Misstala

Package leaflet: Information for the user

Misstala, 30 mg, coated tablet
Ulipristal acetate
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as advised by
your pharmacist, doctor, or other healthcare professional.
Keep this leaflet as you may need to read it again.
If you have any further questions, please consult your pharmacist.
If you experience any side effects, including any not listed in this leaflet, tell your pharmacist, doctor,
or other healthcare professional. See section 4.

Contents of the leaflet:

1. What Misstala is and what it is used for
2. What you need to know 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 Misstala is and what it is used for

Misstala is an emergency contraceptive medicine.
Misstala is an emergency contraceptive intended to prevent pregnancy after unprotected sexual intercourse or when the contraceptive method used has failed. For example:

• following unprotected sexual intercourse;
• if a condom broke, slipped or was not used correctly;
• if a regular oral contraceptive pill has not been taken according to instructions.

The tablet should be taken as soon as possible after intercourse, within a maximum of 5 days (120 hours) after intercourse.
This is because sperm may remain viable in a woman's body for up to 5 days after intercourse.

This medicine is suitable for all women of reproductive age, including adolescents.
The tablet can be taken on any day of the menstrual cycle.

Misstala is not effective if pregnancy has already occurred.
If your period is delayed, there is a possibility of pregnancy. If you experience a missed period or symptoms of pregnancy (such as breast enlargement, morning sickness), you should consult a doctor or pharmacist before taking the tablet.

If you have unprotected sexual intercourse after taking the tablet, this medicine will not prevent pregnancy. Unprotected intercourse at any time during the menstrual cycle may result in pregnancy.

Misstala is not intended for use as a regular contraceptive method.
If you do not use a regular contraceptive method, you should consult your 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, required for ovulation to occur. As a result, the medicine delays ovulation. Emergency contraception is not always effective.
Out of 100 women who use this medicine, approximately two will become pregnant.

This medicine is a contraceptive method used to prevent pregnancy. If pregnancy has already occurred, it will not terminate it.

Emergency contraception does not protect against sexually transmitted infections
Only condoms provide protection against sexually transmitted infections. This medicine does not protect against HIV infection or other sexually transmitted diseases (such as chlamydia, genital herpes, genital warts, gonorrhoea, hepatitis B, or syphilis). If you have concerns, please consult your doctor or pharmacist.

Additional information about contraception can be found at the end of this leaflet.

2. Important information before taking Misstala

When not to take Misstala
if the patient is allergic to ulipristal acetate or any of the other ingredients of this
medicine (listed in section 6).

Warnings and precautions
Before taking Misstala, speak to your doctor or pharmacist if:

• your period is late or you have symptoms of pregnancy (such as breast tenderness, morning sickness)
  suggesting you might be pregnant (see section "Pregnancy, breastfeeding and fertility");
• you have severe asthma;
• you have severe liver disease.

All women should use emergency contraception promptly after unprotected sexual intercourse.
There is evidence that this medicine may be less effective in women with increased body weight or higher body mass index (BMI), although data are limited and inconclusive. Therefore, Misstala is still recommended for all women regardless of body weight or BMI.

If you have any doubts or concerns regarding the use of emergency contraception, speak to a healthcare professional.
If pregnancy occurs despite taking this medicine, it is important to consult your doctor. See section "Pregnancy, breastfeeding and fertility" for further information.

Other contraceptives and Misstala
This medicine may temporarily reduce the effectiveness of regularly used hormonal contraceptives such as pills and patches.

If you are using hormonal contraception, you may continue taking it as usual after taking the tablet, but you must use condoms during each sexual intercourse until your next menstrual period begins.

Do not take this medicine together 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 currently taking or have recently taken, including those obtained without a prescription, as well as herbal medicines.

Some medicines may reduce the effectiveness of Misstala. If you have taken any of the following medicines within the last 4 weeks, Misstala may not be suitable for you. Your doctor may prescribe another type of (non-hormonal) 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 infection (ritonavir, efavirenz, nevirapine),
• medicine used to treat fungal infections (griseofulvin),
• herbal products containing St John's wort (Hypericum perforatum).

Before using Misstala, speak to your doctor or pharmacist if you are taking (or have recently taken) any of the medicines listed above.

Pregnancy, breastfeeding and fertility

Pregnancy
Before taking this medicine, if your period is late, inform your pharmacist or doctor or perform a pregnancy test to rule out pregnancy (see "Warnings and precautions").

This medicine is an emergency contraceptive intended to prevent pregnancy. It does not terminate an existing pregnancy.

If pregnancy occurs despite taking this medicine, there is no evidence that it will harm the pregnancy. However, it is important to consult your doctor. As with any pregnancy, your doctor may want to check whether the pregnancy is ectopic. This is particularly important if you experience severe abdominal pain or bleeding, or if you have previously had an ectopic pregnancy, tubal surgery, or chronic pelvic infection.

If pregnancy occurs after using Misstala, we encourage you to report the pregnancy to the official registry via your doctor. You may also report it yourself at https://www.ulipristal-pregnancy-registry.com/pl/. Your information will remain anonymous—no one will know the report refers to you. Sharing this information may help women in the future understand the safety or risks of using Misstala during pregnancy.

Breastfeeding
If you take this medicine while breastfeeding, do not breastfeed for one week after taking Misstala. During this time, use a breast pump to maintain milk production, but discard the milk. The effect of breastfeeding within one week after taking this medicine is unknown.

Fertility
This medicine does not affect future fertility. If you have unprotected sexual intercourse after taking the tablet, it will not prevent pregnancy. Therefore, it is important to use condoms until your next period.

