Postinor 1.5 mg orodispersible tablet

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Postinor 1.5 mg orodispersible tablet

levonorgestrel

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

Follow exactly the instructions for administration provided 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 any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Postinor is and what it is used for
2. What you need to know before taking Postinor
3. How to take Postinor
4. Possible adverse effects
5. How to store Postinor
6. Contents of the pack and other 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 having unprotected sex or if the regular 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 correctly, for example if the condom broke, slipped, or was used incorrectly, if the diaphragm was displaced, perforated, torn, or removed too early, or if withdrawal (coitus interruptus) failed (e.g., sperm was ejaculated into the vagina or onto the external genitals).

Postinor contains as its active substance a compound called levonorgestrel. 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 the sooner it is taken 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 after unprotected sex. It does not work if you are already pregnant. If you have unprotected sex after taking Postinor (including if this occurs during the same menstrual cycle), the medicine will not provide contraceptive protection and there is again a risk of pregnancy.

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

Postinor is an orodispersible 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 to 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, 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 medicine will not work if you are already pregnant. If you are already pregnant, Postinor will not interrupt the pregnancy; therefore, 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 around the time your next period was expected;
• after your last period, you had unprotected sex and more than 72 hours have passed.

The use of Postinor is not recommended if:

• you have a small intestine disorder (such as Crohn’s disease) that interferes with 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 a prior infection of the fallopian tubes increases the risk of a new ectopic pregnancy.

For 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 inconclusive. Therefore, Postinor is recommended for all women, regardless of weight or BMI.

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

Children and adolescents

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

If you are concerned about sexually transmitted infections

If you did not use a condom (or it broke or slipped off) during sex, you may have contracted a sexually transmitted infection (STI) or HIV.

This medicine will not protect you from sexually transmitted infections, as only condom use can do so. Consult your doctor, pharmacist, nurse, or family planning clinic 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 need to take any other medicines.

Some medicines may prevent Postinor from working effectively. If you have taken any of the following medicines within 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 (Cu-IUD). If this is not an option for you or if you cannot see your doctor quickly, a double dose of Postinor 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 (griseofulvin)
• herbal medicines containing St. John’s wort (Hypericum perforatum)

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

Consult your doctor as soon as possible after taking the tablets to discuss reliable methods of regular contraception to 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 cyclosporine (an immunosuppressant).

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

How often can Postinor be used

Postinor should only be used in emergency situations and never as a regular contraceptive method. If you use Postinor more than once during the same menstrual cycle, its effectiveness decreases and menstrual cycle disturbances (periods) may occur. Postinor is not as effective as regular contraceptive methods. Your doctor, nurse, or family planning clinic can advise you on long-acting contraceptive methods that are more effective in preventing pregnancy.

Taking Postinor with food and drink

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

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or 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 important to see a doctor. Available data do not indicate that Postinor can harm the embryo when used as directed. 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, fallopian tube surgery, or pelvic inflammatory disease.

Breastfeeding

The active ingredient in this medicine is excreted in breast milk in very small amounts. This is not considered harmful to the baby, but if you are concerned, you may take the tablet immediately after breastfeeding and avoid breastfeeding for at least 8 hours after taking the tablet. This way, you take the tablet well before the next feeding, minimizing the amount of active ingredient your baby might ingest through breast milk.

Fertility

Postinor may cause changes in menstruation that can sometimes lead to earlier or delayed ovulation, thereby altering the timing of fertility. Although there are no long-term fertility data, fertility is expected to return rapidly after treatment with Postinor. Therefore, regular contraceptive methods should be continued or initiated 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 operate machinery.

Postinor contains sunset yellow FCF (E110), aspartame (E951), and sodium

This medicine contains sunset yellow FCF (E110), which may cause allergic reactions.

This medicine contains 0.80 mg of aspartame in each orodispersible tablet. Aspartame contains a source of phenylalanine, which may be harmful if you have 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 orodispersible tablet; this is essentially “sodium-free”.

3. How to take Postinor

Follow exactly the instructions for use of the medicine contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

• You may take Postinor at any time during your menstrual cycle, except if you are already pregnant or think you might be pregnant. Remove the tablet from the blister pack with dry hands. The orodispersible tablet should be placed on the tongue to dissolve and then swallowed with saliva. Do not chew the tablet.

• If you are taking any of the medicines that may reduce the effectiveness of Postinor (see section “Use of other medicines and Postinor”) or if you have taken any of these medicines within the last 4 weeks, Postinor 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 promptly, you may 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 may continue taking it as usual.

If you have unprotected intercourse again after taking Postinor (even if this occurs during the same menstrual cycle), the tablet will not provide contraceptive protection, and there is again a risk of pregnancy.

It is recommended that you consult a healthcare professional if you are concerned about any issues related to the use of emergency contraception.

What to do in case of vomiting

If you vomit within three hours after taking the tablet, you should take another tablet immediately.

After taking Postinor

If you wish to have sexual intercourse after taking Postinor and you are not using oral contraception, you must use condoms or a diaphragm with spermicide until your next menstrual period, since Postinor will not protect you if you have unprotected intercourse again before your next period.

After taking Postinor, it is advisable to schedule an appointment with your doctor approximately three weeks later to confirm that you are not pregnant. If your period is delayed by more than 5 days, or if it is unusually light or heavy, you should contact your doctor as soon as possible. If you become pregnant after taking this medicine, it is important that you consult your doctor.

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

If you continue using your regular hormonal contraception, such as oral contraceptives, and do not have bleeding during the hormone-free interval, consult your doctor to ensure that you are not pregnant.

Your next period after taking Postinor

After using Postinor, your period is usually normal and occurs on the expected date; however, it may sometimes occur a few days earlier or later. If your period starts more than 5 days later than expected, if you experience "abnormal" bleeding, 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 experience dizziness, vomiting, or vaginal bleeding. You should consult your doctor, pharmacist, or 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

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 can cause adverse effects, although not everyone will experience them.

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

• Nausea
• Irregular bleeding until the next menstruation
• Pain in the lower abdomen
• Tiredness
• 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 earlier or later than expected. You may also experience irregular bleeding or spotting until your next period. If your period is delayed by more than 5 days, or is unusually light or heavy, you should contact your doctor as soon as possible.
• Increased breast tenderness, diarrhoea, or dizziness after taking this medicine.

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

• Rash, urticaria, itching, facial swelling, pelvic pain, painful menstruation, abdominal pain.

Reporting of adverse effects

If you experience any 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 Medicines: https://www.notificaram.es. By reporting adverse 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 expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect it from moisture.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Postinor

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

The other components are:

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

Appearance of the product and contents of the pack

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

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

With a slight orange odor.

Postinor orodispersible tablet is packaged in a PVC/aluminum blister. Each blister is contained in a triple-layer laminated PET/ALU/PE pouch. The blister within the pouch is placed in a carton box that includes the package leaflet.

Pack size:

Postinor is available in packs containing 1 orodispersible tablet.

Marketing Authorization Holder and Manufacturer

Gedeon Richter Plc.

Gyömroi ut 19-21

1103 Budapest

Hungary

More information about this medicinal product can be obtained by contacting the local representative of the Marketing Authorization Holder:

Gedeon Richter Iberica S.A.

Sabino Arana, 28 - 4th floor, 2nd door

08028 Barcelona

Spain

Date of the most recent revision of this leaflet: May 2021

Detailed and up-to-date 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/