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use (Website: www.notificaram.es ). By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keepthis medication out of the sight and reach of children.

Do notuse this medicationafter the expiration date that appears on the packaging and blister after CAD. The expiration dateis the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection pointat the pharmacy.If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Levonorgestrel Sandoz

• The active ingredient 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 package

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

Holder of the Marketing Authorization and responsible for manufacturing

Holder of the Marketing Authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

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 medicine is authorized in the member states of the European Economic Area with the following names:

Austria:Levodonna 1500 Mikrogramm Tabletten

Germany:unofem HEXAL 1,5 mg Tablette

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 tablett

Czech Republic:Nulsora 1,5 mg

Sweden:Levodonna 1,5 mg tablett

Finland:Levodonna 1,5mg tabletti

Ireland:Levonorgestrel Rowex 1.5 mg Tablets

Lithuania:Lenostella 1,5 mg tablete

Latvia:Lenostella 1,5 mg tabletes

Portugal:Levodonna Levonorgestrel 1.5 mg Comprimido

Romania:Nulsora 1,5 mg comprimate

This leaflet has been revisedinOctober 2024

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.