Package leaflet: Information for the user

Protleva 1.5 mg tablets

Levonorgestrel
Equivalent medicine
Read this entire leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Protleva is and what it is used for
What you need to know before taking Protleva
How to take Protleva
Possible side effects
How to store Protleva
Contents of the pack and other information

1. What Protleva is and what it is used for

Protleva is an emergency contraceptive that can be used within 72 hours (3 days) after unprotected sexual intercourse, or in case of failure of your usual contraceptive method.
This applies in the following situations:

No form of contraception was used during sexual intercourse.
The contraceptive method was not used correctly; for example, if the condom broke, slipped off, or was used incorrectly; if the vaginal pessary (a rubber, plastic or silicone ring used as a contraceptive device) or diaphragm moved out of place, burst, broke, or was removed too early; or in case of failure to withdraw in time with interrupted intercourse (e.g. ejaculation of sperm into the vagina or onto the external genitals).

This medicine contains a synthetic active substance similar to a hormone called levonorgestrel.
It prevents approximately 84% of expected pregnancies if taken within 72 hours after unprotected sexual intercourse.
It may not always be able to prevent pregnancy, and it is more effective when taken as soon as possible after unprotected intercourse. It is advisable to take it within 12 hours, rather than delaying administration until the third day.
Protleva is believed to work by:

preventing the ovaries from releasing an egg;
preventing sperm from fertilizing an egg already released by the ovaries.

This medicine can prevent pregnancy only if taken within 72 hours after unprotected sexual intercourse. It is not effective if pregnancy has already occurred. If another unprotected sexual intercourse occurs after taking Protleva (even if this happens during the same menstrual cycle), the tablet will not provide contraceptive protection and there is again a risk of pregnancy.
The use of Protleva is not indicated before the first menstrual period (menarche).

2. What you need to know before taking Protleva

Do not take Protleva

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

Warnings and precautions
If any of the following situations apply to you, consult your doctor before taking this medicine,
as emergency contraception may not be suitable for you. Your doctor may prescribe you
an alternative type of emergency contraception.

If you are pregnant or suspect you may be pregnant. This medicine will have no effect if pregnancy has already occurred. If you are already pregnant, Protleva cannot terminate the pregnancy; therefore, this medicine is not an "abortion pill".

You may already be pregnant if:

your menstrual period is more than 5 days late, or you have had unusual vaginal bleeding around the time your next period was expected
you had unprotected sexual intercourse more than 72 hours ago and since your last menstrual period

The use of this medicine is not recommended if:

you suffer from a small intestine disorder (such as Crohn's disease) that impairs absorption of the medicine
you have severe liver problems
you have had ectopic pregnancies in the past (pregnancies where the embryo develops outside the uterus)
you have previously suffered from salpingitis (inflammation of the fallopian tubes).

If you have had a previous ectopic pregnancy or previous infection of the fallopian tubes, the risk
of another ectopic pregnancy increases.
In all women, emergency contraception should be taken as soon as possible after unprotected intercourse.
There is evidence that levonorgestrel (the active substance in this medicine)
may be less effective with increasing body weight or body mass index (BMI),
but these data are limited and not conclusive. Therefore, Protleva is still recommended for
all women regardless of their weight or BMI.
If you are concerned about any issues related to taking emergency contraception,
consult your doctor or a healthcare provider.
Children and adolescents
The use of this medicine is not indicated before the first menstrual period (menarche).
If you are concerned about the risk of sexually transmitted infections
If you did not use a condom (or if it broke or slipped off) during sexual intercourse,
you may have contracted a sexually transmitted infection or HIV.
This medicine will not protect you from sexually transmitted infections: only condoms
can provide such protection. If this concerns you, consult your doctor, nurse,
family planning clinic, or pharmacist.
Other medicines and Protleva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines, including those without a prescription or herbal medicines.
Some medicines can prevent Protleva from working effectively. If you have taken any
of the medicines listed below within the last 4 weeks, this medicine may be less suitable for you.
Your doctor may prescribe you another type of emergency contraception (non-hormonal),
such as a copper intrauterine device (Cu-IUD). If this is not an acceptable option for you
or if you cannot see a doctor promptly, take a double dose of Protleva.

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

Consult your doctor or pharmacist if you need further advice on the appropriate dose of medicine
for you.
After taking the tablets, consult your doctor as soon as possible to obtain further advice
on how to use regular and reliable contraception and to rule out pregnancy. (See also section 3 How to take Protleva for further information).
Protleva may also affect how other medicines work

a medicine called cyclosporine (which suppresses the immune system).

