Nopregy

PACKAGE LEAFLET: INFORMATION FOR THE USER

Nopregy, 1500 micrograms, tablets
Levonorgestrelum
Please read the entire leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

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 package and other information

1. What Nopregy is and what it is used for

Nopregy is an emergency contraceptive method that may be used within
72 hours (3 days) after unprotected sexual intercourse or in case of failure
of a contraceptive method used.
This includes the following situations:

• If no contraception was used during sexual intercourse.
• If the contraceptive method was used incorrectly, for example, if a condom slipped off or was used improperly, if a diaphragm or contraceptive ring has moved, torn, been damaged or removed at the wrong time, or if withdrawal was not performed correctly during coitus interruptus (e.g. ejaculation occurred inside the vagina or onto external genital organs).

Nopregy contains as the active substance a synthetic hormone called levonorgestrel. When taken within 72 hours after unprotected sexual intercourse, this medicine prevents pregnancy in approximately 84% of cases.
It will not prevent pregnancy in every case, and its effectiveness is greater
if taken as soon as possible after unprotected sexual intercourse.
It is best to take the medicine within the first 12 hours rather than waiting until the third day after unprotected intercourse.
Nopregy is believed to work by:

• inhibiting the release of an egg from the ovaries;
• preventing fertilization of an already released egg.

Nopregy prevents pregnancy only when used within 72 hours after
unprotected sexual intercourse. This medicine is not effective if the patient is already pregnant.
If unprotected sexual intercourse occurs after taking Nopregy
(also within the same menstrual cycle), the tablet may not provide contraceptive protection and
there may again be a risk of pregnancy.
Nopregy is not indicated for use before the onset of the first menstrual bleeding (menarche).

2. Important information before taking Nopregy

When not to take Nopregy
if the patient is 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 the patient, she should inform her doctor
before using Nopregy, as emergency contraception may not be suitable for her.
The doctor may prescribe another type of emergency contraception.

If the patient is pregnant or suspects she may be pregnant. This medicine is not effective
if she is already pregnant. If she is already pregnant, Nopregy cannot terminate
the pregnancy, because Nopregy is not an abortion pill.

The patient may already be pregnant if:
her menstrual bleeding is delayed by more than 5 days, or she experiences unusual bleeding on the day her period was expected,
more than 72 hours have passed since unprotected intercourse occurred within the same menstrual cycle.

Nopregy is not recommended if:
the patient has a small intestine disorder (e.g. Crohn's disease) that impairs absorption of the medicine,
the patient has severe liver function disorders,
the patient has previously had an ectopic pregnancy (a pregnancy developing outside the uterus),
the patient has had salpingitis (inflammation of the fallopian tubes).

A previous history of ectopic pregnancy or tubal infection increases the risk of another ectopic pregnancy.

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

If there are any doubts regarding the use of emergency contraception, the patient should consult a doctor, pharmacist, or nurse.

Use in children and adolescents
Nopregy is not indicated for use before the first menstrual period (menarche).

If the patient is concerned about sexually transmitted infections
If a condom was not used during intercourse (or if it broke or slipped off), there may be a risk that the patient has contracted a sexually transmitted infection or HIV.
This medicine does not protect against sexually transmitted infections. Only condom use can protect against infection. If in doubt, the patient should consult a doctor, nurse, family planning specialist, or pharmacist.

Nopregy and other medicines
The patient should inform her doctor or pharmacist about any medicines she is currently taking, has recently taken, or plans to take.

Some medicines may reduce the effectiveness of Nopregy. If the patient has taken any of the following medicines within the last 4 weeks, Nopregy may not be suitable for her. The doctor may prescribe another type (non-hormonal) of emergency contraception (after unprotected intercourse), such as a copper intrauterine device (Cu-IUD). If this does not apply to the patient or she cannot see a doctor immediately, she may take a double dose of Nopregy:

• 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 (ritonavir, efavirenz);
• medicines used to treat fungal infections (griseofulvin);
• herbal products containing St. John's wort (Hypericum perforatum).

For additional information on the correct dosage, the patient should contact her doctor or pharmacist.

After taking the tablets, the patient should contact her doctor as soon as possible for further advice on regular contraception and to confirm she is not pregnant (see also section 3 "How to take Nopregy").

Nopregy may also affect the action of other medicines:

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

How often can Nopregy be used
Nopregy should only be used in emergency situations and not as a regular method of
contraception. If Nopregy is used more than once within the same menstrual cycle, its contraceptive effect is reduced, and there is a higher risk of menstrual cycle disturbances.

Nopregy is not as effective as regular contraceptive methods. For information on long-term contraceptive methods that are more effective in preventing pregnancy, the patient should consult her doctor, nurse, or family planning specialist.

Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Pregnant women should not use this medicine. If the patient becomes pregnant despite using the medicine, it is important to consult a doctor. There is no evidence that Nopregy has harmful effects on the developing fetus if used according to instructions.

However, the doctor may want to rule out an ectopic pregnancy (a pregnancy developing outside the uterus). This is particularly important if the patient experiences severe abdominal pain after taking Nopregy, or if she has previously had an ectopic pregnancy, undergone fallopian tube surgery, or had pelvic inflammatory disease.

