Package Leaflet: Information for the Patient

Levonorgestrel Teva1,5 mgfilm-coated tablet

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

• Follow exactly the administration instructions contained in this leaflet or those given by your doctor, pharmacist or nurse.
• Keep this leaflet, as you may need to read it again.
• For advice on any aspect of your dose, contact your pharmacist.
• Ifyou experience any side effects, consult your doctor, pharmacist or nurse, even if they do not appear in this leaflet. See section 4.

LevonorgestrelTevais an emergency contraceptive.

What is an emergency contraceptive?

An emergency contraceptive is indicated to prevent pregnancies afterhaving unprotected sex or when the 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 having unprotected sex or when the used contraceptive method has failed. It is more effective if taken as soon as possible after unprotected sex.Levonorgestrelcan onlypreventpregnancy if taken within 72 hours after having unprotected sex. It is not effective if already pregnant. If having unprotected sex after takinglevonorgestrel, the medication will not prevent pregnancy.

Levonorgestrelhas demonstrated a 52% to 85% effectiveness in preventing expected pregnancies.

If suspects that may have become pregnant due to any of the following reasons:

• if having had sex and no contraceptives were used;
• if forgot to take the contraceptive pill at the scheduled time;
• if the partner's condom broke, slipped, or fell off;
• if fears that the intrauterine device has been expelled;
• if the vaginal diaphragm or cervical cap has moved or was removed prematurely;
• if concerned that thecoitus interruptusor rhythm method has failed;
• in case of rape.

Levonorgestrelfunctions by preventing the ovaries from releasing an egg. It cannot prevent a fertilized egg from adhering to the uterine wall.

Levonorgestrelis only indicated as an emergency contraceptive,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 bleeding (menarche).

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 takeLevonorgestrelTeva.

The administration ofLevonorgestrelTevais not recommended in the following cases:

- if you have had an ectopic pregnancy,

- if you have had a salpingitis (infection of the Fallopian tubes),

- if you have a personal or family history of known risk factors for thrombosis (blood clots),

- if you have a serious digestive problem that prevents the absorption of food or medicines,

- if you have severe liver disease or a serious disease of the small intestine, such as Crohn's disease,

Previous ectopic pregnancy or salpingitis increases the risk of a new ectopic pregnancy. If you have had an ectopic pregnancy or salpingitis, contact your doctor before takingLevonorgestrelTeva.

If unprotected sex occurred more than 72 hours ago within the same menstrual cycle, consider the possibility of pregnancy.LevonorgestrelTevamay not be effective if you have a second sexual intercourse during treatment.

Repeated administration ofLevonorgestrelTevawithin the same menstrual cycle is not recommended due to the possibility of cycle alterations.

LevonorgestrelTevais not as effective as a conventional contraceptive method. Consult your doctor for the adoption of one of the available conventional contraceptive methods that are more effective in preventing pregnancy.

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

It is recommended that you consult a healthcare professional if you are concerned about any problem 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 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 against sexually transmitted diseases, and does not replace the necessary precautions and measures to prevent transmission risk.

Children and adolescents

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

Use ofLevonorgestrelTevawith other medicines

Inform your doctor or pharmacist if you are taking, or have recently taken, any other medicine, including over-the-counter medicines or herbal medicines.

Some medicines may preventLevonorgestrelTevafrom working effectively.Ifyou have used any of the following medicines in the last 4 weeks, Levonorgestrel Teva 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 Teva:

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

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

- an HIV treatment (ritonavir, efavirenz),

- a medicine 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, to inform you about the reliable methods of regular contraception and to prevent pregnancy (see also section 3 “How to take Levonorgestrel Teva” for more information).

Levonorgestrel Tevamay also affect the correct functioning of other medicines.

- a medicine called ciclosporin (inhibits the immune system).

LevonorgestrelTevashould not be taken with medicines that contain ulipristal acetate.

Pregnancy and breastfeeding

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 medicine.

