NorLevo Tabl 1.5 mg

What is NorLevo 1.5 mg and when is it used?

NorLevo 1.5 mg contains the active substance levonorgestrel and is a medicine for contraception in emergency, i.e. within 72 hours after unprotected sexual intercourse or in the event of failure of a contraceptive method such as:

• torn or forgotten condom;over the maximum acceptable Forgot to take an oral contraceptive ("pill") for a period of time;expelled intrauterine device;premature removal or slipping of a vaginal diaphragm or cervical cap;sexual intercourse during the presumed fertile phase when practicing periodic abstinence (temperature method);rape.

Such drugs are also referred to as the "morning after pill".In studies, NorLevo 1.5 mg prevented pregnancy in 52-85% of affected women.NorLevo 1.5 mg prevents ovulation. It cannot prevent a fertilized egg from implanting in the uterus. If ovulation has already occurred, NorLevo 1.5 mg is therefore no longer effective. Accordingly, NorLevo 1.5 mg is not an agent for abortion.

It is not possible to determine in individual cases whether ovulation has already taken place. In order to reduce the risk of an unwanted pregnancy as much as possible, NorLevo 1.5 mg can therefore generally be taken if the doctor or pharmacist, based on the information you have provided, is of the opinion that use is indicated.

NorLevo 1.5 mg is intended exclusively for emergencies and should under no circumstances replace a regular contraceptive method.

The dispensing takes place exclusively through the doctor or pharmacist. Before dispensing, it must be clarified in a consultation whether the preparation is suitable for you. If there is no menstrual period, a medical check-up is required.

What should be considered?

The use of NorLevo 1.5 mg does not replace the necessary precautionary measures to protect against sexually transmitted diseases. If you have not used a condom during intercourse (or if it has broken or slipped) it is possible that you have been infected with a sexually transmitted disease (including HIV).The more time has passed between having sex and taking NorLevo 1.5 mg, the less NorLevo 1.5 mg is effective. The greatest effect is achieved when taken within 24 hours. After 48 to 72 hours, the effectiveness is still about half. Efficacy could no longer be demonstrated if used after more than 72 hours.

Emergency contraception with NorLevo 1.5 mg does not always prevent pregnancy. Therefore, after using NorLevo 1.5 mg, you should avoid taking medicines (as well as alcohol, nicotine and other drugs) until pregnancy can be definitely ruled out.

When should NorLevo 1.5 mg not be taken?

The medicine must not be taken during pregnancy or in the event of severe liver dysfunction. NorLevo 1.5 mg must not be taken if you are hypersensitive to the active ingredient levonorgestrel or one of the excipients.

When is caution required when taking NorLevo 1.5 mg?

The use of NorLevo 1.5 mg is not recommended in the following cases:

• If you have had a pregnancy outside the uterus (peritoneal cavity pregnancy, ectopic pregnancy), this increases the risk of ectopic pregnancy again. So if you have had an ectopic pregnancy or an infection of the fallopian tubes, it is important to consult your doctor before taking NorLevo 1.5 mg.if you or members of your family are at increased risk of thrombosis (blood clots),or if you suffer from severe malabsorption syndrome (e.g. Crohn's disease).

If you had unprotected intercourse more than 72 hours ago, conception may have already taken place. Taking NorLevo 1.5 mg after a second sexual intercourse may then no longer have a contraceptive effect.

Emergency contraception is only intended for use in exceptional cases.

It is not advisable to take NorLevo 1.5 mg repeatedly within the same menstrual cycle.

NorLevo 1.5 mg should not replace a regular contraceptive method, as it cannot always prevent pregnancy and because if taken regularly, there is a risk of hormonal overdose and disruption of the menstrual cycle. The effect of NorLevo 1.5 mg is inferior to that of long-term contraceptive methods. Consult your doctor about long-term contraceptive methods that are more effective.

If in doubt, if you have taken NorLevo 1.5 mg and your period is more than 5 days late, or if abnormal bleeding occurs at the expected time of the period, pregnancy must be ruled out.

The emergency contraceptive should be used as soon as possible after unprotected intercourse

There is some evidence that NorLevo 1.5 mg (like other emergency contraceptive pills) may be less effective with higher body weight or body mass index.

If you are concerned about any problems that may occur with taking an emergency contraceptive, you should consult a doctor.

This medicine may affect your ability to react, drive and use any tools or machines , as it can cause side effects such as dizziness or tiredness!Inform your doctor or pharmacist if you suffer from other diseases, have allergies or are taking other medicines (including those you bought yourself!) or use them externally!NorLevo 1.5 mg contains lactose monohydrate. Therefore, please only take this medicine after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

It is essential that you inform your doctor or pharmacist if you are taking any of the following medicines or have taken them within the last 4 weeks, as interactions with NorLevo 1.5 mg can occur. Your doctor may prescribe another type of emergency (non-hormonal) contraception, i.e. 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 NorLevo 1.5 mg (2 tablets).

• Medicines to treat epilepsy (e.g. barbiturates, carbamazepine, felbamate, oxcarbazepine, phenytoin, primidone, topiramate)Medicines for treatment narcolepsy, a type of excessive sleepiness (e.g. modafinil)medicines to treat HIV infection (e.g. ritonavir, efavirenz, nevirapine)medicines to treat certain bacterial infections such as tuberculosis (e.g. rifabutin, rifampicin)Herbal medicines containing St. John's wort (Hyperi cum perforatum) to treat depression or anxiety.Drugs to treat certain fungal infections (e.g. itraconazole, voriconazole, clarithromycin)Drugs to treat high blood pressure in the pulmonary circulation (e.g. bosentan)NorLevo 1.5 mg should not be used with medicines that contain ulipristal acetate.

