Package leaflet: Information for the user

1. What Levofemina is and what it is used for

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2. What you need to know before you take Levofemina

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3. How to take Levofemina

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4. Possible side effects

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5. How to store Levofemina

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6. Contents of the pack and other information

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Levofemina is an emergency contraceptive that can be used within 72 hours (3 days) of unprotected sexual intercourse or if your usual method of contraception has failed.

It concerns the following cases:

• • Contraception was not used during sexual intercourse.
• • The contraceptive method adopted was incorrectly used, for example, if the condom broke, slid off, or was used incorrectly; if the vaginal pessary or diaphragm changed position, burst, broke, or was removed ahead of time; if withdrawal did not take place early enough when practicing coitus interruptus (for example, sperm was ejaculated into the vagina or onto the outside of the genitals).

Levofemina contains a synthetic hormone-like substance called levonorgestrel. It prevents around 84% of potential pregnancies when taken within 72 hours of unprotected sexual intercourse. It will not always prevent pregnancy and is most effective when taken as soon as possible after unprotected sexual intercourse. It is better to take it within 12 hours instead of waiting until the third day.

Levofemina is thought to work by:

• • Preventing your ovaries from releasing an egg;
• • Preventing sperm from fertilizing any eggs that may have already been released.

Levofemina can prevent pregnancy only if taken within 72 hours of unprotected sexual intercourse. It does not work if you are already pregnant. If there is further unprotected sexual intercourse after Levofemina use (and if this occurs during the same menstrual cycle), the tablet will not work as a contraceptive and there will be a new risk of pregnancy.

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

Do not take Levofemina:

• • If you are allergic to levonorgestrel or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions:

If any of the following applies to you, talk to your doctor before taking Levofemina because emergency contraception may not be appropriate for you. Your doctor may prescribe you another type of emergency contraception.

• • If you are pregnant or think you may already be pregnant. This medicine does not work if you are already pregnant. If you are already pregnant, Levofemina cannot end your pregnancy, so Levofemina is not an "abortion pill".

You may already be pregnant if:

• • Your period is more than 5 days late or you had unusual bleeding at the time of your following period;
• • You have had unprotected sexual intercourse more than 72 hours previously, and since your last period.

The use of Levofemina is not advised if:

• • You have a disease of the small intestine (such as Crohn’s disease) that could interfere with the absorption of the drug;
• • You have severe liver problems;
• • You have a history of ectopic pregnancy (when the baby develops outside the womb);
• • You have a history of salpingitis (inflammation of the fallopian tubes).

A previous ectopic pregnancy or previous infection of the fallopian tubes increases
the risk of an additional ectopic pregnancy.

In all women, emergency contraception should be taken as soon as possible after unprotected sexual intercourse. There is evidence that Levofemina may be less effective as body weight or body mass index (BMI) increases, but these data were limited and inconclusive. Therefore, Levofemina is still recommended for all women, regardless of their weight or BMI.

It is advisable to speak to a healthcare professional if you have any concerns related to taking emergency contraception.

Children and adolescents

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

If you are concerned about sexually transmitted diseases

If you have not used a condom (or if it has broken or moved from its correct position) during sexual intercourse, you may have contracted a sexually transmitted disease or the HIV virus. This medicine will not protect you against sexually transmitted diseases, only condoms can do so. Consult your doctor, nurse, family planning clinic or pharmacist if you are concerned about this possibility.

Other medicines and Levofemina

Tell your doctor or pharmacist if you are taking, have recently taken or might start taking any other medicines.

Some medicines may stop Levofemina from working effectively. If you have taken any of the following medicines in the previous 4 weeks, Levofemina may not be as suitable for you. Your doctor may prescribe another type of emergency (non-hormonal) contraceptive, i.e. a copper intrauterine device (Cu-IUD). If this is not an option for you or if you cannot see your doctor straight away, you can take a double dose of Levofemina:

• • Barbiturates and other medicines used to treat epilepsy (for example, primidone, phenytoin and carbamazepine).
• • Medicines used to treat tuberculosis (for example, rifampicin, rifabutin).
• • Some treatments for HIV (ritonavir, efavirenz).
• • A medication used to treat fungal infections (griseofulvin).
• • Herbal remedies containing St. John's wort (Hypericum perforatum).

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

Talk to your doctor as soon as possible after taking the tablets for further advice on a reliable regular form of contraception and to rule out pregnancy. (See also section 3 "How to take Levofemina" for further advice).

Levofemina may also affect the way some other medicines work

• • A medicine called cyclosporine (suppresses the immune system).

How often can you take Levofemina

You should only take Levofemina in emergencies and not as a regular method of contraception. If Levofemina is taken more than once in a menstrual cycle, it is less reliable and more likely to disrupt your menstrual cycle (period).

Levofemina does not work as well as regular methods of contraception. Your doctor, nurse or family planning doctor can tell you about the long-term contraception methods that are most effective for preventing pregnancy.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should not take this medicine if you are already pregnant. If you become pregnant even after taking this medicine, it is important that you talk to your doctor. There is no evidence that Levofemina will harm a baby developing in the womb if you take Levofemina as described.

However, your doctor may want to check that the pregnancy is not ectopic (where the baby develops somewhere outside the womb). This is especially important if you develop severe abdominal pain after taking Levofemina or if you have previously had an ectopic pregnancy, fallopian tube surgery or pelvic inflammatory disease.

Breastfeeding

The active substance in this medicine is excreted in breast milk. Therefore, it is suggested that you take your tablet immediately after breast-feeding, then avoid breast-feeding for at least 8 hours after Levofemina administration and extract your breast milk with a pump 8 hours after taking the tablet. This way, you will be taking your tablet in the correct way prior to the following feed and reducing the amount of the active substance your baby may be exposed to through your breast milk.

