Sanova Vikela Protect 1,5 mg 1 Tablet

This contraceptive method should be used as soon as possible after unprotected sex or after a contraceptive method has failed: if possible within 12 hours, but in no case later than 72 hours (= 3 days) afterwards. It is more effective if used as soon as possible after unprotected sex. Vikela can only prevent pregnancy if you take it within 72 hours of having unprotected sex. It does not work if you are already pregnant. If you have unprotected sex 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 are concerned about pregnancy for any of the following reasons:

• if you have had sex without contraception;
• if you forgot to take the “pill” on time;
• if your partner's condom has broken, slipped or slipped off;
• if you are concerned that your intrauterine device (“IUD”) has been expelled;
• if your vaginal pessary or cervical cap has slipped or was removed too soon;
• if you fear that timely interruption of sexual intercourse ("coitus interuptus") or contraception using the calendar method has not worked;1
• after rape.

Vikela works by stopping your ovaries from releasing an egg. It cannot prevent a fertilized egg from implanting in the uterus.

This tablet should only be used as an emergency method of contraception and not as a regular contraceptive, as it is less effective than the 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 (listed in section 6).

interactions

Some medicines can stop Vikela from working effectively. If you have taken any of the following medicines in the last 4 weeks, Vikela may be less suitable for you. Your doctor may prescribe another type of emergency (non-hormonal) contraception, ie a copper IUD. If this is not an option for you, or if you are unable to see your doctor straight away, you can take a double dose of Vikela:

• Barbiturates and other medicines used to treat epilepsy (for example, primidone, phenytoin and carbamazepine)
• medicines to treat tuberculosis (e.g. rifampicin, rifabutin)
• treatment for HIV (ritonavir, efavirenz)
• a medicine used to treat fungal infections (griseofulvin)
• herbal remedies containing St. John's wort (Hypericum perforatum).

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

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 (for more information see also section 3 How to take Vikela?) .

Vikela can also affect how well other medicines work:

• a medicine called ciclosporin (which suppresses the immune system)

Vikela should not be used with medicines containing ulipristal acetate.

pregnancy and breast feeding period

If you are pregnant:
This medicine will not terminate an existing pregnancy.
If you have taken this medicine and still become pregnant, there is no evidence of a risk of birth defects during the development of the baby in the womb according to previous studies. However, this medicine should not be taken if you are pregnant.

If you become pregnant after taking Vikela, contact your doctor. Your doctor may want to clarify whether the pregnancy is not developing outside the uterus (eg in the abdominal cavity). This is particularly important if you get severe stomach pain after taking Vikela, or if you have ever had an ectopic pregnancy, or have had an operation on the fallopian tubes or pelvic inflammatory disease.

If you are breastfeeding:
You may breastfeed. However, because levonorgestrel is excreted in breast milk, you should breast-feed just before taking Vikela and stop breast-feeding 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 think you may be 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 sex. Do not delay taking the tablet. The tablet works best the sooner you take it after unprotected sex. It can only prevent pregnancy if you take the tablet within 72 hours of unprotected sex.

If you are using any of the medicines that may stop Vikela from working properly (see “Other medicines and Vikela” above), 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 another (non-hormonal) type of emergency contraception, ie a copper IUD. If this is not an option for you, or if you are unable to see your doctor straight away, you can take a double dose of Vikela (ie two tablets taken together at the same time).

If you are already using a regular method of birth control such as the pill, you can go back to taking it at your usual time.

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

After using emergency contraception, use a local contraceptive method (condom, foam, vaginal pessary) until the next menstrual period. If you have unprotected sex again (even within the same cycle) after using Vikela, the tablet will no longer have any contraceptive effect and there is a risk of becoming pregnant again. If you are using a usual contraceptive method such as an oral contraceptive (the "pill"), you should continue to take it as usual.

If you normally take a hormonal contraceptive (the "pill"), continue taking the pill as usual after using Vikela. If there is no bleeding during the next tablet-free period, do a pregnancy test to rule out pregnancy.

Your doctor can advise you on long-term birth control methods that are more effective at preventing you from becoming pregnant.

If you continue to use your usual hormonal contraceptive such as the pill and have no bleeding in the pill-free interval, contact your doctor to rule out the possibility of pregnancy.

side effects

The following side effects have been observed:

Very common side effects (affects more than 1 in 10 people):

• dizziness, headache
• Nausea, pain in the lower abdomen
• Breast tenderness, delayed menstrual bleeding, heavy menstrual bleeding, bleeding, uterine pain
• fatigue

Common side effects (affects 1 to 10 users in 100):

• diarrhea, vomiting
• Painful menstrual bleeding

Frequency not known (cannot be estimated from the available data):

• Cases of thromboembolism (blood clots) have been observed in post-marketing experience.
• Allergic reactions such as swelling of the throat and face and skin rash can occur after taking this medicine.

composition

What Vikela 1.5 mg contains

• The active substance is levonorgestrel.
• The other ingredients are: lactose monohydrate, maize starch, povidone, silica colloidal anhydrous, magnesium stearate.

Levonorgestrel belongs to a group of medicines called emergency contraceptives.