Lencya 30 mg - 1 film-coated tablet

Lencya is a contraceptive used to prevent pregnancy after unprotected sex or a failure of the contraceptive method. For example:

• if you have had unprotected sexual intercourse
• If your partner's condom broke, slipped or came off completely, or if you forgot to use a condom
• if you have not taken your birth control pill as recommended

You should take the tablet as soon as possible after sexual intercourse, but no later than 5 days (120 hours) afterwards.
This is because sperm can survive in your body for up to 5 days after intercourse.
This medicine is suitable for all women of childbearing age, including teenagers. You can take the tablet at any point in the menstrual cycle.

Lencya is not effective if you are already pregnant.
If your period is late, there is a possibility that you are pregnant. If your period is late or if you experience symptoms of pregnancy (heavy breasts, morning sickness), contact a doctor or other healthcare professional before taking the tablet.

If you have unprotected sex after taking the tablet, you can still become pregnant.
You can become pregnant at any point in your cycle if you have unprotected sex.

Lencya is not suitable for regular contraception.
If you are not using a regular method of contraception, talk to your doctor or nurse to choose a method that is right for you.

How Lencya works
Lencya contains the active ingredient ulipristal acetate, which changes the effect of the natural hormone progesterone, which is necessary for ovulation. As a result, this medicine delays ovulation. Emergency contraception is not effective in all cases: about 2 in 100 women who take this medicine will still become pregnant.
This medicine is a contraceptive used to prevent pregnancy from occurring. If you are already pregnant, it will not terminate the existing pregnancy.

Emergency contraceptives do not protect against sexually transmitted diseases.
Only condoms can protect you from sexually transmitted diseases. This medicine does not protect against HIV infection or other sexually transmitted diseases (e.g. chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, syphilis). If you have any concerns, contact your healthcare professional.

Contraindications

Lencya must not be taken if you are allergic to ulipristal acetate or any of the other ingredients of this medicine listed in section 6.

Interactions

Tell your doctor, pharmacist or other healthcare professional if you are taking, have recently taken or might take any other medicines, including non-prescription or herbal medicines.

Some medicines can make Lencya less effective. If you have taken any of the following medicines within the last 4 weeks, Lencya may be less suitable for you. Your doctor may prescribe another type of (non-hormonal) emergency contraception, such as: B. a copper spiral:

• Medicines used to treat epilepsy (for example primidone, phenobarbital, phenytoin, fosphenytoin, carbamazepine, oxcarbazepine and barbiturates)
• Medicines used to treat tuberculosis (for example rifampicin, rifabutin)
• Medicines used to treat HIV infection (ritonavir, efavirenz, nevirapine)
• Medicines used to treat fungal infections (griseofulvin)
• herbal medicines containing St. John's wort (Hypericum perforatum).

Before taking Lencya, talk to your doctor or pharmacist if you are taking (or have recently taken) one or more of the medicines listed above.

Pregnancy, breast-feeding and fertility
Pregnancy
If your period is late, talk to your doctor, pharmacist or other healthcare professional before taking this medicine, or take a pregnancy test to make sure you are not already pregnant (see Warnings and Pregnancy section). Precautions").
This medicine is a contraceptive used to prevent pregnancy from occurring.
If you are already pregnant, taking it will not terminate the existing pregnancy.
If you become pregnant despite taking this medicine, there is no evidence that it will affect your pregnancy. However, be sure to consult your doctor. As with any pregnancy, the doctor will examine whether the pregnancy is not occurring outside the uterine cavity. This is particularly important if you experience severe abdominal (stomach) pain or bleeding, or if you have previously had a pregnancy outside the uterine cavity, had surgery on the fallopian tubes, or had a long-term (chronic) infection of the genitals.

If you become pregnant despite taking Lencya, ask your doctor to register your pregnancy in an official database. You can also enter this information yourself at www.ulipristal-pregnancy-registry.com. Your information will be treated confidentially, meaning no one will know that this information came from you. By sharing your information, you will help other women understand the safety and risks of Lencya during pregnancy.

Breast-feeding
If you are taking this medicine while you are breast-feeding, do not breast-feed your child for one week after taking this medicine. During this period, you are advised to express breast milk to stimulate and maintain milk production, but to dispose of it. The effects on the child of breast-feeding during the first week after taking this medicine are not known.