If you wish to start or continue using a regular contraceptive method after taking this medicine, you may 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 any of these symptoms, do not drive or operate machinery.

Misstala contains lactose and sodium
If you have been previously diagnosed with an intolerance to certain sugars, inform your pharmacist before taking Misstala.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet; this means the medicine is considered "sodium-free".

3. How to take Misstala

This medicine should always be taken exactly as described in this patient leaflet or as advised by your doctor, pharmacist or other healthcare professional. If in doubt, consult your pharmacist or doctor.

How to take the Misstala coated tablet
Take one tablet orally as soon as possible, no later than 5 days (120 hours) after unprotected sexual intercourse or in case the contraceptive method used has failed. The medicine should be taken without delay.
The tablet may be taken on any day of the menstrual cycle.
The tablet may be taken at any time of day, before, after or during a meal.
If the patient is taking any medicines that may reduce the effectiveness of Misstala (see section 2 "Important information before taking Misstala") or if the patient has taken any of these medicines within the last 4 weeks, Misstala may not be suitable. Consult your doctor or pharmacist before using Misstala. Your doctor may prescribe another type of (non-hormonal) emergency contraception, such as a copper intrauterine device (Cu-IUD).

Vomiting after taking Misstala
If vomiting occurs within 3 hours after taking the tablet, take another tablet immediately.

Having further sexual intercourse after taking Misstala
If unprotected sexual intercourse occurs after taking the tablet, pregnancy may occur. After taking the tablet, until the next menstrual period appears, condoms must be used for every sexual intercourse.

Delayed menstruation after taking Misstala
A delay of a few days in the onset of menstruation after taking the tablet is normal.
If menstruation is more than 7 days late; is unusually light or unusually heavy; or if symptoms such as abdominal (stomach) pain, breast tenderness, nausea or vomiting occur, pregnancy may have occurred. A pregnancy test should be performed immediately. In case of pregnancy, it is important to consult a doctor (see section "Pregnancy, breastfeeding and fertility").

Taking more than the recommended dose of Misstala
There have been no reports of harmful effects following the intake of more than the recommended dose. Nevertheless, consult a pharmacist, doctor or other healthcare professional.

If you have any further questions about the use of this medicine, consult your pharmacist, doctor or other healthcare professional.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Some symptoms such as breast tenderness and abdominal (stomach) pain, vomiting, feeling unwell
(nausea) are also possible signs of pregnancy. If menstruation does not occur and you experience any
of the above symptoms after taking Misstala, a pregnancy test should be performed
(see section 2 "Pregnancy, breastfeeding and fertility").

Frequent adverse reactions (may occur in 1 out of 10 people):
nausea, abdominal (stomach) pain, feeling of discomfort in the abdomen, vomiting
painful menstruation, pelvic pain, breast tenderness
headache, dizziness, mood changes
muscle pain, back pain, fatigue.

Uncommon adverse reactions (may occur in 1 out of 100 people):
diarrhea, heartburn, flatulence, dry mouth;
abnormal or irregular vaginal bleeding, heavy or prolonged menstrual bleeding,
premenstrual tension syndrome, vaginal irritation or discharge, decreased or increased
libido;
hot flushes;
changes in appetite, emotional disturbances, anxiety, restlessness, sleep problems,
drowsiness, migraine, visual disturbances;
flu-like symptoms;
acne, skin changes, skin itching;
fever, chills, feeling unwell.

Rare adverse reactions (may occur in 1 out of 1000 people):
pain or itching of the genital organs, pain during sexual intercourse, ovarian cyst rupture,
abnormally light menstrual bleeding;
difficulty concentrating, dizziness, tremor, disorientation, fainting;
unusual sensation in the eye, eye redness, photophobia;
dry throat, thirst, taste disturbances;
allergic reactions such as urticaria, rash or facial swelling.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the 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 the abbreviation "EXP". The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from light.
This medicine does not require any special storage temperature precautions.
Medicines must not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer in use. 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: monohydrate lactose, pregelatinized starch (corn), sodium carboxymethyl starch (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, imprinted with the code "U30" on one side.
Misstala is supplied in a cardboard carton containing one transparent PVC/PVDC/Aluminium blister pack with 1 tablet.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer:
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
48159 Münster
Germany

For more detailed information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00
{logo of the Marketing Authorisation Holder}

This medicinal product is authorised in the following European Economic Area countries under the following names:
Netherlands: Misstala
Poland: Misstala

USEFUL INFORMATION ABOUT CONTRACEPTION
ADDITIONAL INFORMATION ABOUT EMERGENCY CONTRACEPTION
The sooner emergency contraception is used, the greater the chance of avoiding pregnancy.
Emergency contraception does not affect fertility.
Emergency contraception may delay ovulation in the current menstrual cycle, but it does not prevent pregnancy if unprotected sexual intercourse is repeated. After using emergency contraception and until the next menstrual period occurs, condoms must be used during every sexual intercourse.

ADDITIONAL INFORMATION ABOUT REGULAR CONTRACEPTIVE METHODS
If emergency contraception has been used and you are not using a regular contraceptive method (or are not using an adequate contraceptive method), you should consult your doctor or a family planning clinic.
There are many different contraceptive methods available, allowing you to choose the most suitable one for yourself.

Examples of regular contraceptive methods:

Daily methods
Contraceptive tablet

Methods used once a week or once a month
Contraceptive patch
Vaginal ring

Long-acting methods
Contraceptive implant
Intrauterine device