Package Insert: Information for the User

Postinor 1.5 mg Buccal Tablet

levonorgestrel

Read this package insert carefully before starting to take this medication, as it contains important information for you.

Follow exactly the administration instructions contained in this package insert or those indicated by your pharmacist.

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

1. What is 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 sexual intercourse or if the usual contraceptive method has failed.

It is used in the following cases:

• If no contraceptives were used during sexual intercourse.
• If the contraceptive was not used properly, 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 the withdrawal method failed (e.g., semen was ejaculated into the vagina or external genitalia).

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

Postinor acts:

• 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 following unprotected sexual intercourse. It does not work if you are already pregnant. If you have unprotected sexual intercourse after taking Postinor (also if this occurs during the same menstrual cycle), the medication will not exercise its contraceptive effect and the risk of pregnancy returns.

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

Postinor is a buccal tablet that dissolves in the mouth.

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 starting to take Postinor.

If any of the following situations 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. This medicine 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 by more than 5 days, or if you have had unusual bleeding when your next period was due;
• after your last period, you have had unprotected sex and more than 72 hours have passed.

Postinor is not recommended if:

• you have a condition 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 medicine will not protect you against sexually transmitted diseases, as only the use of a condom can do so. 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 or have recently taken any other medicine.

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 another type of emergency contraceptive (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 medicines used to treat epilepsy (e.g., primidone, phenytoin, and carbamazepine)
• medicines used to treat tuberculosis (e.g., rifampicin and rifabutin)
• medicines for HIV treatment (ritonavir, efavirenz)
• a medicine for fungal infections (griseofulvin)
• medicines based on plants 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, so that they can inform you about reliable methods of regular contraception and prevent 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 (inhibits the immune system).

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

How often you can 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 is not as effective as regular contraceptive methods. Your doctor, nurse, or family planning center may advise you about long-term contraceptive methods that are more effective for preventing pregnancy.

Taking Postinor with food and drinks

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

The buccal tablet can be used even in situations where there is no liquid available.

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 medicine.

Pregnancy

You should not take this medicine if you are pregnant. If you become pregnant after taking this medicine, it is essential to see 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 ever had an ectopic pregnancy, tubal surgery, or pelvic inflammatory disease.

Breastfeeding

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

Fertility

Postinor increases the likelihood of changes in menstruation that may cause the ovulation date to be advanced or delayed, thereby affecting fertility. 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 Postinor use are recommended.

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 containsyellow orange S (E110), aspartame (E951), and sodium

This medicine containsyellow orange S(E110) which may cause allergic reactions.

This medicine contains 0.80 mg of aspartame in each buccal tablet. Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of 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 with dry hands. The buccal tablet must 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 medications that can prevent Postinor from working correctly (see section “Use of 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 (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 another unprotected sex 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 the use of 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 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 sex again without protection 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 will be normal and will start on the usual 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 you have an 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 Frequent (may affect more than 1 in 10 people):

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

Frequent (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 by more than 5 days 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.

Rare Adverse Effects (may affect up to 1 in 10,000 people):

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

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 of 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 moisture.

This medication does not require special storage conditions.

Do not dispose of medications through drains or trash. Deposit empty containers and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of empty containers and unused medications. By doing so, you 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:

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

Appearance of the product and contents of the packaging

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

With the mark “” engraved on one side, the other side unengraved.

With a light orange odor.

Postinor buccal dispersible tablet is packaged in a PVC/aluminum blister. Each blister is contained in a laminated PET/ALU/PE triple-layered overwrap. The blister inside the overwrap is packaged in a box that includes the leaflet.

Package size:

Postinor is presented in packages containing 1 buccal dispersible tablet.

Holder of the marketing authorization and responsible manufacturer

Gedeon Richter Plc.

Gyömroi ut 19-21

1103 Budapest

Hungary

For further information about this medicine, please contact the local representative of the marketing authorization holder:

Gedeon Richter Iberica S.A.

Sabino Arana, 28 - 4th 2nd

08028 Barcelona

Spain

Last review date of this leaflet: May 2021

For detailed and updated information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/