LEVONORGESTREL TEVA 1.5 mg TABLETS

Introduction

Patient Information Leaflet

Levonorgestrel Teva1,5 mgfilm-coated tablet

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

• Follow the administration instructions for the medicine contained in this leaflet or as indicated by your doctor, pharmacist, or nurse.
• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet.

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

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

Levonorgestrel Teva is an emergency contraceptive pill.

What is emergency contraception?

Emergency contraception is used to prevent pregnancy after unprotected sex or when the contraceptive method has failed.

When should emergency contraception be used?

This contraceptive method should be used as soon as possible, preferably within 12 hours, and no later than 72 hours (3 days) after unprotected sex or when the contraceptive method has failed. It is more effective if taken as soon as possible after unprotected sex. Levonorgestrel can only prevent pregnancy if taken within 72 hours after unprotected sex. It is not effective if you are already pregnant. If you have unprotected sex after taking levonorgestrel, the medicine will not prevent pregnancy.

Levonorgestrel has been shown to prevent 52% to 85% of expected pregnancies.

If you suspect you may be pregnant for any of the following reasons:

• if you have had unprotected sex and did not use contraception;
• if you forgot to take your contraceptive pill on time;
• if your partner's condom broke, slipped, or fell off;
• if you fear your intrauterine device has been expelled;
• if your vaginal diaphragm or cervical cap has moved or was removed too early;
• if you are concerned that the withdrawal method or rhythm method failed;
• in case of rape.

Levonorgestrel works by preventing your ovaries from releasing an egg. It cannot prevent a fertilized egg from attaching to the uterus wall.

Levonorgestrelis only indicated as an emergency contraceptive, it is not a regular contraceptive, as it is less effective than a regular contraceptive pill ("the pill").

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

2. What you need to know before taking Levonorgestrel Teva

Do not takeLevonorgestrelTeva

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Levonorgestrel Teva.

Administration of Levonorgestrel Teva is not recommended in the following cases:

• if you have had an ectopic pregnancy,
• if you have had an infection in the fallopian tubes (salpingitis),
• if you have a personal or family history of known risk factors for thrombosis (blood clots),
• if you have a severe digestive problem that prevents food or medicine absorption,
• if you have severe liver or small intestine disease, such as Crohn's disease,

A previous ectopic pregnancy or fallopian tube infection increases the risk of a new ectopic pregnancy. If you have had an ectopic pregnancy or fallopian tube infection, contact your doctor before taking Levonorgestrel Teva.

If you had unprotected sex more than 72 hours ago within the same menstrual cycle, you should consider the possibility of pregnancy. Levonorgestrel Teva may not be effective if you have a second instance of unprotected sex during treatment.

Repeated administration of Levonorgestrel Teva within the same menstrual cycle is not recommended due to the possibility of cycle disturbances.

Levonorgestrel Teva is not as effective as a conventional contraceptive method. Consult your doctor for the adoption of one of the conventional contraceptive methods available, which are more effective in preventing pregnancy.

In all women, emergency contraception should be taken as soon as possible after unprotected sex. There is some evidence that Levonorgestrel Teva may be less effective with increasing weight or body mass index (BMI), but these data are limited and not conclusive. Therefore, Levonorgestrel Teva 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.

After taking this medicine:

It is mandatory to rule out the possibility of pregnancy by performing a pregnancy test:

• if your next menstrual period is delayed by more than five days,
• if you experience abnormal bleeding on the expected date of your next menstruation.

If you did not use a condom (or it broke or slipped) during sex, you may have acquired a sexually transmitted disease or HIV. Emergency contraception will not protect you from sexually transmitted diseases, and it does not replace the necessary precautions and measures to prevent transmission risk.

Children and adolescents

Do not take this medicine before the first menstrual period (menarche).

Use ofLevonorgestrelTevawithother 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.

Some medicines may prevent Levonorgestrel Teva from working properly. If you have used any of the following medicines in the last 4 weeks, Levonorgestrel Teva 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 Teva (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 medicine used to treat fungal infections (griseofulvin),
• herbal medicines 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 they can inform you about reliable methods of regular contraception and prevent pregnancy (see also section 3 "How to take Levonorgestrel Teva" for more information).

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

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

Levonorgestrel Teva should not be taken with medicines containing ulipristal acetate.

Pregnancy and breastfeeding

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

If you are pregnant:

This medicine does not interrupt an existing pregnancy.

If you take this medicine and still become pregnant, study results indicate that there is no risk of malformation to the developing fetus. In any case, this medicine should not be administered if you are pregnant.

