Package Insert: Information for the User

Levonorgestrel Stada 1.5 mg Tablet EFG

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

• Keep this package insert, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Contents of the package and additional information.

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

It is used in the following cases:

• If no contraceptives were used during sex.
• If the contraceptive was not used properly, for example if the condom broke, slipped, or was used incorrectly, if the diaphragm was moved out of position or if it was perforated, broken, or removed too early, or if the withdrawal method failed (e.g., semen was ejaculated into the vagina or onto the external genitals).

It containsas its active ingredient a substance called levonorgestrel, which is a synthetic hormone.

You should take this medication as soon as possible, preferably within 12 hours and no later than 72 hours (3 days) after having unprotected sex or if a contraceptive method has failed.

This medication can only prevent pregnancy if taken at most 72 hours after having unprotected sex. It will not work if you are already pregnant.If you have unprotected sex after taking this medication, it will not prevent pregnancy.

The exact mechanism of action of levonorgestrel is unknown. It is likely that it prevents the ovaries from releasing an egg. There may be other processes involved, including the prevention of the implantation of a fertilized egg in the uterus. It is not effective once implantation has begun.

This tablet is only indicated for emergency contraception, not as a regular contraceptive method, as it is less effective than the regular contraceptive pill ("the pill").

Do not take Levonorgestrel Stada

If you are allergic to levonorgestrel or any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

Noit is recommended to use this medication in the following cases:

-If you have had an ectopic pregnancy.

-If you have had pelvic inflammatory disease (salpingitis).

-Ifyou or a family member have a known risk factor forthrombosis (blood clot formation).

- If you have a severe digestive disorder that alters the absorption of food and drugs.

-If you have a severe liver disease or a severe small intestine disease, such as Crohn's disease.

Emergency contraception should be taken as soon as possible after unprotected sex. There is some evidence that Levonorgestrel Stada may be less effective with increased weight or body mass index (BMI), but these data were limited and inconclusive. Therefore, Levonorgestrel Stada is recommended for all women, regardless of their weight or BMI.

Consult a healthcare professional if you are concerned about any problem related to emergency contraception.

Previous ectopic pregnancy and a previous infection of the Fallopian tubes increase the risk of a new ectopic pregnancy.Therefore, if you have had a previous ectopic pregnancy or a previous infection of the Fallopian tubes, you should consult your doctor before taking this medication.

Emergency contraception should be used as an occasional method onlyand should not replace any regular contraceptive method, as:

-It does not always prevent pregnancy.

-The risk of receiving an excess of hormones can cause the interruption of the menstrual cycle.

Emergency contraception does not interrupt a pregnancy.

Ifyou have had unprotected sex more than 72 hours ago, it may already be too late for the treatment with levonorgestrel to prevent pregnancy.

Do not repeat the administration of levonorgestrel in the same menstrual cycle, as it may interrupt the cycle.

This medication is not as effective as regular contraceptive methods (the pill or condoms). Your doctor may advise you on more effective long-term contraceptive methods to avoid pregnancy.

After using this medication, it is mandatory to exclude the possibility of a pregnancy by performing a pregnancy test:

-When the next menstrual period is delayed by more than five days.

-In case of abnormal bleeding, even on the date of the expected period.

Ifyou do not use condoms during sex (or if they break or slip), you may have contracted a sexually transmitted disease (STD) or HIV. The use of emergency contraceptive pills does not offer protection against STDs or HIV infection and cannot replace the necessary measures and precautions to be taken in case of risk of transmission of a disease.

Use of Levonorgestrel Stada with other medications

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

This medication should not be used in conjunction with emergency contraceptives that contain ulipristal acetate.

Some medications may prevent Levonorgestrel Stada from working effectively. If you have used any of the following medications in the last 4 weeks, Levonorgestrel Stada may not be suitable for you. Your doctor may prescribe another type of emergency contraception (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 Stada:

-barbiturates and other medications used to treat epilepsy (e.g., primidone, phenytoin, and carbamazepine),

-medications used to treat tuberculosis (e.g., rifampicin and rifabutin),

-an HIV treatment (ritonavir,efavirenz),

-an antifungal medication (griseofulvin),

-herbal medications containing St. John's Wort (Hypericum perforatum),

Consult your doctor or pharmacist if you need additional information on the correct dose for you.

Consult your doctor as soon as possible after taking the pills, so they can inform you about reliable methods of regular contraception and avoid pregnancy (see also section 3 “How to take Levonorgestrel Stada” for more information).

Levonorgestrel Stada may also affect the proper functioning of other medications.

-A medication called cyclosporine (inhibits the immune system).

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Ifyou are pregnant, this medication will not cause the abortion of an ongoing pregnancy.

