Kallya 1.5 mg tablet
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Kallya 1.5 mg tablet
levonorgestrel
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your pharmacist has instructed you.
- Keep this leaflet, as you may need to read 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 effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Kallya 1.5 mg tablet (hereinafter Kallya) is and what it is used for
- What you need to know before taking Kallya
- How to take Kallya
- Possible adverse effects
- Storage of Kallya
- Contents of the pack and other information
1. What Kallya is and what it is used for
Kallya is an emergency contraceptive that can be used within 72 hours (3 days) after having unprotected sex or if the regular contraceptive method has failed.
It is used in the following cases:
- If no contraceptives were used during sexual intercourse.
- If the contraceptive was not used correctly, for example if the condom broke, slipped, or was used incorrectly, if the diaphragm was displaced, or if it was perforated, torn, or removed too early, or if withdrawal during coitus interruptus failed (e.g., sperm was ejaculated into the vagina or onto the external genitals).
Kallya contains as its active ingredient a synthetic hormone called levonorgestrel. 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 will not work if you are already pregnant. If you have unprotected sex after taking Kallya (including if this occurs during the same menstrual cycle), the medicine will not provide contraceptive protection and there is again a risk of pregnancy.
Kallya is not indicated for use before the first menstrual bleeding (menarche).
2. What you need to know before taking Kallya
Do not take Kallya:
If you are allergic to levonorgestrel or to 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 another type of emergency contraceptive.
If you are pregnant or think you may be pregnant. This medicine will not work if you are already pregnant. If you are already pregnant, this medicine will not interrupt the pregnancy, so this medicine is not an "abortion pill".
You may already be pregnant if:
- your period is more than 5 days late, or you have had abnormal bleeding around the time your next period was expected;
- you have had unprotected sex after your last period and more than 72 hours have passed.
This medicine is not recommended if:
- you have a small intestine disorder (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 a history of fallopian tube infection 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 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 consult a healthcare professional if you have concerns about any issues related to emergency contraception.
Children and adolescents
This medicine is not indicated for use before the first menstrual bleeding (menarche).
If you are concerned about sexually transmitted infections
If you did not use a condom (or it broke or slipped off) during sex, you may have contracted a sexually transmitted infection (STI) or HIV.
This medicine will not protect you against sexually transmitted infections, as only condom use can do so.
Talk to your doctor, pharmacist, or family planning clinic 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 need to take any other medicines, including those obtained without a prescription.
Some medicines may prevent this medicine from working effectively. If you have taken any of the following medicines within the last 4 weeks, this medicine may be less suitable for you. Your doctor may prescribe another type of emergency contraception (non-hormonal), that is, a copper intrauterine device (Cu-IUD). If this is not an option for you or you cannot see your doctor quickly, a double dose of this medicine may be taken:
- 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 medicines containing St John's wort (Hypericum perforatum).
Consult your doctor or pharmacist if you need further information about the correct dose for you.
Consult your doctor as soon as possible after taking the tablets, so you can be advised about reliable methods of regular contraception to prevent pregnancy. (See also section 3 “How to take Kallya” for more information.)
This medicine may also affect how other medicines work.
- a medicine called cyclosporine (which suppresses the immune system).
How often you can 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 decreases and menstrual cycle disturbances (period) may occur.
This medicine is not as effective as regular contraceptive methods. Your doctor, nurse, or family planning clinic can advise you on long-acting contraceptive methods that are more effective at preventing pregnancy.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not take this medicine if you are pregnant. If you become pregnant after taking this medicine, it is important to see a doctor. Available data do not indicate that this medicine can cause harm to the embryo when used as directed.
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 ever had an ectopic pregnancy, fallopian tube surgery, or pelvic inflammatory disease.
Breastfeeding
The active ingredient in 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; during the 8 hours following tablet intake, express milk with a breast pump and discard it. This way, you take the tablet well before the next feeding, reducing the amount of active ingredient that your baby might ingest through breast milk.
