Misstala

Leaflet accompanying the packaging: information for the user

Misstala, 30 mg, coated tablet

Ulipristal acetate

Please read carefully the contents of the leaflet before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by the pharmacist, doctor, or other healthcare professional. You should keep this leaflet to be able to read it again if needed. If you have any further questions, ask your pharmacist. If you experience any side effects, including those not listed in this leaflet, tell your pharmacist, doctor, or other healthcare professional. See section 4.

Table of contents of the leaflet:

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

1. What is Misstala and what is it used for

Misstala is an emergency contraceptive product for use in cases of unprotected sex or when the contraceptive method used has failed. Misstala is an emergency contraceptive intended to prevent pregnancy after unprotected sex or when the contraceptive method used has failed. For example: in cases of unprotected sex; if a condom has broken, slipped, or been incorrectly used by either partner, or if it has not been used; if a regular contraceptive pill has not been taken as directed. The tablet should be taken as soon as possible after unprotected sex, within a maximum of 5 days (120 hours) after sex. This is because sperm can remain viable in a woman's body for up to 5 days after sex. This medicine is suitable for all women of childbearing age, including young women. The tablet can be taken at any time during the menstrual cycle. Misstala is not effective if pregnancy has already occurred. If there is a delay in the menstrual cycle, there is a possibility of pregnancy. If a menstrual period is missed or symptoms of pregnancy (breast enlargement, morning sickness) occur, consult a doctor or pharmacist before taking the tablet. If unprotected sex occurs after taking the tablet, it will not prevent pregnancy. Unprotected sex at any time during the menstrual cycle can lead to pregnancy. Misstala is not intended for use as a regular contraceptive method. If there is no regular contraceptive method in place, consult a doctor or pharmacist to choose an appropriate method. How Misstala works Misstala contains a substance called ulipristal acetate, which affects the activity of the natural hormone progesterone, which is necessary for ovulation to occur. As a result, the medicine delays ovulation. Emergency contraception is not always effective. Out of 100 women who take this medicine, approximately two will become pregnant. This medicine is a contraceptive method used to prevent pregnancy. If pregnancy occurs, it will not terminate the pregnancy. Emergency contraception does not protect against sexually transmitted infections. Only condoms protect against sexually transmitted infections. This medicine does not protect against HIV or other sexually transmitted diseases (such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis). If concerned, consult a doctor or pharmacist. More information about contraception can be found at the end of this leaflet.

2. Important information before taking Misstala

When not to take Misstala

if you are allergic to ulipristal acetate or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Misstala, talk to your doctor or pharmacist if you: have a delayed menstrual period or symptoms of pregnancy (breast enlargement, morning sickness) suggesting you may be pregnant (see section "Pregnancy, breastfeeding, and fertility"); have severe asthma; have severe liver disease. All women should take emergency contraception as soon as possible after unprotected sex. There is evidence that this medicine may be less effective in women with a higher body mass index (BMI), but this evidence is limited and inconclusive. Therefore, Misstala is still recommended for all women, regardless of body weight or BMI. If you have any doubts or concerns about emergency contraception, talk to a healthcare professional. If you become pregnant despite taking this medicine, it is important to consult a doctor. See section "Pregnancy, breastfeeding, and fertility" for more information.

Other contraceptive medicines and Misstala

This medicine may temporarily reduce the effectiveness of regularly used contraceptive methods, such as the pill and patch. If you are taking hormonal contraception after taking the tablet, you can continue to take it as usual, but you should also use condoms during each act of sex until your next menstrual period. Do not take this medicine with other emergency contraceptive pills containing levonorgestrel. Taking them together may reduce the effectiveness of this medicine.