NorLevo 1.5 mg may also affect how well other medicines work:

• such as the effect of ciclosporin, a medicine used to suppresssuppression of the immune system.

Can NorLevo 1.5 mg be taken during pregnancy or while breastfeeding?

NorLevo 1.5 mg must not be taken during pregnancy.

If pregnancy occurs despite the use of NorLevo 1.5 mg, studies have shown that no harmful effects on the unborn child are to be expected. This medicine cannot be used to terminate an existing pregnancy.If you do become pregnant after taking NorLevo 1.5 mg, please contact your doctor. He or she may then want to make sure it's not an ectopic or ectopic pregnancy. This is especially important if you get severe abdominal pain after taking NorLevo 1.5 mg or have ever had an ectopic pregnancy, surgery on your fallopian tubes, or pelvic inflammatory disease.Breastfeeding is possible. However, because levonorgestrel is excreted in breast milk, it is recommended that you breast-feed immediately before taking the tablet and delay breast-feeding by at least 6 hours after taking NorLevo 1.5 mg (during this time express and discard milk).Consult your doctor or pharmacist or before taking any medicine. Your doctor or pharmacist for advice.

How to use NorLevo 1.5 mg?

The treatment requires taking 1 tablet as a single dose. The tablet must be taken as soon as possible - preferably within 12 hours - but no later than 72 hours (3 days) after unprotected sex. The earlier the tablet is taken, the better the contraceptive effect.If you are taking certain medicines or have taken them in the past 4 weeks (see the section "When should you take caution with NorLevo 1.5 mg"), NorLevo 1.5 mg may be less effective for you. Talk to your doctor or pharmacist before taking NorLevo 1.5 mg. Your doctor may prescribe another (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 straight away, the pharmacist may recommend that you take a double dose.

If vomiting occurs within three hours of taking the tablet, you should immediately take 1 more tablet.

If vomiting occurs within three hours of taking a double dose of NorLevo 1.5 mg (2 tablets), seek medical advice quickly aecologist or gynecologist who will decide how to proceed.The tablets should be taken with a glass of water and should not be chewed. NorLevo 1.5 mg should be taken before meals.After using NorLevo 1.5 mg, a local contraceptive (condom, cervical cap, spermicide) should be used until the next bleeding. If unprotected intercourse takes place again after using NorLevo 1.5 mg (even if this happens during the same menstrual cycle), the tablets will not have a contraceptive effect. This means there is a risk of pregnancy again. If you have used NorLevo 1.5 mg in addition to a hormonal contraceptive (pill, vaginal ring, contraceptive patch), continue taking the pill or using the vaginal ring or contraceptive patch as usual. If no bleeding occurs during the subsequent break in administration or use of the vaginal ring or contraceptive patch, a pregnancy must be investigated.

After taking NorLevo 1.5 mg, the menstrual bleeding occurs in most cases at the expected time and with normal intensity. But it can also start sooner or later. If at the expected ZIf you start having a period that is not typical for you or if you do not have a period for more than 5 days, pregnancy should be ruled out. However, you should also take a pregnancy test if you think you might be pregnant for any other reason. If you still become pregnant after taking this medicine, you should definitely contact your doctor.Emergency contraceptives such as NorLevo 1.5 mg are only intended for use in exceptional cases. They are not suitable for regular contraception because they are less reliable than other methods. Ask your doctor about other long-term methods of contraception that are suitable for you.

Children and adolescents

There is only limited experience of use in adolescents under 16 years of age. NorLevo 1.5 mg should not be used before the first menstrual period (menarche).Stick to the dosage given in the package leaflet or as prescribed by your doctor. If you think the medicine is too weak or too strong, talk to your doctor or pharmacist."

What side effects can NorLevo 1.5 mg have?

The following side effects can occur when taking NorLevo 1.5 mg:

Very common (affects more than 1 in 10 users)

Nausea is very common headache, abdominal pain, tiredness, dizziness, vomiting and breast tenderness.

Common (affects 1 to 10 users in 100)

Diarrhea and period pains can also occur frequently. Spotting, irregular and heavy bleeding may occur and continue until the next menstrual period, which may be delayed.There have been reports of thromboembolic events (blood clots) after the marketing of this medicine. Allergic reactions such as skin rash or swelling of the throat and face may also occur after taking this medicine.With the exception of possible menstrual disorders and blood clots, the undesirable effects generally disappear within 48 hours of taking the tablet.The limited data on the safety profile in adolescents do not show any relevant differences compared to adult users. Only abdominal pain seemed to be more common in adolescents than in adults.If you notice any side effects, talk to your doctor or pharmacist. This also applies in particular to side effects that are not listed in this leaflet.

What else needs to be taken into account?

The medicine may only be used up to the date marked «EXP» on the container.

Storage instructions

NorLevo 1.5 mg should be kept out of the reach of children, at room temperature (15-25 °C) and protected from light in the original packaging.Your doctor or pharmacist can provide you with further information. These people have the detailed technical information.

What does NorLevo 1.5 mg contain?

1 tablet contains

active ingredients

1.5 mg levonorgestrel and

auxiliary substances

lactose and other auxiliary substances.

Authorization number

62876 (Swissmedic).

Where can you get NorLevo 1.5 mg? Which packs are available?

In pharmacies without a doctor's prescription.

In packs of 1 tablet.

Authorization holder

HRA-Pharma Switzerland Sàrl, 1260 Nyon.

This package leaflet was last checked by the medicines authority (Swissmedic) in June 2019.