Levonorgestrel Teva 1.5 mg tablet EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Levonorgestrel Teva 1.5 mg tablet EFG

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

• Follow exactly the instructions for use of this medicine contained in this leaflet or as advised 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 any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Leaflet contents

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 adverse effects
5. How to store Levonorgestrel Teva
6. Contents of the pack and other information

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

Levonorgestrel Teva is an emergency oral contraceptive.

What is an emergency contraceptive?

Emergency contraception is indicated to prevent pregnancy after having had unprotected sex or when a contraceptive method has failed.

When should an emergency contraceptive 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 contraceptive failure. It is more effective the sooner it is taken after unprotected intercourse. 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 have become pregnant for any of the following reasons:

• you had sex without using contraception;
• you forgot to take your contraceptive pill at the scheduled time;
• your partner's condom broke, slipped, or came off;
• you suspect your intrauterine device (IUD) may have been expelled;
• your vaginal diaphragm or cervical cap moved or was removed too early;
• you are concerned that the withdrawal method (coitus interruptus) or rhythm method may have 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 wall of the uterus.

Levonorgestrel is only indicated as an emergency contraceptive. It is not intended for regular contraception, 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 take Levonorgestrel Teva

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Levonorgestrel Teva.

The use 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 personal or family history of known risk factors for thrombosis (blood clots),
• if you have a serious digestive disorder that impairs the absorption of food or medicines,
• if you have severe liver problems or a serious disease of the small intestine, such as Crohn's disease.

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

If unprotected sexual intercourse occurred 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 unprotected sexual intercourse during the treatment period.

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

Levonorgestrel Teva is not as effective as conventional contraceptive methods. Please consult your doctor to adopt one of the available conventional contraceptive methods, which are more effective in preventing pregnancy.

For all women, emergency contraception should be taken as soon as possible after unprotected sexual intercourse. There is some evidence that Levonorgestrel Teva may be less effective with increasing body weight or body mass index (BMI), but these data are limited and inconclusive. Therefore, Levonorgestrel Te wan 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.

After taking this medicine:

It is mandatory to exclude 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 around the expected date of your next menstruation.

If you did not use a condom (or it broke or slipped off) during sexual intercourse, you may have contracted a sexually transmitted infection or HIV. Emergency contraception does not protect you against sexually transmitted infections, and does not replace the necessary precautions and measures to prevent transmission risk.

Children and adolescents

Do not take this medicine before your first menstrual bleeding (menarche).

Use of Levonorgestrel Teva with other medicines

Inform 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 effectively. If you have taken any of the following medicines within the last 4 weeks, Levonorgestrel Teva 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 Teva 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)

Please consult your doctor or pharmacist if you need further information on the correct dosage for you.

Consult your doctor as soon as possible after taking the tablets, so that you can be advised on reliable methods of regular contraception to 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 cyclosporine (an immunosuppressant).

Levonorgestrel Teva must not be taken together 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 established pregnancy.

If you take this medicine and become pregnant despite its use, study results indicate there is no risk of fetal malformation. However, this medicine must not be administered if you are pregnant.

If you become pregnant after taking Levonorgestrel Teva, contact your doctor. Your doctor may wish 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 ever 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 to avoid breastfeeding for at least 8 hours after administration of Levonorgestrel Teva.

Driving and use of machines

After taking Levonorgestrel Teva, 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 on the ability to drive or use machinery.

Levonorgestrel Teva contains lactose

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

3. How to take Levonorgestrel Teva

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

If you are taking any of the medicines that may prevent levonorgestrel from working properly (see section "Taking other medicines with Levonorgrel Teva") or if you have taken any of these medicines within the last 4 weeks, levonorgestrel may be less effective for you. Your doctor may prescribe you 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, you may 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 oral contraceptives, you may continue taking it as usual.

If you vomit within three hours of taking the levonorgestrel tablet, you should take another tablet immediately. Contact 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 intercourse after taking levonorgestrel (during the same menstrual cycle), the tablet will not provide contraceptive protection and you are again at risk of pregnancy. If you are using a regular contraceptive method, such as oral contraceptives, you may continue taking it as usual.

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

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

Your next menstrual period after taking Levonorgestrel Teva

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

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

If you take more Levonorgestrel Teva than you should

Acute toxicity or serious harmful effects have not been observed after ingestion of several tablets of this medicine. 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, 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.

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

4. Possible adverse effects

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

The frequency of possible adverse effects is defined below using the following convention:

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 available data

The following adverse effects have been observed:

• Very common (may affect more than 1 in 10 people): dizziness, headache,
  nausea, abdominal pain,
  increased breast tenderness, menstrual delay, abnormally heavy menstruation, bleeding, uterine pain,
  fatigue.

• Common (may affect up to 1 in 10 people): diarrhoea, vomiting,
  painful periods.

• Frequency not known (cannot be estimated from available data): cases of thromboembolic events (blood clots) have been reported during the post-marketing period,
  allergic reactions such as swelling of the throat and face and urticaria may occur while taking this medicine.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 on the blister after EXP. The expiry date refers to the last day of the month indicated.

Do not use this medicine if you notice any visible signs of deterioration; in such case, return it to your pharmacist.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levonorgestrel Teva

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

Levonorgestrel belongs to a group of medicines called emergency contraceptives.

Appearance of the product and contents of the pack

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

Each pack of Levonorgestrel Teva contains one tablet of 1.5 milligrams of levonorgestrel.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

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

28108 Madrid, Spain

Manufacturer

Merckle GmbH

Ludwig-Merckle-Strasse, 3

89143 Blaubeuren, Germany

Or

Teva Pharma S.L.U

C/C, nº4, Poligono Industrial Malpica,

50016 Zaragoza, Spain

This medicinal product 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 about this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es.

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