Misstala and other medicines

Tell your pharmacist or doctor about all medicines you are taking, or have recently taken, including those obtained without a prescription or herbal medicines. Some medicines may reduce the effectiveness of Misstala. If you have taken any of the following medicines in the last 4 weeks, Misstala may not be suitable for you. Your doctor may prescribe a different type of emergency contraception, such as a copper intrauterine device (Cu-IUD): medicines used to treat epilepsy (e.g., primidone, phenobarbital, phenytoin, fosphenytoin, carbamazepine, oxcarbazepine, and barbiturates); medicines used to treat tuberculosis (e.g., rifampicin, rifabutin); medicines used to treat HIV (ritonavir, efavirenz, nevirapine); a medicine used to treat fungal infections (griseofulvin); herbal medicines containing St. John's Wort (Hypericum perforatum). Before taking Misstala, talk to your doctor or pharmacist if you are taking, or have recently taken, any of these medicines.

Pregnancy, breastfeeding, and fertility

PregnancyBefore taking this medicine, if your menstrual period is delayed, tell your pharmacist or doctor, or perform a pregnancy test to rule out pregnancy (see "Warnings and precautions"). This medicine is a contraceptive method used to prevent pregnancy. It will not terminate an existing pregnancy. If you become pregnant despite taking this medicine, there is no evidence that it will harm the pregnancy. However, it is essential to consult a doctor. As with any pregnancy, your doctor may want to check that the pregnancy is not developing outside the womb. This is especially important if you have severe abdominal pain or bleeding, or if you have had an ectopic pregnancy, tubal surgery, or a long-term (chronic) pelvic infection in the past. If you become pregnant despite taking Misstala, we encourage you to register your pregnancy with your doctor in the official registry. You can also report this information yourself on the website https://www.ulipristal-pregnancy-registry.com/pl/. This information will remain anonymous - no one will know that it relates to a specific person. Sharing this information may help women in the future understand the safety or risks of taking Misstala during pregnancy. BreastfeedingIf you take this medicine while breastfeeding, do not breastfeed for one week after taking Misstala. During this time, it is recommended to use a breast pump to maintain milk production, but discard the milk. The effect of breastfeeding within a week of taking this medicine is unknown. FertilityThis medicine does not affect future fertility. If you have unprotected sex after taking the tablet, it will not prevent pregnancy. Therefore, it is essential to use condoms until your next menstrual period. If you want to start or continue using a regular contraceptive method after taking this medicine, you can do so, but you should also use condoms until your next menstrual period.

Driving and using machines

After taking this medicine, some women may experience dizziness, drowsiness, blurred vision, and/or impaired concentration (see section 4 "Possible side effects"). If you experience these symptoms, do not drive or operate machinery.

Misstala contains lactose and sodium

If you have been diagnosed with an intolerance to some sugars, inform your pharmacist before taking Misstala. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Misstala

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or other healthcare professional. If you are unsure, ask your pharmacist or doctor. How to take the Misstala tablet Take one tablet as soon as possible, no later than 5 days (120 hours) after unprotected sex or when the contraceptive method used has failed. Take the medicine without delay. The tablet can be taken at any time during the menstrual cycle. The tablet can be taken at any time of day, before, after, or during a meal. If you are taking any medicines that may reduce the effectiveness of Misstala (see section 2 "Important information before taking Misstala"), or if you have taken any of these medicines in the last 4 weeks, Misstala may not be suitable for you. Before taking Misstala, talk to your doctor or pharmacist. Your doctor may prescribe a different type of emergency contraception, such as a copper intrauterine device (Cu-IUD). Vomiting after taking Misstala If you vomit within 3 hours of taking the tablet, take another tablet as soon as possible. Having sex again after taking Misstala If you have unprotected sex after taking the tablet, it will not prevent pregnancy. After taking the tablet, use condoms during each act of sex until your next menstrual period. Delayed menstrual period after taking Misstala After taking the tablet, a delay of a few days in the menstrual period is normal. If your menstrual period is more than 7 days late, or is unusually light or heavy, or if you experience symptoms such as abdominal pain, breast tenderness, nausea, or vomiting, you may be pregnant. Take a pregnancy test as soon as possible. If you are pregnant, it is essential to consult a doctor (see section "Pregnancy, breastfeeding, and fertility"). Taking more Misstala than recommended There have been no reports of harmful effects from taking more than the recommended dose of Misstala. However, if you have any concerns, talk to your pharmacist, doctor, or other healthcare professional. If you have any further questions about taking Misstala, ask your pharmacist, doctor, or other healthcare professional.

