Vikela 1.5 mg Tablet - Emergency Contraception

Product Details & Mandatory Information

Vikela 1.5 mg is an emergency contraceptive medicine for use after unprotected sexual intercourse or contraceptive failure. The active ingredient is levonorgestrel.

It should be taken as soon as possible, preferably within 12 hours and no later than 72 hours (3 days) after unprotected sexual intercourse.

Vikela is intended for emergency contraception only and is not suitable for regular birth control. The medicine cannot terminate an existing pregnancy.

Vikela is not indicated for use before the first menstrual period (menarche).

Area of application

This contraceptive method should be used as soon as possible after unprotected sexual intercourse or contraceptive failure: preferably within 12 hours, but no later than 72 hours (= 3 days) afterwards.

It is more effective the sooner it is used after unprotected intercourse. Vikela can only prevent pregnancy if you take it within 72 hours after unprotected sexual intercourse.

It does not work if you are already pregnant. If you have unprotected sexual intercourse again after taking Vikela, it will not prevent a possible pregnancy.

Vikela has been shown to prevent 52% to 85% of expected pregnancies.

If you fear pregnancy for any of the following reasons:

• if you had sex without contraception

• if you forgot to take the "pill" on time

• if your partner's condom broke, slipped, or came off

• if you fear that your intrauterine device ("coil") has been expelled

• if your diaphragm or cervical cap slipped or was removed too early

• if you fear that withdrawal ("coitus interruptus") or the calendar method of contraception did not work

• after rape

Vikela works by preventing your ovaries from releasing an egg. It cannot prevent the implantation of a fertilized egg in the uterus.

This tablet should only be used as an emergency method of contraception and not as regular contraception, as it is less effective than usual hormonal contraceptives ("the pill").

Vikela is not indicated for use before the first menstrual period (menarche).

Contraindications

Do not take Vikela if you are allergic to levonorgestrel or any of the other ingredients of this medicine.

Interactions

Some medicines may prevent Vikela from working effectively. If you have taken any of the following medicines during the last 4 weeks, Vikela may be less suitable for you.

Your doctor may prescribe you a different type of non-hormonal emergency contraception, i.e. a copper IUD. If this is not an option for you or if you are unable to see your doctor immediately, you can take a double dose of Vikela:

• barbiturates and other medicines to treat epilepsy, for example, primidone, phenytoin, and carbamazepine

• medicines to treat tuberculosis, for example, rifampicin and rifabutin

• medicines to treat HIV infection, particularly ritonavir and efavirenz

• a medicine to treat fungal infections: griseofulvin

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

Talk to your pharmacist or doctor if you need further advice on the correct dose.

See your doctor as soon as possible after taking the tablets for further advice on a reliable form of regular contraception and to rule out pregnancy.

Vikela can also affect how well other medicines work:

• Ciclosporin, a medicine that suppresses the immune system

Vikela should not be used together with medicines containing ulipristal acetate.

Pregnancy and breastfeeding

If you are pregnant:

This medicine does not terminate an existing pregnancy.

If you have taken this medicine and still become pregnant, current studies show no indication of a risk of malformations during the baby's development in the womb. However, this medicine should not be taken if you are pregnant.

If you become pregnant after taking Vikela, contact your doctor. Your doctor may check whether the pregnancy is developing outside the uterus, for example, in the abdominal cavity.

This is particularly important if you experience severe abdominal pain after taking Vikela or if you have previously had a pregnancy outside the uterus, fallopian tube surgery, or pelvic inflammatory disease.

If you are breastfeeding:

You can breastfeed. However, since levonorgestrel passes into breast milk, you should breastfeed immediately before taking Vikela and interrupt breastfeeding for at least 8 hours after taking it.

Ask your doctor or pharmacist for advice before taking any medicine.

Application

Vikela can be taken at any time during your menstrual cycle, provided you are not already pregnant or suspect you are pregnant.

Do not chew the tablet, but swallow it whole with water.

Take the tablet 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 tablet works best the sooner you take it after unprotected sexual intercourse. It can only prevent pregnancy if you take the tablet within 72 hours after unprotected sexual intercourse.

If you are using any of the medicines that can prevent Vikela from working properly, or if you have taken any of these medicines in the past 4 weeks, Vikela may be less effective for you.

Your doctor may prescribe you a different non-hormonal type of emergency contraception, i.e. a copper IUD. If this is not an option for you or if you are unable to see your doctor immediately, you can take a double dose of Vikela, i.e. two tablets together at the same time.

If you are already using a regular method of contraception, such as the pill, you can resume taking it at your usual time.

In case of vomiting

If you vomit within three hours of taking the tablet, you should take another tablet immediately. Contact your doctor or pharmacist for another tablet.

Contraception after use

After using an emergency contraceptive, use a local contraceptive method, such as a condom, spermicide, or diaphragm, until your next period.

If you have unprotected sexual intercourse again after using Vikela – even within the same cycle – the tablet will not have a contraceptive effect for this subsequent intercourse, and there is again a risk of becoming pregnant.

If you are using a regular hormonal contraceptive method, such as "the pill," you should continue taking it as usual.

If no bleeding occurs during the subsequent pill-free interval, perform a pregnancy test to rule out pregnancy.

Your doctor can advise you on longer-term methods of contraception that will protect you more effectively from becoming pregnant.

Ingredients

Active ingredient:

One tablet contains 1.5 mg of levonorgestrel.

Levonorgestrel belongs to a group of medicines called emergency contraceptives.

Other ingredients:

• Lactose monohydrate

• Corn starch

• Povidone

• Highly dispersed anhydrous silicon dioxide

• Magnesium stearate

Side effects

Very common side effects – affects more than 1 in 10 treated individuals:

• Dizziness

• Headaches

• Nausea

• Lower abdominal pain

• Breast tenderness

• Delayed period

• Heavy periods

• Bleeding

• Uterine pain

• Fatigue

Common side effects – affects 1 to 10 in 100 treated individuals:

• Diarrhea

• Vomiting

• Painful periods

Frequency not known – cannot be estimated from the available data:

• Cases of thromboembolism (blood clots) have been observed post-marketing

• Allergic reactions such as swelling of the throat and face and skin rash may occur after taking this medicine