If you become pregnant after taking Levonorgestrel Teva, contact your doctor. 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 Teva or if you have had an ectopic pregnancy, fallopian tube surgery, or pelvic inflammatory disease.

If you are breastfeeding:

Breastfeeding is possible. However, considering that levonorgestrel is excreted in breast milk, it is recommended to breastfeed immediately before taking Levonorgestrel Teva and avoid breastfeeding for at least 8 hoursafter administration of Levonorgestrel Teva.

Driving and using machines

After taking Levonorgestrel Teva, some women feel drowsy and dizzy (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 on the ability to drive and use machines.

LevonorgestrelTevacontains lactose

Levonorgestrel Teva contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medicine.

3. How to take Levonorgestrel Teva

Always use this medicine exactly as described in the leaflet or as directed by your doctor, pharmacist, or nurse. Consult your doctor, pharmacist, or nurse if you have any doubts.

If you are using one of the medicines that may prevent levonorgestrel from working properly (see section "Use of other medicines and Levonorgestrel Teva") 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 contraceptive pill, you can continue taking it with the same regularity.

If you vomit within 3 hours of taking the levonorgestrel tablet, you should take another tablet immediately. Consult your pharmacist or doctor to obtain another tablet.

After using this emergency contraceptive method, it is recommended to use a barrier contraceptive method (condom, spermicide, cervical cap) until the start of your next menstrual cycle. If you have unprotected sex after taking levonorgestrel (during the same menstrual cycle), the tablet will not have a contraceptive effect, and you will be at risk of pregnancy again. If you are using a regular contraceptive method, such as the contraceptive pill, you can continue taking it with the same regularity.

Your doctor may inform you about long-term contraceptive methods, as they are more effective in preventing pregnancy.

If you continue using regular hormonal contraception, such as the pill, and do not have bleeding during your pill-free period, consult your doctor to confirm that you are not pregnant.

Your next menstrual period after takingLevonorgestrelTeva

After taking levonorgestrel, your cycle is usually normal and will start on the usual day; however, sometimes it may be earlier or later by a few days.

If your period is delayed by more than 5 days or is unusually light or heavy, or if you think you may be pregnant for any reason, you should confirm whether you are pregnant by performing a pregnancy test. If you become pregnant despite taking this medicine, consult your doctor.

If you take moreLevonorgestrelTevathan you should

After ingesting several tablets of this medicine, no acute toxicity or serious adverse effects have been observed. However, you may feel dizzy, nauseous (vomiting), or experience 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.

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

4. Possible side effects

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

The following convention is used to define the frequency of possible side effects:

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

Frequency not known: cannot be estimated from the available data

The following side effects have been observed:

Very common side effects:

• dizziness, headache,
• nausea, abdominal pain,
• increased breast tenderness, delayed menstruation, exceptionally heavy menstruation, bleeding, uterine pain,
• fatigue.

Common side effects:

• diarrhea, vomiting,
• painful periods.

Side effects of unknown frequency:

• thromboembolic events (blood clots) have been reported during the post-marketing period,
• allergic reactions such as throat and face swelling and hives may occur while taking this medicine.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Levonorgestrel Teva

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

No special storage conditions are required.

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

Do not use this medicine if you notice visible signs of deterioration; it should be returned to your pharmacist.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your 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 Teva

• The active ingredient is levonorgestrel. Each tablet contains 1.5 milligrams of levonorgestrel.
• The other ingredients are lactose monohydrate (lactose) (see section 2 "Levonorgestrel Teva contains lactose"), povidone, corn starch, colloidal anhydrous silica, and magnesium stearate

Levonorgestrel belongs to a group of medicines called emergency contraceptives

Product Appearance and Package Contents

Levonorgestrel Teva is a round, white to off-white, flat, uncoated tablet, 8 mm in size, marked with "145" on one side and unmarked on the other side.

Each package of Levonorgestrel Teva contains one 1.5 milligram tablet of levonorgestrel

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

Anabel Segura, 11, Edificio Albatros B, 1st floor, Alcobendas

28108 Madrid

Manufacturer

Merckle GmbH

Ludwig-Merckle-Strasse, 3

89143 Blaubeuren, Germany

Or

Teva Pharma B.V.

Swensweg 5, 2031 GA Haarlem

Netherlands

Or

Teva Pharma S.L.U.

C/C, nº4, Poligono Industrial Malpica,

50016 Zaragoza, Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet:March 2023

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

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/78802/P_78802.html