4. Possible side effects

Like all medicines, Misstala can cause side effects, although not everybody gets them. Some symptoms, such as breast tenderness and abdominal pain, nausea, vomiting, and feeling unwell, are also possible symptoms of pregnancy. If your menstrual period is missed and you experience these symptoms after taking Misstala, take a pregnancy test (see section 2 "Pregnancy, breastfeeding, and fertility"). Common side effects (may affect up to 1 in 10 people): nausea, abdominal pain, discomfort, vomiting painful menstruation, pelvic pain, breast tenderness headache, dizziness, mood swings muscle pain, back pain, fatigue. Uncommon side effects (may affect up to 1 in 100 people): diarrhea, heartburn, gas, dry mouth; unusual or irregular vaginal bleeding, heavy or prolonged menstrual bleeding, premenstrual syndrome, vaginal irritation or discharge, decreased or increased libido; hot flashes; changes in appetite, emotional disturbances, anxiety, restlessness, sleep disturbances, drowsiness, migraine, visual disturbances; flu; acne, skin changes, itching; fever, chills, feeling unwell. Rare side effects (may affect up to 1 in 1,000 people): pain or itching of the genitals, pain during sex, ovarian cyst rupture, unusually light menstrual bleeding; impaired concentration, dizziness, tremors, disorientation, fainting; unusual sensation in the eye, eye redness, photophobia; dry throat, thirst, taste disturbances; allergic reactions such as hives, rash, or facial swelling. Reporting side effects If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects 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 You can also report side effects 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 Misstala

Keep the medicine out of the 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 month. Store in the original packaging to protect from light. The medicine does not require any special storage precautions. Medicines should 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 Misstala contains

The active substance is ulipristal acetate. Each tablet contains 30 milligrams of ulipristal acetate. The other ingredients are: lactose monohydrate, maize starch, sodium carboxymethylcellulose (type A), magnesium stearate, hypromellose, hydroxypropylcellulose, stearic acid, talc, titanium dioxide (E 171).

What Misstala looks like and contents of the pack

White, round, biconvex tablet with a diameter of 9.0 - 9.2 mm, with "U30" engraved on one side. Misstala is available in a carton containing one transparent blister pack (PVC/PVDC/Aluminum) with 1 tablet.

Marketing authorization holder and manufacturer

Marketing authorization holder

Zentiva k.s. U kabelovny 130 Dolní Měcholupy 102 37 Prague 10 Czech Republic

Manufacturer:

Haupt Pharma Münster GmbH Schleebrüggenkamp 1548 159 Münster Germany

To obtain more detailed information about this medicine, please contact the local representative of the marketing authorization holder:

Zentiva Polska Sp. z o.o. ul. Bonifraterska 17 00-203 Warsaw tel.: +48 22 375 92 00 {logo of the marketing authorization holder}

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

Netherlands: Misstala Poland: Misstala Date of last revision of the leaflet:December 2024

USEFUL INFORMATION ABOUT CONTRACEPTION

ADDITIONAL INFORMATION ABOUT EMERGENCY CONTRACEPTION

IN CASES OF UNPROTECTED SEX

Taking emergency contraception as soon as possible after unprotected sex increases the chances of preventing pregnancy. Emergency contraception does not affect fertility. Emergency contraception may delay ovulation in the current menstrual cycle, but it will not prevent pregnancy if you have unprotected sex again. After taking emergency contraception and until your next menstrual period, use condoms during each act of sex.

ADDITIONAL INFORMATION ABOUT REGULAR CONTRACEPTIVE METHODS

If you have taken emergency contraception and are not using a regular contraceptive method (or do not have an appropriate method), consult a doctor or family planning clinic. There are many different contraceptive methods available to choose from. Examples of regular contraceptive methods: Methods used daily Contraceptive pill Methods used once a week or once a month Contraceptive patch Vaginal ring Long-acting methods Contraceptive implant Intrauterine device (IUD)