Postinor 1.5 mg tablet

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Postinor 1.5 mg tablet

levonorgestrel

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

Always take this medicine exactly as described in this leaflet or as your pharmacist has instructed 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 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 1.5 mg tablet (hereinafter referred to as 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. Storage of 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 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 correctly, for example, if the condom broke, slipped, or was used incorrectly, if the diaphragm was displaced, or if it tore, broke, or was 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 synthetic hormone 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 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 (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).

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

Talk to your doctor or pharmacist before taking Postinor.

If any of the following apply to you, discuss this with 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, 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 around the time your next period was expected;
  • you have had unprotected sex after your last period 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 impairs 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.

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 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.

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 or HIV virus.

This medicine will not protect you against sexually transmitted infections, as only condom use can do so.

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

Other medicines and Postinor

Tell 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), namely a copper intrauterine device (Cu-IUD). If this is not an option for you or if you cannot see your doctor quickly, you may 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),
• 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 about the correct dosage for you.

Consult your doctor as soon as possible after taking the tablets, so you can be advised about 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 immune system inhibitor).

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 decreases and menstrual cycle disturbances (period) may occur.

Postinor does not work as well as regular contraceptive methods. Your doctor, nurse, or family planning clinic can advise you about long-acting contraceptive methods that are more effective at preventing pregnancy.

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 cause harm to 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. Therefore, it is recommended that you take the tablet immediately after breastfeeding and avoid breastfeeding for at least 8 hours after taking levonorgestrel. During the 8 hours following tablet intake, express your milk with a breast pump and discard it. This way, you take the tablet well before the next feeding, reducing the amount of active ingredient that your baby might ingest through breast milk.

Fertility

Postinor increases the likelihood of menstrual disturbances, which may 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, you should continue or start using regular contraceptive methods 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 lactose

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

3. How to take Postinor

Follow exactly the dosing instructions provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult 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 medicine is more effective the sooner it is taken after unprotected intercourse. It can only prevent pregnancy if taken within 72 hours after unprotected sex.

• You may take Postinor at any time during your menstrual cycle, except if you are already pregnant or suspect you might be pregnant. Swallow the tablet whole with a little water and do not chew it.
• If you are taking any of the medicines that may reduce the effectiveness of Postinor (see section “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 another episode of unprotected sex 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 have any concerns regarding the use of emergency contraception.

What to do in case of vomiting

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

After taking Postinor

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

After taking Postinor, it is advisable to schedule an appointment with your doctor about three weeks later to confirm that you are not pregnant. 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. If you become pregnant after taking this medicine, it is important that you consult your doctor.

Your doctor will also advise you on long-acting contraceptive methods, which are more effective in preventing pregnancy.

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

Your next period after taking Postinor

After using Postinor, your period is usually normal and will start on the expected day; however, sometimes it may occur a few days earlier or later. If your period is more than 5 days late, if 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 experience dizziness, vomiting, or 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, stating the medicine 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 may cause adverse effects, although not everyone experiences them.

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

• Nausea
• Irregular bleeding until the next menstrual period
• Pain in the lower abdomen
• 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 earlier or later than usual.
  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, diarrhea, 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.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via 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 which is stated on the outer packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicines and their packaging to your pharmacy’s SIGRE collection point. If you are unsure, ask your pharmacist how to properly dispose of medicines and their packaging that you no longer need. 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:

potato starch,

corn starch,

anhydrous colloidal silica,

magnesium stearate,

talc,

lactose monohydrate.

Appearance of the product and contents of the pack

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

Pack: one tablet in a PVC/aluminum blister pack contained within a cardboard box.

Marketing Authorization Holder and Manufacturer

Gedeon Richter Plc.

Gyömroi ut 19-21

1103 Budapest

Hungary

For further information about 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

This medicinal product is authorized in the European Economic Area member states under 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

Date of the most recent review of this leaflet: 2/07/2021

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/