NORLEVO 1.5 mg TABLET

Introduction

Package Leaflet: Information for the User

NorLevo 1.5 mg tablet

Levonorgestrel

Package Leaflet Contents

1. What is NorLevo and what is it used for
2. What you need to know before taking NorLevo
3. How to take NorLevo
4. Possible side effects
5. Storage of NorLevo
6. Package Contents and Additional Information

1. What is NorLevo and what is it used for

NorLevo is an emergency contraceptive.

Emergency contraception is indicated for the prevention of pregnancy after unprotected sex or in case of failure of a contraceptive method (e.g., if you have forgotten to take the contraceptive pill at the right 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 withdrawal method or rhythm 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 no later than 72 hours (3 days) after unprotected sex or when the contraceptive method used 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 it, the medication will not prevent you from getting pregnant.

This medication works by stopping the release of an egg from your ovaries. It does not prevent a fertilized egg from attaching to the uterus.

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

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

2. What you need to know before taking NorLevo

Do not take NorLevo

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

Warnings and Precautions

Consult your doctor or pharmacist before starting to take NorLevo.

• If you have had an ectopic pregnancy (when the fertilized egg implants outside the uterus, in the fallopian tubes),
• 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 the absorption of food or medications, such as Crohn's disease,
• If you have severe liver problems.

An ectopic pregnancy and a previous infection in the fallopian tubes increase the risk of a new ectopic pregnancy. Additionally, if you have had an ectopic pregnancy or an infection in the fallopian tubes, you should contact your doctor before taking this medication.

Emergency contraception is a method that should only be used occasionally. Under no circumstances should it replace a conventional contraceptive method because:

• It does not always prevent pregnancy;
• In the case of habitual use, there is a risk of hormonal overload and the appearance of problems during the cycle that are not recommended.

Emergency contraception does not interrupt pregnancy.

If you 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 unprotected sex during treatment.

Repeated administration of this medication within the same menstrual cycle is not recommended due to the possibility of alterations in the cycle.

It 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.

After taking this medication:

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.

In all women, emergency contraception should be taken as soon as possible after unprotected sex. There is some evidence that NorLevo may be less effective with increasing weight or body mass index (BMI), but these data were limited and not conclusive. Therefore, this medication 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 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 from sexually transmitted diseases, as only the use of a condom can do so.

Children and Adolescents

The efficacy of NorLevo in adolescents (under 18 years) is comparable to that in the adult population. The dose for adolescents is the same as for adults.

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

Using NorLevo with Other Medications

Tell your doctor or pharmacist if you are taking, or have recently taken, any other medication, including medications that can be obtained without a prescription or herbal remedies.

Some medications may prevent NorLevo from working effectively. If you have used any of the medications listed below in the last 4 weeks, this medication may be less suitable for you. If your doctor can 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 NorLevo (i.e., 2 tablets taken at the same time):

• 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 treating fungal infections (griseofulvin),
• herbal remedies that contain St. John's Wort (Hypericum perforatum).

Consult your doctor or pharmacist if you need additional information about the correct dose for you.

Consult your doctor as soon as possible after taking the tablets, so that they can inform you about reliable methods of regular contraception and avoid pregnancy (see also section 3 "How to take NorLevo" for more information).

This medication may also affect the proper functioning of other medications.

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

It should not be used with medications that contain 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 medication.

Pregnancy

This medication does not interrupt an existing pregnancy.

If you take this medication and still become pregnant, the results of epidemiological studies indicate that there is no risk of malformation to 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 this medication or if you have had an 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 avoid breastfeeding for at least 8 hours after administration of this medication. During this time, if you express milk, it should be discarded.

Driving and Using Machines

After taking NorLevo, some women feel drowsy and dizzy (see section 4 of this package leaflet); 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.

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.

3. How to Take NorLevo

Always use this medication exactly as described in the package leaflet 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. It can only prevent pregnancy if taken within 72 hours after unprotected sex.

If you are using one of the medications that may prevent NorLevo from working correctly (see section "Using 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), 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 (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 tablet(s), you should take another tablet immediately (or two tablets if you are taking one of the medications that may prevent NorLevo from working correctly, see section "Using Other Medications and NorLevo" above). Contact your doctor or pharmacist to obtain another tablet(s).

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 this medication (during the same menstrual cycle), you are at risk of pregnancy again. Its use does not contraindicate continued use of regular hormonal contraception.

If you have taken this medication while using a contraceptive pill, you should continue taking the pills until the end of the treatment, as usual. If you do not have menstrual bleeding during the pill-free period, you should perform a pregnancy test to rule out possible pregnancy.

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 contraceptive pill, and do not have menstrual bleeding during the pill-free period, you should consult your doctor to confirm that you are not pregnant.

After using NorLevo, your menstrual cycle is usually normal and will start on the usual day; however, it may sometimes 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 medication, you should consult your doctor.

If You Take More NorLevo Than You Should

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

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Possible side effects are listed below by frequency:

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

Common (may affect up to 1 in 10 people)

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

Frequency not known (cannot be estimated from available data)

The following side effects have been observed:

Very common side effects:

• Dizziness, headache.
• Nausea, abdominal pain.
• Increased breast sensitivity, delayed menstruation, exceptionally heavy menstruation, bleeding, uterine pain.
• Fatigue.

Common side effects:

• Diarrhea, vomiting.
• Painful menstruation.

Side 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 exanthema, urticaria, itching, swelling of the face.

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

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

If your next menstrual period is delayed by more than 5 days, you should rule out a possible pregnancy.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of NorLevo

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 stated on the packaging after EXP. The expiration date is the last day of the month indicated.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

NorLevo Composition

• The active ingredient is levonorgestrel.
• The other ingredients are lactose monohydrate (lactose), cornstarch, povidone, colloidal anhydrous silica, and magnesium stearate.

NorLevo Appearance and Package Contents

White, round, biconvex tablet with the code NL 1.5 engraved on one side.

Each package contains one 1.5 mg levonorgestrel tablet.

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)

You can request more information about this medication by contacting 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

Tel: +34 902 889 010

Date of the Last Revision of this Package Leaflet:May 2025

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