POSTINOR 1.5 mg TABLET

Introduction

Leaflet: Information for the user

Postinor 1.5 mg tablet

levonorgestrel

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

Always take this medication exactly as described in this leaflet or as your pharmacist has told you.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your doctor or 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 leaflet:

1. What Postinor 1.5 mg tablet (hereafter Postinor) is and what it is 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. Package contents and additional information

1. What Postinor is and what it is used for

Postinor is an emergency contraceptive that can be used within 72 hours (3 days) after 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 failed (e.g., sperm was ejaculated into the vagina or onto the external genitalia).

Postinor contains the active ingredient levonorgestrel, a synthetic hormone. 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 best to take it within the first 12 hours, rather than delaying until the third day.

Postinor may work 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 after 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 medication will not have a contraceptive effect, and there is a risk of pregnancy again.

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

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 medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before taking Postinor.

If any of the following points 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 contraception.

If you are pregnant or think you may be pregnant. This medication 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 abnormal bleeding when your next period was due;
• since 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 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 weight or body mass index (BMI), but these data were limited and not conclusive. 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 medication will not protect you from sexually transmitted diseases, as only condom use can do so.

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

Other medications and Postinor

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

Some medications may prevent Postinor from working effectively. If you have used any of the following medications 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:

• barbiturates and other medications used to treat epilepsy (e.g., primidone, phenytoin, and carbamazepine),
• medications used to treat tuberculosis (e.g., rifampicin and rifabutin),
• HIV treatment (ritonavir, efavirenz),
• a medication for treating fungal infections (griseofulvin),
• herbal remedies 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 be informed 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 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 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.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be 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 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 in the past.

Breastfeeding

The active ingredient of this medication is excreted in breast milk. Therefore, it is recommended to take the tablet immediately after breastfeeding and avoid breastfeeding for at least 8 hours after administration of levonorgestrel; then express milk with a breast pump during the 8 hours following tablet intake and discard it. This way, you will be taking your tablet well before the next feeding and reducing the amount of active ingredient that your child could ingest with breast milk.

Fertility

Postinor increases the possibility of changes in menstruation, which can sometimes lead to advancing or delaying the date of ovulation, modifying fertility 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

It is unlikely that Postinor will affect your ability to drive or use machines. However, if you feel tired or dizzy, do not drive or use 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 with them before taking this medication.

3. How to take Postinor

Follow the administration instructions of the medication contained in this leaflet or as 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 unprotected sex. Do not delay taking the tablet. The medication works better the sooner you take it after unprotected sex. It can only prevent pregnancy if taken within 72 hours after 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 whole tablet with a little water and do not chew it.
• If you are using one of the medications that may 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 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 there is a risk of pregnancy again.

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

What to do in case of vomiting

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 to 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 exceptionally light or heavy, you should contact your doctor as soon as possible. If you become pregnant after taking this medication, 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 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 abnormal bleeding at that time, or if you think you might be pregnant, 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 medication and the amount ingested.

If you have any further questions on 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 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 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 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 exceptionally light or heavy, you should contact your doctor as soon as possible.

• Increased breast tenderness, diarrhea, or dizziness after taking this medication.

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

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

Reporting 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 them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Postinor

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

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

Store in the original packaging to protect from light.

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and unused medications 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

Composition of Postinor

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

The other ingredients are:

potato starch,

cornstarch,

colloidal anhydrous silica,

magnesium stearate,

talc,