Label: information for the user

Postinor 1.5 mg tablet

levonorgestrel

Read this label carefully before starting to use this medication, as it contains important information for you.

Take this medication exactly as described in this label or as told by your pharmacist.

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

1. What is Postinor 1.5 mg tablet (hereafter Postinor) and for what it is used

2. What you need to know before starting to take Postinor

3. How to take Postinor

4. Possible adverse effects

5. Storage of Postinor

6. Contents of the package and additional information

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

following unprotected sex or if the usual contraceptive method has failed.

It is used in the following cases:

• If no contraceptives were used during sex.
• If the contraceptive was not used correctly, for example if the condom broke, slipped, or was used incorrectly, if the diaphragm was moved out of position or if it was perforated, broken, or removed too early, or if withdrawal (coitus interruptus) failed (e.g., semen was ejaculated into the vagina or onto external genitals).

Postinor contains a synthetic hormone called levonorgestrel as its active ingredient. It prevents approximately 84% of expected pregnancies when taken within 72 hours after unprotected sex. It does not always prevent pregnancy and is more effective if taken as soon as possible after unprotected sex. It is better to take it within the first 12 hours than to delay it until the third day.

Postinor may work:

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

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

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

Do not take Postinor:

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 Postinor.

If any of the following points affect you, tell your doctor before taking Postinor as emergency contraception may not be suitable for you. Your doctor may prescribe another type of emergency contraceptive. If you are pregnant or think you may be pregnant. This medication will not work if you are already pregnant. If you are already pregnant, Postinor will not interrupt the pregnancy, so Postinor is not an "abortive pill".

You may already be pregnant if:

-your period has been delayed for more than 5 days, or if you have had abnormal bleeding when it was due for your next period;

• after your last period, you have had unprotected sex 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 the absorption of the drug;

• 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 a new ectopic pregnancy.

Emergency contraception should be taken as soon as possible after unprotected sex. There is some evidence that Postinor may be less effective with increased 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 problem related to emergency contraception.

Girls and adolescents

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

If you are concerned about sexually transmitted diseases

If you have not used a condom (or it has broken or slipped) during sex, you may have acquired a sexually transmitted disease or HIV.

This medication will not protect you against sexually transmitted diseases, as only the use of a condom can do so.

Consult your doctor or pharmacist or your family planning center for advice if you are concerned about this.

Other medications and Postinor

Inform your doctor or pharmacist if you have taken recently or may need to take any other medication.

Some medications may prevent Postinor from working effectively.If you have used any of the medications listed below in the last 4 weeks, Postinor may be less 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 Postinor:

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

Consult your doctor or pharmacist if you need additional information about the correct dose 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 avoid pregnancy. (See also section 3 "How to take Postinor" for more information).

Postinormay also affect the proper functioning of other medications.

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

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 lower 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 may advise you about long-term contraceptive methods that are more effective in preventing pregnancy.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

You should not take this medication if you are pregnant. If you become pregnant after taking this medication, it is essential to see your doctor. The available data do not indicate that Postinor can cause harm to the embryo if used as recommended. 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 ever had an ectopic pregnancy, tubal surgery, or pelvic inflammatory disease.

Breastfeeding

The active ingredient of this medication is excreted in breast milk. Therefore, take the tablet immediately after feeding your baby and avoid breastfeeding for at least 8 hours after administering levonorgestrel; after that, express and discard the milk for 8 hours after taking the tablet, and then resume breastfeeding. In this way, you are taking your tablet well before the next feeding and reducing the amount of active ingredient that your baby may ingest with the breast milk.

Fertility

Postinor increases the likelihood of changes in menstruation that may cause the ovulation date to be advanced or delayed, thereby affecting the fertility date. Although there are no long-term fertility data, it is expected that fertility will return quickly after treatment with Postinor, and therefore, regular contraceptive methods or initiation of them as soon as possible after using Postinor should be continued.

Driving and operating machinery

It is unlikely that Postinor will affect your ability to drive or operate machinery. However, if you feel tired or dizzy, do not drive or operate machinery.

Postinor contains lactose

This medication contains lactose (142.5 mg of lactose monohydrate). If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medication.

