KALLYA 1.5 mg TABLET

Introduction

Package Leaflet: Information for the User

Kallya 1.5 mg tablet

levonorgestrel

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this package leaflet or as your pharmacist has told you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What Kallya 1.5 mg tablet (hereafter Kallya) is and what it is used for
2. What you need to know before taking Kallya
3. How to take Kallya
4. Possible side effects
5. Storage of Kallya
6. Contents of the pack and further information

1. What is Kallya and what is it used for

Kallya is an emergency contraceptive that can be used within 72 hours (3 days) after unprotected sex or if your regular contraceptive method has failed.

It is used in the following cases:

• If you did not use contraception during sex.
• If your contraceptive was not used correctly, for example if the condom broke, slipped, or was used incorrectly, if the diaphragm was displaced or perforated, or if the withdrawal method failed (e.g., semen was ejaculated into the vagina or onto the external genitalia).

Kallya contains the active substance levonorgestrel, a synthetic hormone. It prevents approximately 84% of expected pregnancies when taken within 72 hours after unprotected sex. It does not always prevent pregnancy and is more effective the sooner it is taken after unprotected sex. It is best to take it within the first 12 hours, rather than delaying until the third day.

Kallya may work by:

• preventing the ovaries from releasing an egg;
• preventing sperm from fertilizing any egg that may have been released.

Kallya can only prevent you from becoming pregnant if taken within 72 hours after unprotected sex. It does not work if you are already pregnant. If you have unprotected sex after taking Kallya (even during the same menstrual cycle), the medicine will not have a contraceptive effect, and you will be at risk of pregnancy again.

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

2. What you need to know before taking Kallya

Do not take Kallya:

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

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine.

If any of the following apply to you, tell your doctor before taking this medicine, as emergency contraception may not be suitable for you. Your doctor may prescribe a different type of emergency contraception (non-hormonal), such as a copper intrauterine device (IUD).

If you are pregnant or think you might be pregnant. This medicine will not work if you are already pregnant. If you are pregnant, this medicine will not interrupt the pregnancy, so it is not an "abortion pill".

You might already be pregnant if:

• your period is more than 5 days late, or you have had unusual bleeding when your next period was due;
• you have had unprotected sex since your last period and more than 72 hours have passed.

This medicine is not recommended if:

• you have a disease of the small intestine (such as Crohn's disease) that impairs drug absorption;
• you have severe liver problems;
• you have a history of ectopic pregnancy (when the fertilized egg implants outside the uterus);
• you have a history of salpingitis (inflammation of the fallopian tubes).

A previous ectopic pregnancy or salpingitis increases the risk of another ectopic pregnancy.

In all women, emergency contraception should be taken as soon as possible after unprotected sex. There is some evidence that this medicine may be less effective with increasing body weight or body mass index (BMI), but these data were limited and inconclusive. Therefore, this medicine is recommended for all women, regardless of their weight or BMI.

You are advised to talk to a healthcare professional if you are concerned about any issues related to emergency contraception.

Girls and adolescents

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

If you are concerned about sexually transmitted diseases

If you did not use a condom (or it broke or slipped) during sex, you may have acquired a sexually transmitted disease or HIV.

This medicine will not protect you against sexually transmitted diseases; only the use of condoms can do that.

Talk to your doctor or pharmacist or visit a family planning center for advice if you are concerned about this.

Other medicines and Kallya

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Some medicines may prevent this medicine from working effectively. If you have used any of the following medicines in the last 4 weeks, this medicine may be less suitable for you. Your doctor may prescribe a different type of emergency contraception (non-hormonal), such as a copper intrauterine device (IUD). If this is not an option for you or if you cannot see your doctor quickly, you can take a double dose of this medicine:

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

Talk to your doctor or pharmacist if you need more information about the correct dose for you.

Talk to your doctor as soon as possible after taking the tablets, so they can inform you about reliable methods of regular contraception and avoid pregnancy. (See also section 3 "How to take Kallya" for more information).

This medicine may also affect the proper functioning of other medicines.

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

How often can you use Kallya

You should only use this medicine in emergency situations and never as a regular contraceptive method. If you use this medicine more than once during the same menstrual cycle, its effectiveness is reduced, and you may experience changes in your menstrual cycle (period).

This medicine does not work as well as regular contraceptive methods. Your doctor, nurse, or family planning center can advise you on long-term contraceptive methods that are more effective in preventing pregnancy.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, talk to your doctor or pharmacist before using this medicine.

Pregnancy

You should not take this medicine if you are pregnant. If you become pregnant after taking this medicine, it is important that you see your doctor. The data available do not indicate that this medicine can harm the embryo if used as advised.

However, your doctor may want to confirm that your pregnancy is not ectopic (when the fertilized egg implants outside the uterus). This is especially important if you experience severe abdominal pain after taking this medicine or if you have had an ectopic pregnancy, fallopian tube surgery, or pelvic inflammatory disease.