Fertility

Levofemina increases the chance of menstrual disorders, which can sometimes lead to ovulation occurring before or after the anticipated date, resulting in a change in the fertility window. Although there are no long-term fertility data, a rapid return to fertility after Levofemina treatment is expected and therefore regular contraception should be continued or started as soon as possible after taking Levofemina.

Driving and operating machinery

Your Levofemina tablet is unlikely to affect your ability to drive a car or operate machinery. However, if you feel tired or dizzy, do not drive or operate machinery.

Levofemina contains lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is practically "sodium-free".

Take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are unsure, check with your doctor or pharmacist.

• • Levofemina can be taken at any time during your menstrual cycle, as long as you are not pregnant or think you may be pregnant. Do not chew the tablet, swallow it whole with water.
• • If you are taking one of the medicines that can prevent Levofemina from working effectively (see the section above entitled "Other medicines and Levofemina"), or if you have taken any of those medicines in the previous 4 weeks, Levofemina may not work effectively for you. Your doctor may prescribe another type of emergency (non-hormonal) contraceptive, i.e. a copper intrauterine device (Cu-IUD). If this is not an option for you or if you cannot see your doctor immediately, you can take a double dose of Levofemina (i.e. 2 tablets taken together at the same time).
• • If you are already using a regular method of contraception such as the contraceptive pill, you can continue to take it at the usual time.

If you have unprotected sexual intercourse again after taking Levofemina (also if it occurs during the same menstrual cycle), the tablet will not work as a contraceptive and there is a further risk of pregnancy.

You should talk to a healthcare professional if you have any concerns regarding the use of emergency contraception.

What to do if you experience vomiting

If you vomit within three hours of taking your tablet, you should take another
tablet immediately.

After you have taken Levofemina

If you want to have sexual intercourse after taking Levofemina and you are not using the contraceptive pill, you should use condoms or a female condom plus spermicide until your next menstrual period. This is because Levofemina will not work if you have unprotected sexual intercourse again before your next period.

After taking Levofemina, it is advisable to make an appointment to see your doctor about three weeks later to make sure that it has been effective. If your period is more than 5 days late or unusually light or very heavy, you should see your doctor as soon as possible. If you become pregnant even after taking this medicine, it is important that you see your doctor.

Your doctor may also tell you about the long-term methods of contraception that are most effective for preventing pregnancy.

If you continue to use regular hormonal contraception methods like the contraceptive pill and do not lose menstrual blood in the pill-free interval, see your doctor to check if you are pregnant.

Your next period after taking Levofemina

After using Levofemina, your period is usually normal and will start on the usual day, but sometimes it may be a few days later or earlier. If your period starts more than 5 days later than the expected date, or if "abnormal" bleeding occurs at this time or you think you may be pregnant, you should check if you are pregnant using a pregnancy test.

If you take more Levofemina than you should

Although there have been no reports of serious side effects from taking too many tablets at the same time, you may feel nauseous or even experience vomiting or vaginal bleeding. You should check with your pharmacist, doctor, nurse or family planning clinic, especially if you have vomited, as the tablet may not have worked properly.

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible side effects are listed below according to how common they are:

Very common (may affect more than 1 in 10 people):

• • Feeling nauseous
• • You may have some irregular bleeding until your next period
• • You may have pain in the lower abdomen
• • Tiredness
• • Headache

Common (can affect up to 1 in 10 people):

• • Vomiting. If you experience vomiting, read the section "What to do if you experience vomiting";
• • Your period may be different. Most women will have a normal period at the expected time, but some may have their period later or earlier than normal. You may also experience some irregular bleeding or vaginal microbleeding until your next period. If your period is more than 5 days late or is unusually light or very heavy, you should see your doctor as soon as possible;
• • After taking this medicine, you may have tender breasts, diarrhoea, or feel dizzy.

Very rare side effects (may affect up to 1 in 10,000 people):

• • Skin rash, hives (itchy rash), pruritus (itching), facial edema, pelvic pain, painful menstruation.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to INFARMED, I.P. using the contact information indicated below. By reporting side effects, you can help provide more information on the safety of this medicine.

Website: http://www.infarmed.pt/web/infarmed/submissaoram
(preferably)
or at the following addresses:
Direção de Gestão do Risco de Medicamentos
Parque da Saúde de Lisboa, Av. Brasil 53
1749-004 Lisbon
Tel: +351 21 798 73 73
Medicine Helpline: 800222444 (free)
email: farmacovigilancia@infarmed.pt

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date indicated on the outer packaging. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Levofemina contains

The active substance is levonorgestrel. Each tablet contains 1.5 mg of levonorgestrel.

The other ingredients are microcrystalline cellulose, lactose monohydrate, poloxamer 188, croscarmellose sodium and magnesium stearate.

What Levofemina looks like and contents of the pack

Each pack contains a complete treatment course of one round, biconvex, white tablet, marked "C" on one side and "1" on the other.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Towa Pharmaceutical, S. A.
Av. do Forte, 3, Edif. Suécia IV, Piso 0,
2794-093 Carnaxide
Portugal

Manufacturer:
Laboratorios Leon Farma, S.A.
C/ La Vallina, s/n, Polígono Industrial Navatejera,
24193 Villaquilambre (León),
Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Portugal: Levofemina

Spain: Levofemina

Detailed and up-to-date information on this medicine is available by scanning the 2D code printed on the pack with a smartphone. The same information is also available at the following URL: https://www.tolifeotc.com/levofemina.

This leaflet was last revised in February 2026.