Follow exactly the administration instructions of the medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

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

• You can take Postinor at any time during your menstrual cycle except if you are already pregnant or think you may be pregnant. Take the entire tablet with a little water and do not chew it.
• If you are taking one of the medications that can prevent Postinor from working correctly (see section “Other medications and Postinor”) or if you have used one of these medications in the last 4 weeks, Postinor 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 Postinor (that is, 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 (also if this occurs during the same menstrual cycle), the tablet will not exert its contraceptive effect and there is again a risk of pregnancy.

We recommend that you consult a healthcare professional if you are concerned about any problem related to taking emergency contraceptives.

What to do in case of vomiting

If you vomit before three hours have passed since taking the tablet, you must take another tablet immediately.

After taking Postinor

If you want to have sex again after taking Postinor, and you are not using oral contraceptives, you must use condoms or a diaphragm with spermicide until your next menstruation, since Postinor will not work if you have unprotected sex again before your next menstruation.

After taking Postinor, it is advisable to schedule an appointment to see your doctor three weeks later to confirm that you are not pregnant. If your menstruation is delayed by more than 5 days or is exceptionally light or heavy, you should contact your doctor as soon as possible. If you become pregnant after taking this medication, it is essential that you consult your doctor.

Your doctor will also advise you about long-term contraceptive methods that are more effective to prevent pregnancy.

If you continue using hormonal contraceptives, such as oral contraceptives, and do not have bleeding during the period when you do not take the contraceptive, go to your doctor to ensure that you are not pregnant.

Your next period after taking Postinor

After using Postinor, your period usually returns to normal and will start on the expected day; however, in some cases, it may start a few days earlier or later. If your period starts more than 5 days later than expected, if there is abnormal bleeding at that time, or if you think you may be pregnant, you should perform a pregnancy test.

If you take more Postinor than you should

Although no serious adverse effects have been observed after taking several tablets at once, you may feel dizzy, vomit, or have vaginal bleeding. You should consult your doctor or pharmacist or your family planning center for advice, especially if you have vomited, since 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 medication and the amount ingested.

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

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

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

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

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

• Vomiting. If you experience vomiting, read the section “What to do in case of vomiting”.
• Your period may be different. Most women will have a normal period at the expected time, but some may have their period later or earlier than normal.

You may also experience irregular or spotting bleeding until your next period. If your period is delayed more than 5 days or is exceptionally light or heavy, you should contact your doctor as soon as possible.

You may also experience increased breast tenderness, diarrhea, or dizziness after taking this medication.

• Affecting the list above.

Rare adverse effects (may affect up to 1 in 10,000 people):

• Exanthema, urticaria, pruritus, facial swelling, pelvic pain, painful menstruation.

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 Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

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

Store in the original packaging to protect it from light.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and

the medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt

ask your pharmacist how to dispose of the containers and medicines you no longer

need. This will help protect the environment.

Composition of Postinor

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

The other components are:

potato starch,

cornstarch,

anhydrous colloidal silica,

magnesium stearate,

talco,

monohydrate lactose.

Appearance of the product and content of the packaging

Tablet: almost white, flat, beveled, approximately 8 mm in diameter, with the mark “G00” printed on one side.

Package: one tablet in a PVC/aluminum blister inside a cardboard box.

Holder of the marketing authorization and responsible for manufacturing

Gedeon Richter Plc.

Gyömroi ut 19-21

1103 Budapest

Hungary

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Gedeon Richter Iberica S.A.

Sabino Arana, 28 4º 2º

08028 Barcelona

Spain

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

Germany: Postinor

Austria: Postinor

Belgium: Postinor 1500

Spain: Postinor 1.5 mg tablets

France: Levonorgestrel Biogaran

Greece: Postinor 1500

Ireland: Prevenelle

Iceland: Postinor

Italy: Escapelle

Lithuania: Escapelle

Luxembourg: Postinor

Netherlands: Postinor

Norway: Postinor

Poland: Escapelle

Portugal: Postinor

United Kingdom: Levonelle 1500

Czech Republic: Escapelle

Sweden: Postinor

Last review date of this prospectus:2/07/2021

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