Estradiol tablets (Julina) are a natural source oral preparation of 17 β - estradiol, used to treat estrogen deficiency related conditions and regulate the endometrial environment in reproductive assistance technology by supplementing the physiological deficiency of endogenous estrogen.

1、 Drug name

1. Common name: Estradiol

2. Product Name: ジェリ\Nana ® (Julina)

2、 Indications

This product is suitable for treating the following conditions:

1. The following symptoms accompany menopausal disorders and ovarian deficiency: vascular motor nerve symptoms (hot flashes, excessive sweating), vaginal atrophy symptoms.

2. Postmenopausal osteoporosis.

3. The starting period of regulating controlled ovarian stimulation in assisted reproductive technology.

4. Hormone supplementation cycle in frozen thawed embryo transfer.

3、 Specifications and characteristics

1. Specification: Each tablet contains 0.5mg of estradiol.

2. Appearance: This product is a light gray yellow film coated tablet with a diameter of 6 millimeters, a thickness of 2.85 millimeters, and a mass of 82 milligrams.

3. Identification: The tablet is printed with the "HM" identification code.

4、 Main components

1. Active ingredient: estradiol.

2. Additives: lactose hydrate, corn starch, pre gelatinized starch, polyvinylpyrrolidone, magnesium stearate, hydroxypropyl methylcellulose, polyethylene glycol 6000, talcum powder, titanium oxide, yellow ferric oxide, ferric oxide.

5、 Usage and dosage

1. Menopausal disorders and symptoms of ovarian deficiency: Adults usually take 0.5mg orally once a day. It can be increased to 1.0mg orally once a day depending on the situation.

2. Postmenopausal osteoporosis: Adults usually take 1.0mg orally once a day.

3. Adjust the start period of ovarian stimulation: usually once a day, orally take 0.5 or 1.0mg, continuously take for 21-28 days, and use progesterone in the second half of the administration.

4. Hormone supplementation cycle for frozen thawed embryo transfer: usually 0.5-4.5mg orally per day. After the endometrium is fully thickened, progesterone is used in combination. This medication continues until around 8 weeks of pregnancy. The single dose should not exceed 2.0mg.

6、 Dose adjustment

1. The dosage of this product needs to be adjusted according to specific indications and the patient's response to treatment.

2. When used for menopausal symptoms, it can start from 0.5mg. If the therapeutic effect is insufficient, it can be increased to 1.0mg under the guidance of a doctor.

3. When used for frozen thawed embryo transfer, the dosage range is wide (0.5-4.5mg/day) and needs to be personalized according to indicators such as endometrial thickness.

4. Regardless of the indication, the lowest effective dose that can achieve therapeutic effects should be used to avoid long-term and aimless use.

7、 Medication precautions

1. Timing of administration: Usually taken orally once a day, it is recommended to take it at a fixed time every day.

2. Forgetting to take medication (missing medication): If you forget to take medication, you should immediately take it when you remember. But if the next dose is approaching, the missed dose should be skipped and the next dose should be taken at the normal time. You should not take twice the dose at once.

3. Vomiting after taking medication: Vomiting may occur shortly after taking medication, and the medication may not be fully absorbed. It should not be taken again and should be taken according to the normal plan for the next dose.

4. Women who have not had their uterus removed: In principle, it must be combined with progesterone to prevent endometrial cancer.

8、 Medication for special populations

1. Pregnant women: Prohibited for use on pregnant or potentially pregnant women.

2. Breastfeeding women: Medication is prohibited. It is known that estradiol can be transferred to human milk.

3. Children: Not applicable.

4. Elderly people: Medication should be administered with caution while observing the patient's condition. The clinical trial excluded individuals aged 75 and above.

5. Patients with liver dysfunction:

Patients with severe liver damage: medication is prohibited.

Patients with liver damage (except severe cases): may worsen liver damage.

6. Patients with renal function damage: excessive administration may lead to fluid retention and worsen the condition.

7. Other patients who need careful medication: endometriosis, hysteromyoma, hypertension, heart disease, migraine, epilepsy, diabetes, breast cancer high-risk patients, etc.

9、 Adverse reactions

1. Serious adverse reactions:

Venous thromboembolism and thrombophlebitis (incidence unknown).

2. Other adverse reactions:

Reproductive system: genital secretions, genital bleeding, discomfort in the external genitalia and vagina, cervical polyps, etc.

Breast: discomfort, breast pain, nipple pain, breast cyst, breast disease.

Digestive system: bloating, abdominal pain, nausea, constipation, abdominal discomfort, diarrhea, gastritis.

Mental nervous system: dizziness, headache, insomnia, decreased sensation (numbness in limbs, etc.).

Circulating system: elevated blood pressure, palpitations.

Other: Swelling, increased triglycerides in the blood, increased TSH, fatigue, eczema, etc.

10、 Contraindications

The following patients are prohibited from using this product:

1. Estrogen dependent malignant tumors (such as breast cancer, endometrial cancer) and those suspected of having such tumors.

2. Untreated patients with endometrial hyperplasia.

3. Have a history of breast cancer.

4. Individuals with thrombophlebitis, pulmonary embolism, or a history of such conditions.

5. Individuals with arterial thromboembolic diseases (such as coronary heart disease, stroke) or a history of such diseases.

6. Breastfeeding women.

7. Patients with severe liver damage.

8. Diagnose patients with undetermined abnormal genital bleeding.

9. Individuals with a history of allergies to the ingredients of this medication.

10. Pregnant or potentially pregnant women.

11、 Drug interactions

This product is mainly metabolized by the drug metabolizing enzyme CYP3A4. When used in combination with the following drugs, attention should be paid:

1. Drugs that increase the blood concentration of this product include macrolide antibiotics (such as erythromycin), imidazole antifungal drugs (such as ketoconazole), triazole antifungal drugs (such as itraconazole), and HIV protease inhibitors (such as ritonavir). When used together, the effect may be enhanced.

2. Drugs that reduce the blood concentration of this product include rifampicin, barbiturates (such as phenobarbital), carbamazepine, and non nucleoside reverse transcriptase inhibitors (such as nevirapine and efavirenz). The effect may be weakened when used together.

3. St. John's Wort: Foods containing this ingredient may cause changes in the blood concentration of this product.

12、 Storage method

1. Please store out of reach of children.

2. PTP packaged drugs should be taken by patients after being removed from the PTP board to prevent damage to the esophageal mucosa caused by ingestion.

13、 Manufacturer

1. Manufacturer/Distributor: Bayer AG

2. Address: 4-9 Umeda 2-chome, Kita ku, Osaka City, Japan

Julinainformation