If you are taking this medication and become pregnant, the studies conducted up to the present date do not show any risk of malformations for the fetus. However, do not take this medication if you are pregnant.

Ifyou become pregnant after taking levonorgestrel, you should consult your doctor. Your doctor may check if you have an ectopic pregnancy (if the fetus develops in a place other than the uterus). This is especially important if you experience severe abdominal pain after taking this medication, if you have had a previous ectopic pregnancy, or if you have undergone surgery on your Fallopian tubes or have had pelvic inflammatory disease.

Breastfeeding

It is possible to breastfeed, but sincelevonorgestrel is excreted in breast milk, you should breastfeed your baby immediately before taking this medication and suspend breastfeeding for at least 8 hours after taking levonorgestrel.

Children and adolescents
This medication is not recommended for girls.
There are very few data available for women under 16 years old.

Driving and operating machines

After taking levonorgestrel, some women may experience drowsiness and dizziness (see section 4, "Possible side effects"): do not drive or operate machines if you experience these symptoms.

Nostudies have been conducted on the effects of levonorgestrel on the ability to drive and operate machines.

Thismedication contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

Use this medication exactly as described in the package insert or as directed by your pharmacist. Consult your doctor or pharmacist if you have any doubts.

• You can take Levonorgestrel Stada at any time during your menstrual cycle, except if you are already pregnant or think you may be pregnant. Take the entire tablet with a little water and do not chew it.

• If you are taking one of the medications that can prevent Levonorgestrel Stada from working correctly (see section “Use of other medications and Levonorgestrel Stada”) or if you have used one of these medications in the last 4 weeks, Levonorgestrel Stada 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 Stada (i.e., 2 tablets taken at the same time).

• If you are already using a regular contraceptive method, such as oral contraceptives, you can continue taking it with the same regularity.

If you vomit within the three hours after taking the tablet, you must take another tablet.

Contact your doctor if more than 72 hours have passed since unprotected sex.

After taking Levonorgestrel Stada

After taking levonorgestrel, use a barrier contraceptive method (condom, diaphragm) until your next menstrual period begins.

If you are already using a regular contraceptive method, such as oral contraceptives, you can continue taking it with the same regularity. If you do not have any menstrual bleeding during your next menstrual period, you should have a pregnancy test to rule out a possible pregnancy. Your doctor may recommend effective long-term contraceptive methods to prevent pregnancy.

If you have had unprotected sex again after taking this medication (even during the same menstrual cycle), the tablets will have no contraceptive effect and there is a risk of pregnancy. If you use a regular contraceptive method, such as oral contraceptives, you should continue using it as usual.

The next period after taking Levonorgestrel Stada

After taking this medication, your menstrual period is usually normal and will occur on the expected day, although it may be delayed or advanced by a few days in some cases. If your menstrual period is delayed by more than five days or is unusually light or heavy, or if you suspect you may be pregnant for any other reason, check by having a pregnancy test. If you become pregnant even after taking this medication, it is essential to consult your doctor.

If you take more Levonorgestrel Stada than you should

No cases of acute poisoning or severe adverse effects have been reported after taking too many doses of levonorgestrel at once. However, you may experience nausea, vomiting, or vaginal bleeding. Consult your doctor or pharmacist for advice.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The frequency of occurrence of the possible adverse effects listed below is defined as follows:

Very frequent (may affect more than 1 in 10 people)

Frequent (may affect up to 1 in 10 people)

Uncommon(may affect up to 1 in 100 people)

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

Very rare (may affect up to 1 in 100,000 people)

Not known (the frequency cannot be estimated from the available data).

The following adverse effects have been observed:

Very frequent adverse effects:

• Dizziness, headache
• Nausea, abdominal pain
• Mammary tenderness to palpation, delayed menstrual period, very intense menstrual periods, bleeding
• Fatigue

Frequent adverse effects:

• Diarrhea
• Vomiting

Unknown frequency:

• There have been reported cases of post-marketing episodes of thromboembolic events (blood clots).
• Hypersensitivity skin reactions may occur after taking this medication.

Reporting Adverse Effects

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

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

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

Composition of Levonorgestrel Stada

·The active ingredient is levonorgestrel. Each tablet contains 1.5mg of levonorgestrel.

·The other components (excipients)are:microcrystalline cellulose, lactose monohydrate, poloxamer 188, sodium croscarmellose, and magnesium stearate (E572).

Appearance of the product and contents of the package

Each package containsone tabletof1.5mgoflevonorgestrel, round and white, approximately 6 mm in diameter, and marked with “C” on one side and with “1” on the other.

Holder of the marketing authorizationand responsible for manufacturing

Holder of the marketing authorization

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain