NOPREGY 1500 mcg Tablets

Contents of the leaflet

1. LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE USER
2. Nopregy, 1500 micrograms, tablets
   1. You should carefully read the contents of this leaflet before taking the medicine, as it contains
   2. Contents of the pack
3. What Nopregy is and what it is used for
4. Important information before taking Nopregy
   1. When not to take Nopregy
   2. Warnings and precautions
   3. Use in children and adolescents
   4. If you are worried about sexually transmitted diseases
   5. Nopregy and other medicines
   6. How often can Nopregy be used
   7. Pregnancy, breastfeeding, and fertility
   8. Driving and using machines
   9. Nopregy contains lactose and sodium
5. How to take Nopregy
   1. The tablet should be taken 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 sooner it is taken
   2. What to do if you vomit
   3. After taking Nopregy
   4. Next menstrual period after taking Nopregy
   5. Overdose
6. Possible side effects
   1. Very common (may affect more than 1 in 10 people):
   2. Common (may affect up to 1 in 10 people):
   3. Very rare (may affect up to 1 in 10,000 people):
   4. Reporting of side effects
7. How to store Nopregy
8. Contents of the pack and other information
   1. What Nopregy contains
   2. What Nopregy looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder:
   5. Manufacturer:
   6. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   7. Date of last revision of the leaflet:

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE USER

Nopregy, 1500 micrograms, tablets

Levonorgestrel

You should carefully read the contents of this leaflet before taking the medicine, as it contains

important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

• 1. What Nopregy is and what it is used for
• 2. Important information before taking Nopregy
• 3. How to take Nopregy
• 4. Possible side effects
• 5. How to store Nopregy
• 6. Contents of the pack and other information

1. What Nopregy is and what it is used for

Nopregy is an emergency contraceptive that can be used within 72 hours (3 days) of unprotected sex or when a contraceptive method has failed.

• If no contraceptive method was used during sex.
• If the contraceptive method was not used correctly, for example, if the condom slipped or was not put on correctly, if the diaphragm or cap was not in place, if it broke or was removed too early, if the penis was not withdrawn from the vagina in time during interrupted sex (e.g., ejaculation occurred in the vagina or on the external genitalia).

Nopregy contains a synthetic hormone called levonorgestrel. If taken within 72 hours of unprotected sex, it prevents pregnancy in about 84% of cases.

• It works by preventing the release of an egg from the ovaries.
• It prevents fertilization of an already released egg.

Nopregy only prevents pregnancy if taken within 72 hours of unprotected sex. It is not effective if you are already pregnant.

2. Important information before taking Nopregy

When not to take Nopregy

If you are allergic to levonorgestrel or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

If any of the following apply to you, tell your doctor before taking Nopregy, as emergency contraception may not be suitable for you. Your doctor may prescribe a different type of emergency contraception.

Nopregy may not be suitable for you if you are pregnant or think you might be pregnant. This medicine is not effective if you are already pregnant. If you are already pregnant, Nopregy will not terminate the pregnancy, as it is not an abortion pill.

You may already be pregnant if:

• Your period is more than 5 days late or you have unusual bleeding at the time of your expected period.
• More than 72 hours have passed since you had unprotected sex in the same menstrual cycle.

Nopregy is not recommended if you have:

• A disease of the small intestine (e.g., Crohn's disease) that impairs the absorption of the medicine.
• Severe liver dysfunction.
• A history of ectopic pregnancy (when the embryo develops outside the uterus).
• A history of salpingitis (inflammation of the fallopian tubes).

A history of ectopic pregnancy or salpingitis increases the risk of another ectopic pregnancy.

For all women, emergency contraception should be taken as soon as possible after unprotected sex. There is evidence that Nopregy may be less effective with increasing body weight or body mass index (BMI), but the data are limited and inconclusive. Therefore, Nopregy is still recommended for all women, regardless of their weight or BMI.

If you have any doubts about emergency contraception, talk to your doctor, pharmacist, or nurse.

Use in children and adolescents

Nopregy is not intended for use before the first menstrual period (menarche).

If you are worried about sexually transmitted diseases

If you did not use a condom (or it was damaged or slipped off), you may have been exposed to a sexually transmitted disease or HIV.

This medicine does not protect against sexually transmitted diseases. Only the use of condoms can protect against infection. If you have any doubts, talk to your doctor, nurse, family planning specialist, or pharmacist.

Nopregy and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and any you plan to take.

Some medicines may reduce the effectiveness of Nopregy. If you have taken any of the following medicines in the last 4 weeks, Nopregy may not be suitable for you. Your doctor may prescribe a different type of emergency contraception (e.g., a copper intrauterine device - Cu-IUD). If this is not the case, or if you cannot see your doctor immediately, you can take a double dose of Nopregy (i.e., 2 tablets at the same time).

• Barbiturates and other medicines used to treat epilepsy (e.g., primidone, phenytoin, and carbamazepine).
• Medicines used to treat tuberculosis (e.g., rifampicin, rifabutin).
• Medicines used to treat HIV infection (e.g., ritonavir, efavirenz).
• Medicines used to treat fungal infections (e.g., griseofulvin).
• Herbal medicines containing St. John's Wort (Hypericum perforatum).

After taking the tablets, you should see your doctor as soon as possible for further advice on regular contraception and to ensure you are not pregnant (see also section 3 "How to take Nopregy").

Nopregy may also affect the way other medicines work:

• Cyclosporin (a medicine that suppresses the immune system).

How often can Nopregy be used

Nopregy should only be used in emergency situations, not as a regular method of contraception. If Nopregy is used more than once in the same menstrual cycle, its contraceptive effect is reduced, and the risk of menstrual disturbances (menstruation) is increased.

Nopregy is not as effective as regular contraceptive methods. For information on long-term contraceptive methods that are more effective in preventing pregnancy, talk to your doctor, nurse, or family planning specialist.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Women who are pregnant should not take this medicine. If you become pregnant despite taking Nopregy, it is important to see your doctor. There is no evidence that Nopregy is harmful to the developing baby if taken according to the instructions.

However, your doctor will want to check that the pregnancy is not ectopic (when the embryo develops outside the uterus). This is especially important if you have severe abdominal pain after taking Nopregy or if you have had an ectopic pregnancy, had surgery on your fallopian tubes, or had inflammation in your pelvis.

Breastfeeding

The active substance of this medicine passes into breast milk. It is recommended that you take the tablet after breastfeeding, and then avoid breastfeeding for at least 8 hours after taking the tablet. You can express and discard the milk during this time. By taking the tablet much earlier before the next feed, you can reduce the amount of active substance that may pass to your baby through your milk.

Fertility

Taking Nopregy can increase the likelihood of menstrual disturbances, which can sometimes lead to delayed or early ovulation, affecting your fertility period. Although there is no data on the long-term effect on fertility, after taking Nopregy, you can expect a quick return to fertility, and therefore, after taking Nopregy, you should continue to use regular contraception or start using it as soon as possible.

Driving and using machines

It is unlikely that Nopregy will affect your ability to drive or use machines. However, if you feel tired or dizzy, you should not drive or operate machinery.

Nopregy contains lactose and sodium

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which is essentially "sodium-free".

3. How to take Nopregy

The tablet should be taken 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 sooner it is taken

after unprotected sex, the more effective it will be. The tablet will only prevent pregnancy if taken within 72 hours of unprotected sex.

This medicine should always be taken exactly as directed by your doctor. If you are unsure, talk to your doctor or pharmacist.

• The tablet should be taken as soon as possible, preferably within 12 hours and no later than 72 hours (3 days) after unprotected sex. Nopregy can be taken at any time during the menstrual cycle, provided you are not pregnant or do not think you might be pregnant. The tablet should be swallowed whole, with water, without chewing. Do not delay taking the tablet. The sooner it is taken after unprotected sex, the more effective it will be.