Breastfeeding
The active ingredient in this medicine passes into breast milk. It is recommended that the patient take the tablet immediately after breastfeeding, then avoid breastfeeding for at least 8 hours after taking levonorgestrel, and express milk using a breast pump during these 8 hours. By taking the tablet well before the next feeding, the amount of active ingredient transferred to the infant through breast milk can be minimized.

Fertility
Taking Nopregy may cause menstrual disturbances, which may sometimes delay or accelerate ovulation, thereby affecting the fertile period. Although there are no data on long-term effects on fertility, fertility is expected to return quickly after using Nopregy. Therefore, after taking Nopregy, the patient should continue using regular contraception or start using it as soon as possible.

Driving and operating machinery
It is unlikely that Nopregy affects the ability to drive or operate machinery. However, if the patient experiences fatigue or dizziness, she should not drive or operate machinery.

Nopregy contains lactose and sodium
If the patient has been previously diagnosed with intolerance to certain sugars, she should consult her doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "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 sexual intercourse. Do not delay taking the tablet. The sooner the tablet is taken after unprotected sexual intercourse, the more effective it will be. The tablet prevents pregnancy only if taken within 72 hours after unprotected sexual intercourse.
This medicine should always be used according to the doctor's instructions. If in doubt, consult a 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 sexual intercourse. Nopregy may be used on any day of the menstrual cycle, provided the woman is not pregnant and does not suspect she may be pregnant. The tablet must not be chewed; it should be swallowed whole with water. Do not delay taking the tablet. The sooner it is taken after unprotected sexual intercourse, the more effective it will be.

• If the woman is taking any medicines that may interfere with the proper action of Nopregy (see section above "Nopregy and other medicines") or if she has taken any of these medicines within the last 4 weeks, Nopregy may not be suitable for her. The doctor may prescribe another type of (non-hormonal) emergency contraception (after unprotected sexual intercourse), such as a copper-containing intrauterine device (Cu-IUD). If this does not apply to the woman or if she cannot see a doctor immediately, a double dose of Nopregy (i.e. 2 tablets taken simultaneously) may be taken.

• If the woman is using regular contraception, such as oral contraceptives, she may continue taking them as recommended.

If another episode of unprotected sexual intercourse occurs after taking Nopregy (including within the same menstrual cycle), the tablet will not provide contraceptive protection, and there is again a risk of pregnancy.

What to do if vomiting occurs
If vomiting occurs within three hours after taking the tablet, another tablet should be taken immediately.

After taking Nopregy
If the woman is not using any contraceptive methods and plans to have sexual intercourse after taking Nopregy, she should use condoms or a cervical cap together with spermicidal agents until the next menstrual bleeding occurs. This is necessary because Nopregy is not effective in preventing pregnancy from any further unprotected sexual intercourse before the next expected menstrual period.

Approximately three weeks after taking Nopregy, it is recommended that the woman visits a doctor to confirm that the treatment was effective. If menstrual bleeding is delayed by more than 5 days or if the bleeding is unusually light or heavy, the woman should contact her doctor as soon as possible. If pregnancy occurs despite taking the medicine, it is important to consult a doctor.

The doctor may also provide information about long-term contraceptive methods that offer more effective protection against pregnancy.

If the woman continues using regular hormonal contraception, such as oral contraceptives, and does not experience menstrual bleeding during the tablet-free interval, she should consult a doctor to rule out pregnancy.

Next menstrual bleeding after taking Nopregy
After taking Nopregy, menstrual bleeding usually occurs at the expected time, although it may sometimes occur a few days earlier or later. If menstrual bleeding starts more than 5 days later than expected, if the bleeding is unusual, or if the woman suspects she may be pregnant, she should confirm whether she is pregnant using a pregnancy test.

Taking more than the recommended dose of Nopregy
Although severe adverse effects have not been reported following an overdose of the tablets taken simultaneously, nausea, vomiting, and vaginal bleeding may occur. A doctor, pharmacist, nurse, or family planning specialist should be consulted, especially if vomiting has occurred, as the tablet may not have been effective in such a case.

If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The possible side effects are listed below, grouped by frequency of occurrence:
Very common (may occur in more than 1 in 10 women):

• Nausea;
• Irregular intermenstrual bleeding may occur until the next menstrual bleeding;
• Lower abdominal pain may occur;
• Feeling of fatigue;
• Headache.

Common (may occur in up to 1 in 10 women):

• Vomiting. If vomiting occurs, refer to the information provided in the section "What to do if vomiting occurs".
• Menstrual bleeding may differ from the usual pattern. Most women will have normal menstrual bleeding at the expected time, but in some women it may occur earlier or later than usual. Irregular bleeding or intermenstrual spotting may also occur. If menstrual bleeding is delayed by more than 5 days, or is unusually light or heavy, the woman should contact her doctor as soon as possible.
• Breast tenderness, diarrhoea, dizziness, which may occur after taking the medicine.

Very rare (may occur in up to 1 in 10,000 women):

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

Reporting of side effects
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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 Authorisation Holder.
Reporting of adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Nopregy

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the stated month.
No special storage instructions for this medicinal product.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This 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 dose in the form of a round, white tablet approximately 6 mm in diameter, marked with the letter "C" on one side and "1" on the other.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 authorised in the European Economic Area member states 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