Norlevo 1.5 mg tablet

Patient Information Leaflet

Introduction

Patient Information Leaflet

NorLevo 1.5 mg tablet

Levonorgestrel

Package leaflet contents

1. What NorLevo is and what it is 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. Contents of the pack and other information

1. What NorLevo is and what it is used for

NorLevo is an emergency contraceptive.

Emergency contraception is indicated for the prevention of pregnancy following unprotected sexual intercourse or in the event of contraceptive failure (for example: if you forgot to take your contraceptive pill at the scheduled time; if your partner's condom broke or slipped; if you suspect you expelled your intrauterine device; if your vaginal diaphragm or cervical cap moved or was removed too early; if you are concerned that the withdrawal method or rhythm method may have failed).

Levonorgestrel belongs to a group of medicines 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 sexual intercourse or contraceptive failure. It is more effective the sooner you take it after unprotected intercourse. NorLevo can only prevent pregnancy if taken within 72 hours of unprotected sex. It is not effective if you are already pregnant. If you have unprotected sex after taking the medicine, it will not prevent pregnancy.

This medicine works by preventing the release of an egg from your ovaries. It does not prevent the attachment of a fertilized egg to the uterus.

It is not a regular contraceptive and is only indicated for emergency use.

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 to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking NorLevo if:

• You have ever had an ectopic pregnancy (when the fertilized egg implants outside the uterus, in the fallopian tubes),
• You have had an infection in the fallopian tubes (salpingitis),
• You have personal or family history of known risk factors for thrombosis (blood clots),
• You have a severe digestive disorder that impairs the absorption of food or medicines, such as Crohn's disease,
• You have severe liver problems.

An ectopic pregnancy and previous infection in the fallopian tubes increase the risk of another ectopic pregnancy. In addition, if you have had an ectopic pregnancy or an infection in the fallopian tubes, you should contact your doctor before taking this medicine.

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;
• Repeated use carries the risk of hormonal overload and disturbances in the menstrual cycle, which are not advisable.

Emergency contraception does not terminate an existing pregnancy.

If unprotected sexual intercourse occurred 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 episode of unprotected sex during the same cycle.

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

It is not as effective as a conventional contraceptive method. You should consult your doctor to adopt one of the available conventional contraceptive methods, which are more effective in preventing pregnancy.

After taking this medicine:

It is essential to rule out 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 time of your next period.

In all women, emergency contraception should be taken as soon as possible after unprotected sexual intercourse. There is some evidence that NorLevo may be less effective with increasing weight or body mass index (BMI), but these data were limited and inconclusive. Therefore, this medicine is recommended for all women, regardless of weight or BMI.

You are advised to consult a healthcare professional if you have concerns about emergency contraception.

If you did not use a condom (or it broke or slipped off) during intercourse, you may have been exposed to a sexually transmitted infection (STI) or HIV. Emergency contraception will not protect you against sexually transmitted infections, as only condom use can provide such protection.

Children and adolescents

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

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

Taking NorLevo with other medicines

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

Some medicines may prevent NorLevo from working effectively. If you have taken any of the following medicines within the past 4 weeks, this medicine may be less suitable for you. Your doctor may prescribe another type of emergency contraception (non-hormonal), i.e., 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 NorLevo 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 (griseofulvina),
• Herbal medicines containing St. John’s wort (Hypericum perforatum).

Consult your doctor or pharmacist if you need further information about the correct dosage for you.

Consult your doctor as soon as possible after taking the tablets to discuss reliable methods of regular contraception and to avoid pregnancy (see also section 3 “How to take NorLevo” for more information).

This medicine may also affect the proper functioning of other medicines.

• A medicine called cyclosporine (an immunosuppressant).

NorLevo must not be used together with medicines containing ulipristal acetate.

Pregnancy and breastfeeding

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

Pregnancy

This medicine does not interrupt an established pregnancy.

If you take this medicine and become pregnant despite its use, epidemiological studies indicate there is no risk of fetal malformations. Nevertheless, this medicine should not be given to pregnant women.

If you become pregnant after taking NorLevo, 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 medicine or if you have previously had an ectopic pregnancy, fallopian tube surgery, or pelvic inflammatory disease.

Breastfeeding

Breastfeeding is possible. However, since levonorgestrel passes into breast milk, it is recommended to breastfeed immediately before taking NorLevo and to avoid breastfeeding for at least 8 hours after taking the medicine. During this time, any expressed milk should be discarded.

Driving and using machines

After taking NorLevo, some women may experience fatigue and dizziness (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 or operate machinery.

NorLevo contains lactose

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult with him or her before taking this medicine.

3. How to take NorLevo

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has advised you. 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 having had unprotected sex. Do not delay taking the tablet. This medicine is most effective the sooner it is taken after unprotected intercourse. It can only prevent pregnancy if taken within 72 hours after unprotected sex.

If you are taking any of the medicines that may reduce the effectiveness of NorLevo (see section "Taking other medicines and NorLevo") or if you have taken any of these medicines within the past 4 weeks, NorLevo may be less effective 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, you may take a double dose (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 after taking the tablet(s), you should take another tablet immediately (or two more tablets if you are taking one of the medicines that may reduce the effectiveness of NorLevo; see section "Taking other medicines 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 medicine (during the same menstrual cycle), you are again at risk of pregnancy. Using this medicine does not prevent you from continuing regular hormonal contraception.

If you have taken this medicine while using an oral contraceptive (birth control pill), you should continue taking your pills until the end of the treatment cycle, as usual. If you do not have menstrual bleeding during the pill-free interval, a pregnancy test should be performed to rule out pregnancy.

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

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.

After using NorLevo, your menstrual 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 if it 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 NorLevo than you should

Acute toxicity or serious harmful effects have not been observed after ingestion of multiple 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, consult your doctor or the Toxicology Information Service, telephone 91 562 04 20.

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

4. Possible adverse effects

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

The possible adverse effects listed below are categorized according to their 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 the available data)

The following adverse effects have been observed:

Very common adverse effects:

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

Common adverse effects:

• Diarrhea, vomiting.
• Painful menstruation.

Adverse effects of unknown frequency:

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

These adverse reactions usually resolve within 48 hours after administration of NorLevo. Breast tenderness and spotting or irregular 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 the next menstrual period is delayed by more than 5 days, a possible pregnancy should be ruled out.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products at https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of NorLevo

Keep this medicine 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 medicine after the expiry date stated on the packaging 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 cases, 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 point in your pharmacy. If in doubt, 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 NorLevo

• The active substance is levonorgestrel.
• The other components are monohydrate lactose (lactose), corn starch, povidone, anhydrous colloidal silica and magnesium stearate.

Appearance of NorLevo and contents of the pack

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

Each pack 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)

For further information about this medicinal product, 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
Tel: +34 902 889 010

Date of the most recent revision of this leaflet: May 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es.