If you are taking any medicines that may reduce the effectiveness of Nopregy (see "Nopregy and other medicines" above) or if you have taken any of these medicines in the last 4 weeks, Nopregy may not be suitable for you. Your doctor may prescribe a different type of emergency contraception (e.g., a copper intrauterine device - Cu-IUD). If this is not the case, or if you cannot see your doctor immediately, you can take a double dose of Nopregy (i.e., 2 tablets at the same time).

• If you are using a regular contraceptive method, such as the pill, you can continue to take it as usual.

If you have unprotected sex again (even in the same menstrual cycle) after taking Nopregy, the tablet will not have a contraceptive effect, and there is a risk of becoming pregnant again.

What to do if you vomit

If you vomit within 3 hours of taking the tablet, you should take another tablet as soon as possible.

After taking Nopregy

If you are not using a contraceptive method and plan to have sex after taking Nopregy, you should use a condom or a diaphragm with spermicides until your next period. This is necessary because Nopregy will not be effective if you have unprotected sex again before your next period.

About 3 weeks after taking Nopregy, you should see your doctor to ensure that the treatment was effective. If your period is more than 5 days late or you experience unusual bleeding, you should see your doctor as soon as possible. If you become pregnant despite taking Nopregy, it is important to see your doctor.

Your doctor may also provide information on long-term contraceptive methods that are more effective in preventing pregnancy.

If you continue to use a regular hormonal contraceptive method (e.g., the pill) and do not have a period during the pill-free interval, you should see your doctor to rule out pregnancy.

Next menstrual period after taking Nopregy

After taking Nopregy, your period is usually normal and starts on the expected date, but it may start a few days earlier or later than usual. If your period is more than 5 days late or you experience unusual bleeding, you should see your doctor as soon as possible.

Overdose

Although no serious side effects have been reported after taking too many tablets at once, you may experience nausea, vomiting, and bleeding from the genital tract. You should talk to your doctor, pharmacist, nurse, or family planning specialist, especially if you vomit, as the tablet may not work.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Nopregy can cause side effects, although not everybody gets them.

Some side effects are listed below, according to their frequency:

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

• Nausea;
• Until the next menstrual period, you may experience irregular bleeding or spotting;
• Lower abdominal pain may occur;
• Feeling tired;
• Headache.

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

• Vomiting. If you vomit, read the section "What to do if you vomit".
• Your period may be different than usual. Most women have a normal period at the expected time, but some may experience a delayed or early period. You may also experience irregular bleeding or spotting. If your period is more than 5 days late or you experience unusual bleeding, you should see your doctor as soon as possible.
• Breast tenderness, diarrhea, dizziness, which may occur after taking the medicine.

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

• Rash, hives, itching, swelling of the face, pelvic pain, painful periods.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist.

Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nopregy

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

Do not use this medicine after the expiry date stated on the packaging and blister after EXP.

The expiry date refers to the last day of the month.

There are no special storage instructions for this medicinal product.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Nopregy contains

The active substance is levonorgestrel. Each tablet contains 1500 micrograms of levonorgestrel.

The other ingredients are microcrystalline cellulose, lactose monohydrate, poloxamer 188, sodium croscarmellose, and magnesium stearate.

What Nopregy looks like and contents of the pack

Each pack contains one complete treatment in the form of a round, white tablet, approximately 6 mm in diameter, marked with "C" on one side and "1" on the other.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Medreg s.r.o.

Na Florenci 2116/15

Nové Město

110 00 Prague 1

Czech Republic

tel.: (+420) 516 770 199

Manufacturer:

Laboratorios León Farma, S.A.

C/La Vallina s/n, Poligono Industrial Navatejera

24193 Villaquilambre, León

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Netherlands:

Levonorgestrel 1,5 mg Focus, tabletten

Poland:

Nopregy

Portugal:

Ivolen

Romania:

Emergana 1,5 mg comprimate

Spain:

Kallya 1,5 mg comprimido

Date of last revision of the leaflet: