POSTINOR 1.5 mg ORALLY DISINTEGRATING TABLET

Introduction

Package Leaflet: Information for the User

Postinor 1.5 mg Oral Dispersible Tablet

levonorgestrel

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

Follow the administration instructions of the medicine contained in this leaflet or as indicated by your pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Postinor and what is it used for
2. What you need to know before taking Postinor
3. How to take Postinor
4. Possible side effects
5. Storage of Postinor
6. Contents of the pack and further information

1. What is Postinor and what is it used for

Postinor is an emergency contraceptive that can be used within 72 hours (3 days)

following unprotected sex or if your regular contraceptive method has failed.

It is used in the following cases:

• If you did not use contraception during sex.
• If the contraceptive was not used correctly, for example, if the condom broke, slipped, or was used incorrectly, if the diaphragm was displaced or perforated, or if the withdrawal method (coitus interruptus) failed (e.g., sperm was ejaculated into the vagina or external genitalia).

Postinor contains the active substance levonorgestrel. It prevents approximately 84% of expected pregnancies when taken within 72 hours of unprotected sex. It does not always prevent pregnancy and is more effective if taken as soon as possible after unprotected sex. It is best to take it within the first 12 hours, rather than delaying until the third day.

Postinor works by:

• preventing the ovaries from releasing an egg;
• preventing sperm from fertilizing any egg that may have been released.

Postinor can only prevent pregnancy if taken within 72 hours of unprotected sex. It does not work if you are already pregnant. If you have unprotected sex after taking Postinor (even during the same menstrual cycle), the medicine will not have a contraceptive effect, and you will be at risk of pregnancy again.

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

Postinor is an oral dispersible tablet that dissolves in the mouth.

2. What you need to know before taking Postinor

Do not take Postinor:

• 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 or pharmacist before taking Postinor.

If any of the following situations apply to you, inform your doctor before taking Postinor, as emergency contraception may not be suitable for you. Your doctor may prescribe a different type of emergency contraceptive.

• If you are pregnant or think you may be pregnant. This medicine will not work if you are already pregnant. If you are pregnant, Postinor will not interrupt the pregnancy, so Postinor is not an "abortion pill".

You may already be pregnant if:

• your period is more than 5 days late, or you have had unusual bleeding when your next period was due;
• you have had unprotected sex since your last period and more than 72 hours have passed.

Postinor is not recommended if:

• you have a disease of the small intestine (such as Crohn's disease) that inhibits drug absorption;

• you have severe liver problems;
• you have a history of ectopic pregnancy (when the fertilized egg implants outside the uterus);
• you have a history of salpingitis (inflammation of the fallopian tubes).

A previous ectopic pregnancy or salpingitis increases the risk of another ectopic pregnancy.

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

Girls and adolescents

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

If you are concerned about sexually transmitted diseases

If you did not use a condom (or it broke or slipped) during sex, you may have acquired a sexually transmitted disease or HIV.

This medicine will not protect you from sexually transmitted diseases, as only condom use can do that. Consult your doctor, pharmacist, nurse, or family planning center for advice if you are concerned about this.

Other medicines and Postinor

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Some medicines may prevent Postinor from working effectively. If you have used any of the following medicines in the last 4 weeks, Postinor may be less suitable for you. Your doctor may prescribe a different type of emergency contraception (non-hormonal), i.e., a copper intrauterine device (IUD). If this is not an option for you or if you cannot see your doctor quickly, you can take a double dose of Postinor (i.e., 2 tablets taken at the same time):

• 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)

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 reliable methods of regular contraception and to avoid pregnancy (see also section 3 "How to take Postinor" for more information).

Postinor may also affect the proper functioning of other medicines:

• a medicine called ciclosporin (which suppresses the immune system).

Consult your doctor before taking Postinor if you are using any of the above medicines.

How often can you use Postinor

You should only use Postinor in emergency situations and never as a regular contraceptive method. If you use Postinor more than once during the same menstrual cycle, its effectiveness is reduced, and you may experience changes in your menstrual cycle (period). Postinor does not work as well as regular contraceptive methods. Your doctor, nurse, or family planning center can advise you on long-term contraceptive methods that are more effective in preventing pregnancy.

Taking Postinor with food and drinks

Postinor can be taken at any time, regardless of meal times.

The oral dispersible tablet can be used even in situations where liquids are not available.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

You should not take this medicine if you are pregnant. If you become pregnant after taking this medicine, it is essential to consult your doctor. The available data do not indicate that Postinor can harm the embryo if used as advised. However, your doctor may want 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 Postinor or if you have had an ectopic pregnancy, fallopian tube surgery, or pelvic inflammatory disease.

Breastfeeding

The active substance of this medicine is excreted in breast milk in small amounts. It is not believed to be harmful to the baby, but if you are concerned, you can take the tablet immediately after breastfeeding and avoid breastfeeding for at least 8 hours after taking the tablet. This way, you will take your tablet well before the next feeding and reduce the amount of active substance that your child may ingest with breast milk.

Fertility

Postinor increases the possibility of changes in menstruation, which can sometimes lead to earlier or later ovulation, modifying the fertility date accordingly. Although there is no long-term fertility data after treatment with Postinor, a rapid return to fertility is expected, and regular contraceptive methods should be continued or started as soon as possible after using Postinor.

