Package Insert: Information for the User

NorLevo 1.5 mg Tablet

Levonorgestrel

NorLevo is an emergency contraceptive.

Emergency contraception is indicated for the prevention of pregnancies after having unprotected sex or in case of failure of a contraceptive method (for example: if you have forgotten to take your contraceptive pill on time; if your partner's condom has broken or slipped; if you suspect that you have expelled your intrauterine device; if your vaginal diaphragm or cervical cap has moved or if you have removed it too early; if you are concerned that the rhythm method or withdrawal method has failed).

Levonorgestrel belongs to a group of medications called emergency contraceptives.

When should emergency contraception be used?

This contraceptive method should be used as soon as possible, preferably within 12 hours and never 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. NorLevo 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 NorLevo, the medication will not prevent you from becoming pregnant.

NorLevo works by stopping the release of an egg from your ovaries. It does not stop the implantation of a fertilized egg in the uterus.

NorLevo is not a regular contraceptive, and it is only indicated as an emergency contraceptive.

NorLevo is not indicated for use before the first menstruation (menarche).

Do not take NorLevo

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take NorLevo.

• If you have had a history of ectopic pregnancy (when the fertilized egg implants outside the uterus, in the fallopian tubes),
• If you have had a history of salpingitis (infection in 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 medication, such as Crohn's disease,
• If you have severe liver problems.

A history of ectopic pregnancy and a previous infection in the fallopian tubes increases the risk of a new ectopic pregnancy. Additionally, if you have had an ectopic pregnancy or a previous infection in the fallopian tubes, you should contact your doctor before taking NorLevo.

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

The repeated administration of NorLevo within the same menstrual cycle is not recommended, due to the possibility of cycle alterations.

NorLevo is not as effective as a conventional contraceptive method. Consult your doctor to adopt one of the available conventional contraceptive methods that are more effective in preventing pregnancy.

After taking this medication:

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 menstrual period.

In all women, emergency contraception should be taken as soon as possible after having unprotected sex. There is some evidence that NorLevo may be less effective with increased weight or body mass index (BMI), but these data were limited and inconclusive. Therefore, NorLevo 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.

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, as only the use of a condom can do so.

Children and adolescents

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

Use of NorLevo with other medications

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

Some medications may prevent NorLevo from working effectively.If you have used any of the following medications in the last 4 weeks, NorLevo may not be suitable for you. Your doctor may prescribe another type of emergency contraception (non-hormonal), such as 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 NorLevo::

• barbiturates and other medications used to treat epilepsy (e.g., primidone, phenytoin, and carbamazepine),
• medications used to treat tuberculosis (e.g., rifampicin and rifabutin),
• a treatment for HIV (ritonavir, efavirenz),
• a medication for fungal infections (griseofulvin),
• herbal medications containing St. John's Wort (Hypericum perforatum).

Consult your doctor or pharmacist if you need additional information on the correct dosage for you.

Consult your doctoras 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 NorLevo” for more information).

NorLevo may also affect the proper functioning of other medications.

• a medication called cyclosporine (inhibits the immune system).

NorLevo should not be used with medications that contain ulipristal acetate.

Pregnancy and breastfeeding

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

Pregnancy

This medication does not interrupt an already established pregnancy.

If you take this medication and become pregnant despite this, the results of epidemiological studies indicate that there are no risks of malformation for the developing fetus. In any case, this medication should not be administered to pregnant women.

If you become pregnant after taking NorLevo, you should contact your doctor. Your doctor may want to confirm that your pregnancy is not ectopic. This is especially important if you experience severe abdominal pain after taking NorLevo or if you have had a previous ectopic pregnancy, fallopian tube surgery, or pelvic inflammatory disease.

Breastfeeding

Breastfeeding is possible. However, considering that levonorgestrel passes into breast milk, it is recommended to breastfeed just before taking NorLevo, and to avoid breastfeeding for at least 8 hours after taking NorLevo.