Fertility
This medicine has no effect on your ability to have children in the future. If you have unprotected sex after taking this medicine, it will not prevent a possible pregnancy. Therefore, it is important that you use condoms until your next period.
If you want to start or continue a regular method of contraception after taking this medicine, you can do so, but please use additional condoms until your next period.

Driving and using machines
Warning: This medicine may impair the ability to react and drive.
Some women experience dizziness, drowsiness, blurred vision and/or loss of concentration after taking this medicine (see section 4). If you experience these symptoms, you should not drive a motor vehicle or use machines.

Application

Always take this medicine exactly as described in this leaflet or exactly as discussed with your doctor, pharmacist or nurse. If you are unsure, ask your doctor, pharmacist or nurse.

How to take the Lencya tablet

• Take a tablet as soon as possible and no more than 5 days (120 hours) after unprotected sexual intercourse or contraceptive failure. Do not delay taking the tablets.
• You can take the tablet at any time during your menstrual cycle.
• You can take the tablet at any time of the day and before, with or after a meal.
• If you are taking any of the medicines that can make Lencya less effective (see section 2 above, “What should you consider before taking Lencya?”) or if you have taken any of these medicines in the past 4 weeks, Lencya may be less effective for you. Before taking Lencya, talk to your doctor or pharmacist. Your doctor may prescribe another (non-hormonal) type of emergency contraception, such as: B. a copper spiral.

If you vomit after taking Lencya
If you vomit (vomit) within 3 hours of taking the Lencya tablet, take a second tablet as soon as possible.

If you have sex again after taking Lencya
If you have unprotected sex again after taking the tablet, this will not prevent pregnancy. For this reason, you should use condoms every time you have sex after taking the tablet until your next period.

If your next period is delayed after taking Lencya
After taking the tablet, it is normal for your next period to be delayed by a few days.
However, if your period is delayed for more than 7 days, if it is unusually light or unusually heavy, or if you experience symptoms such as abdominal (stomach) pain, breast tenderness, vomiting or nausea, there is a possibility that you may be pregnant are. In this case, take a pregnancy test immediately. If you are pregnant, be sure to consult your doctor (see “Pregnancy, breast-feeding and fertility” section).

Side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. Some symptoms such as breast tenderness and abdominal (stomach) pain, vomiting (vomiting), nausea (feeling sick) can also be signs of pregnancy. If you miss your period and experience the symptoms described after taking Lencya, take a pregnancy test (see section 2 “Pregnancy, breast-feeding and fertility”).

Common side effects (may affect up to 1 in 10 people)

• Nausea, abdominal (stomach) pain or discomfort in the stomach area, vomiting
• Menstrual pain, pelvic pain, breast tenderness
• Headaches, dizziness, mood swings
• Muscle pain, back pain, fatigue

Uncommon side effects (may affect up to 1 in 100 people)

• Diarrhea, heartburn, flatulence, dry mouth
• abnormal or irregular vaginal bleeding, heavy/prolonged periods, premenstrual syndrome, vaginal inflammation or discharge, decreased or increased libido
• Hot flashes
• Changes in appetite, emotional disturbances, anxiety, general physical restlessness, sleep disturbances, sleepiness, migraines, vision problems
• Influenza
• Acne, rash, itching
• Fever, chills, feeling sick

Rare side effects (may affect up to 1 in 1,000 people)

• Pain or itching in the genital area, pain during intercourse, shedding of an ovarian cyst, unusually light periods
• Loss of concentration, dizziness, shaking, confusion, fainting
• unusual feeling in the eyes, red eye, sensitivity to light
• dry throat, impaired sense of taste
• Feeling thirsty
• allergic reactions such as skin rash, hives or facial swelling

composition

The active ingredient is ulipristal acetate.
Each tablet contains 30 milligrams of ulipristal acetate.

The other ingredients are:
Tablet core: lactose monohydrate, pre-gelatinized starch (corn), sodium starch glycolate (type A), magnesium stearate (E 470b).
Tablet coating: hypromellose (E 464), hydroxypropylcellulose (E 463), stearic acid ( E 570), talc (E 553b), titanium dioxide (E 171)

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