Driving and using machines

Postinor is unlikely to affect your ability to drive or use machines. However, if you feel dizzy or nauseous, do not drive or operate machinery.

Postinor containsorange yellow S (E110), aspartame (E951), and sodium

This medicine contains orange yellow S (E110), which may cause allergic reactions.

This medicine contains 0.80 mg of aspartame in each oral dispersible tablet. Aspartame is a source of phenylalanine, which may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

This medicine contains less than 23 mg of sodium (1 mmol) per oral dispersible tablet; it is essentially "sodium-free".

3. How to take Postinor

Follow the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

• You can take Postinor at any time during your menstrual cycle, except if you are already pregnant or think you may be pregnant. Remove the tablet from the blister pack with dry hands. The oral dispersible tablet should be placed on the tongue to dissolve and can be swallowed with saliva. Do not chew the tablet.
• If you are using one of the medicines that may prevent Postinor from working correctly (see section "Using other medicines and Postinor") or if you have used one of these medicines in the last 4 weeks, Postinor may be less effective for you. Your doctor may prescribe a different type of emergency contraception (non-hormonal), i.e., a copper intrauterine device (IUD). If this is not an option for you or if you cannot see your doctor quickly, you can take a double dose of Postinor (i.e., 2 tablets taken at the same time).

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

If you have unprotected sex again after taking Postinor (even during the same menstrual cycle), the tablet will not have a contraceptive effect, and you will be at risk of pregnancy again.

You are advised to consult a healthcare professional if you are concerned about any issues related to taking emergency contraceptives.

What to do if you vomit

If you vomit within 3 hours of taking the tablet, you should take another tablet immediately.

After taking Postinor

If you want to have sex after taking Postinor and are not using an oral contraceptive, you should use condoms or a diaphragm with spermicide until your next period, as Postinor will not work if you have unprotected sex again before your next period.

After taking Postinor, it is recommended that you schedule a doctor's appointment about 3 weeks later to confirm that you are not pregnant. If your period is more than 5 days late or is unusually light or heavy, you should contact your doctor as soon as possible. If you become pregnant after taking this medicine, it is essential to consult your doctor.

Your doctor will also advise you on long-term contraceptive methods that are more effective in preventing pregnancy.

If you continue to use regular hormonal contraception, such as oral contraceptives, and do not have bleeding during the period when you are not taking the contraceptive, you should consult your doctor to ensure you are not pregnant.

Your next period after taking Postinor

After using Postinor, your period usually starts on the expected day; however, it may start a few days earlier or later. If your period is more than 5 days late or you experience unusual bleeding, you should take a pregnancy test.

If you take more Postinor than you should

Although no serious harmful effects have been observed after taking several tablets at once, you may feel dizzy, vomit, or experience vaginal bleeding. You should consult your doctor or pharmacist or visit your family planning center for advice, especially if you have vomited, as the tablet may not have worked properly.

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 further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• Nausea
• Irregular bleeding until the next period
• Lower abdominal pain
• Fatigue
• Headache

Common (may affect up to 1 in 10 people):

• Vomiting. If you vomit, read the section "What to do if you vomit".
• Your period may be different. Most women will have a normal period at the expected time, but some may have their period earlier or later than usual. You may also experience irregular bleeding or spotting until your next period. If your period is more than 5 days late or is unusually light or heavy, you should contact your doctor as soon as possible.
• Increased breast tenderness, diarrhea, or dizziness after taking this medicine.

Very rare side effects (may affect up to 1 in 10,000 people):

• Rash, urticaria, itching, swelling of the face, pelvic pain, painful menstruation, abdominal pain.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Postinor

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

Do not use Postinor after the expiration date stated on the packaging and blister pack after EXP. The expiration date is the last day of the month indicated.

Store in the original packaging to protect from moisture.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Packaging Content and Additional Information

Composition of Postinor

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

The other components are:

mannitol (E 421), pregelatinized corn starch, low-substituted hydroxypropylcellulose, type B crospovidone, sodium stearyl fumarate, and opadry orange 03A230010 (hypromellose 2910, titanium dioxide (E 171), aluminum lake yellow FDC 6 (E 110), yellow iron oxide (E 172), aluminum lake carmine indigo (E 132)), anhydrous colloidal silica, aspartame (E 951), orange flavor (maltodextrin (corn), flavoring agents, alpha-tocopherol (E 307)).

Product Appearance and Packaging Content

Round tablet with a diameter of 6 mm, biconvex, pale orange in color with darker spots.

With the mark "" engraved on one side, the other side unmarked.

With a slight orange odor.

Postinor buccal dispersible tablet is packaged in a PVC/aluminum blister pack. Each blister pack is contained in a triple-layer PET/ALU/PE laminated envelope. The blister pack inside the envelope is packaged in a box that includes the package insert.

Packaging Size:

Postinor is available in packages containing 1 buccal dispersible tablet.

Marketing Authorization Holder and Manufacturer

Gedeon Richter Plc.

Gyömroi ut 19-21

1103 Budapest

Hungary

For further information on this medicinal product, please contact the local representative of the marketing authorization holder:

Gedeon Richter Iberica S.A.

Sabino Arana, 28 - 4º 2º

08028 Barcelona

Spain

Date of Last Revision of this Package Insert:May 2021

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