How often can you use Protleva
Protleva should only be used in emergency situations and not as a regular method of contraception. If
this medicine is used more than once in the same menstrual cycle, it is less reliable and more likely
to affect your menstrual cycle (periods).
Protleva is not as effective as regular contraceptive methods. Your doctor, nurse, or
family planning clinic can inform you about long-term contraceptive methods that are
more effective in preventing pregnancy.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding,
consult your doctor or pharmacist before taking any medicine.
Pregnancy
Do not take this medicine if you are already pregnant. If you become pregnant despite taking this
medicine, it is important that you see a doctor. There is no evidence that levonorgestrel is
harmful to the developing fetus in the womb if you take this medicine according to the
instructions. Nevertheless, your doctor may wish to check that you do not have an ectopic pregnancy
(a pregnancy where the embryo grows outside the uterus). This is particularly important if
you experience severe abdominal pain after taking this medicine, or if you have previously had
an ectopic pregnancy, surgery on the fallopian tubes, or pelvic inflammatory disease.
Breastfeeding
The active ingredient of this medicine is excreted in breast milk. Therefore, it is recommended that
you take the tablet immediately after breastfeeding and avoid breastfeeding for at least 8 hours
after taking levonorgestrel, and collect and discard breast milk with a pump 8 hours after taking the tablet.
This way, you will take the tablet well before the next breastfeeding session and reduce the amount of active ingredient that your baby might receive through breast milk.
Fertility
This medicine may increase the likelihood of menstrual cycle disturbances, which can sometimes lead to
earlier or delayed ovulation, thereby altering the fertile period. Although there are
no data on long-term fertility, normal fertility is expected to return rapidly after treatment with levonorgestrel; therefore, after using Protleva, regular contraception should be continued or started as soon as possible.
Driving and using machines
It is unlikely that this medicine will affect your ability to drive or use machines. However, do not drive or operate machinery if you feel tired or dizzy.
Protleva contains lactose (a type of sugar)
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking
this medicine.
3 How to take Protleva
Take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed. If you have any doubts, consult your doctor or pharmacist.

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 sooner the tablet is taken after unprotected intercourse, the more effective it is. It can only prevent pregnancy if taken within 72 hours of unprotected intercourse.
This medicine can be taken at any time during the menstrual cycle, provided you are not already pregnant or think you may be. Do not break or chew the tablets. Swallow the tablet whole with water.
If you are taking any of the medicines that may prevent Protleva from working properly (see section above Other medicines and Protleva), it may be less effective for you. Your doctor may prescribe you another type of emergency contraception (non-hormonal), such as a copper intrauterine device (Cu-IUD). If this is not an acceptable option for you or if you cannot see a doctor promptly, take a double dose of Protleva (i.e. 2 tablets taken together at the same time).
If you are already using a regular contraceptive method, such as the pill, you may continue taking it at your usual times.

If you have another unprotected sexual intercourse after using Protleva (even within the same
menstrual cycle), the tablet will have no contraceptive effect and there will again be a risk of pregnancy.
If you are concerned about any issues related to taking emergency contraception,
consult your doctor or a healthcare provider.
What to do in case of vomiting
If you vomit within three hours of taking the tablet, you must take another tablet immediately.
After taking Protleva
After taking Protleva, if you wish to have sexual intercourse and are not using the contraceptive pill,
you must use condoms or a diaphragm with spermicide until your next menstrual period.
This is because Protleva will have no effect if you have another unprotected sexual intercourse before
your next period.
After taking this medicine, it is advisable to make an appointment with your doctor about three
weeks later to confirm that the medicine has worked. If your period is delayed by
more than 5 days, or is unusually light or heavy, contact your doctor as soon as possible. If
you become pregnant despite taking this medicine, it is important that you see a doctor.
Your doctor can also advise you on longer-term contraceptive methods that are more
effective in preventing pregnancies.
If you continue using your regular hormonal contraception, such as the pill, and your period does not occur during the usual pill-free interval, see your doctor to rule out pregnancy.
Your next menstrual cycle after taking Protleva
After using this medicine, your menstrual flow is usually normal and starts on the expected day; however, sometimes your period may be a few days earlier or later. If your period is delayed by more than 5 days compared to the expected date, if you notice 'abnormal' vaginal bleeding around that time, or if you think you may be pregnant, you should perform a pregnancy test to check whether you are pregnant.
If you take more Protleva than you should
Although no serious harmful effects have been reported from taking too many tablets at once, you may feel unwell, become sick (vomit), or experience vaginal bleeding. Consult your pharmacist, doctor, nurse, or family planning clinic, especially if you have vomited, as in this case the tablet may not have worked properly.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Very common (may affect more than 1 in 10 people):

Feeling unwell (nausea)
Possible irregular bleeding until the next menstrual period
Possible lower abdominal pain
Tiredness
Headache

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

Vomiting. If you have vomited, read the section 'What to do in case of vomiting'.
Your menstrual period may be different than usual. Most women will have normal bleeding at the expected time, but in some cases the period may be delayed or come earlier. Irregular bleeding or spotting may also occur until the next menstrual period. If your period is more than 5 days late, or is unusually light or heavy, contact your doctor as soon as possible.
After taking this medicine, you may experience breast pain, diarrhoea, dizziness.

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

Rash, urticaria, itching, facial swelling, pelvic pain, painful menstruation, abdominal pain.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Protleva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Protleva contains
The active substance is levonorgestrel. Each tablet contains 1.5 milligrams of levonorgestrel.
The other ingredients are: potato starch, maize starch, anhydrous colloidal silica (E 551), magnesium stearate (E 470b), talc (E 553b) and monohydrate lactose.

Description of the appearance of Protleva and contents of the pack
Protleva 1.5 mg tablets are white to off-white, round, flat-surfaced tablets with bevelled edges, marked with the code "J06" on one side and plain on the other.
Protleva is available in PVC/aluminum blisters containing one tablet. The blister is packed in a cardboard carton.

Marketing Authorization Holder and Manufacturer
Aristo Pharma GmbH
Wallenroder Strasse 8-10,
13435 Berlin
Germany.

Manufacturer
Pharmadox Healthcare Limited
Kw20a Kordin Industrial Park
PLA 3000 Paola
Malta

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: Protleva
Netherlands: Levonorgestrel Aristo 1.5 mg tabletten
Germany: Levonorgestrel Adalvo 1.5 mg Tabletten
Spain: Levonorgestrel Adalvo 1.5 mg comprimidos EFG