Medication info
Gibez Tablet

Gibez Tablet

Prescription medicationTablet경구
Ingredient · strength
Drospirenone›3mg / 1 tabletEthinyl Estradiol›0.02mg / 1 tablet
Manufacturer / importer
알보젠코리아(주)
Appearance
Placebo tablet - white or off-white, convex, round, film-coated tablet Active tablet - pink, convex, round, film-coated tablet
Packaging
28 tablets/box [(28 tablets/PTP)]
Approval status
Active

MFDS item code 202201788 · Approved 2022.05.03

Summary

Main use
Contraception in women and treatment of premenstrual dysphoric disorder and dysmenorrhea
Who takes it
Adults
Adult dose
This medication is to be taken as one pink tablet once daily for 24 days during the menstrual cycle, followed by four days of white or off-white tablets. It can be initiated on the first day of the menstrual cycle (Day 1 start) or on the first Sunday after the start of the menstrual cycle (Sunday start). For first-time users, take one pink tablet starting from Day 1 of menstrual onset or from the first Sunday, for 24 consecutive days, followed by four days of placebo tablets.

Ingredients

Manufacturer
알보젠코리아(주)

Efficacy & effects

Contraception in women and treatment of premenstrual dysphoric disorder and dysmenorrhea

  • Symptoms of premenstrual dysphoric disorder
  • moderate acne
  • dysmenorrhea
View approved original text

This medication demonstrates contraceptive effects in women and is also used for the treatment of symptoms of premenstrual dysphoric disorder and dysmenorrhea. Additionally, it is utilized for the treatment of moderate acne in females who have started menstruating after age 14, where contraception is not contraindicated. In summary, this medication is used for various symptoms related to women's contraception and acne improvement.

How to take

Adult dose

This medication is to be taken as one pink tablet once daily for 24 days during the menstrual cycle, followed by four days of white or off-white tablets. It can be initiated on the first day of the menstrual cycle (Day 1 start) or on the first Sunday after the start of the menstrual cycle (Sunday start). For first-time users, take one pink tablet starting from Day 1 of menstrual onset or from the first Sunday, for 24 consecutive days, followed by four days of placebo tablets.

Precautions

This medication requires special caution in women who smoke. Smoking significantly increases the risk of serious cardiovascular adverse effects, such as thrombosis, when taking this medication. In particular, women over 35 years of age who smoke more than 15 cigarettes a day should not take this medication. The drospirenone component in this medication can raise serum potassium levels, so it is contraindicated in patients with renal or liver impairment or those with hyperkalemia risk. Moreover, women who are taking other medications that can elevate serum potassium levels must have their serum potassium levels tested before starting this medication. This medication should only be used for the treatment of moderate acne and for birth control purposes in females over 14 who have begun menstruating, and only when there are no contraindications for taking oral contraceptives. It should not be taken before menarche. To reduce cardiovascular risks, it is essential to discontinue use immediately if any symptoms related to thrombosis occur, and to stop taking this medication 4 weeks before and 2 weeks after any surgery. It is advisable to avoid starting this medication within 4 weeks after delivery. Oral contraceptives containing drospirenone carry a slightly higher risk of venous thromboembolism compared to other contraceptives, thus individual risk must be assessed before taking it. Those with a history of estrogen-dependent tumors or thromboembolic diseases, severe hypertension, liver or kidney dysfunction, adrenal dysfunction, liver tumors, severe metabolic disorders, pregnant women or those who may become pregnant, and lactose intolerant patients should not take this medication. For women over 40, patients with epilepsy, a family history of breast cancer, a history of depression, patients with severe heart and mind failure, gallbladder disorders, endometriosis, asthma, headaches, or certain specific conditions or symptoms, careful consideration should be taken before administering this medication. Various adverse reactions such as thrombosis, high blood pressure, liver tumors, gallbladder disease, gastrointestinal symptoms, breast changes, mental changes, skin rashes, etc. may occur when taking this medication, and immediate consultation with a physician is advised if any abnormal symptoms arise. When taken as an oral contraceptive, regular monitoring of blood pressure, breast exams, pelvic exams, etc. is essential, and it is important to evaluate risk factors based on family and personal history. It is safer to avoid taking this medication in cases of thromboembolism and cardiovascular disease risk. Moreover, there may be interactions with other medications, so it is essential to inform healthcare providers of any ongoing medications. In case of sudden bleeding, severe headaches, or vision changes, the medication should be stopped immediately and medical attention should be sought.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough + fever, jaundice (yellowing of skin or eyes), extreme fatigue throughout the body, sudden and very severe headaches, lightning-like headaches, seizures, confusion of consciousness, vision disturbances, paralysis, urination issues

Mild side effects

Nausea, vomiting, gastrointestinal symptoms, persistent bleeding, petechiae, changes in menstrual cycle, amenorrhea, edema, persistent melasma, breast changes (breast pain, enlargement, nipple discharge, breast tenderness, breast secretion), weight changes (increase or decrease), uterine changes, decreased lactation right after delivery, jaundice, migraine, rash (allergic), mental depression, reduced glucose tolerance, vaginal candidiasis, changes in corneal curvature, discomfort with contact lenses, mood changes

Not everyone experiences these, and they can vary from person to person.

Storage

This medication must be stored in a tightly sealed container to prevent air or moisture from entering. Additionally, when storing this medication, it is best to keep it at room temperature, maintaining a temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Placebo tablet - white or off-white, convex, round, film-coated tablet Active tablet - pink, convex, round, film-coated tablet

Package unit

28 tablets/box [(28 tablets/PTP)]

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.