Driving and operating machinery

After taking NorLevo, some women may feel drowsy and dizzy (see section 4 of this leaflet); do not drive or operate machinery if you experience these symptoms.

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

NorLevo contains lactose

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

Use this medication exactly as described in the package insert or as directed by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

The recommended dose of NorLevo is 1 tablet.

Take the tablet as soon as possible, preferably within 12 hours, and no later than 72 hours (3 days) after unprotected sex. Do not delay taking the tablet. This medication works best when taken as soon as possible after unprotected sex. You can only prevent pregnancy if you take it within 72 hours after unprotected sex.

If you are using one of the medications that may prevent NorLevo from working correctly (see section “Use of other medications and NorLevo”) or if you have used one of these medications in the last 4 weeks, NorLevo 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 NorLevo (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 NorLevo tablet(s), you must take another tablet immediately(or two tablets if you are taking one of the medications that may prevent NorLevo from working correctly, see section “Use of other medications and NorLevo, above). Contact your doctor or pharmacist to obtain another tablet.

After using this emergency contraceptive method, it is recommended to use a barrier method (condom, spermicide, cervical cap) until the start of the next menstrual cycle. If you have unprotected sex again after taking NorLevo (during the same menstrual cycle), you are again at risk of pregnancy. The use of NorLevo does not contraindicate continuing with regular hormonal contraception.

If you have taken this medication while using an oral contraceptive (birth control pill), you should continue taking the tablets as usual until the end of the treatment. If you do not have a menstrual period during the break in taking the pill, you should perform a pregnancy test to rule out possible pregnancy.

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 birth control pill, and do not have a menstrual period during your break from the pill, you should consult your doctor to confirm that you are not pregnant.

After using NorLevo, your cycle is usually normal and will start on the usual day; however, it may be delayed or advanced by a few days.

If your period is delayed by more than 5 days or is unusually 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 medication, consult your doctor.

If you take more NorLevo than you should

After ingesting several tablets of this medication, 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 the Toxicological Information Service, phone 91 562 04 20.

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

Like all medications, this medication may produce adverse effects, althoughnot all people may experience them.

The possible adverse effects are listed below in order of their frequency:

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

Frequent (may affect up to 1 in 10 people)

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

Frequency unknown (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 pain.

Adverse effects of unknown frequency:

• During the post-marketing period, isolated cases of thromboembolic events (blood clots) have been reported.
• Cutaneous hypersensitivity reactions that may include rash, urticaria, itching, facial swelling.

These adverse reactions, usually disappear within 48 hours after administration of NorLevo. The increase in breast sensitivity and irregular spotting and bleeding have been reported in up to 30% of treated women, and may manifest until the next menstrual period, which may be delayed.

The bleeding patterns may be temporarily altered, but most women will have their next menstrual period within 7 days of the expected date.

If the next menstrual period is delayed by more than 5 days, a possible pregnancy should be ruled out.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Usehttps://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Store the blister pack in the outer packaging to protect it from light.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if 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 SIGRE drop-off point at 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 NorLevo

- The active ingredient is levonorgestrel.

- The other components are lactose monohydrate (lactose), cornstarch, povidone, anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and contents of the packaging

NorLevo is a white, round, biconvex tablet with the code NL 1.5 engraved on one face.

Each package of NorLevo contains a tablet containing 1.5 mg of levonorgestrel.

Marketing Authorization Holder

Laboratoire HRA Pharma

200 avenue de Paris

92320 CHATILLON

France

Manufacturers

Cenexi

17, rue de Pontoise

95520 Osny (France)

Delpharm Lille S.A.S.

Parc d’activités Roubaix-Est

22 rue de Toufflers

CS 50070

59452 Lys-lez-Lannoy (France)

For further information about this medicine, please contact the local representative of the marketing authorization holder:

Perrigo España S.A.

Pza. Xavier Cugat, 2 Edif. D Pl. 1ª.

08174 Sant Cugat del Vallès, Barcelona, Spain

Phone: +34 902 889 010

Last review date of this leaflet:September 2021

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