ellaOne® 30 mg tablet - emergency contraception

Product Details & Mandatory Information

ellaOne® 30 mg is an emergency contraceptive used to prevent pregnancy after unprotected sexual intercourse or contraceptive failure.

• Active ingredient: 30 mg Ulipristal acetate

• For emergency contraception

• Take as soon as possible after unprotected sexual intercourse

• Take no later than 120 hours (5 days)

• Suitable for women of childbearing age, including adolescents

• Can be taken at any time during the menstrual cycle

• Not intended for regular contraception

• Does not terminate an existing pregnancy

• Does not protect against sexually transmitted diseases

• Contains lactose

Like all emergency contraceptives, ellaOne® cannot prevent pregnancy in every case. Approximately 2 out of 100 women who take ellaOne® will still become pregnant.

Area of Application

ellaOne® is an emergency contraceptive to prevent pregnancy after unprotected sexual intercourse or contraceptive failure.

For example, it may be necessary to use it:

• if you have had unprotected sexual intercourse

• if the condom broke, slipped, or came off completely

• if a condom was forgotten to be used

• if the birth control pill was not taken as recommended

You should take ellaOne® as soon as possible after intercourse, but no later than 5 days or 120 hours afterwards.

The reason for this is that sperm can survive in the body for up to 5 days after intercourse.

ellaOne® is suitable for women of childbearing age, including adolescents.

The tablet can be taken at any time during the menstrual cycle.

How does ellaOne® work?

ellaOne® contains the active ingredient ulipristal acetate. This alters the effect of the natural hormone progesterone, which is necessary for ovulation. This allows ellaOne® to postpone ovulation.

Emergency contraceptives are not always effective. Approximately 2 out of 100 women who take ellaOne® will still become pregnant.

ellaOne® prevents the occurrence of pregnancy. If a pregnancy already exists, taking it will not terminate it.

Important Information Regarding Pregnancy

ellaOne® is not effective if a pregnancy already exists.

If your period is delayed or you experience symptoms of pregnancy such as breast tenderness or morning sickness, you should contact a doctor, pharmacist, or other healthcare professional, or perform a pregnancy test before taking it.

If you become pregnant despite taking ellaOne®, you should contact your doctor.

As with any pregnancy, it should be medically checked whether the pregnancy is developing within the uterus. This is especially important in cases of severe abdominal pain or bleeding, as well as in the case of a previous ectopic pregnancy, surgery on the fallopian tubes, or a prolonged infection of the genital organs.

No Protection against Repeated Unprotected Sexual Intercourse

If you have unprotected sexual intercourse again after taking ellaOne®, the tablet taken previously will not prevent a possible pregnancy resulting from this.

Therefore, condoms should be used during every sexual encounter until your next period.

No Protection against Sexually Transmitted Diseases

ellaOne® offers no protection against HIV or other sexually transmitted diseases such as:

• Chlamydia

• Genital herpes

• Genital warts

• Gonorrhea

• Hepatitis B

• Syphilis

Condoms can reduce the risk of transmitting sexually transmitted diseases.

Not for Regular Contraception

ellaOne® is intended exclusively for emergency contraception and is not suitable as a regular method of contraception.

If no regular contraception is used, an appropriate method should be selected with a doctor or healthcare professional.

Contraindications

ellaOne® must not be taken if you are allergic to ulipristal acetate or any of the other ingredients of this medicine.

Interactions

Inform your doctor or pharmacist if you are taking, have recently taken, or intend to take any other medicines.

Some medicines can reduce the effectiveness of ellaOne®. These include in particular:

• Phenytoin

• Fosphenytoin

• Phenobarbital

• Primidone

• Carbamazepine

• Oxcarbazepine

• Ritonavir

• Efavirenz

• Nevirapine

• Rifampicin

• Rifabutin

• St. John's wort (Hypericum perforatum) and medicines containing St. John's wort

These medicines are used, among other things, to treat epilepsy, HIV infections, or tuberculosis.

Other Contraceptives and ellaOne®

ellaOne® can temporarily impair the effect of regular hormonal contraceptives such as birth control pills or contraceptive patches.

If you use hormonal contraceptives, continue to use them after taking ellaOne® according to the instructions for use. Condoms should also be used until your next period.

ellaOne® must not be used together with emergency contraceptives containing levonorgestrel. Concurrent use may reduce the effectiveness of ellaOne®.

Pregnancy

ellaOne® is used to prevent pregnancy. An existing pregnancy will not be terminated by ellaOne®.

If you become pregnant despite taking ellaOne®, you should contact your doctor.

Breastfeeding

If you take ellaOne® while breastfeeding, you should not breastfeed your child for one week after taking it.

During this period, it is recommended to pump and discard breast milk to maintain milk production.

Fertility

ellaOne® has no effect on future fertility.

After taking it, ovulation can occur again in the same cycle. Unprotected sexual intercourse after taking it can therefore lead to pregnancy.

ellaOne® contains lactose

If you know that you are intolerant to certain sugars, you should consult your doctor or pharmacist before taking it.

Application and Dosage

Take one ellaOne® 30 mg tablet as soon as possible, but no later than 120 hours or 5 days after unprotected sexual intercourse or contraceptive failure.

Taking it should not be unnecessarily delayed.

ellaOne® can be taken:

• at any time during the menstrual cycle

• at any time of day

• before, during, or after a meal

If you vomit after taking it

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

If you have sexual intercourse again after taking it

If you have unprotected sexual intercourse again after taking it, ellaOne® will not prevent a possible pregnancy resulting from this.

Therefore, condoms should be used during every sexual encounter until your next period.

If your next period is delayed

After taking ellaOne®, your next period may be delayed by a few days.

A pregnancy test should be performed if:

• your period is delayed by more than 7 days

• your period is unusually light or unusually heavy

• abdominal pain occurs

• breast tenderness occurs

• nausea or vomiting occurs

If the pregnancy test is positive, a doctor should be consulted.

If you have taken a larger quantity

No harmful effects have been described so far after taking a higher dose than recommended. Nevertheless, in this case, a doctor, pharmacist, or other healthcare professional should be contacted.

Ingredients

Active Ingredient

One tablet contains:

• 30 mg Ulipristal acetate

Other Ingredients

• Lactose

• Povidone K30

• Croscarmellose sodium

• Magnesium stearate

Side Effects

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

Some symptoms such as breast tenderness, abdominal pain, vomiting, or nausea can also be signs of pregnancy. If your period is missed and such symptoms occur after taking it, a pregnancy test should be performed.

Common side effects – may affect up to 1 in 10 people:

• Nausea

• Abdominal pain or discomfort in the abdominal area

• Vomiting

• Menstrual pain

• 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

• Flatulence

• Dry mouth

• Abnormal or irregular vaginal bleeding

• Heavy or prolonged periods

• Premenstrual syndrome

• Vaginal inflammation or discharge

• Decreased or increased libido

• Hot flashes

• Changing appetite

• Mood swings

• Anxiety

• General physical restlessness

• Sleep disorders

• Drowsiness

• Migraine

• Visual disturbances

• Influenza

• Acne

• Rash

• Itching

• Fever

• Chills

• Feeling unwell

Rare side effects – may affect up to 1 in 1,000 people:

• Pain or itching in the genital area

• Pain during sexual intercourse

• Rupture of an ovarian cyst

• Unusually light period

• Concentration disorders

• Dizziness

• Tremors

• Confusion

• Fainting spells

• Unusual feeling in the eyes

• Red eyes

• Photosensitivity

• Dry throat

• Impairment of taste

• Hives

• Feeling of thirst