LEVONORGESTREL STADA 1.5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Levonorgestrel Stada 1.5 mg tablet EFG

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your pharmacist.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Levonorgestrel Stada and what is it used for.
2. What you need to know before you take Levonorgestrel Stada.
3. How to take Levonorgestrel Stada.
4. Possible side effects.
5. Storage of Levonorgestrel Stada.

Contents of the pack and further information.

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

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

It is used in the following cases:

• If you did not use any contraceptive during sex.
• If the contraceptive was not used correctly, for example, if the condom broke, slipped, or was used incorrectly, if the diaphragm was displaced or perforated, or if the withdrawal method failed (e.g., sperm was ejaculated into the vagina or onto the external genitalia).

It contains the active substance levonorgestrel, which is a synthetic hormone.

You should take this medicine as soon as possible, preferably within 12 hours, and no later than 72 hours (3 days) after unprotected sex or contraceptive failure.

This medicine can only prevent pregnancy if taken within 72 hours after unprotected sex. It will not work if you are already pregnant.

If you have unprotected sex after taking this medicine, 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. Other processes may also be involved, including preventing the implantation of a fertilized egg in the uterus. It is not effective once implantation has begun.

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

2. What you need to know before you take Levonorgestrel Stada

Do not take Levonorgestrel Stada

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

Warnings and precautions

This medicine is not recommended for use in the following cases:

• If you have had an ectopic pregnancy.
• If you have had pelvic inflammatory disease.
• If you or a family member have a known risk factor for blood clots.
• If you have a severe digestive disorder that affects the absorption of food and drugs.

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

In all women, emergency contraception should be taken as soon as possible after unprotected sex. There is some evidence that Levonorgestrel Stada may be less effective with increasing body 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.

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

A history of ectopic pregnancy and previous infection of the fallopian tubes increases the risk of having another ectopic pregnancy. Therefore, if you have had an ectopic pregnancy or a previous infection of the fallopian tubes, you should consult your doctor before taking this medicine.

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

• It does not always prevent pregnancy.
• The risk of receiving too much hormone can disrupt the menstrual cycle.

Emergency contraception does not interrupt an existing pregnancy.

If you have had unprotected sex more than 72 hours ago, you may already be pregnant. Therefore, treatment with levonorgestrel after the second instance of unprotected sex may not be effective in preventing pregnancy.

Repeated administration of levonorgestrel in the same menstrual cycle is not recommended, as it may disrupt the cycle.

This medicine 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 prevent pregnancy.

After using this medicine, it is mandatory to rule out a possible pregnancy by taking a pregnancy test:

• When your next menstrual period is delayed by more than five days.
• In case of abnormal bleeding, even on the expected date of your period.

If you 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 provide protection against STDs or HIV and cannot replace the necessary precautions to be taken in case of risk of transmission of a disease.

Using Levonorgestrel Stada with other medicines

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

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

Some medicines may prevent Levonorgestrel Stada from working effectively. If you have used any of the following medicines in the last 4 weeks, Levonorgestrel Stada may be less suitable for you. Your doctor may prescribe a different 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 Stada (i.e., 2 tablets taken at the same time):

• Barbiturates and other medicines used to treat epilepsy (e.g., primidone, phenytoin, and carbamazepine),
• Medicines used to treat tuberculosis (e.g., rifampicin and rifabutin),
• HIV treatment (ritonavir, efavirenz),
• A treatment for fungal infections (griseofulvin),
• Herbal medicines containing St. John's Wort (Hypericum perforatum),

Consult your doctor or pharmacist if you need more information on 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 prevent pregnancy (see also section 3 "How to take Levonorgestrel Stada" for more information).

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

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

Pregnancy, breastfeeding, and fertility

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

Pregnancy

If you are pregnant, this medicine will not cause an abortion of an ongoing pregnancy.

If you take this medicine and become pregnant, studies to date have not shown any risk of malformations to the fetus. However, you should not take this medicine if you are pregnant.

If you become pregnant after taking levonorgestrel, you should consult your doctor. Your doctor can check if you have an ectopic pregnancy (if the fetus is developing outside the uterus). This is especially important if you have severe stomach pain after taking this medicine, if you have had an ectopic pregnancy before, or if you have had surgery on the fallopian tubes or have had pelvic inflammatory disease.

Breastfeeding

Breastfeeding is possible, but since levonorgestrel is excreted in breast milk, you should breastfeed your baby immediately before taking this medicine and avoid breastfeeding for at least 8 hours after taking levonorgestrel.

Children and adolescents

Levonorgestrel is not recommended for use in girls.

There is very limited data available in women under 16 years of age.

Driving and using machines

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

No studies have been conducted on the effects of levonorgestrel on the ability to drive and use machines.

This medicine contains lactose and sodium

If your doctor has told you that you have an intolerance to some 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 Stada

Always use this medicine exactly as described in the package leaflet or as your pharmacist has told you. 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 tablet whole with a little water and do not chew it.

• If you are using one of the medicines that may prevent Levonorgestrel Stada from working correctly (see section "Using other medicines and Levonorgestrel Stada") or if you have used one of these medicines in the last 4 weeks, Levonorgestrel Stada may be less effective for you. Your doctor may prescribe a different 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 Stada (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 as usual.

If you vomit within 3 hours of taking the tablet, you should 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.

If you are already using a regular contraceptive method, such as the pill, you can continue taking it as usual. If you do not have any menstrual bleeding during your next 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 unprotected sex again after taking this medicine (even during the same menstrual cycle), the tablets will not have any contraceptive effect, and you may become pregnant. If you are using a regular contraceptive method, such as the pill, you should continue to use it as usual.

The next period after taking Levonorgestrel Stada

After taking this medicine, your menstrual period usually occurs at the expected time, although it may be early or late by a few days. If your period is delayed by more than five days or is unusually light or heavy, or if you think you may be pregnant for any other reason, you should have a pregnancy test. If you become pregnant even after taking this medicine, it is important that you consult your doctor.

If you take more Levonorgestrel Stada than you should

No cases of acute overdose or serious side 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, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

4. Possible side effects

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

The frequency of possible side effects listed below is defined as follows:

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

Common (may affect up to 1 in 10 people)

Uncommon (may affect up to 1 in 100 people)

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

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

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

The following side effects have been observed:

Very common side effects:

• Dizziness, headache
• Nausea, abdominal pain
• Breast tenderness, delayed menstrual period, heavy menstrual bleeding, bleeding
• Fatigue

Common side effects:

• Diarrhea
• Vomiting

Frequency not known:

• There have been reports of thromboembolic events (blood clots) after marketing.
• Skin hypersensitivity may occur after taking this medicine.

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) at www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Levonorgestrel Stada

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

This medicine does not require any special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Levonorgestrel Stada

• The active substance is levonorgestrel. Each tablet contains 1.5 mg of levonorgestrel.
• The other ingredients (excipients) are: microcrystalline cellulose, lactose monohydrate, poloxamer 188, sodium croscarmellose, and magnesium stearate (E572).

Appearance and packaging

Each pack contains one tablet of 1.5 mg levonorgestrel, which is a round, white tablet, approximately 6 mm in diameter, and marked with "C" on one side and "1" on the other.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Laboratorios León Farma, S.A.

Pol. Ind. Navatejera

La Vallina s/n

24193-Villaquilambre (León)

Spain

Date of last revision of this package leaflet: January 2019

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