Fertility
This medicine may cause menstrual disturbances, which can sometimes lead to earlier or delayed ovulation, thereby altering the timing of fertility. Although there are no long-term fertility data, fertility is expected to return rapidly after treatment with Kallya, so 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 operate 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 certain sugars, consult with 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 exactly the instructions for taking this medicine as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, 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 having unprotected sex. Do not delay taking the tablet. The medicine is more effective the sooner it is taken after unprotected sex. It can only prevent pregnancy if taken within 72 hours after unprotected intercourse.
- You may take this medicine at any time during your menstrual cycle, except if you are already pregnant or think you may be pregnant. Swallow the tablet whole with a little water and do not chew it.
- If you are taking any of the medicines that may reduce the effectiveness of this medicine (see section “Other medicines and Kallya”) or if you have taken any of these medicines within the last 4 weeks, this medicine may be less effective for you. Your doctor may prescribe you another type of emergency contraception (non-hormonal), i.e. a copper intrauterine device (Cu-IUD). If this is not an option for you or if you cannot see your doctor promptly, you may 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 oral contraceptives, you may continue taking it as usual.
If you have unprotected sex again after taking this medicine (even if it occurs during the same menstrual cycle), the tablet will not provide contraceptive protection and there is again a risk of pregnancy.
It is recommended that you consult a healthcare professional if you have concerns about any issues related to the use of emergency contraception.
What to do if you vomit
If you vomit within three hours of taking the tablet, you should take another tablet immediately.
After taking Kallya
If you wish to have sex after taking this medicine and you are not using oral contraceptives, you must use condoms or a diaphragm with spermicide until your next menstrual period, as this medicine will not work if you have unprotected sex again before your next period.
After taking this medicine, it is advisable to schedule an appointment with your doctor about three weeks later to confirm that you are not pregnant. If your period is delayed by more than 5 days or is unusually light or heavy, you should contact your doctor as soon as possible. If you become pregnant after taking this medicine, it is important that you consult your doctor.
Your doctor will also advise you on long-acting contraceptive methods that are more effective in preventing pregnancy.
If you continue using your regular hormonal contraception such as oral contraceptives and do not have bleeding during the pill-free interval, consult your doctor to ensure that you are not pregnant.
Your next period after taking Kallya
After using this medicine, your period is usually normal and will start on the expected day; however, sometimes it may occur a few days earlier or later. If your period starts more than 5 days later than expected, if you experience "abnormal" bleeding at that time, or if you think you might be pregnant, 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 experience dizziness, vomiting, or vaginal bleeding. You should consult your doctor or pharmacist or visit your 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
Very common (may affect more than 1 in 10 people):
- Nausea
- Irregular bleeding until the next menstrual period
- Pain in the lower abdomen
- Tiredness
- 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 earlier or later than usual. You may also experience irregular bleeding or spotting until your next period. If your period is delayed by more than 5 days, or is unusually light or heavy, you should contact your doctor as soon as possible.
- Increased breast tenderness, diarrhoea, or dizziness after taking this medicine.
Very rare adverse effects (may affect up to 1 in 10,000 people):
- Rash, urticaria, itching, facial swelling, pelvic pain, painful menstruation.
Reporting of 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 leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 on the blister after EXP. The expiry date refers to the last day of the month indicated.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE Point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of any unused medicines and their packaging. This will help protect the environment.
6. Contents of the container and additional information
Composition of Kallya
The active substance is levonorgestrel. Each tablet contains 1.5 mg of levonorgestrel.
The other components are: microcrystalline cellulose, monohydrate lactose, poloxamer 188, sodium croscarmellose, and magnesium stearate.
Appearance of the medicinal product and content of the container
Each pack contains one complete treatment consisting 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 floor
28046 - Madrid
Spain
Manufacturer
Laboratorios León Farma, S.A.
C/ La Vallina s/n, Polígono Industrial Navatejera
24193 - Villaquilambre, León
Spain
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Netherlands: Levonorgestrel 1,5 Focus, tabletten
Poland: Nopregy
Portugal: Ivolen
Romania: Emergana 1.5 mg comprimate
Spain: Kallya 1.5 mg comprimidos
Date of the most recent revision of this leaflet: December 2023
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/