If you are pregnant:

This medicine does not interrupt an already established pregnancy.

If you take this medicine and become pregnant despite this, the studies indicate that there are no risks of malformation for the developing fetus. In anycase,this medicine should not be administered if you are pregnant.

If you become pregnant after takingLevonorgestrelTevayou should contact your doctor. Your doctor may want to confirm if your pregnancy is not ectopic (when the fertilized egg implants outside the uterus).

This is especially important if you experience severe abdominal pain after takingLevonorgestrelTevaor if you have ever had an ectopic pregnancy, tubal 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 just before takingLevonorgestrelTevaand to avoid breastfeeding for at least 8 hoursafter administration ofLevonorgestrelTeva.

Driving and operating machines

After takingLevonorgestrelTeva, some women may feel drowsiness and dizziness (see section 4 “Possible side effects”); do not drive or operate machines if you experience these symptoms.

No studies have been conducted on the effects on the ability to drive and operate machines.

LevonorgestrelTevacontains lactose

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

Use this medicine exactly as described in the package insert 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 correctly (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), 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 (that is, 2 tablets taken at the same time).

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

If you vomit within three hours of taking the levonorgestrel tablet, you should take another tablet immediately. Go to your pharmacist or doctor to get another tablet.

After using this emergency contraceptive method, it is recommended to use a barrier method of contraception (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 its contraceptive effect and you will be at risk of pregnancy again. If you are using a regular contraceptive method, such as the oral contraceptive pill, you can continue taking it with the same regularity.

Your doctor may inform you of long-term contraceptive methods since they are more effective in preventing pregnancy.

If you continue using regular hormonal contraception, such as the contraceptive pill, and do not have bleeding during your pill-free period, go to 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, it may sometimes be delayed or advanced by a few days.

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

If you take moreLevonorgestrelTevathan you should

After taking several tablets of this medicine, no acute toxicity or serious harmful 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 ingested.

If you have any other doubts about the use of thismedicine, ask your doctor, pharmacist, or nurse.

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

Below, the frequency of possible adverse effects is defined using the following convention:

Very frequent:may affect more than 1 in 10 people

Frequent: may affect up to 1 in 10 people

Infrequent: 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

Unknown frequency: cannot be estimated from available data

The following adverse effects have been observed:

Very frequent adverse effects:

• dizziness, headache,
• nausea, abdominal pain,
• increased sensitivity in the breasts, delayed menstruation, exceptionally intense menstruation, bleeding, uterine pain,
• fatigue.

Frequent adverse effects:

• diarrhea, vomiting,
• menstrual cramps.

Adverse effects of unknown frequency:

• cases of thromboembolic events (blood clots) have been reported during the post-marketing period,
• allergic reactions such as throat and facial swelling and urticaria may occur while taking this medication.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Itdoes not require special storage conditions.

Do not usethis medicationafter the expiration date that appears onthe packaging and in the blisterafter CAD. The expiration date is the last day of the month indicated.

Do not usethis medicationif you observe visible signs of deterioration; it should be returned to your pharmacist.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGREpoint of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Levonorgestrel Teva

-The active ingredient is levonorgestrel. Each tablet contains 1.5 milligrams of levonorgestrel.

-The other components are lactose monohydrate (lactose) (see section 2 “Levonorgestrel Teva contains lactose”), povidone, cornstarch, 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 size, marked with “145” on one side and not marked on the other side.

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

Marketing authorization holder and manufacturer responsible

Marketing authorization holderofLevonorgestrel Teva

Teva Pharma, S.L.U.

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

28108 Madrid

Manufacturer responsible

Merckle GmbH

Ludwig-Merckle-Street, 3

89143 Blaubeuren, Germany

Or

Teva Pharma B.V.

Swensweg 5, 2031 GA Haarlem

Netherlands

Or

Teva Pharma S.L.U

C/C, nº4, Polígono Industrial Malpica,

50016 Zaragoza, Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of thisleaflet:March 2023

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es.

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