Indications
Oral contraception
Usage
Each package contains 26 colored active tablets and 2 white inactive tablets. Take one tablet daily at approximately the same time, with a small amount of water, regardless of meals. When used correctly, the failure rate of combined oral contraceptives is approximately 1% per year. The likelihood of an unwanted pregnancy increases if the medication is missed or used incorrectly.
Preparing the Package
To facilitate pill intake control, the package includes 7 strips of stickers with the days of the week. Choose the strip that starts with the day corresponding to the start of the medication (e.g., for Wednesday, use the strip starting with “Wed”). Stick the strip on top of the Klaira package where indicated (“Stick the strip here”), so the first day of intake is above tablet number 1. Follow the arrows to take the tablets one by one until all 28 are finished.
Menstrual-like Bleeding
Usually, menstrual-like bleeding begins with the intake of the second dark red tablet or the white tablet and may not end before starting a new pack. Some women may experience bleeding even after starting the new pack. Do not take a break before starting the new pack; begin the next pack the day after finishing the current one, even if the bleeding continues. This ensures the new pack starts on the same day of the week each month, maintaining contraceptive efficacy, including during the intake of inactive tablets.
Starting Qlaira
Without prior hormonal contraceptives: Start on the first day of the menstrual cycle (first day of menstrual bleeding).
Switching from another combined oral contraceptive, vaginal ring, or transdermal patch: Begin Klaira the day after taking the last active tablet of the previous combined oral contraceptive. Do not take inactive tablets from the previous pack. For vaginal rings or transdermal patches, start Klaira the day the device is removed, or as advised by a doctor.
Switching from progestin-only methods (mini-pills, injections, implants) or intrauterine system: Start Klaira the day after stopping mini-pills, on the day of implant removal, or when the next injection is due. Use additional barrier methods for the first 9 days of Klaira intake.
After a miscarriage: As advised by a doctor.
After childbirth: Start Klaira after the first physiological menstrual cycle. If sexual intercourse has occurred, exclude possible pregnancy or wait for menstruation before starting. Consult a doctor when breastfeeding or uncertain about the start date.
Missing a Tablet
Inactive tablets: Missing a white tablet (2 at the end of the pack) does not require taking it later. Take the next tablet on time and remove the missed inactive tablets from the pack.
Active tablets (1–26 tablets): Depending on the menstrual cycle day of the missed tablet, additional contraception might be needed. If the delay is less than 12 hours, take the missed tablet as soon as possible and continue the next tablets at the usual time. If the delay is more than 12 hours, contraceptive efficacy may decrease. Follow the instructions based on the specific day of the cycle (see also the guidelines for missed tablets).
Guidelines for Missed Tablets
More than one active tablet missed: Consult a doctor.
One active tablet missed:
Days 1–9: Consult a doctor.
Days 10–17: Take the missed tablet, continue the next tablets at the usual time, use additional contraception for the next 9 days.
Days 18–24: Do not take the missed tablet, start a new pack, use additional contraception for the next 9 days.
Days 25–26: Take the missed tablet, continue the next tablets at the usual time, no additional contraception needed.
Days 27–28: Do not take the missed tablet, continue the next tablets at the usual time, no additional contraception needed.
Do not take more than 2 active tablets in a day. If the start of the next pack is missed, or ≥1 tablet is missed between days 3–9 of the current pack, consult a doctor due to the increased risk of pregnancy.
Vomiting or Severe Diarrhea
During vomiting or severe diarrhea within 3–4 hours of taking active tablets, follow the instructions for missed tablets. Severe diarrhea requires consulting a doctor. Vomiting or diarrhea during the intake of inactive tablets does not affect contraceptive efficacy.
Stopping Qlaira
Stop taking Qlaira at any time. To conceive, wait for the next menstrual bleeding before attempting conception to help determine the due date.
Contraindications
Do not use Qlaira if any of the following conditions exist:
Deep vein thrombosis, pulmonary embolism, or other thrombosis.
Acute coronary syndrome or cerebrovascular accident.
Prodromal symptoms of acute coronary syndrome or cerebrovascular accident.
Migraine with focal neurological symptoms.
Diabetes with vascular complications.
Pancreatitis with hyperlipidemia.
Liver disease until liver function normalizes.
Hormone-dependent tumors of genital organs or breasts.
Benign or malignant liver tumors.
Unexplained vaginal bleeding.
Known or suspected pregnancy.
Hypersensitivity to estradiol valerate, dienogest, or other components.
Special Instructions
Do not use calendar or temperature methods as they may be unreliable. Qlaira does not protect against HIV (AIDS) or other sexually transmitted diseases. Regular monitoring is required for certain conditions, including smoking, diabetes, obesity, hypertension, heart valve disease, varicose veins, migraine, epilepsy, family history of hypercholesterolemia, breast cancer, liver or gallbladder disease, Crohn’s disease, systemic lupus erythematosus, hemolytic uremic syndrome, sickle cell anemia, alopecia, porphyria, herpes infection, Sydenham’s chorea, chloasma, and hereditary angioedema.
Stop Qlaira immediately if signs of thrombosis or stroke occur. Irregular vaginal bleeding may occur in the first few months. If used incorrectly, or if there is significant vomiting or diarrhea, or if expected bleeding does not occur twice in a row, consult a doctor.
Pregnancy and Breastfeeding
Do not use during pregnancy or if suspected. Stop Qlaira before planning a pregnancy. Not recommended during breastfeeding.
Children
No data on the use in children under 18 years.
Effects on Reaction Speed
No data on the effect on driving or using machinery.
