Label: information for the user

Kallya 1.5 mg tablet

levonorgestrel

Read this label carefully before starting to use this medication, as it contains important information for you.

Always take this medication exactly as described in this label or as told by your pharmacist.

• Keep this label, as you may need to refer to it again.
• If you need advice or more information, consult your doctor or pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

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

It is used in the following cases:

• If no contraceptives were used during sex.
• If the contraceptive was not used properly, for example if the condom broke, slipped, or was used incorrectly, if the diaphragm was moved incorrectly, if it was perforated, broken, or removed too early, or if the withdrawal method failed (e.g., semen was ejaculated into the vagina or external genitals).

Kallya contains a synthetic hormone called levonorgestrel as its active ingredient. It prevents approximately 84% of expected pregnancies when taken within 72 hours after having unprotected sex. It does not always prevent pregnancy and is more effective if taken as soon as possible after having unprotected sex. It is better to take it within the first 12 hours rather than delaying it until the third day.

Kallya may work:

Kallya can only prevent pregnancy if taken within 72 hours after having unprotected sex. It does not work if you are already pregnant. If you have unprotected sex again after taking Kallya (even if this occurs during the same menstrual cycle), the medication will not exert its contraceptive effect and the risk of pregnancy returns.

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

Do not take Kallya:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

If any of the following points affect you, inform your doctor before taking this medication as emergency contraception may not be suitable for you. Your doctor may prescribe another type of emergency contraceptive.

If you are pregnant or think you may be. This medication will not work if you are already pregnant. If you are already pregnant, this medication does not interrupt the pregnancy, so this medication is not an "abortive pill".

You may already be pregnant if:

• Your period has been delayed for more than 5 days, or if you have had abnormal bleeding when your next period was due;
• After your last period, you have had unprotected sex and more than 72 hours have passed.

This medication is not recommended if:

• You have a disease of the small intestine (such as Crohn's disease) that inhibits the absorption of the drug;
• 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 a new ectopic pregnancy.

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

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

Girls and adolescents

This medication is not indicated for use before the first menstrual bleeding (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 medication will not protect you against sexually transmitted diseases, as only the use of a condom can do so.

Consult your doctor or pharmacist or at your family planning center for advice if you are concerned about this.

Other medications and Kallya

Inform your doctor or pharmacist if you are taking or have recently taken any other medication, including those obtained without a prescription.

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

• Barbiturates and other medications used to treat epilepsy (e.g., primidone, phenytoin, and carbamazepine),
• Medications used to treat tuberculosis (e.g., rifampicin and rifabutin),
• Treatment for HIV (ritonavir, efavirenz),
• A medication for fungal infections (griseofulvin),
• Medications based on plants containing St. John's Wort (Hypericum perforatum),

Consult your doctor or pharmacist if you need additional information about the correct dose for you.

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

This medication may also affect the proper functioning of other medications.

• A medication called cyclosporine (inhibits the immune system).

How often can you use Kallya

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

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

You should not take this medication if you are pregnant. If you become pregnant after taking this medication, it is essential to see your doctor. The available data do not indicate that this medication can cause harm to 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 medication or if you have ever had an ectopic pregnancy, tubal surgery, or pelvic inflammatory disease.

Breastfeeding

The active ingredient in this medication is excreted in breast milk. Therefore, take the pill immediately after feeding your baby and avoid breastfeeding for at least 8 hours after administering levonorgestrel; then express milk with a breast pump during the 8 hours after taking the pill, and discard it. In this way, you are taking your pill well before the next feeding and reducing the amount of active ingredient that your baby may ingest with breast milk.

Fertility

This medication increases the likelihood of changes in menstruation that may sometimes lead to advancing or delaying ovulation, thereby modifying the date of fertility. Although there are no long-term fertility data, it is expected that fertility will return quickly after treatment with Kallya, and therefore, regular contraceptive methods or initiation of them as soon as possible after using this medication should be continued.

Driving and operating machinery

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

Kallya contains lactose and sodium

This medication contains lactose (43.3 mg of lactose). If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

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

Follow exactly the administration instructions of the medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, 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 having unprotected sex. Do not delay taking the tablet. The medication works best as soon as you take it after having unprotected sex. You can only prevent pregnancy if you take it within 72 hours after having unprotected sex.

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

If you have unprotected sex again after taking this medication (also if this occurs during the same menstrual cycle), the tablet will not exert its contraceptive effect and there is again a risk of pregnancy.

We recommend that you consult a healthcare professional if you are concerned about any problem related to taking emergency contraceptives.

What to do in case of vomiting

If you vomit before three hours have passed since taking the tablet, you must take another tablet immediately.

After taking Kallya

If you want to have sex again after taking this medication, and you are not using oral contraceptives, you must use condoms or a diaphragm with spermicide until your next menstruation, since this medication will not work if you have unprotected sex again before your next menstruation.

After taking this medication, it is recommended to schedule an appointment to see your doctor three weeks later to confirm that you are not pregnant. If your menstruation is delayed by more than 5 days or is exceptionally light or heavy, you should contact your doctor as soon as possible. If you become pregnant after taking this medication, it is essential that you consult your doctor.

Your doctor will also advise you about long-lasting contraceptive methods that are more effective to prevent pregnancy.

If you continue using hormonal contraceptives, such as oral contraceptives, and do not have bleeding during the period when you do not take the contraceptive, go to your doctor to ensure that you are not pregnant.

Your next period after taking Kallya

After using this medication, your period usually will be normal and will start on the expected day; however, in some cases, it may start a few days earlier or later. If your period starts more than 5 days later than expected, if there is abnormal bleeding at that time, or if you think you may be pregnant, a pregnancy test should be performed.

If you take more Kallya than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

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

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

• Vomiting. If you experience vomiting, read the section “What to Do in Case of 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 usual. You may also experience irregular or spotting bleeding until your next period. If your period is delayed by more than 5 days or is exceptionally light or heavy, you should contact your doctor as soon as possible.
• Increased breast tenderness, diarrhea, or dizziness after taking this medication.

Rare adverse effects (may affect up to 1 in 10,000 people):

• Exanthema, urticaria, pruritus, facial swelling, pelvic pain, painful menstruation.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging and on the blister pack after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Kallya Composition

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

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

Product appearance and packaging contents

Each package contains the complete treatment of 1 round, white tablet, approximately 6 mm in diameter, 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

28046 - Madrid

Spain

Responsible 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 with 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

Last review date of this leaflet: December 2023

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/