Levonorgestrel Stada 1.5 mg tablet EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Levonorgestrel Stada 1.5 mg tablet EFG

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

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

Leaflet contents

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

Pack contents and other information

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

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

It is used in the following cases:

• If no contraceptives were used during sexual intercourse.
• If the contraceptive was not used correctly, for example, if the condom broke, slipped, or was used incorrectly, if the diaphragm was displaced, or if it was punctured, torn, or removed too early, or if withdrawal during coitus interruptus failed (e.g., semen was ejaculated into the vagina or onto the external genitals).

It contains as its active ingredient a substance called 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 having unprotected sex or after a contraceptive failure.

This medicine can only prevent you from becoming pregnant if taken within 72 hours after having unprotected sex. It will not work if you are already pregnant. If you have unprotected sex after taking this medicine, it will not prevent you from becoming pregnant.

The exact mechanism of action of levonorgestrel is unknown. It most likely 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 intended only for emergency contraception, not as a regular contraceptive method, as it is less effective than the standard oral contraceptive pill ("the pill").

2. What you need to know before taking Levonorgestrel Stada

Do not take Levonorgestrel Stada

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

Warnings and precautions

The use of this medicine is not recommended in the following cases:

• If you have had an ectopic pregnancy (pregnancy outside the uterus).
• If you have had pelvic inflammatory disease (salpingitis).
• If you or a family member have a known risk factor for thrombosis (blood clot formation).
• If you have a severe digestive disorder affecting the absorption of food and drugs.
• If you suffer from severe liver disease or a serious small intestine disorder, such as Crohn's disease.

In all women, emergency contraception should be taken as soon as possible after unprotected sexual intercourse. There is some evidence that Levonorgestrel Stada may be less effective with increasing weight or body mass index (BMI), but these data are 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 have concerns about any issues related to emergency contraception.

A history of tubal (ectopic) pregnancy or previous infection of the fallopian tubes increases the risk of a new ectopic pregnancy. Therefore, if you have previously had a tubal (ectopic) pregnancy or a fallopian tube infection, you should consult your doctor before taking this medicine.

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

• It does not always prevent pregnancy.
• The risk of excessive hormone exposure may disrupt the menstrual cycle.

Emergency contraception does not interrupt an existing pregnancy.

If you have had another unprotected sexual intercourse more than 72 hours ago, conception may already have occurred. Therefore, treatment with levonorgestrel after the second intercourse may not be effective in preventing pregnancy.

Repeated administration of levonorgestrel within the same menstrual cycle is not recommended, as it may disrupt the cycle. This medicine is not as effective as regular contraceptive methods (such as the pill or condoms). Your doctor can advise you on long-term contraceptive methods that are more effective in preventing pregnancy.

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

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

If you do not use condoms during sexual intercourse (or if a condom breaks or slips off), you may have contracted a sexually transmitted infection (STI) or HIV. The use of emergency contraceptive pills does not protect against sexually transmitted infections or HIV infection and cannot replace the necessary measures and precautions that should be taken if there is a risk of transmission.

Use of Levonorgestrel Stada 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.

This medicine must not be used in combination with emergency contraceptives containing ulipristal acetate.

Some medicines may prevent Levonorgestrel Stada from working effectively. If you have taken any of the following medicines within the last 4 weeks, Levonorgestrel Stada may be less suitable 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, a double dose of Levonorgestrel Stada 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),
• HIV treatment (ritonavir, efavirenz),
• A medicine used to treat fungal infections (griseofulvin),
• Herbal medicines containing St. John’s wort (Hypericum perforatum).

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

Consult 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 Stada" for more information).

Levonorgestrel Stada may also affect how other medicines work.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, 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 abortion of an existing pregnancy.
Studies conducted to date show no risk of fetal malformations if you become pregnant after taking this medicine. However, you should not take this medicine if you are pregnant.

If you become pregnant after taking levonorgestrel, consult your doctor. Your doctor may check whether you have an ectopic pregnancy (a pregnancy developing outside the uterus). This is especially important if you experience severe abdominal pain after taking this medicine, if you have previously had an ectopic pregnancy, 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 child immediately before taking this medicine and suspend breastfeeding for at least 8 hours after levonorgestrel administration.

Children and adolescents
The use of levonorgestrel is not recommended in girls. Very limited data are available in women under 16 years of age.

Driving and use of machines

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

No studies have been conducted on the effects of levonorgestrel on the ability to drive or operate machinery.

This medicine contains lactose and sodium

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

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

3. How to take Levonorgestrel Stada

Always use this medicine exactly as described in this leaflet or as instructed by your pharmacist. If you have any doubts, consult your doctor or pharmacist.

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

• If you are taking any of the medicines that may reduce the effectiveness of Levonorgestrel Stada (see section “Use of other medicines and Levonorgestrel Stada”) or if you have taken any of these medicines within the last 4 weeks, Levonorgestrel Stada 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 promptly, you may 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 may continue taking it as usual.

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

Contact your doctor if more than 72 hours have passed since the unprotected sexual intercourse.

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 may continue taking it as usual. If you do not have any menstrual bleeding during the next tablet-free interval, you should perform a pregnancy test to rule out pregnancy. Your doctor may recommend effective long-term contraceptive methods to prevent pregnancy.

If you have had unprotected sexual intercourse again after taking this medicine (even during the same menstrual cycle), the tablets will not provide any contraceptive effect and there is a risk of becoming pregnant. If you use a regular contraceptive method such as oral contraceptives, you should continue using it as usual.

Your next period after taking Levonorgestrel Stada

After taking this medicine, your menstrual period is usually normal and occurs on the expected day, although sometimes it may occur a few days earlier or later. 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, take a pregnancy test to confirm. If you become pregnant despite taking this medicine, it is important that you consult your doctor.

If you take more Levonorgestrel Stada than you should

No cases of acute poisoning or serious adverse effects have been reported after taking excessive 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 or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible adverse effects

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

The frequency of occurrence of the possible adverse 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 adverse effects have been observed:

Very common adverse effects:

• Dizziness, headache
• Nausea, abdominal pain
• Breast tenderness on palpation, delayed menstrual period, very heavy menstrual periods, bleeding
• Fatigue

Common adverse effects:

• Diarrhea
• Vomiting

Frequency not known:

• Thromboembolic events (blood clots) have been reported in post-marketing cases.
• Skin hypersensitivity may occur after taking this medicine.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse 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 must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point located at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levonorgestrel Stada

• The active substance is levonorgestrel. Each tablet contains 1.5 mg 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 pack

Each pack contains one 1.5 mg levonorgestrel tablet, round and white, approximately 6 mm in diameter, 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 the most recent revision of this package leaflet: January 2019

Detailed 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/.