Breastfeeding

The active substance 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 administration of levonorgestrel; then express and discard the milk for the next 8 hours. This way, you will be taking your tablet well before the next feed and reducing the amount of active substance that your child could ingest with the breast milk.

Fertility

This medicine increases the possibility of changes in your menstrual cycle, which can sometimes lead to earlier or later ovulation, modifying your fertility window. Although there are no long-term fertility data, after treatment with Kallya, a rapid return to fertility is expected, and you should continue or start using regular contraceptive methods as soon as possible after using this medicine.

Driving and using machines

It is unlikely that this medicine will affect your ability to drive or use machines. However, if you feel tired or dizzy, do not drive or use machinery.

Kallya contains lactose and sodium

This medicine contains lactose (43.3 mg of lactose). If your doctor has told you that you have an intolerance to some sugars, talk to them before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take Kallya

Follow the instructions for taking the medicine exactly as described in this package leaflet or as your doctor or pharmacist has told you. If you are unsure, ask 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 sex. Do not delay taking the tablet. The medicine works better the sooner it is taken after unprotected sex. It can only prevent you from becoming pregnant if taken within 72 hours after unprotected sex.

• You can take this medicine at any time during your menstrual cycle, except if you are already pregnant or think you might be pregnant. Take the whole tablet with a little water and do not chew it.
• If you are using one of the medicines that may prevent this medicine from working correctly (see section "Other medicines and Kallya") or if you have used one of these medicines in the last 4 weeks, this medicine may be less effective for you. Your doctor may prescribe a different type of emergency contraception (non-hormonal), such as a copper intrauterine device (IUD). If this is not an option for you or if you cannot see your doctor quickly, you can take a double dose of this medicine (i.e., 2 tablets taken at the same time).
• If you are already using a regular contraceptive method, such as the pill, you can continue taking it as usual.

If you have unprotected sex again after taking this medicine (even during the same menstrual cycle), the tablet will not have a contraceptive effect, and you will be at risk of pregnancy again.

You are advised to talk to a healthcare professional if you are concerned about any issues related to taking emergency contraceptives.

What to do if you vomit

If you vomit within 3 hours of taking the tablet, you should take another tablet as soon as possible.

After taking Kallya

If you want to have sex after taking this medicine and you are not using a regular contraceptive method, you should use condoms or a diaphragm with spermicide until your next period, as this medicine will not work if you have unprotected sex again before your next period.

After taking this medicine, it is recommended that you make an appointment to see your doctor about 3 weeks later to confirm that you are not pregnant. If your period is more than 5 days late or is unusually light or heavy, you should talk to your doctor as soon as possible. If you become pregnant after taking this medicine, it is important that you see your doctor.

Your doctor will also advise you on long-term contraceptive methods that are more effective in preventing pregnancy.

If you continue to use hormonal contraception, such as the pill, and do not have a period during the week when you are not taking the pill, see your doctor to ensure you are not pregnant.

Your next period after taking Kallya

After using this medicine, your period usually starts on the expected date; however, it may start a few days earlier or later. If your period is more than 5 days late or you experience unusual bleeding, you should take a pregnancy test.

If you take more Kallya than you should

Although no serious harmful effects have been observed after taking several tablets at once, you may feel dizzy, vomit, or experience vaginal bleeding. You should talk to your doctor or pharmacist or visit a family planning center for advice, especially if you have vomited, as the tablet may not have worked properly.

In case of overdose or accidental ingestion, talk to your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, stating the medicine and the amount taken.

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

4. Possible side effects

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

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

• Nausea
• Irregular bleeding until the next period
• Lower abdominal pain
• Fatigue
• Headache

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

• Vomiting. If you vomit, read the section "What to do if you vomit".
• 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 usual. You may also experience irregular bleeding or spotting until your next period. If your period is more than 5 days late or is unusually light or heavy, you should talk to your doctor as soon as possible.
• Increased breast tenderness, diarrhea, or dizziness after taking this medicine.

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

• Rash, urticaria, itching, swelling of the face, pelvic pain, painful menstruation.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Kallya

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

Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date is the last day of the month shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. If you are unsure, ask your pharmacist how to dispose of the packaging and unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Kallya

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

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

Appearance and packaging

Each pack contains a complete treatment of 1 round, white tablet, approximately 6 mm in diameter, and marked with a "C" on one side and a "1" on the other.

Marketing authorization holder

Apotheke Laboratorios, S.L.

Paseo de la Castellana 40, 8th floor

28046 - Madrid

Spain

Manufacturer

Laboratorios León Farma, S.A.

c/ La Vallina s/n, Navatejera Industrial Estate

24193 - Villaquilambre, León

Spain

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

Netherlands: Levonorgestrel 1.5 Focus, tablets

Poland: Nopregy

Portugal: Ivolen

Romania: Emergana 1.5 mg tablets

Spain: Kallya 1.5 mg tablets

Date of last revision of this package leaflet: December 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/